小柯机器人

美国加州大学Richard L. Gallo研究团队取得最新进展。他们报告了用于特应性皮炎（AD）细菌治疗的人类皮肤共生微生物的开发，及在1期随机临床试验中的用途。该研究于2021年2月22日发表于《自然-医学》杂志。

课题组研究了从健康人皮肤中分离出的一种细菌人源葡萄球菌A9（ShA9）的安全性和作用机理，可作为AD的局部疗法。ShA9杀死了小鼠皮肤上的金黄色葡萄球菌，并抑制了促进炎症的金黄色葡萄球菌毒素（psmα）的表达。在54位成人金黄色葡萄球菌阳性AD（NCT03151148）的前臂皮肤上局部应用ShA9或安慰剂，首次人类1期、双盲、随机1周试验达到了其主要安全性终点，参与者接受ShA9的人与AD相关的不良事件更少。

在所有接受ShA9治疗的参与者中评估湿疹严重程度，没有显著差异，但是观察到并达到次要终点时，金黄色葡萄球菌明显减少，ShA9 DNA增加。参与者的一些金黄色葡萄球菌菌株并未被ShA9直接杀死，但所有菌株中表达psmα的mRNA均受到抑制。对由ShA9直接杀死的金黄色葡萄球菌参与者的事后分析表明，局部湿疹严重程度有所改善。这些观察证明了细菌疗法对AD的安全性和潜在益处。

据悉，金黄色葡萄球菌定植于AD患者，并通过促进炎症加剧疾病。

附：英文原文

Title: Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial

Author: Teruaki Nakatsuji, Tissa R. Hata, Yun Tong, Joyce Y. Cheng, Faiza Shafiq, Anna M. Butcher, Secilia S. Salem, Samantha L. Brinton, Amanda K. Rudman Spergel, Keli Johnson, Brett Jepson, Agustin Calatroni, Gloria David, Marco Ramirez-Gama, Patricia Taylor, Donald Y. M. Leung, Richard L. Gallo

Issue&Volume: 2021-02-22

Abstract: Staphylococcus aureus colonizes patients with atopic dermatitis (AD) and exacerbates disease by promoting inflammation. The present study investigated the safety and mechanisms of action of Staphylococcus hominis A9 (ShA9), a bacterium isolated from healthy human skin, as a topical therapy for AD. ShA9 killed S. aureus on the skin of mice and inhibited expression of a toxin from S. aureus (psmα) that promotes inflammation. A first-in-human, phase 1, double-blinded, randomized 1-week trial of topical ShA9 or vehicle on the forearm skin of 54 adults with S. aureus-positive AD (NCT03151148) met its primary endpoint of safety, and participants receiving ShA9 had fewer adverse events associated with AD. Eczema severity was not significantly different when evaluated in all participants treated with ShA9 but a significant decrease in S. aureus and increased ShA9 DNA were seen and met secondary endpoints. Some S. aureus strains on participants were not directly killed by ShA9, but expression of mRNA for psmα was inhibited in all strains. Improvement in local eczema severity was suggested by post-hoc analysis of participants with S. aureus directly killed by ShA9. These observations demonstrate the safety and potential benefits of bacteriotherapy for AD.

DOI: 10.1038/s41591-021-01256-2

Source: https://www.nature.com/articles/s41591-021-01256-2

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