不同剂量和疗程伐昔洛韦治疗带状疱疹的多中心随机双盲对照研究  

A multi-center randomized and double-blind comparative clinical trial of different doses and durations of valaciclovir in the treatment of herpes zoster

作　　者：周村建[1] 王莉[1] 郭在培[2] 涂亚庭[3] 卢念祖[4] 郝飞[1] 

机构地区：[1]第三军医大学西南医院皮肤科,重庆400038 [2]四川大学华西医院皮肤科,四川成都610041 [3]华中科技大学同济医学院附属协和医院皮肤科,湖北武汉430022 [4]中山大学附属第一医院皮肤科,广东广州510080

出　　处：《临床皮肤科杂志》2007年第7期420-422,共3页Journal of Clinical Dermatology

摘　　要：目的:比较不同剂量和疗程伐昔洛韦治疗带状疱疹的疗效和安全性。方法:选择带状疱疹患者为研究对象,采用多中心、随机、双盲、对照的临床试验。试验组患者采用伐昔洛韦1000mg每日3次口服,共服7d;对照组患者采用伐昔洛韦300mg每日2次口服,共服10d。用药后第3、6和10天观察疗效和不良反应。结果:共入组128例,全分析集(FAS)分析128例,符合方案集(PPS)分析118例。治疗后第3、6和10天,试验组和对照组患者的症状、体征积分下降值及有效率比较差异无统计学意义(P>0.05);疼痛视觉模拟评分法(visnal analogue scale,VAS)值比较,两组间差异无统计学意义(P>0.05),但入组时疼痛VAS值≥8的患者,FAS集分析显示,在治疗后第6、10天VAS值下降两组均存在统计学差异(P<0.05);PPS集分析显示治疗后第10天VAS值下降,两组间存在统计学差异(P<0.05)。试验组和对照组不良反应发生率分别为17.18%和12.50%,主要为嗜睡和恶心。结论:增加伐昔洛韦用量治疗带状疱疹安全、有效,与较低剂量伐昔洛韦组相比,对疼痛程度较严重的患者能更显著地减轻疼痛。Objective： To investigate and compare the effect and safety of different doses and durations using oral valaciclovir for the treatment of herpes zoster. Methods： A multi-center, randomized and double-blind comparative clinical trial was conducted. Patients in research group（1 000 mg, 3/d） and control group （300 mg, 2/d） took drugs for 7 days and 10 days respectively, and were followed up on the 3rd day, 6th day and 10th day after starting treatment. Results： A total of 128 patients were evaluated for the safety and 118 were evaluated for the effect at the end of the study. The effective rates and degradation of pain were no significant difference between the two groups during the course of study （P 〉 0.05）. Otherwise, in patients with pain VAS value exceeded 8, there was a significant difference between the two groups at 6th day and 10th day （P〈0.05）. The adverse reactions in research and control group were 17.18%and 12.50% respectively, which included nausea and dizziness, etc. Conclusion： Valaciclovir is an effective and safe agent for the treatment of herpes zoster. It is more effective in shortening the duration of zoster-associated pain in patients with severe pain under a higher dose.

关 键 词：带状疱疹 伐昔洛韦 临床试验 

分 类 号：R752.12[医药卫生—皮肤病学与性病学]