Chinese General Practice

Interpretation of the Newly Released European Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries：Improving the Ability of Hierarchical Diagnosis and Treatment，and Strengthening the Joint Management of General Practitioners and Specialist Physicians　

HUANG Baotao，CHEN Mao

2021, 24(2): 125-131. DOI: 10.12114/j.issn.1007-9572.2020.00.632

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Ischaemia with non-obstructive coronary arteries（INOCA）refers to a disease with suspected ischemic symptoms，while no obstructive coronary artery stenosis（stenosis degree ≥50%）is found by coronary angiography.The disease is prevalent but individuals with INOCA are significantly undertreated.Recently，an EAPCI expert consensus document was released on ischaemia with non-obstructive coronary arteries in collaboration with European society of cardiology working group on coronary pathophysiology & microcirculation endorsed by coronary vasomotor disorders international study group.We interpreted the consensus document from the aspects of INOCA endotypes，epidemiology，risk factors，pathophysiology mechanism，clinical features，prognostic significance，noninvasive and invasive diagnostic methods，and patient management and medication，in order to raise awareness of clinicians for INOCA，prompt them to put a high value on INOCA endotypes and take tailored treatment，with the ultimate goals of improving angina symptoms and prognosis of patients with INOCA，and reducing medical cost.

Advances in Etiology and Prognosis of Myocardial Infarction with Non-obstructive Coronary Arteries　

ZHANG Yiman，HUANG Baotao，SHI Ruijuan，CHEN Mao

2021, 24(2): 132-137. DOI: 10.12114/j.issn.1007-9572.2021.00.055

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Myocardial infarction with non-obstructive coronary arteries（MINOCA）is a syndrome with multiple causes，which accounts for 5%-25% of acute myocardial infarction and arouses widespread concern in clinical practice in recent years.As the global definition of myocardial infarction has changed，the etiology of MINOCA may have also changed.Meanwhile，the prognosis of MINOCA remains unclear due to the influence of different causes.In this review，according to the Fourth Universal Definition of Myocardial Infarction and recent accumulating evidence on MINOCA，the etiology and diagnostic algorithm of MINOCA were further summarized，and the short-term middle-term and long-term prognosis of MINOCA were analyzed.We suggested that patients diagnosed with MINOCA should be evaluated to uncover the potential cause as far as possible for improving the prognosis，and hoped that further research would be carried out to explore the impact of different causes on the prognosis of MINOCA.

Relationship between Gene-environment Interaction and Hypertension and Its Implications for Community Management　

SHI Yuncong，WANG Lili，GUO Yifang

2021, 24(2): 138-142. DOI: 10.12114/j.issn.1007-9572.2020.00.521

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Hypertension is a complicated disease affected by both gene-gene and gene-environment interactions.Risk factors for hypertension mainly consist of environmental（lifestyle）and genetic factors.Previous genome-wide association studies have indicated the polygenic complexity of hypertension.We summarized the recent advances in gene-environmental interactions in hypertension，finding that non-drug therapy is the basic approach to hypertension.However，whether using drug therapy or not，these patients should maintain a healthy lifestyle，including a healthy diet，quitting smoking，moderate alcohol consumption，improving sleep，and exercising regularly.Although several gene mutation sites associated with hypertension have been found，further experimental studies are needed to explore the regulatory mechanisms of hypertension-related genes.

Computer-aided Diagnosis Model Assists Paroxysmal Atrial Fibrillation Diagnosis in Primary Care　

YAO Yi，LIAO Xiaoyang，LI Zhichao

2021, 24(2): 143-147. DOI: 10.12114/j.issn.1007-9572.2020.00.552

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Atrial fibrillation is a common arrhythmia that can cause many serious complications.Among them，paroxysmal atrial fibrillation is difficult to diagnose due to paroxysmal and asymptomatic characteristics.Big ECG data obtained by long-term ECG can improve the detection rate of paroxysmal atrial fibrillation.However，the interpretation of ECG big data has become a burden and problem for primary medical institutions.To solve the problems，a variety of shallow learning models based on ECG features have been developed，which highly rely on manual feature extraction and have limitations.Deep learning is a data-driven automatic feature learning algorithm，which can make up for the shortcomings of shallow learning.As an emerging method for rapid analysis of ECG big data，the Lorenz scatterplots using two-dimensional graphs is high-quality materials for deep learning.This paper reviews the latest advances in ECG features of atrial fibrillation using computer-aided model for diagnosis，and the application of machine learning in atrial fibrillation diagnosis，providing new insights into the development of a good computer-aided diagnosis model，and a new perspective for the interpretation of ECG big data in primary care.

Effects of Long-term Blood Pressure Variability on Arteriosclerosis　

WU Aiping，MA Yihan，LI Xingyu，HAN Xu，LIU Qian，SONG Yongjian，LI Guo，WU Shouling，WU Yuntao

2021, 24(2): 148-153. DOI: 10.12114/j.issn.1007-9572.2021.00.060

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Background　Long-term blood pressure variability（BPV）is an important independent risk factor for cardiovascular disease.It is unclear how long-term BPV contributes to the development of cardiovascular disease.There are no studies on the relationship between long-term BPV and arterial stiffness in China.Objective　To investigate the effect of long-term BPV on arteriosclerosis.Methods　A total of 21 420 eligible workers of Kailuan Group who attended annual staff physical examinations（2006，2008 and 2010）with complete data of examinations were recruited.Data were collected，such as body mass index（BMI），low-density lipoprotein（LDL），high-density lipoprotein（HDL），fasting blood glucose（FBG），blood pressure，brachial-ankle pulse wave velocity（baPWV），and calculated standard deviation of systolic blood pressure（SBP_SD）.The differences across tertiles groups of SBP_SD〔low SBP_SD group（n=7 188），medium SBP_SD group（n=7 102），and high SBP_SD group（n=7 130）〕 were analyzed.The relationship between SBP_SD and baPWV was analyzed by multiple linear regression.Multivariate Logistic regression analysis was used to investigate the association of SBP_SD with arteriosclerosis.Results　Compared with low SBP_SD group，medium SBP_SD group had greater average age，higher average SBP_SD，baPWV，BMI，FBG and LDL，and higher average SBP in 2006，2008 and 2010（P<0.05），and high SBP_SD group showed higher average SBP_SD，baPWV，BMI，hear rate，FBG and LDL，and higher average SBP in 2006，2008 and 2010（P<0.05）.Multiple linear regression analysis showed that SBP_SD was an influential factor of baPWV（P<0.05）.Multivariate logistic regression analysis showed that SBP_SD was an influential factor in the occurrence of arteriosclerosis（P<0.05）.SBP_SD remained an influential factor in baPWV and the development of arteriosclerosis in both non-hypertensive and hypertensive groups（P<0.05）.Conclusion　Long-term BPV may be a risk factor for arteriosclerosis，which may cause arteriosclerosis.

