A randomised trial of lung sealant versus medical therapy for advanced emphysema.

Autor:	Come CE; For a full list of the authors' affiliations please see the Acknowledgements ccome@partners.org., Kramer MR; For a full list of the authors' affiliations please see the Acknowledgements., Dransfield MT; For a full list of the authors' affiliations please see the Acknowledgements., Abu-Hijleh M; For a full list of the authors' affiliations please see the Acknowledgements., Berkowitz D; For a full list of the authors' affiliations please see the Acknowledgements., Bezzi M; For a full list of the authors' affiliations please see the Acknowledgements., Bhatt SP; For a full list of the authors' affiliations please see the Acknowledgements., Boyd MB; For a full list of the authors' affiliations please see the Acknowledgements., Cases E; For a full list of the authors' affiliations please see the Acknowledgements., Chen AC; For a full list of the authors' affiliations please see the Acknowledgements., Cooper CB; For a full list of the authors' affiliations please see the Acknowledgements., Flandes J; For a full list of the authors' affiliations please see the Acknowledgements., Gildea T; For a full list of the authors' affiliations please see the Acknowledgements., Gotfried M; For a full list of the authors' affiliations please see the Acknowledgements., Hogarth DK; For a full list of the authors' affiliations please see the Acknowledgements., Kolandaivelu K; For a full list of the authors' affiliations please see the Acknowledgements., Leeds W; For a full list of the authors' affiliations please see the Acknowledgements., Liesching T; For a full list of the authors' affiliations please see the Acknowledgements., Marchetti N; For a full list of the authors' affiliations please see the Acknowledgements., Marquette C; For a full list of the authors' affiliations please see the Acknowledgements., Mularski RA; For a full list of the authors' affiliations please see the Acknowledgements., Pinto-Plata VM; For a full list of the authors' affiliations please see the Acknowledgements., Pritchett MA; For a full list of the authors' affiliations please see the Acknowledgements., Rafeq S; For a full list of the authors' affiliations please see the Acknowledgements., Rubio ER; For a full list of the authors' affiliations please see the Acknowledgements., Slebos DJ; For a full list of the authors' affiliations please see the Acknowledgements., Stratakos G; For a full list of the authors' affiliations please see the Acknowledgements., Sy A; For a full list of the authors' affiliations please see the Acknowledgements., Tsai LW; For a full list of the authors' affiliations please see the Acknowledgements., Wahidi M; For a full list of the authors' affiliations please see the Acknowledgements., Walsh J; For a full list of the authors' affiliations please see the Acknowledgements., Wells JM; For a full list of the authors' affiliations please see the Acknowledgements., Whitten PE; For a full list of the authors' affiliations please see the Acknowledgements., Yusen R; For a full list of the authors' affiliations please see the Acknowledgements., Zulueta JJ; For a full list of the authors' affiliations please see the Acknowledgements., Criner GJ; For a full list of the authors' affiliations please see the Acknowledgements., Washko GR; For a full list of the authors' affiliations please see the Acknowledgements.
Jazyk:	angličtina
Zdroj:	The European respiratory journal [Eur Respir J] 2015 Sep; Vol. 46 (3), pp. 651-62. Date of Electronic Publication: 2015 Apr 02.
DOI:	10.1183/09031936.00205614
Abstrakt:	Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility. (Copyright ©ERS 2015.)
Databáze:	MEDLINE
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