骨化三醇静脉注射与口服冲击治疗继发性甲状旁腺功能亢进患者的临床疗效观察
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湖北省科技攻关课题(2015AA301C10)


Analysis of clinical efficacy and safety of calcitriol intrarenous injection and oral granules in treating secondary hyperparathyroidism
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    摘要:

    【摘要】 目的 对比骨化三醇静脉注射与口服冲击治疗继发性甲状旁腺功能亢进患者临床疗效及安全性。方法 选取本院2014年9月~2017年9月收治的104例继发性甲状旁腺功能亢进的维持性血液透析患者,按照随机数字表法分为观察组与对照组,每组各52例。对照组给予骨化三醇口服治疗,观察组给予骨化三醇静脉注射治疗,两组患者均治疗12周。分别于治疗前、治疗后4、8、12周测定两组患者血清全段甲状旁腺激素(iPTH)、碱性磷酸酶(AKP)、钙、磷水平,比较两组患者临床疗效及不良反应情况。结果 治疗后,两组患者骨痛、贫血、瘙痒、不宁腿症状均有不同程度改善,但观察组骨痛、皮肤瘙痒症状较对照组改善更显著,差异有统计学意义(P<005);治疗后,观察组不同时间点血钙、血磷水平差异均无统计学意义(P>005),对照组不同时间点血钙、血磷水平差异均有统计学意义(P<005),且两组患者治疗4、8、12周血钙、血磷水平比较差异均无统计学意义(P>005);两组患者治疗4、8、12周AKP、iPTH水平比较差异均有统计学意义(P<005);观察组患者治疗后总有效率对照组比较,差异有统计学意义(P<005);观察组不良反应总发生率明显低于对照组,差异有统计学意义(P<005)。结论 骨化三醇静脉注射治疗较口服冲击治疗临床疗效更显著,且能有效降低iPTH、AKP水平,维持钙磷平衡,无严重不良反应,安全有效,可在临床上推广使用。

    Abstract:

    【Abstract】 Objective To investigate the clinical efficacy and safety of calcitriol intravenous injection and oral granules in the treatment of secondary hyperparathyroidism.Methods 104 patients with secondary hyperparathyroidism who underwent maintenance hemodialysis from September 2014 to September 2017 in our hospital were enrolled. According to random number table, the patients were divided into observation group and control group. The control group was given oral calcitriol treatment and the observation group was given intravenous calcitriol treatment. Both groups were treated for 12 weeks. The clinical data of two groups were retrospectively analyzed. Serum total parathyroid hormone (iPTH), alkaline phosphatase (AKP), serum creatinine Calcium level, phosphorus level were observed. The clinical effects of two groups were compared and analyzed to observe the improvement of their symptoms and adverse reactions.Results After treatment, the symptoms of bone pain, anemia, pruritus and restless legs in both groups were improved to some extent. The symptoms of pruritus in the observation group improved significantly (the difference was statistically significant ( P<005). There was no significant difference in the improvement of other symptoms after treatment, with no significant difference (P>005). After treatment on the changes of serum calcium, the observation group at different time points no significant difference in serum calcium levels (P>005). The difference of blood calcium level in control group at different time points was obvious (P<005). There was no significant difference between the two groups in the difference of blood calcium levels at 4 weeks, 8 weeks and 12 weeks (P>005). The observation group at different time points no significant difference in serum phosphorus levels (P>005). The control group had no significant difference in serum phosphorus levels at different time points (P>005). There was no significant difference in serum phosphorus levels between the two groups after 4, 8 and 12 weeks of treatment (P>005). The AKP level of the observation group at different time points showed significant difference (P<005). The difference of AKP level in control group at different time points was significant (P<005). AKP levels in both groups after treatment for 4 weeks, 8 weeks and 12 weeks were significantly different (P<005). The observation group at different time points iPTH levels were significantly different (P<005). The difference of iPTH level in control group at different time points was significant (P<005). There were significant differences in iPTH levels between the two groups after 4, 8 and 12 weeks of treatment (P<005). The total effective rate of observation group was 50 cases (9615%) after treatment, while the total effective rate of control group was 41 cases (7885%) after treatment. The observation group's total effective rate was significantly higher than the control group (P<005). After treatment, the total incidence of adverse reactions in the observation group was 577%. The incidence of adverse reactions in the control group was 1923%. The incidence of adverse reactions in the control group was significantly higher than that in the observation group (P<005).Conclusion For the treatment of secondary hyperparathyroidism, intravenous calcitriol injection compared with oral granules can effectively reduce the level of iPTH and AKP, maintain calcium and phosphorus balance and has no serious adverse reactions.

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  • 在线发布日期: 2019-02-25
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