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大剂量夏枯草对桥本甲状腺炎的影响:一项随机临床试验系统评价与荟萃分析方案

Effect of large dosage of Prunella on Hashimoto's thyroiditis: A protocol of systematic review and meta-analysis of randomized clinical trials.

作者信息

Chen Pei, Li Chaomin, Zhao Siliang, Wang Lizhen, Liu Lingyu, Fan Qiuhong

机构信息

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

出版信息

Medicine (Baltimore). 2020 Dec 11;99(50):e23391. doi: 10.1097/MD.0000000000023391.

Abstract

INTRODUCTION

Hashimoto's Thyroiditis (HT) is one of the common autoimmune diseases, which can lead to thyroid reduction, increase the risk of tumor, and seriously affect women's reproductive health. Many other autoimmune diseases are easy to occur, seriously harming people's health.large dose herb Prunella or compound prescription contain large dose Prunella for treatment of HT has already been confirmed. However, due to the lack of evidence, there is no specific method or suggestion, it is necessary to carry out a systematic evaluation on Prunella and provide effective evidence for further research.

METHODS AND ANALYSIS

The following databases will be searched from their inception to October 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WangFang, VIP medicine information, and China National Knowledge Infrastructure.

MAIN RESULTS

serum thyroid peroxidase antibody (TPOAb), thyroid globulin antibody (TGAb), other results: serum thyroid stimulating hormone (TSH), serum free triiodothyronine (FT3), serum free thyroid hormone (FT4). 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 (SR)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 efficacy and safety of large dose prunella salicorrhizae in the intervention of people with HT.

CONCLUSION

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

ETHICS AND COMMUNICATION

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 Fra mework (OSF) registration number:October 21, 2020.osf.io/fcyqp. (https://osf.io/fcyqp).

摘要

引言

桥本甲状腺炎(HT)是常见的自身免疫性疾病之一,可导致甲状腺功能减退,增加肿瘤风险,并严重影响女性生殖健康。还易并发其他多种自身免疫性疾病,严重危害人们的健康。大剂量夏枯草或含大剂量夏枯草的复方制剂治疗HT已得到证实。然而,由于缺乏证据,尚无具体的方法或建议,有必要对夏枯草进行系统评价,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10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、中国知网。

主要结果

血清甲状腺过氧化物酶抗体(TPOAb)、甲状腺球蛋白抗体(TGAb),其他结果:血清促甲状腺激素(TSH)、血清游离三碘甲状腺原氨酸(FT3)、血清游离甲状腺激素(FT4)。由2名研究人员独立提取数据,基于Cochrane干预系统评价手册(SR)评估Meta分析的偏倚风险。所有数据分析将采用数据统计软件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夏枯草干预HT患者的疗效和安全性。

结论

本研究的系统评价将总结目前已发表的大剂量夏枯草治疗HT的证据,可为其进一步推广应用提供指导。

伦理与传播

本研究为系统评价,结果基于已发表的证据,故本研究无需伦理委员会审查和批准。我们计划在期刊或会议报告中发表研究结果。开放科学框架(OSF)注册号:2020年10月21日。osf.io/fcyqp。(https://osf.io/fcyqp)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d095/7738013/76580e4f8971/medi-99-e23391-g001.jpg

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