Relationship between Noninvasively Measured Central Aortic Pulse Pressure and Hypertensive Atherosclerotic Cardiovascular Disease　

WU Cuncao，CHEN Qiling

2021, 24(2): 154-158. DOI: 10.12114/j.issn.1007-9572.2021.00.052

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Background　As a major cause of disability and primary death worldwide，atherosclerotic cardiovascular disease（ASCVD）in hypertensive patients should be diagnosed and intervened as early as possible.It has been reported that central aortic pressure has a higher predictive value for cardiovascular events than peripheral arterial blood pressure.However，there are few reports on the association of noninvasively measured central aortic pressure with hypertensive ASCVD.Objective　To investigate the differences of noninvasively measured central aortic systolic pressure（CASP），central aortic diastolic pressure（CADP），central aortic pulse pressure（CAPP），and brachial artery pressure in hypertensive patients with and without ASCVD.Methods　Clinical data of 239 hypertensive outpatients were recruited from Peking University People’s Hospital from August to December 2019， including 61 with ASCVD and 178 without. Brachial artery pressure，and noninvasively measured CASP，CADP and CAPP were compared between ASCVD and non-ASCVD groups.Multivariate Logistic regression was performed to identify the factors affecting the occurrence of hypertensive ASCVD．Results　Compared with non-ASCVD group，ASCVD group had greater average age，less average heart rate and lower prevalence of smoking，lower average brachial arterial diastolic pressure and CADP，and higher average CAPP（P<0.05）.In all the participants，ASCVD group or non-ASCVD group，the average CASP was lower than the average brachial arterial systolic pressure（P<0.05），the average CAPP was lower than the average brachial arterial pulse pressure（P<0.05），and the average CADP was higher than the average brachial arterial diastolic pressure（P<0.05）.Age was related to hypertensive ASCVD〔OR（95%CI）=1.073（1.040，1.108），P<0.05﹞.Further univariate analysis revealed that in patients aged 65 and above（n=99），those with ASCVD had lower average brachial arterial systolic pressure than those without（P<0.05）.In patients aged less than 65（n=140），those with ASCVD had greater average age，less average heart rate and higher average CAPP than those without（P<0.05）.Conclusion　Compared with brachial artery pulse pressure，noninvasively measured CAPP is a more sensitive marker of hypertensive ASCVD.In those younger than 65 years，increased noninvasively measured CAPP is related to ASCVD.

Association of Hyperhomocysteinemia with Cardio-cerebral Atherosclerosis in Patients with Hypertension　

LI Lei，YANG Ruiling，LI Liyan，WANG Chunqing，ZHAO Xudong，LI Pingjing，ZHAO Yali

2021, 24(2): 159-163. DOI: 10.12114/j.issn.1007-9572.2020.00.556

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Background　Hyperhomocysteinemia is a new risk factor for atherosclerosis，but its detailed association with atherosclerosis is still controversial in China．This study investigated the associations of hyperhomocysteinemia level with the severity of cardio-cerebral atherosclerosis as well as stroke and coronary heart disease prevalence in hypertension.Objective　To explore the associations of different hyperhomocysteinemia levels〔homocysteine（Hcy）≥10μmol/L or ≥15μmol/L 〕 with the severity of cardio-cerebral atherosclerosis in hypertension.Methods　One hundred and sixty-eight patients with newly diagnosed mild-to-moderate hypertension from Department of General Practice and Health Center，the Affiliated Hospital of Xuzhou Medical University from October to November 2019 were enrolled，and assigned to three groups according to Hcy level：group A（Hcy<10 μmol/L，n=50），group B （10 μmol/L≤Hcy<15 μmol/L，n=52） and group C（Hcy≥15 μmol/L，n=66）．Clinical data〔BMI，systolic and diastolic blood pressure，plasma lipid profile （total cholesterol，triglyceride，high-density lipoprotein，low-density lipoprotein），fasting plasma glucose，glycosylated hemoglobin，uric acid，folic acid，Hcy〕，ultrasound-assessed endothelium-dependent vasodilation of brachial artery（UEVBA）and carotid intima-media thickness，carotid intima-media thickness and lacunar infarction and coronary heart disease prevalence were compared among the groups．Multivariate Logistic regression was used to analyze the factors associated with lacunar infarction and coronary heart disease．Results　The average plasma folic acid level decreased successively across groups A，B，C（P<0.05）．Group C showed higher lacunar infarction prevalence than group A（P<0.001） and group B（P=0.045）．Group B had higher lacunar infarction prevalence than group A（P=0.035）．Coronary heart disease prevalence in group C was higher than that in group A（P=0.021） and group B（P=0.035）．There was no significant difference in coronary heart disease prevalence between groups A and B（P=0.802）．Multivariate Logistic regression analysis showed that systolic blood pressure，diastolic blood pressure，total cholesterol，high-density lipoprotein，Hcy≥10 μmol/L and carotid intima-media thickness were associated with lacunar infarction （P<0.05），and systolic blood pressure，diastolic blood pressure，total cholesterol，low-density lipoprotein，Hcy ≥15 μmol/L and UEVBA were associated with coronary heart disease（P<0.05）．Conclusion　Hyperhomocysteinemia may aggravate atherosclerosis in patients with hypertension．Our study suggests that Hcy≥10 μmol/L is an influencing factor of lacunar infarction，and Hcy≥15 μ mol/L is an influencing factor of coronary heart disease in hypertension.

Effect of G Protein-coupled Receptor Kinase 4 Gene Polymorphism and Its Combined with Salt Sensitivity on Hypertension in Tibetans　

