利多卡因凝胶膏治疗疱疹后神经痛有效性和安全性临床研究  

Efficacy and safety of lidocaine cataplasms 5% for the treatment of post-herpetic neuralgia

作　　者：王爱平[1] 王晓雯[1] 赵俊英[2] 葛蒙梁[3] 郭在培[4] 宋智琦[5] 白彦萍[6] 韩秀萍[7] 杨雪源 李明[9] 陆前进[10] 鲁建云[11] 顾军[12] 谢红付[13] 陈涛[14] 郑捷[15] 邱双军 丁娜[16] 李若瑜[1] 

机构地区：[1]北京大学第一医院皮肤性病科,100034 [2]首都医科大学附属北京友谊医院 [3]卫生部北京医院 [4]四川大学华西医院 [5]大连医科大学附属第一医院 [6]中日友好医院 [7]中国医科大学附属盛京医院 [8]中国医学科学院皮肤病医院 [9]复旦大学附属中山医院 [10]中南大学湘雅二医院 [11]中南大学湘雅三医院 [12]第二军医大学长海医院 [13]中南大学湘雅医院 [14]内蒙古包钢医院 [15]上海交通大学医学院附属瑞金医院 [16]北京泰德制药股份有限公司

出　　处：《实用皮肤病学杂志》2015年第3期181-184,共4页Journal of Practical Dermatology

摘　　要：目的比较5%利多卡因凝胶膏与安慰剂治疗疱疹后神经痛(PHN)的有效性和安全性。方法采用中央随机、双盲、安慰剂对照、平行分组、多中心的临床研究方法。5%利多卡因凝胶膏或安慰剂凝胶膏覆盖疼痛最严重区域,每次最多使用3贴,每日贴敷不超过12 h,疗程4周。结果与基线相比,在第4周时采用受试者日记卡中的疼痛视觉模拟评分(VAS)平均下降值为主要疗效。结果显示,VAS平均下降差值利多卡因凝胶膏组为(20.71±19.07)mm,安慰剂组为(8.04±14.25)mm(P<0.0001)。其中在第4周时VAS下降达到30%的分别为56.07%和20.39%(P<0.0001);VAS下降达到50%的分别为36.45%和11.65%(P<0.0001)。早期脱离率分别为1.68%和7.83%(P=0.0264)。与研究药物可能相关的不良反应发生率5%利多卡因凝胶膏组为10.83%,安慰剂组为12.93%(P=0.6183),主要表现为皮肤刺激,发生率分别为5%和6.03%(P=0.7277)。结论 5%利多卡因凝胶膏外用治疗PHN疗效明显优于安慰剂,不良反应与安慰剂相似,耐受性好,安全性高,使用方便。Objective To compare efifcacy and safety of lidocaine cataplasms 5% with placebo cataplasms treatment in patients with post-herpetic neuralgia（PHN）. Methods The design of this trial was a central-randomized, double-blind, vehicle-controlled, parallel group, multicenter study. The most painful area had to be coverable by up to three cataplasms in patients with PHN. The cataplasms had to be applied to the area of maximal pain for up to 12 hours within each 24-hour period for 4 weeks. Results To evaluate the primary outcome at 4 weeks, pain relief was measured with VAS compared with baseline in patients’ diaries. Results showed good pain relief, which was associated with a reduction of （20.71±19.07）mm for lidocaine cataplasms 5% group, compared with placebo cataplasms group （8.04±14.25）mm （P〈0.0001）. At 4 weeks, a reduction of VAS of at least 30% was achieved in 56.07% and 20.39% （P〈0.0001）, respectively, a reduction of VAS of at least 50% was observed in 36.45% and 11.65% （P〈0.0001）, respectively. The early withdraw rates were 1.68% and 7.83% （P=0.0264）, respectively. Drug-related adverse events occurred in 10.83% of the lidocaine cataplasms 5% group, and 12.93% of the placebo cataplasms group （P=0.6183）, mainly as localized skin reactions, incidences rates were 5% and 6.03% （P =0.7277）, respectively. Conclusion Lidocaine cataplasms 5% therapy provides signiifcant efifcacy compared with placebo cataplasms, and is a well-tolerated, safe and convenient treatment option for PHN patients.

关 键 词：神经痛 疱疹后 5%利多卡因凝胶膏 安慰剂凝胶膏 临床疗效 安全性 

分 类 号：R752.12[医药卫生—皮肤病学与性病学]