Robledo Sara María, Puerta Juan Alberto, Muñoz Diana Lorena, Guardo Mónica, Vélez Iván Darío
Programa de Estudio y Control de Enfermedades Tropicales, Universidad de Antioquia, Medellín, Columbia.
Biomedica. 2006 Oct;26 Suppl 1:188-93.
Current treatment for human cutaneous leishmaniasis (CL) relies on pentavalent antimonials. Although efficacy of these drugs is high (around 85%), their widely documented toxicity and increasing resistance makes the search for therapeutic alternatives a priority for endemic countries.
To evaluate the efficacy and tolerability of the pentamidine isethionate for the treatment of cutaneous leishmaniasis caused by L. (V) panamensis in a pilot clinical trial.
Sixty three individuals suffering CL were enrolled. Patients received four intramuscular injections of pentamidine (4 mg/Kg/injection) administered every other day, and both clinical efficacy and side effects were documented during the following 6 months.
Of the 63 patients enrolled, 43 could be followed for 6 months. 86% (37/43) of treated patients healed all their lesions by 1.5 months after therapy. Treatment failure was observed in only five patients (11.6%; 5/43). One patient showed relapse. Overall tolerance of treatment was good, with adverse events such as local pain and swelling at the site of injection, dizziness and fever, varying from mild to moderate. Hypoglycemia, hypotension or diabetes were not observed.
These results confirm the previously reported efficacy of pentamidine for the treatment of CL in Colombia and Brazil, and, additionally, highlight the low intensity and frequency of side effects in a civilian population. No serious adverse events were recorded.
目前人类皮肤利什曼病(CL)的治疗依赖于五价锑剂。尽管这些药物的疗效很高(约85%),但其毒性已被广泛记录且耐药性不断增加,这使得寻找治疗替代方案成为流行国家的当务之急。
在一项试点临床试验中评估乙磺半胱氨酸喷他脒治疗由巴拿马利什曼原虫(Viannia)引起的皮肤利什曼病的疗效和耐受性。
招募了63例患有CL的个体。患者每隔一天接受四次肌肉注射喷他脒(4毫克/千克/次),并在接下来的6个月内记录临床疗效和副作用。
在招募的63例患者中,43例可随访6个月。86%(37/43)的治疗患者在治疗后1.5个月时所有病灶均愈合。仅5例患者(11.6%;5/43)出现治疗失败。1例患者复发。治疗的总体耐受性良好,不良事件如注射部位局部疼痛和肿胀、头晕和发热,程度从轻度到中度不等。未观察到低血糖、低血压或糖尿病。
这些结果证实了先前报道的喷他脒治疗哥伦比亚和巴西CL的疗效,此外,突出了平民中副作用的低强度和低频率。未记录到严重不良事件。