文献简介

出版社:Clinical Infectious Diseases: An Official Publication Of The Infectious Diseases Society Of America

作  者:Sacks SL ; Aoki FY ; Martel AY ; Shafran SD ; Lassonde M

编  号:

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年  份:2005   点击量:825

文献摘要

Background. Famciclovir, the oral prodrug of penciclovir, is effective for the treatment of recurrent genital herpes. This randomized, clinic-initiated, double-blind trial compared the therapeutic efficacy and safety of treatment with famciclovir at dosages of 125 mg, 250 mg, and 500 mg twice daily for 5 days with placebo in immunocompetent adults with a recurrent episode of genital herpes.

研究背景:泛昔洛韦(喷昔洛韦口服前体药物)能有效治疗复发性生殖器疱疹。这项随机的、由临床发起的、双盲实验旨在研究,应用泛昔洛韦(剂量为125mg250mg500mg2/日,持续治疗5日)与安慰剂对照相比,治疗伴有复发性生殖器疱疹的免疫功能正常患者的有效性与安全性。

Methods. Efficacy and tolerability were assessed in 308 patients with lesions present for no more than 6.5 h at the time of the first dose. Two assessments per day were performed to increase the precision of the determination of study end points.

研究方法:对首次给予剂量在不超过6.5h内出现皮损的308例患者进行有效性和耐受性的评估。每日进行2次评估来确定研究终点的精准度。

Results. All doses of famciclovir were significantly more effective than placebo in reducing the time to cessation of viral shedding, complete lesion healing, and loss of all lesion-associated symptoms, particularly lesion tenderness, pain, and itching. Patients receiving treatment with famciclovir were significantly less likely to experience new lesions than were patients receiving placebo. All doses of famciclovir were tolerated as well as placebo was. There was no difference in efficacy or tolerability among the different doses of famciclovir; the lowest effective dose was 125 mg twice per day.

研究结果:与安慰剂对照相比,服用泛昔洛韦能更显著有效缩短病毒停止排出时间、皮损愈合、以及所有皮损相关症状,特别是病变压痛、疼痛和瘙痒的消失。接受泛昔洛韦治疗的患者发生新的皮损病变的可能性明显小于安慰剂对照组。每种剂量的泛昔洛韦所表现出的耐受性同安慰剂对照组一致。不同剂量的泛昔洛韦其疗效或耐受性之间没有显着差异;最低有效剂量为125毫克(2/日)。

Conclusions. In immunocompetent adults with recurrent genital herpes, a 5-day course of famciclovir at a dosage of 125 mg, 250 mg, or 500 mg twice per day was significantly more effective than was placebo in reducing the duration of viral shedding and symptoms and in accelerating lesion healing. These results support the use of treatment with famciclovir at a dosage of 125 mg for 5 days as an effective, well-tolerated treatment for episodes of recurrent genital herpes.

研究结论:对患有复发性生殖器疱疹的免疫功能正常的患者应用泛昔洛韦(剂量为125mg250mg500mg2/日,连续5日)进行治疗,其疗效与安慰剂对照组相比,在减少病毒排出以及症状持续时间,加速皮损愈合方面,泛昔洛韦显示出了更好的疗效。这些实验结果表明应用泛昔洛韦125mg/剂量,持续5日)治疗复发性生殖器疱疹发作是有效的并且耐受性良好。

 

 

Stephen L. Sacks et.alClinical Infectious Diseases: An Official Publication Of The Infectious Diseases Society Of America2005 Oct 15Vol. 41 (8), pp. 1097-104.