Li Hui-Min, Liao Xing, Hu Rui-Xue, Yu Dan-Dan, Gu Hao, Wang Le, Zhao Hui, Zhang Yun-Ling
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Graduate School of China Academy of Chinese Medical Sciences Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2020 May;45(9):2210-2220. doi: 10.19540/j.cnki.cjcmm.20200103.503.
The purpose of this study was to evaluate the selection situation of outcome indexes in randomized controlled trials of traditional Chinese medicine(TCM) in the treatment of acute ischemic stroke and to provide suggestions for future research. In this study, four Chinese databases and three English databases were searched from January 2017 to June 2019. The randomized controlled trials of traditional Chinese medicine in the treatment of ischemic stroke were selected according to the pre-established selection criteria. Cochrane bias risk assessment tool was used to evaluate the quality of the included studies. A total of 20 651 related articles were searched, and 11 662 ones were left after eliminating the repetitions. Finally, 42 articles were included, including 36 articles in Chinese and 6 articles in English, 40 randomized controlled trials and 2 registration schemes of randomized controlled trials. The results showed that the outcome indexes of 42 randomized controlled trials were mainly divided into seven categories, that is clinical outcome index, blood biochemical index, mental state evaluation index, cerebral hemodynamics index, index of evaluating the degree of carotid artery stenosis, safety indicators and other indicators. The blood biochemical index was the one with highest frequency, followed by the clinical outcome index. TCM syndrome score was used as an indicator of curative outcome in 17 studies. After the analysis, it was found that there were many problems in selecting the outcome indexes for the randomized controlled trials of traditional Chinese medicine in the treatment of cerebral apoplexy. For example, the end point index and hard index were rarely selected as the main outcome indicators, and the vast majority of them were intermediate alternative indexes; recognized curative effect could not be obtained; there were too many kinds of outcome indicators and excessive heterogeneity, hindering the promotion of superior treatment measures of traditional Chinese medicine in clinical practice. Therefore, we should draw lessons from the establishment method of the international core index outcome index set, construct the core index outcome index set of traditional Chinese medicine in the treatment of ischemic stroke, and develop the outcome index set which accords with the curative effect characteristics of traditional Chinese medicine treatment mea-sures to solve the problems effectively.
本研究旨在评估中医药治疗急性缺血性脑卒中随机对照试验中结局指标的选取情况，为未来研究提供建议。本研究于2017年1月至2019年6月检索了四个中文数据库和三个英文数据库。根据预先设定的纳入标准选取中医药治疗缺血性脑卒中的随机对照试验。采用Cochrane偏倚风险评估工具评估纳入研究的质量。共检索到20651篇相关文献，剔除重复文献后剩余11662篇。最终纳入42篇文献，其中中文36篇、英文6篇，40项随机对照试验和2项随机对照试验注册方案。结果显示，42项随机对照试验的结局指标主要分为七类，即临床结局指标、血液生化指标、精神状态评估指标、脑血流动力学指标、评估颈动脉狭窄程度指标、安全性指标及其他指标。血液生化指标出现频率最高，其次为临床结局指标。17项研究将中医证候评分作为疗效指标。分析发现，中医药治疗脑卒中随机对照试验结局指标选取存在诸多问题。例如，终点指标和硬指标很少被选为主结局指标，绝大多数为中间替代指标；未能获得公认的疗效；结局指标种类繁多且异质性过大，阻碍了中医药优势治疗措施在临床实践中的推广。因此，应借鉴国际核心指标结局指标集的建立方法，构建中医药治疗缺血性脑卒中的核心指标结局指标集，制定符合中医药治疗措施疗效特点的结局指标集，以有效解决上述问题。
