中成药治疗脑梗死急性期临床试验结局指标分析

Analysis of clinical trial outcome indicators of Chinese patent medicine for treating cerebral infarction in acute phase

[目的]分析2018年发表的中成药治疗脑梗死急性期的随机对照试验(RCT)结局指标,为构建脑梗死急性期临床试验的核心指标集(COS)奠定基础。[方法]计算机检索中国期刊全文数据库(CNKI)、万方数据库(WanFang Data)、中国生物医学文献数据库(SionMed)、Pubmed、Cochrane Library、Emabse和Web of Science7个数据库,收集中成药治疗脑梗死急性期的RCT,检索时间限定为2018年。由2名研究者按照纳入排除标准背对背进行文献筛选,之后采用前期在Access软件设定好的模板进行资料提取。[结果]纳入63个研究,共计6 397位患者,96个结局指标。单个研究结局指标使用数量为1~14个,平均为5个。[结论]急性脑梗死临床试验结局指标名称不统一,不规范,指标使用差异大,不具有中医药特色等问题。

[Objective]To analyze the randomized clinical trials(RCT)outcome indicators of Chinese patent medicine for acute cerebral infarction published in 2018,and lay a foundation for constructing the core outcome sets(COS)of clinical trials in acute cerebral infarction.[Methods]Seven databases including CNKI,WanFang Data,Chinese Biomedical Literature Database(SionMed),Pubmed,Cochrane Library,Emabse and Web of Science were searched by computer to collect RCT of Chinese patent medicine for the treatment of acute cerebral infarction.The retrieval time was limited to 2018.Two researchers screened the literature back to back according to the inclusion and exclusion criteria,and then used the template set in Access software to extract the data.[Results]A total of 6397 patients and 96 outcome indicators were included in 63 studies.The number of outcome indicators used in a single study ranged from 1 to 14,with an average of 5.[Conclusion]There are some problems in clinical trials of acute cerebral infarction,such as the name of indicators is not uniform and standardized,the use of indicators is quite different,and there is no characteristic of traditional Chinese medicine.