POTASSIUM-MAGNESIUM CITRATE TRIAL IN PATIENTS COMPLETING LITHOTRIPSY

产品描述：（直接摘自申请）本项目的总体目标是寻求柠檬酸钾在正常尿钙肾结石中的安全替代品。这一目标将通过在一项已完成的随机试验中验证K-Mag的疗效和安全性来实现，并表明该治疗在正常钙尿患者中比在高钙尿患者中特别有效。因此，将使用K-Mag进行一项多临床、安慰剂对照的随机试验，参与患者将是近期接受过体外冲击波碎石术（ESWL）取石的复发性钙性肾结石患者，这些患者患有单纯性钙结石疾病。将入组正常尿钙和高尿钙患者。将通过生存概率（保持无结石的患者百分比）分析治疗结局。该项目将检验以下假设：1 K-Mag在抑制结石方面比安慰剂更有效 正常钙尿和高钙尿患者中的形成，2 正常钙尿患者的反应K-Mag将优于上级 高钙尿症患者，由于致病作用， 高钙尿症，3例 复发性结石形成的倾向不受ESWL的影响， 强调了医疗管理的重要性。

Description: (Taken directly from the application) The overall goal of this project is to seek a safe alternative to potassium citrate in normocalciuric nephrolithiasis. This goal will be pursued by obtaining validation of the efficacy and safety of K-Mag in an already completed randomized trial, and show that this treatment is particularly effective in normocalciuric patients than in hypercalciuric patients. Thus, a multiclinic, placebo-controlled randomized trail will be conducted with K-Mag. Participating patients will be those with recurrent calcium nephrolithiasis suffering from uncomplicated calcium stone disease who have recently undergone extracorporeal shock Wave Lithotripsy (ESWL) for removal of stones. Both normocalciuric and hypercalciuric patients will be enrolled. The treatment outcome will be analyzed by survival probability (percentage of patients remaining stone-free). The project will test the hypothesis that: 1 K-Mag would be more effective than placebo in inhibiting stone formation in both normocalciuric and hypercalciuric patients, 2 The response of normocalciuric patients K-Mag would be superior to that of hypercalciuric patients, due to the pathogenetic role of hypercalciuria, and 3 The propensity from recurrent stone formation is unaffected by ESWL, thus emphasizing the importance of medical management.