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西那卡塞治疗血液透析患者继发性甲状旁腺功能亢进：一项分层分析研究

Cinacalcet in hemodialysis patients with secondary hyperparathyroidism: a stratified study

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【作者】 安玉； 付平； 姜埃利； 章海涛； 陈佩玲； 刘章锁； 陈晓农； 凌毅生； 肖观清； 叶建明； 陈靖； 楼季庄； 王德光； 何强； 倪兆慧； 王世相； 丁国华； 毛永辉； 左力； 张爱华； 陈朝生； 牛建英； 刘虹； 李雪梅； 黄杰； 刘志红；

【Author】 AN Yu;FU Ping;JIANG Aili;ZHANG Haitao;CHEN Peiling;LIU Zhangsuo;CHEN Xiaonong;LING Yisheng;XIAO Guanqing;YE Jianming;CHEN Jing;LOU Jizhuang;WANG Deguang;HE Qiang;NI Zhaohui;WANG Shixiang;DING Guohua;MAO Yonghui;ZUO Li;ZHANG Aihua;CHEN Chaosheng;NIU Jianying;LIU Hong;LI Xuemei;HUANG Jie;LIU Zhihong;National Clinical Research Center for Kidney Diseases, Jinling Hospital;West China Hospital of Sichuan University,Kidney Research Laboratory, Division of Nephrology and National Clinical Research Center for Geriatrics;The Second Hospital of Tianjin Medical University, Tianjin Institute of Urology, Department of Kidney Disease & Blood Purification Treatment;The First Affiliated Hospital of Zhengzhou University, Department of Nephrology;Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Department of Nephrology;Zhongshan Hospital, Xiamen University, Department of Nephrology;The First People’s Hospital of Foshan, Nephrology Department;The First People’s Hospital of Kunshan, Department of Nephrology;Huashan Hospital, Shanghai Medical College, Fudan University, National Clinical Research Center for Aging and Medicine, Division of Nephrology;Nanjing First Hospital, Nanjing Medical University, Division of Hemodialysis;The Second Affiliated Hospital of Anhui Medical University, Department of Nephrology;Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, Nephrology Division;Renji Hospital, School of Medicine, Shanghai Jiaotong University, Department of Nephrology;Beijing Chao-Yang Hospital, Capital Medical University, Nephrology Faculty, Department of Blood Purification;Renmin Hospital of Wuhan University, Division of Nephrology;Beijing Hospital, Department of Nephrology, National Center of Gerontology;Peking University People’s Hospital, Department of Nephrology;Xuanwu Hospital Capital Medical University, Department of Nephrology;The First Affiliated Hospital of Wenzhou Medical University, Department of Nephrology;The Fifth People’s Hospital of Shanghai, Fudan University, Department of Nephrology;The Second Xiangya Hospital, Central South University, Department of Nephrology, Key Lab of Kidney Disease and Blood Purification in Hunan;Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Department of Nephrology;Kyowa Kirin China Pharmaceutical Co., Ltd, Department of Medical Affairs;

【通讯作者】 刘志红;

【机构】 东部战区总医院国家肾脏疾病临床医学研究中心； 四川大学华西医院肾脏病研究实验室国家老年医学临床研究中心； 天津医科大学第二医院天津市泌尿外科研究所肾脏病与血液净化治疗科； 郑州大学第一附属医院肾脏病科； 上海交通大学医学院瑞金医院肾内科； 厦门大学中山医院肾内科； 佛山市第一人民医院肾内科； 昆山市第一人民医院肾内科； 复旦大学上海医学院华山医院国家衰老与医学临床研究中心肾脏病科； 南京医科大学南京第一医院血液透析科； 安徽医科大学第二附属医院肾内科； 四川省医学科学院四川省人民医院肾脏病研究室； 上海交通大学医学院仁济医院肾内科； 首都医科大学附属北京朝阳医院血液净化科首都医科大学肾脏病学院； 武汉大学人民医院肾内科； 北京医院肾内科国家老年医学中心； 北京大学人民医院肾内科； 首都医科大学宣武医院肾内科； 温州医科大学附属第一医院肾内科； 复旦大学附属上海市第五人民医院肾内科； 中南大学湘雅二医院肾内科湖南省肾脏疾病与血液净化重点实验室； 中国医学科学院北京协和医学院北京协和医院肾内科； 维健医药有限公司医学部；

