Chinese General Practice

Diagnosis and Treatment of Autoimmune and IgG4-related Hypophysitis：Clinical Guidelines of the Japan Endocrine Society in 2020：Interpretation and Implication to General Practice Development in China　

CHEN Xiaoyi，CHEN Shuchun

2020, 23(36): 4535-4540. DOI: 10.12114/j.issn.1007-9572.2020.00.582

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China issued the Compendium of China's First List of Rare Diseases and 2019 Chinese Guidelines for the Diagnosis and Management of Rare Diseases in 2018 and 2019，which shows that the Chinese government attaches great importance to the diagnosis，treatment and security of rare diseases.Autoimmune hypophysitis is a rare disease that can cause pituitary dysfunction.As low morbidity，changeable symptoms and untypical imaging characteristics，it is easily misdiagnosed，and untimely treatment may lead to life-threatening outcome.In 2020，the Japan Endocrine Society issued the Diagnosis and Treatment of Autoimmune and IgG4-related Hypophysitis：Clinical Guidelines of the Japan Endocrine Society，which are the first clinical guidelines with clear definition，diagnosis and treatment of autoimmune hypophysitis and IgG4-related hypophysitis.This paper interprets the guidelines from the definition，diagnosis and treatment of autoimmune hypophysitis and IgG4-related hypophysitis，and analyzes its implication to general practice development in China，providing a reference for general practitioners' diagnosis and treatment in China.

Coping with Undifferentiated Diseases：from Over-diagnosis to Shared Decision Making　

YE Kangli，XU Zhijie，DU Yaping，REN Jingjing

2020, 23(36): 4541-4547. DOI: 10.12114/j.issn.1007-9572.2020.00.513

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Undifferentiated disease is defined as medically unexplained physical symptoms or the disease which is still in the early stage and not clearly attributed to a specific system.In the diagnosis and treatment of such diseases，excessive medical resources are often consumed，resulting in more medical and social problems.This article summarizes the characteristics and over-diagnosis of undifferentiated diseases，then deeply analyzes four major factors（of patient-，physician-，medical examination techniques- and medical industry-related）associated with over-diagnosis，and proposes that shared decision making is an effective way to solve these over-diagnosis problems.In addition，to achieve effective shared decision making for intervening such diseases，clinicians should provide patients with professional advice，and deliver interventions based on fully considering the patient's demands as well as develop a contractual mode of physician-patient relationship.

Correlation between Post-stroke Fatigue and Post-traumatic Growth in First Stroke Patients　

SHU Meichun，YANG Suili，HONG Xianchai，YE Weimin，LU Zhongqiu

2020, 23(36): 4547-4553. DOI: 10.12114/j.issn.1007-9572.2020.00.445

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Background　Previous studies have found that 30%-72% of stroke patients develop post-stroke fatigue，with poorer neurological outcome，and higher risk of recurrent stroke and mortality.Post-traumatic growth，a positive psychological factor，may enable patients to recover from trauma，but its relationship with post-stroke fatigue has been rarely studied.Objective　To investigate the status of post-stroke fatigue，post-traumatic growth and associated factors，as well as the relationship between post-stroke fatigue and post-traumatic growth in first stroke patients.Methods　By use of convenience sampling and strict inclusion and exclusion criteria used in this study，first stroke inpatients were recruited from Department of Neurology，the First Affiliated Hospital of Wenzhou Medical University from December 2017 to July 2018.The self-developed General Data Questionnaire for Stroke Patients，Post-traumatic Growth Inventory （PTGI） and Fatigue Severity Scale （FSS） were used in a survey to collect the general data and analyze the status of post-traumatic growth and post-stroke fatigue，respectively.Multiple linear regression was used to analyze the factors affecting post-traumatic growth.Results　The survey obtained a response rate of 94.1%（207/220）.The average scores of PTGI and FSS for the 207 respondents were （55.4±11.0） and （36.4±10.9），respectively.The results of Spearman rank correlation analysis showed that FSS score was negatively correlated with interpersonal relationship，personal strength，life perception，new possibility，mental change and PTGI score （rs=-0.687，-0.404，-0.684，-0.707，-0.306，-0.768，P<0.001）.Multiple linear regression analysis showed that marital status（β'=0.207），education level （β'=0.407），medical payment （reimbursed by the social insurance program）（β'=0.106），living condition （β'=0.072） and FSS score （β'=-0.437） were influencing factors of post-traumatic growth in first stroke patients.Conclusion　Post-traumatic growth level of convalescent patients was affected by post-stroke fatigue in the early stage of first stroke.So health care workers should take intervention measures to alleviate early fatigue to improve post-traumatic growth level and physical and mental health，and quality of life in these patients.

Sex-specific Correlation between Serum Uric Acid and Blood Pressure：a Propensity-matched Analysis　

NIE Zhichao，LI Shuangjing，TIAN Tian，LI Tingting，JIA Hong

2020, 23(36): 4554-4561. DOI: 10.12114/j.issn.1007-9572.2020.00.503

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Background　Hypertension is one of the main risk factors of cardiovascular diseases.Prehypertension，an early warning sign for hypertension，has become a widely concerned major public health problem.Recently，some studies have shown that elevated serum uric acid level is a risk factor of prehypertension and hypertension with sex-specific differences，but the conclusions are not consistent.Objective　To perform a propensity-matched analysis of sex-specific correlations of serum uric acid with prehypertension and hypertension.Methods　Data about general demographic and physiological and biochemical parameters（including sex，age，nationality，smoking prevalence，drinking prevalence，body mass index，years of education，occupation，total cholesterol，triacylglycerol，fasting plasma glucose，blood pressure and serum uric acid） were collected from the survey（consisting of a field questionnaire investigation，physical examination and blood sample analysis） supported by the project of Dietary Nutrition Research and Education Fund of Danone Institute.Subjects were a stratified cluster sample selected during 2014—2016 from the areas inhabited by the Yi and non-Yi people of Xichang City and three counties（Dechang，Mianning and Yanyuan） of Liangshan Yi Autonomous Prefecture，including part of permanent residents from Xichang and from Pingchuan Town of Yanyuan，and all permanent residents from 6 villages of Dechang and from 8 villages of Mianning.They were divided into Q1，Q2，Q3 and Q4 groups based on the quartile of serum uric acid levels （P25，P50 and P75）.Propensity score matching was used to achieve a balance of covariates between groups.Multivariate Logistic regression analysis was used to explore sex-specific correlations of serum uric acid with prehypertension and hypertension before and after matching.Results　A total of 3 188 subjects were surveyed.After excluding 273 ineligible cases，other 2 915 were included for final analysis，including 760 with hypertension，1 240 with prehypertension and 915 with normal blood pressure.By the propensity score matching，248 pairs of hypertension and non-hypertension women were successfully matched，and 388 male pairs were successfully matched；384 pairs of prehypertension and normal blood pressure women were successfully matched，and 321 pairs of men were successfully matched.Multivariate Logistic regression analysis showed that in women，the risk of hypertension was 4.213 times higher in Q3 group 〔95%CI （2.245，7.908）〕（P<0.001），and was 1.739 times higher in Q4 group 〔95%CI （1.023，2.956）〕（P=0.041） compared with that of Q1 group.In men，the risk of prehypertension in Q4 group was 1.817 times higher 〔95%CI （1.185，2.788）〕（P=0.006） compared with that of Q1 group.The risk of hypertension was 2.948 times higher in Q3 group 〔95%CI （1.772，4.905）〕（P<0.001），and was 5.852 times higher in Q4 group 〔95%CI （3.309，10.351）〕（P<0.001） compared with that of Q1 group.Conclusion　Both men and women with elevated serum uric acid had a higher risk of hypertension，which indicates that there may be a correlation between serum uric acid and hypertension.In addition，men with high serum uric acid had a higher risk of prehypertension，but similar result was not found in women.

