西那卡塞联合小剂量骨化三醇治疗终末期肾脏病继发性甲状旁腺功能亢进的疗效分析

目的 探讨西那卡塞联合小剂量骨化三醇与骨化三醇冲击疗法对终末期肾脏病继发性甲状旁腺功能亢进(甲旁亢)患者的疗效及安全性.方法 重庆市大足区人民医院2013年1月至2016年5月确诊为终末期肾脏病继发性甲旁亢患者150例,区组随机化分组将患者平均分为3组,每组50例,分别采用西那卡塞治疗、骨化三醇冲击治疗、西那卡塞联合小剂量骨化三醇治疗.其中,西那卡塞联合小剂量骨化三醇组采用盐酸西那卡塞片口服,初始25 mg·d-1,整片吞服;随后每2~4周根据患者耐受情况调整1次剂量,最大剂量75 mg·d-1;同时,口服骨化三醇胶丸,初始0.25μg·d-1,每2~4周调整1次剂量,最大剂量0.5μg·d-1.检测三组患者治疗前及治疗后6个月血钙、血磷含量水平,并对全段甲状旁腺激素(iPTH)进行检测.结果 骨化三醇冲击治疗组治疗后6个月血钙、血磷与治疗前比较明显升高血钙(2.12±0.62)mmol·L-1比(2.47±0.59)mmol·L-1,t=2.827,P=0.007;血磷(1.72±0.42)mmol·L-1比(1.95±0.56)mmol·L-1,t=2.366,P=0.022],而iPTH明显下降iPTH 560.58(334.2~728.47)pg·mL-1比331.23(213.95~424.62)pg·mL-1,Z=4.387,P<0.001];西那卡塞治疗组与西那卡塞联合小剂量骨化三醇治疗组血清磷水平、iPTH与治疗前比较明显下降(P<0.05)血磷西那卡塞治疗组(1.46±0.72)mmol·L-1比(1.73±0.58)mmol·L-1,t=2.034,P=0.047,血磷西那卡塞联合小剂量骨化三醇治疗组(1.44±0.63)mmol·L-1比(1.76±0.39)mmol·L-1,t=3.014,P=0.004,iPTH西那卡塞治疗组277.02(180.34~344.56)pg·mL-1比544.11(386.8~749.42)pg·mL-1,Z=5.237,P<0.001,iPTH西那卡塞联合小剂量骨化三醇治疗组194.85(132.04~295.64)pg·mL-1比575.49(438.04~665.65)pg·mL-1,Z=6.144,P<0.001],且西那卡塞联合小剂量骨化三醇治疗组血钙水平未见明显影响(P>0.05),而单纯西那卡塞治疗组的血钙水平较治疗前明显下降(P<0.05).结论 西那卡塞联合小剂量骨化三醇治疗终末期肾病继发性甲旁亢患者可降低血磷水平,还可以降低iPTH,但不影响血钙,不容易出现低钙血症,降低骨饥饿综合征的发生.

Efficacy and safety of cinacalcet in combination with low doses of calcitriol and calcitriol in the treatment of secondary hyperparathyroidism in patients with end-stage renal disease

Objective To investigate the efficacy and safety of Cinacalcet plus low dose calcitriol and calcitriol in the treatment of sec -ondary hyperparathyroidism in patients with end -stage renal disease (ESRD).Methods Totally 150 patients with secondary hyperpar -athyroidism diagnosed as ESRD from January 2013 to May 2016 in People's Hospital of Dazu District were included and zone Group randomization assigned into 3 groups,50 patients in each group.The groups received respectively Cinacalcet treatment ,calcitriol pulse therapy,Cinacalcet combined with low doses of calcitriol treatment .Before treatment and 6 months after treatment,serum calcium,phos-phorus levels of the three groups were detected ,and iPTH was detected.Results The serum calcium and phosphorus levels in the cal -citriol pulse therapy group six months after treatment were significantly higher ,serum calcium(2.12 ±0.62)mmol· L-1 vs (2.47 ±-1 ,t =2.827,P =0.007,serum phosphorus (1.72 ±0.42)mmol· L-1 vs (1.95 ±0.56)mmol· L-1 ,t =2.366,P =0.022];but iPTH was significantly decreased iPTH 560.58(334.2 -728.47) pg· mL-1 vs 331.23(213.95 -424.62) pg· mL-1 , Z =4.387,P <0.001];the serum phosphorus,iPTH levels were decreased significantly in the Cinacalcet treatment group and the Cina -calcet combined with low dose calcitriol treatment group compared with before treatment (P <0.05) serum phosphorus in the Cinacal -cet treatment group (1.46 ±0.72)mmol· L-1 vs (1.73 ±0.58)mmol· L-1 ,t =2.034,P =0.047,serum phosphorus in the Cinacal -cet combined with low dose calcitriol treatment group (1.44 ±0.63)mmol· L -1 vs (1.76 ±0.39)mmol· L -1 ,t =3.014,P =0.004, iPTH in the Cinacalcet treatment group 277.02(180.34 -344.56) pg· mL -1 vs 544.11(386.8 -749.42) pg· mL -1 ,Z =5.237,P 0.59)mmol· L<0.001,iPTH in the Cinacalcet combined with low dose calcitriol treatment group 194.85(132.04 -295.64) pg· mL -1 vs 575.49 (438.04 -665.65) pg· mL-1 ,Z =6.144,P <0.001,and the serum calcium levels in the Cinacalcet plus low dose calcitriol treatment group had no significant effect (P >0.05),but the serum calcium levels in the Cinacalcet treatment group were significantly decreased compared with before treatment (P <0.05).Conclusions Cinacalcet combined with low doses of calcitriol in the treatment of second -ary hyperparathyroidism in patients with end -stage renal disease can reduce serum phosphorus levels and iPTH levels ,but does not af-fect serum calcium,which is not prone to hypocalcemia ,and reduce the development of bone hunger syndrome .