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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。
Objective To compare the efficacy and safety of valacyclovir in treatment of recurrent genital herpes with different dosage and duration of treatment. Methods Reproductive genital herpes was selected as the research object, and a multicenter, randomized, double-blind, controlled clinical study was conducted. The experimental group valacyclovir 2 times a day, each 500 mg, orally for 5 days, the control group varenicline 2 times a day, each 300 mg, orally for 7 days. Blister fluid or wound secretions were collected and herpes virus was cultured on the first day and the second day after treatment. The curative effect and adverse reactions were observed on the 1st, 2nd, 7th day after treatment. Results A total of 142 patients were enrolled in this study. 142 patients were analyzed by FAS and 133 patients were eligible for PPS. On the 1st, 2nd and 7th day after treatment, there was no significant difference between the experimental group and the control group (P> 0.05). FAS set was used to analyze the positive rate of herpes simplex virus (HSV) culture. From the first day after treatment, the test group decreased from 87.50% to 28.85%, while the control group decreased from 92.86% to 54.55%. There was significant difference between the two groups (P = 0.007). PPS set positive HSV culture analysis of the first day after treatment, the experimental group decreased from 90.00% to 28.00%, the control group decreased from 92.59% to 55.56%, the difference between the two groups was statistically significant (P = 0.005). Adverse reactions in trial and control groups were 0% and 4.23%, respectively. Conclusion Increasing the dosage of valacyclovir in the treatment of recurrent genital herpes can significantly improve the clearance rate of HSV on the first day after treatment and shorten the existence time of HSV in the local lesion.