From the Skin Research Center, Shahid Beheshti University of Medical Sciences.
Department of Pharmacology, School of Medicine, Iran University of Medical Sciences.
Sex Transm Dis. 2020 May;47(5):338-343. doi: 10.1097/OLQ.0000000000001165.
Anogenital warts (AGWs) are a common therapeutic challenge. All therapies are associated with burning, pain, and frustrating high rate of recurrence. The search for a new alternative continues. Recently, a diterpene ester extracted from the Euphorbia peplus plant (ingenol mebutate [IM]) has been shown to possess activity against AGWs.
This study aimed to compare and evaluate the therapeutic efficacy and safety of topical 0.05% ingenol gel with another herbal extract medication (topical 25% podophyllin solution) in treatment of AGWs.
This was a comparative single blinded nonrandomized, 2-arm trial of ingenol 0.05% gel versus podophyllin solution 25% administered up to 6 times to patients with AGWs. To evaluate the therapeutic efficacy, the complete clearance rate and recurrence rate were assessed 1 and 12 weeks after last treatment, respectively. Safety was assessed by occurrence and severity of pain and local skin reaction (LSR).
Of 31 and 36 patients in the IM group and podophyllin group who completed the study, initial complete resolution was observed in 20 (64.5%) and 14 (38.9%) patients, respectively (P = 0.03). The initial clearance was faster in the IM group (2.00 ± 0.91 weeks) compared with the podophyllin group (4.21 ± 1.05 weeks, P = 0.00). After 3 months, recurrence was seen in 13 (65.0%) of 20 patients in the IM group and 6 (42.8%) of 14 in the podophyllin group (P = 0.20). The number of patients with complete resolution after 3 months was not different between the 2 groups (7/31 in the IM group and 8/36 in the podophyllin group, P = 0.97). The mean ± SD severity scores for LSR and pain in the IM group were 6.65 ± 1.76 and 6.13 ± 2.57, respectively, which was significantly higher than their scores (3.39 ± 1.57 and 2.58 ± 1.38) in the podophyllin group (P = 0.00).
Ingenol mebutate 0.05% gel is effective as podophyllin 25% solution in treating AGWs, with further benefit of being much more rapid. However, high recurrence rate, sever pain, and LSR limit its use.
肛门生殖器疣（AGWs）是一种常见的治疗挑战。所有疗法都伴有烧灼感、疼痛，并令人沮丧地具有高复发率。人们仍在寻找新的替代疗法。最近，从 Euphorbia peplus 植物中提取的二萜酯（ ingenol mebutate [IM]）已被证明对 AGWs 具有活性。
本研究旨在比较和评估局部使用 0.05% ingenol 凝胶与另一种草药提取物药物（局部 25%鬼臼毒素溶液）治疗 AGWs 的疗效和安全性。
这是一项比较研究，采用单盲、非随机、2 臂试验，将 ingenol 0.05%凝胶与 podophyllin 溶液 25%分别用于 31 例和 36 例 AGWs 患者，最多治疗 6 次。为评估治疗效果，分别在末次治疗后 1 周和 12 周评估完全清除率和复发率。通过疼痛和局部皮肤反应（LSR）的发生和严重程度评估安全性。
在接受 IM 组和 podophyllin 组治疗并完成研究的 31 例和 36 例患者中，初始完全缓解分别为 20 例（64.5%）和 14 例（38.9%）（P = 0.03）。IM 组的初始清除速度更快（2.00 ± 0.91 周），而 podophyllin 组为 4.21 ± 1.05 周（P = 0.00）。3 个月后，IM 组的 20 例患者中有 13 例（65.0%）复发，而 podophyllin 组的 14 例患者中有 6 例（42.8%）复发（P = 0.20）。3 个月后完全缓解的患者数量在两组之间无差异（IM 组 7/31 例，podophyllin 组 8/36 例，P = 0.97）。IM 组 LSR 和疼痛的平均严重程度评分分别为 6.65 ± 1.76 和 6.13 ± 2.57，明显高于 podophyllin 组的 3.39 ± 1.57 和 2.58 ± 1.38（P = 0.00）。
与 25%鬼臼毒素溶液相比，0.05% ingenol 凝胶治疗 AGWs 同样有效，且起效更快。然而，高复发率、严重疼痛和 LSR 限制了其应用。
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