2015年中药治疗稳定性心绞痛临床试验结局指标文献研究

Outcome Measures of Clinical Trials of Stable Angina Pectoris Treated by Chinese Medicine in 2005:Literature Research

目的分析2015年发表的中药治疗稳定性心绞痛随机对照试验的结局指标,为构建稳定性心绞痛临床试验的核心指标集提供数据基础。方法计算机检索CNKI、WanFang Data、SinoMed、PubMed、Cochrane Library、Embase和Web of Science 7个数据库,搜集中医药干预的稳定性心绞痛随机对照试验。检索时间随机抽样限定为2015年。由2位作者严格按照纳入与排除标准独立筛选文献、提取资料,如有分歧,经讨论解决。结果最终纳入71篇RCTs,共计6 784例患者,73个结局指标。单个研究采用指标数量为1~14个,平均为4个。使用频次排前15位的指标依次为:心电图疗效、心绞痛疗效、临床疗效、不良反应、中医证候疗效、安全性分析、血脂、心绞痛发作次数、中医证候积分、血液流变学指标、中医症状积分、硝酸甘油停减率、心绞痛持续时间、硝酸甘油用量、西雅图心绞痛量表评分。指标存在的主要问题有:各研究采用指标数量差异大,同一指标存在多个测量时点与测量方法;连续性变量被转换成等级资料以百分率报告;理化指标为主,生活质量、长期结局指标以及经济学指标欠缺;缺少中医药相关特色指标。结论临床试验结局指标存在差异大、不规范、不实用等共性问题。建立稳定性心绞痛中医药临床试验核心指标集对从源头提高中医药临床研究价值至关重要。

Objective To systematically analyze outcome measures in randomized clinical trials of stable angina pectoris published in 2015 with interventions of Chinese medicine（CM）, and then to pro- vide data for core outcome set（COS） of CM about stable angina pectoris. Methods Databases including CNKI, WanFang Data, SinoMed, PubMed, Cochrane Library, Embase and Web of Science were retrieved to collect randomized controlled trials （RCTs）about CM treatments for stable angina in 2005. Two reviewers independently screened literature and extracted data according to the inclusion and exclusion criteria. Disa- greements were resolved by discussion. Results A total of 71 RCTs were included, involving 6 784 pa- tients and 73 outcomes. The number of outcomes in one of the included RCTs varied from 1 to 14 with the average of 4. After frequency analysis, the top 15 outcomes were rate of electrocardiogram （ECG） effica- cy, angina pectoris curative effect, clinical efficacy, adverse events, curative effect of CM syndrome, safety evaluation, blood lipid, the frequency of angina attack, scores of CM syndrome, hemorheology inde- xes, total scores of CM symptoms, withdrawal rate of nitroglycerin, duration of angina attack, usage of ni- troglycerin and scores of Seattle Angina Questionnaire. There were also several significant problems about outcomes in the included trials. Firstly, the number of outcomes in one study was various and the same outcomes was different in the way that when and how to measure. Secondly, continuous data were arbitrari-ly transformed into ranked data to report. Thirdly, outcomes about living quality, long-term efficacy and e- conomy were neglected, while biochemical indexes were taken seriously. Lastly, there was no efficacy in- dexes relevant to CM characteristics. Conclusions There were some common problems about outcomes of clinical trials, such as heterogeneity, non-standardization and impracticability. Thus, it was a vital impor- tance to develop COS-CM to improve the quality of clinical researches of CM.