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低剂量甲氨蝶呤与黏膜不良反应:系统文献回顾和随机对照试验荟萃分析的结果。

Low-Dose Methotrexate and Mucocutaneous Adverse Events: Results of a Systematic Literature Review and Meta-Analysis of Randomized Controlled Trials.

机构信息

Brigham and Women's Hospital, Boston, Massachusetts, and Florida Atlanta University Charles E. Schmidt College of Medicine, Boca Raton.

Brigham and Women's Hospital, Boston, Massachusetts, and General Hospital of the Chinese People's Liberation Army, Beijing, China.

出版信息

Arthritis Care Res (Hoboken). 2020 Aug;72(8):1140-1146. doi: 10.1002/acr.23999.

DOI:10.1002/acr.23999
PMID:31150157
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6885092/
Abstract

OBJECTIVE

Methotrexate (MTX) increases the risk of alopecia and stomatitis, but the prevalence of these adverse events among rheumatic patients taking MTX is poorly defined. We conducted a systematic literature review and meta-analysis to estimate the prevalence of alopecia and stomatitis with MTX in rheumatic diseases.

METHODS

We searched PubMed, The Cochrane Library, and CINAHL databases for double-blind randomized controlled trials (RCTs) with an MTX monotherapy arm. Alopecia, stomatitis, and oral/mouth ulcers data were extracted. The quality of trials was assessed by 2 authors. We included trials published since 1990 that used at least 10 mg of MTX weekly, coadministered with folic or folinic acid. We estimated the prevalence using random-effects models because heterogeneity was anticipated. Two estimates of prevalence were included; the lower bound estimate included all trials (assuming no alopecia and stomatitis if not mentioned), and the upper bound estimate included only those that specifically described prevalence estimates of alopecia or stomatitis.

RESULTS

Of 3,954 studies identified, 20 RCTs were included, with a total of 24 MTX monotherapy arms, of which 10 reported the prevalence of alopecia (n = 1,113), and 21 reported stomatitis or mouth/oral ulcers (n = 2,056). The prevalence of alopecia was between 1.0% and 4.9%. The prevalence of stomatitis was between 5.7% and 8.0%.

CONCLUSION

This meta-analysis gives more precise estimates of mucocutaneous adverse events that occur in rheumatic disease patients taking MTX. These estimates will help inform patient decision-making regarding MTX.

摘要

目的

甲氨蝶呤(MTX)会增加脱发和口腔炎的风险,但风湿患者使用 MTX 后出现这些不良反应的患病率尚未明确。我们进行了系统的文献回顾和荟萃分析,以评估风湿疾病患者使用 MTX 时脱发和口腔炎的患病率。

方法

我们检索了 PubMed、Cochrane 图书馆和 CINAHL 数据库中的双盲随机对照试验(RCT),其中包括 MTX 单药治疗组。提取脱发、口腔炎和口腔/口部溃疡的数据。两名作者评估了试验的质量。我们纳入了自 1990 年以来发表的试验,这些试验使用了至少 10mg/周的 MTX,与叶酸或亚叶酸联合使用。由于预计会存在异质性,我们使用了随机效应模型来估计患病率。我们包括了两种患病率估计值;低值估计值包括了所有试验(如果没有提到脱发和口腔炎,则假设不存在),高值估计值仅包括那些具体描述了脱发或口腔炎患病率的试验。

结果

在 3954 项研究中,有 20 项 RCT 被纳入,共有 24 个 MTX 单药治疗组,其中 10 个报告了脱发的患病率(n=1113),21 个报告了口腔炎或口腔/口部溃疡的患病率(n=2056)。脱发的患病率在 1.0%至 4.9%之间。口腔炎的患病率在 5.7%至 8.0%之间。

结论

这项荟萃分析更准确地估计了风湿疾病患者使用 MTX 时发生的黏膜皮肤不良反应。这些估计值将有助于为患者在 MTX 治疗方面做出决策提供信息。

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