Ben Salah A, Zakraoui H, Zaatour A, Ftaiti A, Zaafouri B, Garraoui A, Olliaro P L, Dellagi K, Ben Ismail R
Laboratoire d'Epidemiologie et d'Ecologie Parasitaire, Institut Pasteur de Tunis, Tunisia.
Am J Trop Med Hyg. 1995 Aug;53(2):162-6. doi: 10.4269/ajtmh.1995.53.162.
A randomized, placebo-controlled, double-blind trial was carried out in 1992 in central Tunisia to assess the tolerability and efficacy of paromomycin ointment against zoonotic cutaneous leishmaniasis caused by Leishmania major. One hundred fifteen patients, 2--60 years of age, with a single lesion of parasitologically confirmed cutaneous leishmaniasis, were included in the trial. The ointment was applied twice a day from day 1 through day 14. Clinical and parasitologic evaluations of lesions were done at days 0, 15, 45, and 105. Fifty-seven patients were allocated the treatment and 58 the placebo. Based on local toxicity and laboratory evaluation, there was no difference in tolerability between the two groups. Parasitologic evaluation at day 15 showed that 74.5% of the treated group had negative smears compared with 56.4% among controls (P = 0.06). This difference was no longer apparent at days 45 and 105. Clinical evaluation at days 15, 45, and 105 did not indicate any difference between the two groups. The clinical evaluation at day 15 was a good predictor of the final prognosis of the lesion in the two groups when analyzed separately, suggesting no clinical relapse in either group. These findings suggest that paromomycin ointment should not be used in the present formulation as a treatment for zoonotic cutaneous leishmaniasis in Tunisia.
1992年在突尼斯中部开展了一项随机、安慰剂对照、双盲试验，以评估巴龙霉素软膏治疗由硕大利什曼原虫引起的人兽共患皮肤利什曼病的耐受性和疗效。该试验纳入了115名年龄在2至60岁之间、患有经寄生虫学确诊的单一皮肤利什曼病损伤的患者。从第1天到第14天，软膏每天涂抹两次。在第0、15、45和105天对损伤进行临床和寄生虫学评估。57名患者被分配接受治疗，58名患者接受安慰剂。根据局部毒性和实验室评估，两组之间的耐受性没有差异。第15天的寄生虫学评估显示，治疗组74.5%的涂片为阴性，而对照组为56.4%（P = 0.06）。在第45天和105天时，这种差异不再明显。第15、45和105天的临床评估未显示两组之间有任何差异。分别分析时，第15天的临床评估是两组损伤最终预后的良好预测指标，表明两组均无临床复发。这些发现表明，在突尼斯，目前配方的巴龙霉素软膏不应作为人兽共患皮肤利什曼病的治疗药物。
