Chinese General Practice

Chinese Guideline for Use of Essential Medicines in Palliative and Hospice Care　

General Practice Branch of Cross-Strait Medicine Exchange Association

2021, 24(14): 1717-1734. DOI: 10.12114/j.issn.1007-9572.2021.00.418

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Palliative and hospice care are medical specialities that provide multidisciplinary supports to help improve painful physical and/or mental symptoms to improve the quality of life till passing away with dignity and comfort in patients of all ages in the end or terminal stage of various incurable conditions.Rational use of medicines is one of the essential components in palliative and hospice care.Therefore，the guideline panel initiated the first Chinese Guideline for Use of Essential Medicines in Palliative and Hospice Care based on relevant research and clinical practice following the international criteria for guideline development.Focusing on 33 physical，mental and refractory symptoms of diseases affecting the whole body and various systems commonly seen in patients with terminal conditions，this guideline recommends 23 medicines for symptom control，20 of which are included in the current National Essential Medicines List.To facilitate the accessibility of medical workers for reference，the guideline describes in detail the fundamental theories of palliative and hospice care，principles of clinical prescription，as well as matters about rational usage，dosage and precautions of related drugs.This guideline helps to improve the quality of care for end-stage patients in various clinical specialities，basically ensuring that they can obtain care with comfort and dignity，and filling a gap in domestic development of palliative and hospice care.

Comparative Analysis of the New Coronavirus Pneumonia Treatment Guidelines Issued by the US NIH in 2021 and the New Coronavirus Pneumonia Treatment Plans Issued by China　

LI Shuren，ZHAO Wenjing，LI Jianchao，MENG Yang，HAO Xiao，ZHANG Qianhui

2021, 24(14): 1735-1744. DOI: 10.12114/j.issn.1007-9572.2021.00.498

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At present，the new coronavirus pneumonia （COVID-19） has swept most countries in the world. At present，there is no specific medicine and targeted treatment methods for it. The medication treatment mainly aimed to suppress the excessive activation of the immune system and support organ after anti-virus treatment. This article compared the treatment methods according to National Institute of Health（NIH） and Chinese recommendations for diagnosis and treatment of novel coronavirus （SARS-CoV-2） infection（Trial 8th version），in order to provide a theoretical basis for clinicians in the treatment of COVID-19.

The Latent Class of Clinical Subtypes of Obstructive Sleep Apnea and the Analysis of Characteristics of Initial Exposure to CPAP Therapy　

QIU Jian，CHENG Jinxiang1REN Jiafeng，SUN Shuyu，ZHAO Xianchao，JIANG Yingcong，SU Changjun

2021, 24(14): 1745-1751. DOI: 10.12114/j.issn.1007-9572.2021.00.161

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Background　Obstructive sleep apnea（OSA）is a highly heterogeneous disorder，and different subtypes suggest different characteristics.In the previous study，we found that there was significant diversity of initial exposure to continuous positive airway pressure（CPAP）therapy among OSA physiologic phenotypes.However，a detailed description for this problem is lacking in current at home and abroad.Objective　To use latent class analysis to explore the clinical subtypes of OSA patients，and to analyze the differences of diagnostic polysomnography（PSG）before and after initial exposure to CPAP therapy among different subtypes.Methods　The study retrospectively analyzed data for 491 OSA patients who underwent initial exposure to CPAP therapy at the Tangdu Hospital Sleep Medicine Center from January 2011 to December 2016.22 kinds of clinical symptoms：difficulty falling asleep，multiple awaking，early awaking，snoring，apnea，sudden awaking with breath holding，nightmare，dreamtalk，enuresis，limb twitching during sleep，morning headache，dizziness，anxiety，depression，cognition dysfunction，lack of concentration，confusion，impaired reaction time，work impairment，palpitation，fatigue and daytime sleepiness were included in the latent category analysis model.Then the symptoms distribution，sleep characteristics of diagnostic PSG and responses to initial CPAP therapy among different subtypes were compared.Results　A model with four phenotype clusters provided the best fit：cluster 1 "apnea with daytime sleepiness group"（143 cases，29.1%），cluster 2 " minimally symptomatic group "（189 cases，38.5%），cluster 3 "severely impaired daytime function group"（64 cases，13.0%）and cluster 4 "combined with insomnia group"（95 cases，19.3%）.The average age of cluster 2 " minimally symptomatic group " was younger and have a higher proportion of men，while the opposite result of cluster 4 "combined insomnia group".Statistical differences were observed among all the OSA symptoms（P<0.05），with the exception of apnea.There were statistically significant differences for sleep latency（SL），N1%，N2%，N3%，REM% of diagnostic PSG among four subtypes（P<?0.05）.These differences for total sleep in time（TST），sleep efficiency（SE），N1%，N2%，N3%，REM%，wake after sleep onset（WASO），oxygen desaturation index（ODI），time spent at pulse oxygen saturation（SpO2）below 90%，the lowest SpO2（LSpO2），average SpO2 after initial exposure to CPAP treatment were also statistically significant（P<?0.05）.Conclusion　The clinical symptoms of OSA can be divided into four clinical subtypes by latent class analysis，and initial exposure to CPAP treatment of four clinical subtypes is statistically different.These findings emphasize the need to identify a series of OSA clinical symptoms and carry out individualized treatment.

ZHAO Tiefu，WANG Shengyu，ZHANG Chunxiao，ZHANG Ming，CHEN Hong，MA Hanying

2021, 24(14): 1752-1757. DOI: 10.12114/j.issn.1007-9572.2021.00.499

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Background　Coronary artery bypass grafting has become an important treatment for coronary artery disease（CHD）．With the improvement of surgical techniques and instruments，more than 30 000 cases of CHD receive this procedure every year in China，and the number is increasing．Post-procedure levels of physiological indicators have been well noted，while problems related to psychological rehabilitation have been ignored by clinicians previously．Objective　To investigate the effect of exercise intervention on health-related quality of life in middle-aged patients after off-pump coronary artery bypass grafting（OPCAB）．Methods　A total of 348 middle-aged patients with OPCAB were selected from the single operation group from Department of Cardiac Surgery，Beijing Anzhen Hospital，Capital Medical University from January 2014 to June 2017，and divided into exercise group（144 cases）and control group（204 cases）according to whether they could meet the exercise criteria 6 to 18 months after surgery．Two groups were compared at postoperative 6 and 18 months，respectively，in terms of ejection fraction（EF）and left ventricular end-diastolic diameter（LVEDD），the scale sore and domain scores 〔physical functioning（PF），physical role functioning（RP），bodily pain（BP），general health perceptions（GH），vitality（VT），social role functioning（SF），emotional role functioning（RE），mental health（MH）〕 and physical component summary（PCS）and mental component summary（MCS）scores of the 36-Item Short Form Health Survey（SF-36）．Results　At 6 months after operation，there were no significant differences in the mean values of EF and LVEDD，mean scores of PF，RP，BP，GH，VT，SF，RE，MH，PCS and MCS，as well as the scale score of the SF-36 between the two groups（P>0.05）．Eighteen months after operation，except the mean value of LVEDD was still similar in both groups（P>0.05），other 12 indictors in the exercise group were all much better than those in the control group（P<0.05）．Compared to the results of 6 months post-procedure，the mean value of LVEDD decreased significantly and mean scores of other 12 indicators increased significantly at 18 months post-procedure in both groups（P<0.05）．Conclusion　In middle-aged patients after OPCAB，the standard exercise intervention may significantly improve the health-related quality of life．

