摘要
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.
出处
《中华皮肤科杂志》
CAS
CSCD
北大核心
2007年第1期34-37,共4页
Chinese Journal of Dermatology
关键词
皮炎
特应性
吡美莫司
随机对照试验
Dermatitis, atopic
Pimecrolimus
Randomized controlled trials