中医健脾补肾法治疗重症肌无力的系统评价和 Meta 分析方案。

Tonifying spleen and replenishing kidney method of traditional Chinese medicine for myasthenia gravis: A protocol for systematic review and meta-analysis.

机构信息

Chengdu Eighth People's Hospital (Geriatric Hospital of Chengdu Medical College).

Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.

出版信息

Medicine (Baltimore). 2021 May 28;100(21):e25966. doi: 10.1097/MD.0000000000025966.

DOI:10.1097/MD.0000000000025966

PMID:34032708

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8154406/

Abstract

BACKGROUND

Myasthenia gravis (MG) is an autoimmune antibody-mediated disorder caused by dysfunction at the neuromuscular junction spreads. The main clinical features of this disease are fluctuating fatigue, and weakness of the skeletal muscles of the eyes and limbs. At present, the tonifying the spleen and replenishing the kidney method in traditional Chinese medicine has been widely used for MG. The present study was conducted to evaluate the efficacy and safety of the tonifying the spleen and replenishing the kidney method in traditional Chinese medicine for MG.

METHODS

The following 10 databases were searched from inception to March 2021: PubMed, Cochrane Library, EMBASE, Web of Science, Springer, China National Knowledge Infrastructure (CNKI), Wan fang, VIP Chinese Science and Technique Journals Database, the Chinese Bio Medical Database (CBM), and Baidu Scholar. The language was limited to the Chinese and English language. Merely randomized controlled trials (RCTs) were included. The Cochrane Collaboration risk-of-bias tool was used for the methodological quality assessment and risk of bias. The meta-analysis was assessed using the Cochrane RevMan 5.3 software.

RESULTS

In the present study, a meta-analysis was conducted, and RCTs that met the eligibility criteria were included. Furthermore, the different outcome indicators of different methods were objectively compared. The main outcome indicators included the effective rate, quantitative myasthenia gravis (QMG) scores, adverse events, and quality of life (QOL). The secondary outcome indicators included AchRAb, serum-related immune cells (such as CD3+CD4+cells and CD4+/CD8+cells), the traditional Chinese medicine syndrome score scale (TCMSSS), the serum interleukin-6 level, the level of IFN-γ and its mRNA, and the clinical score that contains the clinical absolute score (CAS) and clinical relative score (CRS).

CONCLUSION

This study would provide credible evidence to determine whether the tonifying the spleen and replenishing the kidney method in traditional Chinese medicine is an effective treatment method for MG.

TRIAL REGISTRATION NUMBER

INPLASY202110097.

摘要

背景

重症肌无力（MG）是一种由神经肌肉接头处功能障碍引起的自身免疫抗体介导的疾病。该病的主要临床特征是波动性疲劳和眼肌及四肢骨骼肌无力。目前，中医健脾补肾法已广泛应用于 MG。本研究旨在评估中医健脾补肾法治疗 MG 的疗效和安全性。

方法

从建库至 2021 年 3 月，检索了以下 10 个数据库：PubMed、Cochrane Library、EMBASE、Web of Science、Springer、中国知网（CNKI）、万方、维普中文科技期刊数据库、中国生物医学文献数据库（CBM）和百度学术。语言限制为中文和英文。仅纳入随机对照试验（RCT）。采用 Cochrane 协作偏倚风险工具进行方法学质量评估和偏倚风险评估。使用 Cochrane RevMan 5.3 软件进行荟萃分析。

结果

本研究进行了荟萃分析，纳入了符合纳入标准的 RCT，并客观比较了不同方法的不同结局指标。主要结局指标包括有效率、定量重症肌无力（QMG）评分、不良反应和生活质量（QOL）。次要结局指标包括乙酰胆碱受体抗体（AchRAb）、血清相关免疫细胞（如 CD3+CD4+细胞和 CD4+/CD8+细胞）、中医证候评分量表（TCMSSS）、血清白细胞介素-6 水平、IFN-γ 及其 mRNA 水平以及包含临床绝对评分（CAS）和临床相对评分（CRS）的临床评分。