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

作　　者：谢先达 唐代荣 邹琴[1] 陈香文[1] 陈喆 晏雄 廖湘平[1] XIE Xian-da;TANG Dai-rong;ZOU Qin;CHEN Xiang-wen;CHEN Zhe;YAN Xiong;LIAO Xiang-ping(Department of Renal Rheumatology and Immunology,Chenzhou First People's Hospital,Chenzhouu423000,Hunan Province,China)

机构地区：[1]郴州市第一人民医院肾脏风湿免疫科,湖南郴州423000

出　　处：《中国临床药理学杂志》2025年第5期636-640,共5页The Chinese Journal of Clinical Pharmacology

基　　金：湖南省卫生健康委科研计划基金资助项目(D202305038688);郴州市科技局课题基金资助项目(lcy12021044)。

摘　　要：目的探讨西那卡塞治疗慢性肾病(CKD)血液透析继发性甲状旁腺功能亢进(SHPT)患者的临床研究。方法将CKD血液透析SHPT患者按队列法分为对照组和试验组。对照组给予骨化三醇胶囊0.25μg,qd,口服;试验组在对照组治疗的基础上给予西那卡塞片25 mg,qd,口服。2组患者均持续治疗12周。比较2组患者的临床疗效、甲状旁腺体积、甲状旁腺功能[血磷、血钙、碱性磷酸酶(ALP)、全段甲状旁腺激素(iPTH)]、心血管功能[肌酸激酶同工酶(CK-MB)、高敏肌钙蛋白Ⅰ(hs-cTnⅠ)、肌红蛋白(MYO)],并评价安全性。结果试验组和对照组分别入组62和58例。治疗后,试验组和对照组的总有效率分别为93.55%(58例/62例)和77.59%(45例/58例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血磷水平分别为(1.31±0.16)和(1.50±0.34)mmol·L^(-1),血钙水平分别为(2.63±0.91)和(2.25±0.72)mmol·L^(-1),ALP水平分别为(83.28±8.40)和(126.46±12.39)U·L^(-1),iPTH水平分别为(215.32±16.69)和(307.65±20.14)pg·mL^(-1),在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的甲状旁腺腺体的长分别为(0.58±0.10)和(0.77±0.19)cm,宽分别为(0.34±0.08)和(0.45±0.16)cm,厚分别为(0.25±0.05)和(0.33±0.15)cm,体积分别为(0.82±0.15)和(1.13±0.22)cm^(3),在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组血清CK-MB水平分别为(4.18±0.73)和(6.53±1.26)ng·mL^(-1),hs-cTnⅠ水平分别为(0.04±0.01)和(0.07±0.03)ng·mL^(-1),MYO水平分别为(70.69±9.41)和(112.39±12.60)ng·mL^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应主要有恶心呕吐、血压增高、肌痛。试验组和对照组的药物不良反应总发生率分别为8.06%(5例/62例)和22.41%(13例/58例),在统计学上差异有统计学意义(P<0.05)。结论西那卡塞治疗CKD血液透析SHPT患者的疗效显著,可缩小甲�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 0.25μg of calcitriol capsules once a dayviaoral administration.On this basis,the treatment group was treated with 25 mg of cinacalcet tablets once a dayviaoral 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 troponinⅠ(hs-cTnⅠ)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)and77.59%(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(allP<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)cm^(3).The differences were statistically significant(allP<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-cTnⅠlevels wer

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 

分 类 号：R97[医药卫生—药品]