摘要
目的重点观察0.03%他克莫司软膏的临床疗效、安全性及不良反应,寻求儿童特发性皮炎(AD)新的治疗途径。方法将特应性皮炎患儿随机分为3组,采用双盲赋形剂平行对照临床实验,分别于患处外用0.03%他克莫司软膏,0.025%氟轻松软膏及赋形剂,每日2次,疗程3周,从接诊起至治疗后3周,每周随访1次,停药后1个月又随访1次,共4次,本组92例患者全部完成本实验。结果治疗结束时,0.03%他克莫司软膏和0.025%氟轻松软膏临床有效率分别为87.5%和93.3%,明显高于赋形剂33.3%,差异有显著性(P<0.05);而0.03%他克莫司和0.025%氟轻松则无明显差异(P>0.05)。停药后1个月访视,原有病情无好转甚至加重或复发者。0.03%他克莫司组6例(18.7%),0.025%氟轻松组12例(40.0%),赋形剂组22例(73.3%)。3组之间的差异有显著性(P<0.05),0.03%他克莫司软膏主要不良反应表现为用药部位出现瘙痒或瘙痒加重、灼热感、刺痛,时间短暂,多数于第1周出现。治疗前后实验室检查未发现异常改变。结论0.03%他克莫司软膏是目前认为比较安全、有效且复发率低的治疗儿童特应性皮炎的一种新的外用药物。
Objective To observe the clinical efficacy safety and side effect, to explore tere divhe new treatment way of children atopy dermatitis. Methods Children with atopy dermatitis were divided into 3 groups randomly,and double- blind excipient parallel comparing test was taken. 0.03 % Tacrolimus group, 0.025 % Fluocinonide Ointment and excipient group, two times a day, three weeks for a course of treatment, following up study one time a week, one time after stopping treatment, four times in all. From begin- ning till after treatment for three weeks. Results The effective rate of Tacrolimus group was 87.5 %, Fluocinonide Ointment group was 93.3%, excipient group 33.3%, showing significant defferences among Tacralimus, Fluocinonide Ointment and excipient group （ P 〈 0.05 ） and no significant difference was observed between Tacralimus and Fluocinonide Ointment （ P 〉 05）. Results of a follow up of a month showed that condition of 6 cases in Tacrolimus group （18.7%）, 12 in Fluocinonide Ointment group （40%） and 22 in excipient group （73.3%） was tither without improvement or got worse. The side effect of pruritus or worse pruritus, burning sensation, twinge lested just a moment and appear in the first week after the treatment were noticed in Tacrolimus group. Conclusion 0.03% Tacrolimus paste is a new safe, efficacy and lower recurrence external application medication for treatment of children with atopic dermatitis.
出处
《中国热带医学》
CAS
2007年第5期757-758,818,共3页
China Tropical Medicine
