Jean Guillaume, Vanel Thierry, Terrat Jean-Claude, Hurot Jean-Marc, Lorriaux Christie, Mayor Brice, Deleaval Patrick, Vovan Cyril, Chazot Charles
Centre de rein artificiel, 42, avenue du 8-mai-1945, 69160 Tassin-La-Demi-Lune, France.
Nephrol Ther. 2010 Apr;6(2):105-10. doi: 10.1016/j.nephro.2009.12.004. Epub 2010 Feb 24.
The treatment of secondary hyperparathyroidism (SHPT) in dialysis patients has changed with the introduction of cinacalcet (CC), which represents a medical alternative to surgical parathyroidectomy (PTX). The aim of our study is to prospectively assess the tolerance and efficacy of CC in patients, treated in one centre using long haemodialysis, with SHPT who do not respond to conventional therapy.
We prospectively observed all patients treated with CC between September 2004 and 2009. The characteristics of the patients were compared with that recorded for the patients non treated with CC. Biological factors and the efficacy of the treatment in the patients were compared before (T-0) and after (T-End) CC therapy. The haemodialysis (HD) schedule was 3 x 5 to 3 x 8 h per week. The biological criteria for CC prescription were a serum PTH level greater than 300 pg/ml, calcium level greater than 2.45 mmol/l and bone alkaline phosphatase level greater than 20 microg/l or, in cases of tertiary hyperparathyroidism (THPT), a calcium level greater than 2.55 mmol/l.
Eighty-one (14.7%) among the 550 HD patients were treated with CC. As compared to the untreated population, these patients were younger and had higher body mass index (BMI) and higher protein-catabolic rate (nPCR). The treatment failed in 6.1% of the treated patients; 12.3% had severe gastrointestinal side effects and 10% underwent PTX. The treatment was successful in 81.4% patients who were prescribed a mean final CC dosage of 51+/-30 mg/day. Between T-0 and T-End (18+/-15) months), the serum PTH levels decreased by 77%, calcaemia levels decreased by 10% and phosphataemia levels decreased by 14%. Therefore, the percentage of patients with normal biological parameters increased significantly : serum PTH (150-300 pg/ml: 0 to 50%), calcaemia (2.1-2.37 mmol/l: 6 to 77%) and phosphataemia (1.15-1.78 mol/l: 58 to 84%). After 12 months, eight patients (10%) successfully weaned from CC therapy. No episodes of hypocalcaemia (<2.0 mmol/l) occurred. Treatments with alfacalcidol (68 to 40%) and sevelamer (72 to 50%) decreased, treatments with CaCO(3) remained stable (20%), those with native vitamin D increased (55 to 95%).
The treatment of HD patients having SHPT and THPT with CC and vitamin D derivatives was efficacious and well tolerated in a majority of cases after the failure of conventional therapies. These treatments improved mineral metabolism significantly.
随着西那卡塞（CC）的引入，透析患者继发性甲状旁腺功能亢进（SHPT）的治疗发生了变化，CC为甲状旁腺切除术（PTX）提供了一种药物替代方案。我们研究的目的是前瞻性评估在一个中心接受长期血液透析、对传统治疗无反应的SHPT患者使用CC的耐受性和疗效。
我们前瞻性观察了2004年9月至2009年期间所有接受CC治疗的患者。将这些患者的特征与未接受CC治疗的患者记录进行比较。比较患者在CC治疗前（T-0）和治疗后（T-End）的生物学因素及治疗效果。血液透析（HD）方案为每周3次，每次5至8小时。CC处方的生物学标准为血清甲状旁腺激素（PTH）水平大于300 pg/ml、钙水平大于2.45 mmol/l、骨碱性磷酸酶水平大于20 μg/l，或者在三发性甲状旁腺功能亢进（THPT）病例中，钙水平大于2.55 mmol/l。
550例HD患者中有81例（14.7%）接受了CC治疗。与未治疗人群相比，这些患者更年轻，体重指数（BMI）和蛋白质分解代谢率（nPCR）更高。6.1%的接受治疗患者治疗失败；12.3%有严重胃肠道副作用，10%接受了PTX。81.4%接受治疗的患者治疗成功，这些患者平均最终CC剂量为51±30 mg/天。在T-0至T-End（18±15）个月期间，血清PTH水平下降了77%，血钙水平下降了10%，血磷水平下降了14%。因此，生物学参数正常的患者百分比显著增加：血清PTH（150 - 300 pg/ml：从0至50%）、血钙（2.1 - 2.37 mmol/l：从6至77%）和血磷（1.15 - 1.78 mol/l：从58至84%）。12个月后，8例患者（10%）成功停用CC治疗。未发生低钙血症（<2.0 mmol/l）发作。阿法骨化醇治疗（从68%降至40%）和司维拉姆治疗（从72%降至50%）减少，碳酸钙治疗保持稳定（20%），天然维生素D治疗增加（从55%增至95%）。
在传统治疗失败后，使用CC和维生素D衍生物治疗HD合并SHPT和THPT的患者在大多数情况下有效且耐受性良好。这些治疗显著改善了矿物质代谢。