Gastroscopic and Pathological Characteristics of Helicobacter Pylori Infection in Childhood and the Treatment Effect Analysis in Guiyang　

LONG Mei，ZHU Li，BAO Linlin，PAN Peiying

2020, 23(36): 4562-4566. DOI: 10.12114/j.issn.1007-9572.2020.00.357

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Background　With the popularization of gastroscopy in children，studies have found that Helicobacter pylori （H.pylori） infection in childhood is closely related to the occurrence of gastrointestinal diseases.However，the studies regarding the gastroscopy and pathological examination are relatively few.Objective　To investigate the gastroscopic and pathological characteristics of H.pylori infection in childhood and analyze the treatment effect in Guiyang.Methods　A total of 210 children with symptoms such as abdominal pain，vomiting，and gastrointestinal bleeding who were admitted to the Department of Gastroenterology，Guiyang Maternal and Child Health Hospital/Guiyang Children's Hospital were randomly selected as the research objects from June 2016 to September 2018.After the H.pylori detection，children with positive results were assigned to the positive group，and those with negative results were to the control group.The gastroscopic and pathological characteristics of H.pylori infection were collected and the treatment effect was analyzed.Results　Among the 210 children，104 children were in the positive group and 106 children were in the control group.The infection rate was 49.5%，and the average onset age of H.pylori infection was（7.2±1.3）.Gastroscopy in the positive group revealed 58 cases of erosive hemorrhagic gastritis，23 cases of peptic ulcers，13 cases of nodular gastritis，and 10 cases of peptic ulcer with nodular gastritis.Gastroscopy in the control group revealed 84 cases of erosive hemorrhagic gastritis，18 cases of peptic ulcer，three cases of nodular gastritis，and one case of peptic ulcer with nodular gastritis.The incidence of erosive hemorrhagic gastritis in the positive group was significantly lower than that in the control group，incidence of nodular gastritis，and peptic ulcer with nodular gastritis was significantly higher in the positive group than that in the control group（P<0.05）.The incidence of mild inflammation in the positive group was lower than that in the control group，and the incidence of severe inflammation was higher（P<0.05）.The positive group had a higher incidence of lymphocytes with positive results than the control group（P<0.05）.Standard triple therapy was given to children in the positive group，and then 13C urea breath test was performed.The results showed 93 cases with negative results and 11 cases with positive results.Conclusion　The H.pylori infection rate in children in Guiyang was 49.5%，and mainly in school-age children.The erosive hemorrhagic gastritis，peptic ulcer，and nodular gastritis were the main manifestations observed by gastroscopy in H.pylori infection children.The incidence of erosive hemorrhagic gastritis was significantly reduced，and the incidence of nodular gastritis，and peptic ulcer with nodular gastritis were significantly increased.The pathology examination of gastric mucosa showed that the inflammation was mainly severe inflammation.The severe inflammation and the degree of lymphocyte infiltration were associated with H.pylori infection.The eradication rate of H.pylori by standard triple therapy was 89.4%.

Bi-directional Referrals for Diabetes：a Survey in the Public Medical Institutions of Pudong New Area，Shanghai　

HUANG Dazhi，DING Yibiao，DU Zhaohui

2020, 23(36): 4567-4572. DOI: 10.12114/j.issn.1007-9572.2020.00.586

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Background　As diabetes is a complex lifelong chronic disease，treatment of diabetes is a long-term management that needs to be adjusted continuously according to the disease condition.The implementation of bi-directional referrals for diabetes plays an extremely important role in rationally utilizing medical resources and diminishing the burden of the family and the country.Objective　To investigate the cognition and satisfaction regarding bi-directional referrals for diabetes among medical workers in public medical institutions in Pudong New Area，Shanghai，to provide a reference for improving hierarchical medical system and medical consortium development in this area.Methods　In October 2019，participants（n=621） were recruited from public medical institutions in Pudong New Area，including endocrinologists from 7 secondary and tertiary medical institutions，and general practitioners（GPs） from 47 community health centers（CHCs）.They were invited to complete an online survey conducted on www.wjx.cn platform using a self-administered questionnaire developed by our research group，covering demographic information，knowledge of bi-directional referrals for diabetes（single-choice questions），knowledge of causes and criteria of bi-directional referrals for diabetes（multiple choice questions），and attitudes and satisfaction regarding bi-directional referrals for diabetes（single-choice questions）.Results　The survey achieved a response rate of 95.01%（590/621）.The prevalence of knowing bi-directional referrals for diabetes was 82.88%（489/590）.The prevalence of knowing bi-directional referral system for diabetes well and very well was 50.84%（300/590）.The prevalence of knowing criteria of bi-directional referrals for diabetes well and very well was 54.92%（324/590）.The prevalence of knowing their hospital had a designated institution for referring diabetics bi-directionally was 83.22%（491/590）.Professional title was associated with the difference in the choice of the answer to "Whether knowing bi-directional referral system for diabetes"（P<0.05）.The prevalence of choosing "Limited categories of drugs available in primary care" as the answer to "The most common cause of upward referrals for diabetics" was 84.92%（501/590）.The prevalence of choosing "Getting an initial diagnosis of diabetes in primary care（and needing services such as diabetic classification and diabetic complications detection）" as the answer to "Criteria of bi-directional referrals for diabetes" was 35.59%（210/590）.The prevalence of choosing "The detected chronic diabetic complications are stable with interventions" as the answer to "Downward referral criteria for diabetes（from a higher level hospital to the CHCs）" was 95.76%（565/590）.The prevalence of choosing "Short distance to the CHCs from home facilitates convenient access to care" as the answer to "Reasons for diabetics' preference of getting back to the CHCs for treatment" was 96.10%（567/590）.The prevalence of choosing "Insufficient drugs available in primary care" as the answer to "Reasons for diabetics' reluctance to get back to the CHCs for treatment" was 87.63%（517/590）.99.15%（585/590） of the respondents believed that diabetics referral should be determined by GPs or endocrinologists.98.47%（581/590）of the respondents believed that bi-directional referrals are needed for diabetes.15.25%（90/590） and 56.10%（331/590）of the respondents thought that the effects of referrals for diabetes were very good and relatively good，respectively.94.75%（559/590） of the respondents were willing to refer diabetics.90.68%（535/590）of the respondents thought that the treatment option modification and condition evaluation should be continued after the downward referral.10.68%（63/590） and 45.08%（266/590） of the respondents of the respondents were very satisfied and relatively satisfied with bi-directional referrals for diabetes.Conclusion　Medical workers in public medical institutions in Pudong New Area had an intermediate understanding of bi-directional referrals for diabetes.They did not reach a consensus on the criteria of bi-directional referrals for diabetes，and were not very satisfied with such referral services generally.In view of this，new patterns for bi-directional referrals for diabetes should be further explored，and the consensus on criteria of bi-directional referrals should be reached.

