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基于手臂的网络荟萃分析治疗外阴硬化性苔藓,并呼吁制定核心结局集。

An arm-based network meta-analysis on treatments for vulvar lichen sclerosus and a call for development of core outcome sets.

机构信息

Laboratory of Experimental Surgery and Surgical Research N.S Christeas, National and Kapodistrian University of Athens, Athens, Greece; Third Department of Obstetrics and Gynecology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.

Laboratory of Experimental Surgery and Surgical Research N.S Christeas, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Am J Obstet Gynecol. 2020 Jun;222(6):542-550.e6. doi: 10.1016/j.ajog.2019.10.095. Epub 2019 Nov 5.

Abstract

OBJECTIVE

The purpose of the present systematic review is to evaluate the available medical treatments for vulvar lichen sclerosus, using an arm-based network meta-analysis protocol.

DATA SOURCES

We searched Medline (1966-2019), Scopus (2004-2019), Cochrane Central Register of Controlled Trials CENTRAL (1999-2019), Clinicaltrials.gov (2008-2019) databases, and Google Scholar (2004-2019) database along with the reference list of all included studies.

STUDY ELIGIBILITY CRITERIA

All observational, randomized, and single-arm studies that evaluated medical treatments for vulvar lichen sclerosus were considered eligible for inclusion in the present systematic review.

STUDY APPRAISAL

A network meta-analysis was carried out in R 3.4.3 using the pcnetmeta package, which uses a Bayesian hierarchical model (based in Markov chain Monte Carlo convergence simulation).

RESULTS

Sixteen studies were included in this present meta-analysis, which recruited 954 women with vulvar lichen sclerosus. Their quality was evaluated with the JADAD, Cochrane risk of bias, and risk of bias in nonrandomised studies of interventions-I tools. Clobetasol treatment ranked as the best treatment for disease remission after evaluating rank probabilities (40% chance of ranking first compared with tacrolimus [38%]). However, the density plot revealed partial overlapping with tacrolimus. The lowest probability of experiencing a relapse was observed with pimecrolimus (15% [2-48%]); however, the density plot revealed significant overlapping with mometasone furoate, testosterone, and clobetasol.

CONCLUSION

Robust evidence concerning the superiority of potent steroids at least over calcineurin inhibitors is still lacking in the field of vulvar lichen sclerosus. On the other hand, the gross heterogeneity in terms of selected population, duration of treatment, administered regimen, outcome reporting, and selection of outcome measures leaves several fields unanswered.

摘要

目的

本系统评价的目的是使用基于手臂的网络荟萃分析方案评估外阴硬化性苔藓的现有医学治疗方法。

数据来源

我们检索了 Medline(1966-2019 年)、Scopus(2004-2019 年)、Cochrane 对照试验中心注册库 CENTRAL(1999-2019 年)、Clinicaltrials.gov(2008-2019 年)数据库以及 Google Scholar(2004-2019 年)数据库,并查阅了所有纳入研究的参考文献列表。

研究入选标准

所有评估外阴硬化性苔藓医学治疗方法的观察性、随机和单臂研究均被认为有资格纳入本系统评价。

研究评估

使用 R 3.4.3 中的 pcnetmeta 包进行网络荟萃分析,该包使用贝叶斯层次模型(基于马尔可夫链蒙特卡罗收敛模拟)。

结果

本荟萃分析纳入了 16 项研究,共纳入 954 例外阴硬化性苔藓女性患者。使用 JADAD、Cochrane 偏倚风险和非随机干预研究偏倚风险工具-I 评估了这些研究的质量。在评估秩概率后,发现氯倍他索治疗的疾病缓解率最高(与他克莫司相比,有 40%的概率排名第一[38%])。然而,密度图显示与他克莫司存在部分重叠。米莫司汀乳膏复发率最低(15%[2-48%]);然而,密度图显示与莫米松糠酸酯、睾酮和氯倍他索有显著重叠。

结论

在外阴硬化性苔藓领域,关于强效类固醇至少优于钙调磷酸酶抑制剂的优势,仍然缺乏可靠的证据。另一方面,在选择人群、治疗持续时间、给药方案、结果报告以及选择结果测量方面存在的巨大异质性,使得一些领域的问题仍未得到解答。

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