Bonnez W, Elswick R K, Bailey-Farchione A, Hallahan D, Bell R, Isenberg R, Stoler M H, Reichman R C
Department of Medicine, University of Rochester School of Medicine and Dentistry, New York.
Am J Med. 1994 May;96(5):420-5. doi: 10.1016/0002-9343(94)90168-6.
For the patient-administered treatment of anogenital warts, 0.5% podofilox (podophyllotoxin), one of the active compounds of podophyllin, has been shown to be more effective than the vehicle alone. This study was designed to evaluate the safety and efficacy of 0.5% podofilox treatment followed by prophylaxis.
A total of 103 patients were entered in stage 1 of the study. Stage 1 was an open label study, and patients self-administered 0.5% podofilox twice daily for 3 consecutive days per week for 4 weeks. A total of 100 patients remained available for efficacy and safety analyses. At the end of stage 1, patients who had a complete response proceeded to stage 2 of the study. Patients who had a 50% to 99% reduction in measured total wart area were offered cryotherapy every 10 days, up to 5 times. If cleared of warts, they were also entered into stage 2. A total of 57 patients were enrolled into stage 2, a double-blind, randomized, placebo-controlled prophylactic study of 0.5% podofilox self-administered once daily for 3 days per week for 8 weeks, on the sites of healed warts. A total of 45 patients in stage 2 were available for efficacy analysis.
By the end of stage 1, 68% of the warts had disappeared, and 29 of 100 patients (29%) had a complete response. A total of 49 patients had a 50% or greater improvement in wart area and underwent cryotherapy. Rates of local side effects after 1 week of treatment were 57% for inflammation, 39% for erosion, 47% for pain, 48% for burning, and 44% for itching. However, these symptoms and signs were mostly mild to moderate in intensity and diminished over time. Therefore, overall treatment was well tolerated. In stage 2, only 4 of 21 patients (19%) in the podofilox group experienced a recurrence as opposed to 12 of 24 (50%) in the placebo group (P = 0.031). As in stage 1, the side effects were modest, and the drug was well tolerated.
This study confirms the efficacy and good tolerance of 0.5% podofilox in the treatment of anogenital warts. It also establishes the safety and superior efficacy of patient-administered podofilox over the vehicle alone as prophylaxis against recurrence of lesions. Although long-term efficacy and tolerance remain to be established, podofilox appears to be a useful agent in the control of this disease.
对于患者自行给药治疗肛门生殖器疣，0.5%鬼臼毒素（鬼臼树脂的活性成分之一）已被证明比单独使用赋形剂更有效。本研究旨在评估0.5%鬼臼毒素治疗后进行预防的安全性和有效性。
共有103名患者进入研究的第1阶段。第1阶段是一项开放标签研究，患者每周连续3天每天自行涂抹0.5%鬼臼毒素两次，共4周。共有100名患者可进行疗效和安全性分析。在第1阶段结束时，完全缓解的患者进入研究的第2阶段。疣体总面积减少50%至99%的患者每10天接受一次冷冻治疗，最多5次。如果疣体清除，他们也进入第2阶段。共有57名患者进入第2阶段，这是一项双盲、随机、安慰剂对照的预防性研究，在疣体愈合部位每周3天每天自行涂抹0.5%鬼臼毒素一次，共8周。第2阶段共有45名患者可进行疗效分析。
在第1阶段结束时，68%的疣体消失，100名患者中有29名（29%）完全缓解。共有49名患者疣体面积改善50%或更多并接受了冷冻治疗。治疗1周后的局部副作用发生率为：炎症57%、糜烂39%、疼痛47%、灼痛48%、瘙痒44%。然而，这些症状和体征大多为轻至中度，且会随时间减轻。因此，总体治疗耐受性良好。在第2阶段，鬼臼毒素组21名患者中只有4名（19%）复发，而安慰剂组24名患者中有12名（50%）复发（P = 0.031）。与第1阶段一样，副作用较小，药物耐受性良好。
本研究证实了0.5%鬼臼毒素治疗肛门生殖器疣的有效性和良好耐受性。它还确立了患者自行给药的鬼臼毒素在预防病变复发方面比单独使用赋形剂更安全且疗效更佳。尽管长期疗效和耐受性仍有待确定，但鬼臼毒素似乎是控制这种疾病的一种有用药物。
