[参芍胶囊治疗冠心病心绞痛的Meta分析与试验序贯分析]

[Meta-analysis and trial sequential analysis of Shenshao Capsules in treatment of angina pectoris in coronary heart disease].

作者信息

Sun Heng, Xing Zuo-Ying, Huang Jin-Yu, Qiu Bo-Yong, Wang Yong-Xia

机构信息

Department of Cardiovascular Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China First Clinical Medical College, Henan University of Chinese Medicine Zhengzhou 450000, China.

Department of Cardiovascular Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2024 Jun;49(12):3385-3395. doi: 10.19540/j.cnki.cjcmm.20240219.501.

Abstract

The efficacy and safety of Shenshao Capsules in combination with conventional western medicine for the treatment of angina pectoris in coronary heart disease were systematically evaluated. Computer search of seven databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library, was conducted to identify randomized controlled trial(RCT) on Shenshao Capsules for the treatment of angina pectoris in coronary heart disease up to December 2023. According to inclusion and exclusion criteria, articles were screened, and data was extracted. Cochrane bias risk assessment tool 2.0(RoB 2.0) was used to evaluate the quality of the included articles. Meta-analysis was performed by RevMan 5.4 and Stata/SE 15.1 software, and evidence quality was rated by the GRADE system. TSA 0.9.5.10 beta software was used for the trial sequential analysis(TSA). Twelve RCTs, with a total of 1 128 participants(567 in the experimental group and 561 in the control group), were included. Meta-analysis showed that Shenshao Capsules + conventional western medicine significantly improved clinical efficacy(RR=1.20, 95%CI[1.15, 1.26], P<0.000 01) and electrocardiogram efficacy(RR=1.16, 95%CI[1.04, 1.30], P=0.01), reduced the frequency of weekly angina pectoris attacks(MD=-2.85, 95%CI[-5.27,-0.43], P=0.02), daily angina pectoris attacks(MD=-0.30, 95%CI[-0.57,-0.03], P=0.03) and the duration of angina pectoris attacks(RR=-2.28, 95%CI[-3.44,-1.12], P=0.000 1). There was no statistically significant difference in adverse reactions between the two groups(RR=1.33, 95%CI[0.71, 2.51], P=0.37). TSA indicated that the cumulative evidence for clinical efficacy exceeded the traditional boundary but did not exceed the TSA boundary, suggesting a potential false positive result. According to GRADE assessment, except for clinical efficacy, which was rated as low-quality evidence, the remaining outcomes were rated as very low-quality evidence. The results indicate that Shenshao Capsules + conventional western medicine may have certain advantages in improving clinical efficacy and electrocardiographic efficacy, reducing the frequency and duration of angina pectoris attacks. However, due to the limitations of this study, more rigorous and high-quality RCT is needed to validate its efficacy and safety.

摘要

系统评价参芍胶囊联合常规西药治疗冠心病心绞痛的疗效及安全性。通过计算机检索中国知网(CNKI)、万方、维普、中国生物医学文献数据库(SinoMed)、PubMed、EMbase、Cochrane图书馆7个数据库,检索截至2023年12月关于参芍胶囊治疗冠心病心绞痛的随机对照试验(RCT)。根据纳入与排除标准筛选文献并提取数据。采用Cochrane偏倚风险评估工具2.0(RoB 2.0)评价纳入文献的质量。运用RevMan 5.4和Stata/SE 15.1软件进行Meta分析,采用GRADE系统对证据质量进行分级。使用TSA 0.9.5.10 beta软件进行试验序贯分析(TSA)。共纳入12项RCT,总计1128例参与者(试验组567例,对照组561例)。Meta分析结果显示,参芍胶囊联合常规西药可显著提高临床疗效(RR=1.20,95%CI[1.15,1.26],P<0.000 01)及心电图疗效(RR=1.16,95%CI[1.04,1.30],P=0.01),减少每周心绞痛发作次数(MD=-2.85,95%CI[-5.27,-0.43],P=0.02)、每日心绞痛发作次数(MD=-0.30,95%CI[-0.57,-0.03],P=0.03)及心绞痛发作持续时间(RR=-2.28,95%CI[-3.44,-1.12],P=0.000 1)。两组不良反应差异无统计学意义(RR=1.33,95%CI[0.71,2.51],P=0.37)。TSA结果显示,临床疗效的累积证据超过传统界值但未超过TSA界值,提示可能存在假阳性结果。根据GRADE评估,除临床疗效为低质量证据外,其余结局均为极低质量证据。结果表明,参芍胶囊联合常规西药在提高临床疗效和心电图疗效、减少心绞痛发作频率及持续时间方面可能具有一定优势。然而,由于本研究存在局限性,尚需更严谨、高质量的RCT来验证其疗效及安全性。

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