泛昔洛韦治疗带状疱疹的Ⅱ期临床试验  

Phase Ⅱ Clinical Trial of Famciclovirin Treatment for Herpes Zoster

作　　者：林宝珠[1] 曾凡钦[1] 毛越苹[1] 卞宗沛[2] 徐慧珍[2] 郑岳臣[3] 曾敬思 

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]上海第二医科大学瑞金医院皮肤科,上海200025 [3]武汉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》2000年第3期176-178,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：本临床研究采用多中心、随机、对照试验，评价泛昔洛韦治疗带状疱疹的疗效和安全性，以阿普洛韦作对照。泛昔洛韦治疗131例，阿昔洛韦治疗129例，共260例。研究结果为泛昔洛韦的止疱时间是2.82±1．76d,阿昔洛韦是4．01±2．8d;两组结痴时间分别是5．12±2．84d和6．06±2．74d；脱痴时间是1148±3．87d和13.29±3．65d；疼痛缓解时间是4．31±2.47d和6．6.71±4．33d；急性神经痛持续时间是9．15±3．94d和12．19±4．25d；疱疹后神经痛的发生，泛普洛韦是44／31（3．59％），阿昔洛韦是26／29（58．91％）。经统计学处理，两组间有显著性差异（P＜0.01）；泛昔洛韦在促进皮疹消退和缩短急性神经痛的时间方面比阿普洛韦更优越，且大大降低了后遗神经痛的发生率。两组药物不良反应的发生率分别是8．40％和6．98％（P＞0．05），两药对血液系统，肝、肾功能均无明显的影响。所有的临床资料证明，泛昔洛韦治疗带状疱疹疗效高，且耐受性好。This study conducted a randomized controlled-multicenter clinical trial, toevaluate the effcacy and safty of famciclovir in the treatment of herpes zoster.Acyclovir was chosen as the control. There were l3l cases in famciclovir group and129 cases in acyclovir group, total 260 cases. The results: the time to stop vesiculationwere 2.82±1.76 (d) for patients receiving famciclovir and 4.01± 2.48 (d) forpatients receiving acyclovir.The time to full crusting of famciclovir and acyclovirwere 5.12±2.84 (d) and 6.06± 2.74 (d), the time to lose crusts were 11.48±3.87(d) and 13.29±3.65 (d) respectively. The time to relief acute-phase pain were 4.31±2.47 (d) of famciclovir vs. 6.67±4.33 (d) of acyclovir.The times topersistenceof acute-phase pain of famciclovir were 9.15± 3.94 (d) vs. 12.19± 4.25 (d) ofacyclovir.Of the 131 famciclovir group, 44(33.59%) developed posteherpetic neuralgia,of the 129 acyclovir group, 76 (58.91%). There was a statistical significant differencebetween the two groups (P<0.01). The adverse drug reactions of the two groups were8.40% and 6.98% (P<0.05), the blood system, liver and kidney function with obviousinfluence. Available clinical data indicated that famciclovir is an effective and easilytolerated agent for treatment of herpes zoster.

关 键 词：泛昔洛韦 带状疱疹 临床试验 疗效 安全性 

分 类 号：R752.12[医药卫生—皮肤病学与性病学] R969[医药卫生—临床医学]