Layegh Pouran, Rajabi Omid, Jafari Mahmoud Reza, Emamgholi Tabar Malekshah Parisa, Moghiman Toktam, Ashraf Hami, Salari Roshanak
Research Center for Skin Diseases & Cutaneous Leishmaniasis, Ghaem Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
J Parasitol Res. 2011;2011:656523. doi: 10.1155/2011/656523. Epub 2011 Nov 24.
Background. Topical treatment of cutaneous leishmaniasis is an attractive alternative avoiding toxicities of parenteral therapy while being administered through a simple painless route. Recently liposomal formulations of amphotericin B have been increasingly used in the treatment of several types of leishmaniasis. Aims. The efficacy of a topical liposomal amphotericin B formulation was compared with intralesional glucantime in the treatment of cutaneous leishmaniasis. Methods. From 110 patients, the randomly selected 50 received a topical liposomal formulation of amphotericin B into each lesion, 3-7 drops twice daily, according to the lesion's size and for 8 weeks. The other group of 60 patients received intralesional glucantime injection of 1-2 mL once a week for the same period. The clinical responses and side effects of both groups were evaluated weekly during the treatment course. Results. Per-protocol analysis showed no statistically significant difference between the two groups (P = 0.317, 95% confidence interval (CI) = 1.610 (0.632-4.101)). Moreover, after intention-to-treat analysis, the same results were seen (P = 0.650, 95% CI = 0.1.91 (0.560-2.530)). Serious post treatment side effects were not observed in either group. Conclusions. Topical liposomal amphotericin B has the same efficacy as intralesional glucantime in the treatment of cutaneous leishmaniasis.
背景。皮肤利什曼病的局部治疗是一种有吸引力的替代方法，可避免肠胃外治疗的毒性，且给药途径简单无痛。最近，两性霉素B脂质体制剂越来越多地用于治疗几种类型的利什曼病。目的。比较局部用两性霉素B脂质体制剂与病灶内注射葡糖胺聚糖治疗皮肤利什曼病的疗效。方法。从110例患者中随机选取50例，根据病灶大小，每个病灶每日两次给予3 - 7滴局部用两性霉素B脂质体制剂，持续8周。另一组60例患者在同一时期每周一次病灶内注射1 - 2 mL葡糖胺聚糖。在治疗过程中每周评估两组的临床反应和副作用。结果。符合方案分析显示两组之间无统计学显著差异（P = 0.317，95%置信区间(CI) = 1.610(0.632 - 4.101)）。此外，意向性分析后也得到相同结果（P = 0.650，95% CI = 0.1.91(0.560 - 2.530)）。两组均未观察到严重的治疗后副作用。结论。局部用两性霉素B脂质体制剂在治疗皮肤利什曼病方面与病灶内注射葡糖胺聚糖具有相同的疗效。
