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补充维生素D对慢性肝病患者纤维化进展的影响:一项系统评价和荟萃分析方案

The effect of vitamin D supplementation on the progression of fibrosis in patients with chronic liver disease: A protocol for a systematic review and meta-analysis.

作者信息

Chen Tiantian, Zuo Xiaohong, Wang Shengju, Yu Penglong, Yuan Jie, Wei Shujun, Chen Jiayi, Sun Yue, Gao Yongxiang, Li Xueping

机构信息

Department of Rheumatology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072.

School of basic medical sciences, Chengdu University of Traditional Chinese Medicine, Chengdu 611137.

出版信息

Medicine (Baltimore). 2020 May;99(19):e20296. doi: 10.1097/MD.0000000000020296.

Abstract

BACKGROUND

Hepatic fibrosis (HF) is the common pathological basis of chronic liver disease (CLD). Many data indicate that serum vitamin D (VD) levels in patients with liver fibrosis are significantly lower than those without liver fibrosis, and lower level of serum 1,25(OH)2D3 is also an independent risk factor for patients with liver fibrosis combined with other diseases. VD has the functions of anti-fibrosis, regulating cell proliferation and differentiation, anti-inflammatory, and immune regulation, Therefore, serum 1,25(OH)2D3 level may be negatively correlated with the progression of liver fibrosis. But there is absent convincing evidence-based medicine to confirm the efficacy of VD supplementation for CLD. Thus, we aimed to conduct this meta-analysis to summarize the efficacy of VD supplementation on the progression of fibrosis in patients with CLD.

METHODS

The study only selects clinical randomized controlled trials of VD supplementation for CLD. We will search each database from the built-in until September 2020. The English literature mainly searches Cochrane Library, Pubmed, EMBASE, and Web of Science. While the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Meanwhile, we will retrieve clinical trial registries and gray literature. Two researchers worked independently on literature selection, data extraction and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on the heterogeneity. The serum VD level, hepatic function and serological indexes of hepatic fibrosis were evaluated as the main outcomes. While several secondary outcomes were also evaluated in this study. The statistical analysis of this Meta-analysis was conducted by RevMan software version 5.3.

RESULTS

This meta-analysis will further determine the beneficial efficacy of VD supplementation on the progression of fibrosis in patients with CLD.

CONCLUSION

This study determines the positive efficacy of VD supplementation for CLD.

ETHICS AND DISSEMINATION

This review is based solely on a secondary study of published literatures and does not require ethics committee approval. Its conclusion will be disseminated in conference papers, magazines or peer-reviewed journals.

REGISTRATION NUMBER

INPLASY202040054.

摘要

背景

肝纤维化(HF)是慢性肝病(CLD)的常见病理基础。许多数据表明,肝纤维化患者的血清维生素D(VD)水平显著低于无肝纤维化者,血清1,25(OH)2D3水平降低也是肝纤维化合并其他疾病患者的独立危险因素。VD具有抗纤维化、调节细胞增殖与分化、抗炎及免疫调节等功能,因此,血清1,25(OH)2D3水平可能与肝纤维化进展呈负相关。但目前尚无令人信服的循证医学证据证实补充VD对CLD的疗效。因此,我们旨在进行此项荟萃分析,以总结补充VD对CLD患者纤维化进展的疗效。

方法

本研究仅选取补充VD治疗CLD的临床随机对照试验。我们将检索自建库至2020年9月的各个数据库。英文文献主要检索Cochrane图书馆、Pubmed、EMBASE及Web of Science。中文文献来自中国知网、中国生物医学文献数据库、维普资讯网及万方数据库。同时,我们还将检索临床试验注册库及灰色文献。两名研究人员独立进行文献筛选、数据提取及质量评估。二分类数据以相对危险度(RR)表示,连续性数据以均数差(MD)或标准化均数差(SMD)表示,最终根据异质性采用固定效应模型(FEM)或随机效应模型(REM)对数据进行合并。将血清VD水平、肝功能及肝纤维化血清学指标作为主要结局指标。本研究还评估了几个次要结局指标。本荟萃分析的统计分析采用RevMan 5.3软件进行。

结果

本荟萃分析将进一步确定补充VD对CLD患者纤维化进展的有益疗效。

结论

本研究确定了补充VD对CLD的积极疗效。

伦理与传播

本综述仅基于已发表文献的二次研究,无需伦理委员会批准。其结论将在会议论文、杂志或同行评审期刊上发表。

注册号

INPLASY202040054

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24af/7220037/c4cd54b6bab6/medi-99-e20296-g002.jpg

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