Antithrombotic Therapies for Patients with Nonvalvular Atrial Fibrillation：a Single-center Comparative Analysis and Recommendations　

XIE Huanglie，HAN Pengyu，ZHENG Chaoyang，ZHU Wei，TAO Wenxiang，WANG Hengkun

2021, 24(14): 1758-1763. DOI: 10.12114/j.issn.1007-9572.2021.00.157

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Background　Nonvalvular atrial fibrillation（AF）is a common clinical arrhythmia disease，and AF-related stroke is one of its commonest complications.Available relevant clinical studies mainly focus on antithrombotic therapies or the achievement of antithrombotic goals in coronary heart disease（CHD）patients with AF，but rarely compare the long-term safety and efficacy of different therapies.Objective　To compare the efficacy，safety and one-year AF-related endpoint events of different antithrombotic therapies in nonvalvular AF patients，regardless of age and by age group.Methods　The included 354 nonvalvular AF inpatients were recruited from Department of Cardiovascular，Guangdong Provincial Hospital of Chinese Medicine from January to October 2018.Information was collected，including gender，age，type of AF（paroxysmal，perpetual，persistent，long-standing persistent），complications（stroke/ transient ischemic attack，heart failure，hypertension，diabetes，CHD，hyperlipidemia），cTnT，CHA2DS2-VASc score，and HAS-BLED score.Also，the incidence of thromboembolic events，hemorrhagic events，all-cause deaths and readmission within one-year follow-up period was obtained.The efficacy and safety were compared between groups treated with non-antithrombotic regimen（42 cases），aspirin（21 cases），clopidogrel（51 cases），dual antiplatelet therapy（25 cases），warfarin（49 cases），dabigatran（89 cases）and rivaroxaban（89 cases）.And these regimens' efficacy and safety were further analyzed based on age group﹝<65 age group（60 cases），65-75 age group（92 cases），>75 age group（202 cases）﹞.Results　The proportion of men in dual antiplatelet therapy group was higher than that in non-antithrombotic regimen group（P<0.05）.The average age of warfarin group was younger than that of clopidogrel group（P<0.05）.Paroxysmal AF prevalence in rivaroxaban group was lower than that in dual antiplatelet therapy group（P<0.05）.CHD prevalence in non-antithrombotic group was lower than that of clopidogrel group or dual antiplatelet therapy group，and so did that in warfarin group（P<0.05）.CHD prevalence in dual antiplatelet therapy group was higher than that of rivaroxaban group or dabigatran group（P<0.05）.The average cTnT level of dual antiplatelet therapy group was higher than that of other five groups（P<0.05）.Clopidogrel group had higher average HAS-BLED score than dabigatran group（P<0.05）.The groups treated with different regimens showed statistically significant differences in the incidence of thromboembolic events within one-year follow-up（χ2=12.404，P=0.054）.They also showed statistically obvious differences in the incidence of bleeding events within one-year follow-up（χ2=14.420，P=0.019）.But they demonstrated similar incidence of all-cause deaths（χ2=9.925，P=0.128）.The readmission rate of patients in three age groups was significantly different（P<0.05）.Conclusion　Early identification of AF and timely antithrombotic therapy are of great significance in preventing thromboembolism.New oral anticoagulants（NOAC）or warfarin may be the first choice for antithrombotic treatment of nonvalvular AF.NOAC is not inferior to warfarin in preventing thrombosis and bleeding，but the risk of gastrointestinal bleeding should be paid attention to.For elderly AF patients，individualized anticoagulant therapy may be more effective.

Changes of Electrocardiographic Repolarization Indices in Patients with Coronary Chronic Total Occlusion after Successful Revascularization　

QIU Xin，YU Xiaofan，YE Qing，ZHOU Junling，CHEN Hongwu，MA Likun

2021, 24(14): 1764-1769. DOI: 10.12114/j.issn.1007-9572.2021.00.466

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Background　Previous studies have pointed out that the improvement of clinical symptoms of patients with coronary chronic total occlusion（CTO） can be achieved after the percutaneous coronary intervention（PCI）.However，which ECG repolarization index is associated with the improvement，is still less known，and relevant studies are rare.Objective To investigate the changes of ECG repolarization indices after PCI for CTO between patients with single-vessel and multi-vessel CTO，providing objective electrophysiological evidence for CTO-PCI in patients with different types of CTO.Methods　We enrolled 249 patients with successful CTO-PCI（residual coronary stenosis after CTO-PCI <30% and antegrade coronary flow > TIMI grade 3） from Cardiovascular Department，the First Affiliated Hospital of USTC during May 2017 to May 2019，including 192 with single-vessel CTO and 57 with multi-vessel（two- or three-vessel） CTO divided by the number of occluded main coronary artery（including the anterior descending branch，circumflex branch and the right coronary artery）.Heart rate，Rentrop's classification for coronary collaterals，corrected QT interval（QTc），QT dispersion，T wave peak-to-end interval，the number of patients with improved T-wave，and post-PCI 6-month follow-up NYHA class as well as the incidence of major adverse cardiac events（MACEs） were compared between the groups.Results　There was no predominant difference in Rentrop's classification for coronary collaterals between the groups（P>0.05）.Patients with multi-vessel CTO had shorter average QTc and higher rate of having improved T-wave than those with single-vessel CTO（P<0.05）.Postoperative follow-up showed that there was statistically significant difference in MACEs incidence between the groups（P<0.05）.Conclusion　After revascularization，improvement was obtained in the repolarization indices in all patients with CTO，which was more obvious in those with multi-vessel CTO.The clinical benefit may derive from the dual improvement of increased cell viability and dispersion indices of repolarization.

Influencing Factors of Treatment Outcome of Chronic Heart Failure in Primary Hospitals　