CAO Jing，LIU Xibo，WANG Yun，WANG Shuxia1LI Mingyang，HU Jihong

2021, 24(2): 164-169. DOI: 10.12114/j.issn.1007-9572.2020.00.581

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Background　Hypertension is associated with both genetic and environmental factors.Studies have found that either G protein-coupled receptor kinase 4（GRK4）gene or salt sensitivity can affect the occurrence of hypertension，and there may be an interaction between GRK4 gene and salt sensitivity，but the specific relationship is still unclear，and relevant studies in ethnic minorities are rare in China.Objective　To explore the influence of GRK4 gene polymorphism and its combined with salt sensitivity on hypertension among Tibetan population in Gannan Tibetan Autonomous Prefecture.Methods　A total of 799 Tibetans with essential hypertension and 674 Tibetans with normal blood pressure were selected from Xiahe County and Hezuo City，Gannan Tibetan Autonomous Prefecture with multistage random sampling method from August 2013 to November 2014.A questionnaire developed by our project team was used to survey data regarding gender，age，occupation，educational level，lifestyle（smoking，drinking，physical exercise）.Blood pressure，weight，and height were examined，and body mass index（BMI）was calculated.Salt sensitivity was determined by using improved salt-loading test.The single nucleotide polymorphisms（SNP）of GRK4 in the peripheral venous sample was tested.The differences of basic characteristics and distribution of genotypes at each locus among two groups were analyzed.Logistic regression was used to analyze the effect of GRK4 and salt sensitivity and their interaction on hypertension.Results　The gender ratio，average age，distribution of occupation and education level，prevalence of smoking，drinking，and physical exercise，average systolic blood pressure，BMI and salt sensitivity all were significantly different in two groups（all P<0.05）.The distributions of genotypes and allele frequencies in rs2488815，rs12506119，rs1419043 and rs1801058 were significantly different in two groups（all P<0.05）.The four SNPs of rs12506119，rs1419043，rs2471338 and rs3733219 in GRK4 gene were consistent with Hardy-Weinberg equilibrium in two groups（all P>0.05）.Results from logistic regression analysis showed that，salt sensitivity was associated with increased risk of hypertension〔OR=1.69，95%CI（1.14，2.50）P<0.05〕，while CG genotype of rs1419043 was associated with decreased risk of hypertension〔OR=0.13，95%CI（0.02，0.99）P<0.05〕.Analysis of the interaction between genes and salt sensitivity showed that，in participants without salt sensitivity，GA genotype of rs12506119〔OR=0.33，95%CI（0.15，0.73）〕and CG genotype of rs1419043〔OR=0.32，95%CI（0.15，0.68）〕were associated with decreased risk of hypertension（P<0.05）.In those with salt sensitivity，GG genotype of rs12506119〔OR=1.45，95%CI（1.09，1.92）〕，GG genotype of rs1419043〔OR=1.43，95%CI（1.07，1.90）〕，AA genotype of rs2471338〔OR=1.49，95%CI（1.11，2.00）〕，TT genotype〔OR=1.40，95%CI（1.02，1.91）〕and CT genotype〔OR=1.60，95%CI（1.07，2.40）〕of rs3733219 were risk factors of hypertension（P<0.05）.Conclusion　GRK4 gene may be related to hypertension in Tibetans，and the effects of different loci in GRK4 gene on hypertension varied significantly by salt sensitivity.

Diagnostic Value of Platelet Endothelial Cell Adhesion Molecule-1 Combined with Serum Lipoprotein-associated Phospholipase A2 in Evaluating the Stability of Carotid Atherosclerotic Plaque　

HUANG Liqiang，CHENG Daobin，YE Ziming，HU Ruiting，ZHOU Mengxiao，QIN Chao

2021, 24(2): 170-175. DOI: 10.12114/j.issn.1007-9572.2020.00.331

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Background　The shedding and rupture of carotid atherosclerotic plaques are independent risk factors for acute stroke，but the stability of carotid atherosclerotic plaques lacks quantitative evaluation indicators.Objective　To explore the diagnostic value of platelet endothelial cell adhesion molecule-1 （PECAM-1/CD31）combined with serum lipoprotein-associated phospholipase A2 （Lp-PLA2）in evaluating the stability of carotid atherosclerotic plaque.Methods　139 patients with carotid atherosclerosis plaque admitted to Department of Neurology，the First Affiliated Hospital of Guangxi Medical University from October 2017 to March 2019 were enrolled，including 76 with unstable plaques and 63 with stable plaques detected by contrast-enhanced ultrasound.Gender，age，BMI，smoking，drinking，hypertension and atrial fibrillation prevalence，fasting plasma glucose（FPG），serum white blood count（WBC），red blood count（RBC），neutrophil count，platelet，creatinine，uric acid，fibrinogen，high-sensitivity C-reactive protein（hs-CRP），total cholesterol，triacylglycerol，high-density lipoprotein，low-density lipoprotein and Lp-PLA2，and PECAM-1/CD31were collected.The independent risk factors affecting the stability of carotid atherosclerotic plaque were screened out by multivariate Logistic regression analysis，and the ROC curve of the indicator，either alone or in combination，was established to evaluate the efficiency in evaluating the stability of carotid atherosclerotic plaque.Results　The prevalence of smoking and atrial fibrillation，average levels of hs-CRP，total cholesterol，triacylglycerol，high-density lipoprotein，low-density lipoprotein，PECAM-1 / CD31，and Lp-PLA2 in unstable plaque group were higher than those of stable plaque group（P<0.05）.Multivariate Logistic regression analysis showed that low-density lipoprotein 〔OR=2.453，95%CI（2.322，2.591）〕，PECAM-1/CD31 〔OR=1.372，95%CI（1.166，1.614）〕and Lp-PLA2〔OR=1.827，95%CI（1.565，2.133）〕were associated with the occurrence of unstable carotid atherosclerotic plaques（P<0.05）.PECAM-1 / CD31（r=0.090，P=0.031）and Lp-PLA2（r=0.090，P=0.005）were significantly positively correlated with low-density lipoprotein.The area under the ROC curve（AUC）of PECAM-1 / CD31 for the diagnosis of stability of carotid atherosclerotic plaque was 0.686〔95%CI（0.224，0.405）〕，when the optimal cut-off point was determined as 11.050 mg / L，with 77.60% sensitivity and 60.30% specificity.The AUC of Lp-PLA2 was 0.724〔95%CI（0.189，0.364）〕，when the optimal cut-off point was determined as 176.585 mg / L，with 98.70% sensitivity and 47.60% specificity.And the AUC of PECAM-1 / CD31 in combination with Lp-PLA2 was 0.875〔95%CI（0.112，0.254）〕，when the optimal cut-off point was determined as 125.28 mg / L，with a sensitivity of 89.50%，and a specificity of 83.20%.Conclusion　Either PECAM-1 / CD31 or Lp-PLA2 showed efficiency in diagnosing unstable carotid atherosclerotic plaque.The combination of the two showed higher value，which may be used as a quantitative diagnostic indicator.

