可降解药物洗脱消化道支架的研究进展与前景

Advances and prospects of degradable drug-eluting gastrointestinal stents

背景:目前消化道支架的临床应用较为普遍,常规的自膨胀金属及塑料支架存在易移位、取出困难、术后再狭窄等问题,可降解药物洗脱消化道支架凭借生物可降解、术后再狭窄率低等优点成为消化道支架研究的热点。目的:总结可降解药物洗脱消化道支架的研究进展,对可降解药物洗脱消化道支架的前景作出展望。方法:检索中国知网、万方、Pub Med、Web of Science数据库中1994年1月至2024年3月发表的相关文献,中文检索词为“可降解,药物洗脱支架,食管支架,胆道支架,胰管支架,肠道支架,消化道支架”,英文检索词为“biodegradable,drug-eluting stent,esophageal stent,biliary stent,pancreatic duct stent,intestinal stent,gastrointestinal stent”,最终纳入64篇文献进行综述分析。结果与结论:(1)可降解药物洗脱消化道支架以生物可降解材料为主体,搭载并局部洗脱不同治疗目的的药物,发挥物理支撑及药物治疗双重作用。通过调整支架材料性质、改进制造工艺及辅助手段可以加快或减缓支架降解速度,满足临床需求。药物洗脱技术以药物涂层、纳米颗粒、聚合物载药膜等为载药平台,使药物精准释放,提高病变部位局部药物浓度,减少药物损耗及毒性药物的全身吸收量。(2)可降解药物洗脱消化道支架主要为一种或多种功能性药物结合可生物降解聚合物、金属或纳米纤维材料。可用的功能性药物分为抗炎抗增生类、抗肿瘤类、溶石类、酶抑制剂类。(3)维持支架机械性能稳定和精准控释药物是可降解药物洗脱消化道支架现阶段需要解决的问题,开发新型可降解消化道支架,研究新型载药及释药方式、制造工艺和辅助手段是未来研究方向。

BACKGROUND:At present,the clinical application of gastrointestinal stents is relatively common.Conventional self-expanding metal and plastic stents have the problems of easy displacement,difficulty to remove,and postoperative restenosis.With the advantages of biodegradability and low postoperative restenosis rate,biodegradable drug-eluting stents have become the hot spot in the research of gastrointestinal stents.OBJECTIVE:To summarize the research progress of biodegradable drug-eluting gastrointestinal stents and to provide a forecast of biodegradable drug-eluting gastrointestinal stents.METHODS:Relevant articles were retrieved on CNKI,WanFang,PubMed,and Web of Science databases from January 1994 to March 2024.The Chinese and English search terms were“biodegradable,drug-eluting stent,esophageal stent,biliary stent,pancreatic duct stent,intestinal stent,gastrointestinal stent.”Finally,64 articles were included for review and analysis.RESULTS AND CONCLUSION:(1)Biodegradable drug-eluting gastrointestinal stent is a medical device that uses biodegradable material as the main body of the stent,carries and locally elutes drugs for different therapeutic purposes,and plays the dual roles of physical support and drug therapy.By adjusting the properties of stent materials,improving manufacturing processes and auxiliary means,the degradation rate of stents can be accelerated or slowed down to meet clinical needs.Drug elution technology uses drug coatings,nanoparticles,and polymer drug-loaded films,as drug-loading platforms to accurately release drugs,increase local drug concentrations in lesions,and reduce drug loss and systemic absorption of toxic drugs.(2)The main structure of biodegradable drug-eluting gastrointestinal stent is one or more functional drugs combined with biodegradable polymers,metals or nanofiber materials.The available functional drugs are divided into anti-inflammatory and antiproliferative,antitumor,lithotripsy,and enzyme inhibitors.(3)Maintaining the stability of the mechanical properties of gastrointestinal stent and precise controlled drug release are the problems that need to be solved at this stage of biodegradable drug-eluting gastrointestinal stent.The development of new biodegradable materials and the continuous innovation of drug-carrying and drug-releasing methods,manufacturing processes and auxiliary means are the future research directions.