Pérez-Ricart Ariadna, Galicia-Basart Maria, Comas-Sugrañes Dolors, Cruzado-Garrit Josep-Maria, Segarra-Medrano Alfons, Montoro-Ronsano José-Bruno
Pharmacy Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Nephrology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Kidney Res Clin Pract. 2019 Jun 30;38(2):229-238. doi: 10.23876/j.krcp.18.0088.
Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD). Cinacalcet use is controversial in non-dialysis patients.
This retrospective observational study recruited patients receiving cinacalcet (off-label use) in 2010 and 2011. Patients were followed for three years from the beginning of treatment using an intention-to-treat approach.
Forty-one patients were studied: 14 CKD stage 3 (34.1%), 21 CKD stage 4 (51.2%), and 6 CKD stage 5 (14.6%). Median baseline parathyroid hormone (PTH) was 396 (101-1,300) pg/mL. Upon cinacalcet treatment (22 ± 12 months), PTH levels decreased by ≥ 30% in 73.2% of patients ( < 0.001; 95% confidence interval [CI], 59-87%), with a mean time for response of 18.7 months (95% CI, 15.4-22.1). Sixteen patients were followed for 36 months and treated for 32 ± 9 months. Mean reduction in their PTH levels was 50.1% ( < 0.001; 95% CI, 33.8-66.4%) at 36 months, with 62.5% of patients ( < 0.001; 95% CI, 35.9-89.1%) presenting reductions of ≥ 30%. Serum calcium levels decreased from 9.95 ± 0.62 mg/dL to 9.21 ± 0.83 and 9.12 ± 0.78 mg/dL at 12 and 36 months, respectively ( < 0.001). Serum phosphorus levels increased from 3.59 ± 0.43 to 3.82 ± 0.84 at 12 months ( = 0.180), remaining so at 36 months ( = 0.324). At 12 and 36 months, 2 (12.5%) patients experienced hypocalcemia. Meanwhile, 1 (6.3%) and 4 (25.0%) patients reported hyperphosphatemia at 12 and 36 months, respectively.
Cinacalcet remained effective for at least 36 months in non-dialysis patients with SHPT. Electrolytic disturbances were managed with concurrent use of vitamin D and its analogs or phosphate binders.
继发性甲状旁腺功能亢进（SHPT）是慢性肾脏病（CKD）的常见并发症。西那卡塞在非透析患者中的使用存在争议。
这项回顾性观察性研究纳入了2010年和2011年接受西那卡塞（超说明书用药）治疗的患者。采用意向性分析方法，从治疗开始对患者进行了三年的随访。
共研究了41例患者：14例为CKD 3期（34.1%），21例为CKD 4期（51.2%），6例为CKD 5期（14.6%）。甲状旁腺激素（PTH）基线中位数为396（101 - 1300）pg/mL。在西那卡塞治疗（22±12个月）后，73.2%的患者PTH水平下降≥30%（P<0.001；95%置信区间[CI]，59 - 87%），平均起效时间为18.7个月（95%CI，15.4 - 22.1）。16例患者随访36个月，治疗32±9个月。36个月时，他们的PTH水平平均降低50.1%（P<0.001；95%CI，33.8 - 66.4%），62.5%的患者（P<0.001；95%CI，35.9 - 89.1%）PTH水平降低≥30%。血清钙水平在12个月和36个月时分别从9.95±0.62mg/dL降至9.21±0.83mg/dL和9.12±0.78mg/dL（P<0.001）。血清磷水平在12个月时从3.59±0.43升高至3.82±0.84（P = 0.180），36个月时仍维持此水平（P = 0.324）。在12个月和36个月时，各有2例（12.5%）患者发生低钙血症。同时，分别有1例（6.3%）和4例（25.0%）患者在12个月和36个月时报告发生高磷血症。
西那卡塞在非透析SHPT患者中至少36个月内仍有效。通过同时使用维生素D及其类似物或磷结合剂来处理电解质紊乱。
