連結：微菌叢植入導致患者死亡 FDA警告：FMT並非沒有風險
美國FDA報告中表示，兩名患者在接受微菌叢植入（Fecal Microbiota for Transplantation，FMT）後，受到具有抗生素抗藥性之細菌感染，其中一名患者死亡，FDA提醒，雖然FDA十分支持微菌叢植入這個領域的發展，但用於移植的糞便微生物群還是具有一定風險。
在這次案例中，兩名患者的免疫系統在移植時已經受到損害。該機構沒有解釋為什麼患者已免疫受損，還為患者進行移植，也沒有說明是誰執行FMT與在何時何地執行。 兩名患者的移植均來自同一捐贈者，而在該報告中並沒有說明糞便是以液體形式進入消化道或是口服膠囊方式植入病人腸道。
在患者感染後，他們檢測發現捐贈者糞便樣本中含有一種大腸桿菌，產生一種稱為廣效性乙內醯胺分解酶（extended-spectrumβ-lactamase，ESBL），會對β-lactam類抗生素具有抗藥性。在給予患者治療之前，該機構並未在捐贈者糞便中檢測出來。
FDA對研究人員發出警告，應對微菌叢移植中的捐贈者糞便進行抗藥性微生物篩查，若有查出則不予以使用，同時也還警告患者微菌叢植入可能存在風險，需得到FDA批准，並僅用在常規治療無效之困難梭菌感染病人。
“The medical community is actively engaged in exploring the potential uses of Fecal Microbiota for Transplantation, or FMT. Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies. The agency also works to strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs. For example, the FDA has issued guidance stating that it intends to exercise enforcement discretion, under limited conditions, regarding the investigational new drug requirements for FMT used to treat Clostridium difficile infection unresponsive to standard therapies,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “While we support this area of scientific discovery, it’s important to note that FMT does not come without risk. We’ve become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death. We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients. Today’s safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise.”
小編評：之前小編也關注過腸道菌移植治療法，沒想到已經有問題案列出現了…