Charlotte Desprez, Charlène Brochard, Véronique Vitton, Isabelle Etienney, Frank Zerbib, Gérard Amarenco, Francois Mion, Michel Queralto, Guillaume Gourcerol, Laurent Siproudhis, Henri Damon, Julie Philip, Elie Lacroix, André Gillibert, Anne-Marie Leroi
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引用次数: 0
Abstract
Background: The efficacy and safety of intrarectal botulinum toxin A (BoNT/A) injections in patients with urge fecal incontinence (FI) were evidenced in a large, multicenter, randomized, placebo-controlled study (FI-TOXIN). The aims of the present study were to evaluate the long-term efficacy and safety of intrarectal BoNT/A injections in a real-world setting in patients who participated in the FI-TOXIN study.
Methods: Data collected from patients who had previously participated in the FI-TOXIN study in 8 French centers from November 2015 to November 2020 were retrospectively analyzed. Given the transient effect of BoNT/A, patients who had received the first injection in the FI-TOXIN study could be re-injected if symptoms recurred. Information on re-injections, satisfaction of patients, severity of FI symptoms, adverse effects, and the switch to another treatment was retrospectively collected from medical charts between M6 (end of the double-blind phase) and M54 of the inclusion in the FI-TOXIN study.
Key results: Of the 191 patients in the initial FI-TOXIN cohort, 147 (77.0%) were included at M6. Between M6 and M54, 114 of these patients received 233 injections (68 first injections, 165 re-injections). Satisfaction information was available for 70 patients, of whom 43/70 (61.4%) were satisfied with all their injections. The treatment failed in 52/147 (35.4%) of the patients, with rejections of the treatment by patients due to insufficient perceived efficacy (34 patients), adverse effects or poor tolerance (11 patients), or switch to a surgical treatment (23 patients). Nonsevere adverse events were recorded after 45/233 (19.3%) injections. The two severe adverse events (cervical cancer and psychiatric hospitalization) were unrelated to the treatment.
Conclusions: Intrarectal injections of BoNT/A displayed moderate long-term efficacy without major adverse effects.
期刊介绍：
Neurogastroenterology & Motility (NMO) is the official Journal of the European Society of Neurogastroenterology & Motility (ESNM) and the American Neurogastroenterology and Motility Society (ANMS). It is edited by James Galligan, Albert Bredenoord, and Stephen Vanner. The editorial and peer review process is independent of the societies affiliated to the journal and publisher: Neither the ANMS, the ESNM or the Publisher have editorial decision-making power. Whenever these are relevant to the content being considered or published, the editors, journal management committee and editorial board declare their interests and affiliations.
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