Low dose systemic or intralesional meglumine antimoniate treatment for American tegumentary leishmaniasis results in low lethality, low incidence of relapse, and low late mucosal involvement in a referral centre in Rio de Janeiro, Brazil (2001-2013)

BACKGROUND American tegumentary leishmaniasis (ATL) is a non-lethal parasitic disease that presents with cutaneous (CL) and mucosal (ML) clinical forms. ATL treatment aims at healing the lesions and preventing the development of the late mucosal form. Systemic meglumine antimoniate (MA) therapy with 10-20 mg Sb5+/kg/day is the first choice of treatment. However, alternative therapies using 5 mg Sb5+/kg/day or intralesional (IL) MA are the usual regimens at the National Institute of Infectious Diseases (NIID), Rio de Janeiro, Brazil. OBJECTIVES To evaluate lethality and the incidence of relapse and development of late ML in CL patients treated at NIID from 2001 until 2013. METHODS Data were recovered from records of all ATL patients diagnosed during that period. FINDINGS Out of 777 patients, 753 were treated with MA (96.9%). Of those, 89.1% received alternative therapy of 9.9% IL and 79.2% systemic 5 mg Sb5+/kg/day. Some patients required 1-3 additional courses of treatment, thus making a total of 997 courses; 85.2% of them were subjected to alternative therapies. Lethality was 0.1%, relapse incidence 5.8%, and late ML incidence 0.25%. As a final outcome for the 777 patients, 95.9% were cured, 0.1% died and 4.0% were not able to follow-up. MAIN CONCLUSIONS Alternative MA schedules resulted in low lethality without increase of relapse or late ML incidence.

背景（BACKGROUND）：美洲皮肤利什曼病（American tegumentary leishmaniasis, ATL）是一类非致死性寄生虫病，可表现为皮肤利什曼病（cutaneous leishmaniasis, CL）与黏膜利什曼病（mucosal leishmaniasis, ML）两种临床分型。ATL的治疗目标为愈合皮损并预防迟发性黏膜病变的发生。每日10~20 mg五价锑（Sb5+）/kg的葡甲胺锑（meglumine antimoniate, MA）全身疗法为一线治疗方案，但巴西里约热内卢国家传染病研究所（National Institute of Infectious Diseases, NIID）临床常用的替代方案为每日5 mg Sb5+/kg的给药方案或病灶内（intralesional, IL）注射MA。
研究目标（OBJECTIVES）：评估2001年至2013年于NIID接受治疗的CL患者的病死率、复发率及迟发性ML的发生率。
研究方法（METHODS）：研究数据来源于该时间段内所有确诊ATL患者的诊疗记录。
研究结果（FINDINGS）：777例患者中，753例接受了MA治疗（占比96.9%）。其中89.1%采用替代疗法，具体包括79.2%接受每日5 mg Sb5+/kg的全身给药方案，9.9%接受病灶内注射MA方案。部分患者需接受1~3个额外疗程，总疗程共计997个，其中85.2%采用替代疗法。整体病死率为0.1%，复发率为5.8%，迟发性ML发生率为0.25%。针对全部777例患者的最终转归显示：95.9%痊愈，0.1%死亡，4.0%失访。
主要结论（MAIN CONCLUSIONS）：采用替代MA给药方案的患者病死率较低，且未出现复发率或迟发性ML发生率升高的情况。