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碳酸司维拉姆治疗维持性血液透析患者的临床研究OA北大核心CSTPCD

Clinical trial of sevelamium carbonate in the treatment of maintenance hemodialysis patients

中文摘要英文摘要

目的 探究碳酸司维拉姆对维持性血液透析(MHD)患者血磷、血管钙化及甲状旁腺功能的影响.方法 入选MHD患者为研究对象,依据治疗方案按照队列法分为试验组和对照组.对照组患者给予碳酸钙咀嚼片嚼服1.25 g,bid;试验组患者给予碳酸司维拉姆片口服0.8 g,tid;2组疗程均为6个月.比较2组患者的临床疗效,比较血磷、血钙、冠状动脉钙化积分、甲状旁腺功能[全段甲状旁腺激素(iPTH)、甲状旁腺体积]和炎症因子[C反应蛋白(CRP)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)]水平,记录药物不良反应的发生情况.结果 试验组和对照组的临床总有效率分别为92.45%(49例/53例)和77.55%(38例/49例),在统计学上差异有统计学意义(P<0.05).治疗后6个月,试验组和对照组血磷分别为(1.63±0.31)和(2.07±0.36)mmol·L-1,血钙分别为(2.31±0.17)和(2.47±0.12)mmol·L-1,冠状动脉钙化积分分别为(71.81±15.45)和(86.03±17.49)分,iPTH 表达量分别为(223.59±64.85)和(304.25±74.61)pg·mL-1,甲状旁腺体积分别为(1.03±0.26)和(1.17±0.21)cm3,CRP 表达量分别 为(5.12±1.35)和(6.59±1.66)mg·L-1,IL-6 表达量分别为(16.32±2.81)和(19.84±3.62)ng·L-1,TNF-α表达量分别为(18.54±3.88)和(22.69±4.89)ng·L-1.试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05).试验组和对照组的总药物不良反应发生率分别为9.43%(5例/53例)和6.12%(3例/49例),在统计学上差异无统计学意义(P>0.05).结论 碳酸司维拉姆可降低MHD患者血磷水平,对血钙浓度影响较小,且能改善患者甲状旁腺功能,延缓血管钙化,临床应用效果较好.

Objective To explore the effect of sevelamer carbonate on blood phosphorus,vascular calcification,and parathyroid function in maintenance hemodialysis(MHD)patients.Methods MHD patients were selected as the research subjects and divided into treatment group and control group according to the treatment plan using a cohort method.The control group was given calcium carbonate chewable tablets orally at a dose of 1.25 g,bid,while the treatment group was given sevelamer carbonate tablets orally at a dose of 0.8 g,tid;the duration of treatment for both groups was 6 months.The clinical efficacy,blood phosphorus,blood calcium,coronary artery calcification score,parathyroid function[intact parathyroid hormone(iPTH),parathyroid volume],and levels of inflammatory factors[C-reactive protein(CRP),interleukin-6(IL-6),tumor necrosis factor-α(TNF-α)]were compared between the two groups,and the occurrence of adverse drug reactions was recorded.Results The total effective rates of the treatment group and the control group were 92.45%(49 cases/53 cases)and 77.55%(38 cases/49 cases)respectively,showing statistically significant difference(P<0.05).After 6 months of treatment,the blood phosphorus levels of the treatment group and the control group were(1.63±0.31)and(2.07±0.36)mmol·L-1,respectively;blood calcium levels were(2.31±0.17)and(2.47±0.12)mmol·L-1,respectively;coronary artery calcification scores were 71.81±15.45 and 86.03±17.49,respectively;iPTH expression levels were(223.59±64.85)and(304.25±74.61)pg·mL-1,respectively;parathyroid volumes were(1.03±0.26)and(1.17±0.21)cm3,respectively;CRP expression levels were(5.12±1.35)and(6.59±1.66)mg·L-1,respectively;IL-6 expression levels were(16.32±2.81)and(19.84±3.62)ng·L-1,respectively;TNF-αexpression levels were(18.54±3.88)and(22.69±4.89)ng·L-1,respectively.The differences in the above indicators between the treatment group and the control group were all statistically significant(all P<0.05).The total incidence of adverse drug reactions in the treatment group and the control group were 9.43%(5 cases/53 cases)and 6.12%(3 cases/49 cases),respectively,with no statistically significant difference(P>0.05).Conclusion Sevelamer carbonate can reduce blood phosphorus levels in MHD patients,has minimal effect on blood calcium concentration,improves parathyroid function in patients,delays vascular calcification,and has good clinical application effects.

杨巍;程丽;陈芳;赵化南

亳州市中医院肾病科,安徽亳州 236800

药学

碳酸司维拉姆;维持性血液透析;血磷;甲状旁腺功能

sevelamer carbonate;maintenance hemodialysis;serum phosphorus;parathyroid function

《中国临床药理学杂志》 2024 (008)

1140-1144 / 5

10.13699/j.cnki.1001-6821.2024.08.011

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