帕立骨化醇治疗血液透析患者继发性甲状旁腺功能亢进的临床研究

Clinical trial of paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients

目的观察帕立骨化醇治疗血液透析患者继发性甲状旁腺功能亢进的效果。方法将40例患者分为对照组和试验组,每组20例。2组患者在治疗期间保持低磷饮食,维持正常血液透析方案以及基础疾病治疗方案不变。对照组给予骨化三醇注射液,每次1.0μg,每周3次(每次血液透析后),静脉注射。试验组给予帕立骨化醇注射液,每次5.0μg,每周3次(每次血液透析后),静脉注射。2组治疗时间均为3个月。比较2组的血清矿物质浓度指标、全段甲状旁腺激素水平、甲状旁腺体积指标、治疗效果及安全性。结果治疗后,试验组和对照组的治疗总有效率分别为95.00%(19例/20例)和65.00%(13例/20例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清钙离子分别为(2.30±0.15)和(2.13±0.18)mmol·L^(-1),磷离子分别为(1.56±0.18)和(1.73±0.20)mmol·L^(-1),碱性磷酸酶分别为(112.65±28.07)和(134.73±30.45)U·L^(-1),甲状旁腺激素(i PTH)分别为(802.67±103.59)和(910.31±181.25)pg·m L^(-1),甲状旁腺体积分别为(0.80±0.17)和(1.05±0.21)cm3,差异均有统计学意义(均P<0.05)。试验组出现皮肤瘙痒症状1例,胃肠道不适症状1例,药物不良反应发生率为10.00%(2例/20例);对照组出现皮肤瘙痒症状1例,继发性低钙血症症状2例,药物不良反应发生率为15.00%(3例/20例),差异无统计学意义(P>0.05)。结论对于血液透析后继发性出现甲状旁腺功能亢进的患者,使用帕立骨化醇进行治疗,可有效改善血清钙磷水平,降低甲状旁腺激素水平以及甲状旁腺体积,安全性良好。

Objective To observe the effect of paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.Methods All 40 patients were divided into control group and treatment group,20 patients in each group.Two groups of patients maintained a low-phosphorus diet during the treatment period;maintained the normal hemodialysis regimen and the underlying disease treatment regimen unchanged.Control group was treated with calcitriol injection,1.0μg each time,3 times a week(after each hemodialysis),intravenously.Treatment group was treated with paricalcitol injection,5.0μg each time,3 times a week(after each hemodialysis),intravenously.The treatment time of both groups was 3 months.The serum mineral concentration indicators,full parathyroid hormone levels,parathyroid volume indicators,clinical effect and safety in two groups were compared.Results After treatment,the total effective rates in treatment group and control group were 95.00%(19 cases/20 cases)and 65.00%(13 cases/20 cases),with significant difference(P<0.05).After treatment,the serum calcium ions of treatment group and control group were(2.30±0.15)and(2.13±0.18)mmol·L^(-1),phosphorus ions were(1.56±0.18)and(1.73±0.20)mmol·L^(-1),alkaline phosphatase were(112.65±28.07)and(134.73±30.45)U·L^(-1),parathyroid hormone(i PTH)were(802.67±103.59)and(910.31±181.25)pg·m L^(-1),the volume of parathyroid glands were(0.80±0.17)and(1.05±0.21)cm3,the difference were all statistically significant(all P<0.05).There were 1case of skin pruritus,1 case of gastrointestinal discomfort in treatment group,the incidence of adverse drug reactions was 10.00%(2 cases/20 cases).There were 1 case of skin pruritus and 2 cases of secondary hypocalcemia symptom in control group,the incidence of adverse drug reactions was 15.00%(3 cases/20 cases),without significant difference(P>0.05).Conclusion For patients with secondary hyperparathyroidism after hemodialysis,the treatment with paricalcitol can effectively improve serum calcium and phosphorus levels,reduce parathyroid hormone levels and parathyroid volume,with good safey.