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欧洲药品管理局(EMEA)宣布,根据人用药品委员会(CHMP)的结论:含西布曲明(sibutramine)的药剂,其风险大于效益;并建议在欧盟范围内暂停销售。西布曲明是一种5-羟色胺-去甲肾上腺素再摄取抑制药,结合饮食控制和运动以治疗肥胖病。肥胖患者BMI≥30kg·m~(-2),而超重者BMI≥27kg·m~(-2),并且有其他危险因素,如2型糖尿病或脂质代谢障碍。西布曲明心血管病转归试验(SCOUT)及其他该药减轻体重的研究表明,凡过去有心血管疾病的患者,发生严重心血管病事件(如心脏病发作或卒中)的风险增加。心脏病患者使用西布曲明应为禁忌证。CHMP得出的结论是西布曲
The European Medicines Agency (EMEA) announced that based on the conclusions of the Commission on Human Medicines (CHMP) that sibutramine-containing agents are at greater risk than beneficial; it is proposed to suspend sales within the European Union. Sibutramine is a serotonin-norepinephrine reuptake inhibitor that combines dietary control and exercise to treat obesity. Obese patients with BMI ≥ 30kg · m -2, while those with overweight BMI ≥ 27kg · m -2, and other risk factors, such as type 2 diabetes or lipid metabolism disorders. Studies on sibutramine cardiovascular outcome (SCOUT) and other weight-loss studies have shown that patients with past cardiovascular disease have an increased risk of developing serious cardiovascular events such as heart attacks or strokes. The use of sibutramine in heart disease should be contraindicated. CHMP concluded that sibutramine