西那卡塞联合活性维生素D治疗维持性血液透析继发性甲状旁腺功能亢进症的疗效观察

An observation of curative effect of cinacalcet combined with activated vitamin D for treatment of patients with secondary hyperparathyroidism undergoing maintenance hemodialysis

要：目的 观察西那卡塞联合活性维生素D对维持性血液透析（MHD）继发性甲状旁腺功能亢进症（SHPT）患者临床疗效的影响.方法 选择2014年4月至2016年4月在解放军武汉总医院血液净化中心行MHD的86例SHPT患者,按随机数字表法将患者分为观察组和对照组,每组43例.对照组口服盐酸西那卡塞,初始剂量为25 mg/d,最大剂量不得超过75 mg/d;观察组在对照组基础上联合阿法骨化醇冲击疗法,两组均连续用药12周.治疗后比较两组临床疗效和血钙、血磷、钙磷乘积、全段甲状旁腺激素（iPTH）水平以及不良反应发生情况的差异.结果 观察组治疗后总有效率明显高于对照组〔90.70%（39/43）比74.42%（32/43）,P〈0.05〕;两组治疗后血钙、钙磷乘积均较治疗前升高〔血钙（mmol/L）：对照组为2.24±0.25比1.99±0.26,观察组为2.60±0.21比2.03±0.24;钙磷乘积（mmol2/L2）：对照组为4.05±0.34比3.79±0.35,观察组为4.25±0.37比3.86±0.36〕,血磷（mmol/L：对照组为1.69±0.14比2.09±0.12,观察组为1.15±0.18比2.03±0.16）和iPTH（pg/mL：对照组为297.36±59.73比499.54±69.32,观察组为198.53±57.32比492.92±67.54）均较治疗前降低（均P〈0.05）,且以观察组治疗后的变化较对照组更显著〔血钙（mmol/L）：2.60±0.21比2.24±0.25,血磷（mmol/L）：1.15±0.18比1.69±0.14,钙磷乘积（mmol2/L2）：4.25±0.37比4.05±0.34,iPTH（ng/mL）：198.53±57.32比297.36±59.73,均P〈0.05〕.观察组不良反应发生率明显低于对照组〔4.65%（2/43）比20.93%（9/43）,P〈0.05〕.结论 西那卡塞联合活性维生素D治疗SHPT患者疗效显著,可降低iPTH水平,同时减少不良反应发生.

Objective To observe the clinical curative effect of cinacalcet combined with activated vitamin D for treatment of patients with secondary hyperparathyroidism （SHPT） undergoing maintenance hemodialysis （MHD）.Methods Eighty-six patients with SHPT undergoing MHD admitted to the Blood Purification Center of Wuhan General Hospital of Chinese People＇s Liberation Army from April 2014 to April 2016 were enrolled, and they were divided into an observation group and a control group by random number table, 43 cases in each group. The patients in control group were given cinacalcet whose initial dose was 25 mg/d and maximum dose should not exceed 75 mg/d, and the calcium acetate orally; on the basis of control group, the patients in observation group were additionally given activated vitamin D therapy, and both groups were treated for consecutive 12 weeks. After treatment, the clinical therapeutic effect, serum calcium, serum phosphorus, calcium phosphorus product, intact parathyroid hormone （iPTH） levels and the incidence of adverse reactions were compared between the two groups.Results The total effective rate in observation group was higher than that of the control group [90.70% （39/43） vs. 74.42% （32/43）,P 〈 0.05]. After treatment, the difference of the serum calcium, calciumphosphorus product were higher than those before treatment in both groups [serum calcium （mmol/L）： the control group was 2.24±0.25 vs. 1.99±0.26, observation group was 2.60±0.21 vs. 2.03±0.24; calcium phosphorus product （mmol2/L2）： the control group was 4.05±0.34 vs. 3.79±0.35, observation group was 4.25±0.37 vs. 3.86±0.36, allP 〈 0.05], serum phosphorus, iPTH were lower than those before treatment in both groups [phosphorus （mmol/L）： the control group was 1.69±0.14 vs. 2.09±0.12, observation group was 1.15±0.18 vs. 2.03±0.16; iPTH （ng/L）： the control group was 297.36±59.73 vs. 499.54±69.32, observation group was 198.53±57.32 vs. 492.92±67.54, allP 〈 0.05], the degrees of changes in observation group were more significant than those in control group [serum calcium （mmol/L）： 2.60±0.21 vs. 2.24±0.25, serum phosphorus （mmol/L）： 1.15±0.18 vs. 1.69±0.14, calcium phosphorus product （mmol2/L2）： 4.25±0.37 vs. 4.05±0.34, iPTH （ng/L）： 198.53±57.32 vs. 297.36±59.73, allP 〈 0.05]; and the incidence of adverse reactions was significantly lower in observation group than that of the control group [4.65% （2/43） vs. 20.93% （9/43）,P 〈 0.05].Conclusion Cinacalcet combined with activated vitaminD for treatment of SHPT patients undergoing maintenance hemodialysis shows obvious curative effect, reduces the whole segment of iPTH, and simultaneously has less adverse reactions.