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环孢素治疗慢性特发性荨麻疹:一项双盲、随机、安慰剂对照试验。

Cyclosporine in chronic idiopathic urticaria: a double-blind, randomized, placebo-controlled trial.

作者信息

Vena Gino A, Cassano Nicoletta, Colombo Delia, Peruzzi Elena, Pigatto Paolo

机构信息

2nd Dermatology Clinic, MIDIM Department, University of Bari, Italy.

出版信息

J Am Acad Dermatol. 2006 Oct;55(4):705-9. doi: 10.1016/j.jaad.2006.04.078.

Abstract

BACKGROUND

Treatment of severe recalcitrant chronic idiopathic urticaria (CIU) is difficult.

OBJECTIVE

To assess the efficacy and safety of oral cyclosporin A (CsA) in CIU.

METHODS

The response to CsA was evaluated in 99 CIU patients with a double-blind, randomized, three-armed study: 16-week CsA, 8-week CsA +8-week placebo, and 16-week placebo. All patients received cetirizine throughout the study period and were followed-up after 8 weeks.

RESULTS

Fewer therapeutic failures occurred with 16-week CsA (n = 3) than with placebo (n = 11) and 8-week CsA (n = 8). After 8 and 16 weeks, symptom scores significantly improved in both CsA groups over with placebo. Two patients discontinued because of hypertension.

LIMITATIONS

During the study period, CsA was not administered at a constant dose; from day 28 the daily dose was 3 mg/kg, which is likely to be less effective and better tolerated than higher dosages.

CONCLUSION

CsA in addition to background therapy with cetirizine may be useful in the treatment of CIU.

摘要

背景

重度难治性慢性特发性荨麻疹(CIU)的治疗颇具难度。

目的

评估口服环孢素A(CsA)治疗CIU的疗效及安全性。

方法

采用双盲、随机、三臂研究对99例CIU患者使用CsA的反应进行评估:16周CsA治疗组、8周CsA + 8周安慰剂组以及16周安慰剂组。所有患者在整个研究期间均服用西替利嗪,并在8周后进行随访。

结果

16周CsA治疗组(n = 3)的治疗失败病例少于安慰剂组(n = 11)和8周CsA治疗组(n = 8)。在8周和16周时,CsA两组的症状评分均显著优于安慰剂组。两名患者因高血压停药。

局限性

在研究期间,CsA并非以恒定剂量给药;从第28天起,每日剂量为3 mg/kg,这可能比更高剂量的疗效更差且耐受性更好。

结论

除使用西替利嗪进行基础治疗外,CsA可能对CIU的治疗有益。

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