2015年6月23日，美国FDA批准抗凝药新型注射剂cangrelor（商品名：Kengreal，CHIESI USA INC）上市，用于避免成人患者在经皮冠状动脉介入治疗（percutaneous coronary intervention，PCI）过程中因凝血造成的冠状动脉堵塞。和其它抗血小板药物一样，Kengreal最严重的风险是大出血，有时甚至危及生命。在一个有1万余人参与的头对头比较Kengreal和Plavix（氯吡格雷）的临床实验中，Kengreal和氯吡格雷相比更能显着降低心肌梗死的发生率，尽管两个组的严重出血事件发生率都比较低，但Kengreal组（1/170）高于氯吡格雷对照组（1/275）。   经皮冠状动脉介入治疗（PCI）也称血管成形术（angioplasty），是一种经皮穿刺周围动脉，将球囊导管及（或）支架等治疗器械送至冠状动脉，扩张、疏通冠状动脉狭窄病变的一种心脏导管治疗技术。根据美国疾病和控制中心的数据，在美国每年有大约5万人进行PCI疗法。在中国自1977年第一例经皮冠状动脉介入治疗开始，PCI已经成为挽救冠心病患者最有效的疗法之一。   国外上市情况   坎格雷洛，是由The Medicines Company公司研发的新型P2Y12受体拮抗剂，2013年7月1日，美国FDA接受了Medicines Company的关于静脉注射抗血小板药坎格雷洛的新药申请，2015年3月获欧盟批准上市，是欧盟批准的**也是**一个静脉抗血小板药物，可提供即时、一致、迅速可逆的P2Y12抑制作用。2015年6月获美国FDA批准上市，商品名为KENGREAL。   包装供应/贮存和处置   KENGREAL 50MG VL 10X10ML CANGRELOR TETRASODIUM  NDC：10122062010 KENGREAL小瓶应被贮存在美国药典USP控制室温，[20°C至25°C(68°F至77°F)与外出允许在15°C和30°C(59°F和86°F)间]。   完整资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958lbl.pdf KENGREAL(cangrelor) for Injection General Information Kengreal (cangrelor) is a direct P2Y12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signaling and platelet activation. Kengreal is specifically indicated as an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients in who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. Kengreal is supplied as asterile white to off-white lyophilized powder for reconstitution into an IV infusion. The recommended dosage is a 30 mcg/kg IV bolus followed immediately by a 4 mcg/kg/min IV infusion. Initiate the bolus infusion prior to PCI. The maintenance infusion should ordinarily be continued for at least 2 hours or for the duration of PCI, whichever is longer. IMPORTANT SAFETY INFORMATION KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding. KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product. Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL® than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour. The most common adverse reaction is bleeding. INDICATION KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. https://kengreal.com/dosing-and-administration/