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[摘要]
目的 研究骨化三醇联合西那卡塞治疗血液透析患者继发性甲状旁腺功能亢进的临床疗效。方法 选取2008年1月—2014年12月天津市第一中心医院收治的血液透析后继发性甲状旁腺功能亢进患者100例,随机分为对照组和治疗组,每组各50例。对照组患者进食时口服盐酸西那卡塞片,初始剂量为25 mg/d。随后根据患者耐受情况,每2~4周调整1次剂量,最大剂量75 mg/d。治疗组在对照组治疗基础上口服骨化三醇胶丸,初始计量为0.25 μg/d,3次/周,频率不超过每2天1次,每2~4周调整1次剂量。两组均连续治疗3个月。观察两组患者的临床疗效,同时比较治疗前后两组患者血肌酐(Scr)、血尿素氮(BUN)、尿素清除指数(KT/V)、钙(Ca)、磷(P)、碱性磷酸酶(ALP)、全段甲状旁腺激素(iPTH)、甲状旁腺体积的变化情况。结果 治疗后,对照组和治疗组的总有效率分别为82.0%、94.0%,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者的BUN、Scr和Kt/V较治疗前均无显著差异;治疗后,两组患者Ca显著升高,P、ALP、iPTH、甲状旁腺体积均显著降低,同组治疗前后差异有统计学意义(P<0.05);且治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。对照组和治疗组不良反应发生率分别为18.0%、8.0%,两组比较差异具有统计学意义(P<0.05)。结论 骨化三醇联合西那卡塞治疗血液透析患者继发性甲状旁腺亢进具有较好的临床疗效,可降低甲状旁腺素,缩小甲状旁腺体积,并降低不良反应的发生率,具有一定的临床推广应用价值
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[Abstract]
Objective To observe the clinical effect of calcitriol combined with cinacalcet in the treatment of hemodialysis patients with secondary hyperparathyroidism. Methods Hemodialysis patients (100 cases) with secondary hyperparathyroidism in Tianjin First Center Hospital from January 2008 to December 2014 were randomly divided into control and treatment groups, and each group had 50 cases. The patients in the control group were po administered with Cinacalcet Hydrochloride Tablets, and the initial dosage was 25 mg/d. The dosage was adjusted according to the patient tolerance, once every 2 — 4 weeks, and the maximum dosage was 75 mg/d. The patients in treatment group were po administered with Calcitriol Soft Capsules on the basis of the control group, and the initial dosage was 0.25 μg/d, three times weekly. The frequency was no more than once every two days, and the dosage was adjusted once every 2 — 4 weeks. The patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the changes of Scr, BUN, KT/V, Ca, P, ALP, iPTH and volume of parathyroid gland in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 82.0% and 94.0%, respectively, and there were differences between two groups (P < 0.05). After treatment, BUN, SCr, and Kt/V in two groups had no significant difference compared before treatment. Ca in two groups was significantly increased, P, ALP, iPTH, and volume of parathyroid gland in two groups were significantly reduced, and the difference was statistically significant in the same group (P < 0.05). After treatment, the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups (P < 0.05). The incidence of adverse reactions in the control and treatment groups were 18.0% and 8.0%, respectively, and there were differences between two groups (P < 0.05). Conclusion Calcitriol combined with cinacalcet has clinical curative effect in the treatment of hemodialysis patients with secondary hyperparathyroidism, and can reduce parathyroid hormone and parathyroid gland volume, also can reduce the incidence of adverse reactions, which has a certain clinical application value.
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[基金项目]
天津市卫生局科技基金项目(2013KZ024)