Clinical Features，Diagnosis and Treatment and Prognosis of Patients with Hepatic Echinococcosis in Xinjiang：a 10-year Single-center Retrospective Study　

ZHANG Jie，QI Baowen，SONG Wei，WANG Jinguo，BAHETI·Kalifu，LI Yupeng，TIAN Guanglei，MENG Yuan，CHEN Xiong

2020, 23(36): 4573-4577. DOI: 10.12114/j.issn.1007-9572.2020.00.355

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Background　Hepatic echinococcosis is a high-prevalent disease that seriously threatens the health of nomads in western China.Surgical approaches for this disease（especially laparoscopic treatment），are seen to have fundamental changes during the process of gradually maturing along with the development of precise and minimally invasive surgical theories.We performed a 10-year retrospective study of the impact of changes regarding the diagnosis and treatment on the prognosis in such patients Objective　To explore the clinical characteristics，diagnosis and treatment and prognosis of patients with hepatic echinococcosis during a 10-year period in Xinjiang.Methods　By reviewing the electronic medical record system of People's Hospital of Xinjiang Uygur Autonomous Region，723 hepatic echinococcosis patients with surgical treatment were enrolled from January 2009 to June 2018 and were divided into first-phase group（324 receiving surgeries completed mainly via open approach during 2009 to 2013） and second-phase group（399 receiving surgeries completed mainly via laparoscopic approach during 2014 to June 2018） for ease of comparing postoperative recurrence before and after the widening application of laparoscopic surgical treatment for hepatic echinococcosis since 2014 in Xinjiang.Clinical data，such as age of onset，surgical method，prevalence of postoperative grade C bile leakage，recurrence，disease detection method，admission check-up，postoperative adherence to oral albendazole，and local recurrence or metastasis were collected.All of them were followed up once every 3 months within 3 years after surgery，and once every 6 months between 4 and 5 years after surgery by outpatient review，inpatient review，letter and telephone，and prognostic data during the follow-up were obtained.Results　Two groups showed no significant difference in average age of onset（P>0.05）.Second-phase group had higher prevalence of laparoscopic subtotal removal of endocysts and/or exocysts，laparoscopic complete removal of exocysts，and laparoscopic anatomical hepatectomy，and lower prevalence of open subtotal removal of endocysts and/or exocysts，and open complete removal of exocysts compared with the first-phase group（P<0.05）.The second-phase group showed lower proportion of detecting hepatic echinococcosis by treating discomfort，but higher proportion of detecting hepatic echinococcosis by mass health examination or health screening（P<0.05）.The second-phase group had higher proportions of undergoing color Doppler sonography（CDS） of the abdomen，low- and high-frequency CDS of the abdomen，and contrast-enhanced abdominal CT at admission（P<0.05）.Moreover，higher percent of patients in the second-phase group had good postoperative adherence to oral albendazole（P<0.05）.Also，local recurrence rate of echinococcosis，and prevalence rates of Grade C bile leakage，postoperative liver dysfunction and intra-abdominal infection as well as intraoperative bleeding greater than 775 ml were lower in the second-phase group（P<0.05）.Occupation- and sex-specific analysis showed that female nomads from minority ethnic groups were the high-risk group for hepatic echinococcosis.Conclusion　During the 10-year period in Xinjiang，the onset of age of hepatic echinococcosis showed no significant changes，but diagnosis and treatment for this disease as well as patient prognosis were improved obviously.Laparoscopic complete excision of the hydatid cysts has gradually become the first surgical method，with unique advantages in terms of reducing complications，small trauma，and good curativeness.Combined with the comprehensive development of early screening，it has benefited an increasing number of such patients.

Effect of Dexmedetomidine with Ulinastatin on Perioperative Neurocognitive Disorders in Elderly Patients Undergoing Laparoscopic Surgery for Colorectal Cancer——a Multicenter，Randomized，Double-blind，Controlled Study　

