Velez I, Agudelo S, Hendrickx E, Puerta J, Grogl M, Modabber F, Berman J
PECET, Universidad de Antioquia, Madellin, Colombia.
Ann Intern Med. 1997 Feb 1;126(3):232-6. doi: 10.7326/0003-4819-126-3-199702010-00010.
Hundreds of thousands of cases of cutaneous leishmaniasis occur each year worldwide. Available therapies are parenteral, moderately toxic, and costly.
To determine the efficacy of and tolerance for oral allopurinol as monotherapy for cutaneous leishmaniasis.
Randomized, controlled trial.
Outpatient clinics in 11 regions of Colombia in which cutaneous leishmaniasis is endemic.
187 otherwise healthy adults with cutaneous leishmaniasis. Eighty-four percent of patients were infected with or were from regions with Leishmania panamensis; 16% were infected or were from regions with L. braziliensis.
Patients were randomly assigned to one of three treatment groups. The first group received allopurinol, three 100-mg tablets four times daily (20 mg/kg of body weight per day) for 28 days. The second group received three placebo tablets four times daily for 28 days. The third group received Glucantime, 20 mg of intramuscular antimony/kg per day for 20 days.
Complete cure was defined as complete clinical reepithelialization of all lesions at 3 months and no relapse during 12 months of follow-up.
Of 182 patients whose data could be analyzed, 157 (86%) were evaluated. In the allopurinol group, 18 of 55 (33% [95% CI, 21% to 47%]) patients were cured; in the placebo group, 17 of 46 patients (37% [CI, 23% to 52%]) were cured (difference, 4% [CI, -14% to 22%]; P = 0.68); and in the Glucantime group, 52 of 56 patients (93% [CI, 83% to 98%]) were cured (P < 0.001 compared with the allopurinol and placebo groups combined). In most cases, therapy was considered to have failed because the lesion did not reepithelialize by 1.5 months after the end of therapy. Three cases of relapse (two in the allopurinol group and one in the placebo group) at the nasal mucosa (mucosal leishmaniasis) had occurred by the end of 12 months of follow-up.
Allopurinol monotherapy has no effect on Colombian cutaneous disease primarily caused by L. panamensis and therefore is unlikely to be effective against cutaneous leishmaniasis in other endemic regions.
全球每年有数十万例皮肤利什曼病病例。现有的治疗方法为肠胃外给药，毒性中等且成本高昂。
确定口服别嘌呤醇单药治疗皮肤利什曼病的疗效和耐受性。
随机对照试验。
哥伦比亚11个皮肤利什曼病流行地区的门诊诊所。
187名患有皮肤利什曼病的健康成年人。84%的患者感染了巴拿马利什曼原虫或来自有该原虫的地区；16%的患者感染了巴西利什曼原虫或来自有该原虫的地区。
患者被随机分配到三个治疗组之一。第一组接受别嘌呤醇治疗，每日4次，每次3片100毫克（每日20毫克/千克体重），共28天。第二组每日4次，每次服用3片安慰剂，共28天。第三组接受葡糖锑胺治疗，每日20毫克/千克体重的肌肉注射锑剂，共20天。
完全治愈定义为3个月时所有病变完全临床再上皮化，且随访12个月无复发。
在182例可分析数据的患者中，157例（86%）接受了评估。在别嘌呤醇组，55例患者中有18例（33%[95%CI，21%至47%]）治愈；在安慰剂组，46例患者中有17例（37%[CI，23%至52%]）治愈（差异为4%[CI，-14%至22%]；P = 0.68）；在葡糖锑胺组，56例患者中有52例（93%[CI，83%至98%]）治愈（与别嘌呤醇组和安慰剂组合并相比，P < 0.001）。在大多数情况下，治疗被认为失败是因为治疗结束后1.5个月病变未再上皮化。随访12个月结束时，鼻黏膜（黏膜利什曼病）出现3例复发（别嘌呤醇组2例，安慰剂组1例）。
别嘌呤醇单药治疗对主要由巴拿马利什曼原虫引起的哥伦比亚皮肤疾病无效，因此在其他流行地区不太可能对皮肤利什曼病有效。
