英文药名：KREMEZIN Fine Granules(Spherical suction charcoal) 中文药名：碳素粉（球形吸着炭細粒） 生产厂家：田边三菱 クレメジン細粒分包2g 治疗类别名称 慢性肾功能衰竭 有效成分 予含2G（通过还原处理和氧化在高温下的球形碳质吸附剂得到的石油烃衍生的球形微细多孔碳）的球形碳质吸附剂中的一个包。 药效药理： 1.对慢性肾功能衰竭的效果 (1) 当给予肾衰竭大鼠模型，获得肾衰竭条件恶化抑制（维护食品消费，体重，增加血清肌酐，尿素氮的抑制，抑制减少肾小球滤过功能，恶化抑制肾组织病变的），生存时间延长 (2) 当施用于透析前慢性肾功能衰竭患者中，血清肌酐升高受到抑制，尿毒症症状改善，时间到透析被延长 1.作用机序 这种药物，慢性肾功能衰竭和吸附在胃肠道中通过口服尿毒症毒素，通过随着粪便排泄被，导致延迟的改善和透析的尿毒症症状的效果 适合病症： 尿毒症  肾衰竭 用法用量 成年人：每日分口服三次，每次2克口服给药 劑型/包裝 クレメジン細粒分包2g*84包 生产厂家：田边三菱 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name : KREMEZIN Fine Granules 2g 　Active ingredient: Spherical carbon adsorbent obtained by oxidizing and reducing spherical activated carbon at high temperature, which is derived from hydrocarbon from petroleum. 　Dosage form: black fine granules 　Print on wrapping: クレメジン細粒分包2g, KREMEZIN Effects of this medicine In patients with chronic renal failure, this medicine adsorbs uremic toxins in the gastrointestinal tract, so that they are excreted in the feces. This alleviates uremic symptoms such as loss of appetite, bad breath, nausea and itchiness, making it possible to delay initiation of dialysis. Usually, it is used to alleviate uremic symptoms and delay dialysis initiation in patients with progressive chronic renal failure. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. •If you are patients with gastrointestinal obstruction. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, for adults, take 1 packet (2 g of the active ingredient) three times a day. Strictly follow the instructions. •If you are currently taking any other medicines, do not take them at the same time; you should try to leave 30 minutes to 1 hour after taking the other medicine before taking this medicine. However, there may be differences in the effectiveness of medicines between individuals and between different medicines, so sufficient consideration should be given to the effects of the other medicine. •If you miss a dose, take a dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. 包装规格 细颗粒包裹 2G：2克×84盒 胶囊:200mg：1000粒胶囊（10胶囊×100） 附：本品胶囊及其他介绍资料 球形活性炭颗粒、胶囊-为治疗慢性肾功能衰竭的第一选择用药 剂型：颗粒规格：2g/包  胶囊：200mg 适应症：主要用于治疗慢性肾功能不全病人，延缓其进入肾功能衰竭的时间。 概况 球形活性炭球形活性炭系仿制日本吴羽化学工业株式会社的AST-120，即直径为0.2~0.4mm的多孔质球形活性炭，用于慢性肾功能衰竭（CRF）病人口服后，在胃肠道内吸附尿毒症毒素物质，随粪便排出体外，使病情得到改善，延长透析导入期。原研单位将AST-120（即球形活性炭）灌装入胶囊或小包装后即成为胶囊剂或颗粒剂，被命名为KREMEZIN胶囊200与KREMEZIN颗粒，分别已于1991年10月4日及 2000年2月14日为日本厚生省批准生产上市。参照日本吴羽化学工业株式会社的上市产品，开发了2g/包的球形活性炭颗粒，已经获得国家食品药品监督管理局颁发的临床批件。 