GUO Zongfeng，WANG Xiang，CAO Su，XU Xingguo，ZHANG Changwei，YU Xiaoyan，XU Weidong

2020, 23(36): 4578-4584. DOI: 10.12114/j.issn.1007-9572.2020.00.553

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Background　Perioperative neurocognitive disorders （PND） are a kind of mental disorders syndrome characterized by an acute onset and fluctuating course and induced by perioperative anesthesia and surgery with no effective preventive measures available.Thus，how to prevent and treat PND has become a hot topic in recent years.Objective　To investigate the effect of dexmedetomidine with ulinastatin on PND in elderly patients undergoing laparoscopic surgery for colorectal cancer.Methods　Six hundred and fifty-four elderly patients who were scheduled for elective laparoscopic surgery for colorectal cancer under general anesthesia were recruited from Nantong University Haian Hospital，Affiliated Hospital of Nantong University，and Nantong First People’s Hospital from May 2018 to June 2019，18 of them were excluded（7 were due to suspended surgery，and 11 disagreed to attend this study），and other 636 were finally included and equally randomized into control group （received 0.9% sodium chloride solution by infusion pump），dexmedetomidine group（received a loading dose of dexmedetomidine hydrochloride of 0.5 μg/kg using a micro-pump within 15 minutes before anesthesia induction，followed by continuous infusion at 0.3 μg?kg-1?h-1 until the end of surgery），ulinastatin group （received a loading dose of ulinastatin of 2 ku/kg using a micro-pump within 15 minutes before anesthesia induction，followed by continuous infusion at 1 ku·kg-1·h-1 until the end of surgery） and dexmedetomidine with ulinastatin group（received the same dexmedetomidine regimen as dexmedetomidine group and the same ulinastatin regimen as ulinastatin group）.ELISA was used to detect plasma levels of sTREM1，IL-6 and TNF-α on the day before surgery and on the 1st，3rd，and 7th days after surgery，respectively.Confusion Assessment Method （CAM） was used to assess delirium on the 1st，3rd，and 7th days after surgery，respectively.Z-score was used to assess neurocognitive disorder at 30，60 and 90 days after surgery，respectively.Results　Compared with the control group，the average levels of plasma sTREM1，IL-6 and TNF-α were significantly decreased in other three groups at each measurement （P<0.05）.Compared with dexmedetomidine and ulinastatin groups，the average levels of plasma sTREM1，IL-6 and TNF-α were significantly decreased in dexmedetomidine with ulinastatin group at each measurement（P<0.05）.Compared with the control group，postoperative delirium prevalence was significantly decreased in other three groups at each assessment（P<0.008 3）.Compared with dexmedetomidine and ulinastatin groups，the postoperative delirium prevalence at 7 days after surgery was significantly decreased in dexmedetomidine with ulinastatin group （P<0.008 3）.Compared with the control group，the postoperative neurocognitive disorders prevalence was significantly decreased in dexmedetomidine with ulinastatin group at each measurement（P<0.008 3）.Compared with dexmedetomidine and ulinastatin groups，the neurocognitive disorders prevalence at 60 days after surgery was significantly decreased in dexmedetomidine with ulinastatin group （P<0.008 3）.Conclusion　In elderly patients undergoing laparoscopic surgery for colorectal cancer，ulinastatin with dexmedetomidine may decrease the incidence of short-term postoperative delirium and long-term postoperative neurocognitive disorders，which may be achieved by down-regulating the levels of plasma sTREM1，IL-6 and TNF-α proteins.

Mildly Lowering Dialysate Sodium Concentration May Effectively Reduce the Blood Pressure and Plasma Sodium in End-stage Renal Disease Patients with Hypertension，Dry Weight，and Maintenance Hemodialysis：a Multicenter，Self-controlled Study　

ZHANG Yin，ZHOU Yilun，ZHAO Haidan，SHEN Yulan，MA Yunling4，GUO Zengyu，ZHOU Peiyi，LI Hong，LI Jianjun，DING Xia，GONG Yong，LIU Jing

2020, 23(36): 4585-4589. DOI: 10.12114/j.issn.1007-9572.2020.00.514

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Background　Hypertension is one of the common complications in end-stage renal disease patients undergoing maintenance hemodialysis.Previous studies have shown that lowering dialysate sodium concentration could adjust the water and sodium retention and thus reduce the blood pressure in end-stage renal disease patients with hypertension and maintenance hemodialysis，however，most of these studies have a small sample size，and the clinical significance of lowering dialysate sodium concentration is still controversial.Objective　 To verify the effect and safety of lowering dialysate sodium concentration for controlling blood pressure and plasma sodium in a large sample of end-stage renal disease patients with hypertension，dry weight and maintenance hemodialysis.Methods　In this multicenter，self-controlled study，154 end-stage renal disease patients with hypertension and maintenance hemodialysis from seven blood purifying centers in Beijing were enrolled between September and November 2018.The dialysate sodium concentration of them was adjusted to 138 mmol/L on December 1，2018 and maintained to December 31，2018（defined as pre-intervention），then adjusted to 136 mmol/L on January 1，2019 and maintained to April 30， 2019（defined as post-intervention）.Pre-hemodialysis plasma hemoglobin，albumin，calcium，phosphorus，parathormone，systolic and diastolic blood pressure，pre- and post-hemodialysis plasma sodium measured in the last week of December 2018 and the first week of May 2019 were compared.Interdialytic dry weight gain，kinds of antihypertensive drugs being used and incidence of adverse events during hemodialysis were recorded.Results　The average pre- and post-intervention pre-hemodialysis plasma hemoglobin，albumin，calcium，phosphorus and parathormone in all cases were not significantly different（P>0.05），but the average pre- and post-hemodialysis plasma sodium，pre-hemodialysis systolic and diastolic blood pressure，and interdialytic dry weight gain as well as the kinds of antihypertensive drugs being used showed significant reduction after intervention（P<0.05）.There was no significant difference in incidence of hypotension or muscle spasm during hemodialysis before and after intervention（P>0.05）.Conclusion　Mildly lowering dialysate sodium concentration may effectively reduce the blood pressure and plasma sodium in end-stage renal disease patients with hypertension，dry weight，and maintenance hemodialysis，with relatively high safety，which is worthy of appropriate promotion in primary hemodialysis institutions.

Illness Perception of Impaired Awareness of Hypoglycemia as Defined by the Common-sense Model in Type 2 Diabetics：a Mixed Methods Study　

SHEN Zhijia，LUO Caifeng，LIU Qiaoyan，BU Hongbing，YIN Wei，ZHU Dongmei

2020, 23(36): 4590-4596. DOI: 10.12114/j.issn.1007-9572.2020.00.618

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Background　Illness perception has great significant implications for patient disease management and health outcomes.Currently，quite few reports focus on the level and specific experience of illness perceptions of impaired awareness of hypoglycemia （IAH） following insulin therapy in type 2 diabetics.Objective　To explore the level and specific experience of illness perception of IAH as defined by the common-sense model following insulin therapy in type 2 diabetics，to provide a basis for delivering targeted interventions for such patients.Methods　This study adopted a two-phase，mixed-methods sequential explanatory design.The first phase was a quantitative analysis.Eligible type 2 diabetes inpatients with IAH following insulin therapy were recruited from Department of Endocrinology，Affiliated Hospital of Jiangsu University from February to December 2019 and received a self-administered or researcher-administered questionnaire survey using Demographic Questionnaire developed by our research group，the Brief Illness Perception Questionnaire（BIPQ） and Simplified Coping Style Questionnaire（SCSQ）.The scale score of BIPQ，and scores of consequences，timeline，personal and treatment control，identity，concern，overall comprehension of illness，and emotional response were compared by coping strategies.The second phase was a qualitative analysis.Qualitative data were derived from semi-structured face-to-face in-depth interviews with 14 cases selected from the participants of the first phase of study and were analyzed comparatively，including real experience of IAH，and illness perceptions of IAH（consequences，personal control，identify，concern，overall comprehension of illness，and emotional response） related to coping strategies.Results　The questionnaire survey obtained a response rate of 100.0%（113/113）.The prevalence of using negative and positive coping strategies was 36.8%（49/133） and 63.2%（84/133），respectively.Participants who used positive coping strategies had higher mean scale score of BIPQ，and higher mean scores of consequences，personal control，identity，concern，overall comprehension of illness，and emotional response（P<0.05）.5 themes were summarized from the interview results of participants using positive coping strategies：difficulties to take appropriate prevention and treatment measures for IAH，sensitivity to recognize the symptoms of IAH，restricted social communication，emotional responses，typical behaviors and eager for illness knowledge.5 themes were also summarized from the interview results of those using negative coping strategies：identifying hypoglycemia based on personal experience，rationalizing the prevalence of IAH，denying suffering from the negative impact of IAH，lack of psychological fluctuation experience caused by illness and emphasizing the dangers of hyperglycemia.Conclusion　Most of type 2 diabetics with IAH following insulin therapy had negative responses to their illness，and their illness perceptions differed by coping strategies.In view of this，medical workers should provide professional and personalized health education and emotional support based on the patient's illness perceptions and coping strategies.

