Community Medicine Department, Qazvin University of Medical Sciences, Qazvin, Iran.
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
PLoS Negl Trop Dis. 2022 Jul 8;16(7):e0010569. doi: 10.1371/journal.pntd.0010569. eCollection 2022 Jul.
Treatment of Cutaneous leishmaniasis (CL) is based on using antimoniate derivatives; patients' compliance for systemic injections is low due to the pain and systemic complications. In this randomized open trial, the efficacy of intra-lesional (IL) injections of meglumine antimoniate (MA) once a week vs. twice a week in the treatment of Anthrpoponothic CL caused by L. tropica was studied. Eligible volunteer patients were selected according to inclusion/exclusion criteria. The included patients were randomly allocated to receive IL-MA injections once a week or twice a week. The primary outcome was set as complete healing of the lesion(s), and defined as complete re-epithelialization and absence of induration in the lesions. A total of 180 parasitologicaly proven CL patients caused by L. tropica were recruited, 90 patients were treated with weekly IL-MA and 90 patients received IL-MA twice a week. The complete cure was 87.9% vs. 89.2% in the group received weekly and twice a week IL-MA injections, respectively (P = 0.808). Patients' compliance was acceptable and side effects were limited to a few local allergic reactions to MA. Median time to healing was significantly shorter in patients who received IL-MA twice a week (median ± SE) 37±3.8, (CI: 29.6-44.4) days compared to whom received IL-MA once a week 60±2.3, (CI: 55.6-64.5) days (P< 0.001), however the number of injections was higher in group who received IL-MA twice a week (12 vs. 9 injections). In conclusion, the rate of cure in the group of CL patients with IL-MA twice a week was not significantly different from the group who received IL-MA once a week shorten, but the duration of healing was shorter in the group who received IL-MA twice a week while the group received more injections so is recommended to use IL-MA once a week due to the fact the compliance is acceptable with limited side effects. Clinical Trial Registration: IRCT20081130001475N13; https://en.irct.ir/.
治疗皮肤利什曼病（CL）的方法是基于使用锑制剂衍生物；由于疼痛和全身并发症，患者对全身注射的依从性较低。在这项随机开放试验中，研究了每周一次和每周两次皮内（IL）注射葡甲胺锑酸盐（MA）治疗由 L. tropica 引起的人类利什曼病的疗效。根据纳入/排除标准选择合格的志愿者患者。将纳入的患者随机分配接受每周一次或每周两次 IL-MA 注射。主要结局设定为病变完全愈合，定义为病变完全再上皮化且无硬结。共招募了 180 例经寄生虫学证实的由 L. tropica 引起的 CL 患者，90 例患者接受每周 IL-MA 治疗，90 例患者接受每周两次 IL-MA 治疗。每周和每周两次接受 IL-MA 注射的患者完全治愈率分别为 87.9%和 89.2%（P=0.808）。患者的依从性可以接受，副作用仅限于对 MA 的少数局部过敏反应。每周两次接受 IL-MA 治疗的患者的愈合中位数时间明显短于每周一次接受 IL-MA 治疗的患者（中位数±SE）37±3.8，（CI：29.6-44.4）天与每周一次接受 IL-MA 治疗的患者 60±2.3，（CI：55.6-64.5）天（P<0.001），但每周两次接受 IL-MA 治疗的患者接受的注射次数更高（12 次 vs. 9 次）。总之，每周两次接受 IL-MA 的 CL 患者的治愈率与每周一次接受 IL-MA 的患者无显著差异，但每周两次接受 IL-MA 的患者的愈合时间更短，而每周接受 IL-MA 的患者的注射次数更多因此，由于依从性可接受且副作用有限，建议每周使用一次 IL-MA。临床试验注册：IRCT20081130001475N13；https://en.irct.ir/。
