Brocklehurst P, Kinghorn G, Carney O, Helsen K, Ross E, Ellis E, Shen R, Cowan F, Mindel A
Academic Department of Genitourinary Medicine, UCL Medical School, London.
Br J Obstet Gynaecol. 1998 Mar;105(3):275-80. doi: 10.1111/j.1471-0528.1998.tb10086.x.
To evaluate the efficacy and safety of a suppressive course of acyclovir in late pregnancy in women with recurrent genital herpes infection on the incidence of viral shedding, herpes lesion development and caesarean section for recurrent genital herpes.
Double-blind, randomised placebo controlled clinical trial.
A department of genitourinary medicine in Sheffield and an antenatal clinic in London.
Pregnant women with recurrent genital herpes infection at < 36 weeks of gestation.
Participating women were given acyclovir 200 mg four times a day (or matching placebo) from 36 weeks of gestation until the time of delivery. Women were seen weekly and viral cultures were obtained from the cervix and vulva. Decisions regarding mode of delivery were left to the discretion of the attending obstetrician.
Delivery by caesarean section for recurrent genital herpes infection. Number of episodes of recurrent genital herpes infection and number of episodes of asymptomatic viral shedding during the treatment period. In addition blood was taken at two weekly intervals to determine acyclovir levels.
The total number of women recruited was 63 (31 received acyclovir and 32 received placebo). The number of women undergoing delivery by caesarean section for recurrent herpes at the time of delivery was 12 (19%). The odds ratio for delivery by caesarean section in women taking acyclovir, compared with those taking placebo, was 0.44 (95% CI 0.09-1.59). The odds ratio for clinical recurrences during treatment was 0.10 (95% confidence interval 0.00-0.86) and the odds ratio for clinical recurrence or asymptomatic shedding during treatment was 0.32 (95% CI 0.05-1.56).
This trial was unable to demonstrate that acyclovir can significantly decrease the number of caesarean section deliveries; however, the number of clinical recurrences was significantly reduced. Two episodes of asymptomatic virus shedding both occurred in women taking acyclovir. At the present time there is little evidence to suggest that acyclovir should be used outside randomised controlled trials for the suppression of recurrent genital herpes infection during pregnancy.
评估妊娠晚期接受阿昔洛韦抑制性疗程治疗的复发性生殖器疱疹感染女性，其病毒排出、疱疹病变发展及因复发性生殖器疱疹行剖宫产的发生率，以评价阿昔洛韦的疗效和安全性。
双盲、随机、安慰剂对照临床试验。
谢菲尔德的泌尿生殖医学科和伦敦的产前诊所。
妊娠<36周的复发性生殖器疱疹感染孕妇。
参与研究的女性从妊娠36周起至分娩时，每天4次服用200mg阿昔洛韦（或匹配的安慰剂）。每周对女性进行检查，并从宫颈和外阴获取病毒培养样本。分娩方式由主治产科医生决定。
因复发性生殖器疱疹感染行剖宫产分娩。治疗期间复发性生殖器疱疹感染发作次数及无症状病毒排出发作次数。此外，每隔一周采血以测定阿昔洛韦水平。
共招募63名女性（31名接受阿昔洛韦，32名接受安慰剂）。分娩时因复发性疱疹行剖宫产的女性有12名（19%）。服用阿昔洛韦的女性与服用安慰剂的女性相比，剖宫产分娩的比值比为0.44（95%可信区间0.09 - 1.59）。治疗期间临床复发的比值比为0.10（95%置信区间0.00 - 0.86），治疗期间临床复发或无症状排出的比值比为0.32（95%可信区间0.05 - 1.56）。
本试验未能证明阿昔洛韦能显著减少剖宫产分娩的数量；然而，临床复发次数显著减少。两次无症状病毒排出均发生在服用阿昔洛韦的女性中。目前几乎没有证据表明在随机对照试验之外，阿昔洛韦应用于孕期抑制复发性生殖器疱疹感染是合理的。
