Goldberg L H, Kaufman R, Kurtz T O, Conant M A, Eron L J, Batenhorst R L, Boone G S
Department of Dermatology, Baylor College of Medicine, Houston, TX 77030.
Arch Dermatol. 1993 May;129(5):582-7.
This multicenter trial (19 sites) was initiated in 1984 in more than 1100 immunocompetent individuals with a history of frequently recurring genital herpes (mean, > or = 12 episodes per year). The first year of this suppressive therapy trial was placebo controlled, with acyclovir being provided for episodic treatment in both groups. Thereafter, patients were treated with open-label acyclovir suppressive therapy on a long-term basis (400 mg twice daily) to continue to assess its long-term safety and efficacy. Complete data are available on 389 of the 430 patients who began the fifth year of the study.
Patients were seen quarterly for review of diaries and clinical laboratory evaluations. The percentage of patients recurrence free for any 3-month quarter of the fifth year ranged from 86% to 90%. The mean annual number of recurrences per patient declined from 1.7 during the first year to 0.8 during the fifth year of suppressive therapy. The frequency of false prodromes has also decreased over time. More than 20% of the patients receiving suppressive therapy for 5 years have been recurrence free the entire time. The duration of herpetic outbreaks during suppressive therapy has not changed.
This study extends the safety and efficacy profile of oral acyclovir in the suppression of genital herpes to 5 years. The majority of the patients were recurrence free on an annual basis during suppressive therapy. Therapy was well tolerated. Acyclovir usage was not associated with serious side effects or cumulative toxicity.
这项多中心试验（19个地点）于1984年启动，涉及1100多名有复发性生殖器疱疹病史（平均每年发作≥12次）的免疫功能正常个体。在这项抑制性治疗试验的第一年，采用安慰剂对照，两组均提供阿昔洛韦用于发作期治疗。此后，患者长期接受开放标签的阿昔洛韦抑制性治疗（每日两次，每次400毫克），以继续评估其长期安全性和疗效。在开始研究第五年的430名患者中，有389名患者的完整数据可用。
每季度对患者进行随访，审查日记并进行临床实验室评估。在第五年的任何一个3个月季度中无复发的患者百分比在86%至90%之间。每位患者每年的平均复发次数从抑制性治疗第一年的1.7次降至第五年的0.8次。随着时间的推移，假前驱症状的频率也有所下降。接受抑制性治疗5年的患者中，超过20%的患者在整个期间都没有复发。抑制性治疗期间疱疹发作的持续时间没有变化。
本研究将口服阿昔洛韦抑制生殖器疱疹的安全性和疗效记录延长至5年。在抑制性治疗期间，大多数患者每年无复发。治疗耐受性良好。使用阿昔洛韦未出现严重副作用或累积毒性。
