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目的评估碳酸镧长期应用于高磷血症维持性血液透析(MHD)患者的临床疗效和安全性。方法 MHD患者56例,血清磷>1.78 mmol·L-1,随机分为两组。碳酸镧组35例,予碳酸镧咀嚼片,起始剂量750 mg,bid,总剂量<3 000 mg·d-1。碳酸钙组21例,予碳酸钙D3片,起始剂量600 mg,bid,总剂量<3 000 mg·d-1。根据血磷和血钙检测结果调整药物剂量,疗程均为36个月。观察两组治疗前和治疗1、3、6、12、24、36个月患者血清钙、磷、全段甲状旁腺激素(i PTH)、成纤维细胞生长因子23(FGF-23)水平变化情况和不良反应,并在治疗前和治疗36个月行心脏彩超和螺旋CT,评估左心室肥厚和冠状动脉钙化状况。结果共39例患者完成本次研究,碳酸镧组25例,碳酸钙组14例。与治疗前比较,两组血磷水平治疗1个月起即下降(P<0.05)。碳酸镧组治疗期间血钙水平无明显变化,而碳酸钙组于治疗6个月血钙开始增高(P<0.05)。碳酸镧组i PTH水平治疗6个月起下降(P<0.05),碳酸钙组治疗期间i PTH水平无明显变化。碳酸镧组FGF-23水平治疗1个月起即下降(P<0.05),碳酸钙组于治疗12个月起下降(P<0.05)。治疗36个月,碳酸镧组血磷、钙、i PTH、FGF-23水平均低于碳酸钙组(P<0.05)。治疗前后血磷水平变化值和血FGF-23水平变化值进行相关分析,两者呈正相关(r=0.605,P<0.01)。治疗36个月,两组左心室质量指数和冠状动脉钙化评分均较治疗前上升(P<0.05),但碳酸镧组两项指标的进展幅度均小于碳酸钙组(P<0.05)。两组均无严重不良反应发生。结论对于高磷血症MHD患者,碳酸镧降血磷效果优于碳酸钙,且能同时降低血FGF-23和i PTH水平,而不引起血钙蓄积,还能够延缓MHD患者左心室肥厚和冠状动脉硬化的进展。
Objective To evaluate the long-term clinical efficacy and safety of lanthanum carbonate in hyperphosphatemia-supporting hemodialysis (MHD) patients. Methods 56 cases of MHD patients, serum phosphorus> 1.78 mmol·L-1, were randomly divided into two groups. Lanthanum carbonate group of 35 cases, to the lanthanum carbonate chewable tablets, the initial dose of 750 mg, bid, the total dose of <3 000 mg · d-1. 21 cases of calcium carbonate group, calcium carbonate D3 tablets, the initial dose of 600 mg, bid, the total dose of <3 000 mg · d-1. According to blood phosphorus and calcium test results to adjust the drug dose, treatment were 36 months. The changes of serum calcium, phosphorus, i PTH, FGF-23 levels before and 1, 3, 6, 12, 24 and 36 months after treatment were observed Conditions and adverse reactions, and before treatment and 36 months of treatment underwent echocardiography and spiral CT, assessment of left ventricular hypertrophy and coronary artery calcification. Results A total of 39 patients completed the study, 25 cases of lanthanum carbonate group and 14 cases of calcium carbonate group. Compared with the pre-treatment, the two groups of phosphorus levels decreased from 1 month after treatment (P <0.05). There was no significant change of serum calcium level during the treatment of lanthanum carbonate group, while the calcium level of calcium carbonate group began to increase at 6 months after treatment (P <0.05). The level of i PTH in lanthanum carbonate group decreased from 6 months (P <0.05), and there was no significant change in i PTH level during calcium carbonate treatment. The levels of FGF-23 in the lanthanum carbonate group decreased from 1 month after treatment (P <0.05), and decreased from 12 months in the calcium carbonate group (P <0.05). After 36 months treatment, the levels of serum phosphorus, calcium, i PTH, FGF-23 in lanthanum carbonate group were lower than those in calcium carbonate group (P <0.05). Before and after treatment, the changes of serum phosphorus levels and blood FGF-23 levels were analyzed, and there was a positive correlation between them (r = 0.605, P <0.01). After 36 months of treatment, the left ventricular mass index and coronary artery calcification score in both groups were significantly higher than those before treatment (P <0.05). However, the progression of the two indexes in the group of lanthanum carbonate was smaller than that in the group of calcium carbonate (P <0.05). No serious adverse reactions occurred in both groups. Conclusions Lanthanum phosphate is superior to calcium carbonate in reducing blood phosphate levels in MHD patients with hyperphosphatemia and in reducing blood FGF-23 and i PTH levels without inducing calcium accumulation. It also delays left ventricular hypertrophy and coronary artery disease in patients with MHD Progress in atherosclerosis.