摘要
目的评价目前中医药治疗不稳定性心绞痛随机对照试验选用的结局指标情况,为中医药治疗不稳定心绞痛核心指标集研究提供基础。方法计算机检索PubMed、EMbase、The Cochrane Library、CBM、CNKI、WanFang Data和VIP数据库搜集中医药治疗不稳定性心绞痛的随机对照试验(randomized controlled trial,RCT),检索时限均从2009年1月至2019年8月。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用定性分析的方法描述纳入研究的结局指标情况。结果共纳入43个RCT,涉及的结局指标主要分为7大类:临床症状体征指标、生活质量评价、血生化指标、心电图指标、心功能指标、安全性指标(包括不良反应和不良事件)和其他指标。血生化指标为出现频次最高的指标,临床症状体征指标次之。43个RCT中有35个RCT使用了中医证候疗效作为疗效结局指标。但结局指标的使用仍存在问题:主次不分,主要结局指标绝大多数为中间替代指标;证候疗效评价标准不统一;忽视主观结局指标测量时的盲法测量;重视疗效指标,轻视不良结局指标;指标名称表述不规范;结局指标的统计学表达有待改进;指标选择异质性大;中医药相关疗效指标多使用有效率,但判定标准不一致。结论对中医药治疗不稳定性心绞痛的随机对照试验结局指标遴选现状堪忧并存在较多问题,应该借鉴国际核心指标结局指标集的创建方法,构建符合中医药治疗措施、疗效特色的核心结局指标集。
Objective To evaluate the outcomes used in randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) in the treatment of unstable angina pectoris, so as to provide references for the study of the core outcome set of TCM on the treatment of unstable angina pectoris. Methods We searched RCTs of TCM on the treatment of unstable angina pectoris in the databases of PubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP from January 2009 to August 2019. Two reviewers independently screened all records, extracted data and evaluated risk of bias of included trials. A qualitative analysis was conducted to analysis the outcomes.Results A total of 43 RCTs were included and their outcomes were categorized into 7 categories: clinical symptoms and signs, quality of life evaluation, blood biochemical outcomes, ECG, cardiac function outcomes, safety outcomes(including adverse reactions and events), and other related outcomes. Blood biochemical outcomes were the most frequently reported outcomes, followed by the clinical symptoms and signs. Of the 43 RCTs, 35 RCTs applied TCM syndromes efficacy as outcomes. Our analysis identified a series of problems in the application of outcomes: no distinction between primary and secondary outcomes, and most of the primary outcomes were intermediate alternative outcomes;the efficacy evaluation standards for TCM syndromes were different;the blinding method was ignored when the subjective outcomes were measured;less attention was paid on adverse outcomes than efficacy outcomes;the names of the same outcome were not standardized;the statistical expression of outcomes required improvement;the quantity of outcomes selected in different studies varied significantly;in TCM related efficacy outcomes, the effective rates were frequently used, however, the evaluation criteria were different. Conclusions There are numerous problems for the outcomes’ selecting for RCTs of TCM treatment of unstable angina pectoris. We should use the international standardized method of creating the core outcome sets to establish a core outcome set in line with the characteristics and laws of diagnosis and treatment of traditional Chinese medicine.
作者
李慧敏
熊兴江
胡瑞学
于丹丹
杨伟
廖星
商洪才
LI Huimin;XIONG Xingjiang;HU Ruixue;YU Dandan;YANG Wei;LIAO Xing;SHANG Hongcai(Center for Evidence Based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,P.R.China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine,Beijing 100091,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2020年第7期817-828,共12页
Chinese Journal of Evidence-based Medicine
基金
国家科技部重点研发计划项目(编号:2017YFC1700400
2017YFC1700406-2)
国家自然科学基金项目(编号:81774159)
中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(编号:ZZ13-YQ-075)
中国中医科学院中央级公益性科研院所基本科研业务费自主选题(第十三批)(编号:Z0650)。
关键词
中医药
不稳定性心绞痛
随机对照试验
结局指标
Traditional Chinese medicine
Unstable angina pectoris
Randomized controlled trial
Outcome
