School of Pharmacy, Gansu University of Chinese Medicine, Lanzhou, Gansu, China.
Shaanxi University of Chinese Medicine, Xianyang, China.
Complement Ther Med. 2024 Aug;83:103053. doi: 10.1016/j.ctim.2024.103053. Epub 2024 May 25.
Shenmai injection is a classic herbal prescription, and is often recommended for the treatment of anthracycline-induced cardiotoxicity. However, the efficacy and safety of Shenmai injection for the treatment of anthracycline-induced cardiotoxicity have not been reported.
We conducted a comprehensive search of eight literature databases and two clinical trial registries, retrieving all randomized controlled trials (RCTs) related to the treatment of anthracycline-induced cardiotoxicity with Shenmai injection from the establishment of the databases to July 1, 2023. Data analysis was performed using the Meta package in RStudio and RevMan 5.4. The GRADE pro3.6.1 software was utilized for assessing the quality of evidence.
A total of 16 RCTs including 2140 patients were included in this study. Meta-analysis showed that Shenmai injection had an advantage in improving ST-T segment changes (RR = 0.28; 95 % CI, 0.20 to 0.39; P < 0.0001) (P < 0.01), creatine kinase isoenzyme (SMD = -3.49; 95 % CI, -5.24 to -1.74; P < 0.0001), Prolonged QT interval (RR = 0.46; 95 % CI, 0.28 to 0.75; P = 0.0018), Low QRS Voltage (RR = 0.44; 95 % CI, 0.27 to 0.71; P = 0.0007), sinus tachycardia (RR = 0.41; 95 % CI, 0.28 to 0.60; P < 0.0001), atrial premature beats (RR = 0.55; 95 % CI, 0.35 to 0.87; P = 0.01), Premature Ventricular Contractions (RR = 0.39; 95 % CI, 0.26 to 0.59; P < 0.0001) and creatine kinase (SMD = -1.43; 95 % CI, -2.57 to -0.29; P < 0.0001) in patients with anthracycline-induced cardiotoxicity. advantage, which was supported by sensitivity analyses, but not in improving left ventricular ejection fraction (MD = 16.01; 95 % CI, -3.10 to 35.12; P = 0.10) and atrioventricular block (RR = 0.49; 95 % CI, 0.24 to 1.03; P = 0.06). The literature included in the study did not refer to data regarding the safety aspects of Shenmai injection, so we do not yet know the safety of Shenmai injection. The results of subgroup analyses suggested that heterogeneity was not related to the administered dose and chemotherapy regimen. The publication bias test showed no publication bias. The quality of evidence for the results ranged from "very low" to "moderate."
This study suggests that Shenmai injection is effective in treating anthracycline-induced cardiotoxicity and is a potential treatment for anthracycline-induced cardiotoxicity. However, due to the poor methodological quality of the included RCTs, we recommend rigorous, high-quality, large-sample trials to confirm our findings.
参麦注射液是一种经典的中药方剂,常用于治疗蒽环类药物引起的心脏毒性。然而,参麦注射液治疗蒽环类药物引起的心脏毒性的疗效和安全性尚未得到报道。
我们全面检索了八个文献数据库和两个临床试验注册库,检索了从数据库建立到 2023 年 7 月 1 日期间与参麦注射液治疗蒽环类药物引起的心脏毒性相关的所有随机对照试验(RCT)。使用 RStudio 中的 Meta 包和 RevMan 5.4 进行数据分析。使用 GRADE pro3.6.1 软件评估证据质量。
共有 16 项 RCT 纳入了 2140 名患者。Meta 分析显示,参麦注射液在改善 ST-T 段改变方面具有优势(RR=0.28;95%CI,0.20 至 0.39;P<0.0001)(P<0.01),肌酸激酶同工酶(SMD=-3.49;95%CI,-5.24 至-1.74;P<0.0001),QT 间期延长(RR=0.46;95%CI,0.28 至 0.75;P=0.0018),低 QRS 电压(RR=0.44;95%CI,0.27 至 0.71;P=0.0007),窦性心动过速(RR=0.41;95%CI,0.28 至 0.60;P<0.0001),房性早搏(RR=0.55;95%CI,0.35 至 0.87;P=0.01),室性早搏(RR=0.39;95%CI,0.26 至 0.59;P<0.0001)和肌酸激酶(SMD=-1.43;95%CI,-2.57 至-0.29;P<0.0001)。在蒽环类药物引起的心脏毒性患者中,参麦注射液具有优势,该优势得到了敏感性分析的支持,但在改善左心室射血分数(MD=16.01;95%CI,-3.10 至 35.12;P=0.10)和房室传导阻滞(RR=0.49;95%CI,0.24 至 1.03;P=0.06)方面没有优势。研究中纳入的文献没有提到参麦注射液安全性方面的数据,因此我们还不知道参麦注射液的安全性。亚组分析结果表明,异质性与给药剂量和化疗方案无关。发表偏倚检验表明没有发表偏倚。结果的证据质量从“非常低”到“中等”不等。
本研究表明参麦注射液对蒽环类药物引起的心脏毒性有效,是治疗蒽环类药物引起的心脏毒性的一种潜在药物。然而,由于纳入的 RCT 方法学质量较差,我们建议进行严格、高质量、大样本的试验来证实我们的发现。