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评价局部人血小板裂解物与局部卤倍他索治疗甲氨蝶呤诱导的类风湿关节炎患者口腔黏膜炎的疗效:随机对照临床试验。

Evaluation of topical human platelet lysate versus topical clobetasol in management of methotrexate-induced oral ulceration in rheumatoid arthritis patients: Randomized-controlled clinical trial.

机构信息

Department of Oral Medicine and Periodontology, Faculty of Dentistry, Beni-Suef University, Egypt.

Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University, Egypt.

出版信息

Int Immunopharmacol. 2019 Aug;73:389-394. doi: 10.1016/j.intimp.2019.05.028. Epub 2019 May 28.

Abstract

BACKGROUND

There is no mainstay protocol for management of Methotrexate-induced oral ulcers; commonly used protocols are cessation of Methotrexate, folic acid treatment, corticosteroids or combination. A new era of oral ulcers management is represented by platelet concentrates. The current study assessed the effect of topical human platelet lysate compared to topical Clobetasol Propionate in management of methotrexate-induced oral ulceration in rheumatoid arthritis patients.

METHODS

This randomized controlled clinical trial include 30 patients in two parallel groups (intervention - human platelet lysate, control - Clobetasol Propionate), with allocation ratio 1:1. Outcome measures were pain intensity using numerical rating scale, WHO scale for oral mucositis, measuring size of the largest ulcer and total number of oral ulcers.

RESULTS

A statistically significant difference was detected between HPL and Clobetasol groups on comparing numerical rating scale, WHO mucositis scale, size and total number of oral ulcers throughout all visits. A considerable quick pain reduction and clinical improvement were noticed in HPL group compared to Clobetasol.

CONCLUSION

Human platelet lysate has superior effect when compared to one of the most potent topical corticosteroids, Clobetasol Propionate, in reducing pain and clinical signs of Methotrexate-induced oral ulcers in patients with rheumatoid arthritis.

摘要

背景

目前针对甲氨蝶呤引起的口腔溃疡,尚无标准的治疗方案,常用的方案有停用甲氨蝶呤、叶酸治疗、皮质类固醇或联合治疗。血小板浓缩物开创了口腔溃疡治疗的新时代。本研究评估了局部应用人血小板裂解物与局部应用氯倍他索丙酸酯治疗类风湿关节炎患者甲氨蝶呤诱导的口腔溃疡的效果。

方法

这是一项随机对照临床试验,纳入了 30 例患者,分为两组(干预组-人血小板裂解物,对照组-氯倍他索丙酸酯),分配比例为 1:1。采用数字评分法评估疼痛强度,采用世界卫生组织口腔黏膜炎量表评估口腔黏膜炎的严重程度,测量最大溃疡的大小和总的口腔溃疡数量。

结果

在所有就诊期间,人血小板裂解物组与氯倍他索组在数字评分法、世界卫生组织口腔黏膜炎量表、溃疡大小和总的口腔溃疡数量方面均存在统计学差异。与氯倍他索相比,人血小板裂解物组能更快地减轻疼痛,临床症状改善更明显。

结论

与最有效的局部皮质类固醇之一氯倍他索丙酸酯相比,人血小板裂解物在减轻类风湿关节炎患者甲氨蝶呤诱导的口腔溃疡的疼痛和临床症状方面具有更好的效果。

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