Xunxun Yuan , Xianjie Feng , Jun He , Sheng Xu , Xu Zhou , Lihua Wang
{"title":"生脉注射液治疗慢性肺心病的疗效和安全性:31项随机对照试验荟萃分析和试验序贯分析的系统评价","authors":"Xunxun Yuan , Xianjie Feng , Jun He , Sheng Xu , Xu Zhou , Lihua Wang","doi":"10.1016/j.eujim.2023.102318","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>This study aimed to systematically evaluate the efficacy and safety of Shengmai injection (<em>Radix ginseng, Radix ophiopogonis,</em> and <em>Fructus Schisandrae chinensis</em>) as an adjunct to conventional medicine in the treatment of chronic cor pulmonale.</p></div><div><h3>Methods</h3><p>A search of ten databases was conducted up to March 27, 2023, to identify randomized controlled trials that assessed the efficacy of Shengmai injection plus conventional medicine versus conventional medicine alone in the treatment of chronic cor pulmonale. Meta-analysis was performed using RevMan version 5.4, with risk ratios (RRs), mean differences (MDs), and 95 % confidence intervals (CIs) used as effect measures. Trial sequential analyses were conducted to quantify the statistical reliability of the data in the studies.</p></div><div><h3>Results</h3><p>A total of 31 studies involving 3,036 patients were included in the meta-analysis. The results showed that Shengmai injection combined with conventional therapies significantly improved the response to treatment (RR 1.24, CIs 1.19 to 1.29) as well as heart function (e.g., left ventricular ejection fraction: MD 8.14 % [CIs 2.33 to 13.95]; right ventricular ejection fraction: MD 8.51 % [CIs 3.61 to 13.41], stroke volume: MD 12.38 mL [CIs 4.80 to 19.96], cardiac output: MD 0.35 L/min, [CIs 0.19 to 0.50], cardiac index: MD 0.45 L/min·m<sup>2</sup>, [CIs 0.19 to 0.72]), blood gas indicators (SaO<sub>2</sub>: MD 4.18 % [CIs 3.12 to 5.25], PaO<sub>2</sub>: MD 5.63 mmHg [CIs 4.26 to 7.00]), and lung function (FEV<sub>1</sub>: MD 0.40 L [CIs 0.26 to 0.53], FEV<sub>1</sub>/FVC: MD 10.10 % [CIs 7.43 to 12.77]) in patients with cor pulmonale. Additionally, no significant improvement was observed in creatine kinase isoenzyme- myocardial band or plasma viscosity compared with the controls. Two cases (4 %) of mild adverse events (dry mouth) possibly related to Shengmai injection were reported, but no serious adverse events were observed.</p></div><div><h3>Conclusions</h3><p>Shengmai injection may be an effective supplemental therapy for chronic cor pulmonale, potentially improving treatment response, heart and lung functioning, blood gas analysis, and hemorheological indicators, with an acceptable safety profile. However, the risk of selection bias and high heterogeneity in some studies highlight the need for further multicenter, large-sample randomized controlled trials to validate these findings.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"65 ","pages":"Article 102318"},"PeriodicalIF":1.9000,"publicationDate":"2023-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S187638202300094X/pdfft?md5=a2a653895ad67f5c3f56c0a2df40b625&pid=1-s2.0-S187638202300094X-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of Shengmai injection for chronic cor pulmonale: A systematic review with meta-analysis and trial sequential analysis of 31 randomized controlled trials\",\"authors\":\"Xunxun Yuan , Xianjie Feng , Jun He , Sheng Xu , Xu Zhou , Lihua Wang\",\"doi\":\"10.1016/j.eujim.2023.102318\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>This study aimed to systematically evaluate the efficacy and safety of Shengmai injection (<em>Radix ginseng, Radix ophiopogonis,</em> and <em>Fructus Schisandrae chinensis</em>) as an adjunct to conventional medicine in the treatment of chronic cor pulmonale.</p></div><div><h3>Methods</h3><p>A search of ten databases was conducted up to March 27, 2023, to identify randomized controlled trials that assessed the efficacy of Shengmai injection plus conventional medicine versus conventional medicine alone in the treatment of chronic cor pulmonale. Meta-analysis was performed using RevMan version 5.4, with risk ratios (RRs), mean differences (MDs), and 95 % confidence intervals (CIs) used as effect measures. Trial sequential analyses were conducted to quantify the statistical reliability of the data in the studies.