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Abstract：
Aim: This study aimed to investigate the effects of topical liposomal clarithromycin in combination with meglumine antimoniate (Glucantime®) on cutaneous leishmaniasis (CL) lesions. Methods: This pilot, randomized, double-blinded clinical trial was conducted on patients with CL lesions. Patients were randomly assigned to two groups: the first group received liposomal clarithromycin in combination with Glucantime for 28 days, while the second group received Glucantime and a placebo. Afterward, patients were followed up at 1.5, 3, and 6 months after treatment initiation and were evaluated for recovery time, induration, and size of the lesions. Results: Sixty patients with CL lesions were divided into two separate groups with 30 members each and were examined. Within-group analysis revealed that recovery time in the clarithromycin group was 26.65 ± 5.12 days, while in the placebo group, it was 32.84 ± 24.43, which was statistically insignificant (p = 0.18). Lesion size comparison in the first and last follow-ups reduced in both groups: 7.73 ± 4.31 to 0.48 ± 0.50 in the clarithromycin group (p = 0.006) and 5.47 ± 5.83 to 0.76 ± 0.88 in the placebo group (p = 0.03). Moreover, the size of lesions in the intervention group was significantly reduced compared to that in the placebo group (p = 0.02). Recognizable induration reduction was observed in the clarithromycin group (2.60 ± 0.77 to 1.0 ± 0.00). No adverse effects attributable to clarithromycin were reported. Conclusion: The administration of liposomal clarithromycin in combination with systemic Glucantime had a significant beneficial effect on reducing lesion size in leishmaniasis. Further studies on larger populations are recommended. Systematic Review Registration: https://www.irct.ir/trial/46611.
摘要：
目的：本研究旨在研究局部脂质体克拉霉素联合抗蒙酸葡甲胺（Glucoantime®）对皮肤利什曼病（CL）病变的影响。方法：这个飞行员，随机化，对CL病变患者进行了双盲临床试验.患者被随机分为两组：第一组接受脂质体克拉霉素联合葡聚糖多糖28天，而第二组接受了葡聚糖和安慰剂。之后,患者在治疗开始后1.5、3和6个月进行随访，并评估恢复时间，硬结,和病变的大小。结果：将60例CL病变患者分为两个单独的组，每组30人，并进行检查。组内分析显示，克拉霉素组的恢复时间为26.65±5.12天，而在安慰剂组，为32.84±24.43，统计学上无统计学意义(p=0.18)。两组在第一次和最后一次随访中的病变大小比较均减少：克拉霉素组（p=0.006）为7.73±4.31至0.48±0.50，安慰剂组（p=0.03）为5.47±5.83至0.76±0.88。此外，与安慰剂组相比,干预组的病灶大小显著减小(p=0.02).在克拉霉素组中观察到可识别的硬结减少(2.60±0.77至1.0±0.00)。没有报告可归因于克拉霉素的不良反应。结论：脂质体克拉霉素联合全身葡聚糖对减少利什曼病的病灶大小具有明显的有益作用。建议对更大的人群进行进一步的研究。系统审查注册：https://www。irct.ir/trial/46611。
