Sosa Estani S, Segura E L, Ruiz A M, Velazquez E, Porcel B M, Yampotis C
Centro Nacional de Diagnóstico e Investigación de Endemo-Epidemias/Administración Nacional de Laboratorios e Institutos de Salud, Dr. Carlos G. Malbrán, Buenos Aires, Argentina.
Am J Trop Med Hyg. 1998 Oct;59(4):526-9. doi: 10.4269/ajtmh.1998.59.526.
A double-blind, randomized, clinical field trial was designed to test the efficacy and tolerance of a specific drug treatment in children in the indeterminate phase of infection by Trypanosoma cruzi. Children were treated with benznidazole at a dose of 5 mg/kg/day for 60 days or placebo and followed-up for 48 months. The treated children showed a significant decrease in geometric mean titers of antibodies against T. cruzi measured by indirect hemagglutination, indirect immunofluorescence, and ELISA. After a four year follow-up, 62% of the benznidazole-treated children and no placebo-treated child were seronegative for T. cruzi when tested by an ELISA using a T. cruzi flagellar calcium-binding protein (F29). Xenodiagnosis carried out after 48 months of follow-up was positive in 4.7% of the benznidazole-treated children and in 51.2% of the placebo-treated children. These results show the tolerance to and efficacy of benznidazole against T. cruzi in seropositive children six to 12 years of age. We used an early serologic marker of cure after treatment, consisting of a recombinant antigen implemented in a rapid, conventional serologic procedure.
设计了一项双盲、随机、临床现场试验，以测试一种特定药物治疗对处于克氏锥虫感染不确定阶段儿童的疗效和耐受性。儿童接受剂量为5mg/kg/天的苯硝唑治疗60天或接受安慰剂治疗，并随访48个月。接受治疗的儿童通过间接血凝、间接免疫荧光和酶联免疫吸附测定法测得的抗克氏锥虫抗体几何平均滴度显著下降。经过四年随访，当使用克氏锥虫鞭毛钙结合蛋白（F29）通过酶联免疫吸附测定法检测时，62%接受苯硝唑治疗的儿童克氏锥虫血清学检测呈阴性，而接受安慰剂治疗的儿童无一例血清学检测呈阴性。随访48个月后进行的虫媒接种诊断显示，4.7%接受苯硝唑治疗的儿童结果呈阳性，而接受安慰剂治疗的儿童这一比例为51.2%。这些结果表明，苯硝唑对6至12岁血清反应阳性儿童的克氏锥虫具有耐受性和疗效。我们使用了一种治疗后治愈的早期血清学标志物，它由一种重组抗体制成，用于快速、常规的血清学检测程序。