Correlation between Gamma-glutamyl Transferase and Coronary Heart Disease　

JIANG Yuanying，SHI Ling，LIU Yao

2021, 24(2): 176-182. DOI: 10.12114/j.issn.1007-9572.2020.00.422

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Background　In recent years，studies have suggested that the gamma-glutamyl transferase （GGT） is related to coronary heart disease（CHD）.As GGT exists in a variety of human tissues and organs，it is still unclear whether GGT level can predict CHD.Objective　This paper aimed to study the correlation between GGT level and CHD.Methods　We selected 481 patients who underwent coronary angiography in Huashan Hospital，Fudan University from September 2016 to January 2018，including 351 with coronary angiography-detected CHD （CHD group） and 130 without （non-CHD group）.We analyzed their general condition，laboratory results，left ventricular ejection fraction （LVEF），and severity of the coronary lesion determined by the Gensini score［stratified into low risk （<20 points）（n=260），medium risk （20-50 points）（n=121），and high risk （>50 points）（n=100），respectively］．We used multivariate Logistic regression analysis to identify the associated factors for CHD，and used ROC curve analysis to evaluate the diagnostic value of GGT in CHD.Results　CHD and non-CHD groups showed significant differences in sex ratio，average age，prevalence of history of diabetes and cerebral infarction，smoking rate，average HbA1c，GGT，high-density lipoprotein cholesterol，lipoprotein（a），albumin，uric acid，creatinine，ALT，AST，platelet-to-lymphocyte ratio （PLR），LVEF（P<0.05）.Low，medium and high risk groups had significant differences in average GGT and NLR （P<0.05）.In CHD group，those aged less than 65 years old had higher average GGT than those aged 65 or over （P<0.05），but they showed similar average Gensini score （P>0.05）.However，in non-CHD group，those aged less than 65 and those aged 65 or over had no significant differences in average GGT level and Gensini score （P>0.05）.Multivariate Logistic regression analysis showed that HbA1c 〔OR=1.403，95%CI（1.022，1.912）〕，GGT 〔OR=1.049，95%CI（1.011，1.089）〕，ALT 〔OR=1.062，95%CI（1.017，1.110）〕，AST 〔OR=0.892，95%CI（0.816，0.974）〕 and Gensini score 〔OR=1.534，95%CI（1.374，1.712）〕 were associated with CHD （P<0.05）.In diagnosing CHD，the AUC of Gensini score，HbA1c，and GGT was 0.959 〔95%CI（0.937，0.975）〕，0.572〔95%CI（0.527，0.617）〕，and 0.679 〔95%CI（0.635，0.720）〕，respectively，showing that Gensini score had a greater AUC than HbA1c and GGT （Z=10.305，P<0.001；Z=13.865，P<0.001），and GGT had a greater AUC than HbA1c （Z=2.906，P=0.004）.Conclusion　Increased GGT level is correlated with CHD independently，and shows a positive association with the severity of CHD，which may partially contribute to the diagnosis and prognosis prediction of early onset CHD and severe CHD.

Clinicopathological Characteristics and Prognosis of Minimal Change Nephropathy with Type 2 Diabetes Mellitus　

YAO Xingchen1，2，ZHAI Yaling，GAO Jingge，CHEN Yazhuo，WANG Xinnian，LU Shan，ZHAO Zhanzheng

2021, 24(2): 183-189. DOI: 10.12114/j.issn.1007-9572.2020.00.451

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Background　In recent years，type 2 diabetes（T2DM）incidence is increasing in the young population，and minimal change disease（MCD）combined with T2DM is becoming less uncommon clinically.But the clinical and pathological characteristics and prognosis of MCD with T2DM are still unclear.Objective　To analyze the clinical and pathological characteristics and prognosis of patients with MCD combined with T2DM.Methods　Participants with renal biopsy-confirmed MCD were recruited from Department of Nephrology，the First Affiliated Hospital of Zhengzhou University during from June 1，2017 to June 1，2018，including 20 with MCD and T2DM（MCD with T2DM group），and 100 with MCD（MCD group）from 306 with simple MCD using a random number table generated by the SPSS 22.0.The clinicopathological and follow-up data of all patients（follow up from the first renal biopsy to recurrence or to June 2019）were collected，and clinical manifestations，pathological characteristics and prognosis were retrospectively analyzed.Univariate and multivariate logistic regression analyses were used to explore the independent risk factors of MCD with T2DM.Log-rank test was used to compare the cumulative complete remission rate and cumulative relapse-free survival rate of MCD and MCD with T2DM groups.Results　Compared with the MCD group，the median age，systolic blood pressure（SBP），fasting blood glucose，serum glycosylated hemoglobin（HbA1c），albumin（ALB）and serum IgG levels and prevalence of hypertension were higher，and male ratio，median levels of total cholesterol（TC），high-density lipoprotein（HDL），low-density lipoprotein（LDL）erythrocyte sedimentation rate（ESR），and 24-hour quantitative proteinuria were lower in MCD with T2DM group（P<0.05）.Moreover，MCD with T2DM group also showed higher rates of having higher severity of vascular injury and renal tubular atrophy，and higher prevalence of renal interstitial fibrosis，renal interstitial inflammation and glomerular sclerosis（P<0.05）.Univariate Logistic regression analysis showed that sex〔OR=5.108，95%CI（1.717，15.200）〕，age〔OR=1.068，95%CI（1.006，1.133）〕，hypertension〔OR=6.000，95%CI（1.982，18.165）〕，HbA1c〔OR=84.019，95%CI（12.465，566.317）〕，ALB〔OR=1.173，95%CI（1.100，1.250）〕，TC〔OR=0.730，95%CI（0.619，0.861）〕，ESR〔OR=0.978，95%CI（0.960，0.996）〕，24-hour quantitative proteinuria〔OR=0.818，95%CI（0.705，0.948）〕，IgG〔OR=1.568，95%CI（1.288，1.908）〕，prevalence of glomerular sclerosis〔OR=13.286，95%CI（4.142，42.614）〕，the severity of vascular injury，renal tubular atrophy and interstitial fibrosis〔OR=17.000，95%CI（4.833，59.794）〕 and renal interstitial inflammation〔OR=10.111，95%CI（2.684，38.087）〕were associated with MCD combined with T2DM（P<0.05）.Multivariate logistic regression analysis showed that IgG level〔OR=1.476，95%CI（1.190，1.831）〕and the severity of vascular injury and renal interstitial fibrosis〔OR=12.433，95%CI（2.032，76.065）〕were associated with MCD combined with T2DM（P<0.05）.Log-rank test showed that the cumulative complete remission rate of MCD with T2DM group was significantly lower than that of MCD group（P=0.027）.However，there was no significant difference in cumulative relapse-free survival rate of between the two groups（P=0.318）.Conclusion　Compared with the MCD group，the clinical manifestations of MCD with T2DM group are relatively slighter，but the pathological manifestations are more serious，which indicates the importance of renal biopsy by clinicians.Renal interstitial fibrosis，severe vascular injury，and elevated IgG level are risk factors for MCD combined with T2DM.The prognosis of MCD combined with T2DM is poor.

