泛昔洛韦单日疗法治疗复发性生殖器疱疹的临床对照研究

Single-day famciclovir therapy for recurrent genital herpes: a randomized,controlled clinical trial

目的探讨泛昔洛韦单日疗法治疗复发性生殖器疱疹的疗效及安全性。方法采用随机、对照临床实验,比较泛昔洛韦单日疗法(1 000mg,2次/日,共1日)与传统的阿昔洛韦五日疗法(400mg,3次/日,共5日)的疗效及安全性。结果 136例复发性生殖器疱疹患者参加试验。试验组与对照组疗效比较,皮损愈合时间、症状消退时间、总病愈时间分别为(4.00±0.63)天vs.(3.85±0.90)天(t=1.13,P=0.26),(3.32±0.55)天vs.(3.18±0.77)天(t=1.22,P=0.22),(4.53±0.65)天vs.(4.45±0.95)天(t=0.57,P=0.57)。皮损顿挫比率分别为32.4%vs.26.8%(χ2=0.58,P=0.31),差异均无统计学意义。两种治疗方案不良反应发生率相近(28.0%vs.19.1%)(χ2=0.91,P=0.34),表现以头痛为主。结论泛昔洛韦单日疗法治疗复发性生殖器疱疹有效、安全,运用方便。

Objective To assess the efficacy and safety of single-day regimen of famciclovir for the treatment of episodic recurrent genital herpes（RGH）.Methods A randomized,non-placebo controlled clinical trial was conducted tp compare single-day oral famciclovir regimen（1000 mg twice daily） with traditional acyclovir regimen（400mg three times a day for 5 days） for the treatment of episodic RGH.Results One hundred twenty six adults with a history of recurrent genital herpes were enrolled into the study,No significant difference was found between the single-day famciclovir therapy group and the acyclovir 5-days therapy group in the timing of lesion healing（3.00±0.63 days vs.3.85±0.90 days,t=1.13,P=0.26）,duration of symptomatic remission（3.32±0.55 days vs.3.18±0.77 days,t=1.22,P=0.22）,resolution of all signs and symptoms（4.53±0.63 days vs.4.45±0.95 days,t=0.57,P=0.57）,and the proportion of patients with aborted lesions（32.4% vs.26.8%,x2=0.58,P=0.31）.The overall incidence of adverse events was similar in the two groups（28.0% vs.19.1%,x2=0.91,P=0.34）,with headache as the main side effect.Conclusion Single-day famciclovir therapy was effective and safe,representing a more convenient treatment for patients with recurrent genital herpes.