Objectives: Cutaneous leishmaniasis is a neglected disease, associated with high morbidity, which is partially due to the toxicity of available therapies. The pentavalent antimonial derivatives intralesional infiltration has proven to be as effective as the intravenous drug-based therapy, however, there is a lack of robust safety data.Methods: Phase II, uncontrolled, unicenter clinical trial to assess the safety profile of a standardized meglumine antimionate intralesional therapy, based on weekly infiltrations.Results: Fifty-three patients were studied, predominantly men (60%) and young adults (43.7 ± 17.1 years). Overall, 86.9% of the patients had at least one clinical adverse event. Local events were the most frequent (83%), followed by systemic ones (47.3%). Fourteen participants (26%) presented biochemical abnormalities. In all cases, laboratorial alterations were classified as mild and treatment discontinuation was not required. Differently, the two hypersensitivity (3.8%) reactions observed led to permanent treatment interruption. QTc interval prolongation was recorded in 14 patients (25.5%). The following risk associations to adverse events were identified in the multiple analysis: hypertension with systemic clinical events and smoking with QT interval prolongation.Expert commentary: In general, MA-IL was well tolerated and although associated with local and systemic adverse events, there was a low risk of high intensity or severe complications.

中文翻译：

---

葡甲胺锑酸盐病灶内浸润治疗皮肤利什曼病的安全性概况。

目的：皮肤利什曼病是一种被忽视的疾病，与高发病率有关，部分原因是现有疗法的毒性。五价锑衍生物病灶内浸润已被证明与基于静脉药物的疗法一样有效，但是，缺乏可靠的安全性数据。方法：II期，非对照，单中心临床试验，用于评估标准化葡甲胺的安全性结果：研究了53例患者，主要是男性（60％）和年轻人（43.7±17.1岁）。总体而言，有86.9％的患者至少有一项临床不良事件。本地事件是最常见的（83％），其次是全身事件（47.3％）。14名参与者（26％）出现了生化异常。在所有情况下，实验室改变被分类为轻度，不需要停药。不同的是，观察到的两种超敏反应（3.8％）导致永久性治疗中断。QTc间隔延长记录在14例患者中（25.5％）。在多重分析中确定了与不良事件相关的以下风险关联：高血压与全身性临床事件以及吸烟与QT间隔延长。专家评论：一般而言，MA-IL耐受性良好，尽管与局部和全身性不良事件相关，高强度或严重并发症的风险低。QTc间隔延长记录在14例患者中（25.5％）。在多重分析中确定了与不良事件相关的以下风险关联：高血压与全身性临床事件以及吸烟与QT间隔延长。专家评论：一般而言，MA-IL耐受性良好，尽管与局部和全身性不良事件相关，高强度或严重并发症的风险低。QTc间隔延长记录在14例患者中（25.5％）。在多重分析中确定了与不良事件相关的以下风险关联：高血压与全身性临床事件以及吸烟与QT间隔延长。专家评论：一般而言，MA-IL耐受性良好，尽管与局部和全身性不良事件相关，高强度或严重并发症的风险低。