J Autoimmunity:粪便微生物群移植治疗系统性红斑狼疮的安全性和有效性:EXPLORER试验

2022-08-07 MedSci原创 MedSci原创

粪便微生物群移植(FMT)在活动性系统性红斑狼疮 (SLE) 患者中的首次临床试验提供了支持性证据,FMT 有效地改变了SLE患者的肠道微生物群落并改变了短链脂肪酸代谢谱。

目的:肠道菌群失调与系统性红斑狼疮 (SLE) 的发展有关。尚未探索粪便微生物群移植(FMT)治疗SLE患者的安全性和有效性。在这项为期12周的单臂试验性临床试验中,从健康供体到活动性SLE患者的口服包裹粪便微生物组,来自中南大学附属第二医院皮肤科的研究团队旨在评估FMTSLE患者中的安全性和有效性 (ChiCTR2000036352)

方法:该研究招募了20SLEDAI6SLE患者。FMT每周进行一次,连续三周,同时进行标准治疗,并对患者进行12周的随访。在整个试验过程中评估了安全性。主要终点是第12周的 SLE响应指数-4 (SRI-4)。测量肠道中的微生物组组成、短链脂肪酸(SCFA)水平和血清中细胞因子的水平以及淋巴细胞表型。

结果FMT 后未观察到严重的不良事件。在第12周,SRI-4反应率为42.12%,与基线相比,观察到SLEDAI-2K评分和血清抗dsDNA抗体水平显著降低。观察到产生SCFAs的细菌类群显著富集和炎症相关细菌类群减少,同时肠道中SCFAs的产生增加,外周血中IL-6 CD4+记忆/幼稚比的水平降低。此外,SRI-4有反应的患者在FMT前后均表现出特定的微生物群特征

结论FMT在活动性SLE患者中的首次临床试验提供了支持性证据FMT 有效地改变了SLE患者的肠道微生物群落并改变了短链脂肪酸代谢谱表明FMT通过改变肠道微生物组及其代谢特征可能是SLE患者可行、安全和潜在有效的治疗方法。

 

出处:Huang C, Yi P, Zhu M, Zhou W, Zhang B, Yi X, Long H, Zhang G, Wu H, Tsokos GC, Zhao M, Lu Q. Safety and efficacy of fecal microbiota transplantation for treatment of systemic lupus erythematosus: An EXPLORER trial. J Autoimmun. 2022 Jun;130:102844. doi: 10.1016/j.jaut.2022.102844. Epub 2022 Jun 8. Erratum in: J Autoimmun. 2022 Jul 4;131:102862. PMID: 35690527.

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  5. 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  6. 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  7. 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    2022-08-08 zhouqu_8
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    2022-08-08 Homburg

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