【摘要】 目的探讨帕立骨化醇治疗血液透析伴继发性甲状旁腺功能亢进(secondary hyperparathyroidism, SHPT)患者的有效性及安全性。方法纳入北京市第六医院维持性血液透析合并SHPT患者11例(帕立骨化醇起始剂量按0.04～0.10μg/kg给药)。治疗起始后,监测血清全段甲状旁腺素(intact parathyroid hormone,iPTH)、钙、磷、碱性磷酸酶(alkaline phosphatase,ALP)水平并评估视觉模拟法(visual analogue scale,VAS)评分。本观察性研究的主要疗效指标为治疗12周后,iPTH水平较基线下降>50%的患者比例。次要疗效指标包括:治疗12周后,iPTH平均水平较基线的下降幅度;iPTH水平降至150～300pg/m1的患者比例;研究结束时不良事件的发生率。结果 11例患者基线平均iPTH水平为(1283.56±443.71)pg/ml,接受12周帕立骨化醇治疗后,平均iPTH水平降至(346.38±223.72)pg/ml,差异有统计学意义(t=6.578,P<0.001),下降73.01%。全部11例患者的终点iPTH水平较基线下降幅度均超过50%,达到主终点的患者比例为100%。研究结束时,共有7例患者的iPTH水平降至150～300pg/ml范围内,达标比例为63.64%。11例患者的终点血清钙、磷及ALP的平均水平较基线无显著变化,均无统计学意义(t值分别是2.952,1.305,1.513;P值分别是0.088,0.206,0.145),VAS评分较基线显著降低(t=15.976,P<0.001)。仅有1例患者发生高钙血症(血钙水平为2.64mmol/L)。结论本研究证实,帕立骨化醇能够有效治疗血液透析患者SHPT,显著降低血清iPTH水平和患者骨痛VAS评分,同时血钙、磷变化相对稳定。更多还原

【Abstract】 Objectives To investigate the efficacy and safety of paricalcitol in the treatment of hemodialysis patients complicated with secondary hyperparathyroidism(SHPT). Methods Eleven maintenance hemodialysis patients with SHPT treated in Beijing Sixth Hospital were enrolled in this study. Their initial dose of paricalcitol was 0.04-0.10 μg/kg. During the treatment period, serum levels of intact parathyroid hormone(iPTH), calcium, phosphorus, alkaline phosphatase(ALP) were monitored, and the score of visual analogue scale(VAS) was used to assess patient’s condition. The major efficacy parameter was the decrease of iPTH more than 50% of baseline value after 12 weeks of the treatment. The secondary efficacy parameters included the average range of iPTH below baseline value, the proportion of the patients with the i PTH level within150～300 pg/ml after 12 weeks of the treatment, as well as the incidence of adverse events at the end of the study. Results The average baseline iPTH level of the 11 patients was 1283.56 ± 443.71 pg/ml. After 12 weeks of paricalcitol treatment, the average i PTH level decreased by 73.01% of the baseline value to 346.38±223.72 pg/ml(t=6.578, P<0.001). In all of the 11 patients, the endpoint iPTH level decreased by more than50% of the baseline value. At the endpoint of the study, iPTH levels reduced to 150-300 pg/ml in 7 of the 11 patients and reached the compliance rate in 63.64% patients; serum calcium(t=2.952, P=0.088), phosphorus(t=1.305, P=0.206) and ALP(t=1.513, P=0.145) had no significant differences compared to the baseline values in the 11 patients; VAS score was significantly lower than baseline value(t=15.976, P<0.001). One patient developed hypercalcemia(serum calcium 2.64 mmol/L). Conclusions This study confirmed that paricalcitol can effectively treat SHPT in hemodialysis patients. It can reduce serum iPTH level and the bone pain VAS score, without changes of serum calcium and phosphorus.更多还原