Safety and efficacy of 0.5% podofilox gel in the treatment of anogenital warts

被引:64
作者
Tyring, S
Edwards, L
Cherry, LK
Ramsdell, WM
Kotner, S
Greenberg, MD
Vance, JC
Barnum, G
Dromgoole, SH
Killey, FP
Toter, T
机构
[1] Univ Texas, Med Branch, Dept Dermatol, Galveston, TX 77555 USA
[2] Univ Texas, Med Branch, Dept Microbiol & Immunol, Galveston, TX 77555 USA
[3] Ctr Clin Studies, Nassau Bay, TX USA
[4] Carolinas Med Ctr, Dept Dermatol, Charlotte, NC 28203 USA
[5] Brown Univ, Providence, RI 02912 USA
[6] VRG Int, San Diego, CA USA
[7] Grad Hosp Philadelphia, Dept Obstet & Gynecol, Philadelphia, PA 19146 USA
[8] Hennepin Med Ctr, Dept Dermatol, Minneapolis, MN USA
[9] Univ Washington, Dept Internal Med, Seattle, WA 98195 USA
[10] Oclassen Pharmaceut Inc, San Rafael, CA USA
关键词
D O I
10.1001/archderm.134.1.33
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Objective: To determine the safety and efficacy of a new gel formulation of podofilox in the treatment of anogenital warts. Design: Double-blind, randomized, multicenter, vehicle-controlled investigation. Setting: Private dermatology practices, university clinics (dermatology, gynecology, and infectious diseases), and contract research organizations. Patients: Three hundred twenty-six patients with anogenital warts. Main Outcome Measure: Number of patients with clearing of all treated warts (treatment success). Results: The 0.5% podofilox gel was significantly better than vehicle gel for successfully eliminating and reducing the number and size of anogenital warts. In the intent-to-treat population, 62 (37.1%) of 167 patients treated with 0.5% podofilox gel had complete clearing of the treated areas (treatment successes) compared with 2 (2.3%) of 86 patients who had clearing of warts with the vehicle gel (P<.001) after 4 weeks. Nineteen additional patients treated with 0.5% podofilox gel and 2 patients treated with vehicle gel had clearing of warts with continued treatment up to 8 weeks. After 8 weeks, 35.9% of the baseline anogenital warts treated with 0.5% podofilox gel remained; this was significantly fewer than in the vehicle-treated group (88.4% of the baseline number) (P=.001). The 0.5% podofilox gel was generally well tolerated, with predominantly mild or moderate local adverse reactions occurring in the majority of patients. Only 7 patients (3.2%), all receiving 0.5% podofilox gel, discontinued study treatment because of drug-related local reactions. Conclusions: The results demonstrated that 0.5% podofilox gel is safe and significantly more effective than vehicle gel in the treatment of anogenital warts.
引用
收藏
页码:33 / 38
页数:6
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