Ren Si-Lin, Ge Zhao, Wu Xu-Dong, Zhou Zhou, Li Zhi-Jun, Zhou Meng-Xue, Li Mo-Han, Wang Xian-Liang
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300381, China Graduate School of Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300381, China.
Zhongguo Zhong Yao Za Zhi. 2024 Nov;49(22):6224-6234. doi: 10.19540/j.cnki.cjcmm.20240815.503.
This study systematically reviewed the randomized controlled trial(RCT) of traditional Chinese medicine(TCM) treatment of coronary heart disease patients with angina pectoris after percutaneous coronary intervention(PCI). The basic elements of these RCTs, including sample size and estimation method, randomizing scheme, allocation concealment, blind method implementation, data integrity, statistical method, TCM syndrome, intervention measures, treatment course, follow-up time, and outcome indicators, were analyzed to provide reference for the design of future RCT and the clinical application of TCM in treating angina pectoris after PCI. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, ClinicalTrials.gov, and Chinese Clinical Trial Registry were searched for the RCT about TCM treatment of coronary heart disease patients with angina pectoris after PCI according to pre-defined criteria, with the time interval from inception to January 31, 2024. A total of 188 RCTs were included, of which 184 were clinical research articles and 4 were clinical trial registration schemes. These RCTs involved a total of 15 521 patients, with an average sample size of 83 patients and a maximum sample size of 248 patients. Among them, 126 RCTs reported TCM syndromes, the top three of which were Qi deficiency and blood stasis(38.89%), phlegm combined with stasis(17.46%), and Qi stagnation and blood stasis(9.52%). The control group received guideline-directed medical therapy(GDMT) or GDMT combined with placebo, and the treatment group received GDMT combined with TCM. The treatment mainly lasted for 4-8 weeks, most of the RCTs did not set the follow-up period or the follow-up period was unknown. A total of 160 outcome indicators were used, with the total frequency of 1 348. According to functional attributes, the outcome indicators can be categorized into 6 groups: symptoms/signs(403, 29.90%), TCM syndromes/symptoms(182, 13.50%), physical and chemical examination(468, 34.72%), quality of life(89, 6.60%), long-term prognosis(5, 0.37%), and safety evaluation(201, 14.91%). The clinical trial design of TCM intervention in angina pectoris after PCI of coronary heart disease is becoming more and more rigorous, while it remains to be improved. It is expected that more clinical trial schemes with rigorous design and taking into account the TCM advantages can be adopted in the future to provide a basis for the TCM treatment of angina pectoris after PCI of coronary heart disease.
本研究系统评价了中医药治疗经皮冠状动脉介入治疗（PCI）术后冠心病心绞痛患者的随机对照试验（RCT）。分析了这些RCT的基本要素，包括样本量及估算方法、随机方案、分配隐藏、盲法实施、数据完整性、统计方法、中医证候、干预措施、疗程、随访时间和结局指标，为未来RCT设计及中医药治疗PCI术后心绞痛的临床应用提供参考。根据预先设定的标准，检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆、Web of Science、ClinicalTrials.gov和中国临床试验注册中心中关于中医药治疗PCI术后冠心病心绞痛患者的RCT，时间跨度从建库至2024年1月31日。共纳入188项RCT，其中184篇为临床研究文章，4篇为临床试验注册方案。这些RCT共纳入15521例患者，平均样本量为83例，最大样本量为248例。其中，126项RCT报告了中医证候，前三位分别为气虚血瘀（38.89%）、痰瘀互结（17.46%）和气滞血瘀（9.52%）。对照组接受指南导向药物治疗（GDMT）或GDMT联合安慰剂，治疗组接受GDMT联合中医药治疗。治疗主要持续4 - 8周，大多数RCT未设置随访期或随访期不明。共使用了160项结局指标，总频数为1348次。根据功能属性，结局指标可分为6组：症状/体征（403项，29.90%）、中医证候/症状（182项，13.50%）、理化检查（468项，34.72%）、生活质量（89项，6.60%）、远期预后（5项，0.37%）和安全性评价（201项，14.91%）。冠心病PCI术后心绞痛中医药干预的临床试验设计越来越严谨，但仍有待改进。期望未来能采用更多设计严谨且兼顾中医药优势的临床试验方案，为冠心病PCI术后心绞痛的中医药治疗提供依据。
