中医药治疗慢性乙型肝炎临床试验的核心结局指标集研究  

Core outcome sets of traditional Chinese medicine on the treatments of chronic hepatitis B clinical trails

作　　者：孙亚男[1,2] 何丽云[2] 雒琳[2] 于长禾[2,3] SUN Ya-nan;HE Li-yun;LUO Lin;YU Chang-he(Department of TCM,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Tuina and Pain Management Department,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]首都医科大学宣武医院中医科,北京100053 [2]中国中医科学院中医临床基础医学研究所,北京100700 [3]北京中医药大学东直门医院推拿疼痛科,北京100700

出　　处：《中华中医药杂志》2020年第9期4684-4688,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家“十二五”艾滋病和病毒性肝炎等重大传染病防治专项“中医药防治重大传染病疗效评价及共性技术研究”(No.2012ZX10005009);国家自然科学基金青年科学基金项目(No.81803956,No.81603719)。

摘　　要：目的:建立中医药治疗慢性乙型肝炎临床研究的核心结局指标集。方法:本研究采用系统评价方法和专家共识方法进行研究:第一部分通过系统评价确定潜在的结局域与结局指标,第二部分通过专家问卷和专家会议确定核心结局、结局指标和测量时间点。结果:系统评价纳入了2009年至2014年间共960篇文献,总结123个结局指标及其测量时间点,20个测量方法。保留出现频次≥20或在结局域中频次最高的结局指标,并依据结局指标来源、检测方法、学科归属等综合因素初步定义结局及结局指标的归属,结果进入第二部分专家问卷和共识会议。专家共识的结果为血清学指标(ALT、AST、GGT、TBIL/DBIL、A、G、AFP、PT、PTA或INR)、病毒学指标(乙肝五项、HBVDNA定量)、生活质量(CLDQ)、安全性指标(肝、肾功能,血、尿、便常规,心电图)、影像学指标(肝脾B超)、不良反应/事件和中医证候积分。所有结局指标的测量时间点为基线期、治疗期(1、3、6、12个月)、随访期(6个月)。测量工具由于各临床研究单位的设备、方法不同,故专家对此尚未达成共识。结论:中医药治疗慢性乙型肝炎的核心结局指标集在中医药领域基本达成共识,可以作为中医药治疗慢性乙型肝炎随机对照研究选择结局指标的依据。但是此共识还需要获得西医专家和国际专家的进一步共识。Objective:To develop the core outcome set(COS)of TCM for chronic hepatitis B(CHB)(TCM-COS-CHB).Methods:Two stages were conducted in the study.In the first stage,a systematic review of random clinical trails(RCTs)on CHB participant sample was conducted to determine the core domains and underlying outcomes and their measuring time.Results:Nine hundred and sixty literatures were included in the systematic review during 2009 and 2014,and 123 outcomes with their measuring time and 20 instruments were identified.With the priori domains according to the sources of the specimen,methods of test and the discipline categories,the outcomes and domains were firstly identified,and outcomes were clustered within their own domains.Besides,outcomes based on the criteria that the frequency of more than 20 or the top frequency of the outcome among the domain remained in the Stage Two.The results of expert panel were that the domains and their own outcomes were serum indexes[including alanine aminotransferase(ALT),aspartate aminotransferase(AST),glutamyltransferase(GGT),total bilirubin(TBIL),direct bilirubin(DBIL),albumin(A),globulin(G),alpha fetoprotein(AFP),prothrombin time(PT),prothrombin activity(PTA),international normalized ratio(INR)],virus index(five index of hepatitis b,quantity level of HBVDNA),quality of life(chronic liver disease questionnaire(CLDQ),safety indexes(renal function test,blood,urine and stool routine test,electrocardiogram),imaging indicators(ultrasounds of liver and spleen)the adverse reaction or adverse events,and calculation of TCM patterns.The measuring time points of each core outcomes were baseline,treatment periods of first,third,sixth,and twelfth month,and the follow-up of sixth month.However,the consensus of instruments has not been reached due to different equipment,methods applied in different researches.Conclusion:TCM-COS-HBV representing the minimum outcome set at least to be measured in the clinical trials of TCM treatment for CHB patients was established by the consensus and could be recommend

关 键 词：慢性乙型肝炎 核心结局指标集 临床研究 疗效评价 中医药治疗 中西医结合治疗 

分 类 号：R259[医药卫生—中西医结合]