Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
Pediatric Dermatology Service, Soroka University Medical Center, Beer Sheva, Israel.
Int J Dermatol. 2023 Jan;62(1):40-47. doi: 10.1111/ijd.16407. Epub 2022 Aug 30.
Cutaneous leishmaniasis (CL) topical treatments may have low efficacy, while systemic treatments have adverse effects (AEs) and high cost. Since treatment options for CL nowadays have numerous disadvantages, an alternative topical treatment is vastly needed. We assessed liposomal amphotericin B gel (LAmB gel) treatment efficacy and safety.
A randomized, double-blind, placebo-controlled trial. Adults with CL (PCR proven, ≤5 lesions) were randomized for 28 days with LAmB gel (cases) versus placebo gel (controls), followed by LAmB gel for 28 days (both groups). Lesion size, ulceration, induration, scarring, swelling, and AEs (pain, itch, erythema, discharge, fever, and urticaria) were assessed at days 1, 28, and 56. PCR was repeated at day 56.
Thirteen patients (four cases, nine controls) with 39 lesions (11 cases, 28 controls) caused by Leishmania major (L. major) were randomized. Ulcer, induration, scarring, and swelling were noted in 18%, 91%, 0%, and 27% of cases, respectively, versus 86%, 89%, 7%, and 54% of controls, respectively. At day 28, improvement rates were low in both groups. Induration improved comparing LAmB gel treatment for 56 days versus 28 days. Ulceration, induration, and swelling improved comparing all patients at 56 days versus 28 days. PCR turned negative in three of four cases and eight of nine controls. Mild, only local, AEs were reported in <30% of the patients.
LAmB gel is safe and may be considered as an alternative topical treatment for CL caused by L. major. Further, larger-scale studies are warranted to evaluate the long-term impact of LAmB gel on the management of CL.
皮肤利什曼病（CL）的局部治疗可能疗效较低，而全身治疗则有不良反应（AE）且费用高昂。由于目前 CL 的治疗选择存在诸多弊端，因此非常需要一种替代的局部治疗方法。我们评估了脂质体两性霉素 B 凝胶（LAmB 凝胶）的治疗效果和安全性。
这是一项随机、双盲、安慰剂对照试验。患有 CL（PCR 阳性，≤5 处病变）的成年人随机接受 28 天的 LAmB 凝胶（病例组）或安慰剂凝胶（对照组）治疗，随后两组均接受 28 天的 LAmB 凝胶治疗。在第 1、28 和 56 天评估病变大小、溃疡、硬结、瘢痕、肿胀和 AE（疼痛、瘙痒、红斑、分泌物、发热和荨麻疹）。在第 56 天重复进行 PCR。
13 例患者（4 例病例，9 例对照）共 39 处病变（11 例病例，28 例对照）由利什曼原虫（L. major）引起。病例组分别有 18%、91%、0%和 27%的患者出现溃疡、硬结、瘢痕和肿胀，对照组分别为 86%、89%、7%和 54%。在第 28 天，两组的改善率均较低。与仅治疗 28 天相比，治疗 56 天可改善硬结。与所有患者在第 28 天相比，在第 56 天溃疡、硬结和肿胀都有改善。在 4 例患者中有 3 例和 9 例对照中有 8 例 PCR 转为阴性。不到 30%的患者报告有轻微、仅局部的 AE。
LAmB 凝胶是安全的，可被视为治疗由 L. major 引起的 CL 的一种替代局部治疗方法。进一步的研究还需要评估 LAmB 凝胶对 CL 管理的长期影响。