REN Lixia，JIA Xu，WANG Zhihao，ZHANG Wei，ZHONG Ming，MA Xiao

2021, 24(14): 1769-1775. DOI: 10.12114/j.issn.1007-9572.2021.00.474

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Background　The treatment outcome of chronic heart failure during hospitalization is affected by many factors.Previous research mostly focused on the provincial hospital，but rarely focused on primary hospital.Objective　To explore the influencing factors of the treatment outcome of chronic heart failure（CHF）treated in primary hospitals.Methods　339 inpatients diagnosed with CHF of gradeⅡ-Ⅳby New York Heart Association（NYHA）classification in Zaozhuang Central District People's Hospital during June 2012 to July 2018 were selected as the research objects.They were divided into improvement group（n=320）and deterioration group（n=19）according to treatment outcome.The data of gender，age，admission factors，medical history，diagnosis，imaging examination，cardiac ultrasound，biochemical examination，medication，treatment outcome was collected，and the differences between the two groups was compared by unconditional Logistic regression analysis，to explore the influencing factors of the treatment outcome.The patients were divided into ≤100 mm Hg group（41 cases），100 mm Hg < systolic pressure < 130 mm Hg group（132 cases），≥130 mm Hg group（166 cases） according to the systolic blood pressure at admission and the clinical treatment outcomes in the 3 groups were compared.Results　The proportion of pulmonary infection，left ventricular end-diastolic diameter，pulmonary artery systolic blood pressure，transglutaminase，urea nitrogen，NT-proBNP，and the application rate of dobutamine in the worsening group were higher than the improvement group.The high-density lipoprotein cholesterol，prealbumin，blood sodium，blood chloride，application rate of β-blockers and statins were lower than the improvement group（P<0.05）.The results of unconditional Logistic regression analysis showed that systolic blood pressure〔OR=0.977，95%CI（0.972，0.981），P<0.001〕，pulmonary infection〔OR=4.799，95%CI（1.156，19.919），P=0.031〕，aspartate aminotransferase〔OR=1.003，95%CI（1.000，1.006），P=0.039〕，albumin 〔OR=0.910，95%CI（0.891，0.928），P<0.001〕，application rate of β-blockers 〔OR=0.202，95%CI（0.046，0.898），P=0.036〕，application rate of spironolactone〔OR=0.125，95%CI（0.066，0.235），P<0.001〕，application rate of statins 〔OR=0.307，95%CI（0.121，0.779），P=0.013〕，application rate of dobutamine 〔OR=9.173，95%CI（1.351，62.272），P=0.023〕 are the influencing factors of treatment outcome of CHF patients（P< 0.05）.In the ≤100 mm Hg group，7 cases（17.1%）deteriorated，34 cases improved（82.9%）；in the 100 mm Hg < systolic pressure <130 mm Hg group，5 cases（3.8%）deteriorated，127 cases improved（96.2%）；in the ≥130 mm Hg group，7 cases deteriorated（4.2%），159 cases（95.8%）improved.Comparison among the three groups，the differences of improvement rates of CHF patients were statistically significant（χ2=8.369，P=0.015）；the proportion of deterioration in the ≤100 mm Hg group was higher than the 100 mm Hg < systolic pressure <130 mm Hg group（χ2=6.619，P=0.010）and the ≥130 mm Hg group（χ2=6.700，P=0.010）.Conclusions　The treatment outcome of CHF in primary hospitals can be affected by many factors.Pulmonary infection，systolic blood pressure ≤100 mm Hg at admission，low albumin protein，impaired liver function，and application of dobutamine are risk factors for treatment outcome of CHF，and the use of β-blockers，spironolactone and statins are protective factors.

Semi-quantitative Urine Strip for Screening Microalbuminuria in Patients with Hypertension：an Exploratory Study　

XI Yang，WANG Hongyi，YANG Fan，SUN Ningling

2021, 24(14): 1776-1779. DOI: 10.12114/j.issn.1007-9572.2021.00.427

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Background　Microalbuminuria（MAU）is one of the markers of early renal damage in hypertension．　The urine albumin-to-creatinine ratio（ACR）has been recommended as the first choice for the detection of MAU．At present，the main detection methods of ACR include radioimmunoassay，chemiluminescence immunoassay and immunoturbidimetric assay．But these methods need special instruments and equipment as well as professional inspectors to implement，which can not be used in primary medical institutions and epidemiological investigations．Identifying a simple method to measure MAU is helpful to evaluate early renal damage in hypertensive primary care patients，and may provide an efficient tool for related epidemiological investigation．Semi-quantitative urine strip is a simple and inexpensive method for rapidly detecting MAU，which has been recommended for clinical efficacy monitoring in primary care，patient home monitoring and epidemiological investigation．However，the domestic research is less at present．Objective　The study aimed to evaluate the clinical accuracy and application value of semi-quantitative urine strip in screening for MAU，comparing with the result predicted by ACR measured by using immunoturbidimetric assay．Methods　284 hypertensive patients（aged 18-85 years）without a history of using antihypertensive drugs were recruited from Heart Center，Peking University People's Hospital from November 2016 to August 2017．Their urine samples were collected and tested with immunoturbidimetry and semi-quantitative urine strip separately for ACR．The accuracies of five categories ACR values（30-300 mg/g，50-300 mg/g，80-300 mg/g，100-300 mg/g，150-300 mg/g）tested by semi-quantitative urine strip for the diagnosis of MAU were estimated by comparing with the accuracy of ACR tested by immunoturbidimetry（the gold standard for screening MAU）in terms of sensitivity，specificity，rate of omitted diagnosis，misdiagnosis rate，Youden index and positive likelihood ratio．Results Of the five categories of ACR values for diagnosing MAU，ACR value of 100-300 mg/g had the largest Youden index（6.83%）and positive likelihood（1.25），ACR value of 150-300 mg/g had the highest specificity（75.61%）and lowest misdiagnosis rate（24.39%）．Conclusion　ACR value of 100-300 mg/g detected by semi-quantitative urine strip can be used as a semi-quantitative method for the diagnosis of MAU，which may be a tool for effectively screening for MAU in primary care with certain clinical application value．

Effect of Dihydroartemisinin on TLR-mediated MyD88-dependent Signaling Pathway in Peripheral Blood Mononuclear Cells in Patients with Rheumatoid Arthritis

YAN Huiming，AN Yan，ZHANG Xue，LIU Yongmei，QIN Jieli，LIU Yuan，WANG Wulong，YUE Jianwei，ZHAO Hong

2021, 24(14): 1780-1784. DOI: 10.12114/j.issn.1007-9572.2021.00.061

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Background　The pathogenesis of rheumatoid arthritis（RA） is complicated.Previous studies have proved that toll-like receptor（TLR） plays a key role in the development of RA，which is expressed on the surface of cells such as dendritic cells，macrophages，T cells，B cells，identifies different molecular structures of pathogens，and then raises the inflammatory cytokines and chemokines，activates intracellular signal transduction pathways，causes an autoinflammatory response in the host cell，playing an important role in autoimmune diseases.Objective　To observe the effect of dihydroartemisinin （DHA） on TLR-mediated MyD88-dependent signaling pathway of peripheral blood mononuclear cells（PBMCs） and the express of protein.Methods　From the Second Affiliated Hospital of Baotou Medical College，Inner Mongolia University of Science & Technology from October 2017 to December 2018，10 active RA patients and 10 randomly selected physical examinees from the medical examination center were enrolled.PBMCs of two groups were isolated，cultured and divided into 5 groups with 5 multiple pores in each group.（1）control group：the PBMCs of the healthy volunteers were not interfered with TLR-mediated signaling pathway.（2）RA group：the PBMCs of RA patients were not interfered with TLR-mediated signal pathway.（3）TLR2 inhibitors group：the PBMCs of RA patients were treated with TLR2 inhibitors（100 μg/L） to interfere with TLR-mediated signaling pathway.（4）Low-dose DHA group：the PBMCs of RA patients were treated with DHA（200 μmol/L） to interfere with TLR-mediated signaling pathway.（5）High-dose DHA group：the PBMCs of RA patients were treated with DHA（1 000 μmol/L） to interfere with TLR-mediated signaling pathway.The positive expression rate of TLR2，and levels of TLR2 mRNA，MyD88 mRNA，TLR2，MyD88，TNF-α and IL-6 were detected and compared among the five groups.Results　（1）The positive expression rate of TLR2 in RA group was higher than that in control or TLR2 inhibitors group （P<0.05）.The positive expression rate of TLR2 in low-dose DHA group was higher than that in high-dose DHA group （P<0.05）.（2）RA group had higher average levels of TLR2 mRNA and MyD88 mRNA than control group or TLR2 inhibitors group（P<0.05）.Low-dose DHA group had higher average levels of TLR2 mRNA and MyD88 mRNA than high-dose DHA group （P<0.05）.（3） The control group had lower average levels of TLR2 and MyD88 than each of other groups（P<0.05）.The average levels of TLR2 and MyD88 in RA group were higher than those of TLR2 inhibitors group（P<0.05）.The average levels of TLR2 and MyD88 in low-dose DHA group were higher than those of high-dose DHA group（P<0.05）.（4） The control group had lower average levels of TNF-α and IL-6 than each of other groups（P<0.05） .The average levels of TNF-α and IL-6 in RA group were higher than those of TLR2 inhibitors group（P<0.05）.The average levels of TNF-α and IL-6 in low-dose DHA group were higher than those of high-dose DHA group（P<0.05）.Conclusion　DHA may inhibit the expression of TLR2 and MyD88 in mononuclear cells of RA patients，and the levels of TNF-αand IL-6 in the supernatant，which may be related to the inhibition of the inflammatory response by the TLR4-mediated MyD88-dependent signaling pathway.

