复方丹参滴丸联合西医常规治疗不稳定型心绞痛的Meta分析及GRADE评价

Meta-analysis and GRADE Evaluation of Compound Danshen Dripping Pills(复方丹参滴丸) Combined with Western Medicine in the Treatment of Unstable Angina Pectoris

目的系统评价复方丹参滴丸联合西医常规治疗不稳定型心绞痛(UAP)的有效性及安全性。方法检索中国知网、维普中文期刊数据库、万方数字化期刊全文数据库、中国生物医学文献数据库、Embase、PubMed、Cochrane Library,收集复方丹参滴丸治疗UAP的随机对照试验,检索时限均为从建库至2019年5月31日。采用偏倚风险评估量表评价纳入研究的方法学质量。采用RevMan 5.3软件对结局指标[包括心血管事件发生率、心绞痛发作次数、超敏C反应蛋白(hs-CRP)、心电图疗效、心绞痛持续时间、不良事件发生率]进行Meta分析,并按照GRADE标准进行证据质量评价。结果共纳入43篇随机对照试验,共计4545例患者。Meta分析显示:与单用西医常规治疗相比,复方丹参滴丸联合西医常规治疗在降低6个月内心血管事件发生率[RR=0.47,95%CI(0.26,0.83),P=0.010]、减少心绞痛发作次数[SMD=-2.43,95%CI(-3.66,-1.20),P=0.001]、降低hs-CRP[SMD=-1.70,95%CI(-2.79,-0.61),P=0.002]、改善心电图疗效[RR=1.31,95%CI(1.25,1.37),P<0.001]、缩短心绞痛持续时间[MD=-2.97,95%CI(-4.09,-1.85),P<0.001]方面,疗效均更显著;且不良事件发生率更低[RR=0.71,95%CI(0.54,0.93),P=0.01]。根据GRADE标准,心血管事件发生率、hs-CRP、心电图疗效、不良事件发生率4个结局指标为低质量证据,心绞痛发作次数、心绞痛持续时间为极低质量证据。结论复方丹参滴丸联合常规西医治疗UAP的疗效优于单用西医常规治疗,不良反应少,但研究的质量较低,尚需更多设计严谨的多中心随机对照试验以增加证据强度。

Objective To evaluate the efficacy and safety of Compound Danshen Dripping Pills(复方丹参滴丸)combined with western medicine in the treatment of unstable angina pectoris(UAP).Methods China National Knowledge Infrastructure,VIP Chinese Journal Database,Wanfang Digital Journal Full-text Database,China Biomedical Literature Database,Embase,PubMed,Cochrane Library were retrieved to collect randomized controlled trials of Compound Danshen Dripping Pills for UAP.The search time was from database begining to May 31,2019.The methodological quality of the included studies was assessed using a bias risk assessment scale.Meta-analysis of outcome measures including cardiovascular events,angina pectoris,high-sensitivity C-reactive protein(hs-CRP),electrocardiogram efficacy,duration of angina pectoris,and adverse event rates was performed by using RevMan 5.3 software,and according to GRADE criteria,an evaluation of the quality of the evidence was conducted.Results A total of 43 randomized controlled trials involving 4545 patients were included.Meta-analysis showed that the Compound Danshen Dripping Pills combined with western medicine conventional treatment more significantly reduced the incidence of cardiovascular events within 6 months[RR=0.47,95%CI(0.26,0.83),P=0.010],reduced angina attacks[SMD=-2.43,95%CI(-3.66,-1.20),P=0.001],reduced hs-CRP[SMD=-1.70,95%CI(-2.79,-0.61),P=0.002],improved ECG efficacy[RR=1.31,95%CI(1.25,1.37),P<0.001],shortened angina duration[MD=-2.97,95%CI(-4.09,-1.85),P<0.001];and the incidence of adverse events was lower[RR=0.71,95%CI(0.54,0.93),P=0.01]as compared with simple use western medicine conventional treatment.According to the GRADE criteria,the 4 outcome measures of cardiovascular event rate,hs-CRP,ECG efficacy,and adverse event rate were low-quality evidence,and the number of angina attacks and angina duration were extremely low-quality evidence.Conclusion The effect of Compound Danshen Dripping Pills combined with conventional western medicine in treating UAP is better than that of conventional western medicine alone.The adverse reactions are few,but the quality of the research is low.More well-designed multi-center controlled trials are needed to increase the intensity of evidence.