Serviço de Imunologia, Hospital Universitário Prof. Edgar Santos, Universidade Federal da Bahia, Salvador, Brazil.
Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Fiocruz-BA, Salvador-BA, Brasil.
Trop Med Int Health. 2018 Sep;23(9):936-942. doi: 10.1111/tmi.13119. Epub 2018 Jul 11.
There is a clear need for new strategies of leishmaniasis treatment. This work was conducted to evaluate the efficacy of the co-administration of tamoxifen and meglumine antimoniate (Sb ) in a phase II pilot clinical trial in localised cutaneous leishmaniasis patients.
A randomised controlled pilot clinical trial was conducted to evaluate the efficacy and safety of oral (40 mg/day for 20 days) or topical tamoxifen (0.1% tamoxifen citrate for 20 days) combined with meglumine antimoniate (20 mg Sb /kg/day for 20 days) vs. a standard Sb protocol (20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis. Primary outcome was complete epithelisation of the lesion 6 months after the end of treatment. Secondary outcomes were lesion healing 2 months after the end of treatment and frequency and severity of adverse events.
A total of 38 subjects were included in the trial, 15 were treated with standard Sb and 23 with the combination of tamoxifen and Sb . Of the patients treated with the co-administration scheme, 12 received tamoxifen orally and 11 were treated with topical tamoxifen. Tamoxifen administered by the oral or topical routes was well tolerated. Cure rates 6 months after the end of treatment per intention to treat were 40% in the group treated with the standard Sb scheme, and 36.4% and 58%, respectively, for groups treated with Sb plus topical or oral tamoxifen.
In the doses and schemes used in this study, co-administration of oral tamoxifen and Sb resulted in higher cure rates in comparison with the standard scheme of treatment, although not to statistically significant levels.
迫切需要新的利什曼病治疗策略。本研究旨在评估他莫昔芬与葡甲胺锑联合治疗局限性皮肤利什曼病患者的疗效，并进行了一项 II 期临床试验。
采用随机对照临床试验，评估口服（20 天，每天 40mg）或局部（20 天，每天 0.1%枸橼酸他莫昔芬）他莫昔芬联合葡甲胺锑（20 天，每天 20mg/kg）与标准葡甲胺锑方案（20 天，每天 20mg/kg）治疗皮肤利什曼病的疗效和安全性。主要结局是治疗结束后 6 个月皮损完全上皮化。次要结局是治疗结束后 2 个月皮损愈合情况和不良事件的频率和严重程度。
共有 38 例患者入组本试验，15 例患者接受标准葡甲胺锑治疗，23 例患者接受他莫昔芬联合葡甲胺锑治疗。联合治疗组中，12 例患者口服他莫昔芬，11 例患者局部使用他莫昔芬。口服和局部使用他莫昔芬均耐受良好。根据意向治疗原则，治疗结束后 6 个月的治愈率分别为标准葡甲胺锑方案组的 40%，以及联合局部或口服他莫昔芬方案组的 36.4%和 58%。
在本研究中使用的剂量和方案下，与标准治疗方案相比，联合口服他莫昔芬和葡甲胺锑可提高治愈率，但未达到统计学显著水平。