Recurrence and Associated Factors in Cured Patients with Newly Diagnosed Smear-positive Pulmonary Tuberculosis：a Follow-up Study　

LI Ying，WANG Zukang，WEI Youliang，GONG Zhihua

2021, 24(14): 1785-1789. DOI: 10.12114/j.issn.1007-9572.2021.00.510

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Background　There are chances of tuberculosis recurrence in cured patients with newly diagnosed smear-positive pulmonary tuberculosis（NDSPT），which is a major barrier to controlling the disease，and how to control it has become a key and difficult part in containing the disease.Objective　To explore the recurrence and associated factors in NDSPT patients cured by antituberculosis chemotherapy by analyzing the follow-up results.Methods　One hundred and fifteen cured patients with NDSPT treated in Department of Respiratory Medicine，the Third People's Hospital of Pingxiang City，from January 2015 to January 2018 were recruited.All of them were treated with 2HRZE/4HR as a standard antituberculosis chemotherapy for at least months，and were followed up for two consecutive years after being cured.Sputum smear microscopy for tuberculosis mycobacterium and sputum culture were performed during the follow-up and the results were collected to analyze the recurrence.Multivariate Logistic regression analysis was used to explore the factors associated with tuberculosis recurrence.Results　In total，94.8%（109/115）of the patients who were cured（sputum smear- and culture-negative）after completing the chemotherapy were finally included.The recurrence rate was 7.34%（8/109）during the follow-up，but there was no death caused by tuberculosis.The recurrence rate differed significantly by age and the time to sputum smear /culture conversion（P<0.05）.Those aged 60 or over had a higher recurrence rate than those aged 18-39 years old（P<0.05）.And those who needed more than three months to have sputum smear/culture conversion had higher recurrence rate than those who needed two months（P<0.05）.Multivariate Logistic regression analysis indicated that 60 years or older〔OR=1.768，95%CI（1.275，2.896）〕 and requiring more than three months to have sputum smear /culture conversion 〔OR=4.254，95%CI（2.983，6.415）〕 were risk factors for recurrence（P<0.05）.Conclusion　The recurrence in cured patients with NDSPT may be associated with older age，and longer time to sputum smear/culture conversion.To reduce the recurrence rate，chemotherapy regimen can be modified in accordance with the sputum test results in the short-term chemotherapy.

Effects of Electrostatic Acupoint Plaster Cranial Electrotherapy Stimulation Treatment on the Sleep Quality and Symptom Distress of Chronic Anemia Patients　

YAO Yanmei，XU Liqiong，ZHOU Youliang，FAN Fenglei，ZHAO Qiaoqiao，DING Ting

2021, 24(14): 1790-1794. DOI: 10.12114/j.issn.1007-9572.2021.00.112

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Background　Sleep disorder has become a common health issue in chronic anemia patients，and its induced impaired sleep quality may increase the level of anxiety and decrease the recovery of anemia symptoms.Drug therapy can improve sleep quality，but has a series of side effects.So nonpharmacological interventions for improving sleep quality has obtained increasing attentions from medical professionals.However，there is no enough clinical evidence that demonstrates whether the use of electrostatic acupoint plaster （EAP） cranial electrotherapy stimulation（CES） can improve the quality of sleep and efficacy of anemia treatment in this population.Objective　To explore the effect of EAP CES therapy on the sleep quality and symptom distress of chronic anemia patients.Methods　A total of 96 chronic anemia patients treated in General Practice Department，the Affiliated Hospital of Hangzhou Normal University were enrolled from November 2018 to January 2019，and were randomized into intervention group and control group with 48 cases in each.Both groups received routine therapy，the intervention group received EAP CES treatment for 8 weeks additionally.The sleep quality and symptom distress of the two groups were compared by the results measured by the improved Pittsburg Sleep Quality Index （PSQI） before and after the intervention.Results　There were no significant differences in the pre-intervention global and each component scores of the improved PSQI between the two groups （P>0.05）.After the intervention，no significant changes were found in the average global and component scores of the improved PSQI in the control group（P>0.05），but in the intervention group，except the average score of cough or snore loudly almost remained the same（P>0.05），obvious declines were found in the average global score of improved PSQI，and the average scores of bed time，hours of sleep per night，wake up easy and early，frequent urination，feel too cold and hot，had bad dreams，take medicine to help sleep，daytime sleepiness，and daytime energy deficiency（P<0.05）.In comparison with the control group，the intervention group showed lower post-intervention average global score of improved PSQI，and lower average scores of bed time，hours of sleep per night，wake up easy and early，frequent urination，feel too cold and hot，had bad dreams，take medicine to help sleep，daytime sleepiness，and daytime energy deficiency（P<0.05），but similar average score of cough or snore loudly（P>0.05）.There was no significant intergroup difference in the incidence of anemia symptoms before intervention （P>0.05），but the intervention group showed lower incidence of daytime sleepiness，fatigue，dizziness，palpitation，shortness of breath and anorexia after intervention （P<0.05）.Conclusion　EAP CES treatment may help to effectively improve sleep quality and anemia symptoms in patients with chronic anemia.

Influencing Factors for Mental Disorders Occurring in Sheehan's Syndrome Patients with Pituitary Crisis　

