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.
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。