通补法治疗冠心病国内RCT文献质量评价  

Quality evaluation of domestic RCT literature on treatment of coronary heart disease with purgation-tonifying therapy

作　　者：宋烨闻 黄烨[1] SONG Yewen;HUANG Ye(Department of Emergency,Xiyuan Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院急诊科,北京100091

出　　处：《新疆医科大学学报》2022年第12期1467-1473,共7页Journal of Xinjiang Medical University

基　　金：国家自然科学基金面上项目(81573803);国家自然科学基金青年基金(81202777)。

摘　　要：目的 探讨通补法治疗冠心病(Coronary atherosclerotic heart disease,CHD)的疗效和安全性。方法 对中国知网全文数据库(China national knowledge infrastructure,CNKI)、中国生物医学文献数据库(Chinese biomedical literature database,CBM)、维普中文科技期刊全文数据库(VIP chinese scitech journal full-text database,VIP)和万方数据库建库至2021年2月文献进行检索。收集通补法治疗CHD随机对照试验(Randomized controlled trial,RCT),根据临床试验报告标准声明(2010版)(Consolidated standards of reporting trials,CONSORT)条目进行RCT文献质量评价,限定中文检索词为通阳、活络、补气、益气、冠心病、胸痹、胸痛、心痛。并总结纳入研究文献中结局指标的报告情况。结果纳入9篇RCT文献,包括849例CHD患者,文献发表的时间从2007年至2020年;9篇文献中有3篇仅提及随机分配,1篇未提取分组方式,所有文献均未提及盲法和隐藏、未见报道脱落情况;文献质量评价中通补法治疗的理论依据、加减治疗、心绞痛急性发作处理、治疗疗程、其他干预措施以及引用文献说明对照干预的合理性报告不够充分,报告率分别为22.22%、44.44%、33.33%、33.33%、11.11%和11.11%;结局指标报告中心电图改善、中医证候积分、血脂、血液流变学、血清炎症指标以及不良反应报告率分别为55.56%、33.33%、44.44%、11.11%、33.33%和44.44%。结论 目前通补法治疗CHD的国内RCT文献质量普遍较低,今后的研究有待严格遵循CONSORT条目设计、实施和报告研究方案,以进一步提高报道质量。Objective To explore the efficacy and safety in treatment of coronary heart disease with purgation-tonifying therapy. Methods As of February 2021, literature searches were carried out in China National Knowledge Internet(CNKI), Chinese biomedical literature database(CBM), VIP Chinese Sci-tech Journal Full-text Database(VIP)and Wanfang Database. Randomized controlled trial(RCT) was collected in reatment of coronary heart disease with purgation-tonifying therapy;RCT literature quality evaluation was performed according to CONSORT(2010 edition)items;and the reporting status of the outcome indicators included in the research literature were summarized. Results 9 RCT literature were enrolled, including 849 patients with coronary heart disease. The publication time of literature was from 2007 to 2020. 3 of the 9 literatures only mentioned random allocation, a article did not extract the grouping method, and all the literature did not mention blindness and concealment and no reports of shedding. For literature quality evaluation, the rationality reports of theoretical basis of purgation-tonifying therapy, addition and subside treatment, acute attack treatment of angina, treatment course, other intervention measures and citing literature to explain controlled interventions were not sufficient, and the report rates were 22. 22%, 44. 44%, 33. 33%,33. 33%, 11. 11% and 11. 11% respectively. The the report rates of outcome indicators reports on electrocardiograph improvement, TCM syndromes scores, blood lipids, hemorheology, serum inflammatory indicators and adverse reactions were 55. 56%, 33. 33%, 44. 44%, 11. 11%, 33. 33% and 44. 44% respectively. Conclusion At present, the quality of domestic RCT literature on the treatment of coronary heart disease by purgation-tonifying therapy is generally low. Future research needs to strictly follow the CONSORT item design, implementation and report research plan to further enhancing the quality of the report.

关 键 词：通补法 冠心病 随机对照试验 质量评价 

分 类 号：R222[医药卫生—中医基础理论]