{"title":"生脉散治疗病毒性心肌炎的有效性和安全性：随机对照试验的系统回顾和元分析","authors":"Bing-rui Zhang, Xue-han Liu, Yu-tong Ling, Chun-li Lu, Xin-yan Jin, Yi-ming Wei, Yi-qing Cai, Nicola Robinson, Jian-ping Liu","doi":"10.1155/2024/2127018","DOIUrl":null,"url":null,"abstract":"<p><b>Background:</b> Shengmai San (SMS) is a traditional Chinese medicine formula used for supplementing <i>Qi</i> and <i>Yin</i> and can mitigate symptoms related to malignant arrhythmia and heart failure. This systematic review aimed at exploring the effectiveness and safety of SMS for viral myocarditis (VMC).</p><p><b>Methods:</b> Eight databases from their inception to June 2023 were searched to identified randomized controlled trials (RCTs) focusing on SMS for VMC. The Cochrane Risk of Bias Tool was used to assess methodological quality. Mean difference (MD), standardized mean difference (SMD), and risk ratio (RR) with 95% confidence interval (CI) were calculated and input into the meta-analysis using RevMan 5.4.</p><p><b>Results:</b> Forty-four RCTs were included involving 4298 participants. The interventions included 29 types of modified SMS decoctions and 15 patent medicines. Overall study quality was low. Compared with western medicine (WM), SMS was associated with higher recovery rate from palpitations (RR 2.3, 95% CI 1.59, 3.33, 2 RCTs, <i>n</i> = 89), chest pain (RR 1.57, 95% CI [1.17, 2.09], 2 RCTs, <i>n</i> = 89), and lower cTnI (MD −0.82 ng/ml, 95% CI −0.98, −0.66, 1 RCT, <i>n</i> = 60). SMS plus WM was more effective than WM in palpitation recovery rate (RR 1.52, 95% CI 1.21, 1.92, 3 RCTs, <i>n</i> = 136), dyspnea recovery rate (RR 1.47, 95% CI 1.12, 1.94, 3 RCT, <i>n</i> = 267), ECG (RR 1.43, 95% CI 1.32, 1.55, 20 RCT, <i>n</i> = 2035), CK-MB (MD −6.36, 95% CI −8.43, −4.28, 8 RCT, <i>n</i> = 946), and cTnI (MD −0.06, 95% CI −0.06, −0.05, 3 RCT, <i>n</i> = 307). No serious adverse events were reported using SMS alone or in combination with WM.</p><p><b>Conclusion:</b> SMS used alone or combined with WM may have potential effectiveness on symptom alleviation, ECG recovery rate, myocardial injury markers, and cardiac function, but the effectiveness is uncertain due to the low quality and absence of placebo-controlled trials. The exact efficacy of SMS for VMC needs to be confirmed by high-quality double-blind RCTs in the future.</p>","PeriodicalId":9582,"journal":{"name":"Cardiovascular Therapeutics","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/2127018","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and Safety of Shengmai San for Viral Myocarditis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials\",\"authors\":\"Bing-rui Zhang, Xue-han Liu, Yu-tong Ling, Chun-li Lu, Xin-yan Jin, Yi-ming Wei, Yi-qing Cai, Nicola Robinson, Jian-ping Liu\",\"doi\":\"10.1155/2024/2127018\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><b>Background:</b> Shengmai San (SMS) is a traditional Chinese medicine formula used for supplementing <i>Qi</i> and <i>Yin</i> and can mitigate symptoms related to malignant arrhythmia and heart failure. This systematic review aimed at exploring the effectiveness and safety of SMS for viral myocarditis (VMC).</p><p><b>Methods:</b> Eight databases from their inception to June 2023 were searched to identified randomized controlled trials (RCTs) focusing on SMS for VMC. The Cochrane Risk of Bias Tool was used to assess methodological quality. Mean difference (MD), standardized mean difference (SMD), and risk ratio (RR) with 95% confidence interval (CI) were calculated and input into the meta-analysis using RevMan 5.4.</p><p><b>Results:</b> Forty-four RCTs were included involving 4298 participants. The interventions included 29 types of modified SMS decoctions and 15 patent medicines. Overall study quality was low. Compared with western medicine (WM), SMS was associated with higher recovery rate from palpitations (RR 2.3, 95% CI 1.59, 3.33, 2 RCTs, <i>n</i> = 89), chest pain (RR 1.57, 95% CI [1.17, 2.09], 2 RCTs, <i>n</i> = 89), and lower cTnI (MD −0.82 ng/ml, 95% CI −0.98, −0.66, 1 RCT, <i>n</i> = 60). SMS plus WM was more effective than WM in palpitation recovery rate (RR 1.52, 95% CI 1.21, 1.92, 3 RCTs, <i>n</i> = 136), dyspnea recovery rate (RR 1.47, 95% CI 1.12, 1.94, 3 RCT, <i>n</i> = 267), ECG (RR 1.43, 95% CI 1.32, 1.55, 20 RCT, <i>n</i> = 2035), CK-MB (MD −6.36, 95% CI −8.43, −4.28, 8 RCT, <i>n</i> = 946), and cTnI (MD −0.06, 95% CI −0.06, −0.05, 3 RCT, <i>n</i> = 307). No serious adverse events were reported using SMS alone or in combination with WM.