GUO Jiuchang，ZHANG Lin，WANG Qian，YANG Dan，ZHANG Ying，ZHANG Han，LIAO Xin，GAO Lin

2021, 24(14): 1795-1799. DOI: 10.12114/j.issn.1007-9572.2020.00.613

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Background　It is reported that mental disorders occur in some Sheehan's Syndrome（SS）patients during treatment，which is more prevalent in those with pituitary crisis，bringing difficulties to further treatment．At present，there are few studies on the influencing factors of mental disorders in patients with SS and pituitary crisis．Objective　To investigate the influencing factors of mental disorders in SS patients with pituitary crisis during treatment．Methods　A total of 47 SS patients with pituitary crisis from the Affiliated Hospital of Zunyi Medical University were enrolled from January 2010 to August 2019，and were divided into psychiatric symptoms group（PS group，n=20）and normal psychiatric symptoms group（NPS group，n=27）by the prevalence of mental disorders．Blood pressure，height and body weight，calculated BMI，and levels of parameters 〔hemoglobin，serum sodium ion，glucose，free triiodothyronine，free thyroxine，thyroid stimulating hormone，follicular hormon，luteinizing hormone，prolactin，estradiol，growth hormone，adrenocorticotropic hormone（ACTH）and cortisol〕 in the blood sample withdrawn from forearm veins，blood lipid parameters（total cholesterol and triglyceride ）in the fasting peripheral venous blood sample were collected．The dosage of hydrocortisone（HC）in the first 24 hours of treatment and the dosage of HC before the mean occurrence time of mental disorders were also collected．Binary Logistic regression was used to explore the influencing factors of mental disorders．ROC analysis was conducted to evaluate the values of serum sodium ion，HC in the first 24 hours of treatment and the combination of them in predicting mental disorders．Results　Compared with NPS group，the mean levels of systolic blood pressure and serum sodium ion in PS group were significantly decreased（P<0.05），but ACTH HC in the first 24 hours of treatment and the mean dosage of HC before the mean occurrence time of mental disorders were significantly increased（P<0.05）．Binary Logistic regression analysis showed that HC in the first 24 hours of treatment〔OR=1.066，95%CI（1.006，1.130）〕 and serum sodium ion〔OR=0.848，95%CI（0.761，0.945）〕were associated with mental disorders（P<0.05）．For predicting mental disorders，the AUC of HC in the first 24 hours of treatment was 0.756〔95%CI（0.614，0.897），P<0.01〕，with 0.750 sensitivity and 0.667 specificity when the optimal cutoff value was chosen as 135.0 mg．The AUC of serum sodium ion level was 0.744〔95%CI（0.599，0.890），P<0.01〕，with 0.741 sensitivity and 0.700 specificity when the optimal cutoff value was chosen as 119.6 mmol/L．And the AUC of the combination of these two indicators was 0.855〔95%CI（0.748，0.961），P<0.01〕，and the sensitivity and specificity were 89.9% and 65.0%，respectively．Two cases received 350 mg HC in total but without mental disorders，the first 100 mg was administered within four hours before admission，and the remaining 350 mg was administered by slow intravenous drip infusion within 20 hours after admission Conclusion　Higher dose of HC in the first 24 hours of treatment and lower level of serum sodium ion may increase the risk of mental disorders in SS patients with pituitary crisis．Starting with a small dose of hormone and controlling the rate of administration may reduce the risk of mental disorders．

Clinical Therapeutic Effect of Escitalopram Plus Chiropractic Therapy on First-episode Depression　

ZHANG Xiaomei，ZHANG Weiying2ZHANG Hongbo，YAN Yangli，ZHONG Hua

2021, 24(14): 1800-1804. DOI: 10.12114/j.issn.1007-9572.2021.00.477

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Background Antidepressant treatment may be negatively impacted by sleep disorders.Escitalopram is a first-line drug for depression，and chiropractic therapy is a TCM treatment improving quality of sleep，but the effect of the combination of the two on depression has not been reported.Objective　To investigate the clinical effect and mechanism of escitalopram plus chiropractic therapy in the treatment of first-episode depression.Methods　One hundred and ten patients with first-episode depression who were hospitalized in the psychosomatic disorders，Huzhou Third People's Hospital from May 2018 to May 2020 were selected，and equally randomized into control group and observation group.Both groups received oral administration of lexapro （escitalopram oxalate） tablets，and the observation group additionally received chiropractic therapy.The Hamilton Rating Scale for Depression（HAMD）and Pittsburgh Sleep Quality Index（PSQI）were used to evaluate the depression state，and sleep quality，respectively，at baseline and 2，4 and 8 weeks after treatment.When the 8-week treatment ended，the overall efficacy was evaluated and expression levels of T-lymphocyte subsets were measured.The adverse reactions during treatment were recorded.Results The intervention method and intervention time did not have interaction on HAMD score and PSQI score（P>0.05）.But both of them produced significant main effect on HAMD score and PSQI score（P<0.05）.In both groups，the HAMD scores assessed three times after intervention were all decreased significantly compared to baseline，and showed a successive decline along with the treatment（P<0.05）.Similar changes in the PSQI score were also found （P<0.05）.The observation group had significantly lower mean HAMD score and PSQI score than control group at each post-intervention assessment time（P<0.05）.The overall response rate of the observation group was higher than that of control group（96.36% vs 83.64%）（P<0.05）.The observation group had lower post-intervention mean level of CD8+ and higher post-intervention mean levels of CD3+，CD4+ and CD4+/CD8+ ratio than the control group（P<0.05）.No significant difference in the incidence of adverse reactions was found between the two groups（P>0.05）.Conclusion　Esmetipram combined with chiropractic therapy could effectively improve the depressive symptoms and sleep quality of patients with first-episode depression，and its mechanism may be related to the regulation of T-lymphocyte level.

Comparisin of Efficacy and Safety of One-stage LCBDE+LC and Sequential Two-stage ERCP/EST+LC in the Treatment of Cholecystolithiasis Complicated with Choledocholithiasis：a Meta-analysis　

LIN Qiuman，WANG Guiliang，WU Zaoxuan，ZHANG Xin，ZHONG Tingxi，GONG Min，LI Xing

2021, 24(14): 1805-1812. DOI: 10.12114/j.issn.1007-9572.2021.00.462

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Background　Cholecystolithiasis complicated with choledocholithias is a common disease in clinical medication.One-stage Laparoscopic common bile duct exploration（LCBDE） + laparoscopic cholecystectomy（LC） and sequential two-stage endoscopic retrograde cholangiopancreatography（ERCP）/endoscopic sphincterotomy（EST） + LC are both accepted as ideal minimally invasive treatment methods，some domastic and foreign scholars have analyzed and compared the advantages and disadvantages of the two methods，but which method is more advantagous still remains uncertain．Objective　To compare the efficacy and safety of one-stage LCBDE+LC and sequential two-stage ERCP/EST +LC in the treatment of cholecystolithiasis complicated with choledocholithiasis．Methods　Randomized controlled trials（RCTs） comparing the efficacy of one-stage LCBDE+LC and sequential two-stage ERCP/EST+LC were searched from the database including PubMed，EMBase，Web of Science，The Cochrane Library，CNKI and WanFang Data Service Platform from January 2009 to March 2020．The first author's name，country，publishing time，time period of the patients，sample number，age，ratio of female，ratio of multiple stones，common bile duct diameter，ASA grade，follow-up period，outcome indexes（the common bile duct calculi clearance ratio，incidence of postoperative complications，surgical transferation ratio，bile leakage ratio，incidence of pancreatitis，residual stone ratio，calculi recurrence ratio，hospitalization fee，length of hospitalization stay，operation time） were recorde．Meta-analysis was performed using RevMan 5.3 software．Results　A total of 20 RCTs were included in this study，and the overall quality of the literatures was good．Choledoch stone clearance ratio 〔OR=1.11，95%CI（0.78，1.58），P=0.55〕，surgical transferance ratio 〔OR=1.11，95%CI（0.64，1.93），P=0.71〕，residual stone ratio 〔OR=0.73，95%CI（0.45，1.19），P=0.21〕，length of hospitalization stay 〔SWD=-0.43，95%CI（-0.87，0.02），P=0.06〕 and operation time 〔SWD=-0.28，95%CI（-1.09，0.53），P=0.50〕 showed no significant differences between the one-stage LCBDE+LC group and sequential two-stage ERCP/EST+LC group．Compared with the sequential two-stage ERCP/EST+LC group，postoperative complication ratio 〔OR=0.57，95%CI（0.43，0.75），P<0.000 1〕，stone recurrence ratio〔OR=0.33，95%CI（0.16，0.69），P=0.003〕，hospitalization cost 〔SWD=-1.07，95%CI（-1.44，-0.69），P<0.000 01〕，pancreatitis ratio 〔OR=0.13，95%CI（0.06，0.27），P<0.000 01〕 significantly decreased，while the bile leakage ratio 〔OR=3.68，95%CI（2.10，6.45），P<0.000 01〕 significantly increased in the one-stage LCBDE+LC group．Conclusion　Compared with sequential two-stage ERCP/EST+LC，one-stage LCBDE+LC showed lower incidence of total complications，stone recurrence ratio and hospitalization cost，but showed obvious advantages in perioperative safety．There were no significant differences in the stone clearance ratio，operation time，length of hospitalization stay，surgical transferance ratio and residual stone ratio between the two groups．

