NEJM:SER-109用于复发性艰难梭菌感染的口腔微生物组疗法

2022-01-21 MedSci原创 MedSci原创

在用标准抗生素治疗后艰难梭菌感染症状消退的患者中,口服SER-109在降低复发性感染风险方面优于安慰剂。研究人员观察到的SER-109的安全性与安慰剂相似。

目前用于复发性艰难梭菌感染的疗法并未解决被破坏的微生物组,后者会促进艰难梭菌孢子萌发成能够产生毒素的细菌。SER-109是一种由纯化的厚壁菌门孢子组成的微生物组治疗剂,用于治疗复发性艰难梭菌感染。

近日,顶级医学期刊NEJM上发表了一篇研究文章,研究人员进行了一项3期、双盲、随机、安慰剂对照试验,其中患有3次或以上艰难梭菌感染发作(包括符合条件的急性发作)的患者在标准抗生素治疗后再接受SER-109或安慰剂(每天四粒胶囊3天)治疗。

该研究的主要疗效目标是SER-109与安慰剂相比在降低治疗后长达8周的艰难梭菌感染复发风险方面的优势。在试验开始时通过毒素检测进行诊断,并根据年龄和接受的抗生素药物进行随机分组。研究人员还进行了安全性、微生物组植入和代谢物分析。

在筛选的281名患者中,该研究共纳入182名患者。SER-109组和安慰剂组复发艰难梭菌感染患者的百分比分别为12%和40%(相对风险为0.32;95%置信区间[CI]为0.18至0.58;相对风险<1.0的P<0.001;对于相对风险<0.833的P<0.001)。

在根据年龄段(年龄<65岁的患者相对风险为0.24[95%CI为0.07至0.78],对于年龄≥65岁的患者为0.36[95%CI为0.18至0.72])和接受抗生素(万古霉素相对风险为0.41[95%CI为0.22至0.79],非达霉素为0.09[95%CI为0.01至0.63])分层的分析中,SER-109导致复发频率低于安慰剂。大多数不良事件为轻度至中度,并且为胃肠道不良事件,两组的数量相似。SER-109剂量种类早在第1周就被检测到,并且与已知抑制艰难梭菌孢子萌发的胆汁酸相关。

由此可见,在用标准抗生素治疗后艰难梭菌感染症状消退的患者中,口服SER-109在降低复发性感染风险方面优于安慰剂。研究人员观察到的SER-109的安全性与安慰剂相似。

原始出处:
 
Paul Feuerstadt,et al.SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection.NEJM.2022.https://www.nejm.org/doi/full/10.1056/NEJMoa2106516

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