Study on the Peptide Spectrum of Saliva Protein Markers in Different Degrees of Fatigue　

XU Yanli，XIAO Di，ZHANG Huifang，YIN Tianlu，HE Lihua，GAO Xiaohuan，GU Yixin，PENG Xianhui，LIU Zhijun，ZHANG Jianzhong

2020, 23(36): 4597-4603.

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Objective　In order to provide a reference basis for exploring convenient and stable fatigue markers，we studied various high-molecular-weight peptide fragments under the fatigue state and non-fatigue state using in the saliva using time of flight mass spectrometry.Methods　The saliva samples were collected from 10 healthy volunteers and the flight time of mass spectrometry was conducted using two kinds of sample treatment methods，the magnetic beads enrichment（MB） and direct detection of stock solution.This was followed by modeling via the mass spectrums of MB and supernatant（stock solution） directly collected after centrifugation.Results　Both MB and direct sampling produced good spectrograms between 2 000 and 150 00 Da，while some peaks were lost in the enrichment.The early and late spectrograms were different in each individual.Due to the limited sample size，the cross validation was not conducted，however two spectrograms were taken for each sample，and 20 early and 20 late spectrograms were used for modeling analysis.Three differential peptides was found in the two groups of stock solution samples.The cross validity of MB model was 92.06%，while that of stock solution model was 95.49%.Conclusion　There were differential peaks within the molecular weight of 2 000-15 000 Da，in different degrees of fatigue which provided a scientific basis for further realization of the convenient fatigue detection method based on biosensor technique，with important theoretical and practical significance.

Advances in the Association of Silent Brain Infarction and Sleep Disorders　

ZENG Ting，TAN Hua

2020, 23(36): 4604-4608. DOI: 10.12114/j.issn.1007-9572.2020.00.590

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Silent brain infarction（SBI） is a kind of cerebral infarction which often has no definite stroke history，typical clinical symptoms and signs of nervous system dysfunction，and needs to be found by cranial imaging or autopsy.With the development of related studies，SBI has been proved to be not completely asymptomatic，it may manifest as non-specific neurological impairments in some patients such as dizziness，headache，sleep disorders，memory loss and so on.Moreover，a large number of clinical reports show that sleep disorders is a common complication after stroke，which often adversely affects the prognosis and quality of life of patients.As one of the types of stroke，SBI is also associated with sleep disorders.However，due to non-specific clinical characteristics，it is often ignored by clinicians，and sleep problems in SBI patients are even less concerned，and there is a lack of related research reports on the association between them at home and abroad.This article reviews the possible mechanism and negative effects of sleep disorders in SBI，to improve clinical concerns of this disease to achieve early diagnosis and treatment.

Prevalence and Influence Factors of Poor Sleep Quality in the Target Population of Stroke Screening　

MA Qinying，LI Bing，XU Yong，LIU Meng，WANG Mingwei，WANG Yanyong

2020, 23(36): 4609-4614. DOI: 10.12114/j.issn.1007-9572.2020.00.468

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Background　Studies showed that sleep quality is closely related to cerebrovascular disease.The target population of stroke screening is the population with influence factors of cerebrovascular disease，but their sleep quality has been seldom studied.Objective　To investigate the prevalence and influence factors of poor sleep quality in the target population for stroke screening.Methods　In this study，residents who participated in stroke screening in Yuhua District，Shijiazhuang City，Hebei Province from December 2016 to June 2017 were selected as the target population for a survey after obtaining their informed consent.During the survey，a self-developed questionnaire named 2016 Follow-up Intervention Targeting Cardio-cerebrovascular Influence factors in Community and Township Population was used to collect parameters such as height，weight，neck circumference，waist circumference，systolic blood pressure and diastolic blood pressure，and so on，and the Pittsburgh Sleep Quality Index （PSQI） was used to evaluate the sleep quality （PSQI>7 and PSQI≤7 were defined as poor and normal sleep quality，respectively）.The questionnaires were filled by the investigators according to participants' verbal answers in response to the questionnaire questions （with oral explanation when necessary） asked by the investigators.Stroke risks were stratified in accordance with the diagnostic criteria of the "8+2" Stroke Risk Screening Program.Multivariate Logistic regression analysis was used to explore the influence factors of poor sleep quality.Results　Among the participants，4 716（99.05%） completed the survey effectively，and 7.91%（373/4 716） were found with poor sleep quality.Multivariate Logistic regression analysis showed that age 〔OR=1.030，95%CI（1.018，1.043）〕，female 〔OR=1.478，95%CI（1.116，1.957）〕，marital status 〔OR=1.044，95%CI（1.005，1.085）〕，retired 〔OR=2.402，95%CI（1.758，3.281）〕，high alcohol consumption 〔OR=1.395，95%CI（1.157，1.681）〕，unhealthy diet 〔OR=1.411，95%CI（1.221，1.630）〕and stroke risks 〔OR=1.484，95%CI（1.176，1.873）〕were associated with increased risk of poor sleep quality in the target population of stroke screening（P<0.05）.Conclusion　The problem of poor sleep quality in the target population of stroke screening can not be ignored，which may be associated with age，female，marital status，retired，high alcohol consumption，unhealthy diet and stroke risks.

Advances in Association of Insomnia with Tension-type Headache and Its Other Inducing Factors　

DAI Ruihong，LIAO Xiaoyang*

2020, 23(36): 4615-4618. DOI: 10.12114/j.issn.1007-9572.2020.00.559

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Tension-type headache （TTH） is among the most common nervous system disorders.In addition to early identified multiple traditional inducing factors of TTH，such as anxiety，depression，5-hydroxytryptamine，and pain，insomnia is a recently found inducing factor of TTH.Increasing epidemiologic studies have suggested insomnia is associated with TTH.This article reviews the latest advances in the association of insomnia with TTH and its other inducing factors，to increase the understanding of insomnia and TTH in primary care physicians，and to provide a reference for TTH prevention and treatment for high-risk groups.

