塑料与金属胆管支架的材料特征及其生物相容性

背景：经消化内镜塑料及金属胆管支架置入技术是治疗胆道良恶性梗阻的有效手段。尤其是高位梗阻胆管内支架置入治疗,对不能进行外科治疗的胆系肿瘤患者急需消除黄疸,顺应生理性引流,延长生存期,提高生活质量有极大的临床应用价值。 目的：对比经消化内镜置入塑料及金属胆管支架治疗胆道良恶性梗阻的临床效果,并探讨塑料及金属胆管支架与宿主间的生物相容性。 方法：由第一作者以“胆道梗阻,塑料胆管支架,金属胆管支架,生物相容性”为中文检索词,以“cerebrovascular disease,stent,biocompartibility”为英文检索词,在中国期刊全文数据库(CNKI：1989/2009)及Medline(1989/2009)数据库中采用电子检索的方式进行文献检索。排除Meta分析及重复性研究。筛选纳入35篇文献进行评价,探讨塑料及金属胆管支架的治疗现状、并发症和生物相容性。 结果与结论：经内镜置入胆管支架是治疗胆道良恶性梗阻的主要手段。胆管内支架主要包括金属支架和塑料支架两种。金属支架在预防细菌滋生,保持支架持久通畅等方面有很大的优势,但价格昂贵。塑料支架较易细菌附着,胆泥淤积导致支架阻塞,但具有容易更换、价格低廉的优点。塑料及金属胆管支架的生物相容性均有待于提高,对于胆管恶性梗阻的患者,胆管内支架置入与放射治疗相结合有助于预防支架梗阻。对于胆泥的形成,支架的移位和堵塞,以及支架降解产物等问题尚需要进一步的观察和研究。     

内镜下支架置入术与放疗联合治疗中晚期食管癌

目的 观察内镜下带膜金属支架置入术联合放射治疗(简称：放疗)治疗中晚期食管癌的临床疗效。方法 对24例和25例中晚期食管癌患分别行内镜下带膜金属支架置入术和支架联合放疗。比较单纯支架治疗和联合放疗患的生存率、临床症状缓解率及并发症发生率。结果 单纯支架治疗组与联合治疗组在吞咽困难症状缓解率、并发症发生率方面无差别；联合治疗组患的9、12个月的生存率明显高于单纯支架组。结论 内镜下带膜金属支架置入术联合放疗是治疗老年人中晚期食管癌的可行方法，其临床疗效明显优于单纯支架置入组，值得临床推广应用。     

雷帕霉素与紫杉醇洗脱支架置入治疗冠状动脉病变的有效性

背景：药物洗脱支架置入治疗冠状动脉病变具有良好的临床效果,但不同支架的治疗效果可能存在一定差异。 目的：比较不同支架置入治疗冠状动脉病变的临床效果。 方法：纳入278例冠状动脉病变患者,均接受冠状动脉支架置入治疗,其中91例置入雷帕霉素洗脱支架,92例置入紫杉醇洗脱支架,95例置入裸金属支架。支架置入后随访12个月,记录死亡和心肌梗死等不良心脏事件发生情况,以及冠状动脉再狭窄发生情况及材料宿主反应。 结果与结论：雷帕霉素洗脱支架组与紫杉醇洗脱支架组冠状动脉再狭窄率、急性心肌梗死发生率、冠状动脉旁路移植或再次经皮冠状动脉介入治疗率均低于裸金属支架组(P < 0.05),雷帕霉素洗脱支架组与紫杉醇洗脱支架组上述指标比较差异均无显著性意义(P > 0.05)。3组死亡率比较差异无显著性意义(P > 0.05)。3组均未发生支架移位、脱落、断裂、置入位置不良及白细胞增多和血小板减少、溶血等情况。表明两种药物洗脱支架的治疗效果相当,均优于裸金属支架。  中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程     

金属和硅酮支架气道置入后引起支架相关呼吸道感染的发生率和病原学比较

目的比较金属和硅酮气道支架引起支架相关呼吸道感染(SARTI)的发生率以及病原学差异。方法中央型气道狭窄患者置入两种不同类型的支架:金属覆膜支架和硅酮支架。对支架置入后发生的"支架相关呼吸道感染"的发生率差异和病原学特点进行比较。结果 1)本组171例患者中,有39例患者(22.81%)发生支架相关呼吸道感染;2)金属支架组SARTI发生率为29.21%(26/89),显著高于硅酮支架组15.85%(13/82)(P<0.05);3)SARTI病原学差异:金属支架组和硅酮支架组的金黄色葡萄球菌感染率分别为38.46%和69.23%,白色念珠菌分别为23.08%和0%,奇异变形杆菌感染分别为7.26%和0%;4)改善管腔狭窄程度,金属支架组从74.27%±7.13%改善到治疗后17.64%±6.22%,硅酮支架组从74.94%±9.18%改善到治疗后12.68%±8.32%(P<0.01);与之相应,金属支架组的气促评分从2.85±0.89降至治疗后0.85±0.68,硅酮支架组从2.88±0.91降至治疗后0±0.61(P<0.05)。结论和金属支架相比,硅酮支架引起的SARTI发生率更低,这可能和硅酮支架表面有钉突以及更好扩张狭窄气道有关。     

