目的:参麦注射液是一种经典的中药方剂,通常被推荐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见报道.
方法:我们对8个文献数据库和2个临床试验注册中心进行了全面检索,检索自数据库建立至2023年7月1日与参麦注射液治疗蒽环类药物所致心脏毒性相关的所有随机对照试验(RCT).使用RStudio和RevMan5.4中的Meta软件包进行数据分析。GRADEpro3.6.1软件用于评估证据质量。
结果:本研究共纳入16项RCTs,包括2140例患者。Meta分析显示,参麦注射液改善ST-T段改变具有优势(RR=0.28;95%CI,0.20~0.39;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),延长QT间期(RR=0.46;95%CI,0.28~0.75;P=0.0018),QRS电压低(RR=0.44;95%CI,0.27至0.71;P=0.0007),窦性心动过速(RR=0.41;95%CI,0.28~0.60;P<0.0001),房性早搏(RR=0.55;95%CI,0.35~0.87;P=0.01),蒽环类药物引起的心脏毒性患者的室性早搏(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)。优势,这得到了敏感性分析的支持,但不能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)。纳入研究的文献未提及参麦注射液安全性方面的数据,所以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。发表偏倚测试表明没有发表偏倚。结果的证据质量从“非常低”到“中等”不等。\"
结论:本研究提示参麦注射液可有效治疗蒽环类所致心脏毒性,是治疗蒽环类所致心脏毒性的潜在药物。然而,由于纳入RCT的方法学质量差,我们建议严格,高品质,大样本试验来证实我们的发现。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.\"
CONCLUSIONS: 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.