产地国家：日本 处 方 药：是 所属类别：200毫克/胶囊 1000胶囊/盒 包装规格：200毫克/胶囊 1000胶囊/盒 计价单位：盒 生产厂家中文参考译名：Mitsubishi Tanabe Pharma Corporation 生产厂家英文名：Mitsubishi Tanabe Pharma Corporation 原产地英文商品名：KREMEZIN(クレメジンカプセル)200mg/Capsules 1000Capsules 原产地英文药品名：KREMEZIN 中文参考商品译名：KREMEZIN(クレメジンカプセル)200毫克/胶囊 1000胶囊/盒 中文参考药品译名：克里美净 曾用名：AST-120

简介

英文药名：KREMEZIN Capsules(KREMEZIN，AST-120) 中文药名：克里美净胶囊 生产厂家：田边三菱制药 药品介绍 【开发单位】吴羽化学 【首次上市】1992年，日本 クレメジンカプセル200mg 治疗类别名称：慢性肾功能衰竭代理商 商标名称：KREMEZIN Capsules 200mg 化学名称：碳 性状：具有约0.2至0.4毫米，无异味黑色球直径的颗粒。几乎不溶于水和乙醇(95)。 药效药理 1. 慢性肾功能衰竭的作用 (1) 当给药于肾衰竭大鼠模型，肾衰竭条件恶化抑制(维护食物消耗，体重，抑制血清肌酐尿素氮的增加，抑制减少肾小球滤过功能，肾组织病变抑制恶化的)，得到生存时间延长。 (2) 给予透析前慢性肾功能衰竭患者中，血清肌酐升高被抑制，改善尿毒症症状，时间到透析被延长。 2. 作用机序 在慢性肾功能衰竭和吸附在通过口服给药胃肠道尿毒症毒素，通过被排出体外与粪便，从而导致延迟的改善和透析的尿毒症症状的效果。 适应症：口服利尿药，用于治疗慢性肾机能不全及尿毒症。 用法与用量：成人，每天三次，每次服用10粒胶囊(活性成分的2克)。或按照医生的指示。 包装规格：胶囊为200mg：1000粒胶囊(10个胶囊×100) 制造厂商：田边三菱制药

英文版说明书

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study of AST-120 (Kremezin) in patients with moderate to severe CKD. Abstract BACKGROUND: AST-120 (Kremezin; Kureha Chemical Industry Co Ltd, Tokyo, Japan) is an orally administered adsorbent showing adsorption ability superior to activated charcoal for certain organic compounds known to be precursors of substances that accumulate in patients with chronic kidney disease (CKD) and that are believed to accelerate the decline in kidney function. AST-120 is approved in Japan for prolonging time to hemodialysis therapy and improving uremic symptoms in patients with CKD. METHODS: A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was designed to examine the nephroprotective effects of 3 doses of AST-120 versus placebo in adult patients with moderate to severe CKD and elevated serum indoxyl sulfate levels while following an adequate protein-intake diet. Eligible patients were randomly assigned to 1 of 3 doses of AST-120 (0.9, 2.1, or 3.0 g) or placebo 3 times daily for 12 weeks. RESULTS: AST-120 decreased serum indoxyl sulfate levels in a dose-dependent fashion. During the 12-week treatment period, AST-120 did not affect serum creatinine levels or 24-hour urine creatinine appearance. Significant improvements in malaise were observed in a dose-dependent fashion. All doses of AST-120 were well tolerated and did not adversely affect the general health status of patients. CONCLUSION: Results suggest that the dose of 3 g 3 times daily is an optimal dose for the US population, and it may be useful in the treatment of patients with CKD. Because AST-120 did not directly affect serum creatinine levels or 24-hour urine creatinine appearance, the composite end point of doubling of serum creatinine level, transplantation, and dialysis therapy would be appropriate for a confirmatory phase III therapeutic outcome study.