Relationship between Sleep Duration or Sleep Quality and Non-alcoholic Fatty Liver Disease：a Meta-analysis　

WU Chutian，ZHANG Chenxing，XIAO Lin，TANG Shaohui

2020, 23(36): 4619-4625. DOI: 10.12114/j.issn.1007-9572.2020.00.548

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Background　Non-alcoholic fatty liver disease （NAFLD） is the most prevalent liver disease worldwide，which is likely to become the leading cause of end-stage liver disease.Unfortunately，the potential risks of NAFLD have not received sufficient attention.Although several studies have attempted to elucidate the relationship between sleep and NAFLD，their results vary widely.Objective　To evaluate the relationship between sleep duration or sleep quality and NAFLD.Methods　Databases of PubMed，EMBase，and CNKI were searched from inception to February 2020 to collect studies about the relationship between sleep duration or sleep quality and NAFLD.Two researchers independently screened the literature based on literature inclusion and exclusion criteria，extracted the data，and used the Newcastle-Ottawa Scale for quality evaluation.The Meta-analysis was performed using Stata 16.0.Results　A total of 16 articles were included.The meta-analysis results show that：short sleep duration（≤6 h） increased the risk of NAFLD by 18%〔OR=1.18，95%CI（1.04，1.33），P=0.01〕.Further subgroup analysis showed that the risk of NAFLD was increased by 28%〔OR=1.28，95%CI（1.11，1.48），P<0.01〕 when sleep duration was <5 h.Long sleep duration （>6 h ） had no effect on the incidence of NAFLD〔OR=0.98，95%CI（0.78，1.23），P=0.87〕.Further subgroup analysis found that the risk of NAFLD was increased by 22%〔OR=1.22，95%CI（1.08，1.36），P<0.01〕 when sleep duration > 8 h.But long sleep duration（>6 h ） reduced men's risk of NAFLD by 17%〔OR=0.83，95%CI（0.74，0.94），P<0.01〕.Poor sleep quality had no effect on the incidence of NAFLD〔OR=1.06，95%CI（0.94，1.20），P=0.36〕.But further subgroup analysis found that poor sleep quality increased the risk of NAFLD by 29% in females〔OR=1.29，95%CI（1.12，1.48），P<0.01〕.Conclusion　Short sleep duration（≤6 h） may increase the risk of NAFLD，and the shorter sleep duration，the higher the risk of NAFLD.The risk of NAFLD may increase when sleep duration is >8 h.But long sleep duration（>6 h ） may reduce men's risk of NAFLD.Poor sleep quality may increase the risk of NAFLD in females.More large-scale cohort studies and related trials are needed to further validate our results.

Constipation Due to Parkinson's Disease：a Case Report and Literature Review and Management of General Practice　

SHAO Shuangyang，LIU Ying，REN Jingjing

2020, 23(36): 4626-4630. DOI: 10.12114/j.issn.1007-9572.2020.00.124

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Constipation is a common clinical symptom.Because of the characteristics of age of onset，constipation due to Parkinson's disease is very common in outpatient clinics of general practice and grassroots health institutions.Through reviewing relevant literature，this paper summarized the etiologg and mechanism，characteristics and prevention of constipation due to Parkinson's disease and fully understood the needs of patients to emphasize that individualized treatment was the fundamental principle.Constipation due to Parkinson's disease belongs to the category of comorbidities.General practitioners should pay attention to the respective conditions of Parkinson's disease and constipation as well as their mutual connection in clinical work，develop personalized intervention and treatment plans following the concept of holistic and whole-process concept，timely carry out the targeted education，and be intend to do a good job in regular follow-up.

Clinical and Pedigree-based Genetic Analysis of 3 Cases of Mitochondrial Diabetes Mellitus　

ZHANG Nana，HUANG Youye，WANG Qi，ZHANG Qiu，HU Honglin

2020, 23(36): 4631-4635. DOI: 10.12114/j.issn.1007-9572.2020.00.450

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Background　Mitochondrial diabetes mellitus is a special type of diabetes mellitus.Due to atypical early clinical manifestations，it is easily misdiagnosed，delaying appropriate treatment.Gene detection is a focus in mitochondrial diabetes mellitus research as a major diagnostic means.Objective　To perform a mitochondrial gene sequencing in 3 clinically suspected mitochondrial diabetes mellitus patients and their family members to help to make a clear diagnosis and deliver precise treatment.Methods　Three suspected mitochondrial diabetes mellitus patients who were treated in Department of Endocrinology，the First Affiliated Hospital of Anhui Medical University and Lu'an People's Hospital between 2017 and 2019 and their 7 family members were enrolled.An analysis was performed on the clinical characteristics，laboratory and mitochondrial gene sequencing results of these patients and their family members.Results　A3243G mutation of the mitochondrial gene was found in the 3 suspected patients，and they were diagnosed with mitochondrial diabetes definitely.Some of their family members were also found to have A3243G mutation of the mitochondrial gene，including those with a previous diagnosis of diabetes.In particular，patient 1's mother，elder brother，and daughter had a presence of A3243G mutation of the mitochondrial tRNA gene，but her daughter had not have diabetic manifestations.Conclusion　Mitochondrial gene sequencing should be proactively performed in suspected mitochondrial diabetes mellitus patients and their family members in order to diagnose the disease and guide the treatment.

Clinical Characteristics of Patients with Resistance to Thyroid Hormone β　

DANG Pingping，XI Yue，JIN Ting，WANG Ranran，XIAO Weiwei，LIANG Yue，ZHAO Defa，WANG Wei，ZHANG Dan，TENG Xiaochun

