Tyring S K, Douglas J M, Corey L, Spruance S L, Esmann J
Department of Dermatology, University of Texas Medical Branch, Galveston, USA.
Arch Dermatol. 1998 Feb;134(2):185-91. doi: 10.1001/archderm.134.2.185.
To compare valacyclovir hydrochloride with acyclovir in the treatment of recurrent genital herpes infection.
A multicenter, double-blind, placebo-controlled, randomized, parallel-design study.
University clinics (dermatology, gynecology, and infectious diseases) and private practices.
One thousand two hundred patients with recurrent genital herpes simplex infections.
Patients self-initiated oral therapy with 1000 mg of valacyclovir hydrochloride twice daily, 200 mg of acyclovir 5 times daily, or placebo for 5 days.
Resolution of all signs and symptoms of recurrent genital herpes infection.
Both drugs were significantly more effective than placebo in speeding resolution of herpetic episodes (median duration, 4.8, 4.8, and 5.9 days, respectively); the hazards ratios for valacyclovir and acyclovir vs placebo were 1.66 (95% confidence interval [CI], 1.38-2.01) and 1.71 (95% CI, 1.41-2.06) (both P < .001). Similarly, valacyclovir and acyclovir significantly hastened lesion healing (hazards ratios vs placebo were 1.88 [95% CI, 1.53-2.32] and 1.90 [95% CI, 1.55-2.34], respectively; P < .001). Pain duration was shorter in valacyclovir- and acyclovir-treated patients (median, 2 vs 3 days). Viral shedding stopped 2.55 times faster in patients treated with valacyclovir and 2.24 times faster in patients treated with acyclovir than in patients treated with placebo. Aborted episodes, in which lesions did not progress beyond the macule or papule stage, tended to occur in more patients treated with valacyclovir (25.9%) or acyclovir (24.8%) than in patients treated with placebo (19.8%). Valacyclovir and acyclovir did not differ significantly with regard to their respective effects on any of the above efficacy parameters. The nature, severity, and frequency of adverse events did not differ among the 3 treatment groups.
Twice-daily valacyclovir was as effective and well tolerated in the treatment of recurrent genital herpes simplex virus infection as 5-times-daily acyclovir. Therefore, valacyclovir could prove a useful alternative to acyclovir when convenience of dosing or compliance issues are the prime considerations in treatment.
比较盐酸伐昔洛韦与阿昔洛韦治疗复发性生殖器疱疹感染的效果。
一项多中心、双盲、安慰剂对照、随机、平行设计的研究。
大学诊所（皮肤科、妇科和传染病科）及私人诊所。
1200例复发性单纯疱疹病毒生殖器感染患者。
患者自行开始口服治疗，盐酸伐昔洛韦1000毫克，每日两次；阿昔洛韦200毫克，每日5次；或安慰剂，疗程均为5天。
复发性生殖器疱疹感染的所有体征和症状消失。
两种药物在加速疱疹发作消退方面均显著优于安慰剂（中位持续时间分别为4.8天、4.8天和5.9天）；伐昔洛韦和阿昔洛韦相对于安慰剂的风险比分别为1.66（95%置信区间[CI]，1.38 - 2.01）和1.71（95%CI，1.41 - 2.06）（均P <.001）。同样，伐昔洛韦和阿昔洛韦显著加速了皮损愈合（相对于安慰剂的风险比分别为1.88[95%CI，1.53 - 2.32]和1.90[95%CI，1.55 - 2.34]；P <.001）。伐昔洛韦和阿昔洛韦治疗的患者疼痛持续时间较短（中位时间分别为2天和3天）。伐昔洛韦治疗的患者病毒排出停止速度比安慰剂组快2.55倍，阿昔洛韦治疗的患者比安慰剂组快2.24倍。皮损未进展至斑疹或丘疹阶段以上的中止发作，在接受伐昔洛韦（25.9%）或阿昔洛韦（24.8%）治疗的患者中比接受安慰剂治疗的患者（19.8%）更易出现。伐昔洛韦和阿昔洛韦在上述任何疗效参数上的各自效果无显著差异。3个治疗组不良事件的性质、严重程度和发生率无差异。
每日两次服用伐昔洛韦在治疗复发性单纯疱疹病毒生殖器感染方面与每日5次服用阿昔洛韦效果相同且耐受性良好。因此，当给药便利性或依从性问题是治疗的主要考虑因素时，伐昔洛韦可能是阿昔洛韦的一个有用替代药物。
