曲尼司特胶囊治疗瘢痕疙瘩的多中心随机双盲平行对照研究  

Treatment of keloid with tranilast capsule:a randomized double-blind, placebo-controlled, multi-center clinical trial

作　　者：曹元华[1] 崔盘根[1] 顾军[2] 郭在培[3] 林麟[1] 贾虹[1] 宗文凯[1] 弓娟琴[1] 刘训荃[1] 李慧珠[1] 冯素英[1] 岳晓玉[1] 胡兹嘉[1] 盛楠[1] 

机构地区：[1]中国医学科学院皮肤病研究所,南京210042 [2]第二军医大学长海医院 [3]四川大学华西医院

出　　处：《国际皮肤性病学杂志》2007年第5期261-263,共3页International Journal of Dermatology and Venereology

摘　　要：目的评价曲尼司特胶囊治疗瘢痕疙瘩的临床疗效和安全性。方法采用多中心、随机、安慰剂平行对照的临床研究方法,将入选患者随机分为治疗组和对照组,分别接受口服曲尼司特和安慰剂治疗,两组均同时外用多磺酸黏多糖(商品名喜辽妥),于治疗后第4、8、12周随访。主要疗效指标为皮损的B超厚度,次要指标为皮损硬度、瘙痒及疼痛的评分。结果共有143例瘢痕疙瘩患者参加本次研究,符合研究方案完成试验者124例,其中治疗组60例,对照组64例。研究结束时,主要疗效指标皮损厚度的下降率,治疗组和对照组间的差异有统计学意义(P=0.001);综合评分的下降率,治疗组和对照组的有效率分别为15.00%、4.69%(P=0.046),差异有统计学意义。两组不良事件的发生率分别为5.88%和2.86%,差异无统计学意义(P=0.438)。结论曲尼司特胶囊治疗瘢痕疙瘩安全并有一定作用。Objective To observe the clinical efficacy and safety of tranilast capsule in the treatment of keloid. Methods A randomized, double-blind, parallel placebo-controlled clinical study was conducted. The patients wcrc randomly divided into two groups, test group and control group, received oral tranilast capsule or placebo capsule, 100rag thrice a day for 12 weeks. Both groups also topically applied Hirudoid cream every day. The primary cndpoint was the thickness of lesions determined by ultra-sound B examination, and secondary cndpoints included the hardness, pruritus, pain intensity of lesions. All patients wcrc evaluated at baseline, 4, 8 and 12 weeks aRcr the beginning of treatment. Side effects wcrc recorded at every follow-up. Results One hundred and forty-three patients with kcloid wcrc enrolled into this study, and 124 patients （ 60 in the test group, and 64 in the control group ） completed the trial followed the protocol. At the end of the study, the decrease rates of lesion thickness and total scores of symptom and sign, effective rate were （ 27.83±21.68 ）%, （ 39.42 ±19.77 ）% and 15.00% respectively in the test group, （15.23± 17.02 ）%, （0.64±0.95 ）% and 4.69% respectively in the control group, with significant difference between the two groups （P = 0.001, 0.006, 0.046, respectively ）. The occurrence rate of side effects wcrc of no significant difference between the two groups （ 5.88% vs 2.86%, P = 0.438 ）. Conclusion The results suggest that tranilast capsule may bc effective and safe in the treatment of kcloid.

关 键 词：瘢痕疙瘩 曲尼司特 随机对照试验 

分 类 号：R622[医药卫生—整形外科]