回顾性队列研究：病灶内五价锑剂治疗皮肤利什曼病的疗效和不良事件。
A retrospective cohort study of the effectiveness and adverse events of intralesional pentavalent antimonials in the treatment of cutaneous leishmaniasis.
机构信息
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.
出版信息
Int J Parasitol Drugs Drug Resist. 2020 Dec;14:257-263. doi: 10.1016/j.ijpddr.2020.11.002. Epub 2020 Nov 19.
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/cm 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 Sb/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.
简介
美国皮肤利什曼病（ACL）的标准治疗方法是静脉注射葡甲胺锑（IV-MA）。然而，由于不良反应（AE）和不依从性，治疗中断很常见。因此，提出了病灶内 MA（IL-MA）治疗方法。
目的
本研究检查了 IL-MA 的有效性和相关不良反应。
方法
我们对 240 例 ACL 患者进行了回顾性队列研究。我们排除了有粘膜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。我们认为方案治疗是主要的风险因素。IL-MA 通过在病灶底部注射足够量的 MA 进行，每周一次，持续 1-8 周，每次注射的体积足以抬高病灶（约每 1cm 病灶面积 1mL）。IV-MA 通过静脉注射 MA 进行，剂量为 10-20mg Sb/kg/天，持续 20 天。主要结局是治疗后 3 个月病灶治愈，不良反应是次要结局。
结果
共纳入 73 例患者。IL-MA 组 21 例，IV-MA 组 52 例。IL-MA 组年龄较大，合并症较多，ACL 既往治疗失败次数较多。该组的锑剂剂量明显较低。IL-MA 的治愈率为 66.7%，低于 IV-MA 组（相对风险（RR）=0.68，95%可信区间：0.50-0.92，p<0.001），而不良反应发生率相似。女性（RR=1.16，95%可信区间：1.02-1.33）、病灶直径≤1cm（RR=1.25，95%可信区间：1.00-1.56）和 IV-MA 治疗（RR=1.43，95%可信区间：1.06-1.93）与治愈有关。合并症（RR=1.7，95%可信区间：1.06-2.98）与不良反应有关。
结论
IL-MA 组患者年龄较大，合并症较多，ACL 既往治疗失败次数较多。尽管如此，IL-MA 的治愈率为 66.7%，在这种情况下仍然有用。建议进行前瞻性随机试验。
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