中华皮肤科杂志

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不同剂量和疗程伐昔洛韦治疗复发性生殖器疱疹的随机双盲研究

周村建1, 王莉1, 饶贤才2, 郭在培3, 涂亚庭4, 卢念祖5, 郝飞1   

  1. 1. 第三军医大学西南医院皮肤科, 重庆400038;
    2. 第三军医大学微生物学教研室;
    3. 四川大学华西医院皮肤科;
    4. 华中科技大学同济医学院附属协和医院皮肤科;
    5. 中山大学附属第一医院皮肤科
  • 收稿日期:2006-09-19 出版日期:2007-05-15 发布日期:2007-05-15
  • 通讯作者: 郝飞,email:haofei@mail.tmmu.com.cn E-mail:haofei@mail.tmmu.com.cn

Different doses and courses of valaciclovir for the treatment of recurrent genital herpes:a multi-center randomized double-blind comparative clinical trial

ZHOU Cun-jian1, WANG Li1, RAO Xian-cai2, GUO Zai-pei3, TU Ya-ting4, LU Nian-zu5, HAO Fei1   

  1. Department of Dermatology, Southwest Hospital, Third Military Medical University, Chongqing 400038, China
  • Received:2006-09-19 Online:2007-05-15 Published:2007-05-15

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摘要： 目的 比较不同剂量和疗程伐昔洛韦治疗复发性生殖器疱疹的疗效和安全性。方法 选择复发性生殖器疱疹为研究对象,采用多中心、随机、双盲、对照临床研究。试验组伐昔洛韦每天2次,每次500 mg,口服5天,对照组伐旨洛韦每天2次,每次300 mg,口服7天。分别于用药前及用药后第1天、第2天取疱液或创面分泌物行疱疹病毒细胞培养,并于用药后第1、2、7天随访观察疗效和不良反应。结果 入组142例,全分析集(FAS)分析142例,符合方案集(PPS)分析133例。治疗后第1、2、7天,试验组和对照组的症状体征积分下降值及有效率比较差异均无统计学意义(P>0.05)。FAS集分析单纯疱疹病毒(HSV)的培养阳性率,治疗后第1天试验组由87.50%下降到28.85%,对照组由92.86%下降到54.55%,两组间差异有统计学意义(P=0.007)。PPS集分析HSV的培养阳性率,治疗后第1天试验组由90.00%下降到28.00%,对照组由92.59%下降到55.56%,两组比较差异有统计学意义(P=0.005)。试验组和对照组不良反应发生率分别为0%和4.23%。结论 加大伐昔洛韦用量治疗复发性生殖器疱疹能显著提高治疗后第1天HSV的清除率,缩短HSV在皮损局部的存在时间。

关键词: 疱疹, 生殖器, 随机对照试验, 伐昔洛韦

Abstract: Objective To investigate and compare the effect and safety of different doses and courses of oral valaciclovir in the treatment of recurrent genital herpes.Methods A multi-center, randomized and double-blind comparative clinical trial was conducted.Patients with recurrent genital herpes were divided into either study group(valaciclovir 500mg twice daily orally for 5 days)or control group (valaciclovir 300mg twice daily orally for 7 days).Vesicle fluid or discharge under crusts was collected from the patients' lesions for HSV culture before treatment and 1,2 days after starting treatment.Patients were observed for therapeutic efficacy and side effects on 1,2,and 7 days after the treatment.Results One hundred and forty two patients were enrolled in this study.Of them,142 were evaluated for safety and 133 for therapeutic effects at the end of the study.No significant difference was observed in the decrease of sign and symptom score or response rate on 1,2,7 days after the treatment(both P>0.05).According to full analysis set(FAS)analysis,the positive rates of HSV culture decreased from 87.50%(before treatment) to 28.85%(1 day after the treatment) and from 92.86% to 54.55% in study and control group, respectively,and there was significant difference in the positive rates of 1 day after the treatment between the two groups(P<0.05).Significant difference was also found using particles per set(PPS)analysis in the positive rates of 1 day after the treatment between the two groups(P<0.05).The occurrence rates of side effects were 0 and 4.23% in the study and control group,respectively.The most common side effects were discomfort in stomach,dizziness and drowsiness.Conclusions The increase in valaciclovir dose could significantly improve the clearance rate of HSV on 1 day after the treatment,and shorten the retention of herpes virus in local lesions during the treatment of recurrent genital herpes.

Key words: Herpes genitalis, Randomized controlled trials, Valaciclovir