麝香保心丸治疗冠心病心绞痛的系统评价

Shexiang Baoxin Pills for Coronary Disease Angina Pectoris:A Systematic Review

目的:系统评价麝香保心丸治疗冠心病心绞痛的有效性与安全性。方法:运用系统评价的方法,全面检索中国期刊全文数据库、中文科技期刊全文数据库、中国生物医学文献数据库的相关文献,筛选到有应用麝香保心丸治疗冠心病心绞痛的随机对照试验(RCT),按照纳入与排除标准选择试验、评价质量和提取有效数据,而后采用RevMan5.0软件进行Meta分析。结果:共纳入30项RCT,包括3153例患者,其方法学质量评价仅有2篇为B级,其余均为C级。Meta分析结果显示,试验组的心绞痛发作有效率[OR=3.82,95%CI(3.15,4.62),P<0.00001]、心电图复查有效率[OR=2.50,95%CI(2.12,2.94),P<0.00001]、ST段缺血情况改善情况[MD=-0.61,95%CI(-0.88,-0.34),P<0.0001]和血液流变学指标改善情况[MD=-2.15,95%CI(-2.55,-1.74),P<0.00001]均优于对照组,2组比较差异有统计学意义。而麝香保心丸组的心绞痛发作情况以及不良反应发生率[OR=0.57,95%CI(0.29,1.11),P=0.10]与对照组比较差异无统计学意义。结论:现有研究表明,麝香保心丸能有效改善冠心病心绞痛患者心肌ST段缺血和各项血液流变学指标,使患者心电图复查有效率显著提高,并最终显著降低心绞痛发作率,且安全性较好。但由于本系统评价纳入研究证据强度不高,且样本量较小,故上述结论尚需更多高质量RCT进一步验证。

OBJECTIVE： To evaluate the efficacy and safety of Shexiang baoxin pills for patients with coronary disease and angina pectoris. METHODS： We electronically searched CNKI, VIP and CBM. Randomized controlled trials （RCT） on Shexiang baoxin pills in the treatment of coronary disease angina pectoris were selected according to inclusion and exclusion standard then to evaluate the quality of them and extract data. Meta-analysis was conducted using Rev Man 5.0 software. RESULTS： 30 RCTs were included, involving 3 153 patients. Only 2 literature was grade B in quality evaluation, others were all grade C. Meta-analysis showed that： effective rate of angina pectoris attack[OR=3.82, 95%CI（3.15, 4.62）, P〈0.000 01], effective rate of ECG[OR=2.50, 95%CI（2.12, 2.94）, P〈0.000 01], the improvement of ST-segment ischemia[MD=-0.61, 95%CI（-0.88, -0.34）, P〈0.000 1] and improvement of hemorheology index[MD=-2.15, 95%CI（-2.55, -1.74）, P〈0.000 01] in trail group was superior to control group, there was statistical significance between 2 groups. The comparison of angina pectoris attack and adverse drug reaction rate[OR=0.57, 95%CI（0.29, 1.11）, P=0.10] in trail group was no statistical significance between 2 groups. CONCLUSION： Shexiang baoxin pills can effectively improve the ST segment ischemia and hemorheology index in patients with angina pectoris, significantly increase the effectiveness of ECG review and eventually significantly reduce the recurrence rate of angina pectoris, and appears to be much safer. Due to low quality and small-scale of samples, high quality RCTs are required to provide further reliable evidence for above conclusion.