Harrod Virginia L, Howard Thad, Abboud Miguel R, Hankins Jane, Lobo Clarisse, Ware Russell E
Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee 38105, USA.
Pediatr Hematol Oncol. 2008 Jun;25(5):423-9. doi: 10.1080/08880010802107273.
Hydroxyurea has documented laboratory and clinical efficacy for children with sickle cell anemia (SCA), and has potential to become an effective and inexpensive treatment option for patients in countries with limited resources. Concerns exist, however, regarding product quality and manufacturing variability among different international vendors, particularly for generic formulations. To address these concerns, hydroxyurea capsules from 8 different pharmaceutical sources were analyzed using quantitative chemical and functional assays. All samples had measured values within 20% of expected results, with no significant differences observed among vendors. Generic hydroxyurea formulations represent a potent yet inexpensive therapeutic option for children with SCA worldwide.
羟基脲已被证明对镰状细胞贫血（SCA）患儿具有实验室和临床疗效，并且有可能成为资源有限国家患者的一种有效且廉价的治疗选择。然而，对于不同国际供应商之间的产品质量和生产变异性存在担忧，特别是对于仿制药配方。为了解决这些担忧，使用定量化学和功能分析方法对来自8个不同制药来源的羟基脲胶囊进行了分析。所有样品的测量值均在预期结果的20%以内，各供应商之间未观察到显著差异。通用羟基脲配方是全球SCA患儿一种有力且廉价的治疗选择。
