Wallon Martine, Kieffer François, Binquet Christine, Thulliez Philippe, Garcia-Méric Patricia, Dureau Pascal, Franck Jacqueline, Peyron François, Bonnin Alain, Villena Isabelle, Bonithon-Kopp Claire, Gouyon Jean-Bernard, Masson Sandrine, Félin Alexandrin, Cornu Catherine
Service de Parasitologie et de Pathologie Exotique Hôpital de la Croix-Rousse, Lyon, France.
Therapie. 2011 Nov-Dec;66(6):473-80. doi: 10.2515/therapie/2011070. Epub 2011 Dec 21.
In France, children with confirmed congenital toxoplasmosis receive a treatment for a period of 12 to 24 months. Such prolonged treatment may generate potentially severe risks, in particular hematologic and cutaneous. Our objective is to compare the effectiveness of two therapeutic strategies on the prevention of retinochoroiditis by a randomized, non-inferiority, open-label, parallel study including 486 children, 3 to 6 months of age with a non-severe form of congenital toxoplasmosis. Following randomization, pyrimethamine-sulphonamide treatment is initiated for a period of three months, followed by a treatment with Fansidar(®) for 9 months, or therapeutic abstention. Follow-up visits during a two-year period will include an examination of the eye, a blood test, and questionnaires to evaluate the children's quality of life and their parents' anxiety. Confirming the non-inferiority of the effectiveness of a short-term treatment will improve the quality of life of parents and children.
在法国,确诊为先天性弓形虫病的儿童需接受为期12至24个月的治疗。如此长时间的治疗可能会产生潜在的严重风险,尤其是血液学和皮肤方面的风险。我们的目标是通过一项随机、非劣效性、开放标签、平行研究来比较两种治疗策略对预防视网膜脉络膜炎的有效性,该研究纳入了486名3至6个月大、患有非严重形式先天性弓形虫病的儿童。随机分组后,开始为期三个月的乙胺嘧啶 - 磺胺治疗,随后用 Fansidar(®) 治疗9个月,或不进行治疗。在两年的随访期间,将进行眼部检查、血液检测以及问卷调查,以评估儿童的生活质量和其父母的焦虑程度。证实短期治疗效果的非劣效性将改善父母和儿童的生活质量。