药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201462919465223.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Zemplar处方资料(仅供参考)
帕立骨化醇注射液(Zemplar ,Paricalcitol Injection) 帕立骨化醇注射剂(paricalcitol injection,商品名Zemplar)获FDA批准,用于5~19岁的儿童及青少年血液透析患者的继发性甲状旁腺功能亢进症(SHPT)。
该产品在1998年问世,目前在美国被广泛应用于成人血液透析患者的SHPT。
在美国,大约有1400名5~19岁的儿童接受血液透析的治疗。这种治疗是通过人工肾对红细胞进行过滤,以去除其中的废物及额外的液体。由于肾衰患者的体内不能产生有活性的维生素D,多数透析患者会发展成为SHPT。SHPT可导致骨疾病的发生,还可累及多个器官及组织等,包括血液、心脏、神经及肌肉。
一项为期12周的随机、双盲、安慰剂对照试验考察了帕立骨化醇注射剂的安全性及有效性。该试验由29位5~19岁接受血液透析治疗的慢性肾衰患者参加。几乎每位患者在试验前都接受过各种形式的维生素D治疗。在帕立骨化醇注射剂治疗组中,60%的患者甲状旁腺激素水平连续两次下降30%,而对照组只有21%的患者取得此种疗效。治疗组中有23%的患者出现了血钙的升高,低于对照组(31%)。
在试验中,治疗组及对照组均未出现高钙血症患者。
但是,临床试验表明,治疗组不良反应的发生率高于对照组5%(无论该不良反应是否与药物有直接的相关性)。常见的不良反应有恶心、呕吐、水肿。
帕立骨化醇注射剂不宜用于维生素D中毒、高钙血症或对该药成分过敏者。 Zemplar Company: Abbott Laboratories Approval Status: Approved April 1998 Treatment for: secondary hyperparathyroidism associated with chronic renal failure Areas: Diabetes / Endocrinology; Urology & Kidneys
General Information Zemplar (paricalcitol injection) has been approved for the treatment of secondary hyperparathyroidism associated with chronic renal failure. Zemplar is the first vitamin D analog available to treat secondary hyperparathyroidism.
Clinical Results In three placebo-controlled studies, chronic renal failure patients treated with Zemplar achieved a mean parathyroid hormone (PTH) reduction of 30% in six weeks. Additionally there was no difference in incidence of hypercalcemia or hyperphosphatemia when compared to placebo.
Side Effects In four, placebo-controlled, double blind, multi center studies, there was no significant difference in the incidence rate for adverse events between Zemplar and placebo-treated patients. The three most frequently reported events in the Zemplar clinical studies were nausea, vomiting and edema, which are commonly seen in hemodialysis patients.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201462919465223.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |