Pang Wen-Tai, Zhang Jun-Hua, Zhai Jing-Bo, Yang Feng-Wen, Jin Xin-Yao, Ji Zhao-Chen, Wang Hu-Cheng, Hu Hai-Yin
Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
Zhongguo Zhong Yao Za Zhi. 2019 Jun;44(11):2390-2396. doi: 10.19540/j.cnki.cjcmm.20190305.005.
To systematically review the efficacy and safety of Tongmai Yangxin Pills in treatment for angina pectoris of coronary heart disease. CNKI, WanFang, VIP, SinoMed, PubMed, EMbase and the Cochrane Library databases were retrieved online to collect randomized controlled trials(RCTs) of Tongmai Yangxin Pills for angina pectoris of coronary heart disease since the establishment to November 2018. Two investigators screened out literatures independently, extracted data and assessed the risk of bias of included studies. The risk assessment of included references was made according to criteria recommended by Cochrane Handbook 5.3. Meta-analysis was then performed by RevMan 5.3 software. A total of 9 RCTs were included. The results of Meta-analysis showed that compared with the single application of chemotherapy, the combined administration with Tongmai Yangxin Pills and Western medicine could significantly improve the clinical efficacy of angina(RR=1.22, 95%CI[1.13, 1.31]), the improvement rate of electrocardiogram(RR=1.31, 95%CI[1.21, 1.42]), and the clinical efficacy of traditional Chinese medicine(TCM) syndrome(RR=1.17, 95%CI[1.02, 1.35]). Only one study reported adverse events, while 5 studies reported no adverse event. According to current evidences, in the treatment of angina pectoris of coronary heart disease, Tongmai Yangxin Pills has a better clinical efficacy in the treatment of angina pectoris of coronary heart disease in terms of the improvement rate of electrocardiogram and the clinical efficacy of TCM syndrome. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
系统评价通脉养心丸治疗冠心病心绞痛的有效性与安全性。通过在线检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase及Cochrane图书馆数据库，收集自建库至2018年11月通脉养心丸治疗冠心病心绞痛的随机对照试验（RCT）。由两名研究者独立筛选文献、提取数据并评估纳入研究的偏倚风险。按照Cochrane Handbook 5.3推荐的标准对纳入文献进行风险评估。然后采用RevMan 5.3软件进行Meta分析。共纳入9项RCT。Meta分析结果显示，与单纯应用化疗药物相比，通脉养心丸联合西药可显著提高心绞痛临床疗效（RR=1.22，95%CI[1.13，1.31]）、心电图改善率（RR=1.31，95%CI[1.21，1.42]）及中医证候临床疗效（RR=1.17，95%CI[1.02，1.35]）。仅1项研究报告了不良事件，5项研究报告无不良事件。根据现有证据，在冠心病心绞痛治疗中，通脉养心丸在心电图改善率及中医证候临床疗效方面治疗冠心病心绞痛具有较好的临床疗效。由于纳入研究的质量和数量有限，尚需更多高质量研究验证上述结论。