【摘要】 目的：探究西那卡塞在伴不同严重程度继发性甲状旁腺功能亢进(SHPT)的维持性血液透析(MHD)患者中的疗效与安全性。方法：本研究为开放标签、平行分组、多中心研究，包括第一阶段为期32周的药物干预研究，以及第二阶段为期20周的试验后随访。根据基线全段甲状旁腺激素(iPTH)水平将患者为轻度(≥300 pg/mL且<600 pg/mL)、中度(≥600 pg/mL且<900 pg/mL)或重度(≥900 pg/mL)SHPT组。在第一阶段，受试者在常规治疗的基础上口服西那卡塞1次/d,剂量从25 mg逐步递增至100 mg,以达到iPTH≥150 pg/mL且<300 pg/mL的目标值。在第二阶段，患者可自行选择是否继续服用西那卡塞。主要疗效指标为第20周和第32周iPTH达标率。结果：共纳入750例SHPT患者，其中轻度组275例(36.7%),中度组224例(29.9%),重度组251例(33.4%)。治疗20周时，三组患者iPTH达标率分别为35.5%、28.3%和12.4%(P<0.001)。治疗32周时，这一比例分别上升至41.2%、27.7%和15.9%(P<0.001)。西那卡塞治疗显著降低了各组患者的血钙、血磷和成纤维细胞生长因子23(FGF-23)水平。随着SHPT程度加重，患者需要的西那卡塞治疗剂量增加，低钙血症发生率也随之升高。试验后随访20周，分别有40.0%和47.6%的患者仍维持了iPTH和FGF-23较基线下降≥30%。结论：MHD患者在SHPT早期阶段启动西那卡塞治疗有助于提高疗效，应重视对西那卡塞不良反应的观察及处理。

【Abstract】 Objective:To Evaluate the efficacy and safety of cinacalcet in maintenance hemodialysis patients with varying severity of secondary hyperparathyroidism(SHPT). Methodology:This open-label, parallel-group, multicenter study consisted of a 32-week cohort study followed by a 20-week post-trial follow-up. Patients were stratified by baseline iPTH levels into mild(≥300 pg/mL and <600 pg/mL), moderate(≥600 pg/mL and <900 pg/mL), or severe(≥900 pg/mL) categories. During the cohort study, participants received oral cinacalcet once daily, titrated from 25 mg to 100 mg, to achieve a target iPTH of ≥150 pg/mL and <300 pg/mL alongside conventional therapy. In the post-trial follow-up, patients chose whether to continue cinacalcet at their own expense. The primary efficacy outcome was the proportion of patients achieving the target iPTH level at weeks 20 and 32. Results:A total of 750 patients were enrolled, including 275 with mild, 224 with moderate, and 251 with severe SHPT. The primary efficacy outcome was achieved by 35.5%, 28.3%, and 12.4% of patients in the mild-to-severe groups, respectively, at week 20(P<0.001). By week 32, these rates increased to 41.2%, 27.7%, and 15.9%, respectively(P<0.001). Cinacalcet significantly reduced serum calcium, phosphorus, and fibroblast growth factor 23(FGF-23) levels across all SHPT severity groups. Higher cinacalcet doses and increased hypocalcemia incidence were observed in patients with more severe SHPT. During the post-trial follow-up, 40.0% and 47.6% of patients maintained ≥30% reductions in iPTH and FGF-23, respectively. Conclusion:These findings support initiating cinacalcet treatment at an early stage of SHPT in patients on maintenance hemodialysis. However, attention should be paid to treatment related adverse events.

【关键词】 西那卡塞； 维持性血液透析； 继发性甲状旁腺功能亢进； 甲状旁腺激素； 成纤维细胞生长因子23；
【Key words】 cinacalcet； maintenance hemodialysis； secondary hyperparathyroidism； parathyroid hormone； fibroblast growth factor 23；
【基金】 国家自然科学基金青年项目(82300835);江苏省卫生健康委创新中心项目(CXZX202202)
  • 【文献出处】 肾脏病与透析肾移植杂志 ,Chinese Journal of Nephrology,Dialysis & Transplantation , 编辑部邮箱 ,2025年06期
  • 【分类号】R692.5;R582.1
  • 【下载频次】7
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