2020, 23(36): 4635-4640. DOI: 10.12114/j.issn.1007-9572.2020.00.510

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Background　Resistance to thyroid hormone β （RTHβ） is a rare endocrine disease that is easily misdiagnosed and mistreated clinically.Objective　To summarize the clinical characteristics of patients with RTHβ，which will be helpful for clinicians to understand this disease.Methods　We selected six patients diagnosed with RTHβ from Department of Endocrinology and Metabolism，the First Affiliated Hospital of China Medical University from 2013 to 2016.We retrospectively analyzed the clinical data of the patients，including gender，age of diagnosis，age of onset，family history，chief complaint，electrocardiogram，thyroid palpation observations，thyroid ultrasound，and static thyroid radionuclide imaging，quantification of thyroid function indicators 〔free triiodothyronine acid （FT3），free thyroxine （FT4），thyroid stimulating hormone （TSH）〕，thyrotropin receptor antibody （TRAb），sex hormone binding protein （SHBG），serum ferritin，lipid metabolism indices，bone metabolism indices，and bone density and gene sequences.Results　The age of diagnosis was higher than the age of onset in all the patients.Before the diagnosis of RTHβ，the patients were misdiagnosed with hyperthyroidism and took antithyroid drugs for a long time.All patients complained of palpitations and hyperhidrosis，and three also had atrial fibrillation.Static thyroid radionuclide imaging showed an increase in the uptake rate of the thyroid double lobe in all six patients.Five patients showed thyroid enlargement on ultrasound，and four showed multiple nodules.All six patients showed elevated serum FT3 and FT4 levels，normal TSH，serum SHBG and ferritin levels，and were negative for TRAb.In gene sequencing，point mutations were observed in thyroid hormone receptor （TR） β in all patients.Conclusion　The clinical manifestations of RTHβ are highly heterogeneous.Therefore，in clinical diagnosis，attention should be given to distinguish RTHβ from hyperthyroidism and hypothyroidism.It should be noted that not all RTHβ patients have TRβ gene mutations.For patients with high suspicion of RTHβ，the thyrotropin-releasing hormone stimulation test，L-triiodothyronine inhibition test，or the combination of these two tests can be used for diagnosis.

Medication Discrepancies and Influencing Factors in Hospital-to-home Transition among Elderly Patients with Osteoporotic Vertebral Fracture　

CAI Guhao，GU Haiyan，GAO Hong，XU Guanhua，SUN Li

2020, 23(36): 4640-4644. DOI: 10.12114/j.issn.1007-9572.2020.00.509

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Background　Generally，medication discrepancies can increase the incidence of adverse drug events，reduce the efficacy of therapy，and even lead to adverse clinical outcomes in a population.Medication discrepancies in hospital-to-home transition has become a hot topic of nursing research in North America.However，in China，many studies focus on medication errors of inpatients，few studies are about patient medication discrepancies in hospital-to-home transition.Objective　To explore the medication discrepancies and influencing factors among elderly patients with osteoporotic vertebral fracture in hospital-to-home transition，to reduce the occurrence of medication discrepancies.Methods　Elderly patients with osteoporotic vertebral fracture who were hospitalized in Spinal Surgery Department，Second Affiliated Hospital of Nantong University between June 2018 and June 2019 were enrolled.Their demographics，disease-related information，and medication data were collected via reviewing medical records on the day before discharge.A telephone follow-up was performed at 4 weeks after discharge to evaluate the occurrence and causes of medication discrepancies.Results　A total of 172 patients were included，of whom 24 were lost to follow-up，and other 148 were included in the analysis，with a final enrollment rate of 86.0%.Among these patients，80 （54.0%） had medication discrepancies（182 times），with an average of 2.28 times per person.Specifically，the major types of medication discrepancies were decreased medication frequency 〔73 times （40.1%）〕 and dose decrease 〔37 times （20.3%）〕.Forgetting to take medicine〔38 times （20.9%）〕 and undetailed medication education at discharge〔58 times （31.9%）〕 were main reasons for the medication discrepancies.Multivariate Logistic regression results showed that medical insurance types〔OR=8.606，95%CI（1.505，49.207）〕，number of fractures〔OR=0.134，95%CI（0.041，0.444）〕，family care index〔OR=2.387，95%CI（1.536，3.710）〕，and knowledge of osteoporosis〔OR=0.881，95%CI（0.797，0.973）〕 were associated with medication discrepancies among elderly patients with osteoporotic vertebral fracture in hospital-to-home transition （P<0.05）.Conclusion　In the period shortly after discharge，there was high prevalence of medication discrepancies among elderly patients with osteoporotic vertebral fracture，which was associated with medical insurance types，number of fractures，family care index，and knowledge of osteoporosis.To reduce and prevent the occurrence of medication discrepancies in hospital-to-home transition，targeted interventions should be delivered by medical workers in collaboration with the patients and their family members.

Rituximab Salvage Therapy Is Inappropriate for Secondary Refractory Nephropathy　

ZHANG Dongliang，LUO Li，ZHENG Liren，HU Nana，WAN Li，YANG Qinghua，ZHANG Zhoucang

2020, 23(36): 4645-4650. DOI: 10.12114/j.issn.1007-9572.2020.00.465

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Background　Rituximab（RTX） has been used to treat glomerular diseases for nearly 20 years.Although there have been accumulated results from evidence-based studies of RTX for primary and secondary nephropathy，there is no research on RTX salvage therapy for severe renal insufficiency.Objective　To study the efficacy and safety of RTX salvage therapy in patients with secondary refractory nephropathy.Methods　Total 48 adult inpatients with refractory nephropathy，who received RTX treatment in Peking University International Hospital from 2018 to 2019，were enrolled in this retrospective study.They were divided into primary nephropathy （PN） group and secondary nephropathy （SN） group according to renal biopsy diagnosis of primary disease.Those in SN group were further divided into SN with non-salvage therapy group （SN-NST subgroup，Scr<300 μmol/L） and SN with salvage therapy group （SN-ST subgroup，Scr≥300 μmol/L） according to the Scr level before RTX treatment.General information （including gender，age，weight，height，body surface area and primary diagnosis），and laboratory tests results before and after using RTX，such as 24-hour urine protein （Upro），white blood cell （WBC） count，red blood cell （RBC） count，platelet （PLT） count，serum albumin （Alb），Scr，and CD4+ cell count as well as calculated CD4+ cell count/WBC ratio were collected.The serious adverse events during RTX treatment 〔including serious infection （treated either by 7 or more days of systemic antibiotic therapy or by more than one antibiotic agents），renal replacement therapy，multiple organ dysfunction syndrome，and death〕，were recorded.3-month renal outcome after the final RTX therapy（namely，whether requiring maintenance hemdialysis） was also recorded.Results　There were 19 （39.6%） patients in PN group，14 （29.2%）in SN-NST subgroup，and 15 （31.2%）in SN-ST subgroup.The mean age of SN-ST subgroup was less than that of PN group and SN-NST subgroup （P<0.05）.PN group showed higher mean baseline levels of 24 hUpro，RBC and PLT，and lower mean Alb than both subgroups SN-NST and SN-ST before using RTX（P<0.05）.SN-ST subgroup had higher mean level of Scr and less mean CD4+ cell count than PN group and SN-NST subgroup before using RTX（P<0.05）.The following several parameters were found with significant pre- and post-RTX treatment differences（P<0.05）：24 hUpro decreased in PN group and SN-NST subgroup，WBC count decreased in subgroups SN-ST and SN-NST，RBC count increased in SN-ST subgroup，PLT count decreased in PN group but increased in SN-ST subgroup，and Alb level increased in PN group and SN-NST subgroup.Post-RTX treatment intergroup comparison found that the mean level of Scr in SN-ST subgroup was higher than that of PN group and SN-NST subgroup （P<0.05）.The accumulated doses of RTX for PN group and SN-NST and SN-ST subgroups were （437±322）mg?month-1?（m2）-1，（503±344）mg?month-1?（m2）-1，and （331±312）mg?month-1?（m2）-1，respectively，showing no significant differences（F=1.048，P=0.359）.SN-ST subgroup had higher rates of serious infection and renal replacement therapy during RTX treatment as well as higher rate of maintenance hemodialysis 3 months after RTX treatment than PN group（P<0.05）.Moreover，compared to SN-NST subgroup，SN-ST subgroup had higher rates of renal replacement therapy during RTX treatment and maintenance hemodialysis 3 months after RTX treatment than PN-NST subgroup（P<0.05）.Conclusion　In those with Scr≥300 μmol/L，rather than improving the remission of nephropathy effectively and safely，RTX therapy may significantly increase the risks of serious infections and renal failure，so it should not be used as salvage therapy in them.

