摘要
目的:对中药制剂治疗稳定型心绞痛的临床随机对照试验(RCTs)进行收集、汇总、分析和评价,以期为更多的临床研究提供参考证据,推动临床研究的进步与发展.方法:通过计算机检索中国知网(CNKI)、万方医学网(WanFang)、维普(VIP)、中国生物医学文献服务系统(CBM)、PubMed、EMbase、the Cochrane Library数据库.检索时间为建库至 2022年 5月 1日.纳入中药制剂治疗稳定型心绞痛的 RCTs,对其发表年份、样本量、疗程、干预/对照措施、结局指标、方法学质量等进行分析和评价.结果:纳入 493 篇RCTs,涉及中药制剂 104种;59篇样本量>150例;共有 31种干预/对照措施,中药制剂+常规治疗 vs常规治疗最多(187 篇);467篇 RCTs报告了具体疗程,以 14~28 d为主.结局指标以理化检测为主,定量指标以血脂为主,定性指标以心电图疗效(有效率)为主.在方法学中,大部分 RCTs对分配隐藏、盲法的实施过程描述不清或未提及,操作不规范.伦理审批、知情同意、试验注册等未提前报告.结论:已发表的中药制剂治疗稳定型心绞痛的 RCTs在设计和实施方面存在些许不足,对试验结果有一定的影响.因此,需进一步加强试验设计与实施的规范性、严谨性,以提高临床试验的可靠性.
Abstract
Objective:Clinical randomized controlled trials(RCTs)of Chinese medicinal preparations for stable angina pectoris were collected,summarized,analyzed and evaluated,with the aim of providing reference evidence for more clinical studies and promoting the progress and development of clinical research.Methods:The databases of Chinese National Knowledge Infrastructure(CNKI),WanFang Medical Network(WanFang),VIP,China Biomedical Literature Service(CBM),PubMed,EMbase,and the Cochrane Library were searched.The search period was from the establishment of the database to May 1,2022.Clinical RCTs of Chinese medicinal preparations for the treatment of stable angina were included,and their year of publication,sample size,duration of treatment,intervention/control measures,outcome indicators,and methodological quality were analyzed and evaluated.Results:A total of 493 RCTs were included,involving 104 Chinese medicinal preparations,59 RCTs with a sample size>150.A total of 31 interventions/controls,with Chinese medicinal preparations+conventional treatment vs conventional treatment being the most frequent(187).A total of 467 RCTs reported specific duration of treatment,with 14-28 d being the predominant.Evaluation of outcome indicators was dominated by physical and chemical tests,and quantitative indicators were dominated by blood lipids,count indicators were dominated by electrocardiographic efficacy(efficiency).In the methodology section,a significant number of RCTs fail to provide clear descriptions or any details regarding the processes of allocation concealment and blinding implementation,resulting in a lack of standardization in their execution.Ethical approval,informed consent,and trial registration were not reported in advance.The published RCTs of Chinese medicinal preparations for stable angina pectoris showed slight deficiencies in design and implementation,which had an impact on the trial results.Therefore,the standardization and rigor of trial design and implementation need to be further strengthened to improve the reliability of clinical trials.
维普
万方数据