Efficacy and Safety of Combination Therapy with Tadalafil and Tamsulosin in Treating Lower Urinary Tract Symptoms and Erectile Dysfunction in Men：a Meta-analysis　

LI Jinze，PENG Lei，LI Yunxiang，WEI Tangqiang，XIONG Wei，NIU Chao，ZHANG Zongping

2021, 24(14): 1813-1819. DOI: 10.12114/j.issn.1007-9572.2021.00.461

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Background　Tamsulosin and tadalafil（TAD）have been widely used for the treatment of lower urinary tract symptoms（LUTS）and erectile dysfunction（ED）．However，the efficacy and safety of the combination therapy of these two medicines for LUTS and ED in men is still controversial．Objective　To systematically investigate the efficacy and safety of TAD plus tamsulosin compared with TAD monotherapy in treating men with LUTS and ED．Methods　PubMed，EMBase，Cochrane Central Register of Controlled Trials，SinoMed，CNKI，WanFang Data Service Platform，and CQVIP databases were searched extensively from inception to February 29，2020 to obtain eligible studies comparing the efficacy and safety of TAD plus tamsulosin and TAD monotherapy in treating men with LUTS and ED．Data were extracted，such as the name（s）of the first author（s），year of publication，geographical location（country）of the research setting，types of research，sample size，age and BMI of the subjects，interventions，dosage，follow-up time and outcome indicators 〔total International Prostate Symptom Score（IPSS）score，IPSS storage subscore，IPSS voiding subscore，quality of life score，maximum urinary flow rate，post-void residual urine volume and International Index of Erectile Function-5（IIEF-5）score〕，incidence of adverse events（including total incidence of adverse events，incidence of headache，myalgia，back pain，dizziness，nasopharyngitis and ejaculation dysfunction），and rate of treatment discontinuation due to adverse events．Revman 5.3.0 was used for data evaluation and statistical analysis．Results　Six studies were included，all were assessed with high methodological quality，involving 776 cases，394 in the combination group and 382 in the TAD group．The results of the meta-analysis indicated that compared with the TAD group，the combination group obtained more benefits from treatment in aspects of total IPSS score 〔MD=-2.67，95%CI（-3.82，-1.50），P<0.001〕，IPSS storage subscore 〔MD=-0.55，95%CI（-0.85，-0.26），P=0.000 2〕，IPSS voiding subscore 〔MD=-0.97，95%CI（-1.43，-0.51），P<0.001〕，quality of life score 〔MD=-0.37，95%CI（-0.51，-0.23），P<0.001〕，and maximum urinary flow rate 〔MD=1.45，95%CI（0.90，1.99），P<0.000 01〕．However，there were no significant differences in post-void residual urine volume 〔MD=-4.22，95%CI（-12.82，4.39），P=0.34〕，IIEF-5 score 〔MD=0.44，95%CI（-0.23，1.11），P=0.19〕，the incidence of adverse events 〔OR=1.43，95%CI（0.98，2.08），P=0.06〕，the incidence of headache 〔OR=1.34，95%CI（0.66，2.72），P=0.42〕，myalgia 〔OR=1.56，95%CI（0.64，3.82），P=0.33〕，back pain 〔OR=1.45，95%CI（0.40，5.22），P=0.57〕，dizziness 〔OR=1.14，95%CI（0.27，4.76），P=0.86〕，nasopharyngitis 〔OR=0.47，95%CI（0.10，2.21），P=0.34〕，ejaculatory dysfunction 〔OR=3.81，95%CI（0.44，32.97），P=0.22〕，and the rate of treatment discontinuation due to adverse events 〔OR=1.44，95%CI（0.88，2.35），P=0.15〕 between the two groups．Conclusion　Both therapies have similar beneficial effects on ED and similar safety，but the combination of TAD plus tamsulosin is more effective for the improvement of the LUTS．Hence，the combination therapy may be recommended as a suitable option for men with both LUTS and ED．However，due to limited evidence，high-quality randomized controlled trials are required to further confirm these findings．

Changes and Clinical Significance of Neutrophil/Lymphocyte Ratio of Intercritical Gout Patients　

YANG Yanyu，LIU Taohong，WANG Dan，HUANG Yuqin，HE Xin，QING Yufeng，ZHANG Quanbo

2021, 24(14): 1820-1827. DOI: 10.12114/j.issn.1007-9572.2021.00.492

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Background　As the most common form of inflammatory arthritis，the morbidity of gout is gradually increasing，and its occurrence is closely related to hyperuricemia.Uric acid is mainly excreted by kidney.The current indicators to evaluate the level of uric acid excretion by kidney mainly include 24-hour urinary uric acid，clearance rate of uric acid and creatinine，fractional excretion of uric acid （FEUA） and urinary uric acid/urinary creatinine.FEUA is an indicator can reflect renal excretion more accurately.Objective　To investigate the changes of neutrophil/lymphocyte ratio （NLR） in gout patients during the intercritical period and FEUA staging，and to analyze whether it can provide a new reference index for FEUA staging.Methods　A total of 386 gout patients in intermittent phase who were treated in the outpatient and inpatient departments of the Affiliated Hospital of North Sichuan Medical College from December 2013 to July 2019 were selected，and 154 healthy persons matched with age and gender were selected.206 gout patients in intermittent phase who completed the 24-hour Urinalysis were treated as the gout group，and 39 of the 154 healthy persons who completed the 24-hour Urinalysis were treated as the control group.Gout group was classified according to the level of FEUA：FEUA<7% was the excretion-decreased type，FEUA 7%-12% was the mixed type，and FEUA>12% was the synthesis-increased type.The data of age，gender，height，body mass，smoking history，drinking，24-hour urine output，24-hour urinary uric acid，24-hour urine creatinine，blood uric acid （UA），creatinine clearance rate （Cr），FEUA，clearance rates of uric acid and creatinine，urinary uric acid/ creatinine，urinary pH，estimated glomerular filtration rate （eGFR） and the laboratory tests 〔including white blood cell count （WBC），neutrophil （GR），lymphocyte （LYM），platelet （PLT），average red blood cells （MCV）〕 in their first-time consultancy，the number of affected joints，the history situation of tophi，plateau living history，hypertension，diabetes，hyperlipidemia，kidney stones and family history of gout in different types of gout patients was collected.Results　BMI，smoking history ratio，drinking history ratio，24-hour urine output，UA，GR and NLR of the gout group were higher than the control group，and FEUA，uric acid clearance rate and eGFR of the gout group were lower than the control group （P<0.05）.NLR level was positively correlated with FEUA in gout patients（rs=0.242，P<0.05），negatively correlated with clearance rate of creatinine（rs=-0.150，P<0.05）.There were 206 subjects in the gout group，including 183 gout patients who had reduced uric acid excretion，15（7.3%） gout patients who had mixed type，and 8 （3.9%） gout patients who had increased uric acid excretion.There were significant differences in the proportion of drinking history，the proportion of renal stone，24-hour urine output，serum uric acid，serum creatinine，FUEA，uric acid clearance rate，creatinine clearance rate，uric acid/urinary creatinine，neutrophils and NLR maong different gout types patients （P<0.05）.Multivariate Logistic regression analysis showed that alcohol consumption，24-hour urine volume，serum uric acid，uric acid excretion fraction，eGFR and NLR were the influencing factors of gout occurrence （P < 0.05）.The area under the ROC curve （AUC） of NLR for the diagnosis of gout was 0.748 （0.674，0.822），the best cutoff value was 1.76，the sensitivity was 78.16%，and the specificity was 61.54%.The AUC of 95%CI of NLR for the diagnosis of excretion-decreased type was 0.739 （0.662，0.816），the best cutoff value was 1.76，the sensitivity was 77.60%，the specificity was 61.54%.The AUC 95%CI of NLR in the diagnosis of mixed gout was 0.758 （0.601，0.915），the best cutoff value was 3.54，the sensitivity was 50.00%，the specificity was 100.00%.The AUC 95%CI of NLR for the diagnosis of synthesis-increased type was 0.936 （0.844，1.000），the best cutoff value was 4.07，the sensitivity was 75.00%，and the specificity was 100.00%.Conclusion　NLR is closely related to the occurrence of gout，and it has important value in the staging of FEUA.It can guide contrapuntally selection of anti-uric acid drugs in clinical medication.