自膨式金属支架及手术解除晚期结直肠癌肠梗阻的疗效比较

背景：对于发生梗阻的晚期结直肠癌患者,置入金属支架的治疗效果尤其是远期疗效知之甚少。 目的：比较自膨式金属支架和姑息性手术解除晚期结直肠癌患者肠梗阻的疗效。 方法：纳入采用自膨式金属支架和姑息性手术两种治疗方式的186例患者,回顾性分析两组患者性别、年龄、梗阻部位、转移部位、支架类型、支架直径、术后并发症、住院时间、化疗、手术至初次化疗时间和晚期梗阻等资料。 结果与结论：支架组的技术成功率低于手术组(P=0.030),临床成功率无差异。与手术组比较,支架组并发症发生率较低,但是主要并发症发生率比较,差异无显著性意义(P=0.839)。支架组住院时间、手术到化疗时间均比较短,但其晚期梗阻的发生率明显高于手术组(P=0.028)。Logistic多元回归分析发现,支架直径和化疗是影响晚期梗阻的独立危险因素。说明对于无法切除并发梗阻的结直肠癌患者支架置入治疗具有更好的早期疗效,但是长期疗效较差,尤其是放置支架直径较小的化疗患者,可能需要再次放置支架或手术以解除晚期梗阻。     

外伤性气管破裂的覆膜气管支架治疗

目的探讨金属气管覆膜支架在气管损伤的应用。方法选择2例胸部外伤后气管多处破裂合并右主支气管破裂患者2例,男性,年龄50岁左右,体征有皮下气肿,呼吸困难,经胸部正位片和CT检查确诊,使用国产覆膜金属支架进行封堵治疗。结果进行支架置入成功后,患者呼吸困难缓解,嘱患者咳嗽时,闭式引流内未见气泡出现。术后3天复查胸片,皮下气肿大部分消除,术后21天顺利取出支架。患者无不适表现。结论覆膜金属支架治疗气管破裂是安全、有效、微创、经济的方法,值得推广应用。     

金属胆道支架在恶性胆道梗阻治疗中的临床应用

目的：探讨金属胆道支架置人结合肿瘤区域化疗在恶性胆道梗阻治疗中的应用价值。方法：46例不能根治切除的恶性胆管梗阻患者中，42例行经皮肝穿刺胆道引流（PTCD）后支架置放术，另4例行经腹胆道支架置放术。支架置放术后，36例采用皮下埋置化疗泵化疗药物注射，8例采用分次动脉插管化疗药物灌注。结果：经PTCD成功后支架置人成功率95．2％，经腹支架置人成功率100％。结论：金属胆道支架置人成功率高，手术损伤，支架通畅率高，结合肿瘤区域化疗，可进一步提高疗效。     

经皮经肝胆管引流途径胆道支架置入与姑息性胆肠内引流治疗恶性梗阻性黄疸的疗效比较

目的：探讨不能手术切除的恶性梗阻性黄疸患者行经皮经肝胆管引流（ PTCD)途径放置胆道支架与姑息性胆肠内引流减轻黄疸方式的疗效差异。方法回顾性分析蚌埠医学院第一附属医院肝胆外科2005年12月—2011年12月不能手术切除且资料完整的210例恶性梗阻性黄疸患者的临床资料,其中 PTCD 途径胆道金属支架置入术137例（支架组),男83例、女54例,年龄（67．64±12．68)岁;姑息性胆肠 Roux-en-Y 内引流术73例（引流组),男50例、女23例,年龄（64．69±12．99)岁。比较两组患者的疗效差异。结果支架组和引流组均可有效解除患者胆道梗阻、改善肝功能;在身体状况、黄疸程度及肝功能损害更严重的情况下,支架组在解除胆道梗阻、改善肝功能方面优于引流组,且不增加手术并发症和住院时间;两组术后生存时间分别为（9．25±6．24)个月和（10．36±8．02)个月,差异亦无统计学意义（P>0．05)。结论对于失去手术切除肿瘤机会的恶性梗阻性黄疸患者,可选择PTCD途径胆道金属支架置入术解除胆道梗阻、改善全身状况,其与姑息性胆肠内引流相比具有简便、安全、创伤小、可重复及可为后续治疗创造条件等优点,可作为首选。     

