Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama
Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama
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DOI：
10.4269/ajtmh.12-0736
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发表时间：
2013-09-01
影响因子：
3.3
通讯作者：
Grogl, Max
中科院分区：
文献类型：
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作者：
Sosa, Nestor;Capitan, Zeuz;Grogl, Max
在这项随机、双盲、2期试验中，30例巴拿马利什曼原虫皮肤利什曼病患者被随机分配（1：1）接受WR 279，396（15%巴龙霉素+0.5%庆大霉素）或单独巴龙霉素（15%巴龙霉素）每日一次局部治疗，持续20天。6个月随访后，WR 279，396组的指标病变治愈率为13/15（87%），巴龙霉素单药组为9/15（60%）（P = 0.099）。当包括所有治疗的病灶时，WR 279，398治疗患者的最终治愈率再次为87%，但巴龙霉素单独治疗患者的最终治愈率为15例中的8例（53.3%; P = 0.046）。两种乳膏均耐受良好，最常见的不良事件为轻度应用部位反应。在这项小型2期研究中，WR 279，396组最终治愈率增加，表明复方制剂可能比巴龙霉素单药治疗L.巴拿马皮肤利什曼病
In this randomized, double-blinded Phase 2 trial, 30 patients with,Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis.