目的系統(tǒng)評價通心絡膠囊聯(lián)合西醫(yī)常規(guī)治療不穩(wěn)定型心絞痛的有效性及安全性，為臨床研究提供循證依據(jù)。方法以中國學術期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)知識服務平臺（Wanfang Data）、維普中文期刊全文數(shù)據(jù)庫（VIP）、中國臨床試驗注冊中心網(wǎng)站（Chinese Clinical Trial Registry）、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）、荷蘭醫(yī)學文摘數(shù)據(jù)庫（Embase）、循證醫(yī)學圖書館（The Cochrane library）、美國生物醫(yī)學期刊文獻數(shù)據(jù)庫（PubMed）為主要檢索來源，檢索時間為建庫始至2020年7月31日。采用偏倚風險評估工具評價納入研究的方法學質量。采用RevMan 5.3軟件對結局指標進行Meta分析。結果最終共納入30個隨機對照試驗（RCTs），共計2 295例不穩(wěn)定型心絞痛患者，其中觀察組1 188例，對照組1 107例。Meta分析結果顯示，試驗組比對照組可顯著降低心血管事件發(fā)生率[RR=0.28，95% CI=（0.18，0.45），P<0.000 01]、提高心絞痛療效[OR=2.46，95% CI=（1.96，3.10），P<0.000 01]，減少心絞痛發(fā)作次數(shù)[SMD=-1.00，95% CI=（-1.58，-0.42），P=0.000 7]、心絞痛持續(xù)時間[SMD=-2.25，95% CI=（-3.31，-1.19），P<0.000 1]及硝酸甘油用量[SMD=-1.47，95% CI=（-2.14，-0.79），P<0.000 1]，提高心電圖療效[OR=2.25，95% CI=（1.64，3.09），P<0.000 01]，降低超敏C反應蛋白水平[SMD=-2.78，95% CI=（-3.95，-1.62），P<0.000 01]；在不良反應發(fā)生率方面，兩組比較差異無統(tǒng)計學意義[RR=0.87，95% CI=（0.48，1.55），P=0.63]。結論在西醫(yī)常規(guī)治療基礎上加用通心絡膠囊對不穩(wěn)定型心絞痛的療效確切，能顯著降低心血管事件發(fā)生率、提高心絞痛療效，減少心絞痛發(fā)作次數(shù)、心絞痛持續(xù)時間及硝酸甘油用量，提高心電圖療效，降低超敏C反應蛋白水平，且無明顯不良反應。但研究的質量較低，尚需更多設計嚴謹?shù)亩嘀行碾S機對照試驗以增加證據(jù)強度。

Objective To systematically evaluate the efficacy and safety of Tongxinluo Capsule combined with conventional western medicine in the treatment of unstable angina pectoris (UAP), and to provide evidence-based basis for clinical research. Methods CNKI, WanFang Data, VIP, Chinese Clinical Trial Registry, CBM, Embase, The Cochrane library and PubMed were used as the main search sources. The search time was limited to July 31, 2020. The bias risk assessment tool was used to evaluate the methodological quality of the included studies. Meta-analysis was performed using RevMan 5.3 software. Results A total of 30 RCTs were included, 2 295 patients with unstable angina pectoris, including 1 188 cases in the observation group and 1 107 cases in the control group. The results of meta-analysis showed that compared with the control group, the experimental group could significantly reduce the incidence of cardiovascular events [RR= 0.28, 95%CI = (0.18, 0.45). P < 0.000 01], improve the efficacy of angina pectoris [OR = 2.46, 95%CI = (1.96, 3.10), P < 0.000 01], reduce the number of angina attacks [SMD = - 1.00, 95%CI = (-1.58, -0.42), P = 0.000 7], duration of angina pectoris [SMD = -2.25, 95%CI = (-3.31, -1.19), P < 0.000 1], the dosage of nitroglycerin [SMD = -1.47, 95%CI = (-2.14, -0.79), P < 0.000 1], improve The efficacy of ECG [OR = 2.25, 95%CI = (1.64, 3.09, P < 0.000 01] and decrease the level of hs-CRP [SMD = -2.78, 95%CI = (-3.95, -1.62), P < 0.000 01]. In the incidence of adverse reactions, there was no significant difference between the two groups[RR = 0.87, 95%CI = (0.48, 1.55), P = 0.63]. Conclusion Tongxinluo Capsule is effective in the treatment of unstable angina pectoris on the basis of conventional western medicine treatment. It can significantly reduce the incidence of cardiovascular events, improve the curative effect of angina pectoris, reduce the number of angina attacks, angina duration and nitroglycerin dosage, improve the curative effect of ECG, reduce the level of high sensitivity C reactive protein, and have no obvious adverse reactions. However, the quality of the study is low, and more rigorously designed multicenter randomized controlled trials are needed to increase the intensity of evidence.

R944.5

國家重點研發(fā)計劃-中醫(yī)藥現(xiàn)代化研究（2019YFC1710005）