Ramalho Dario Brock, Silva Rosiana Estéfane da, Senna Maria Camilo Ribeiro de, Moreira Hugo Silva Assis, Pedras Mariana Junqueira, Avelar Daniel Moreira de, Saraiva Lara, Rabello Ana, Cota Gláucia
Fundação Hospitalar do Estado de Minas Gerais, Hospital Eduardo de Menezes, Belo Horizonte, MG, Brasil.
Fundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Belo Horizonte, MG, Brasil.
Mem Inst Oswaldo Cruz. 2018 Jun 21;113(9):e180200. doi: 10.1590/0074-02760180200.
Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas.
The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL.
It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations.
A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).
皮肤利什曼病（CL）是一个全球性的健康问题，目前缺乏有效、可负担且易于使用的治疗方法。最近，葡甲胺锑酸盐（MA）病灶内注射被纳入美洲利什曼病的可接受治疗方法之中。尽管这种方法颇具吸引力，但目前几乎没有证据支持其在美洲的使用。
本研究旨在提供关于标准化MA病灶内注射技术治疗CL的有效性和安全性的信息。
这是一项在巴西一家转诊中心进行的单臂II期临床试验。对经寄生虫学确诊、最多有三个符合CL的皮肤病变的CL病例，采用经过验证的技术每周进行MA病灶内注射，最多注射八次。
共纳入53例患者（62个病灶）。总体而言，患者在中位治疗期43天（四分位间距25%-75%：28-52天）内接受了中位七次注射（四分位间距25%-75%：5-8次）。在第180天时的最终治愈率为87%（95%置信区间：77%-96%）。大多数不良事件为局部性，强度为轻度或中度。在13%的接受治疗的患者中观察到病灶部位的细菌继发感染，此外还有两例三级不良事件（过敏反应）。
