部份中文克里美净处方资料(仅供参考)
英文名: Kremezin Fine Granules
商品名:AST-120
中文名: 克里美净颗粒
生产商: 田辺三菱製薬
药品简介
AST-120(Kremezin,球形吸收碳)是一种由口服球形碳颗粒组成,可在胃肠道内吸附尿毒症毒素及其前体,通过粪便排出。用于治疗尿毒症症状并延长进展性CKD患者开始透析的时间。
慢性肾脏病(CKD)患者的血液中含有丰富的尿毒症毒素,如硫酸吲哚酚和对甲酚,与CKD和心血管疾病的进展有关。 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
效效分类名
慢性肾不全用剤
批准日期:
商標名
KREMEZIN Capsules 200mg
KREMEZIN Fine Granules 2g
化学名
炭素
性状
它是黑色球形颗粒,直径约0.2至0.4mm,无异味。 几乎不溶于水和乙醇(95)。
药效药理
1.对慢性肾功能衰竭的作用
(1)给予肾衰竭模型大鼠时,可抑制肾衰竭病理的恶化(维持食物摄入/体重,抑制血清肌酐/尿素氮的增加,抑制肾小球滤过功能的降低,抑制肾组织病变的恶化) 获得,生存天数延长。
(2)保守期慢性肾功能衰竭患者,可抑制血清肌酐的上升,改善尿毒症的症状,可延长至透析开始的时间。
2.作用机理
该药物具有吸收尿毒症的作用,可改善尿毒症症状,并通过在胃肠道慢性肾功能衰竭中吸收尿毒物并将其与大便一起排泄而延迟透析的时间。
适应症
改善下列症状中的尿毒症症状和延迟进行透析
慢性肾功能衰竭(进行性)
成人通常的剂量是6克,分为3份口服。
包装
胶囊
200mg:1,000粒(10粒x 100)
细颗粒
2g:2g x 84
制造商和分销商
吴羽株式会社
销售
田边三菱制药有限公司 注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明资料附件: https://www.info.pmda.go.jp/go/pack/3929003C1067_1_05/
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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.