恶性食管癌并发气管瘘成功置入食道近端覆膜支架一例

我院消化科于2002年11月成功地置入食道近端覆膜支架,解决了1例恶性食管癌合并气管瘘患者的进食问题,系重庆市首例,现报告如下。 1 临床资料 病例,男,51岁,于2002年5月无明显诱因出现吞咽梗阻,进普通饮食出现梗阻感,以第一口干饭时明显,偶感胸骨后胀痛不适。来院应诊后确诊为食管中段癌伴狭窄,在肿瘤科多次行化、放疗后感吞咽梗阻有所缓解,此次入院前半月患者出现     

血管内支架材料特点与缺血性脑卒中的治疗效果

背景：新型血管内支架材料是目前脑血管疾病介入治疗的研究热点。 目的：分析血管内支架材料学特征及缺血性脑卒中治疗效果。 方法：第一作者于2012年12月应用计算机检索数据库的相关文章,中文检索词为“缺血性脑卒中;血管内支架;支架材料;介入治疗”,检索时间范围在2003至2012年,共检索到相关文献120篇,符合纳入标准并用于分析的文献24篇。 结果与结论：①金属裸支架在血液中长期存放有腐蚀、金属离子溶出和凝血性等现象,为解决金属材料存在的问题,可以通过金属支架表面改性来处理,提高金属材料的血液相溶性。②药物支架是将治疗药物涂于支架表面,使药物能够持续并高浓度的释放,防止支架置入后再狭窄。③覆膜血管内支架是在金属支架外表覆以可降解或不可降解的聚合物薄膜,抑制血管内皮增生,对血管平滑肌细胞具有良好的生物相容性,可以预防血管支架置入后再狭窄。血管内支架治疗可以降低缺血性脑卒中的风险,是一种安全有效的治疗手段,同时还可以改善缺血性脑病患者的认知功能障碍。基因及细胞种植支架材料在防治脑血管介入后再狭窄方面也具有一定优势,是血管内支架材料研究的新方向。     

A practical method to rapidly dissolve metallic stents

Metallic stents are commonly used in many clinical applications including peripheral vascular disease intervention, biliary obstruction, endovascular repair of aneurysms, and percutaneous coronary interventions. In the examination of vascular stent placement, it is important to determine if the stent is open or has become obstructed. This is increasingly important in the era of drug-eluting stent usage in coronary arteries. We describe a practical, rapid and cost-effective method to dissolve most metallic stents leaving the vascular and luminal tissues intact. This practical method may replace the laborious and expensive plastic embedding methods currently utilized.     

金属支架管在解除输尿管肿瘤源性和慢性良性梗阻中的疗效观察

目的观察留置金属支架管解除输尿管肿瘤源性和慢性良性梗阻方法的治疗效果。方法 2013年10月至2014年4月,我科使用金属支架管治疗输尿管肿瘤源性和慢性良性梗阻患者10例,肾功能显像(ECT)检查用于评估留置金属支架管后单肾功能。结果经过平均4个月时间的随访,单侧肾功能改善11例,1侧肾功能未见明显改善,所有留置金属支架管肾脏功能未见下降。结论留置金属支架管可有效解除输尿管肿瘤源性和慢性良性梗阻,保护肾功能。     

A Systematic Review and Meta-Analysis of Randomized Trials and Prospective Studies Comparing Covered and Bare Self-Expandable Metal Stents for the Treatment of Malignant Obstruction in the Digestive Tract

