Wu Yanhua, Li Shuang, Li Zunjiang, Mo Zhaofan, Luo Ziqing, Li Dongli, Wang Dawei, Zhu Wei, Ding Banghan
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Front Pharmacol. 2022 Nov 24;13:1027131. doi: 10.3389/fphar.2022.1027131. eCollection 2022.
This systematic review and meta-analysis aimed to investigate the adjuvant effect and safety of Shenfu injection (SFI) on the treatment of post-acute myocardial infarction heart failure (PAMIHF). Seven databases were searched to identify randomized controlled trials (RCTs) associated with SFI and PAMIHF treatment from May 1990 to May 2022. Primary outcomes included NT-proBNP and left ventricular ejection fraction (LVEF), and secondary outcomes included total effective rate, BNP, heart rate (HR), cardiac output (CO), and adverse event (AE). The risk of bias evaluation was assessed by the ROB2 tool, meta-analysis, subgroup analysis, sensitivity analysis, and publication bias were conducted by RevMan5.3 software, and the Grade of Recommendations, Assessment, Development, and Evaluations (GRADE) system was used to evaluate the quality of evidence of meta results. A total of 36 studies with 3231 PAMIHF patients were included. The meta results suggested that adjuvant SFI therapy was superior to conventional medical therapy alone. It improved the total effective rate [RR = 1.33; 95% CI (1.25.1.40); < 0.00001], increased LVEF [SMD = 0.98; 95% CI (0.71, 1.24); < 0.00001], and decreased HR [SMD = -1.14; 95% CI (-1.28, -0.99); < 0.00001]. In addition, adjuvant SFI therapy (9.73%, 66/678) had a rate of AE lower than that of conventional medical therapy alone (21.7%, 147/677) when regarding safety [RR = 0.45; 95% CI (0.35, 0.57); < 0.00001]. The quality of the evidence for the outcomes was rated from "very low" to "moderate." Adjuvant SFI therapy was safer to improve the total effective rate and the heart function of PAMIHF patients. However, well-designed RCTs were needed to confirm the efficacy and safety of adjuvant SFI therapy in PAMIHF treatment due to the low quality of the evidence for the outcomes caused by a small sample size and unclear risk of bias existed in included studies. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=151856), identifier CRD42020151856.
本系统评价和荟萃分析旨在探讨参附注射液（SFI）对急性心肌梗死后心力衰竭（PAMIHF）治疗的辅助作用及安全性。检索了七个数据库，以确定1990年5月至2022年5月期间与SFI和PAMIHF治疗相关的随机对照试验（RCT）。主要结局包括N末端B型利钠肽原（NT-proBNP）和左心室射血分数（LVEF），次要结局包括总有效率、B型利钠肽（BNP）、心率（HR）、心输出量（CO）和不良事件（AE）。采用ROB2工具评估偏倚风险，使用RevMan5.3软件进行荟萃分析、亚组分析、敏感性分析以及发表偏倚分析，并运用推荐分级、评估、制定与评价（GRADE）系统评估荟萃结果的证据质量。共纳入36项研究，涉及3231例PAMIHF患者。荟萃结果表明，辅助SFI治疗优于单纯常规药物治疗。它提高了总有效率[RR = 1.33；95%CI（1.25，1.40）；P < 0.00001]，增加了LVEF[SMD = 0.98；95%CI（0.71，1.24）；P < 0.00001]，并降低了HR[SMD = -1.14；95%CI（-1.28，-0.99）；P < 0.00001]。此外，在安全性方面，辅助SFI治疗（9.73%，66/678）的AE发生率低于单纯常规药物治疗（21.7%，147/677）[RR = 0.45；95%CI（0.35，0.57）；P < 0.00001]。结局的证据质量评级为“非常低”至“中等”。辅助SFI治疗在提高PAMIHF患者的总有效率和心功能方面更安全。然而，由于样本量小导致结局证据质量低且纳入研究中存在偏倚风险不明确，因此需要设计良好的RCT来证实辅助SFI治疗在PAMIHF治疗中的疗效和安全性。（https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=151856），标识符CRD42020151856
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