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一项比较口服阿奇霉素和葡甲胺锑酸盐治疗由巴西利什曼原虫(维安尼亚利什曼原虫)引起的美洲皮肤利什曼病的随机临床试验。

A randomized clinical trial comparing oral azithromycin and meglumine antimoniate for the treatment of American cutaneous leishmaniasis caused by Leishmania (Viannia) braziliensis.

作者信息

Krolewiecki Alejandro J, Romero Héctor D, Cajal Silvana P, Abraham David, Mimori Tatsuyuki, Matsumoto Tamami, Juarez Marisa, Taranto Nestor J

机构信息

Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina.

出版信息

Am J Trop Med Hyg. 2007 Oct;77(4):640-6.

PMID:17978064
Abstract

Azithromycin was compared with meglumine antimoniate for treatment of patients with cutaneous leishmaniasis. Patients were randomized to receive oral azithromycin, 500 mg/day (22 patients) or intramuscular meglumine antimoniate, 10 mg Sb/kg/day (23 patients), both for 28 days, with a second cycle of 15 days if necessary, and followed-up for one year after completion of treatment. Efficacy, defined as complete re-epithelization without relapse for 12 months after completing therapy, was 82.6% (95% confidence interval [CI] = 67-98%) for meglumine antimoniate and 45.5% (95% CI = 25-66%) for azithromycin. All patients who failed treatment with azithromycin were treated with meglumine antimoniate and clinically cured. Azithromycin was well tolerated; meglumine antimoniate caused arthralgias and local symptoms in 78% of the patients. In 17 cases, species identification was obtained; Leishmania (Viannia) braziliensis was identified in all of them. For the treatment of American cutaneous leishmaniasis caused by L. (V.) braziliensis, meglumine antimoniate is significatively more efficacious than azithromycin, which was clinically curative in almost half of the patients and well-tolerated.

摘要

将阿奇霉素与葡甲胺锑酸盐用于治疗皮肤利什曼病患者,并进行了比较。患者被随机分为两组,一组口服阿奇霉素,500毫克/天(22例患者),另一组肌肉注射葡甲胺锑酸盐,10毫克锑/千克/天(23例患者),疗程均为28天,必要时进行为期15天的第二个疗程,治疗结束后随访一年。疗效定义为治疗完成后12个月完全上皮再生且无复发,葡甲胺锑酸盐组的疗效为82.6%(95%置信区间[CI]=67-98%),阿奇霉素组为45.5%(95%CI=25-66%)。所有阿奇霉素治疗失败的患者均改用葡甲胺锑酸盐治疗并临床治愈。阿奇霉素耐受性良好;葡甲胺锑酸盐导致78%的患者出现关节痛和局部症状。在17例病例中进行了菌种鉴定;所有病例均鉴定为巴西利什曼原虫(维安尼利什曼原虫)。对于由巴西利什曼原虫(维安尼利什曼原虫)引起的美洲皮肤利什曼病,葡甲胺锑酸盐的疗效明显优于阿奇霉素,阿奇霉素仅使近一半患者临床治愈且耐受性良好。

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