Rotmensz N, De Palo G, Formelli F, Costa A, Marubini E, Campa T, Crippa A, Danesini G M, Delle Grottaglie M, Di Mauro M G
Istituto Nazionale Tumori, Milan, Italy.
Eur J Cancer. 1991;27(9):1127-31. doi: 10.1016/0277-5379(91)90309-2.
A group of 53 patients initially participating in a phase I trial with the synthetic retinoid fenretinide was assessed for the long-term tolerability of this compound. The patients were evaluated after 42 months of drug intake at a dose of 200 mg/day, including a 3-day drug interruption at the end of each month, by the following examinations: a dermatological visit; an ophthalmological evaluation including an ophthalmological questionnaire and an electroretinogram (ERG); a study on blood chemistry and plasma retinol levels; a study on bone densities and on skeletal X-rays; and finally a psychological evaluation including various tests for anxiety, depression and overall mood. The results show that prolonged administration of fenretinide is well tolerated. No acute nor severe toxicity was observed and thus this compound can be considered a good candidate for chemoprevention trials in a variety of patient populations.
一组最初参与合成类视黄醇芬维A胺I期试验的53名患者接受了该化合物长期耐受性评估。在每天服用200毫克药物42个月后，包括每月末停药3天，通过以下检查对患者进行评估：皮肤科就诊；眼科评估，包括眼科问卷和视网膜电图（ERG）；血液化学和血浆视黄醇水平研究；骨密度和骨骼X线研究；最后是心理评估，包括各种焦虑、抑郁和总体情绪测试。结果表明，芬维A胺的长期给药耐受性良好。未观察到急性或严重毒性，因此该化合物可被视为各类患者群体化学预防试验的良好候选药物。