</p></div><div><h3>Results</h3><p>A total of 31 studies involving 3,036 patients were included in the meta-analysis. The results showed that Shengmai injection combined with conventional therapies significantly improved the response to treatment (RR 1.24, CIs 1.19 to 1.29) as well as heart function (e.g., left ventricular ejection fraction: MD 8.14 % [CIs 2.33 to 13.95]; right ventricular ejection fraction: MD 8.51 % [CIs 3.61 to 13.41], stroke volume: MD 12.38 mL [CIs 4.80 to 19.96], cardiac output: MD 0.35 L/min, [CIs 0.19 to 0.50], cardiac index: MD 0.45 L/min·m<sup>2</sup>, [CIs 0.19 to 0.72]), blood gas indicators (SaO<sub>2</sub>: MD 4.18 % [CIs 3.12 to 5.25], PaO<sub>2</sub>: MD 5.63 mmHg [CIs 4.26 to 7.00]), and lung function (FEV<sub>1</sub>: MD 0.40 L [CIs 0.26 to 0.53], FEV<sub>1</sub>/FVC: MD 10.10 % [CIs 7.43 to 12.77]) in patients with cor pulmonale. Additionally, no significant improvement was observed in creatine kinase isoenzyme- myocardial band or plasma viscosity compared with the controls. Two cases (4 %) of mild adverse events (dry mouth) possibly related to Shengmai injection were reported, but no serious adverse events were observed.</p></div><div><h3>Conclusions</h3><p>Shengmai injection may be an effective supplemental therapy for chronic cor pulmonale, potentially improving treatment response, heart and lung functioning, blood gas analysis, and hemorheological indicators, with an acceptable safety profile. However, the risk of selection bias and high heterogeneity in some studies highlight the need for further multicenter, large-sample randomized controlled trials to validate these findings.</p></div>\",\"PeriodicalId\":11932,\"journal\":{\"name\":\"European Journal of Integrative Medicine\",\"volume\":\"65 \",\"pages\":\"Article 102318\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2023-11-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S187638202300094X/pdfft?md5=a2a653895ad67f5c3f56c0a2df40b625&pid=1-s2.0-S187638202300094X-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Integrative Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S187638202300094X\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Integrative Medicine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S187638202300094X","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
Efficacy and safety of Shengmai injection for chronic cor pulmonale: A systematic review with meta-analysis and trial sequential analysis of 31 randomized controlled trials
Introduction
This study aimed to systematically evaluate the efficacy and safety of Shengmai injection (Radix ginseng, Radix ophiopogonis, and Fructus Schisandrae chinensis) as an adjunct to conventional medicine in the treatment of chronic cor pulmonale.
Methods
A search of ten databases was conducted up to March 27, 2023, to identify randomized controlled trials that assessed the efficacy of Shengmai injection plus conventional medicine versus conventional medicine alone in the treatment of chronic cor pulmonale. Meta-analysis was performed using RevMan version 5.4, with risk ratios (RRs), mean differences (MDs), and 95 % confidence intervals (CIs) used as effect measures. Trial sequential analyses were conducted to quantify the statistical reliability of the data in the studies.
Results
A total of 31 studies involving 3,036 patients were included in the meta-analysis. The results showed that Shengmai injection combined with conventional therapies significantly improved the response to treatment (RR 1.24, CIs 1.19 to 1.29) as well as heart function (e.g., left ventricular ejection fraction: MD 8.14 % [CIs 2.33 to 13.95]; right ventricular ejection fraction: MD 8.51 % [CIs 3.61 to 13.41], stroke volume: MD 12.38 mL [CIs 4.80 to 19.96], cardiac output: MD 0.35 L/min, [CIs 0.19 to 0.50], cardiac index: MD 0.45 L/min·m2, [CIs 0.19 to 0.72]), blood gas indicators (SaO2: MD 4.18 % [CIs 3.12 to 5.25], PaO2: MD 5.63 mmHg [CIs 4.26 to 7.00]), and lung function (FEV1: MD 0.40 L [CIs 0.26 to 0.53], FEV1/FVC: MD 10.10 % [CIs 7.43 to 12.77]) in patients with cor pulmonale. Additionally, no significant improvement was observed in creatine kinase isoenzyme- myocardial band or plasma viscosity compared with the controls. Two cases (4 %) of mild adverse events (dry mouth) possibly related to Shengmai injection were reported, but no serious adverse events were observed.
Conclusions
Shengmai injection may be an effective supplemental therapy for chronic cor pulmonale, potentially improving treatment response, heart and lung functioning, blood gas analysis, and hemorheological indicators, with an acceptable safety profile. However, the risk of selection bias and high heterogeneity in some studies highlight the need for further multicenter, large-sample randomized controlled trials to validate these findings.
期刊介绍：
The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education.
EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians.
The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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