目的 系統(tǒng)評價參麥注射液聯(lián)合常規(guī)化學藥治療冠心病心力衰竭的療效與安全性。方法 通過計算機檢索中國學術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（WanFang）、維普生物醫(yī)學數(shù)據(jù)庫（VIP）、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）、Pubmed、Embase、Cochrane等中英文數(shù)據(jù)庫進行檢索，搜集相關(guān)文獻從建庫—2024年5月。應用Revman 5.4和Stata 15.1軟件進行Meta分析，GRADE評價系統(tǒng)進行證據(jù)評級。結(jié)果 共納入3項隨機對照試驗（RCT），樣本量2 884例； Meta分析結(jié)果顯示，參麥注射液聯(lián)合常規(guī)化學藥在提高總有效率[RR＝1.23，95% CI（1.19，1.27），P＜0.000 01]、左室射血分數(shù)[LVEF，MD＝8.18，95% CI（6.83，9.52），P＜0.000 01]、提高6 min步行距離[6MWT，MD＝59.86，95% CI（28.17，91.56），P＝0.000 2]，降低血漿B型利鈉肽[BNP，MD＝-214.27，95% CI （-306.86，-121.67），P＜0.000 01]、左室收縮末期內(nèi)徑[LVESD，MD＝-4.03,95% CI（-6.30，-1.76），P＝0.000 5]和舒張末期內(nèi)徑[LVEDD，MD＝-5.58，95% CI（-8.44，-2.72），P＝0.0001]、左心室收縮末期容積[LVESV，MD＝-18.89，95% CI（-23.44，-14.33），P＜0.000 01)、白細胞介素-6[IL-6，MD＝-6.59，95% CI（-7.75，-5.43]，P＜0.000 01]、腫瘤壞死因子-α[TNF-α，MD＝-38.64，95% CI（-55.91，-21.36），P＜0.000 1]、血清超敏C反應蛋白[hs-CRP，MD＝-2.56，95% CI（-2.88，-2.24），P＜0.000 01]方面優(yōu)于單純化學藥組。GRADE質(zhì)量評級結(jié)果顯示，臨床總有效率、hsCRP和不良反應發(fā)生方面為低質(zhì)量證據(jù)，其余為極低質(zhì)量證據(jù)。試驗序貫分析顯示臨床總有效率累計納入的研究穿過了傳統(tǒng)界值和TSA界值，進一步肯定了臨床療效。在不良反應發(fā)生方面，參麥注射液聯(lián)合常規(guī)化學藥更安全，差異有統(tǒng)計學意義[RR＝0.34，95% CI（0.23，0.53），P＜0.000 01]。結(jié)論 臨床應用參麥注射液聯(lián)合常規(guī)化學藥治療冠心病心力衰竭療效確切，且安全性更好，推薦臨床應用。

Objective Shenmai Injection, a traditional Chinese medicine, has been used in combination with conventional chemical medicine for the treatment of coronary heart disease and heart failure. To systematically evaluate the efficacy and safety of Shenmai Injection as an adjunctive therapy. Methods Computerized searches were performed on Chinese and English databases, including CNKI, WanFang, VIP, CBM, Pubmed, Embase, Cochrane and to collect relevant literature from the establishment of the database until May 2024. Meta-analyses were conducted using RevMan 5.4 and Stata 15.1 software, and the GRADE system was used for evidence grading. Results Three randomized controlled trials (RCTs) with a sample size of 2 884 cases were included; The Meta-analysis results showed that the combination of Shenmai Injection and conventional chemical medicine was superior to chemical medicine alone in terms of improving the total effective rate [RR = 1.23, 95% CI (1.19, 1.27), P <0.000 01], LVEF [MD = 8.18, 95% CI (6.83, 9.52), P <0.000 01], 6MWT [MD = 59.86, 95% CI (28.17, 91.56), P＝ 0.000 2], reducing BNP [MD = -214.27, 95% CI (-306.86, -121.67), P <0.000 01], LVESD and LVEDD [MD = -4.03, 95% CI (-6.30, -1.76), P＝ 0.000 5]; [MD = -5.58, 95% CI (-8.44, -2.72), P＝ 0.000 1], LVESV [MD = -18.89, 95% CI [-23.44, -14.33], P <0.000 01], IL-6 [MD = -6.59, 95% CI -7.75, -5.43), P <0.000 01], TNF-α [MD = -38.64, 95% CI (-55.91, -21.36), P <0.000 1], and hs-CRP [MD = -2.56, 95% CI (-2.88, -2.24), P <0.000 01]. The GRADE quality rating results showed low-quality evidence for the total effective rate, hs-CRP, and adverse reactions, and very low-quality evidence for the rest of the outcomes. The trial sequence analysis showed that the cumulative number of studies on the total effective rate crossed both the traditional threshold and the TSA threshold, further confirming the clinical efficacy. In terms of adverse reactions, the combination of Shenmai Injection and conventional chemical medicine was safer, with a statistically significant difference [RR = 0.34, 95% CI (0.23, 0.53), P <0.000 01]. Conclusion The combination of Shenmai Injection and conventional chemical medicine is effective and safer for the treatment of coronary heart disease and heart failure. It is recommended for clinical application.

R974

國家自然科學基金資助項目（82204885）；天津自然科學基金項目（23JCONJC01070）