Clinical Analysis of Systemic Lupus Erythematosus with Persistent Thrombocytosis　

CUI Peng，XU Dong，XING Tian，REN Guohua，MA Shangmin

2021, 24(14): 1827-1830. DOI: 10.12114/j.issn.1007-9572.2021.00.110

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Background　It is uncommon for systemic lupus erythematosus（SLE） with persistent thrombocytosis，whose causes and pathogenesis remain to be unclear.There are few related studies，and no related reports in China in particular.Objective　To investigate the clinical features and etiology of SLE with persistent thrombocytosis.Methods　The medical records of 393 cases diagnosed with SLE in the First Hospital of Zibo from 2010 to 2019 were retrospectively analyzed.Among them，4 with persistent thrombocytosis and 25 randomly sampled cases without persistent thrombocytosis were assigned to the study group，and control group，respectively.Gender，age，the interval between thrombocytosis and timing of diagnosing SLE，duration of thrombocytosis，number of organs involved，routine blood parameters，erythrocyte sedimentation rate（ESR），C-reactive protein（CRP），complement，24-hour urine protein，antinuclear antibody（ANA），anti-dsDNA antibody，anti-cardiolipin antibody（ACA），lupus anticoagulant（LA），bone marrow morphology，JAK2/v617F mutation，SLEDAI score，selective spleen scintigraphy and others were collected.Results　The 4 cases with persistent thrombocytosis were female，with a mean age of （36.3±15.1） years，median platelet count of 903×109/L（range，732×109/L-1 439×109/L），median interval between thrombocytosis and timing of diagnosing SLE of 3（range，2-7） years，median duration of thrombocytosis of 12（range，8-28） months，and median SLEDAI score of 5（range，2-10）.1 with ESR elevated，1 with CRP elevated，3 with C3 hypocomplementemia，2 with C4 hypocomplementemia，2 with positive anti-dsDNA antibody，3 with positive ACA and 2 with positive LA.In terms of the causes of thrombocytosis：1 was ascribed to essential thrombocythemia，2 were ascribed to hyposplenism，and 1 was cryptogenic.The levels of platelet count，ACA and LA in study group were higher than those of control group（P<0.05）.Conclusion　SLE with persistent thrombocytosis is rarely reported，with hyposplenism as one possible major cause，and essential thrombocythemia in SLE another one.Thrombocytosis was associated with ACA and LA.

Clinical Phenotypes and Genotypes of X-linked Recessive Chondrodysplasia Punctata Caused by ARSE Gene Mutations

LI Lin，DU Kaixian，ZHANG Xiaoli，DONG Yan，GUAN Jing，GAN Ling，JIA Tianming

2021, 24(14): 1831-1836. DOI: 10.12114/j.issn.1007-9572.2020.00.635

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Background X-linked recessive chondrodysplasia punctata（CDPX1） is a rare congenital disorder of bone and cartilage development caused by ARSE gene mutations.In China，there are only a few related reports，with neonates as the subjects，and there is no report about the phenotypes of childhood.Objective　To analyze the clinical phenotypes and genotypes of CDPX1 caused by mutation of ARSE gene.Methods　Clinical features and whole exon sequencing results of a case of CDPX1 caused by ARSE gene mutations who was diagnosed and treated in the Third Affiliated Hospital of Zhengzhou University in June 2018 were collected and analyzed. And a literature review was performed to assess studies of CDPX1 caused by ARSE gene mutations searched in databases of CNKI，WANFANG DATA，PubMed and Human Gene Mutation Database（HGMD） from inception to February 2010 using “点状软骨发育不良”“芳香基硫酸酯酶E”“chondrodysplasia punctate” and“ARSE” as search terms. Then the clinical phenotypes and genotypes of this disease were summarized.Results　The patient selected from the Third Affiliated Hospital of Zhengzhou University is male，had a low and flat nose suggested by fetal ultrasound，and presented postnatal dyspnea，mixed deafness，nasal dysplasia，short stature，limbs and fingers，cognitive and motor retardation，and atrial septal defect.X-ray indicated spotty calcifications of feet and spine. The whole exon sequencing revealed the semi-zygotic variation of ARSE gene c.1219G>A（p.E407k），which has not been reported in the literature at home and abroad. His mother was heterozygous mutation，his father and sister were wide-type.23 cases with detailed descriptions of phenotypes were identified in related studies，including 22 males and 1 female，4 were diagnosed in the prenatal period（including 2 live births，1 abortion at 26 weeks of gestation and 1 unknown case），and 1 died due to DIC in neonatal period. Clinical manifestations of these cases in general: midfacial hypoplasia，brachytelephalangy，stippled epiphyses in spine and limbs，respiratory dysfunction，hearing loss，rachiocamposis or abnormal centrum，stenomycteria or atretorrhinia，short stature，congenital heart disease，cognitive impairment，short neck，calcification of trachea and/or bronchus，airway stenosis，calcifications of larynx，hypotonia，symphysodactylia，slow increase of weight，feeding difficulties，intrauterine growth restriction，small for gestational age，cataract，small thorax，spinal stenosis，contracture of joint. Among them，fetal stage performance: flat facial profile，various degrees of nasal hypoplasia，collapse of the nasal bridge，rachiocamposis，abnormal centrum，spinal stenosis，short upper limbs，diffuse stippled calcification in osteoepiphysis and spine，long bone dysplasia，intrauterine growth restriction.47 variations in ARSE gene were retrieved by searching HGMD，including point mutation，single or multiple exon deletion，complete deletion including ARSE gene，and chromosome translocation.Conclusion　We gave the first report about CDPX1 caused by mutation of ARSE gene c.1219G>A，expanding the mutation spectrum of ARSE gene.And the summary of the phenotypes of patients from fetal period to 2 years old contributes to the understanding of CDPX1 phenotypes and genotypes.

