喷昔洛韦软膏治疗颜面单纯疱疹多中心随机双盲对照临床试验  

Penciclovir Cream for the Treatment of Herpes Simplex Facialis: A Multicenter, Randomized, Double -- blind Controlled Clinical Trial

作　　者：陈明春[1] 曾凡钦[1] 虞瑞尧[2] 李恒进[2] 彭振辉[3] 谭升顺[3] 赵广[4] 涂亚庭[5] 林宝珠[1] 陈建浩[1] 刘恩让[3] 刘厚君[5] 

机构地区：[1]中山医科大学孙逸仙纪念医院皮肤科,广州510120 [2]中国人民解放军总医院皮肤科,北京100853 [3]西安医科大学附属第二医院皮肤科,西安710004 [4]中国人民解放军空军总医院皮肤科,北京100036 [5]同济医科大学协和医院皮肤科,武汉430022

出　　处：《中国临床药理学杂志》2001年第3期175-177,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的：评价１％喷昔洛韦软膏治疗颜面单纯疱疹的临床疗效和安全性，并与３％阿昔洛韦软膏比较。方法：采用多中心、随机、双育对照方法，患者在皮损出现２４ｈ内开始局部外用１％喷昔洛韦软膏（试验组）或３％阿昔洛韦软膏（对照组），一日５次，疗程对。结果：统计的有效病例为２１５例，其中试验组１０７例，对照组１０８例。试验组的止疱时间和全部结痂时间分别为１．６±１．１ｄ和４．４±１．３ｄ，对照组分别为１．９±１．０ｄ和４．９±１．４ｄ，两组比较均有显著性差异（Ｐ＜０．０５）。在７ｄ的治疗期内，试验组和对照组的痊愈例数分别为９３例和８４例，两组的痊愈率比较无显著性差异（Ｐ＞０．０５）。试验组和对照组的痊愈时间分别为５．７±１．３ｄ和６．４±１．２ｄ，两组比较有显著性差异（Ｐ＜０．０５）。试验组有２例、对照组有３例出现轻微的局部药物不良反应，两组比较无差异（Ｐ＞０．０５）。结论：与３％阿昔洛韦软膏相比，１％喷昔洛韦软膏治疗颜面单纯疱疹能够使皮损较快消退，缩短病程，是一种安全有较的外用药物。OBJECTIVE.. To evaluate the efficacy and safety of l% penciclovir cream in the treatment of herpes simplex facialis by comparing with 3% acyclovir cream. METHODS.. In this multicenter, randomized, double-blind controlled clinical trial, treatment was initiated within 24 hours of development of lesions. Patients applied topically either l% penciclovir cream (test group) or 3% acyclovir cream (control group) five times daily for 7 days. RESULTS: 215 patients with herpes simplex facialis were enrolled, of which 107 cases were in the test group, 108 in the control group. The mean time to the cessation of new vesicle and the mean time to complete crusting in test group were l.6 1.1 days and 4.4 l.3 days respectively, and in control group 1.9 l.0 days and 4.9 l.4 days respectively; there were significant differences between two groups(P<0.05). Within a 7-day treatment, 93 cases in test group and 84 cases in control group were cured; there was no statistical difference in the cure rates between two groups (M.05).The mean bine to cure was 5.7 1.3 days in test group and 6.4 l.2 days in control group with significant difference(P<0.05). The incidence of adverse events in two groups was mild and rare, and the occurrence rates of those were not statistical difference between two groups (P>0.05). CONCLUSIONS: Compared with 3% acyclovir cream, 1% penciclovir cream for the treatment of herpes simplex facialis can decrease the time of lesion healing and shorten the course of disease. It is an effective and safe topical agent.

关 键 词：喷昔洛韦 单纯疱疹 局部治疗 临床试验 

分 类 号：R752.11[医药卫生—皮肤病学与性病学]