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Topical Self-Treatment with 0.15% Podophyllotoxin (Wartec® Cream) for Female Genital Warts

女性生殖器疣的局部Wartec® 軟膏療法

摘要


目的:尖形濕疣(Condyloma acuminata)是最普遍之性傳染病之一傳統療法是由醫師做電燒或為病患塗抹具細胞毒素的podophyllin,但有強烈燒灼及可能致癌等副作用,近年來podophyllin內萃取出之活性成份podophyllotoxin,為一安全、方便及經濟療效佳之居家療法。本試驗研究台灣女性生殖器疣,以podophyllotoxin 0.15%(化疣敵乳膏®/Wartec® Cream)治療之成效與副作用。 材料和方法:共二十位女性因患外陰生殖器疣,同意進入本臨床藥物試驗。此外,尿液需呈陰性懷孕反應、年齡18歲及以上並願意完成本試驗。病人早晚各一次塗抹podophyllotoxin 0.15%於患部,連續使用三天後,停藥四天,此為一治療週期。若持續有未治癒之疣,則重複上述之療程,於第八週作最後評估。病人每週回診,評估其療效及副作用。本研究認定根除的疣為完全反應;數目或大小有減少為部份反應。 結果:二十位病人中,有2人放棄,18人完成試驗。病人平均年齡為35.5歲。其中15人(75 %)為首次感染,5人(25 %)為先前接受電燒治療再次復發。第四週及第八週之治癒率分別為61.1%及88.9%;8人(44.4 % ) 呈現輕微局部之副作用。總合的反應率,包括完全及部份反應為百分百。在6個月的試驗期間內,沒有案例出現復發的病灶。 結論:本試驗顯示podophyllotoxin 0.15%提供台灣婦女一安全又方便之第一線非手術根除外陰生殖器疣的有效居家療法。

並列摘要


Objective: Conventional treatments of genital warts with podophyllin lotion or electrosurgery in females are inconvenient, less cost-effective, and time-consuming, both for physicians and patients. There is definitely a need for a refined, simple, safe, fast, and effective first-line treatment modality. The purpose of this clinical study was to evaluate the suitability, tolerability, and effectiveness of 0.15%podophyllotoxin (Wartec® Cream) on female external genital warts in Taiwan. Material(s) and Method(s): Twenty female patients were enrolled in this 8-week clinical study. They were asked to provide their age, marital status, and previous disease history. The inclusion criteria consisted of those who had a clinical diagnosis of exophytic vulvar condylomata acuminata with dimension, in the range between 4 and 600 mm2, had a negative urine pregnancy test, were aged 18 years or older, and were willing to comply with the treatment schedule. Treatment cycles consisted of weekly intervals whereby the medication was self-applied twice daily for the first 3 days, followed by a 4-day rest period with no application. All patients were examined weekly for treatment efficacy and aftereffects. For the purpose of this study, a complete response was considered when all original warts were eradicated; a partial response was recorded as a reduction in the number and/or size of the original warts. Result(s): In total, 20 patients were recruited for this study; 2 defaulted and 18 completed the study. The age range was 24-62 (median, 35.5) years. Fifteen patients (75%) were first infected, and 5 (25%) were recurrent cases in which electrocauterization had previously been performed. The complete response rate after the 4- and 8-week treatments was 61.1% (11/1 8) and 88.9% (16/18), respectively, and 44.4% (8/18) showed mild local adverse reactions. The overall response rate, including both the complete and partial responses, of the 8-week treatment was 100% (18/1 8). In this study, no recurrence was observed during the 6-month follow-up. Conclusion(s): This study shows that 0.15% podophyllotoxin (Wartec® Cream) is a safe, effective, and convenient first-line home treatment for genital condyloma eradication.

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