中医药治疗慢性心力衰竭随机对照临床试验评价指标分析

Evaluation index analysis of randomized controlled clinical trials of traditional Chinese medicine in treating chronic heart failure

关键词:  中医药  慢性心力衰竭  结局指标  核心指标集  随机对照试验

Key words:  traditional Chinese medicine  chronic heart failure  outcome indicator  core outcome set  randomized controlled trial

摘要:

[目的] 对已发表的中医药治疗慢性心力衰竭（CHF）随机对照试验（RCTs）采用的疗效评价指标进行分析，为构建慢性心力衰竭的核心指标集提供基础数据。[方法] 计算机检索8个数据库，搜集中医药干预的CHF的RCTs。中文数据库为CNKI、WanFang、VIP、SinoMed；英文数据库为PubMed、Cochrane Library、EMBASE、Web of Science。论文发表年份限定为2018年。由2名研究者严格根据标题和摘要筛选所有纳入研究，并按照纳入和排除标准选择相关研究进行进一步评估。如有分歧，由第三方协商解决。资料提取包括纳入研究的基本信息、研究对象的基线特征、干预措施、结局指标及不良反应。[结果] 最终纳入157个RCTs，共计17 459位患者，平均样本量为111，共涉及138个疗效评价指标。单个研究采用指标数量为1~13个，平均为6个。使用频次排前15位的指标依次为：超声心动图、临床疗效、NT-proBNP/BNP、不良反应、6 min步行试验、心功能（分级）疗效、中医证候积分、中医证候疗效、生活质量评分量表、心衰（计分）疗效、生命体征、C反应蛋白（CRP）、中医症状积分、肿瘤坏死因子-α（TNF-α）、白介素-6（IL-6）。指标存在的主要问题：不同研究采用的指标及数量均存在较大差异，且相同指标测量时间与测量方法也存在差异；指标报告信息不完整性，连续性变量被转成等级资料以百分比率报告；指标缺乏实用性，存在脱离临床需求问题，且远期预后及安全性指标使用不足。[结论] 中医药治疗CHF临床试验评价指标存在差异大、不规范、不实用等问题，需要开展核心指标集研究，以提高相关临床研究的方法学质量及临床价值。

Abstract:

[Objective] To analyze the efficacy evaluation indexes in randomized controlled trials (RCTs) of chronic heart failure (CHF) published in recent years (focusing on year 2018),using traditional Chinese medicine (TCM) as an intervention,to provide fundamental data for the development of core outcome set (COS) for CHF using TCM treatment.[Methods] Online search of 8 databases including CNKI,WanFang Data,VIP,SinoMed (4 Chinese databases),PubMed,Cochrane Library,EMBASE and Web of Science (4 English databases) were searched to collect RCTs of CHF intervened by TCM in 2018. Two reviewers independently screened selected literature and extracted data according to the inclusion and exclusion criteria. Any discrepancy in the study selection was resolved by discussion with a third reviewer. Basic information,baseline characteristics,intervention measures,outcome measures and adverse events were extracted.[Results] A total of 157 RCTs were included,involving 17 459 patients and 138 efficacy evaluation indicators. The number of outcomes used in a single study was 1 to 13,with an average of 6. After frequency analysis,the top 15 outcomes were:echocardiography,clinical efficacy,NT-proBNP/BNP,adverse events,6min walking test,cardiac function (classification) efficacy,scores of TCM syndrome,TCM syndrome efficacy,quality of life rating scale,heart failure scores,vital signs,CRP,TCM symptom score,TNF-α and IL-6. The main problems of indicators are as follows:the number of outcomes used in different studies varied greatly,with the measurement time and method of the same outcome are also different;incomplete reporting of information for outcomes in the included studies,with the continuous variables being converted to ranked ordinal data or reported in percentages;outcomes reported also show a lack of practicability,with a lack of usage on long-term prognosis and safety outcomes.[Conclusion] Outcomes reported in clinical trials of TCM for CHF vary greatly,with a lack of standardization and practicality. Hence,it is necessary to develop COS to improve the methodological quality and clinical value of relevant clinical studies.