Pan Jie, Zhou Jia-Meng, Wang Xiao-Mei, Zuo Kai-Ni, Wang Zhi-Heng, Lu Si-Qi, Wang Wei, Zhu Wen-Tao
School of Management, Beijing University of Chinese Medicine Beijing 100029, China.
Zhongguo Zhong Yao Za Zhi. 2021 May;46(9):2325-2332. doi: 10.19540/j.cnki.cjcmm.20210322.501.
The aim of the research was to evaluate the efficacy and safety associated with Shexiang Tongxin Dropping Pills combined with conventional therapy for patients with coronary heart disease(CHD). We searched 8 electronic databases up to November 2020, including PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP and SinoMed. Eligible studies were clinical trials of Shexiang Tongxin Dropping Pills combined with conventional therapy used in the treatment of coronary heart disease(CHD). The Meta-analysis was performed using STATA 15 software. A total of 21 RCTs(n=2 186) were shortlisted for the Meta-analysis. The results of efficacy evaluation showed that the total effective rate of Shexiang Tongxin Dropping Pills combined with conventional therapy was higher than that of conventional therapy of coronary heart disease(RR=1.20, 95%CI[1.15, 1.26], Z=8.63, P<0.001). Furthermore, Shexiang Tongxin Dripping Pills combined with conventional therapy had better effect on electrocardiogram efficacy(RR=1.24, 95%CI[1.16, 1.34], Z=5.98, P<0.001) and the number of angina attacks(SMD=-2.30, 95%CI[-3.47,-1.14], Z=3.88, P<0.001), the duration of angina attack(SMD=-2.31, 95%CI[-3.07,-1.55], Z=5.97, P<0.001), with lower levels of LDL-C(SMD=-0.73, 95%CI[-1.32,-0.14], Z=2.42, P=0.016), TC(SMD=-1.16, 95%CI[-1.35,-0.96], Z=11.56, P<0.001) and TG(SMD=-0.87, 95%CI[-1.06,-0.68], Z=8.97, P<0.001), and higher levels of HDL-C(SMD=0.87, 95%CI[0.02, 1.71], Z=2.00, P=0.045). The results of safety evaluation showed that the incidence of adverse reactions of Shexiang Tongxin Dropping Pills combined with conventional therapy was lower than that of conventional therapy of coronary heart disease(RR=0.45, 95%CI[0.22, 0.91], Z=2.23, P=0.026). There were significant differences in the above outcome indexes between the two groups. After the Harbord method test, the total effective rate outcome index has publication bias, but the sensitivity analysis of the cut-and-fill method suggested that the result was stable. In general, limited by the quantity and quality of included literature, more high-quality studies are needed to further verify the conclusions of this study.
本研究旨在评估麝香通心滴丸联合传统疗法治疗冠心病（CHD）患者的疗效和安全性。我们检索了截至2020年11月的8个电子数据库，包括PubMed、Cochrane图书馆、EMbase、Web of Science、中国知网、万方、维普和中国生物医学文献数据库。符合条件的研究为麝香通心滴丸联合传统疗法治疗冠心病（CHD）的临床试验。使用STATA 15软件进行Meta分析。共有21项随机对照试验（n = 2186）被纳入Meta分析。疗效评估结果显示，麝香通心滴丸联合传统疗法的总有效率高于冠心病传统疗法（RR = 1.20，95%CI[1.15，1.26]，Z = 8.63，P<0.001）。此外，麝香通心滴丸联合传统疗法在心电图疗效（RR = 1.24，95%CI[1.16，1.34]，Z = 5.98，P<0.001）、心绞痛发作次数（SMD = -2.30，95%CI[-3.47，-1.14]，Z = 3.88，P<0.001）、心绞痛发作持续时间（SMD = -2.31，95%CI[-3.07，-1.55]，Z = 5.97，P<0.001）方面效果更好，低密度脂蛋白胆固醇（LDL-C）水平更低（SMD = -0.73，95%CI[-1.32，-0.14]，Z = 2.42，P = 0.016），总胆固醇（TC）（SMD = -1.16，95%CI[-1.35，-0.96]，Z = 11.56，P<0.001）和甘油三酯（TG）（SMD = -0.87，95%CI[-1.06，-0.68]，Z = 8.97，P<0.001）水平更低，高密度脂蛋白胆固醇（HDL-C）水平更高（SMD = 0.87，95%CI[0.02，1.71]，Z = 2.00，P = 0.045）。安全性评估结果显示，麝香通心滴丸联合传统疗法的不良反应发生率低于冠心病传统疗法（RR = 0.45，95%CI[0.22，0.91]，Z = 2.23，P = 0.026）。两组上述结局指标存在显著差异。经过Harbord法检验，总有效率结局指标存在发表偏倚，但剪补法敏感性分析表明结果稳定。总体而言，受纳入文献数量和质量的限制，需要更多高质量研究进一步验证本研究结论。
