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异维A酸在白塞病治疗中的作用:一项单盲对照治疗研究。

The therapeutic role of isotretinoin in the management of Behçet's disease: a single-blinded, controlled therapeutic study.

作者信息

Sharquie Khalifa E, Helmi Raad M A, Noiami Adil A, Al-Hayani Raafa K, Kadhom Mohand A A

机构信息

Scientific Council of Dermatology and Venereology, Iraqi Board for Medical Specializations, Baghdad, Iraq.

出版信息

J Drugs Dermatol. 2013 Apr;12(4):e68-73.

Abstract

OBJECTIVES

To evaluate the long-term remission efficacy and safety of isotretinoin in the treatment of Behcet's disease (BD).

PATIENTS AND METHODS

This single-blind, controlled therapeutic study was conducted in the Department of Dermatology and Venereology at Baghdad Teaching Hospital from February 2011 to January 2012. Thirty patients with BD were included in this work. Each patient received isotretinoin 20 mg orally once daily for 3 months. They were assessed at week 2 and then monthly depending on the Clinical Manifestation Index (CMI) and to record any side effects. At week 12, isotretinoin was stopped and patients were given placebo therapy in a form of glucose capsules for another 3 months.

RESULTS

Thirty patients were treated, 14 (46.6%) males and 16 (53.3%) females, with a male to female ratio of 1:1. Their ages ranged from 16 to 64 years (mean +/- standard deviation [SD], 38.4 +/- 10.9 years). During the first 3 months of therapy, the pathergy test, oral pathergy test, and C-reactive protein were significantly minimized. The CMI before isotretinoin therapy ranged between 2 and 8 (mean +/- SD, 4.933 +/- 1.91). After therapy, within the first 14 days, the mean CMI started to decline to a lower level, and it continued to decline significantly until week 12. It then started to increase through week 4 of placebo therapy, but remained statistically significant until the second month of placebo therapy. Isotretinoin therapy also had a statistically significant effect in reducing oral ulcers and skin manifestations.

CONCLUSION

Isotretinoin is an effective therapeutic and prophylactic drug in the management of BD.

摘要

目的

评估异维A酸治疗白塞病(BD)的长期缓解疗效及安全性。

患者与方法

这项单盲对照治疗研究于2011年2月至2012年1月在巴格达教学医院皮肤科与性病科进行。本研究纳入了30例BD患者。每位患者口服异维A酸20mg,每日1次,共3个月。在第2周进行评估,之后根据临床表现指数(CMI)每月评估1次,并记录任何副作用。在第12周时,停用异维A酸,给予患者葡萄糖胶囊形式的安慰剂治疗,持续3个月。

结果

共治疗30例患者,男性14例(46.6%),女性16例(53.3%),男女比例为1:1。年龄范围为16至64岁(平均±标准差[SD],38.4±10.9岁)。在治疗的前3个月,针刺反应试验、口腔针刺反应试验及C反应蛋白均显著降低。异维A酸治疗前CMI范围为2至8(平均±SD,4.933±1.91)。治疗后,在最初14天内,平均CMI开始下降至较低水平,并持续显著下降直至第12周。然后在安慰剂治疗的第4周开始上升,但直到安慰剂治疗的第2个月仍具有统计学意义。异维A酸治疗在减少口腔溃疡和皮肤表现方面也具有统计学意义。

结论

异维A酸是治疗BD的一种有效治疗和预防药物。

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