Stehlik Ludek, Hytych Vladislav, Letackova Jana, Kubena Petr, Vasakova Martina
Department of Respiratory Medicine, Charles University 1st Faculty of Medicine and Thomayer Hospital, Videnska 800, Prague 4, 140 59, Czech Republic.
Department of Thoracic Surgery, Thomayer Hospital, Videnska 800, Prague 4, 140 59, Czech Republic.
BMC Pulm Med. 2015 Dec 21;15:164. doi: 10.1186/s12890-015-0160-6.
Biodegradable stents that disintegrate after a period of time are expected to be well tolerated and have advantages over other stents that are more commonly used in practice today. Polydioxanone is a biodegradable polymer that is widely used during surgery with absorbable sutures.
We present cases from the first four patients to undergo a tracheal polydioxanone stent insertion. Indications included significant non-malignant tracheal stenosis in cases where primary surgical treatment was not possible. The stents were implanted using rigid bronchoscopy and patients received regular follow-ups as needed. This use of biodegradable stents in adult patients was a novel, previously untested approach. The study was approved by the Institutional Ethics Committee and was based on a project entitled; "Biodegradable stents in the management of stenoses of large airways" (project NT 14146-3/2013).
Six biodegradable stents were implanted in four patients with benign stenoses. No technical difficulties occurred and no serious or life-threatening events were recorded. All patients reported some benefit from treatment.
Polydioxanone tracheal stents can be considered when a need for temporary support is expected, and as an alternative to other stents if the latter could compromise the patient. Owing to limited experience and observed disadvantages, further research is needed to fully assess this treatment.
This work is based on project NT14146 - Biodegradable stents in the management of stenoses of the large airways (2013-2015, MZ0/NT), registered from May 1, 2013 in The Research and Development and Innovation Information System of the Czech Republic and in ClinicalTrials.gov, reg. no. NCT02620319, December 2, 2015.
可在一段时间后分解的生物可降解支架有望具有良好的耐受性,且相较于如今在实际应用中更常用的其他支架具有优势。聚二氧六环酮是一种生物可降解聚合物,广泛用于外科手术中的可吸收缝线。
我们展示了首批接受气管聚二氧六环酮支架植入的4例患者的病例。适应症包括在无法进行初次手术治疗的情况下出现的严重非恶性气管狭窄。使用硬支气管镜植入支架,患者根据需要接受定期随访。在成年患者中使用生物可降解支架是一种新颖的、此前未经测试的方法。该研究经机构伦理委员会批准,基于一个名为“生物可降解支架在大气道狭窄管理中的应用”的项目(项目编号NT 14146-3/2013)。
为4例良性狭窄患者植入了6个生物可降解支架。未出现技术困难,也未记录到严重或危及生命的事件。所有患者均表示治疗有一定益处。
当预计需要临时支撑时,可考虑使用聚二氧六环酮气管支架,并且如果其他支架可能对患者造成损害,聚二氧六环酮气管支架可作为替代方案。由于经验有限且观察到存在缺点,需要进一步研究以全面评估这种治疗方法。
本研究基于项目NT14146 - 生物可降解支架在大气道狭窄管理中的应用(2013 - 2015年,MZ0/NT),于2013年5月1日在捷克共和国研发与创新信息系统以及ClinicalTrials.gov注册,注册号为NCT02620319,注册时间为2015年12月2日。