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泛昔洛韦对女性无症状和有症状复发性肛门生殖器单纯疱疹病毒脱落的抑制作用:一项随机、双盲、双模拟、安慰剂对照、平行组、单中心试验。

Famciclovir suppression of asymptomatic and symptomatic recurrent anogenital herpes simplex virus shedding in women: a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single-center trial.

作者信息

Sacks Stephen L

机构信息

Department of Pharmacology and Therapeutics, Faculty of Medicine, University of British Columbia, and Viridae Clinical Sciences, Vancouver, British Columbia, Canada.

出版信息

J Infect Dis. 2004 Apr 15;189(8):1341-7. doi: 10.1086/383038. Epub 2004 Apr 5.

DOI:10.1086/383038
PMID:15073669
Abstract

Genital herpes is most often transmitted while the patient is asymptomatic, presumably during episodes of viral shedding. To determine whether famciclovir is effective in reducing asymptomatic shedding, women with frequent, recurrent genital outbreaks were enrolled in a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 112-day trial of suppressive treatment with famciclovir for anogenital viral shedding. Sixty women received 125 mg of famciclovir 3 times daily, 59 received 250 mg of famciclovir 3 times daily, and 58 received placebo. Patients recorded symptoms and self-obtained cultures daily. Famciclovir reduced asymptomatic shedding, compared with placebo (P < .0001). The onset of asymptomatic shedding was also delayed (P < .0001). Famciclovir reduced symptomatic shedding in a dose-dependent manner (0.72% for 125 mg 3 times daily vs. 0.19% for 250 mg 3 times daily [P < .0001] vs. 5.53% for placebo [P < .0001]). In conclusion, suppressive treatment with famciclovir reduced both asymptomatic and symptomatic viral shedding and delayed the onset of asymptomatic shedding in women with frequently recurring genital herpes. Studies to examine the effects of suppression by famciclovir on the transmission of genital herpes are warranted.

摘要

生殖器疱疹通常在患者无症状时传播,推测是在病毒脱落发作期间。为了确定泛昔洛韦是否能有效减少无症状病毒脱落,频繁复发生殖器疱疹发作的女性被纳入一项为期112天的随机、双盲、双模拟、安慰剂对照、平行组试验,采用泛昔洛韦进行抑制性治疗以减少肛门生殖器病毒脱落。60名女性每日3次服用125毫克泛昔洛韦,59名女性每日3次服用250毫克泛昔洛韦,58名女性服用安慰剂。患者每天记录症状并自行采集培养样本。与安慰剂相比,泛昔洛韦减少了无症状病毒脱落(P < .0001)。无症状病毒脱落的发作也延迟了(P < .0001)。泛昔洛韦以剂量依赖方式减少有症状病毒脱落(每日3次服用125毫克时为0.72%,每日3次服用250毫克时为0.19% [P < .0001],安慰剂组为5.53% [P < .0001])。总之,泛昔洛韦抑制性治疗减少了无症状和有症状的病毒脱落,并延迟了频繁复发生殖器疱疹女性无症状病毒脱落的发作。有必要开展研究以检验泛昔洛韦抑制治疗对生殖器疱疹传播的影响。

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