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霉酚酸酯(骁悉)治疗银屑病:一项双中心、前瞻性、开放标签的临床试验。

Mycophenolate mofetil (CellCept) for psoriasis: a two-center, prospective, open-label clinical trial.

作者信息

Zhou Youwen, Rosenthal Don, Dutz Jan, Ho Vincent

机构信息

Division of Dermatology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

J Cutan Med Surg. 2003 May-Jun;7(3):193-7. doi: 10.1007/s10227-002-0113-6.

Abstract

BACKGROUND

Mycophenolate mofetil (MMF) is an immune suppressant that selectively inhibits activated lymphocytes. Its usefulness in treating psoriasis has not been systematically investigated.

OBJECTIVE

To evaluate efficacy and safety of MMF as a monotherapy for psoriasis.

METHODS

This is a two-center, prospective, open-label clinical trial.

RESULTS

Twenty-three patients with moderate to severe psoriasis [mean psoriasis area and severity index (PASI) of 21.7] were treated with MMF 2-3 g/day for 12 weeks. Eighteen patients completed the study. The PASI was reduced by 24% (p < 0.001) at 6 weeks, and by 47% (p < 0.001) at 12 weeks. At the end of the treatment phase, 77% of the patients had significant reduction of PASI while 22% did not respond. The treatment was well tolerated. Five patients experienced mild nausea. One patient each had periorbital edema and pruritus. One patient had transient leukopenia.

CONCLUSION

In this noncontrolled trial, the majority of patients with moderate to severe psoriasis responded to mycophenolate mofetil monotherapy with few adverse events. A randomized, controlled trial should be considered to confirm the usefulness of MMF as a monotherapy for psoriasis.

摘要

背景

霉酚酸酯(MMF)是一种免疫抑制剂,可选择性抑制活化淋巴细胞。其在治疗银屑病方面的有效性尚未得到系统研究。

目的

评估霉酚酸酯单药治疗银屑病的疗效和安全性。

方法

这是一项双中心、前瞻性、开放标签的临床试验。

结果

23例中度至重度银屑病患者[银屑病面积和严重程度指数(PASI)平均为21.7]接受霉酚酸酯每日2 - 3克治疗12周。18例患者完成研究。6周时PASI降低24%(p < 0.001),12周时降低47%(p < 0.001)。在治疗阶段结束时,77%的患者PASI显著降低,而22%无反应。治疗耐受性良好。5例患者出现轻度恶心。各有1例患者出现眶周水肿和瘙痒。1例患者出现短暂性白细胞减少。

结论

在这项非对照试验中,大多数中度至重度银屑病患者对霉酚酸酯单药治疗有反应,不良事件较少。应考虑进行一项随机对照试验以证实霉酚酸酯作为银屑病单药治疗的有效性。

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