中国临床药理学杂志2025，Vol.41Issue(5)：636-640,5.DOI:10.13699/j.cnki.1001-6821.2025.05.008
西那卡塞治疗CKD血液透析继发性甲状旁腺功能亢进患者的临床研究
Clinical trial of cinacalcet in the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis for CKD
摘要
Abstract
Objective To investigate the clinical effect of cinacalcet in the treatment of secondary hyperparathyroidism(SHPT)in patients undergoing hemodialysis for chronic kidney disease(CKD).Methods Patients who underwent hemodialysis for CKD and had SHPT were divided into the control group and the treatment group according to the cohort method.The control group was treated with 0.25 μg of calcitriol capsules once a day via oral administration.On this basis,the treatment group was treated with 25 mg of cinacalcet tablets once a day via oral administration.Patients in both groups were treated for 12 weeks.Clinical efficacy,parathyroid volume,parathyroid function[serum phosphorus,serum calcium,alkaline phosphatase(ALP)and intact parathyroid hormone(iPTH)],and cardiovascular function[creatine kinase-MB(CK-MB),hypersensitive troponin Ⅰ(hs-cTn Ⅰ)and myoglobin(MYO)]were compared between the two groups.Safety was evaluated.Results Sixty-two cases were enrolled in the treatment group and fifty-eight cases in the control group.After treatment,the total effective rates in the treatment group and the control group were 93.55％(58 cases/62 cases)and 77.59％(45 cases/58 cases),with statistically significant difference(P＜0.05).After treatment,serum phosphorus levels in the treatment group and the control group were(1.31±0.16)and(1.50±0.34)mmol·L-1;serum calcium levels were(2.63±0.91)and(2.25±0.72)mmol·L-1;ALP levels were(83.28±8.40)and(126.46±12.39)U·L-1;iPTH levels were(215.32±16.69)and(307.65±20.14)pg·mL-1.The differences were statistically significant(all P＜0.05).After treatment,the length of the parathyroid gland in the treatment group and the control group were(0.58±0.10)and(0.77±0.19)cm;width were(0.34±0.08)and(0.45±0.16)cm;thickness were(0.25±0.05)and(0.33±0.15)cm;volume were(0.82±0.15)and(1.13±0.22)cm3.The differences were statistically significant(all P＜0.05).After treatment,serum CK-MB levels in the treatment group and the control group were(4.18±0.73)and(6.53±1.26)ng·mL-1;hs-cTn Ⅰ levels were(0.04±0.01)and(0.07±0.03)ng·mL-1;MYO levels were(70.69±9.41)and(112.39±12.60)ng·mL-1.The differences were statistically significant(all P＜0.05).The adverse drug reactions in the treatment group and the control group mainly included nausea and vomiting,increased blood pressure,and myalgia.The total incidence of adverse drug reactions in the treatment group and the control group were 8.06％(5 cases/62 cases)and 22.41％(13 cases/58 cases),respectively,and the difference was statistically significant(P＜0.05).Conclusion Cinacalcet is effective in the treatment of SHPT in patients undergoing hemodialysis for CKD.It can reduce parathyroid gland volume,maintain calcium and phosphorus metabolism,and protect cardiovascular function,with high safety.关键词
西那卡塞片/慢性肾病/血液透析/继发性甲状旁腺功能亢进/甲状旁腺功能/心血管功能Key words
cinacalcet tablet/chronic kidney disease/hemodialysis/secondary hyperparathyroidism/parathyroid function/cardiovascular function分类
药学引用本文复制引用
谢先达,唐代荣,邹琴,陈香文,陈喆,晏雄,廖湘平..西那卡塞治疗CKD血液透析继发性甲状旁腺功能亢进患者的临床研究[J].中国临床药理学杂志,2025,41(5):636-640,5.基金项目
湖南省卫生健康委科研计划基金资助项目(D202305038688) （D202305038688）
郴州市科技局课题基金资助项目(lcy12021044) （lcy12021044）