Background: Self-expandable metal stents (SEMS) are widely used for the palliative treatment of malignant gastrointestinal obstruction. Our aim was to evaluate the evidence comparing covered and bare SEMS in the digestive tract using meta-analytical techniques.Methods: A literature search was performed using PubMed, Cochrane Library, and Embase databases for comparative studies assessing the two types of stents. The primary outcomes of interest were stent patency and patient survival; second outcomes included technical success, clinical success, tumor ingrowth, tumor overgrowth, and stent migration. A random-effects model was conducted. Pooled analysis was done separately based on the different segments of the digestive tract.Results: Eleven studies (8 randomized controlled trials and 3 prospective cohort studies) including a total of 1376 patients were identified. Covered SEMS were equivalent to bare SEMS in terms of technical success, clinical success, stent patency (gastroduodenal obstruction: HR =0.87, 95% CI 0.53-1.42; colorectal obstruction: HR =0.89, 95% CI 0.18-4.45; biliary obstruction: HR =0.73, 95% CI 0.41-1.32) and survival rates (esophageal obstruction: HR =1.80, 95% CI 0.73-4.44; gastroduodenal obstruction: HR =0.83, 95% CI 0.55-1.26; biliary obstruction: HR =0.99, 95% CI 0.77-1.28), although bare stents were more prone to tumor ingrowth (esophageal obstruction: RR =0.10, 95% CI 0.01-0.77; gastroduodenal obstruction: RR =0.12, 95% CI 0.03-0.55; colorectal obstruction: RR =0.21, 95% CI 0.06-0.70; biliary obstruction: RR =0.21, 95% CI 0.06-0.69), whereas covered stents had the higher risk of stent migration (gastroduodenal obstruction: RR =5.01, 95% CI 1.53-16.43; colorectal obstruction: RR =11.70, 95% CI 2.84-48.27; biliary obstruction: RR =8.11, 95% CI 1.47-44.76) and tumor overgrowth (biliary obstruction: RR =2.03, 95% CI 1.08-3.78).Conclusion: Both covered and bare SEMS are comparable in efficacy for the palliative treatment of malignant obstruction in the digestive tract. Each type of the stents has its own merit and demerit relatively.     

Developments in metallic biodegradable stents

Interest in metallic degradable biomaterials research has been growing in the last decade. Both scientific journals and patent databases record a high increase in publications in this area. Biomedical implants with temporary function, such as coronary stents, are the targeted applications for this novel class of biomaterials. It is expected that stents made of degradable biomaterials, named biodegradable stents, will provide a temporary opening into a narrowed arterial vessel until the vessel remodels and will progressively disappear thereafter. Biodegradable stents made of metal have recently been progressed into preclinical tests in humans after their first introduction in early 2000s. By referring to patents and journal publications, this paper reviews the developments in biodegradable stents, with emphasis on those made of metals, starting from the first design ideas to validation testing.     

生物降解消化道支架和金属消化道支架的应用价值

背景：消化道内镜下介入治疗是近20年发展起来的微创伤治疗新技术,已成为治疗消化道狭窄或梗阻的首选方法。 目的：总结分析生物降解消化道支架和金属消化道支架的应用价值。 方法：以“消化道、生物材料、金属支架、复合材料、复合支架”为中文关键词,采用计算机检索中国期刊全文数据库、PubMed数据库1993-01/2010-11相关文章。纳入生物消化道支架-金属消化道支架的应用等相关的文章,排除重复研究或Meta分析类文章。 结果与结论：共入选25篇文章进入结果分析。消化道狭窄采用内镜下高频电凝电切,微波、探条扩张等均有一定效果, 但有疗效短需反复治疗的缺点。金属内支架置入具有操作简便,创伤小,并发症少,且相对费用较低的优点。可降解支架可以解决良恶性狭窄的再通及瘘口的封堵等,在消化道疾病中的应用已经显示其有效的扩张性及临床安全性,但其材料的选择、支架的设计及降解时间的调节等都需要通过未来更多的临床应用来评估。     

Expandable metal stents in the palliation of malignant dysphagia and oesophageal-respiratory fistulae

The use of self expandable metal stents in the palliation of malignant dysphagia and oesophago-respiratory fistulae has increased in recent years. The aim of this study was to report a comprehensive 4 year audit of a Specialist Unit's experience with the expandable stent. 200 expandable metal stents were deployed for palliation of non operable malignant dysphagia or fistulae. Per-operative, early (<30 days) and late (>30 days) complications specific to the stent were documented. Stents were successfully positioned in all patients. There was no mortality associated with the insertion and no perforation. Dysphagia was palliated initially in 93 per cent of cases. The mean dysphagia score improved significantly from 3.2 to 1.5 (p<0.01). This significant benefit persisted at 3 months and 6 months of follow-up. The commonest complication was stent migration (5.5%) and 23 patients (11%) required a second stent insertion. Oesophago-respiratory fistulae were successfully palliated in all cases. This study demonstrates the effectiveness of self expandable metallic stents in the palliation of non operable malignant dysphagia and oesophago-respiratory fistulae. The minimal risk of significant complications and low incidence of reintervention should establish this approach as first line palliation in these patients.     

Bioresorbable polymeric stents: current status and future promise

Metal stents and, more recently, polymer-coated metal stents are used to stabilize dissections, eliminate vessel recoil, and guide remodeling after balloon angioplasty and other treatments for arterial disease. Bioresorbable polymeric stents are being developed to improve the biocompatibility and the drug reservoir capacity of metal stents, and to offer a transient alternative to the permanent metallic stent implant. Following a brief review of metal stent technology, the emerging class of expandable, bioresorbable polymeric stents is described, with emphasis on developments in the authors' laboratory.