关键词: 维持性血液透析, 继发性甲状旁腺功能亢进, 西那卡塞, 真实世界研究

Abstract: Patients with chronic kidney disease (CKD) and uncontrolled secondary hyperparathyroidism (SHPT) are at high risk of cardiovascular events and associated mortality.Cinacalcet,a calcimimetic agent,was reported to effectively and safely reduce parathyroid hormone (PTH) levels in CKD patients with SHPT.However,data on efficacy and safety of cinacalcet in Chinese end stage renal disease patients are lacking.A phase IV,multicenter,openlabel study (ACTIVE) had been conducted to examine the effectiveness and safety of cinacalcet in Chinese maintenance hemodialysis(MHD） patients.This study had been performed in two phases.In phase 1,a cohort study with 32 weeks followup was designed to explore the efficacy and safety of cinacalcetIn phase 2,a realworld study of 20 additional weeks,patients who completed the cohort study decided independently whether to continue taking cinacalcet at their own costMHD patients with a baseline intact PTH (iPTH) ≥300 pg/ml were enrolled.The primary efficacy outcome is the proportion of patients achieving iPTH targets (150 pg/ml≤iPTH<300 pg/ml) after 20 weeks and 32 weeks of cinacalcet treatment.