Establishment and Value Evaluation of Prognostic Model of Acquired Immunodeficiency Syndrome Patients Complicated with Pneumocystis Pneumonia　

CHEN Tao，JIANG Zhongsheng，LI Minji，MO Shenglin，ZHANG Peng，HU Jiaguang，QIN Jinyu，MENG Dali

2021, 24(2): 190-195. DOI: 10.12114/j.issn.1007-9572.2020.00.426

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Background　Pneumocystis pneumonia （PCP），a respiratory opportunistic infection caused by pneumocystis，is an indicative disease of acquired immune deficiency syndrome （AIDS）.AIDS with PCP occurs subacutely in most patients，and progresses rapidly in some patients，which has poor response to medical treatment，with short-term high mortality.Therefore，the recent prognosis of such patients should be accurately predicted in order to guide clinical treatment.Objective　To identify the risk factors associated with the prognosis of AIDS patients with PCP，to develop a prognostic model for such patients.Methods　From January 2009 to August 2017，300 cases of AIDS with PCP from Liuzhou People's Hospital were enrolled，and were randomized into modelling group （n=241） and validation group （n=59） with a grouping scheme developed using SPSS 19.0.The clinical data of the modelling group were analyzed retrospectively，including essential data，complication，laboratory examination，and so on.Univariate and multivariate Logistic regression analyses were used to screen independent prognostic risk factors to construct the prognostic model.The data of validation group were used to evaluate the predictive ability of the prognostic model.Results　Multivariate Logistic regression analysis showed that the independent prognostic factors of AIDS with PCP were albumin （ALB）〔OR=0.759，95%CI（0.595，0.967）〕，lactate dehydrogenase（LDH）〔OR=1.009，95%CI（1.003，1.015）〕，CD4+T lymphocyte count 〔OR=0.878，95%CI（0.790，0.975）〕，alveolar-arterial gradient 〔P（A-a）O2〕〔OR=1.164，95%CI（1.073，1.262）〕（P<0.05）.The algorithm for the prediction model was: P=1/（1+e-y），Y=-0.278-0.276×ALB-0.131×CD4++0.009×LDH+0.152×P（A-a）O2，（P refers to the deteriorative probability，and Y is the prognostic index）.Hosmer-Lemeshow test results showed that the model fitting degree was good（χ2=3.974，df=8，P=0.859）.The AUC for the model's predictive value was 0.986〔95%CI（0.970，1.000），P<0.001〕.In predicting the prognosis of the validation group，the model showed 97.50% specificity，89.47% sensitivity，94.44% positive predictive value，95.12% negative predictive value and 94.91% total accuracy.Conclusion　As independent risk factors for AIDS with PCP，ALB，LDH，CD4+T lymphocyte count and P（A-a）O2 can be used to construct the prognostic model.The prognostic model in this study may accurately predict the short-term prognosis of such patients.

Clinical Features and Prognostic Risk Factors of COVID-19 in Adults: a Retrospective Analysis of 93 Cases　

CAI Miaotian，LI Tongzeng，ZHANG Longyu，XU Hui，MOU Danlei，LIANG Lianchun

2021, 24(2): 196-204. DOI: 10.12114/j.issn.1007-9572.2021.00.056

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Background　Since April 2020， the number of newly diagnosed cases and death cases of COVID-19 have decreased significantly in China but increased rapidly abroad.Early diagnosis and treatment are of great concern to improving the prognosis of COVID-19 patients.Objective　To investigate the clinical features and prognostic risk factors of adult patients with COVID-19，offering a reference for clinical diagnosis and treatment of this disease.Methods　A retrospective design was used.Participants were 93 adult cases of COVID-19 who were treated in Beijing Youan Hospital between January and February 2020.They were categorized into common，severe and critical types by the most serious conditions during hospitalization，in accordance with the Diagnosis and Treatment Protocol for COVID-19（Trial Version 7）issued by the National Health Commission of the People's Republic of China.Indications such as general information，major clinical manifestations，baseline laboratory parameters，APACHE II and SOFA scores within 24 hours of admission，imaging findings，comorbidities and complications，treatments and outcomes were collected.Results　There were 57 cases of common type（61.3%），22 of severe type（23.7%）and 14 of critical type（15.0%）.The male ratio was slighter higher in critical group，and female ratio was slighter higher in other groups，but sex composition showed no significant differences across the groups（P>0.05）.The median age for common，severe and critical groups was 45.0，62.0 and 81.0 years，respectively，showing significant differences（P<0.05）.And the proportion of patients older than 60 years differed across common，severe and critical groups（15.8% vs 54.5% vs 92.9%）（P<0.05）.Compared with common and severe groups，the rate of positive-to negative inversion of SARS-CoV-2 viral load detected by nucleic acid test was decreased，the duration of viral shedding was prolonged，and the interval from onset to dyspnea was shortened，markedly in critical group（P<0.05）.Fever and cough were the most common clinical manifestations whose overall incidences were 88.2% and 87.1%，respectively，showing no significant difference among the groups（P>0.05）.Dyspnea occurred in all severe or critical cases，showing a higher incidence than common cases（100.0% vs 31.6%）（P<0.05）.The incidence of lymphocytopenia in critical group was 100%，which was significantly higher than that in common group（49.1%）or severe group（59.1%）（P<0.05）.Acute liver injury was the most common complication（58.1%）in all cases，but its incidence was obviously increased in severe group （77.3%） or critical group（92.9%），than that of common group（42.1%）（P<0.05）.Chinese medicine therapy was used in 75.3% of all cases，but the severe cases had a higher rate of treating with Chinese medicine than critical cases（90.9% vs 50.0%，P<0.05）.The rate of corticosteroid use in severe cases（63.6%）or critical cases（64.3%）was significantly increased than that of common cases（5.3%）（P<0.05）.Six patients（6.5%）were treated with invasive ventilation， but only 1 of them（16.7%）was successfully extubated ultimately.Nine patients（9.7%）died in hospital due to all causes.Logistic regression analysis revealed that age ≥74 years〔OR（95%CI）=33.714（3.021，376.211），P=0.004〕and baseline SOFA≥2.5〔OR（95%CI）=15.447（1.331，179.260），P=0.029〕were independent risk factors for in-hospital death. Conclusion　COVID-19 mainly manifests as respiratory infections. Severe patients are apt to appear tissue injury and dysfunction of organs like liver， kidney and heart， etc. The majority of patients have a favorable outcome. Age and baseline SOFA score would help to label the prognosis of patients at an early stage.

Analysis of Influencing Factors of Suspected Allergic Reaction to Ossotide Injection：Based on Real Data from 7 Medical Institutions　

RAN Chao，ZHOU Hu，TAN Chao，TAN Juntao，ZHAO Wenlong

2021, 24(2): 205-209. DOI: 10.12114/j.issn.1007-9572.2020.00.486

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Background　 The monitoring data of the National Drug Adverse Reaction Monitoring Center showed that the application of ossotide injection can cause severe allergic reaction，and the occurrence of drug allergic reaction in hospital can prolong the time of hospitalizati，increase the financial burden of patients，and even threaten patients' lives.However，there are few studies on the affecting factors of allergic reaction to ossotide injection.Objective　To investigate the influencing factors of suspected allergic reactions to ossotide injection，and to provide a reference for clinical rational drug use.Methods　The 9 351 cases of inpatient medical records with ossotide injection which were covered by seven 3A general hospitals from January 2010 to January 2020 were collected.The patients with suspected allergic reaction and non-allergic patients were analysised and screened by prescription sequence analysis，and the patients with suspected allergic reaction were included into the group of suspected allergic reaction（n=68）.Propensity score matching was used to match the control group from non-allergic patients in a ratio of 1∶4（n=272）.The age，sex，hospital department，allergy history and medication use of the two groups were collected〔including single dose of ossotide injection，menstruum and combination medication use（the first 20 drugs of ossotide injection combined drug use frequency were selected for analysis due to the limitation of sample size，and only one drug use was recorded for the same patient）〕.Univariate Logistic regression analysis and multivariate Logistic regression analysis were used to analyze the affecting factors of suspected allergic reaction of ossotide injection.Results　Univariate Logistic regression analysis showed that potassium chloride，omeprazole，ambroxol and calcium acetate in the combination of drugs might be the affecting factors of the suspected allergic reaction （P<0.05）.Multiple Logistic regression analysis showed that potassium chloride（OR=3.515，P=0.003），omeprazole（OR=2.901，P=0.005），cervus and cucumis polypeptide（OR=2.693，P=0.014） were the influencing factors of suspected allergic reaction to ossotide injection.Conclusion　The combination with omeprazole，potassium chloride，and cervus and cucumis polypeptide may increase the risk of allergic reactions in ossotide injection.However，the analysis results need to be verified by further prospective studies.

Associated Factors and Outcome of Cardiac Adverse Events in Newly Diagnosed Multiple Myeloma Patients with Bortezomib：a Real-world Study　

SHEN Man，HUANG Zhongxia，LI Xin，ZHANG Jiajia，PEI Xiaojiao，PAN Zhenyu，CHEN Wenming

2021, 24(2): 210-218. DOI: 10.12114/j.issn.1007-9572.2020.00.624

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Background　Multiple myeloma（MM） is a hematological malignancy that easily occurs in older adults，whose morbidity increases with aging.The median overall survival of MM patients has been prolonged to 5-7 years largely owing to wide application of bortezomib and other novel targeted drugs.A number of cases have been reported to a high risk of mortality following cardiac adverse events（CAEs） during bortezomib treatment，but related real-world studies of the influencing factors are rare.Objective　To explore the associated factors and outcome of CAEs in newly diagnosed MM patients with bortezomib.Methods　In this retrospective study，164 newly diagnosed MM patients who were admitted to the Department of Hematology and Oncology，Beijing Chao-Yang Hospital（West），Capital Medical University from January 1，2009 to January 31，2019 were enrolled，and received bortezomib-based chemotherapy as the induction chemotherapy.During bortezomib treatment，26 with CAEs and 138 without were assigned to CAEs group〔including 14 had CAEs during the first treatment course（acute CAEs subgroup），and 12 had CAEs in the second or subsequent treatment course（non-acute CAEs subgroup）〕and control group，respectively.Clinical data of CAEs and control groups were collected and compared.The cumulative dose of bortezomib and clinical manifestations when CAEs occurred were recorded.Factors associated with CAEs were explored.The survival following CAEs was analyzed.Results　Compared with control group，CAEs group had a higher proportion of patients aged over 65，or higher proportion of smokers，patients with a history of heart disease，hypertension，or high-risk cytogenetics（P<0.05）.CAEs group also showed higher mean levels of Scr and LDH and lower mean HGB（P<0.05）.The median cumulative dose of bortezomib for acute and non-acute CAEs patients was 2.69 mg/m2，and 20.8 mg/m2，respectively.Heart failure（100.0%） occurred in all patients with acute CAEs，while in non-acute CAEs subgroup there were 4 cases of heart failure （33.3%），4 cases of atrial fibrillation（33.3%），2 cases of venous thrombosis（16.6%），and 2 cases of coronary syndrome （16.6%）.Dyspnea and palpitation were the most common symptoms of CAEs，followed by edema and increased body weight.Multivariate logistic regression analysis showed that age≥66， smoking，HGB<76 g/L，Scr≥176 μmol/L and LDH≥173 U/L were independently associated with increased risk of CAEs during bortezomib treatment（P<0.05）.The mean overall survival of the CAEs group and control group was 28 and 77 months，respectively，showing a significant difference（χ2=66.563，P<0.01）.The mean overall survival of acute CAEs and non-acute CAEs subgroups was 9 and 36 months，respectively，showing a notable difference as well（χ2=7.229，P<0.01）.Conclusion　The risk factors for CAEs during bortezomib treatment were age≥66， smoking，HGB<76 g/L，Scr≥176 μmol/L and LDH≥173 U/L .Those with CAEs had a poor outcome.In particular，those with acute CAEs had a shorter survival.

Efficacy and Safety of Chimeric Antigen Receptor T-cell in the Treatment of Multiple Myeloma：a Meta-analysis　

WANG Teng，WANG Xiaochen，LYU Chunyi，WANG Jinxin，XU Ruirong

2021, 24(2): 219-224. DOI: 10.12114/j.issn.1007-9572.2021.00.009

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Background　Multiple myeloma（MM）is a malignant plasma cell neoplasm，which is refractory，and prone to relapse.Moreover，there is no cure for it.Chimeric antigen receptor T-cell（CAR-T）is an innovative immunotherapy with great potentials in the treatment of MM，but its efficacy and safety are not well evaluated currently.Objective　To evaluate the efficacy and safety of CAR-T in the treatment of MM systematically，providing evidence-based medical basis for safe and efficient application of the therapy.Methods　Databases of PubMed，EMBase，and the Cochrane Library were systematically searched for published clinical trials articles in English about CAR-T for MM from inception to November 2019.The overall response rate，incidence of severe adverse events（≥ grade 3）and incidence of cytokine release syndrome were used as major therapeutic outcome indicators.R software was used to perform a Meta-analysis of major therapeutic outcomes of patients with CAR-T.Meta-regression analysis was conducted to further analyze major therapeutic outcomes in patients with CAR-T according to pretreatment regimen，costimulatory molecule and the antigen epitope type of CAR-T.Results　A total of 8 articles were included，including 191 patients.Meta-analysis showed that the overall response rate of CAR-T treatment of MM was 0.88 〔95% CI（0.83，0.93）〕，the incidence of serious adverse events was 0.90 〔95%CI（0.83，0.98）〕，and the incidence of cytokine release syndrome was 0.92〔95%CI（0.85，1.00）〕.Further Meta regression analysis suggested：（1）The incidence of severe adverse reactions and cytokine release syndrome differed significantly by pretreatment regimen（P=0.013，P<0.001）.To be specific，Flu+Cy ，Cy pretreatment and no pretreatment subgroup had higher incidence of severe adverse reactions HDM+ASCT pretreatment subgroups（P<0.05）.（2）Costimulatory molecule 4-1BB subgroup had higher overall response rate but lower incidence of severe adverse reactions than costimulatory molecule CD28 subgroup（P<0.05）.（3）The overall response rate，and incidence of severe adverse reactions and cytokine release syndrome in MM patients with different antigen epitope types were statistically significant（P=0.004，0.049，0.023）.BCMA subgroup had lower overall response rate than LCAR-B38M and BCMA +CD19 subgroups（P<0.05），and had higher incidence of severe adverse reactions and cytokine release syndrome than CD19 subgroups（P<0.05）.The incidence of severe adverse reactions and cytokine release syndrome in BCMA+CD19 subgroup was higher than that of CD19 subgroup（P<0.05）.Conclusion　CAR-T may have a good effect on MM，although there are certain controllable safety risks.The pretreatment regimen，costimulatory molecule，and CAR-T antigen type may be factors associated with its efficacy and safety.Due to small sample size and different qualities of the included studies，the above conclusions need to be further verified by large-sample，high-quality randomized controlled clinical trials.

