中医药治疗不稳定型心绞痛临床研究指标分析

Analysis of clinical index of Chinese medicine in treatment of unstable angina pectoris

[目的]分析中医药治疗不稳定型心绞痛随机对照试验的结局指标,为构建中医药治疗不稳定型心绞痛临床试验核心指标集工作奠定基础。[方法]计算机检索2018年中国期刊全文数据库(CNKI)、万方数据库(WanFang)、中国生物医学文献数据库(SinoMed)、PubMed、Cochrane library、Web of Science和Embase数据库中,收录的中药治疗不稳定型心绞痛临床随机对照试验(RCT)。由两名研究者严格按照纳入与排除标准独立进行文献筛选和资料提取,如有分歧,通过讨论解决。[结果]纳入90篇随机对照试验(RCT),共计9778例患者,共使用119个指标,单个研究使用的指标数量为1~16个,平均每个RCT使用4个指标。频次排列前15位的指标为总有效率、心绞痛发作次数、心绞痛持续时间、不良反应、心电图疗效、中医症状积分、低密度脂蛋白(LDL-C)、总胆固醇(TC)、三酰甘油(TG)、血浆黏度、高密度脂蛋白胆固醇(HDL-C)、超敏C反应蛋白(hs-CRP)、左心室射血分数(LVEF)、纤维蛋白原、硝酸甘油用量。各研究采用的指标差异较大,对同一指标采取多个测量时点,指标组合使用随意性大,缺乏重大终点事件指标和体现中医药特色的结局指标。部分研究采用了自拟结局指标。[结论]中医药治疗不稳定型心绞痛RCT指标存在差异性大,组合使用随意性大,指标表达不规范,缺乏规范的测评标准,测量时点差异大,缺少远期指标,缺少中医药特色结局指标,采用自拟结局指标等问题。亟需开展中医药治疗不稳定型心绞痛核心指标集建立工作。

[Objective]To analyze the outcome indexes of the randomized controlled trial of traditional Chinese medicine(TCM)treatment of unstable angina,and to lay a foundation for the establishment of the core index set of the clinical trial of TCM treatment of unstable angina.[Methods]CNKI,WanFang,SinoMed,PubMed,Cochrane library,Embase databases were searched by computer,and the randomized clinical trials(RCTs)of TCM for the treatment of unstable angina pectoris was comprehensively collected.The retrieval time was set in 2018.Literature screening and data extraction were conducted independently by 2 authors according to inclusion and exclusion criteria.[Results]A total of 9778 patients and 119 indicators were included in 90 RCTs.The number of indicators adopted in a single study is 1-16,with an average of 4.The top 15 were clinical efficacy,angina attack frequency,angina duration,adverse reactions,ecg efficacy,TCM symptom score,LDL-C,TC,TG,plasma viscosity,HDL-C,hs-CRP,LVEF,fibrinogen and nitroglycerin dosage.The indexes used in each study differ greatly,and multiple measurement points are adopted for the same index.The combination of indicators is quite random,and there is a lack of significant end-point event indicators and outcome indicators reflecting the characteristics of TCM.[Conclusion]The main problems of indicators include large difference in index selection,large randomness in combination use,non-standard expression of indicators,lack of standardized evaluation standards,large difference in measurement time points,lack of long-term indicators,lack of traditional Chinese medicine characteristic outcome indicators,and use of self-designed outcome indicators.It is urgent to establish the core index set of unstable angina.