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

IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Xunxun Yuan , Xianjie Feng , Jun He , Sheng Xu , Xu Zhou , Lihua Wang
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引用次数: 0

Abstract

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.

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
本研究旨在系统评价生脉注射液(参、麦冬、五味子)作为常规药物辅助治疗慢性肺心病的疗效和安全性。方法检索截至2023年3月27日的10个数据库,筛选随机对照试验,评价生脉注射液联合常规药物与单独常规药物治疗慢性肺心病的疗效。采用RevMan version 5.4进行meta分析,采用风险比(rr)、平均差异(MDs)和95%置信区间(ci)作为效果度量。进行试验序列分析以量化研究中数据的统计可靠性。结果meta分析共纳入31项研究,涉及3036例患者。结果显示,生脉注射液联合常规治疗可显著改善治疗反应(RR = 1.24, CIs = 1.19 ~ 1.29)和心功能(如左室射血分数:MD = 8.14% [CIs = 2.33 ~ 13.95];肺心病患者右心室射血分数:MD 8.51% [CIs 3.61 ~ 13.41],卒中容积:MD 12.38 mL [CIs 4.80 ~ 19.96],心输出量:MD 0.35 L/min, [CIs 0.19 ~ 0.50],心脏指数:MD 0.45 L/min·m2, [CIs 0.19 ~ 0.72]),血气指标(SaO2: MD 4.18% [CIs 3.12 ~ 5.25], PaO2: MD 5.63 mmHg [CIs 4.26 ~ 7.00]),肺功能(FEV1: MD 0.40 L [CIs 0.26 ~ 0.53], FEV1/FVC: MD 10.10% [CIs 7.43 ~ 12.77])。此外,与对照组相比,肌酸激酶同工酶-心肌带或血浆粘度没有明显改善。报告可能与生脉注射液有关的轻度不良事件(口干)2例(4%),未见严重不良事件。结论生脉注射液可能是慢性肺心病的有效补充治疗,可改善治疗效果、心肺功能、血气分析和血液流变学指标,安全性可接受。然而,一些研究存在选择偏倚和高度异质性的风险,需要进一步进行多中心、大样本随机对照试验来验证这些发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
European Journal of Integrative Medicine
European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
4.70
自引率
4.00%
发文量
102
审稿时长
33 days
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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