Miró Guadalupe, Oliva Gaetano, Cruz Israel, Cañavate Carmen, Mortarino Michele, Vischer Claudia, Bianciardi Paolo
Departamento de Sanidad Animal, Facultad de Veterinaria, Universidad Complutense, Madrid, Spain.
Vet Dermatol. 2009 Oct;20(5-6):397-404. doi: 10.1111/j.1365-3164.2009.00824.x.
The aim of this trial was to evaluate the effectiveness and safety of miltefosine-allopurinol combination therapy vs. the current reference combination therapy, meglumine antimoniate-allopurinol, for canine leishmaniosis. Dogs included in the study exhibited clinical signs of the disease, were positive by PCR and serologically positive by immunofluorescent antibody test for leishmaniosis, and negative for ehrlichiosis. Dogs were divided into two groups: Group 1 was treated with 2 mg/kg of miltefosine orally once daily for 28 days and 10 mg/kg of allopurinol orally twice daily for 7 months; Group 2 was treated with 50 mg/kg of meglumine antimoniate sub-cutaneously twice daily for 28 days and allopurinol (same dose as Group 1) for 7 months. Dogs were examined according to the following schedule: pre-inclusion, Day 0 (D0), D14, D28, D84, D140 and D196. At each visit, blood, urine and bone marrow samples were collected. Parameters monitored included haematology, biochemistry, protein electrophoresis, serology, urinary protein/creatinine ratio and RTQ-PCR performed on bone marrow aspirates. A significant reduction in total clinical score and parasite load was observed in both groups over the 7-month study period (P < 0.0001), with no significant difference between groups (P = 0.3). The safety of miltefosine-allopurinol combination therapy was confirmed by lack of effect on renal and hepatic parameters and adverse reactions. Miltefosine, in combination with allopurinol, offers a safe, convenient and effective alternative treatment option for canine leishmaniosis compared to the reference therapy.
本试验的目的是评估米替福新-别嘌醇联合疗法与当前参考联合疗法葡甲胺锑酸盐-别嘌醇治疗犬利什曼病的有效性和安全性。纳入研究的犬表现出该疾病的临床症状，通过聚合酶链反应（PCR）呈阳性，利什曼病免疫荧光抗体检测血清学呈阳性，而埃立克体病检测呈阴性。犬被分为两组：第1组每天口服2mg/kg米替福新，持续28天，每天口服两次10mg/kg别嘌醇，持续7个月；第2组每天皮下注射两次50mg/kg葡甲胺锑酸盐，持续28天，并服用别嘌醇（与第1组剂量相同）7个月。按照以下时间表对犬进行检查：纳入前、第0天（D0）、第14天、第28天、第84天、第140天和第196天。每次就诊时，采集血液、尿液和骨髓样本。监测的参数包括血液学、生物化学、蛋白质电泳、血清学、尿蛋白/肌酐比值以及对骨髓抽吸物进行实时定量聚合酶链反应（RTQ-PCR）。在7个月的研究期内，两组的总临床评分和寄生虫负荷均显著降低（P<0.0001），两组之间无显著差异（P = 0.3）。米替福新-别嘌醇联合疗法对肾脏和肝脏参数及不良反应无影响，证实了其安全性。与参考疗法相比，米替福新联合别嘌醇为犬利什曼病提供了一种安全方便且有效的替代治疗选择。
