Yu Dan-Dan, Xie Yan-Ming, Zhang Yun-Ling, Liao Xing, Zhi Ying-Jie, Zhao Hui
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.
Zhongguo Zhong Yao Za Zhi. 2018 Oct;43(20):4138-4151. doi: 10.19540/j.cnki.cjcmm.20180611.014.
To evaluate the effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease. Four Chinese databases (CNKI, VIP, WanFang, and SinoMed) and three English databases (Cochrane Library, Medline, and ClinicalTrail.gov) were systematically and comprehensively searched from the establishment of each database to March 2018. Randomized controlled trials (RCTs) on the treatment of angina pectoris of coronary heart disease with Kudiezi injection (KDZ) were screened according to the pre-established inclusion criteria and exclusion criteria. The quality of the included studies was evaluated by using the ROB tool developed by the Cochrane Collaboration, and RevMan 5.3 software was used for Meta-analysis. A total of 712 articles were retrieved and finally 38 studies were included. The total sample size was 3 812 cases, 1 945 in the experimental group and 1 867 in the control group. The overall quality of the included studies was generally low. The results of Meta-analysis showed that: KDZ combined with conventional or western medicine was superior to conventional or western medicine alone in the effectiveness and electrocardiogram efficacy of angina pectoris and unstable angina. The descriptive analysis showed that KDZ combined with conventional treatment group was superior to conventional treatment group in agina pectoris associated indicators of angina pectoris and unstable angina. Other outcome measures were easily affected by various factors (such as too large heterogeneity of outcome indicators) and could not be concluded. Adverse reactions included in the study report were all mild adverse reactions and did not affect treatment. Based on the results of this study, it can be seen that Kudiezi injection had a certain effect on the treatment of angina pectoris of coronary heart disease, especially with significant positive effect on the improvement of the curative effect for angina pectoris and the effect of electrocardiogram. No serious adverse reactions occurred. However, due to the limited number of studies included, the generally low quality of the included studies, and the existence of published biases, the quality of the evidence in this study was low, so that caution should be taken to apply this conclusion. The effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease remained to be confirmed in the future with a well-designed and rigorous multi-center randomized controlled trials with standardized report, large sample, and enough follow-up time.
评价苦碟子注射液治疗冠心病心绞痛的有效性和安全性。从各数据库建库至2018年3月，系统全面检索了4个中文数据库（中国知网、维普、万方和中国生物医学文献数据库）和3个英文数据库（考克兰图书馆、医学期刊数据库和临床试验数据库）。根据预先设定的纳入标准和排除标准，筛选苦碟子注射液（KDZ）治疗冠心病心绞痛的随机对照试验（RCT）。采用考克兰协作网开发的ROB工具评价纳入研究的质量，并用RevMan 5.3软件进行Meta分析。共检索到712篇文献，最终纳入38项研究。总样本量为3812例，试验组1945例，对照组1867例。纳入研究的整体质量普遍较低。Meta分析结果显示：KDZ联合常规或西药在心绞痛和不稳定型心绞痛的有效性及心电图疗效方面优于单纯常规或西药。描述性分析显示：KDZ联合常规治疗组在心绞痛和不稳定型心绞痛的心绞痛相关指标方面优于常规治疗组。其他结局指标易受多种因素影响（如结局指标异质性过大），无法得出结论。研究报道的不良反应均为轻度不良反应，不影响治疗。基于本研究结果可见，苦碟子注射液对冠心病心绞痛治疗有一定效果，尤其对心绞痛疗效及心电图改善有显著积极作用，未发生严重不良反应。然而，由于纳入研究数量有限，纳入研究整体质量较低，且存在发表偏倚，本研究证据质量较低，故应用该结论时应谨慎。苦碟子注射液治疗冠心病心绞痛的有效性和安全性仍有待未来通过设计良好、严谨、报告规范、大样本且随访时间足够的多中心随机对照试验加以证实。
