盐酸Cinacalcet:一种治疗慢性肾病继发性甲状旁腺功能亢进的新方法。
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盐酸Cinacalcet:一种治疗慢性肾病继发性甲状旁腺功能亢进的新方法。
人学学报。2006 7月;16(3):253-8。
- PubMed ID
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16825031 (PubMed视图］
- 摘要
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继发性甲状旁腺功能亢进症(SHPT)的发生是由于肾脏衰竭扰乱了甲状旁腺激素(PTH)、钙、磷和维生素d之间复杂的相互作用，从而导致钙稳态受损。12年前，甲状旁腺的钙感应受体(CaR)首次被克隆出来，并被确定为甲状旁腺激素分泌的主要调节因子。细胞外钙(ec(Ca2+))的微小变化激活CaR，调节甲状旁腺激素，降钙素分泌，尿钙排泄，并最终调节骨转换。CaR成为钙模拟药发展的理想目标，能够放大其对ec(Ca2+)抑制甲状旁腺激素分泌的敏感性。Cinacalcet HCl是一种一流的拟钙剂，已在美国和欧盟获得批准，为SHPT的治疗提供了一种新的治疗方法。在三个相似设计的III期临床试验中，比较了接受标准SHPT治疗加盐酸cinacalcet或加安慰剂的患者，研究了盐酸cinacalcet治疗透析患者SHPT的疗效(n = 1136)。在三项研究中，Cinacalcet HCl剂量为30 ~ 180 mg/d，显著降低甲状旁腺激素，同时降低钙、磷和钙磷产物。根据国家肾脏基金会-肾脏疾病结局和质量倡议(NKF-K/DOQI)推荐的骨和矿物质代谢目标，41%的cinacalcet hcl治疗患者同时实现了甲状旁腺激素和钙磷产物目标，而安慰剂组只有6%。最近在美国进行的2项IIIb期研究(TARGET和CONTROL)的结果也表明，cinacalcet HCl可以显著降低或维持甲状旁腺激素的减少，同时降低钙、磷和钙-磷产物。此外，在这两项试验的基线时服用维生素D的患者能够看到维生素D剂量的平均显著降低。对盐酸cinacalcet试验数据的进一步评估显示了对SHPT患者临床结果的一些重要影响。 A combined post-hoc analysis of clinical events using data from 4 (n = 1,184) cinacalcet HCl phase II and III studies suggests that treatment with cinacalcet HCl has a beneficial effect on relative risks of parathyroidectomy, fracture, and hospitalization for cardiovascular complications. Nausea and vomiting occurred more often in patients taking cinacalcet HCl than in those taking a placebo. There were also transient episodes of hypocalcemia in 5% of cinacalcet HCl patients versus 1% of placebo patients. However, these episodes were rarely associated with symptoms. The development of calcimimetics has already changed the treatment of SHPT in renal patients. Its effectiveness on the control of PTH secretion, along with simultaneous reductions in calcium, phosphorus, and calcium-phosphorus product, give this agent an advantage over traditional therapies in all levels of severity of SHPT.
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