益气活血法治疗经皮冠状动脉介入术后气虚血瘀证心绞痛的Meta分析与GRADE评价

Meta-analysis and GRADE Evaluation of Supplementing Qi and Activating Blood for Angina Pectoris with Qi Deficiency and Blood Stasis Syndrome after Percutaneous Coronary Intervention

目的 系统评价以益气活血为主要功效的中药复方(或中成药)联合常规西药治疗经皮冠状动脉介入(PCI)术后气虚血瘀证心绞痛的有效性及安全性。方法 系统检索PubMed、EMbase、the Cochrane Library、中国知网、万方数据库、中文科技期刊数据库及中国生物医学文献数据库,检索时间从建库至2021年10月5日。应用RevMan 5.3软件及Stata 15.1软件进行数据分析,GRADE profiler 3.6软件对Meta分析结局指标进行证据分级。结果 共检索到3 712篇文献,最终纳入22篇文献,涉及1 437例PCI术后气虚血瘀证心绞痛病人。Meta分析结果显示,试验组在提高心绞痛疗效[RR=1.27,95%CI(1.17,1.39),P<0.000 01]、心电图疗效[RR=1.18,95%CI(1.08,1.28),P=0.000 3]、中医证候疗效[RR=1.30,95%CI(1.22,1.39),P<0.000 01],降低总胆固醇(TC)[MD=-0.52,95%CI(-0.77,-0.27),P<0.000 1]、三酰甘油(TG)[MD=-0.35,95%CI(-0.50,-0.19),P<0.000 01]、低密度脂蛋白胆固醇(LDL-C)[MD=-0.36,95%CI(-0.50,-0.22),P<0.000 01]及超敏C反应蛋白(hs-CRP)[MD=-1.31,95%CI(-1.79,-0.82),P<0.000 01],提高高密度脂蛋白胆固醇(HDL-C)[MD=0.11,95%CI(0.02,0.20),P=0.02]均优于对照组。两组不良反应发生率比较,差异无统计学意义[RR=0.25,95%CI(0.06,1.13),P=0.07]。GRADE证据分级结果显示,心绞痛疗效、心电图疗效为中等级,中医证候疗效为低等级,TC、TG、LDL-C、HDL-C、hs-CRP及不良反应均为极低等级。结论 现有证据表明:以益气活血为主要功效的中药复方(或中成药)联合常规西药治疗PCI术后气虚血瘀证心绞痛的疗效优于单用西药治疗,且不良反应较少。

Objective To evaluate the efficacy and safety of traditional Chinese medicine compound(or Chinese patent medicine) with the main efficacy of supplementing Qi and activating blood circulation combined with conventional Western medicine in the treatment of angina pectoris with Qi deficiency and blood stasis syndrome after percutaneous coronary intervention(PCI).Methods PubMed, EMbase, the Cochrane Library, CNKI,WanFang database, Chinese Science and Technology Journal database and Chinese Biomedical literature database were searched systematically from establishment to October 5,2021.RevMan 5.3 software and Stata 15.1 software were used for data analysis, and GRADE profiler 3.6 software was used for evidence grading of Meta-analysis outcome indicators.Results A total of 3 712 literatures were retrieved, and 22 literatures were included, including 1 437 patients.Meta-analysis results showed that the efficacy of angina pectoris[RR=1.27,95%CI(1.17,1.39),P<0.000 01],electrocardiogram efficacy[RR=1.18,95%CI(1.08,1.28),P=0.000 3],traditional Chinese medicine(TCM) syndrome efficacy[RR=1.30,95%CI(1.22,1.39),P<0.000 01],total cholesterol(TC)[MD=-0.52,95%CI(-0.77,-0.27),P<0.000 1],triglyceride(TG)[MD=-0.35,95%CI(-0.50,-0.19),P<0.000 01],low density lipoprotein cholesterol(LDL-C)[MD=-0.36,95%CI(-0.50,-0.22),P<0.000 01],high density lipoprotein cholesterol(HDL-C)[MD=0.11,95%CI(0.02,0.20),P=0.02] and high-sensitivity CRP(hs-CRP)[MD=-1.31,95%CI(-1.79,-0.82),P<0.000 01] in the experimental group were better than those in the control group.In terms of safety, there was no statistical difference in the number of adverse reactions between two groups[RR=0.25,95%CI(0.06,1.13),P=0.07].GRADE evidence grading results showed that the outcome indicators of angina pectoris efficacy and electrocardiogram efficacy were in the medium grade, TCM syndrome efficacy was in the low grade, TC, TG, LDL-C,HDL-C,hs-CRP and adverse reactions were in the very low grade.Conclusion The current evidence showed that traditional Chinese medicine compound(or Chinese patent medicine)with the main efficacy of supplementing Qi and activating blood combined with conventional western medicine were better than western medicine alone in the treatment of angina pectoris with Qi deficiency and blood stasis syndrome after PCI,with fewer adverse reactions.