参麦注射液辅助治疗慢性肺源性心脏病心力衰竭:一项随机对照试验的系统评价与Meta分析

Shenmai injection as an adjuvant treatment for chronic cor pulmonale heart failure: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Shi Liwei, Xie Yanming, Liao Xing, Chai Yan, Luo Yanhua

机构信息

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.

Guang'an men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

BMC Complement Altern Med. 2015 Nov 24;15:418. doi: 10.1186/s12906-015-0939-2.

Abstract

BACKGROUND

Shenmai injection (SM), as a traditional Chinese medicine injection, is widely used for chronic cor pulmonale heart failure in mainland China. It is essential to systematically assess the efficacy and safety of SM as an adjuvant treatment for chronic cor pulmonale heart failure.

METHODS

Eight English and Chinese electronic databases were searched, from inception to December 2014, to identify randomized controlled trials (RCTs) of SM for chronic cor pulmonale heart failure. The Cochrane Risk of Bias tool was used to evaluate the methodological quality of eligible studies. Meta-analysis was performed by Review Manager 5.2.

RESULTS

Twenty-seven RCTs with 2045 participants were identified. The methodological quality of the included studies was generally low. Only one trial reported data on death. None of the included trials reported quality of life. The meta-analysis indicated that compared to conventional treatment, the combination of SM and conventional treatment was more effective in terms of the New York Heart Association classification (RR, 1.26; 95% CI, 1.20-1.32; P < 0.00001), Left Ventricular Ejection Fraction (MD, 11.33; 95% CI, 8.59-14.07; p < 0.00001), partial pressure of oxygen (MD, 1.00; 95% CI, 0.64-1.36; P < 0.00001) and partial pressure of carbon dioxide (MD, 0.83; 95 % CI, 0.58-1.08; p < 0.00001). In addition, two trials reported that SM plus conventional treatment was superior to the conventional treatment alone to reduce B-type natriuretic peptide. No serious adverse drug events or reactions were reported.

CONCLUSIONS

SM plus conventional treatment appeared to be effective and relatively safe for chronic cor pulmonale heart failure. However, due to the generally low methodological quality and small sample size, this review didn't find evidence to support routine use of SM as an adjuvant treatment for chronic cor pulmonale heart failure.

摘要

背景

参麦注射液(SM)作为一种中药注射液,在中国大陆被广泛用于慢性肺源性心脏病心力衰竭的治疗。系统评估参麦注射液作为慢性肺源性心脏病心力衰竭辅助治疗的疗效和安全性至关重要。

方法

检索了8个中英文电子数据库,时间跨度从建库至2014年12月,以确定参麦注射液用于慢性肺源性心脏病心力衰竭的随机对照试验(RCT)。采用Cochrane偏倚风险工具评估纳入研究的方法学质量。使用Review Manager 5.2进行荟萃分析。

结果

共纳入27项RCT,涉及2045名参与者。纳入研究的方法学质量普遍较低。仅有一项试验报告了死亡数据。纳入试验均未报告生活质量情况。荟萃分析表明,与传统治疗相比,参麦注射液联合传统治疗在纽约心脏协会分级(RR,1.26;95%CI,1.20 - 1.32;P < 0.00001)、左心室射血分数(MD,11.33;95%CI,8.59 - 14.07;P < 0.00001)、氧分压(MD,1.00;95%CI,0.64 - 1.36;P < 0.00001)和二氧化碳分压(MD,0.83;95%CI,0.58 - 1.08;P < 0.00001)方面更有效。此外,两项试验报告参麦注射液联合传统治疗在降低B型利钠肽方面优于单纯传统治疗。未报告严重不良药物事件或反应。

结论

参麦注射液联合传统治疗似乎对慢性肺源性心脏病心力衰竭有效且相对安全。然而,由于方法学质量普遍较低且样本量较小,本综述未找到证据支持将参麦注射液作为慢性肺源性心脏病心力衰竭的常规辅助治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a72e/4659214/6b79533bf09c/12906_2015_939_Fig1_HTML.jpg

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