【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。更多还原

【Abstract】 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.更多还原