Department of Pediatrics, Rady Children's Hospital-San Diego, University of California San Diego, 3030 Children's Way, San Diego, CA 92123, USA.
Pediatr Nephrol. 2013 Mar;28(3):507-10. doi: 10.1007/s00467-012-2315-5. Epub 2012 Sep 25.
Patients with nephropathic cystinosis are required to take 6-hourly immediate-release cysteamine (Cystagon®) to reduce disease progression. This arduous regimen affects quality of life, disrupts sleep, and may result in non-compliance with therapy. Enteric-coated cysteamine bitartrate (EC-cysteamine) was developed as a "proof-of-concept" formulation for twice-daily ingestion. Previous reports have shown this therapy to be effective up to a mean of 14 months.
CASE-DIAGNOSIS/TREATMENT: Two subjects (aged 13 and 15 years) received EC-cysteamine for 5-6 years at 60-65 % of their previous total daily dose of immediate-release cysteamine given at 6-h intervals. White blood cell (WBC) cystine levels were monitored every 1-3 months.
The administration of EC-cysteamine did not result in any change in mean trough WBC cystine levels or any deterioration in the estimated glomerular filtration rate, thyroid, or liver function, suggesting that delayed-release, twice-daily EC-cysteamine is an effective long-term treatment alternative to immediate-release cysteamine given at 6-h intervals.
患有遗传性胱氨酸贮积症的患者需要每 6 小时服用一次即释型半胱氨酸(Cystagon®)以减缓疾病进展。这种艰苦的治疗方案会影响生活质量,扰乱睡眠,并且可能导致治疗的不依从性。肠包衣半胱氨酸酒石酸盐(EC-半胱氨酸)作为每日两次摄入的“概念验证”制剂而被开发。先前的报告表明,这种疗法在平均 14 个月内是有效的。
病例诊断/治疗:两名受试者(年龄分别为 13 岁和 15 岁)以其之前每 6 小时接受的即释型半胱氨酸总日剂量的 60-65%的剂量,接受 EC-半胱氨酸治疗 5-6 年。每隔 1-3 个月监测白细胞(WBC)胱氨酸水平。
给予 EC-半胱氨酸不会导致 WBC 胱氨酸平均谷值水平发生任何变化,也不会导致肾小球滤过率、甲状腺或肝功能的任何恶化,这表明延迟释放、每日两次的 EC-半胱氨酸是一种有效的长期治疗选择,可替代每 6 小时给予一次的即释型半胱氨酸。