Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study
Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study
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每周两次将丙酸氟替卡松加入润肤维持治疗中，以降低特应性皮炎复发的风险：随机、双盲、平行组研究
作者：
J. Berth‐Jones;R. Damstra;S. Golsch;J. Livden;Oliver Van Hooteghem;F. Allegra;C. Parker
摘要 目的探讨在润肤剂维持治疗基础上每周使用两次丙酸氟替卡松乳膏和软膏在降低慢性复发性特应性皮炎复发风险方面的有效性和安全性。设计为期 20 周的随机、双盲、平行小组研究。设置皮肤科门诊（6个国家，39个中心）。参与者 患有中度至重度特应性皮炎且正在发作的成人（12-65 岁）患者。方法 参与者定期使用丙酸氟替卡松（0.05%乳膏或0.005%软膏；每天一次或两次），持续四个星期以稳定病情。疾病得到控制的患者随后进入 16 周的维持阶段，每天根据需要使用润肤剂和浴油，并每周两次在通常受影响的区域使用相同配方的丙酸氟替卡松或其安慰剂基质（仅润肤剂）。主要结果测量维持阶段特应性皮炎复发的时间。结果 376 例患者进入稳定期，295 例继续进入维持期。维持阶段 16 周后，133 名患者（87 名使用丙酸氟替卡松，每周两次，46 名单独使用润肤剂）的疾病仍得到控制，135 名患者（40 名丙酸氟替卡松，95 名润肤剂）出现复发，27 名患者已停药。单独使用润肤剂的中位复发时间为 6 周，而额外使用丙酸氟替卡松的中位复发时间则超过 16 周。与单独使用润肤剂的患者相比，每周两次使用丙酸氟替卡松乳膏的患者复发的可能性降低 5.8 倍（95% 置信区间 3.1 至 10.8，P < 0.001），使用丙酸氟替卡松软膏的患者复发的可能性降低 1.9 倍（1.2 至 3.2，P=0.010）。各组的不良事件没有差异。结论 特应性皮炎稳定后，每周两次在润肤剂维持治疗中添加丙酸氟替卡松可显着降低复发风险。
Abstract Objective To explore the efficacy and safety of fluticasone propionate, cream and ointment, applied twice weekly in addition to maintenance treatment with emollients, in reducing the risk of relapse of chronic recurrent atopic dermatitis. Design Randomised, double blind, parallel group study of 20 weeks' duration. Setting Dermatology outpatient clinics (6 countries, 39 centres). Participants Adult (aged 12-65) patients with moderate to severe atopic dermatitis who were experiencing a flare. Methods Participants applied fluticasone propionate (0.05% cream or 0.005% ointment; once or twice daily) regularly for four weeks to stabilise their condition. The patients whose disease was brought under control then continued into a 16 week maintenance phase, applying emollient on a daily basis with a bath oil as needed and either the same formulation of fluticasone propionate or its placebo base (emollient alone) twice weekly to the areas that were usually affected. Main outcome measure Time to relapse of atopic dermatitis during maintenance phase. Results 376 patients entered the stabilisation phase, and 295 continued into the maintenance phase. After 16 weeks in the maintenance phase, the disease remained under control in 133 patients (87 using fluticasone propionate twice weekly, 46 using emollient alone), 135 (40 fluticasone propionate, 95 emollient) had experienced a relapse, and 27 had discontinued. Median time to relapse was six weeks for emollient alone compared with more than 16 weeks for additional fluticasone propionate. Patients who applied fluticasone propionate cream twice weekly were 5.8 times less likely (95% confidence interval 3.1 to 10.8, P < 0.001) and patients using fluticasone propionate ointment 1.9 times less likely (1.2 to 3.2, P=0.010) to have a relapse than patients applying emollient alone. The groups showed no differences in adverse events. Conclusion After atopic dermatitis had been stabilised the addition of fluticasone propionate twice weekly to maintenance treatment with emollients significantly reduced the risk of relapse.
DOI：
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发表时间：
1972
期刊：
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影响因子：
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作者：
D. Cox
通讯作者：
D. Cox