Mei Changlin, Chen Nan, Ding Xiaoqiang, Yu Xueqing, Wang Li, Qian Jiaqi, Wang Mei, Jiang Gengru, Li Xuemei, Hou Fanfan, Zuo Li, Wang Niansong, Liu Hong
Shanghai Changzheng Hospital, Shanghai, China.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Hemodial Int. 2016 Oct;20(4):589-600. doi: 10.1111/hdi.12410. Epub 2016 Mar 4.
Introduction Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment vs. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis. Methods In this double-blind, multicenter, placebo-controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level ≤250 pg/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed. Findings In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH ≤250 pg/mL). Calcium and phosphorus levels and calcium-phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related. Discussion This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels.
引言 继发性甲状旁腺功能亢进（SHPT）发生于慢性肾衰竭患者。盐酸西那卡塞已在美国、欧洲和日本成功用于治疗SHPT，同时维持血清钙和磷水平。西那卡塞治疗与传统治疗相比的疗效和安全性在临床实践中备受关注。在近期在中国进行的这项III期研究中，评估了拟钙剂西那卡塞（协和麒麟株式会社）对接受血液透析的稳定慢性肾病患者SHPT治疗的疗效和安全性。
方法 在这项双盲、多中心、安慰剂对照、随机III期研究中，12个中心招募了238名受试者，并随机分为西那卡塞组和安慰剂组。血清甲状旁腺激素（PTH）水平≤250 pg/mL的患者百分比为主要疗效终点。测量血清钙和磷水平。记录不良事件和严重不良事件，并进行因果分析。
结果 在初步分析中，西那卡塞组25.4%的患者和安慰剂组3.5%的患者达到主要终点（PTH≤250 pg/mL）。与安慰剂组相比，西那卡塞组的钙、磷水平及钙磷乘积较低。报告了11起严重不良事件，认为与研究药物无关。报告了轻度至中度低钙血症和钙水平降低，认为与西那卡塞有关。
讨论 这项III期研究表明，西那卡塞对接受血液透析的中国慢性肾病患者以及基线PTH水平高得多的患者群体治疗SHPT有效且耐受性良好。
