Трансплантация фекальной микробиоты: возможные терапевтические подходы и вопросы правового регулирования

Начиная с работ Ильи Мечникова, в медицинской науке и практике накоплено большое количество доказательств влияния состояния кишечной микробиоты на здоровье человека. Однако лишь в последние годы в исследованиях в этой области произошел качественный перелом: мы стали понимать механизмы влияния микробиоты на гомеостаз, а также выяснять все новые функции живущих в нас микроорганизмов. На этом фоне с 1958 г. развивается трансплантация фекальной микробиоты (ТФМ) от здоровых доноров пациентам с различными заболеваниями, которая восстанавливает нарушенный баланс кишечных микроорганизмов. Наибольшую эффективность данный метод проявляет при терапии тяжелых кишечных инфекций, вызываемых Clostridium difficile. Также ТФМ показала потенциальную эффективность при диарее и запоре различного генеза, рассеянном склерозе, болезни Крона и др. В США, Канаде и других странах ТФМ является предметом интереса не только врачей-клиницистов, но и с недавних пор - регуляторных, органов. В статье также рассматривается возможность применения российского законодательства в сфере обращения лекарственных средств к этому новому методу.

fecal microbiota transplantation, FMT, gut microbiota, Clostridium difficile, multiple sclerosis, probiotic, antibiotic, pharmaceutical legislation, кишечная микробиота, трансплантация кишечной микробиоты, Clostridium difficile, рассеянный склероз, пробиотик, эубиотик, антибиотик, законодательство в сфере обращения лекарственных средств

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