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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 the efficacy and safety of 5% lidocaine gel cream with placebo in the treatment of post-herpetic neuralgia (PHN). Methods A central, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study was performed. 5% lidocaine gel cream or placebo gel cream covering the most severe pain area, each with a maximum of 3 sticks, daily sticking no more than 12 h, a course of 4 weeks. Results At Week 4, the mean reduction in pain visual analogue scale (VAS) in subjects diary card was the primary effect. The results showed that the average decline of VAS was (20.71 ± 19.07) mm in the lidocaine gel group and (8.04 ± 14.25) mm in the placebo group (P <0.0001). Among them, VAS decreased 30% at 56.07% and 20.39% (P <0.0001) respectively at the 4th week, 36.45% and 11.65% (P <0.0001) respectively when the VAS decreased 50%. Early detachment rates were 1.68% and 7.83%, respectively (P = 0.0264). The incidence of adverse reactions that may be related to the study drug 5% lidocaine gel group was 10.83%, placebo group was 12.93% (P = 0.6183), the main manifestations of skin irritation, the incidence rates were 5% and 6.03% (P = 0.7277). Conclusion Topical 5% lidocaine gel cream is superior to placebo in the treatment of PHN. The side effect is similar to that of placebo. It is well tolerated, safe and easy to use.