Bland Christopher M, Love Bryan L, Jones Bruce M
University of Georgia College of Pharmacy, Savannah, GA, USA.
University of South Carolina College of Pharmacy, Columbia, SC, USA.
Am J Health Syst Pharm. 2025 Feb 10;82(4):174-183. doi: 10.1093/ajhp/zxae249.
The primary purposes of this review are to provide a brief overview of the microbiome, discuss the most relevant outcome data and key characteristics of each live microbiome agent, and pose questions for consideration going forward as these agents are integrated into clinical practice.
The management of Clostridiodes difficile infection (CDI) remains a difficult clinical conundrum, with recurrent CDI occurring in 15% to 35% of patients and causing significant morbidity and decreased quality of life. For patients with frequent CDI recurrences, fecal microbiota transplantation (FMT) has been demonstrated to have significant benefit but also significant risks, and FMT is not approved by the US Food and Drug Administration (FDA) for that indication. FDA has established a new therapeutic class for agents known as live biotherapeutic products (LBPs) that offer significant advantages over FMT, including standardized screening, testing, and manufacturing as well as known quantities of organisms contained within. Two new live microbiome products within this class were recently approved by FDA for prevention of CDI recurrences in adult patients following treatment for recurrent CDI with standard antimicrobial therapy. Both agents had demonstrated efficacy in registry trials in preventing CDI recurrence but differ significantly in a number of characteristics, such as route of administration. Cost as well as logistics are current obstacles to use of these therapies.
Live microbiome therapy is a promising solution for patients with recurrent CDI. Future studies should provide further evidence within yet-to-be-evaluated populations not included in registry studies. This along with real-world evidence will inform future use and clinical guideline placement.
本综述的主要目的是简要概述微生物组，讨论每种活微生物组制剂最相关的结果数据和关键特征，并在这些制剂被纳入临床实践时提出一些供未来考虑的问题。
艰难梭菌感染（CDI）的管理仍然是一个棘手的临床难题，15%至35%的患者会出现复发性CDI，导致严重发病并降低生活质量。对于频繁复发CDI的患者，粪便微生物群移植（FMT）已被证明有显著益处，但也有显著风险，并且FMT未被美国食品药品监督管理局（FDA）批准用于该适应症。FDA为一类被称为活生物治疗产品（LBP）的制剂设立了一个新的治疗类别，这类产品比FMT具有显著优势，包括标准化的筛查、检测和生产，以及已知的所含微生物数量。该类别中的两种新型活微生物组产品最近已获FDA批准，用于预防成年患者在接受标准抗菌治疗后复发性CDI的复发。这两种制剂在预防CDI复发的注册试验中均已证明有效，但在许多特征上有显著差异，如给药途径。成本以及物流是目前使用这些疗法的障碍。
活微生物组疗法对于复发性CDI患者是一种有前景的解决方案。未来的研究应在注册研究未纳入的尚未评估的人群中提供进一步的证据。这与真实世界的证据将为未来的使用和临床指南的制定提供参考。
