吡美莫司乳膏治疗特应性皮炎多中心、随机双盲、平行对照研究

Pimecrolimus cream 1% for the treatment of atopic dermatitis in Chinese children and adults： a multicenter, randomized, double-blind, parallel-group, vehicle-controlled trial

目的评价1％吡美莫司乳膏治疗特应性皮炎的安全性和有效性。方法采用多中心、随机双盲、赋形剂平行对照的临床研究。特应性皮炎患者被随机分配至治疗组和安慰剂组，分别外用1％吡美莫司乳膏或赋形剂，每日2次，疗程4周，于治疗前（基线）及治疗后第1、2、4周各访视1次。主要疗效指标为研究者总体评估（IGA）评分，次要疗效指标包括湿疹面积与严重度指数（EASI）、瘙痒程度评分及受试者胪理者主观评分等。结果7个中心共有336例儿童和成人轻、中度特应性皮炎患者纳入意向治疗分析（ITT）。治疗结束时，1％吡美莫司乳膏组总体评估的治疗成功率为31．55％，明显高于赋形剂组的18．45％（P=0．0046）。其他疗效指标在治疗后第1、2．4周1％吡美莫司乳膏组均明显优于赋形剂组（P〈0．05）。1％吡美莫司乳膏组药物相关不良反应发生率为19．64％，赋形剂组为24．40％，主要表现为红斑，红斑加重、疼痛、瘙痒，瘙痒加重、烧灼感和毛囊炎等。结论1％吡美莫司乳膏对治疗儿童和成人轻、中度特应性皮炎疗效确切。安全性较好。

Objective To evaluate the safety and efficacy of 1% pimecrolimus cream in the treatment of Chinese pediatric and adult patients with mild to moderate atopic dermatitis （ AD ）. Methods This multicenter, randomized, double-blind, parallel group, vehicle-controlled trial was conducted at 7 research sites in China. Children and adults with mild to moderate atopic dermatitis were randomly assigned to treatment with 1% pimecrolimus cream or vehicle twice daily for 4 weeks. Efficacy evaluations were performed at baseline and at weeks 1, 2, and 4. The primary efficacy parameter was the Investigator＇s Global Assessment （ IGA ） score. Secondary parameters included Eczema Area and Severity Index （ EASI ） and severity of pruritus scores, Subjects were also asked to assess their disease control as uncontrolled, limited, good or complete. Results A total of 336 patients were included in the intent-to-treat analysis. At the end of study, 31.55% （ 53 of 168 ） of the patients were treated successfully with pimecrolimus cream based on IGA scores, a significant improvement compared with patients treated with vehicle [ 18.45% （ 31 of 168 ） ] （ P = 0.0046 ）. Furthermore, pimecrolimus-treated patients experienced significantly greater improvement than vehicle-treated patients in all efficacy parameters at each postbaseline visit （ P 〈 0.05 ）. There was no significant difference in the incidence of adverse events between the two groups, with 19.64% （ 33/168 ） in the pimecrolimus-treated group and 24.40% （ 41/168 ） in the vehicle-treated group （ P = 0.3568 ）. The most common adverse events were mild-to-moderate local application site reactions, such as erythema, pain, pruritus, burning, and folliculitis. Conclusion Pimecrolimus cream 1% is a safe and effective treatment alternative for Chinese pediatric and adult patients with mild to moderate AD.