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补中益气汤联合西药治疗重症肌无力的疗效及安全性的系统评价和 Meta 分析方案。

Efficacy and safety of Buzhong Yiqi decoction combined with western medicine in the treatment of myasthenia gravis: A protocol for systematic review and meta-analysis.

机构信息

Jiaozhou Central Hospital of Qingdao, Jiaozhou.

Community Health Service Center, Qingdao, Shandong Province, China.

出版信息

Medicine (Baltimore). 2021 Mar 19;100(11):e24807. doi: 10.1097/MD.0000000000024807.

Abstract

BACKGROUND

Myasthenia gravis is a common autoimmune disease in clinic. Although there are various ways and drugs for the treatment of myasthenia gravis in Western medicine, there are still a variety of adverse reactions. Studies have shown that Buzhong Yiqi decoction combined with Western medicine has a certain efficacy in the treatment of myasthenia gravis, but there is a lack of evidence-based medicine. The research carried out in this scheme is to systematically evaluate the efficacy and safety of Buzhong Yiqi decoction combined with Western medicine in the treatment of myasthenia gravis, and to provide reliable evidence for guiding clinical practice.

METHODS

English databases (the Cochrane Library, PubMed, Web of Science, Embase) and Chinese databases (China Biomedical Database, China Science and Technology Journal Database, China National Knowledge Infrastructure, Wanfang) will be searched by computer. In addition, Baidu Academic and Chinese Clinical Trial Registration Center will be searched manually. A randomized controlled clinical trial of Buzhong Yiqi decoction combined with Western medicine in the treatment of myasthenia gravis will be conducted from the establishment of the database to December 2020. The 2 researchers independently carry out data extraction and literature quality evaluation on the quality of the included study, and meta-analysis of the included literature will be carried out by using RevMan 5.3 software.

RESULTS

This study will evaluate the efficacy and safety of Buzhong Yiqi decoction combined with Western medicine in the treatment of myasthenia gravis by Quantitive MGscore, the number of Tregs cells and the content of anti-acetylcholine receptor antibody (AchR-Ab).

CONCLUSION

This study will provide reliable evidence-based evidence for the clinical application of Buzhong Yiqi decoction combined with Western medicine in the treatment of myasthenia gravis.

ETHICS AND DISSEMINATION

Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.

OSF REGISTRATION NUMBER

DOI 10.17605/OSF.IO/MXUPK.

摘要

背景

重症肌无力是临床常见的自身免疫性疾病。西医治疗重症肌无力的方法和药物多种多样,但仍存在各种不良反应。研究表明,补中益气汤联合西药治疗重症肌无力具有一定疗效,但缺乏循证医学证据。本方案开展的研究旨在系统评价补中益气汤联合西药治疗重症肌无力的疗效和安全性,为指导临床实践提供可靠依据。

方法

计算机检索英文数据库(Cochrane 图书馆、PubMed、Web of Science、Embase)和中文数据库(中国生物医学文献数据库、中国科技期刊数据库、中国知网、万方数据知识服务平台),并手检百度学术和中国临床试验注册中心。从建库至 2020 年 12 月,纳入补中益气汤联合西药治疗重症肌无力的随机对照临床试验。由 2 位研究者独立进行纳入研究的资料提取和文献质量评价,采用 RevMan 5.3 软件进行纳入文献的 meta 分析。

结果

本研究将通过 Quantitive MGscore、Tregs 细胞数量及抗乙酰胆碱受体抗体(AchR-Ab)含量评价补中益气汤联合西药治疗重症肌无力的疗效和安全性。

结论

本研究将为补中益气汤联合西药治疗重症肌无力的临床应用提供可靠的循证医学证据。

伦理与传播

不会公布个人信息。本系统评价也不会危及参与者的权利。不需要伦理批准。研究结果可能会发表在同行评议的期刊上,或在相关会议上传播。

OSF 注册号:DOI 10.17605/OSF.IO/MXUPK.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f0b/7982241/a761d89c5469/medi-100-e24807-g001.jpg

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