全球首款口服粪便提取药物在美国上市了!
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当地时间4月26日,美国FDA官网宣布:全球首款口服粪便微生物药物Vowst(SER-109)获批。这款药物由美国公司Seres
Therapeutics研发,用于接受过抗生素治疗的18岁以上成人艰难梭菌感染(CDI)复发预防。
艰难梭菌感染是美国最常见的医疗相关感染之一,每年导致15000至30000人死亡。
某些情况下,如服用抗生素治疗感染后,病人肠道微生物的平衡发生改变,艰难梭菌会繁殖并释放毒素,有可能导致腹泻、腹痛和发烧。在Vowst之前,对于经常复发艰难梭菌感染的病人,一般的治疗方式是用结肠镜移植粪便微生物群来平衡病人体内的肠道微生物群落。FDA官网显示,Vowst每天口服四粒,连服三天。
资料显示,Vowst是由健康合格的人捐赠的粪便制成。粪便经乙醇处理过后,剩下的厚壁菌门菌种的纯化细菌孢子可以影响艰难梭菌疾病的发生。在1b期的临床试验中,有86.7%的患者达到试验主要终点。2015年,美国FDA已授予这一疗法为突破性疗法。
这款药物虽然在II期临床试验中未达到主要终点,但在III期临床试验还是收获了不错的结果。2022年1月,《新英格兰医学杂志》上一篇论文显示,III期实验中,接受Vowst治疗的病人8周后只有12%艰难梭菌感染复发,显著低于安慰剂组的40%复发率。
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