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血府逐瘀汤治疗非酒精性脂肪性肝病的系统评价和 Meta 分析方案。

Xuefu Zhuyu decoction for nonalcoholic fatty liver disease: A protocol for systematic review and meta-analysis.

机构信息

College of Basic Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan.

Hainan Medical University, Haikou, Hainan, China.

出版信息

Medicine (Baltimore). 2021 May 14;100(19):e25358. doi: 10.1097/MD.0000000000025358.

DOI:10.1097/MD.0000000000025358
PMID:34106587
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8133179/
Abstract

BACKGROUND

Nonalcoholic fatty liver disease (NAFLD) includes nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH), which ranks only second to viral hepatitis and poses an increasingly serious challenge to global public health and economy. NAFLD has attracted more and more attention, but there is no drugs with exact curative effects are available. The commonly used drugs for the treatment of NAFLD in clinical practice are statins, such drugs, inevitably increase the burden on the live. Compared to statins, traditional Chinese medicines are believed to be "all natural" with fewer side effects, are associated with strong patient compliance. Accordingly, a great deal of clinical studies have shown that Xuefu Zhuyu decoction (XFZYD) can significantly improve the clinical symptoms and enhance the therapeutic effect. Meanwhile, a system review and meta-analysis are conducted by us to further clarify the effectiveness and safety of XFZYD for NAFLD.

METHODS

We will apply to database mainly range from the English literature searches Cochrane Library, PubMed, excerpt medica database, and Web of Science to the Chinese literature China national knowledge infrastructure, Chinese biomedical literature database, VIP, and Wanfang database, randomized controlled trials (RCTs) are enrolled to evaluate the effectiveness and safety of XFZYD in the treatment of NAFLD, the enrollment of RCTs is from the establishment of the database to February 01, 2021. Simultaneously we will retrieval clinical registration tests and grey literatures. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is expressed in terms of relative risk, the continuous is represented by mean difference or standard mean difference, whether there is heterogeneity is the factor that determines the synthesis of data in fixed effect model or random effect model. Alanine aminotransferase (ALT) or Aspartic acid aminotransferase (AST) coupled with Glutamyltransferase (GGT) is considered as one of the main indicators of the NAFLD, while the pathology, imaging and diagnosis of metabolic syndrome are also auxiliary results. The last, meta-analysis was conducted by RevMan software version 5.3.

RESULTS

This study will provide evidence for treatment of NAFLD with XFZYD in terms of effectiveness and safety.

CONCLUSION

This systematic review aims to confirm the efficacy and safety of XFZYD in the treatment of NAFLD.

OSF REGISTRATION NUMBER

DOI 10.17605/OSF.IO/7CWRK.

摘要

背景

非酒精性脂肪性肝病(NAFLD)包括非酒精性脂肪肝(NAFL)和非酒精性脂肪性肝炎(NASH),其排名仅次于病毒性肝炎,对全球公共卫生和经济构成日益严重的挑战。NAFLD 越来越受到关注,但目前尚无确切疗效的药物。临床上常用于治疗 NAFLD 的药物是他汀类药物,此类药物不可避免地会增加肝脏的负担。与他汀类药物相比,人们认为中药是“纯天然”的,副作用较少,与患者的依从性较强。因此,大量的临床研究表明,血府逐瘀汤(XFZYD)可显著改善临床症状,增强治疗效果。同时,我们进行了系统评价和荟萃分析,以进一步阐明 XFZYD 治疗 NAFLD 的有效性和安全性。

方法

我们将主要从 Cochrane Library、PubMed、摘录医学数据库和 Web of Science 等英文文献数据库,以及中国国家知识基础设施、中国生物医学文献数据库、VIP 和万方数据库等中文文献数据库中搜索评价 XFZYD 治疗 NAFLD 有效性和安全性的随机对照试验(RCTs)。RCTs 的纳入时间为数据库建立至 2021 年 2 月 1 日。同时我们还将检索临床注册试验和灰色文献。2 名研究人员独立进行文献选择、数据提取和质量评估。二分类数据用相对风险表示,连续性数据用均数差或标准均数差表示,是否存在异质性决定了固定效应模型或随机效应模型的数据合成。丙氨酸氨基转移酶(ALT)或天冬氨酸氨基转移酶(AST)与谷氨酰转移酶(GGT)联合作为 NAFLD 的主要指标之一,而代谢综合征的病理、影像学和诊断则作为辅助结果。最后,使用 RevMan 软件版本 5.3 进行荟萃分析。

结果

本研究将为 XFZYD 治疗 NAFLD 的有效性和安全性提供证据。

结论

本系统评价旨在证实 XFZYD 治疗 NAFLD 的疗效和安全性。

OSF 注册号:DOI 10.17605/OSF.IO/7CWRK。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b8a/8133179/3477bc3fce7c/medi-100-e25358-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b8a/8133179/3477bc3fce7c/medi-100-e25358-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b8a/8133179/3477bc3fce7c/medi-100-e25358-g001.jpg

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