| Background: hyperphosphatemia in chronic kidney disease, in particular,is a common complication of end-stage kidney disease patients, the incidencerate of about70%. Hyperphosphatemia can lead to disorders of calcium andphosphorus metabolism, secondary hyperparathyroidism, and further can causethe occurrence of complications of renal osteodystrophy, vascular calcification,which increases the heart, the incidence of cerebrovascular disease and thepatients’ mortality. Therefore, effective control of hyperphosphataemia has animportant significance to improve the prognosis of end-stage kidney diseaseand improve the quality of life of patients. The control of hyperphosphatemia inend-stage kidney disease in several measures: diet, adequate dialysis, oralphosphate binders, parathyroidectomy. Although diet and adequate dialysis canreduce the phosphorus of patients to a certain extent, but the vast majority ofpatients need oral phosphorus binders in order to clear the body of excessphosphorus and serum phosphorus control in the normal range. The traditionalphosphate binders containing aluminum or calcium preparations, but thelong-term use can lead to high alumina and hypercalcemia. Lanthanumcarbonate as a new type of phosphorus binders for patients with ESRD toreduce serum phosphate concentration, it does not contain aluminum, calcium,to avoid patients with long-term application of aluminum-containing toxicity orside effects of calcium drop caused by the phosphorus preparations, with itsunique therapeutic advantages.Objective: This study aimed to system evaluation of lanthanum carbonatefor the treatment of end-stage renal disease in patients with hyperphosphatemia:efficacy and safety. Methods: a multicenter, randomized, double blind, placebo controlmethod, from five centers in220patients with end-stage renal insufficiencywith hyperphosphatemia in patients with system analysis, collecting testpatients before and after treatment of hyperphosphatemia, hypocalcemia,product of calcium and phosphorus, parathyroid hormone levels and otherindicators, using the t test, nonparametric tests, chi-square test, CMH testmethod comparison of treatment group and placebo group efficacy index,consider the center effect on curative effect the effect of mark.Results: The validity of the results after unblinding: FAS and PPSanalysis. In the FAS population, four weeks of the efficacy of lanthanumcarbonate group phosphorus was57.14%in the placebo group was19.82%,considering the central role of CMH chi-square results can be seen, P <0.0001,lanthanum carbonate and placebo groups, the efficiency difference95%confidence interval25.04-49.61%in the lanthanum carbonate group than theplacebo group. Two sets of visits phosphorus measured value and treatment ofphosphorus measured values compared with baseline changes in value inaddition to differences between the baseline outside the group were statisticallysignificant (P <0.01), the first two weeks and four weeks of the lanthanumcarbonate group blood phosphorus compared with baseline decreased, anincrease in the placebo group. Safety outcomes: blood pressure, bodytemperature, heart rate, breathing and other vital signs in the placebo group andthe lanthanum carbonate group before and after treatment had no significantchanges, no statistically significant difference between the two groups. The twogroups were not clinically significant abnormal changes. Laboratory tests in thelanthanum carbonate and placebo groups before and after treatment, blood redblood cell count (RBC), hemoglobin (Hb), white blood cell count (WBC),platelet count (PLT), alanine aminotransferase (ALT), aspartateaminotransferase (AST) the normal rate of serum total bilirubin (TBIL), blood urea nitrogen (BUN) and creatinine (Cr) of the indicators and the abnormal ratebetween the two groups showed no significant difference. Adverse reactions:the lanthanum carbonate group of drug-related adverse reactions, gastroint-estinal reactions, nausea, vomiting, some patients with constipation. With theplacebo group of medication-related adverse reactions were gastrointestinalreactions, mainly nausea, vomiting, abdominal swell discomfort, diarrhea andso on. Lanthanum carbonate group compared to placebo. Vital signs indicators,laboratory parameters, including blood, urine, alanine aminotransferase,aspartate aminotransferase, creatinine, urea nitrogen, electrocardiogram betw-een the two groups before and after treatment comparison and the differe-ncebetween the two groups showed no significant difference.Conclusion: The application lanthanum carbonate treatment of end-stagekidney disease, hyperphosphatemia, its effectiveness is superior to the placebogroup, and the statistical results have very significant difference. In terms ofsecurity, lanthanum carbonate and placebo groups in terms of vital signs andother laboratory findings were not clinically significant abnormal changes. Thetwo groups with varying degrees of gastrointestinal adverse reactions, thelanthanum carbonate group compared to placebo. |
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