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参附注射液治疗危重症:临床试验的叙述性综述

Shenfu injection as treatment for critical illness: a narrative review of clinical trials.

作者信息

Berlin Noa, Shekhar Aditya C, Berg Katherine M

机构信息

Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Department of Clinical Sciences, Cummings School of Veterinary Medicine at Tufts University, North Grafton, MA, USA.

出版信息

J Thorac Dis. 2024 Jan 30;16(1):661-670. doi: 10.21037/jtd-23-105. Epub 2024 Jan 29.

DOI:10.21037/jtd-23-105
PMID:38410595
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10894405/
Abstract

BACKGROUND AND OBJECTIVE

Shenfu injection (SFI) is a traditional herbal medicine derived from components of ginseng and aconite and is commonly used in China to treat a variety of conditions. Shenfu has been suggested to have beneficial effects in various critical illnesses, including heart failure, cardiac arrest, and septic shock. In recent years, there have been a number of studies reporting that SFI improves patient outcomes when used concurrently with other treatments, but its use has not been adopted outside of China. This narrative review explored the results of clinical trials that have tested SFI's efficacy in various critical illnesses.

METHODS

PubMed was searched for clinical trials, systematic reviews and meta-analyses published between 1990 and July 2022 relating to clinical trials using SFI in various critical illnesses. Systematic reviews and meta-analyses were included to enable inclusion of data from trials originally not published in English. The selected articles were then summarized in the following disease categories: heart failure, cardiac arrest, sepsis, and severe pulmonary disease.

KEY CONTENT AND FINDINGS

Clinical trials testing SFI in heart failure, cardiac arrest, sepsis, and pulmonary disease were reviewed. The design, methodology, and key findings of each trial or meta-analysis are summarized and discussed. Key limitations were also highlighted and discussed. Overall, several clinical trials suggest SFI may hold therapeutic potential for the treatment of critical illness, however, additional research is likely still needed.

CONCLUSIONS

Based on the current body of literature, further research-especially multi-center randomized, double-blind trials with detailed reporting of all methods and results according to international guidelines-is needed to evaluate whether SFI is a useful addition to existing treatments for these conditions.

摘要

背景与目的

参附注射液(SFI)是一种源自人参和附子成分的传统草药,在中国常用于治疗多种病症。参附被认为对包括心力衰竭、心脏骤停和感染性休克在内的各种危重病有益。近年来,有多项研究报告称,参附注射液与其他治疗方法同时使用时可改善患者预后,但其应用尚未在中国以外地区采用。本叙述性综述探讨了测试参附注射液在各种危重病中疗效的临床试验结果。

方法

在PubMed上检索1990年至2022年7月间发表的有关在各种危重病中使用参附注射液的临床试验、系统评价和荟萃分析。纳入系统评价和荟萃分析,以便纳入最初未以英文发表的试验数据。然后将所选文章按以下疾病类别进行总结:心力衰竭、心脏骤停、脓毒症和重症肺部疾病。

关键内容与发现

对在心力衰竭、心脏骤停、脓毒症和肺部疾病中测试参附注射液的临床试验进行了综述。总结并讨论了每项试验或荟萃分析的设计、方法和主要发现。还强调并讨论了关键局限性。总体而言,多项临床试验表明参附注射液可能对危重病的治疗具有治疗潜力,然而,可能仍需要更多研究。

结论

基于目前的文献资料,需要进一步研究——尤其是多中心随机双盲试验,并根据国际指南详细报告所有方法和结果——以评估参附注射液是否是这些病症现有治疗方法的有益补充。

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本文引用的文献

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Effects of Shenfu injection on inflammatory factors and immune function in children with Mycoplasma pneumoniae: A protocol for a double-blind, randomized controlled trial.参附注射液对肺炎支原体感染患儿炎症因子及免疫功能的影响:一项双盲、随机对照试验方案。
Medicine (Baltimore). 2021 Oct 22;100(42):e27585. doi: 10.1097/MD.0000000000027585.
2
Efficacy and safety of Shenfu injection in the treatment of sepsis: A protocol for systematic review and meta-analysis.参附注射液治疗脓毒症的有效性和安全性的系统评价和 Meta 分析方案。
Medicine (Baltimore). 2021 Sep 17;100(37):e27196. doi: 10.1097/MD.0000000000027196.
3
Shenfu injection for heart failure based on the AMSTAR-2, PRISMA, and GRADE tools.参附注射液治疗心力衰竭的 AMSTAR-2、PRISMA 和 GRADE 工具评价。
Ann Palliat Med. 2021 Jun;10(6):6535-6555. doi: 10.21037/apm-21-1073. Epub 2021 Jun 15.
4
A Critical Overview of Systematic Reviews of Shenfu Injection for Heart Failure.参附注射液治疗心力衰竭系统评价的批判性综述。
Cardiovasc Ther. 2021 Mar 6;2021:8816590. doi: 10.1155/2021/8816590. eCollection 2021.
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Efficacy and safety of Shenfu injection combined with sodium nitroprusside in the treatment of chronic heart failure in patients with coronary heart disease: A protocol of randomized controlled trial.参附注射液联合硝普钠治疗冠心病慢性心力衰竭的疗效及安全性:一项随机对照试验方案。
Medicine (Baltimore). 2021 Feb 19;100(7):e24414. doi: 10.1097/MD.0000000000024414.
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Shenfu injection combined with furosemide in the treatment of chronic heart failure in patients with coronary heart disease: A protocol of randomized controlled trial.参附注射液联合呋塞米治疗冠心病慢性心力衰竭随机对照试验方案
Medicine (Baltimore). 2021 Jan 22;100(3):e24113. doi: 10.1097/MD.0000000000024113.
7
Effect of shenfu injection on microcirculation in shock patients: A protocol for systematic review and meta-analysis.参附注射液对休克患者微循环的影响:一项系统评价与Meta分析方案
Medicine (Baltimore). 2020 Oct 23;99(43):e22872. doi: 10.1097/MD.0000000000022872.
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The therapeutic effects of traditional chinese medicine on COVID-19: a narrative review.中医药治疗 COVID-19 的疗效:叙述性综述。
Int J Clin Pharm. 2021 Feb;43(1):35-45. doi: 10.1007/s11096-020-01153-7. Epub 2020 Sep 24.
9
Impact of Shenfu injection on a composite of organ dysfunction development in critically ill patients with coronavirus disease 2019 (COVID-19): A structured summary of a study protocol for a randomized controlled trial.参附注射液对 2019 冠状病毒病(COVID-19)危重症患者器官功能障碍发展复合结局的影响:一项随机对照试验研究方案的结构化总结。
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Front Pharmacol. 2020 May 7;11:634. doi: 10.3389/fphar.2020.00634. eCollection 2020.