目的 系統(tǒng)評價參附注射液（SFI）聯(lián)合西醫(yī)常規(guī)治療對急性心肌梗死（AMI）患者經(jīng)皮冠狀動脈介入治療（PCI）術(shù)后的有效性及安全性。方法 計算機(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)知識服務(wù)平臺（Wanfang 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）、PubMed、Cochrane Library及Web of Science數(shù)據(jù)庫中有關(guān)SFI應(yīng)用于AMI患者PCI術(shù)后的臨床隨機(jī)對照試驗(yàn)（RCT），檢索時限均為建庫起至2023年1月，應(yīng)用RevMan 5.3軟件對收集的數(shù)據(jù)進(jìn)行Meta分析。結(jié)果 最終納入12個RCTs，總樣本量1 032例，包括試驗(yàn)組520例、對照組521例。Meta分析結(jié)果顯示，在常規(guī)治療基礎(chǔ)上加用SFI在改善主要不良心血管事件（MACE）發(fā)生率［RR＝0.19，95% CI （0.12，0.31），P＜0.000 01］、肌酸激酶同工酶［MD＝-32.40，95% CI（-62.65，-2.15），P＝0.04］、B型利鈉肽［MD＝-106.76，95% CI（-192.76，-20.76），P＝0.01］、心肌肌鈣蛋白T［MD＝-1.25，95% CI（-2.08，-0.43），P＝0.003］、收縮壓［MD＝5.73，95% CI （1.67，9.79），P＝0.006］、舒張壓［MD＝2.24，95% CI （1.10，3.38），P＝0.000 1］、心率［MD＝-8.84，95% CI（-10.46，-7.22），P＜0.000 01］、TIMI血流分級［RR＝0.58，95% CI（0.46，0.74），P＜0.000 1］及不良反應(yīng)等方面均優(yōu)于對照組，但在改善左心室射血分?jǐn)?shù)［MD＝2.48，95% CI （-3.47，8.43），P＝0.41］及左室舒張末期內(nèi)徑［MD＝-1.20，95% CI（-3.67，1.28），P＝0.34］方面兩組療效相當(dāng)，差異無統(tǒng)計學(xué)意義。結(jié)論 在西醫(yī)常規(guī)治療基礎(chǔ)上聯(lián)合SFI能顯著降低AMI患者PCI術(shù)后MACE發(fā)生率、改善患者心功能水平、降低心肌損傷、改善術(shù)后TIMI血流分級等，優(yōu)于西醫(yī)常規(guī)治療，并且能降低患者不良反應(yīng)發(fā)生率、安全性較好，為臨床合理用藥提供了有效依據(jù)。但納入文獻(xiàn)量較少且質(zhì)量參差不齊，所得結(jié)論仍需更多高質(zhì)量的RCT加以證實(shí)。

Objective To systematically evaluate the efficacy and safety of Shenfu Injection (SFI) combined with conventional western medicine treatment for patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI). Methods Databases such as CNKI, Wanfang Data, VIP, CBM, PubMed, Cochrane Library and Web of Science were searched by computer from foundation to January 2023 to collect randomized controlled trials of application of SFI in AMI patients after PCI. The collected data were analyzed using RevMan 5.3 software for Meta-analysis. Results A total of 12 RCTs were included, involving 1 032 patients, 520 cases in the experimental group and 521 cases in the control group. Meta-analysis showed that adding SFI to conventional Western medicine treatment improved the incidence of MACE events [RR = 0.19, 95%CI (0.12, 0.31), P < 0.000 01], creatine kinase isoenzymes [MD = -32.40, 95%CI (-62.65, -2.15), P = 0.04], B-type natriuretic peptide [MD = -106.76, 95%CI ( - 192.76, - 20.76), P = 0.01], cardiac troponin T [MD = - 1.25, 95%CI ( - 2.08, - 0.43), P = 0.003], and systolic blood pressure [MD = 5.73, 95%CI (1.67, 9.79), P = 0.006] diastolic blood pressure [MD = 2.24, 95%CI (1.10, 3.38), P = 0.000 1], heart rate [MD = -8.84, 95%CI (-10.46, -7.22), P < 0.000 01], TIMI blood flow classification [RR = 0.58, 95%CI (0.46, 0.74), P < 0.000 1], and adverse reactions were better than the control group, but improved left ventricular ejection fraction [MD = 2.48, 95%CI (-3.47, 8.43), P = 0.41] and left ventricular end diastolic diameter [MD = -1.20, 95%CI (-3.67, 1.28), P = 0.34]. The therapeutic effects of the two groups were comparable, and the difference was not statistically significant. Conclusion On the basis of conventional western medicine treatment, the combination of SFI can significantly reduce the incidence of MACE events in patients with acute myocardial infarction after PCI, improve the patient's cardiac function level, reduce myocardial injury, improve postoperative TIMI blood flow grading, etc., which is superior to traditional Western medicine treatment alone, and can reduce the incidence of adverse reactions in patients. The safety is good, providing an effective basis for clinical rational medication. However, the sample size included in the literature is small and the quality is uneven, and the conclusions obtained still need to be confirmed by more highquality RCTs.

R286.1

天津市教委科研計劃項(xiàng)目（2021ZD019）