Penciclovir cream for the treatment of herpes simplex labialis - A randomized, multicenter, double-blind, placebo-controlled trial
Penciclovir cream for the treatment of herpes simplex labialis - A randomized, multicenter, double-blind, placebo-controlled trial
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DOI：
10.1001/jama.277.17.1374
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发表时间：
1997-05-07
影响因子：
120.7
通讯作者：
Boon, R
中科院分区：
文献类型：
--
作者：
Spruance, SL;Rea, TL;Boon, R
客观。-比较局部1%阿昔洛韦乳膏与溶剂对照乳膏（安慰剂）治疗免疫功能正常患者复发性唇疱疹（唇疱疹）的安全性和有效性。随机、双盲、安慰剂对照、患者启动、双组、平行临床试验。患者前瞻性分发研究药物，治疗由患者在复发的第一个体征或症状的1小时内自行启动。美国共有31个门诊诊所，分布在各种环境中，包括私人诊所、公共卫生设施和大学。其他方面健康的个体，有唇单纯疱疹频繁发作史。共有2209名患者入组并给予研究药物，1573名患者开始治疗复发。局部1%阿昔洛韦乳膏或溶剂对照乳膏。受试者连续4天清醒时每2小时进行一次治疗，主要结果指标。病变愈合是主要疗效变量。次要终点包括病变疼痛消失时间和病毒脱落停止时间。与接受赋形剂对照乳膏的患者相比，接受阿昔洛韦治疗的患者典型病变（水疱、溃疡和/或结痂）的愈合快0.7天（中位数，4.8天vs 5.5天;风险比[HR]，1.33; 95%置信区间[CI]，1.18-1.49; P
Objective.-To compare the safety and efficacy of topical 1% penciclovir cream with vehicle control cream (placebo) for the treatment of a recurrent episode of herpes simplex labialis (cold sores) in immunocompetent patients.Design.-Randomized, double-blind, placebo-controlled, patient-initiated, 2-armed, parallel clinical trial. Patients were prospectively dispensed study medication, and treatment was self-initiated by the patient within 1 hour of the first sign or symptom Of a recurrence.Setting.-A total of 31 ambulatory clinics in the United States in a variety of settings, including private practices, public health facilities, and universities.Patients.-Otherwise healthy individuals with a history of frequent episodes of herpes simplex labialis. A total of 2209 patients were enrolled and given study medication, and 1573 initiated treatment for a recurrence.Interventions.-Topical 1% penciclovir cream or vehicle control cream. Subjects applied treatment every 2 hours while awake for 4 consecutive days,Main Outcome Measures.-Lesion healing was the primary efficacy variable. Secondary end points included time to loss of lesion pain and time to cessation of viral shedding.Results.-Healing of classical lesions (vesicles, ulcers, and/or crusts) was 0.7 day faster for penciclovir-treated patients compared with those who received vehicle control cream (median, 4.8 days vs 5.5 days; hazard ratio [HR], 1.33; 95% confidence interval [CI], 1.18-1.49; P