High-dose Intravenous Gamma Globulin in the Treatment of Severe Viral Pneumonia in Adults：a Meta-analysis　

LONG Sidan，JI Shuangshuang，ZHOU Yuanchen，YAO Shukun

2021, 24(2): 225-231. DOI: 10.12114/j.issn.1007-9572.2020.00.628

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Background　Viral pneumonia prevalence is relatively high recently，among which influenza virus-induced viral pneumonia has high mortality.Previous research have shown intravenous immunoglobulins is an adjuvant treatment for severe pneumonia.However，clinical efficacy of this therapy in studies（consisting of only a few articles and case reports）of severe viral pneumonia is insufficient and lack of systematic evidence to further prove it.Objective　To explore the efficacy of high-dose intravenous gamma globulin in adult patients with severe viral pneumonia by a meta-analysis.Methods　Databases of PubMed，EMBase，Web of Science，The Cochrane Library，CNKI，Wanfang Data，CMB and VIP were searched from inception to March 5，2020 for randomized controlled trials（RCTs）in which efficacies of routine treatment with high-dose intravenous gamma globulin were compared with routine treatment in adult patients with severe viral pneumonia.Quality evaluation and data extraction of the included RCTs were carried out.Meta-analysis was performed to evaluate the two types of therapies in terms of clinical efficacy，C-reactive protein（CRP），CD4+，CD4+/CD8+ ratio，IL-2，and incidence of treatment-emergent adverse events.Results　Nine RCTs involving 1 021 patients were included for analysis.All of them were evaluated as grade B in terms of methodological quality.Meta-analysis showed that the experimental group showed higher mean levels of clinical efficacy〔RR=1.24，95%CI（1.18，1.31）〕，CD4+〔MD=10.05，95%CI（9.19，10.90）〕，CD4+/CD8+ ratio〔MD=0.75，95%CI（0.68，0.82）〕and lower CRP〔MD=-3.64，95%CI（-4.23，-3.05）〕，IL-2〔MD=0.61，95%CI（0.45，0.77）〕，incidence of adverse reactionscompared 〔RR=0.30，95%CI（0.16，0.55）〕with the control group（P<0.000 01）.Conclusion　High-dose intravenous infusion of gamma globulin could improve the clinical outcome of severe viral pneumonia in adults.

Clinical Characteristics and Outcome of High-dose Methotrexate on Refractory Langerhans Cell Histiocytosis in Children　

XIE Yao，ZHAO Weihong，HUA Ying，SUN Qing，WU Penghui

2021, 24(2): 232-237. DOI: 10.12114/j.issn.1007-9572.2020.00.629

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Background　Treatment of refractory Langerhans cell histiocytosis（LCH）is difficult.Methotrexate，a classic antitumor drug，is commonly used at a dose of 0.5 g/m2 in the treatment of LCH.Furthermore，high-dose methotrexate（HDMTX） can cross the blood-brain barrier，and its efficacy increases with increasing concentration.So HDMTX may improve the prognosis of refractory LCH，especially with hypophysis involvement.Objective　To analyze and summarize 5 pediatric cases of refractory LCH treated with HDMTX，offering guidance for clinical treatment of LCH with this therapeutic approach.Methods　Five pediatric cases of LCH from Peking University First Hospital between 2005—2019 with multi-organ injuries and risk organ involvement（RO+）or multiple relapses were selected.Their clinical data were retrospectively collected via reviewing medical records，including general information，symptoms and signs，treatment options，prognosis and follow-up situation.Results　（1）General information，symptoms and signs：the 5 cases included 4 boys and 1 girl，with an age of onset of less than 1.Fever was an initial symptom prevalent in all cases，3 cases had rash，1 case had decreased activity of the right lower limb muscles，1 case had orbital and right lower limb masses.All cases developed multi-organ injuries，and 4 of them had RO+，but it was unclear whether the other 1 also had RO+ at the time of consultation.3 cases had pituitary involvement with diabetes insipidus as clinical manifestation.（2）Treatment：all cases received induction therapy with international standard regimen.4 patients were treated with medium-dose MTX（0.5 g/m2）firstly.Due to early onset and risk organ injury，case 1 was treated with HDMTX（1 g/m2） consolidation therapy for a course of treatment.Case 2 was treated with HDMTX（2 g/m2）for 4 courses because of two episodes of relapses and hypophysis involvement.Case 3 recurred at 6-month of treatment，as the rash did not subside after chemotherapy with the original regimen and new defects appeared at the skull，so a regimen of 6-course HDMTX（2 g/m2）was chosen for treatment.Case 4 had good response at 6-week of initial treatment，but recurred after 1 year and 2 months of discontinuation.Bone destruction increased，the pituitary involved，and central diabetes insipidus symptoms appeared.Considering the good ability of HDMTX crossing the blood-brain barrier，HDMTX（1 g/m2）combined with vinblastine and prednisone were used for two courses.In case 5，considering hypophysis involvement，two courses of HDMTX（1 g/m2）were used.（3）Follow-up and outcome：in case 1，vinblastine was used for maintenance therapy after HDMTX treatment，but has been stopped for 13 years and case 1 survives the disease.In case 2，after 4 courses of HDMTX treatment，the masses disappeared，the skull lesions were stable，the pituitary lesions were controlled，and the diabetes insipidus symptoms disappeared，the curative effect was evaluated as intermediate after 6 weeks of treatment.But the third recurrence occurred after 3 months，then clatrabine was finally used for 5 courses and has been stopped for 5 years，case 2 survives.In case 3，the skin rash was controlled，and the bone lesions stable，the curative effect was evaluated as better after 6 weeks of treatment，and then received the maintenance treatment.At present，the drug has been stopped for 3 years，and disease-free survival was achieved.In case 4，the pituitary lesions were smaller，and the diabetes insipidus symptoms were significantly improved，the curative effect was evaluated as intermediate after 6 weeks of treatment，but the scapular bone destruction was slightly deteriorated and new lesions appeared at the frontal bone and clatrabine was used.Now the drug has been stopped for two years，and disease-free survival was achieved.In case 5，the symptoms of diabetes insipidus disappeared，the curative effect was evaluated as intermediate after 6 weeks of treatment.However，due to pulmonary infection during the treatment，HDMTX treatment was discontinued，and now the case is still receiving maintenance therapy and under the follow-up.（4）Side effects：bone marrow suppression was observed in 4 cases，elevation of glutamate aminotransferase was observed in 3 cases，gastrointestinal reactions such as nausea and vomiting were observed in 3 cases，and no serious adverse reactions of grade 3 or above were observed.Conclusion　HDMTX can be used effectively in the chemotherapy for children with refractory or recurrent LCH with RO+，especially in those with pituitary involvement under the condition of ensuring medication safety.

