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局部皮质类固醇治疗口腔移植物抗宿主病是否可行?一项关于随机临床试验的系统观察。

Topical Corticosteroids a Viable Solution for Oral Graft Versus Host Disease? A Systematic Insight on Randomized Clinical Trials.

机构信息

Department of Oral Rehabilitation, University of Medicine and Pharmacy "Iuliu Hatieganu", 400012 Cluj-Napoca, Romania.

Department of Medical Oncology, University of Medicine and Pharmacy "Iuliu Hatieganu", 400012 Cluj-Napoca, Romania.

出版信息

Medicina (Kaunas). 2020 Jul 14;56(7):349. doi: 10.3390/medicina56070349.

Abstract

This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD). An electronic search of the PubMed, Web of Science and Scopus databases was carried out for eligible RCTs. Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English. The Cochrane Risk of Bias tool was used to assess the quality of these studies. Overall, three RCTs were included (an Open, Randomized, Multicenter Trial; a Randomized Double-Blind Clinical Trial; and an Open-Label Phase II Randomized Trial). The trials involved 76 patients, of which 44 patients received topical dexamethasone, 14 patients received topical clobetasol and 18 patients received topical budesonide. Topical agents were most frequently used when oral tissues were the sole site of involvement. It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters. Moreover, both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone. Based on the clinical trials, all three agents seem to be effective in treating oral GVHD and had a satisfactory safety profile. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort.

摘要

本研究旨在提供一个关于局部用地塞米松、卤米松和布地奈德治疗口腔移植物抗宿主病(GVHD)疗效的随机临床试验(RCT)文献的清晰概述。对 PubMed、Web of Science 和 Scopus 数据库进行了电子检索,以寻找符合条件的 RCT。如果研究纳入了接受局部皮质类固醇治疗的口腔 GVHD 成年患者,且 RCT 研究以英文发表,则纳入研究。使用 Cochrane 偏倚风险工具评估这些研究的质量。总体而言,纳入了三项 RCT(一项开放性、随机、多中心试验;一项随机双盲临床试验;和一项开放性 II 期随机试验)。这些试验共纳入了 76 名患者,其中 44 名患者接受了局部地塞米松治疗,14 名患者接受了局部卤米松治疗,18 名患者接受了局部布地奈德治疗。当口腔组织是唯一受累部位时,局部药物最常被使用。似乎布地奈德的总体反应最好,四个臂之间没有差异,其次是卤米松,然后是地塞米松。本研究的局限性主要在于两个研究中的总体反应是从其他参数中得出的。此外,布地奈德和卤米松在每个研究中都只使用了一次,而两个评估地塞米松的研究中都使用了地塞米松。基于临床试验,所有三种药物似乎都能有效治疗口腔 GVHD,且具有令人满意的安全性。仍需要评估高质量的 RCT 来评估这些治疗方法在更大队列中的疗效。

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