转换为碳酸镧单药治疗可有效控制血清磷，减少片剂负担：一项多中心开放标签研究。
Conversion to lanthanum carbonate monotherapy effectively controls serum phosphorus with a reduced tablet burden: a multicenter open-label study.
机构信息
Department of Medicine (Nephrology), Sierra View District Hospital, Porterville, CA, USA.
出版信息
BMC Nephrol. 2011 Sep 30;12:49. doi: 10.1186/1471-2369-12-49.
BACKGROUND
Lanthanum carbonate (FOSRENOL®) is an effective, well-tolerated phosphate binder. The ability of lanthanum to reduce serum phosphorus levels to ≤5.5 mg/dL in patients with end-stage renal disease (ESRD) was assessed in a clinical practice setting.
METHODS
A 16-week, phase IV study enrolled 2763 patients at 223 US sites to evaluate the efficacy of lanthanum carbonate in controlling serum phosphorus in patients with ESRD, and patient and physician satisfaction with, and preference for, lanthanum carbonate after conversion from other phosphate-binder medications. Patients received lanthanum carbonate prescriptions from physicians. These prescriptions were filled at local pharmacies rather than obtaining medication at the clinical trial site. Changes from serum phosphorus baseline values were analyzed using paired t tests. Patient and physician preferences for lanthanum carbonate versus previous medications were assessed using binomial proportion tests. Satisfaction was analyzed using the McNemar test. Daily dose, tablet burden, and laboratory values including albumin-adjusted serum calcium, calcium × phosphorus product, and parathyroid hormone levels were secondary endpoints.
RESULTS
Serum phosphorus control (≤5.5 mg/dL) was effectively maintained in patients converting to lanthanum carbonate monotherapy; 41.6% of patients had controlled serum phosphate levels at 16 weeks. Patients and physicians expressed markedly higher satisfaction with lanthanum carbonate, and preferred lanthanum carbonate over previous medication. There were significant reductions in daily dose and daily tablet burden after conversion to lanthanum carbonate.
CONCLUSIONS
Serum phosphorus levels were effectively maintained in patients converted from other phosphate-binder medications to lanthanum carbonate, with increased satisfaction and reduced tablet burden.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT0016012.
背景
碳酸镧（FOSRENOL®）是一种有效且耐受性良好的磷结合剂。在临床实践环境中评估了镧减少终末期肾病（ESRD）患者血清磷水平至≤5.5mg/dL 的能力。
方法
一项为期 16 周的 4 期研究在 223 个美国地点招募了 2763 名患者，以评估碳酸镧在控制 ESRD 患者血清磷方面的疗效，以及患者和医生对转换为其他磷结合药物后对碳酸镧的满意度和偏好。患者从医生那里获得碳酸镧处方。这些处方在当地药店填写，而不是在临床试验现场获得药物。使用配对 t 检验分析从血清磷基线值的变化。使用二项式比例检验评估患者和医生对碳酸镧与之前药物的偏好。使用 McNemar 检验分析满意度。每日剂量、片剂负担以及包括白蛋白校正的血清钙、钙×磷乘积和甲状旁腺激素水平在内的实验室值是次要终点。
结果
转换为碳酸镧单药治疗的患者有效地维持了血清磷控制（≤5.5mg/dL）；16 周时，41.6%的患者血清磷酸盐水平得到控制。患者和医生对碳酸镧的满意度明显更高，并更喜欢碳酸镧而不是之前的药物。转换为碳酸镧后，每日剂量和每日片剂负担显著减少。
结论
从其他磷结合药物转换为碳酸镧的患者血清磷水平得到有效维持，满意度提高，片剂负担减轻。
试验注册
ClinicalTrials.gov：NCT0016012。
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