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大剂量黄芩和黄连治疗2型糖尿病:一项随机临床试验的系统评价与Meta分析方案

Large dosage Huangqin (Scutellaria) and Huanglian (Rhizoma Coptidis) for T2DM: A protocol of systematic review and meta-analysis of randomized clinical trials.

作者信息

Huang Xiaoying, Wang Lizhen, Yue Rensong, Ding Ning, Yang Hongjing

机构信息

Hospital of Chengdu University of Traditional Chinese Medicine.

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

出版信息

Medicine (Baltimore). 2020 Sep 18;99(38):e22032. doi: 10.1097/MD.0000000000022032.

DOI:10.1097/MD.0000000000022032
PMID:32957320
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7505284/
Abstract

INTRODUCTION

Type 2 diabetes mellitus (T2DM) is a metabolic disease with widespread concern in the world. It has the characteristics of high incidence rate and high disability rate, which seriously affects economic and social development. large dose herb Rhizoma Coptidis (Huanglian) and Scutellaria (Huangqin) or compound prescription contain large dose Huanglian and Huanglian for treatment of T2DM has already been confirmed. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to carry out systematic evaluation on Coptidis and Scutellaria and provide effective evidence for further research.

METHODS AND ANALYSIS

The following databases will be searched from their inception to June 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and China National Knowledge Infrastructure. Primary outcomes: fasting blood-glucose (FBG), 2 Hours Postprandial Blood Glucose (2hPBG), Glycosylated hemoglobin A1c (HbA1c). additional outcomes: Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), triglycerides (TG), total serum cholesterol (TC). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0.

RESULTS

The results of this study will systematically evaluate the effectiveness and safety of large dose Huanglian and Huangqin intervention for people with T2DM.

CONCLUSION

The systematic review of this study will summarize the current published evidence of large dose Huanglian and Huangqin for the treatment of T2DM, which can further guide the promotion and application of it.

ETHICS AND DISSEMINATION

This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations.

OPEN SCIENCE FRAMEWORK (OSF) REGISTRATION NUMBER: July 21, 2020. osf.io/b6r3z. (https://osf.io/b6r3z).

摘要

引言

2型糖尿病(T2DM)是一种在全球范围内受到广泛关注的代谢性疾病。其具有发病率高和致残率高的特点,严重影响经济和社会发展。大剂量黄连和黄芩或含大剂量黄连和黄芩的复方制剂用于治疗T2DM已得到证实。然而,由于缺乏证据,尚无具体方法或建议,因此有必要对黄连和黄芩进行系统评价,为进一步研究提供有效证据。

方法与分析

检索以下数据库自建库至2020年6月的数据:电子数据库包括PubMed、Embase、Cochrane图书馆、Web of Science、Nature、Science online、中国生物医学数据库万方、维普医药信息和中国知网。主要结局指标:空腹血糖(FBG)、餐后2小时血糖(2hPBG)、糖化血红蛋白A1c(HbA1c)。附加结局指标:低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、甘油三酯(TG)、总血清胆固醇(TC)。由2名研究人员独立提取数据,基于Cochrane系统评价干预措施手册评估Meta分析的偏倚风险。所有数据分析将使用数据统计软件Review Manager V.5.3和Stata V.12.0进行。

结果

本研究结果将系统评价大剂量黄连和黄芩干预T2DM患者的有效性和安全性。

结论

本研究的系统评价将总结目前已发表的大剂量黄连和黄芩治疗T2DM的证据,可进一步指导其推广应用。

伦理与传播

本研究为系统评价,结局基于已发表的证据,因此本研究无需伦理委员会审查和批准。我们打算在期刊上发表研究结果或在会议上进行报告。

开放科学框架(OSF)注册号:2020年7月21日。osf.io/b6r3z。(https://osf.io/b6r3z)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4eb7/7505284/9aac9a519c9a/medi-99-e22032-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4eb7/7505284/9aac9a519c9a/medi-99-e22032-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4eb7/7505284/9aac9a519c9a/medi-99-e22032-g001.jpg

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