英文药名：KREMEZIN Capsules/Fine Granules（KREMEZIN，AST-120） 中文药名：克里美净胶囊和细粉 生产厂家：田边三菱制药 クレメジンカプセル200mg／クレメジン細粒分包2g 【开发单位】吴羽化学 【首次上市】1992年，日本 【批准日期】2009年9月 治疗类别名称 慢性肾功能衰竭代理商 商标名称 KREMEZIN Capsules/Fine Granules 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）。 组成 有效成分 胶囊，（通过烃的氧化和还原处理，从在高温下的球形颗粒状多孔碳获得的石油球形吸附炭）200毫克含KREMEZIN保形 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 200mg：1000粒胶囊（10个胶囊×100） クレメジン細粒 2g：2g×84包 制造厂商 田边三菱制药 注：以上中文资料不够完整，使用者以原说明资料附件。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/3929003C1067_1_04/ KREMEZIN Capsules（KREMEZIN，AST-120） 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.