Servicio de Nefrología. Hospital Universitario Dr. Peset. Valencia Spain.
Nefrologia. 2013 Jan 18;33(1):46-60. doi: 10.3265/Nefrologia.pre2012.Nov.11703.
OSERCE is a multi-centre and cross-sectional study with the aim of analysing the biochemical, clinical, and management characteristics of bone mineral metabolism alterations and the level of compliance with K/DOQI guideline recommendations in patients with chronic kidney disease (CKD) not on dialysis. The study included a total of 634 patients from 32 different Spanish nephrology units, all with CKD, estimated glomerular filtration rates <60 ml/min/1.73 m(2), and not on dialysis (K/DOQI stage: 33% stage 3, 46% stage 4, and 21% stage 5). In 409 of these patients, laboratory parameters were also measured in a centralised laboratory, including creatinine, calcium, phosphorous, intact parathyroid hormone (PTH), 25-OH-vitamin D, and 1,25-OH2-Vitamin D levels. The rates of non-compliance with the K/DOQI objectives for calcium, phosphorous, intact PTH, and calcium x phosphate product among these patients were 45%, 22%, 70%, and 4%, respectively. Of the 70% of patients with intact PTH levels outside of the target range established by the K/DOQI guidelines, 55.5% had values above the upper limit and 14.5% had values below the lower limit. Of the 45% of patients with calcium levels outside of the target range, 40% had values above the upper limit and 5% had values below the lower limit. Of the 22% of patients with phosphorous levels outside of the target range, 19% had values above the upper limit, and 3% had values below the lower limit. Finally, 4% of patients also had values for the calcium x phosphate product that were outside of the recommended range. Only 1.8% of patients complied with all four K/DOQI objectives. The values detected in centralised laboratory analyses were not significantly different from those measured in the laboratories at each institution. In addition, 81.5% of patients had a deficiency of calcidiol (25-OH-D3) (<30 ng/ml); of these, 35% had moderate-severe deficiency (<15 ng/ml) and 47% had mild deficiency (15-30 ng/ml). Calcitriol (1,25-OH2-D3) levels were deficient in 64.7% of patients. Whereas the calcidiol deficiency was not correlated with the CKD stage, calcitriol deficit were more pronounced at more advanced stages of CKD. The results of the OSERCE study confirm the difficulty in reaching the target values recommended by the K/DOQI guidelines in patients with CKD not on dialysis, in particular in the form of poor control of secondary hyperparathyroidism and vitamin D deficiency. With this in mind, we must review strategies for treating bone mineral metabolism alterations in these patients, and perhaps revise the target parameters set by current guidelines.
OSERCE 是一项多中心、横断面研究，旨在分析未接受透析的慢性肾脏病（CKD）患者的骨矿物质代谢改变的生化、临床和管理特征，以及对 K/DOQI 指南建议的依从性水平。该研究纳入了来自西班牙 32 个不同肾病单位的 634 例 CKD 患者，所有患者的估计肾小球滤过率<60 ml/min/1.73 m(2)，且未接受透析（K/DOQI 分期：33%为 3 期，46%为 4 期，21%为 5 期）。在其中 409 例患者中，还在中心实验室测量了实验室参数，包括肌酐、钙、磷、全段甲状旁腺激素（PTH）、25-羟维生素 D 和 1,25-羟维生素 D。这些患者中，钙、磷、全段 PTH 和钙磷乘积不依从 K/DOQI 目标的比例分别为 45%、22%、70%和 4%。在甲状旁腺激素水平超出 K/DOQI 指南设定目标范围的 70%患者中，55.5%的患者值超过上限，14.5%的患者值低于下限。在钙水平超出目标范围的 45%患者中，40%的患者值超过上限，5%的患者值低于下限。在磷水平超出目标范围的 22%患者中，19%的患者值超过上限，3%的患者值低于下限。最后，4%的患者的钙磷乘积也超出了推荐范围。只有 1.8%的患者同时符合 K/DOQI 的四项目标。中心实验室分析检测到的数值与各机构实验室测量的值没有显著差异。此外，81.5%的患者存在钙二醇（25-羟维生素 D3）缺乏症（<30ng/ml）；其中，35%为中重度缺乏症（<15ng/ml），47%为轻度缺乏症（15-30ng/ml）。64.7%的患者存在 1,25-羟维生素 D3 缺乏症。钙二醇缺乏症与 CKD 分期无关，但在 CKD 分期较晚时，1,25-羟维生素 D3 缺乏症更为明显。OSERCE 研究的结果证实，未接受透析的 CKD 患者很难达到 K/DOQI 指南推荐的目标值，特别是在继发性甲状旁腺功能亢进和维生素 D 缺乏症的控制不佳方面。有鉴于此，我们必须重新评估这些患者的骨矿物质代谢改变的治疗策略，也许需要修改当前指南设定的目标参数。