</p><p><b>Conclusion:</b> SMS used alone or combined with WM may have potential effectiveness on symptom alleviation, ECG recovery rate, myocardial injury markers, and cardiac function, but the effectiveness is uncertain due to the low quality and absence of placebo-controlled trials. The exact efficacy of SMS for VMC needs to be confirmed by high-quality double-blind RCTs in the future.</p>\",\"PeriodicalId\":9582,\"journal\":{\"name\":\"Cardiovascular Therapeutics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-06-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/2127018\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cardiovascular Therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1155/2024/2127018\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiovascular Therapeutics","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1155/2024/2127018","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：生脉散（SMS）是一种用于补气养阴的传统中药方剂，可减轻恶性心律失常和心力衰竭的相关症状。本系统综述旨在探讨生脉散治疗病毒性心肌炎（VMC）的有效性和安全性：方法：检索了从开始到2023年6月的8个数据库，以确定SMS治疗病毒性心肌炎的随机对照试验（RCT）。采用 Cochrane 偏倚风险工具评估方法学质量。使用RevMan 5.4计算平均差（MD）、标准化平均差（SMD）、风险比（RR）及95%置信区间（CI），并将其输入荟萃分析：共纳入 44 项 RCT，涉及 4298 名参与者。干预措施包括 29 种改良 SMS 煎剂和 15 种中成药。总体研究质量较低。与西药（WM）相比，SMS 与更高的心悸恢复率（RR 2.3，95% CI 1.59，3.33，2 项 RCT，n = 89）、胸痛恢复率（RR 1.57，95% CI [1.17，2.09]，2 项 RCT，n = 89）和更低的 cTnI（MD -0.82ng/ml，95% CI -0.98，-0.66，1 项 RCT，n = 60）相关。在心悸恢复率（RR 1.52，95% CI 1.21，1.92，3 项 RCT，n = 136）、呼吸困难恢复率（RR 1.47，95% CI 1.12，1.94，3 项 RCT，n = 267）、心电图（RR 1.43，95% CI 1.32，1.55，20 项 RCT，n = 2035）、CK-MB（MD -6.36，95% CI -8.43，-4.28，8 项 RCT，n = 946）和 cTnI（MD -0.06，95% CI -0.06，-0.05，3 项 RCT，n = 307）。单独使用SMS或与WM联合使用均未出现严重不良事件：SMS单独使用或与WM联合使用可能对症状缓解、心电图恢复率、心肌损伤标志物和心功能有潜在疗效，但由于安慰剂对照试验质量低且缺乏，疗效尚不确定。SMS对创伤性心肌梗死的确切疗效需要在未来通过高质量的双盲 RCT 试验来证实。
Effectiveness and Safety of Shengmai San for Viral Myocarditis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Background: Shengmai San (SMS) is a traditional Chinese medicine formula used for supplementing Qi and Yin and can mitigate symptoms related to malignant arrhythmia and heart failure. This systematic review aimed at exploring the effectiveness and safety of SMS for viral myocarditis (VMC).
Methods: Eight databases from their inception to June 2023 were searched to identified randomized controlled trials (RCTs) focusing on SMS for VMC. The Cochrane Risk of Bias Tool was used to assess methodological quality. Mean difference (MD), standardized mean difference (SMD), and risk ratio (RR) with 95% confidence interval (CI) were calculated and input into the meta-analysis using RevMan 5.4.
Results: Forty-four RCTs were included involving 4298 participants. The interventions included 29 types of modified SMS decoctions and 15 patent medicines. Overall study quality was low. Compared with western medicine (WM), SMS was associated with higher recovery rate from palpitations (RR 2.3, 95% CI 1.59, 3.33, 2 RCTs, n = 89), chest pain (RR 1.57, 95% CI [1.17, 2.09], 2 RCTs, n = 89), and lower cTnI (MD −0.82 ng/ml, 95% CI −0.98, −0.66, 1 RCT, n = 60). SMS plus WM was more effective than WM in palpitation recovery rate (RR 1.52, 95% CI 1.21, 1.92, 3 RCTs, n = 136), dyspnea recovery rate (RR 1.47, 95% CI 1.12, 1.94, 3 RCT, n = 267), ECG (RR 1.43, 95% CI 1.32, 1.55, 20 RCT, n = 2035), CK-MB (MD −6.36, 95% CI −8.43, −4.28, 8 RCT, n = 946), and cTnI (MD −0.06, 95% CI −0.06, −0.05, 3 RCT, n = 307). No serious adverse events were reported using SMS alone or in combination with WM.
Conclusion: SMS used alone or combined with WM may have potential effectiveness on symptom alleviation, ECG recovery rate, myocardial injury markers, and cardiac function, but the effectiveness is uncertain due to the low quality and absence of placebo-controlled trials. The exact efficacy of SMS for VMC needs to be confirmed by high-quality double-blind RCTs in the future.
期刊介绍：
Cardiovascular Therapeutics (formerly Cardiovascular Drug Reviews) is a peer-reviewed, Open Access journal that publishes original research and review articles focusing on cardiovascular and clinical pharmacology, as well as clinical trials of new cardiovascular therapies. Articles on translational research, pharmacogenomics and personalized medicine, device, gene and cell therapies, and pharmacoepidemiology are also encouraged.
Subject areas include (but are by no means limited to):
Acute coronary syndrome
Arrhythmias
Atherosclerosis
Basic cardiac electrophysiology
Cardiac catheterization
Cardiac remodeling
Coagulation and thrombosis
Diabetic cardiovascular disease
Heart failure (systolic HF, HFrEF, diastolic HF, HFpEF)
Hyperlipidemia
Hypertension
Ischemic heart disease
Vascular biology
Ventricular assist devices
Molecular cardio-biology
Myocardial regeneration
Lipoprotein metabolism
Radial artery access
Percutaneous coronary intervention
Transcatheter aortic and mitral valve replacement.
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