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2013年6月11日和24日,美国食品和药品管理局(FDA)在分析近期发表的有关人工胶体代血浆羟乙基淀粉注射液(hydroxyethyl starch injection,HES-i)的多个随机对照试验~([1-3])、观察性研究及Meta分析~([4-12])后,先后2次发布警告~([13-14]),指出HES-i有增加死亡并导致严重肾损伤及过度出血的风险,要求企业修改说明书,添加黑框警告。FDA
On June 11 and 24, 2013, the United States Food and Drug Administration (FDA) analyzed a number of recent randomized controlled trials of artificial injections of hydroxyethyl starch injection (HES-i) After [~ [1-3], observational studies, and meta-analysis ~ ([4-12]), two warnings were issued twice (13-14), indicating that HES-i has increased mortality and led to severe kidney disease Injury and excessive bleeding risk, requiring companies to modify the instructions, add a black box warning. FDA