Reitano M, Tyring S, Lang W, Thoming C, Worm A M, Borelli S, Chambers L O, Robinson J M, Corey L
Reitano and Stern Research, New York, USA.
J Infect Dis. 1998 Sep;178(3):603-10. doi: 10.1086/515385.
A randomized, double-blind study of valaciclovir for suppression of recurrent genital herpes was conducted among 1479 immunocompetent patients. Patients were randomized to receive valaciclovir (250 mg, 500 mg, or 1 g once daily, or 250 mg twice daily), acyclovir (400 mg twice daily), or placebo, for 1 year. All valaciclovir dosages were significantly more effective than placebo at preventing or delaying recurrences (P < .0001). There was a dose-response relationship (P < .0001) across the once-daily valaciclovir regimens. Twice-daily valaciclovir and acyclovir were similar in effectiveness. Subgroup analysis showed that patients with a history of < 10 recurrences per year were effectively managed with 500 mg of valaciclovir once daily. One gram of valaciclovir once daily, 250 mg of valaciclovir twice daily, or 400 mg of acyclovir twice daily were more effective in patients with > or = 10 recurrences per year. Safety profiles of all treatments were comparable. Thus, valaciclovir is highly effective and well tolerated for suppression of recurrent genital herpes. Once-daily regimens offer a useful option for patients who require suppressive therapy for management of genital herpes.
对1479名免疫功能正常的患者进行了一项关于伐昔洛韦抑制复发性生殖器疱疹的随机双盲研究。患者被随机分配接受伐昔洛韦（每日一次250毫克、500毫克或1克，或每日两次250毫克）、阿昔洛韦（每日两次400毫克）或安慰剂，治疗1年。在预防或延迟复发方面，所有伐昔洛韦剂量均显著优于安慰剂（P <.0001）。在每日一次的伐昔洛韦治疗方案中存在剂量反应关系（P <.0001）。每日两次的伐昔洛韦和阿昔洛韦疗效相似。亚组分析表明，每年复发次数<10次的患者，每日一次服用500毫克伐昔洛韦可有效控制病情。对于每年复发次数≥10次的患者，每日一次服用1克伐昔洛韦、每日两次服用250毫克伐昔洛韦或每日两次服用400毫克阿昔洛韦更为有效。所有治疗的安全性相当。因此，伐昔洛韦在抑制复发性生殖器疱疹方面非常有效且耐受性良好。对于需要进行抑制性治疗来管理生殖器疱疹的患者，每日一次的治疗方案提供了一个有用的选择。