Application of a Novel Rapid Immunofluorescence Assay in Influenza Screening　

LI Xiaoguang，CHEN Jing，WANG Wei，LI Lu，LIN Fei，JIA Ying，ZHANG Biying，XU Jie

2020, 23(36): 4651-4655. DOI: 10.12114/j.issn.1007-9572.2020.00.441

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Background　Compared with nucleic acid tests，traditional rapid detection methods of influenza are less sensitive.New rapid detection methods for influenza need to be explored.Objective　To explore the clinical value of immunofluorescence assay in detecting influenza virus antigen.Methods　Participants were 472 febrile outpatients selected from Department of Infectious Diseases，Peking University Third Hospital in two influenza seasons （from July to December 2017，and from January to February 2019）.Their nasopharyngeal swab specimens were collected for influenza virus antigen detection using fluorescent immunoassay（Sofia system），and two traditional rapid influenza virus antigen tests，immunofiltration assay and colloidal gold technique，as well as RT-PCR，a nucleic acid amplification test.Results　By use of RT-PCR，292 （61.9%） of the 472 cases were found with influenza A/B virus antigens，including 195 （41.3%） with influenza A，94 （19.9%） with influenza B，and 3 with both influenza A and B.By use of immunofluorescence assay，262（55.5%） were found with influenza A/B virus antigens，including 169 （35.8%） with influenza A，and 93 （19.7%） with influenza B.With RT-PCR as the gold standard for influenza A/B detection，the sensitivity of immunofluorescence assay，immunofiltration assay，and colloidal gold technique，was 89.0%，82.9%，84.6%，respectively，and the specificity of them was 98.9%，97.2%，and 93.3%，respectively.For detecting influenza A alone，the sensitivity of immunofluorescence assay，immunofiltration assay，and colloidal gold technique was 85.4%，79.3%，79.3%，respectively，and the specificity of them was 100.0%，99.3%，and 97.1%，respectively.For detecting influenza B alone，the sensitivity of immunofluorescence assay，immunofiltration assay，and colloidal gold technique was 93.8%，87.6% and 89.7%，respectively，and the specificity of them was 99.5%，99.2%，and 97.3%，respectively.Compared with RT-PCR，diagnostic accuracy rates of immunofluorescence assay for influenza A/H1，influenza A/H3 and influenza B were 91.8%（56/61），84.7%（111/131），and 94.8%（91/96），respectively.In four age groups of 16-20，21-40，41-60，and over 60 years，the sensitivity of immunofluorescence assay for influenza A/B was 95.6%，90.2%，87.2% and 78.4%，respectively，and the specificity was 100.0%，98.2%，100.0%，and 100.0%，respectively.Conclusion　Fluorescent immunoassay shows a higher sensitivity in the detection of influenza A/B compared with immunofiltration assay and colloidal gold technique，which is promising in influenza screening.

Cooling Effect and Safety of a New Device for Low-temperature Intravenous Infusion in Patients with Central Hyperthermia　

ZHANG Yunhai，WU Dan，DENG Menghua，MA Mingyuan

2020, 23(36): 4656-4660. DOI: 10.12114/j.issn.1007-9572.2020.00.502

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Background　Physical hypothermia is a major method for inducing hypothermia in patients with central hyperthermia，with different clinical effect and obvious complications reported.Objective　To explore the cooling effect and safety of a new device for low-temperature intravenous infusion（Chinese utility model patent No.ZL2014 2 0070586.4）in central hyperthermia patients.Methods　93 cases of central hyperthermia admitted to the ICU，Foshan Hospital of TCM during 2015—2019 were enrolled and randomized into control group （basic treatment and physical surface cooling，n=29），treatment group 1 （basic treatment，physical surface cooling，and intravenous infusion of 4 ℃ fluids cooled by the refrigerator，n=32），and treatment group 2 （basic treatment，physical surface cooling，and intravenous infusion of fluids with a room temperature maintained by the new device，n=32）.The efficacy of treatment was evaluated by comparing coagulation indicactors〔fibrinogen（FbgC），activated partial thromboplastin time （APTT），prothrombin time （PT） and platelet count （PLT）〕 at 24 and 48 hours after treatment to the baseline levels，and anal temperature at 2，4，8，12，24 and 48 hours after treatment to the baseline level，as well as the Glasgow Coma Scale （GCS） score at one week after treatment to the baseline level.The safety of treatment was evaluated by the incidence of complications during treatment such as chills，arrhythmia and skin damage，and 28-day mortality rate obtained by telephone-based follow-up.Results　There was no interaction between the treatment protocol and treatment duration on FbgC，APTT，PT and PLT （P>0.05）.Different treatment protocols and treatment durations had no main effects on FbgC，APTT，PT and PLT （P>0.05）.Treatment group 2 showed much lower incidence of chills and skin damage than the other groups（P<0.017）.The treatment protocol and treatment duration had an interaction on anal temperature （P<0.05）.Different treatment protocols and treatment durations produced main effects on anal temperature （P<0.05）.In particular，treatment group 2 showed much lower anal temperature at each post-treatment measurement than the other groups （P<0.05）.Treatment group 2 had a much higher average post-treatment GCS score than the other groups（P<0.05）.However，there was no significant difference on 28-day mortality among the three groups （P>0.05）.Conclusion　Endovascular cooling using the new device showed rapid and stable cooling effect in patients with central hyperthermia，with a low rate of complications，so it is worth popularizing in clinical practice.

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