药理药效 球形活性炭是临床上最常用的治疗慢性肾功能不全的药物药物,疗效确切,副作用小, 球形活性炭的主要特性表现在吸附性上，球形活性炭的吸附性能分为物理吸附和化学吸附。物理吸附是由于活性炭具有多孔性，故使其具有巨大的比表面积，致使其具有强吸附性。 球形活性炭的微孔孔容一般约为0.25～0.9ml/g，BET比表面积约为 500～2000m2/g。球形活性炭不仅含碳，而且含功能团形式的氧和氢，例如羰基、羧基、酚类、内酯类、醌类和醚类基团，这些基团可与其它物质的分子形成化学键起到化学吸附的作用。 由于球形活性炭具有较大的比表面积，口服进入肠道后，在肠道内迅速扩散，能有效的吸附尿毒症毒素，使这些有毒物质不再在体内循环，而从肠道中排出体外，使体内肌酐、尿酸的积存量迅速降低，有效减少这些毒性物质经肠道粘膜进入血液，从而改善CRF病人的尿毒症症状，延缓CRF病人开始进行血液透析的时间。本品具有口服后在胃肠道不吸附消化酶、不为胃肠道吸收的特性。 产品特点 1.疗效好,副作用低： 本品原研单位于1978年起对球形活性炭进行了临床药效学和安全性研究。自1978至1998年间，经 460家医疗机构参与，受试者人数达2720例。 临床试验总结证明，球形活性炭颗粒可使肾功能衰竭受试者的血清肌酐值倒数对时间的斜率显著改善，透析间期延长，临床尿毒症症状显著改善。AST-120口服后不良反应发生率较低，经1852例受试者安全性统计，有111例（占受试者5.99%）发生160件不良反应，主要不良反应有便秘、食欲不振、恶心呕吐、腹胀、腹痛、腹泻、瘙痒等胃肠道和皮肤反应；其中有9例临床检验值异常；361例长期受试者中有2例腹痛和GOT、GPT升高，以上不良反应通过停药、继续给药或减少用药，使症状好转或消失，未发现后遗症、死亡等严重不良反应。 2.接受力强： 球形活性炭是市场应用最广泛的一种慢性肾功能不全治疗药物,临床实践的良好结果进一步强化了原有用药患者和医生的认同意识,使患者更容易接受本品。 据日本三共制药公司2006年市场预测报告，在日本有超过30万慢性肾病患者，韩国10万，美国50万，仅在我国沿海省市，就有超过30万的慢性肾病患者，据此推测，我国目前约有超过100万慢性肾功能不全患者，且每年以8－10％的速度递增，多数病人未能得到有效治疗。 本品由日本吴羽化学公司制造，商品名为 “KREMEZIN”的口服药用高性能沥青基球形活性炭，被用作治疗慢性肾衰竭和肾功能不全的药物，取得了良好的疗效。 Kremezin, AST-120（クレメジンカプセル200mg） Uremic Toxins Uremic syndrome results from a malfunctioning of various organ systems due to the retention of compounds which, under normal conditions, would be excreted into the urine and/or metabolized by the kidneys. If these compounds are biologically active, they are called uremic toxins. One of the more important toxic effects of such compounds is cardio-vascular damage.5 Kremezin (AST-120) is an oral adsorbent that slows down the progression of chronic renal failure (CRF) by removing uremic toxins. This spherical carbonaceous adsorbent is composed of microcrystalline carbon with oxygen including surface oxides. It acts as surfactant and gastrointestinal agent. Use of Kremezin The oral adsorbent, AST-120 (Kremezin), can delay the progression of chronic renal failure in undialyzed patients with uremic syndrome.6 Recent studies show that Kremezin may have therapeutic potentials for the treatment of patients with various advanced glycation end products-related disorders such as diabetic microangiopathy, ischemic heart disease and neurodegenerative diseases.1 This orally administered adsorbent shows adsorption ability superior to activated charcoal for certain organic compounds that accumulate in patients with chronic kidney disease (CKD) and that are believed to accelerate the decline in kidney function. http://www.info.pmda.go.jp/go/pack/3929003C1067_1_04/3929003C1067_1_04?view=body#65