A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis,International Journal for Parasitology: Drugs and Drug Resistance

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A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis
International Journal for Parasitology: Drugs and Drug Resistance ( IF 4 ) Pub Date : 2020-11-19 , DOI: 10.1016/j.ijpddr.2020.11.002
Bruna Côrtes Rodrigues ₁ , Marina Freitas Ferreira ₂ , Daniel Holanda Barroso ₁ , Jorgeth Oliveira Carneiro da Motta ₂ , Carmen Déa Ribeiro de Paula ₂ , Cláudia Porto ₂ , Sofia Sales Martins ₃ , Ciro Martins Gomes ₁ , Raimunda Nonata Ribeiro Sampaio ₄

Affiliation

University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Postgraduate in Medical Sciences, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil.
University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil.
University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Postgraduate in Health Sciences, Health Sciences College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil.
University Hospital of Brasília, Dermatology Department, SGAN 605, Asa Norte, Brasília-DF, 70840-901, Brazil; Postgraduate in Medical Sciences, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Dermatomycology Laboratory, Medical College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil; Postgraduate in Health Sciences, Health Sciences College, University of Brasília, UnB - Darcy Ribeiro University Campus, Asa Norte, Brasília-DF, 70.910-900, Brazil.

Introduction

The standard therapy for American cutaneous leishmaniasis (ACL) is intravenous meglumine antimoniate (IV-MA). However, treatment interruptions due to adverse events (AEs) and non-adherence are frequent. Consequently, intralesional MA (IL-MA) was proposed.

Objective

This study examined the effectiveness of and AEs associated with IL-MA.

Methods

We performed a retrospective cohort study of 240 patients with ACL. We excluded patients with mucous lesions and disseminated leishmaniasis and those who received treatment in the previous 6 months. We considered protocol treatments as the main risk factors. IL-MA was performed using a subcutaneous injection of MA in a volume sufficient to elevate the lesion base (approximately 1 mL/cm² of lesion area) once weekly for 1–8 weeks. IV-MA was performed via intravenous injections of MA at a dosage of 10–20 mg Sb⁵⁺/kg/day for 20 days. The primary outcome was defined as a lesion cure 3 months after treatment, and AEs were secondary outcomes.

Results

Seventy-three patients were included. The IL-MA group consisted of 21 patients, and the IV-MA group consisted of 52 patients. The IL-MA group was older, had more comorbidities and more previous unsuccessful treatment of ACL. The antimonial dose was significantly lower in this group. The cure rate for IL-MA was 66.7%, which was lower than that in the IV-MA group (relative risk (RR) = 0.68, 95% CI: 0.50–0.92, p < 0.001), while the rate of AEs was similar. Female sex (RR = 1.16, 95% CI: 1.02–1.33), lesion diameter ≤1 cm (RR = 1.25, 95% CI: 1.00–1.56) and treatment with IV-MA (RR = 1.43, 95% CI: 1.06–1.93) were independently associated with achieving a cure. Comorbidities (RR = 1.7, 95% CI: 1.06–2.98) were independently associated with AEs.

Conclusions

Patients of IL-MA group were older, had more comorbidities and more previous unsuccessful treatment of ACL. Nevertheless, IL-MA had a cure rate of 66.7%, and it was useful in this context. A prospective randomized trial is recommended.

中文翻译：

病灶内注射五价锑治疗皮肤利什曼病的有效性和不良事件的回顾性队列研究

简介

美国皮肤利什曼病 (ACL) 的标准疗法是静脉注射葡甲胺锑酸盐 (IV-MA)。然而，由于不良事件 (AE) 和不依从性而导致的治疗中断是经常发生的。因此，提出了病灶内 MA (IL-MA)。

目标

该研究检查了 IL-MA 的有效性和与 IL-MA 相关的 AE。

方法

我们对 240 名 ACL 患者进行了一项回顾性队列研究。我们排除了有粘液病变和播散性利什曼病的患者以及在过去 6 个月内接受过治疗的患者。我们将方案治疗视为主要风险因素。IL-MA 是通过皮下注射 MA 进行的，其体积足以升高病变基底（约 1 mL/cm ²病变区域），每周一次，持续 1-8 周。IV-MA 通过静脉注射 MA 进行，剂量为 10–20 mg Sb ⁵⁺ /kg/天，持续 20 天。主要结果定义为治疗后 3 个月病变治愈，AE 为次要结果。

结果

包括 73 名患者。IL-MA 组由 21 名患者组成，IV-MA 组由 52 名患者组成。IL-MA 组年龄较大，有更多的合并症和更多的前 ACL 治疗失败。该组的锑剂量显着降低。IL-MA 的治愈率为 66.7%，低于 IV-MA 组（相对风险 (RR) = 0.68，95% CI：0.50-0.92，p < 0.001），而 AEs 的发生率为类似。女性（RR = 1.16，95% CI：1.02-1.33），病变直径 ≤ 1 cm（RR = 1.25，95% CI：1.00-1.56）和 IV-MA 治疗（RR = 1.43，95% CI：1.06） –1.93) 与实现治愈独立相关。合并症（RR = 1.7，95% CI：1.06–2.98）与 AE 独立相关。