目的 系統(tǒng)評(píng)價(jià)注射用益氣復(fù)脈（凍干）聯(lián)合化學(xué)藥治療冠心病心絞痛的有效性和安全性。方法 計(jì)算機(jī)檢索中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)知識(shí)服務(wù)平臺(tái)（Wangfang Data）、維普中文期刊全文數(shù)據(jù)庫（VIP）、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）、美國生物醫(yī)學(xué)期刊文獻(xiàn)數(shù)據(jù)庫（PubMed）、荷蘭醫(yī)學(xué)文摘數(shù)據(jù)庫（Embase）、循證醫(yī)學(xué)圖書館（The Cochrane Library）、美國引文數(shù)據(jù)庫（Web of Science）等，檢索時(shí)間從建庫至2021年8月31日，全面收集注射用益氣復(fù)脈（凍干）聯(lián)合化學(xué)藥治療與單純化學(xué)藥治療冠心病心絞痛的隨機(jī)對(duì)照試驗(yàn)（RCT）和半隨機(jī)對(duì)照試驗(yàn)（CCT）的文獻(xiàn)，采用RevMan 5.3軟件進(jìn)行Meta分析。結(jié)果 共納入9個(gè)RCTs和1個(gè)CCT，總樣本量為1 207例，其中試驗(yàn)組607例、對(duì)照組600例。Meta分析結(jié)果顯示，與化學(xué)藥常規(guī)治療相比，注射用益氣復(fù)脈（凍干）聯(lián)合化學(xué)藥常規(guī)治療能降低心血管事件發(fā)生率［RR=0.14，95% CI（0.06，0.32），P<0.000 01］，提高臨床有效率［RR=1.26，95% CI（1.17，1.35），P<0.000 01］，減少心絞痛發(fā)生次數(shù)［SMD=-2.38，95% CI（-2.64，-2.11），P<0.000 01］、心絞痛持續(xù)時(shí)間［SMD=-3.40，95% CI（-4.10，-2.70），P<0.000 01］，提升西雅圖心絞痛評(píng)分量表評(píng)分［MD=14.15，95% CI（11.69，16.60），P<0.000 01］，提高心電圖改善率［RR=1.20，95% CI（1.05，1.38），P=0.009］，降低全血黏度［MD=-2.23，95% CI（-3.28，-1.18），P<0.000 1］；兩組不良反應(yīng)發(fā)生率比較差異無統(tǒng)計(jì)學(xué)意義［OR=0.58，95% CI（0.21，1.59），P=0.29］。結(jié)論 與單純化學(xué)藥常規(guī)治療相比，注射用益氣復(fù)脈（凍干）聯(lián)合化學(xué)藥常規(guī)治療在降低心血管事件發(fā)生率、提高臨床有效率，減少心絞痛發(fā)作次數(shù)和心絞痛持續(xù)時(shí)間，提高心電圖療效和西雅圖評(píng)分和改善血液流變學(xué)作用方面療效更優(yōu)，且無明顯不良反應(yīng)。但上述研究結(jié)果仍需多中心、大樣本RCT試驗(yàn)進(jìn)一步驗(yàn)證。

Objective To systematically evaluate the efficacy and safety of Yiqi Fumai Lyophilized Injection (YQFM) combined with western medicine in the treatment of angina pectoris of coronary heart disease. Methods CNKI, Wanfang Data, VIP, CBM, PubMed, EMbase, the Cochrane library, and Web of science were searched from the date of establishment of the databases to August 31, 2021. The studies of randomized controlled trial (RCT) and controlled clinical trial (CCT) of YQFM combined with chemical drug and chemical drug alone in the treatment of angina pectoris were comprehensively collected. evaluated studies by the Cochrane risk assessment form. Meta-analysis of the included studies was performed using RevMan 5.3 software. Results A total of nine RCTs and one CCT were included, with a total sample size of 1 207 cases, including 607 cases in the experimental group and 600 cases in the control group. Meta-analysis showed that compared with WM alone, YQFM combined with chemical drug could reduce the incidence of cardiovascular events[RR=0.14, 95%CI (0.06, 0.32), P<0.000 01], increase clinical efficiency[RR=1.26, 95%CI (1.17, 1.35), P<0.000 01], reduce the number of angina attacks[SMD=-2.38, 95%CI (-2.64, -2.11), P<0.000 01], duration of angina pectoris[SMD=-3.40, 95%CI (-4.10, -2.70), P<0.000 01], increase SAQ scores[MD=14.15, 95%CI (11.69, 16.60), P<0.000 01], improve the efficacy of ECG[RR=1.20, 95%CI (1.05, 1.38), P=0.009], reduce whole blood viscosity level[MD=-2.23, 95%CI (-3.28, -1.18), P<0.000 1]. In the incidence of adverse reactions, there was no significant difference between the two groups[OR=0.58, 95%CI (0.21, 1.59), P=0.29]. Conclusion Compared with chemical drug alone, the combination of YQFM and chemical drug can reduce the incidence of cardiovascular events, improve the clinical effective rate, reduce the number of angina attacks and angina duration, improve the curative effect of ECG, SAQ scores, and hemorheology and has no obvious adverse reactions. The above research results still need to be verified by more multicenter randomized controlled trials.

R972;R286.2