Saenz R E, Paz H, Berman J D
Gorgas Memorial Institute, Panama City, Republic of Panama.
Am J Med. 1990 Aug;89(2):147-55. doi: 10.1016/0002-9343(90)90292-l.
PURPOSE, PATIENTS, AND METHODS: The classic agent for cutaneous leishmaniasis is pentavalent antimony. However, there are no reports of the efficacy of antimony versus placebo or of the efficacy of any alternative therapy versus either antimony or placebo. In the present report, the oral antifungal agent ketoconazole (600 mg/day for 28 days) was compared to a recommended regimen of intramuscular Pentostam (20 mg antimony/kg, with a maximum of 850 mg antimony/day, for 20 days) in a randomized study of the treatment of Panamanian cutaneous leishmaniasis due to Leishmania braziliensis panamensis. A separate group of patients with this disease was administered placebo.
Ketoconazole clinically cured 16 of 21 (76%) patients. The lesions on nine patients healed by 1 month after therapy, and the lesions healed by 3 months after therapy on the other seven patients. Side effects were limited to a 27% incidence of mild, reversible hepatocellular enzyme elevation and an asymptomatic, reversible, approximately 70% decrease in serum testosterone in all patients. Pentostam cured 13 of 19 (68%) patients; the lesions on seven patients healed by the end of therapy, and the lesions on four other patients healed by 1 month after the end of therapy. Side effects were a 47% incidence of mild, reversible hepatocellular enzyme elevation and the morbidity due to 20 intramuscular injections in almost all patients. The placebo group of 11 patients had a 0% cure rate. By 1 month after therapy, all placebo-treated patients demonstrated new lesions or one lesion that was 23% to 875% larger than before therapy.
Both ketoconazole and Pentostam were more effective than placebo against L. braziliensis panamensis cutaneous leishmaniasis. Oral ketoconazole is comparable in efficacy to this parenteral Pentostam regimen and can be recommended as initial treatment for this disease.
目的、患者与方法：治疗皮肤利什曼病的经典药物是五价锑。然而，尚无关于锑与安慰剂疗效对比的报道，也没有任何替代疗法与锑或安慰剂疗效对比的报道。在本报告中，在一项针对巴拿马因巴拿马利什曼原虫引起的皮肤利什曼病的随机研究中，将口服抗真菌药酮康唑（600毫克/天，共28天）与推荐的肌肉注射喷他脒方案（20毫克锑/千克，最大剂量850毫克锑/天，共20天）进行了比较。另一组患有这种疾病的患者接受了安慰剂治疗。
酮康唑使21例患者中的16例（76%）临床治愈。9例患者的皮损在治疗后1个月愈合，另外7例患者的皮损在治疗后3个月愈合。副作用仅限于所有患者中27%的轻度、可逆性肝细胞酶升高发生率，以及血清睾酮无症状、可逆性降低约70%。喷他脒使19例患者中的13例（68%）治愈；7例患者的皮损在治疗结束时愈合，另外4例患者的皮损在治疗结束后1个月愈合。副作用为47%的轻度、可逆性肝细胞酶升高发生率，以及几乎所有患者因20次肌肉注射产生的不适。11例患者的安慰剂组治愈率为0%。治疗后1个月，所有接受安慰剂治疗的患者均出现新皮损或一处皮损比治疗前增大23%至875%。
酮康唑和喷他脒治疗巴拿马利什曼原虫引起的皮肤利什曼病均比安慰剂更有效。口服酮康唑的疗效与这种肠外喷他脒方案相当，可推荐作为该病的初始治疗方法。
