Médecins Sans Frontières, Quetta, Pakistan.
Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Centers, location AMC, Amsterdam Public Health, Amsterdam Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands.
PLoS Negl Trop Dis. 2021 Jan 28;15(1):e0008988. doi: 10.1371/journal.pntd.0008988. eCollection 2021 Jan.
BACKGROUND: Cutaneous leishmaniasis (CL) is a neglected tropical skin disease, caused by Leishmania protozoa. In Pakistan, where CL caused by L. tropica is highly endemic, therapy with pentavalent antimonials is the standard of care, but has significant toxicity when used in systemic therapy, while are no evidence-based safer alternative treatment options for L. tropica. The efficacy of oral miltefosine has not been studied in CL caused by L. tropica. We evaluated effectiveness and tolerability of miltefosine in patients with previous treatment failure or with contraindications to systemic antimonial treatment. METHODS: A retrospective review was conducted of a cohort of CL patients who were treated with a 28-day course of miltefosine between December 2017 and August 2019, in urban Quetta, Pakistan, an area endemic for L. tropica. Descriptive analyses were performed, and effectiveness was assessed by initial response after treatment, and final cure at routine follow up visits, six weeks to three months post-treatment. Tolerability was assessed by routinely reported adverse events. RESULTS: Of the 76 CL patients in the cohort, 42 (55%) had contraindications to systemic antimonial treatment, and 34 (45%) had failure or relapse after antimonial treatment. Twelve patients defaulted during treatment and 12 patients were lost to follow up. In the remaining 52 patients, final cure rate was 77% (40/52). In those with contraindications to systemic antimonial treatment the final cure rate was 83% (24/29) and in the failure and relapse group 70% (16/23). Twenty-eight patients (40.0%) reported 39 mild to moderate adverse events with the main complaints being nausea (41.0%), general malaise (25.6%), and stomach pain (12.8%). CONCLUSION: Results indicate that miltefosine is an effective second line treatment in CL in areas endemic for L. tropica. Prospective studies with systematic follow up are needed to obtain definitive evidence of effectiveness and tolerability, including identification of risk factors for miltefosine treatment failure.
背景：皮肤利什曼病（CL）是一种被忽视的热带皮肤疾病，由利什曼原虫引起。在巴基斯坦，L. tropica 引起的 CL 高度流行，五价锑剂治疗是标准的治疗方法，但全身治疗时毒性显著，而没有针对 L. tropica 的基于证据的更安全的替代治疗选择。口服米替福新治疗 L. tropica 引起的 CL 的疗效尚未得到研究。我们评估了米替福新在以前治疗失败或有全身锑剂治疗禁忌的患者中的疗效和耐受性。
方法：对 2017 年 12 月至 2019 年 8 月在巴基斯坦城市奎达接受 28 天米替福新治疗的 CL 患者队列进行了回顾性分析，该地区为 L. tropica 流行区。进行了描述性分析，通过治疗后初始反应和治疗后 6 周至 3 个月的常规随访评估有效性，评估最终治愈率。通过常规报告的不良事件评估耐受性。
结果：在队列中的 76 例 CL 患者中，42 例（55%）有全身锑剂治疗禁忌，34 例（45%）在锑剂治疗后失败或复发。12 例患者在治疗期间失访，12 例患者失访。在其余 52 例患者中，最终治愈率为 77%（40/52）。在有全身锑剂治疗禁忌的患者中，最终治愈率为 83%（24/29），在失败和复发组中为 70%（16/23）。28 例（40.0%）患者报告了 39 例轻至中度不良事件，主要症状为恶心（41.0%）、全身不适（25.6%）和胃痛（12.8%）。
结论：结果表明，米替福新是 L. tropica 流行地区 CL 的有效二线治疗药物。需要进行前瞻性研究并进行系统随访，以获得有效性和耐受性的确切证据，包括确定米替福新治疗失败的危险因素。
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