Abstract：
To determine whether a combination of a single intramuscular (IM) dose of pentamidine (7 mg/kg) followed by oral tamoxifen 40 mg/day for 20 days is non-inferior to three IM doses of pentamidine 7 mg/kg in the treatment of cutaneous leishmaniasis with a margin of 15%.
Phase II, randomised, controlled, open-label, non-inferiority clinical trial. Primary outcome was the complete healing of the lesions 6 months after starting treatment. Secondary outcomes were healing 3 months after starting treatment and determining the presence and severity of adverse effects (AE).
The research was concluded with 49 patients; Leishmania (Viannia) guyanensis was the most frequent species isolated. In the primary outcome, 18 (72%) (95% CI: 52.4%-85.7%) of the 25 patients allocated to the intervention group and 24 (100%) (95% CI: 86.2%-100%) of the control group (p = 0.015) met the established criteria of cure. There was no AE with tamoxifen.
Although a 72% cure rate presented by the combination of tamoxifen and pentamidine was lower than in the control group that achieved a 100% cure, it is still a safe and is a clinically relevant result. It indicates that the therapeutic scheme evaluated may be a promising option for populations in remote areas, however it should be further studied, in order to include a larger number of patients.
Phase II, randomised, controlled, open-label, non-inferiority clinical trial. Primary outcome was the complete healing of the lesions 6 months after starting treatment. Secondary outcomes were healing 3 months after starting treatment and determining the presence and severity of adverse effects (AE).
The research was concluded with 49 patients; Leishmania (Viannia) guyanensis was the most frequent species isolated. In the primary outcome, 18 (72%) (95% CI: 52.4%-85.7%) of the 25 patients allocated to the intervention group and 24 (100%) (95% CI: 86.2%-100%) of the control group (p = 0.015) met the established criteria of cure. There was no AE with tamoxifen.
Although a 72% cure rate presented by the combination of tamoxifen and pentamidine was lower than in the control group that achieved a 100% cure, it is still a safe and is a clinically relevant result. It indicates that the therapeutic scheme evaluated may be a promising option for populations in remote areas, however it should be further studied, in order to include a larger number of patients.
摘要：
目的：确定单次肌内（IM）剂量的喷他脒（7mg/kg），然后口服他莫昔芬40mg/天，持续20天的组合在治疗皮肤利什曼病方面是否不劣于三个IM剂量的喷他脒7mg/kg，幅度为15％。
方法：第二阶段，随机化，控制,开放标签，非劣效性临床试验。主要结果是开始治疗6个月后病变完全愈合。次要结果是开始治疗后3个月愈合，并确定不良反应（AE）的存在和严重程度。
结果：该研究以49例患者为结论；利什曼原虫（Viannia）是最常见的分离物种。在主要结果中，干预组25例患者中有18例（72%）（95%CI：52.4%-85.7%）和对照组24例（100%）（95%CI：86.2%-100%）（p=0.015）符合既定的治愈标准。他莫昔芬没有AE。
结论：尽管他莫昔芬和喷他脒的组合显示72％的治愈率低于达到100％治愈的对照组，它仍然是安全的，并且是临床相关的结果。这表明评估的治疗方案可能是偏远地区人群的一个有希望的选择，然而，它应该进一步研究，以包括更多的患者。
方法：第二阶段，随机化，控制,开放标签，非劣效性临床试验。主要结果是开始治疗6个月后病变完全愈合。次要结果是开始治疗后3个月愈合，并确定不良反应（AE）的存在和严重程度。
结果：该研究以49例患者为结论；利什曼原虫（Viannia）是最常见的分离物种。在主要结果中，干预组25例患者中有18例（72%）（95%CI：52.4%-85.7%）和对照组24例（100%）（95%CI：86.2%-100%）（p=0.015）符合既定的治愈标准。他莫昔芬没有AE。
结论：尽管他莫昔芬和喷他脒的组合显示72％的治愈率低于达到100％治愈的对照组，它仍然是安全的，并且是临床相关的结果。这表明评估的治疗方案可能是偏远地区人群的一个有希望的选择，然而，它应该进一步研究，以包括更多的患者。
