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中药注射液联合甲钴胺治疗糖尿病周围神经病变的疗效及安全性的系统评价和 Meta 分析方案

Efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis.

机构信息

Department of Endocrinology, Foshan Hospital of Traditional Chinese Medicine.

Department of Medicine, Zhangcha Hospital, Foshan, Guangdong Province, China.

出版信息

Medicine (Baltimore). 2021 Jan 8;100(1):e23702. doi: 10.1097/MD.0000000000023702.

Abstract

BACKGROUND

Diabetic peripheral neuropathy is a common complication of diabetes and the main cause of disability. At present, there is no specific therapeutic regimen. Mecobalamin is often used as a neurotrophic drug, and its long-term effects are not satisfactory when used alone. Clinical practice indicates that traditional Chinese medicine injection with mecobalamin has a therapeutic advantage in treating diabetic peripheral neuropathy while it lacks evidence-based medicine. In this scheme, the efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy has been studied.

METHODS

Computers were used to search the English database (PubMed, the Cochrane Library, Embase, Web of Science), and Chinese database (CNKI, Wanfang, CBMDISC, VIP). Besides, manual searching was conducted to search for Baidu Scholar, CHICTR, Google Scholar. During the establishment of the database to November 2020, a randomized controlled trial on traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy was conducted. There were 2 researchers independently conducting data extraction and quality evaluation of literature on the included studies, RevMan5.3 was performed for meta-analysis on the included literature.

RESULTS

In this study, the efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy was evaluated by the total effective rate, motor nerve conduction velocity, sensory nerve conduction velocity, adverse reactions, and glucose metabolism level.

CONCLUSION

This study can provide an evidence-based basis on the clinical applications of traditional Chinese medicine injection with mecobalamin in the treatment of diabetic peripheral neuropathy.

ETHICS AND DISSEMINATION

The study does not involve patient privacy or rights and does not require approval from an ethics committee. The results may be published in peer-reviewed journals or disseminated at relevant conferences.

OSF REGISTRATION NUMBER

DOI 10.17605/OSF.IO/KPW5E.

摘要

背景

糖尿病周围神经病变是糖尿病的常见并发症,也是导致残疾的主要原因。目前尚无特定的治疗方案。甲钴胺通常被用作神经营养药物,单独使用时其长期效果并不理想。临床实践表明,中药联合甲钴胺注射液治疗糖尿病周围神经病变具有治疗优势,但缺乏循证医学证据。本方案旨在研究中药联合甲钴胺注射液治疗糖尿病周围神经病变的疗效和安全性。

方法

计算机检索英文数据库(PubMed、Cochrane 图书馆、Embase、Web of Science)和中文数据库(CNKI、万方、CBMdisc、VIP),同时手工检索百度学术、CHICTR、Google Scholar,建立数据库至 2020 年 11 月,对中药联合甲钴胺注射液治疗糖尿病周围神经病变的随机对照试验进行研究。由 2 名研究者独立对纳入研究进行文献数据提取和质量评价,采用 RevMan5.3 软件对纳入文献进行 meta 分析。

结果

本研究通过总有效率、运动神经传导速度、感觉神经传导速度、不良反应、血糖代谢水平评价中药联合甲钴胺注射液治疗糖尿病周围神经病变的疗效和安全性。

结论

本研究可为中药联合甲钴胺注射液治疗糖尿病周围神经病变的临床应用提供循证医学依据。

伦理与传播

本研究不涉及患者隐私或权利,无需伦理委员会批准。研究结果可能发表在同行评议期刊上或在相关会议上传播。

OSF 注册号:DOI 10.17605/OSF.IO/KPW5E。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c01/7793311/1999d3867e6b/medi-100-e23702-g001.jpg

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