LONG Lang，LUO Feng，WANG Li，YAN Guoqing

2021, 24(14): 1837-1840. DOI: 10.12114/j.issn.1007-9572.2020.00.382

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In recent years，a breakthrough has been made in cancer treatment by immune checkpoint inhibitors （ICIs）.However，with the extensive application of ICIs，reports of immune-related adverse event（irAE） associated with ICIs are increasing，among which immune-related myocarditis is rare but highly fatal.We reported a case of immune-related myocarditis after Atezolizumab treatment of thymoma，and conducted a literature review of the clinical features，possible pathogenesis，treatment and prognosis of this disease.

Establishment of Predictive Model and Development of Scale for HbA1c in Elderly Type 2 Diabetes Patients Based on Logistic Regression　

YANG Hengbo，YUAN Rong，SHI Xia，WU Xingwei

2021, 24(14): 1841-1847. DOI: 10.12114/j.issn.1007-9572.2021.00.475

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Background　Achieving hemoglobin control can reduce the risk of complications of type 2 diabetes among elderly patients and the hemoglobin management is crucial in the daily management of type 2 diabetes.However，there has been increasingly evidence shows that the achieving rate of hemoglobin-control among elderly patients with type 2 diabetes are generally poor.However，the risk prediction models of hemoglobin can be generally used to predict high level hemoglobin risk for individual patients.Objective　To establish target predictive model and scale of HbA1c by exploring influencing factors of hemoglobin-control in elderly patients with type 2 diabetes，in order to provide a kind of versatile and reliable tool for diabetes management.Methods　The basic information and related laboratory indexes of 483 elderly patients with type 2 diabetes referred to the endocrinology department，Sichuan Provincial People's Hospital from March 2018 to December 2019 were collected by face-to-face questionnaire survey，including gender，age，occupation，nationality，marital status，educational level，body size，family history of diabetes，central obesity comparison，previous HbA1c values，the HbA1c test result，the duration of diabetes，fasting blood sugar monitoring situation，fasting blood glucose values，the present stage treatment，medication compliance，type of oral medication，whether to use insulin，glucose-lowering drugs daily cost，high blood pressure，high cholesterol，whether merger diabetes complications，daily exercise time，quality of sleep，diet control，and depression.According to the results of HbA1c examination，the patients were divided into：HbA1c up to standard group （224 cases） and HbA1c not up to standard group（259 cases）.Univariate and multivariate Lasso-Logistic regression were used for variable selection，and hemoglobin values were used as independent variables to build the predictive models and rating scales.Bootstrap method were used for internal validity analysis of the prediction models.The sensitivity，specificity as well as the area under the receiver operating characteristic（ROC）curve（AUC）was evaluated for predict accuracy.The score-occurrence probability graph was used to verify the performance of the rating scales and the best out of cut-points was determined.Results　The statistically significant differences was found in age，central obesity comparison，previous HbA1c value，duration of diabetes，fasting blood glucose，medication compliance，type of oral medication，whether to use insulin，diabetes complications，daily exercise time，diet control，and depression between normal hemoglobin value and high hemoglobin value between the two group（P<0.05）.Univariate Logistic regression analysis revealed that age，central obesity comparison，previous HbA1c value，duration of diabetes，fasting blood glucose，medication compliance，insulin use，daily exercise time and diet control was significantly correlated with hemoglobin-control（P<0.05）.Lasso-Logistic regression analysis revealed that age，previous HbA1c value，duration of diabetes，fasting blood glucose，medication compliance，insulin use，daily exercise time and diet control was significantly correlated with hemoglobin-control（P<0.05）.According to the result of Lasso-Logistic analysis，the logistic regression model is logit（P）=3.89+1.72×〔previous HbA1c（> 7%）〕+0.97×〔（2 years to 10 years）duration of diabetes〕 + 1.41×〔diabetes duration（>10 years）〕+1.51×〔fasting glucose values（≥7mmol）〕 +1.02×〔medication compliance（or poor）］ + 0.85×〔whether to use insulin（yes）〕 + 0.58×〔daily movement time（>0~0.5 h）〕+1.21×〔Daily exercise time（no exercise）］+1.09×〔diet controlled（no）〕（if the condition in 〔〕 is satisfied，it is 1；if it is not satisfied，it is 0）.The discriminatory ability of this model and the results of internal validation showed that the model performed well.The area under the ROC curve was 0.86〔95%CI（0.83，0.89）〕.To derive a simple-to-compute risk score，regression coefficients were converted to weighted scores by dividing each regression coefficient by rounding to the nearest integer，then，a HbA1c rating score with a maximum score of 9 was obtained，ratings increased from 0 to 9 with increasing probability of high level hemoglobin risk.When the cut-off value was set at 0.56 according to the max value of the Youden index，the cut point of the rating table is 5 points，the sensitivity was 79.54%，specificity was 76.79%，and accuracy was equaled to 78.26%.Conclusion　By applying hemoglobin scoring model，clinicians can predict which elderly patients with type 2 diabetes may have a high risk of hemoglobin-control and thus help patients make the right decisions，so this scoring model has clinical application and promotion value.

Analysis of Registration Status of Severe Asthma Clinical Trials Based on WHO ICTRP　

TU Xinmin，WANG Minghang，ZHAO Huanhuan，YANG Jiang，LIN Xiaohong

2021, 24(14): 1848-1852. DOI: 10.12114/j.issn.1007-9572.2021.00.108

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Background　The clinical control of severe asthma is poor and treatment methods are lacking，therefore more relevant clinical studies are urgently needed；the clinical trial registration can lay the foundation for clinical prevention，but the current situation of severe asthma is not clear and can not provide a new perspective for clinical trials.Objective　To study the registration characteristics of clinical trials of severe asthma based on the data of WHO international clinical trial registration platform（ICTRP）.Methods　The WHO ICTRP database was searched by computer，and the data of clinical trials with registration time from the establishment of the database to 2019-12-15 were collected.Two researchers independently screened the trial，extracted data，and then performed a descriptive analysis of the included trials.Results　A total of 235 clinical trials related to severe asthma were retrieved.The number of clinical trial registrations has been increasing year by year since the establishment of the database，and there has been a downward trend in the past 4 years.The trial application countries are unevenly distributed，the countries with high prevalence of severe asthma have few applications.Most trials in the registries come from their own country.The main sources of funds are units and enterprises.The main types of diseases in the study were severe asthma （89.36%），and the ages involved were mainly adults （90.64%）.The main type of trial was intervention （65.96%）.In the intervention trial，random trials accounted for 67.10%，and only 9 trials described their random methods；in the observational study，38.75% of the trials were the cohort study，44.26% of the trials did not indicate the blind method，and most of the other trials were double-blind （25.53%）.The mainly staging of the trial was N/A（32.77%） and phase III trial （20.00%）.The main intervention was drug intervention （77.42%）.The main outcomes were lung function，aggravation of asthma and evaluation of the life quality.Conclusion　The clinical trials of severe asthma have shown a downward trend in recent years，and the country of application for trials is unevenly distributed..The main research diseases are severe asthma，the research types are mainly interventional，and the intervention measures are mostly western medicine.

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