帕立骨化醇在维持性血液透析患者中的应用效果分析

Application of Paricalcitol in the Treatment of Patients with Maintenance Hemodialysis

目的:探讨帕立骨化醇用于维持性血液透析伴有继发性甲状旁腺功能亢进(Secondary hyperparathyroidism,SHPT)患者的临床疗效和安全性。方法:选择哈尔滨医科大学附属第一医院血液净化科长期维持血液透析伴有SHPT的45例患者,将其随机分为三组,一组为帕立骨化醇组(起始剂量0.04μg/kg);一组为骨化三醇组(起始剂量0.01μg/kg),每周三次给药;一组为西那卡塞+小剂量活性维生素D(西那卡塞起始剂量为25 mg/天),根据血清甲状旁腺素(PTH)下降幅度调整药物剂量,主要疗效指标为治疗12周PTH较基线水平下降>50%;次要疗效指标包括:PTH降至正常范围(150～300 pg/mL),血钙、血磷变化。每4周调整一次药物剂量,以PTH浓度降低至少50%为目标,如果连续2周PTH水平降低至低于100 pg/mL,或钙磷乘积≧75,或血清总钙≧10 mg/dl均应减少剂量,通过调整剂量标准达到维持剂量。结果:与骨化三醇、西那卡塞相比,帕立骨化醇基线PTH分别为(847.35±381.09,1228.03±265.49,1204.87±407.7)和3个月PTH分别为(622.71±417.66,787.46±289.61,817.81±403.67),基线血钙水平(2.08±0.19,2.17±0.17,2.52±0.13),血钙平均升高为20%,基线血磷水平(2.2±0.55,1.89±0.42,2.31±0.49),血磷平均升高25.7%,三组PTH达标率分别为(80%,55.5%,45.4%),差异具有统计学意义(P<0.05)。结论:静脉注射帕立骨化醇用于长期维持血液透析伴有SHPT的患者在降低PTH方面更安全,效果更优于骨化三醇及西那卡塞,剂量较高时仍有并发高钙、高磷血症的风险而需调整剂量或暂时停药,须根据患者具体情况选择个体化剂量以获得最佳的临床疗效。

Objective：To investigate the clinical efficiency and security of Paricalcitol in the treatment of patients on maintenance hemodialysis.Methods：45 patients on maintenance hemodialysis with Secondary hyperparathyroidism（SHPT） in the First Hospital of Harbin Medical University were involved in our research.The patients had received hemodialysis for over 3 months.They patients were divided into three groups randomly,and each group contained 15 cases,receiving Paricalcitol（started with 0.04 μg/kg）,Calcitriol（started with 0.01 μg/kg） and Calcimimetics（stared with 25 mg/day） with small dose of active vitmin D,respectively.We mediated the doses of the drugs mainly according to decrease of parathyroid hormone（PTH）,which is 50 percents lower compared to the baseline.And the secondary criterion included PTH decreased to normal range（150-300 pg/mL） and the alteration of calcium and phosphorus.The drug doses were mediated every four weeks aiming at decrease of PTH to 50 percents at least.Additionally,the doses might be lessen,if PTH maintained lower than 100 pg/mL or calcium in blood higher than 10 mg/dL until doses were standard sustaining level.Results：The PTH in baseline was 847.35 ±381.09,1228.03 ±265.49,1204.87 ±407.7 pg/mL for Paricalcitol,Calcitriol and Calcimimetics group,and622.71±417.66,787.46±289.61,817.81±403.67 pg/ml after 6 months of treatment.The calcium was 2.08±0.19,2.17±0.17,2.52±0.13 mmol/L in the baseline of each group,and was 20% higher averagely after 3 months treatment.The phosphorus was 2.2 ±0.55,1.89±0.42,2.31±0.49 mmol/L in the baseline of each group,and was 25.7% higher averagely after 6 months treatment.All the differences were statistically significant（P〈0.05）.Conclusion：Intravenous injection of Paricalcitol showed adventages in deceasing PTH,compared to Calcitriol and Calcimimetics in the treatment of patients on maintenance hemodialysis with Secondary hyperparathyroidism.The dosage of Paricalcitol should be mediated because of the risk in increasing calcium and phosphorus in blood when the dosage was high.We should mediate the dosage individually to achieve the best clinical efficiency.