Clinical Efficacy and Safety of Daratumumab in the Treatment of Relapsed or Refractory Multiple Myeloma

XIANG Qiuqing，LU Minqiu，CHU Bin，WANG Yutong，SHI Lei，GAO Shan，FANG Lijuan，LIU Xi，DING Yuehua，BAO Li

2021, 24(2): 237-242. DOI: 10.12114/j.issn.1007-9572.2021.00.010

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Background　Multiple myeloma will relapse in the majority of such patients as there is no cure for it.Daratumumab，a CD38 human monoclonal antibody，has been reported by foreign studies to have significant clinical activity in relapsed or refractory multiple myeloma.However，there are limited data on its efficacy and toxicity profiles in Chinese patients.Objective　To investigate the clinical efficacy and safety of daratumumab in the treatment of patients with relapsed or refractory multiple myeloma.Methods　From October 2019 to June 2020，9 patients with relapsed or refractory multiple myeloma treated with daratumumab-based chemotherapy were selected from Department of Hematology，Beijing Jishuitan Hospital.Their clinical data，follow-up response and adverse reactions to daratumumab-based regimens were retrospectively analyzed.Results　Among the 9 patients，7 were available for response evaluation.Two（28.6%） achieved complete response，two（28.6%）achieved very good partial response，one（14.3%）achieved partial response，one（14.3%）achieved minimal response and one （14.3%） achieved stable disease.The overall response rate was 71.4%（5/7）.The most common hematological adverse events were thrombocytopenia，neutropenia and lymphopenia，with the incidences of grade 3 and 4 of 33.3%（3/9）and 33.3%（3/9）and 55.6%（5/9），respectively.The percentage of infusion related reactions of daratumumab was 44.4%（4/9）.Conclusion Daratumumab is highly effective and safe in the treatment of relapsed or refractory multiple myeloma.

Clinical Analysis of Topiramate Titration Combined With Venlafaxine in the Treatment of Chronic Migraine With Generalized Anxiety Disorder　

LIANG Junli，LU Mengru，LIANG Jinyu，JIANG Ling，ZHAO Lijun

2021, 24(2): 243-247. DOI: 10.12114/j.issn.1007-9572.2020.00.573

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Background　Chronic migraine is prone to be combined with anxiety and depression disorder.But Chinese guidelines for the prevention and treatment of migraine do not specify the treatments for chronic migraine with generalized anxiety disorder.Neurologists or general practitioners choose the treatments of chronic migraine with generalized anxiety disorder according to personal experience or existing drugs in our hospital，and there is no large sample study report in China.Objective　To explore the efficacy and safety of topiramate titration combined with venlafaxine in the treatment of chronic migraine with generalized anxiety disorder.Methods　158 patients with chronic migraine were selected in the Second Affiliated Hospital of Guangxi Medical University from June 2018 to February 2020.We divided into two groups according to the random number table，one was topiramate group and the other was topiramate combined with venlafaxine group，all of them were treated for 6 months.The attack days，visual analogue scale（VAS），migraine specific quality of life questionnaire（MSQ v2.1），HIT-6，PSQI，HAMA and adverse drug reactions were evaluated before treatment and 3 and 6 months after treatment between two groups.Results　125 patients completed 6 months of treatments and follow-ups，65 cases in topiramate group and 60 cases in topiramate combined with venlafaxine group.There was no interaction between treatment time and treatment method（P>0.05）.Treatment time and treatment method had significant effect on headache attack days，VAS，HIT-6 and PSQI（P<0.05）.After 3 months of treatment，the headache attack days，VAS，HIT-6，PSQI and MSQ V2.1 total scores of the two groups decreased compared with those before treatment（P<0.05）.After 6 months of treatment，the attack days and PSQI in topiramate group were less than those in the same group for 3 months，while the attack days，VAS，HIT-6 and PSQI in the topiramate combined with venlafaxine group were less than those in the same group for 3 months（P<0.05）.After 6 months of treatment，the headache attack days，VAS，HIT-6 of topiramate combined with venlafaxine group were less than those of topiramate group（P<0.05）.There was no interaction between treatment time and treatment method（P>0.05）.Treatment time and treatment method had significant effect on MSQ v2.1 function limitation，function loss，emotional function and total score was significant（P<0.05）.MSQ v2.1 function limitation，function loss，emotional function and total score of the two groups were lower than those before treatment after 3 months of treatment（P<0.05）.After 6 months of treatment，the function limitation，function loss，emotional function and total score of topiramate combined with venlafaxine group were lower than those of the same group for 3 months（P<0.05）.After 6 months of treatment，the function limitation，function loss，emotional function and total score of topiramate combined with venlafaxine group were lower than those of topiramate group（P<0.05）.The effective rate of topiramate combined with venlafaxine group was higher than that of topiramate group at 3 and 6 months（P<0.05）.There were 114 patients with oral topiramate dose of 100 mg/D，accounting for 79.78%（71/89） of the total effective number；18 patients with 150 mg / D accounted for 20.22%（18/89）.There was no significant difference in the incidence of adverse drug reactions between the two groups（χ2=0.170，P=0.680）.Conclusion　Topiramate combined with venlafaxine is safe and effective in the treatment of chronic migraine with generalized anxiety disorder.

Reflections on Methodological Approaches to Telephone Follow-ups in Clinical Trials of Traditional Chinese Medicine　

WANG Tianyuan，SUN Xing，HU Jing，FENG Shuo，ZHANG Huina，WANG Hong，LI Bo

2021, 24(2): 248-252. DOI: 10.12114/j.issn.1007-9572.2020.00.633

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Outcome evaluation is very important for clinical trials of traditional Chinese medicine（TCM）.As a way for obtaining outcome information，the process of telephone follow-up needs to be standardized using methodological approaches due to many problems.To address these problems，we put forward the following practical methodological approaches summarized from real investigation results of TCM clinical trials：（1）Rationally designing the telephone follow-up of a TCM clinical trial；（2）Developing and improving a telephone follow-up investigation responsibility system；（3）Improving the pre-job training system for a telephone follow-up investigator；（4）Improving patients' awareness of disease and follow-up；（5）Optimizing the follow-up mechanism；（6）Hiring a professional follow-up team for regular follow-up.We could probably explore and establish a follow-up data platform，sharing the resource rapidly and comprehensively in the future.

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