Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD
Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD
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DOI：
10.1053/j.ajkd.2005.10.007
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发表时间：
2006-02-01
影响因子：
13.2
通讯作者：
Sprague, SM
中科院分区：
文献类型：
--
作者：
Coyne, D;Acharya, M;Sprague, SM
背景帕立骨化醇注射液用于预防和治疗慢性肾脏病（CKD）5期患者继发性甲状旁腺功能亢进（SHPT）的安全性和疗效已得到充分证实。开发帕立骨化醇胶囊是为了为3期和4期CKD患者提供一种方便的剂型。方法：在伴有SHPT的3期和4期CKD患者中进行了3项随机、安慰剂对照、3期试验。入选标准包括估计的肾小球滤过率在15 - 60 mL/min/ 1.73 n（2）（0.25和1.00 mL/s/1.73 m（2）），平均连续2次全段甲状旁腺激素（iPTH）水平大于150 pg/mL（ng/L），连续2次血清钙水平介于8.0和10.0 mg/dL（2.00和2.50 mmol/L）之间，且连续2次血清磷水平≤ 5.2 mg/dL（：
Background The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 5. The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD. Methods:Three randomized, placebo-controlled, phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT. Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/ 1.73 n(2) (0.25 and 1.00 mL/s/1.73 m(2)), an average of 2 consecutive intact parathyroid hormone (iPTH) levels greater than 150 pg/mL (ng/L), 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL (2.00 and 2.50 mmol/L), and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less (: