Role of antimicrobial-impregnated polymer and teflon in the prevention of biliary stent blockage

Biliary stent blockage and microbial colonization is a common complication associated with polyurethane stents used for the relief of bile-duct obstruction caused by benign or malignant disease. In an attempt to overcome this problem the application of a ‘Teflon” (polytetrafluoroethylene) stent and an antimicrobial benzalkonium chloride (BZC) impregnated polymer were investigated. The effects of these materials on microbial colonization were compared to a polyurethane stent in vitro in broth or bile. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of BZC for three commonly isolated biliary stent pathogens, Staphylococcus epidermidis, Enterococcus faecium and Enterobacter cloacae were also determined. All the isolates were sensitive to BZC. The growth kinetics of the three organisms in broth and in human pooled bile were similar. Adherence to the BZC impregnated polymer was significantly reduced as compared to the polyurethane and Teflon stents (P < 0·05) in nutrient broth. In bile, fewer organisms attached to the Teflon as compared with the polyurethane stent (P < 0·05) for all organisms. For two of the three test organisms there was less bacterial adherence to the Teflon than to the BZC impregnated polymer. The Teflon and antimicrobial stent materials studied may prevent biliary stent blockage resulting from microbial colonization.     

冠脉支架产品的不溶性微粒评价

简要介绍了不溶性微粒的定义、分类、危害、来源及控制,列举了冠脉支架产品的不溶性微粒评价方法,并分析了冠脉支架产品的不溶性微粒评价的发展趋势。     

内镜下双侧塑料支架植入治疗肝门部胆管恶性梗阻的疗效分析

目的：评估双侧塑料支架植入治疗肝门部胆管恶性梗阻的临床疗效,探讨肝门部胆管癌内镜治疗的最佳模式。方法：回顾性分析南京地区2家内镜中心近2年来38例采用经内镜双侧塑料支架植入治疗肝门部胆管癌的临床资料,包括支架放置成功率、有效引流率、早期并发症发生率、支架通畅时间及生存时间。结果：双支架组操作成功率为89.4%,有效引流率为86.8%,术后早期并发症为18.4%,支架通畅率为15.8%,患者中位生存期29周。结论：双侧塑料支架植入治疗肝门部胆管恶性梗阻安全可行并有较高成功率,可有效降低黄疸,提高生活质量。     

局部覆有放射膜的管腔支架研制

人体管腔支架为近年来用于治疗管腔肿瘤造成的狭窄或梗阻的最广泛、有效的治疗手段,临床应用结果表明管腔支架可以有效恢复患者的管腔生理功能,例:恢复患者因食管狭窄而引起的进食问题,恢复患者因胆管梗阻而引起的全身黄疸等。此种方法是一种较为经济有效的晚期姑息治疗手段。但传统的管腔支架对肿瘤本身的发展无任何影响,仅能短期内解决患者的管腔梗阻问题,没有任何治疗作用。针对此种情况,临床需求一种近距离放射治疗的新型管腔支架,该种支架要求:方便采用介入方式植入人体、进入人体后在短时间内能够自我恢复到相应的形状、支架带放射膜的位置准确地贴敷在管腔肿瘤表面上。为了达到上述三个基本要求,我们采用自膨式管腔支架为载体,在覆普通高分子膜工序时留下需要覆放射膜的空位,待普通高分子膜经过烘干、清洗、干燥后实施放射膜的覆膜工序。需要说明的是,与当前使用的放射性粒子三维立体定向放射治疗计划系统(TPS系统)一样,定制的放射膜面积及形状除了与临床影像诊断结果和数据相符外,还需要根据放疗支架TPS系统计算患者的临床处方剂量,经过换算后得出支架出厂时的活度。为了将定制后的放疗支架精确的植入病变管腔还需要结合中国专利200620158384.0带定位中心的介入手术用输送装置合并进行临床应用。临床应用表明放射支架同目前国内研究使用较多的普通支架捆绑"放射性粒子"相比具有下述特点:放射支架表面为放射膜,表面平整光滑,置入管腔后患者感觉舒畅;普通支架捆绑"放射性粒子"因支架表面有存放放射性粒子的"兜"置入管腔后患者会有局部异物或疼痛感;放射支架置入后"回收"非常方便,捆绑粒子的支架回收非常困难;放射性同位素在内放射支架表面的聚胺酯膜内分布均匀,置入管腔后同组织紧密接触,以"表面放射"的形态作用于肿瘤组织而非捆绑粒子的放射支架以点的方式作用于肿瘤组织,避免了腔内照射"盲点"的存在;与捆绑粒子的支架相比较,放射支架"粒子"脱落的风险为零。     

脑血管支架置入对脑梗死的预防作用

目的 探讨脑血管支架置入对脑梗死的预防作用,为脑梗死的临床预防提供参考依据.方法 共纳入54例脑梗死患者,按照患者及家属是否接受脑血管支架置入手术的意愿分为A、B两组,A组给予脑血管支架置入治疗措施;B组给予常规内科治疗措施.随访6个月,观察两组患者脑梗死复发情况,并进行NIHSS评分评价.结果 两组患者NIHSS评分比较结果显示:两组患者术前NIHSS评分比较差异无统计学意义(P＞0.05);术后两组患者NIHSS评分均明显下降,但与B组(常规内科治疗)相比,A组(脑血管支架置入)下降更明显,差异有统计学意义(P＜0.05).术后两组患者脑梗死再发比较结果显示:术后1个月,两组患者均未有脑梗死发作;术后3个月B组(常规内科治疗)患者有1例再发脑梗死;术后6个月,B组(常规内科治疗)患者共有2例再发脑梗死,而A组(脑血管支架置入)未有再发脑梗死发生.结论 脑血管支架置入治疗不仅可以明显改善脑梗死患者的症状,且可以明显降低患者再次发生脑梗死的风险,对脑梗死患者再发有明显的预防作用,值得临床推广应用.     

主动脉夹层动脉瘤2例介入治疗的护理

目的:探讨主动脉夹层动脉瘤行腔内支架植入术的护理配合措施.方法:结合资料分析2例主动脉夹层动脉瘤行腔内支架植入术的临床护理要点.结果:2例病人手术顺利,术后恢复良好,无并发症发生.结论:术前加强生命体征、疼痛的观察,及时有效地控制血压、镇静、止痛,做好术前教育.术后重视并发症的观察,做好相应的出院指导,对确保该术的效果具有重要的临床意义.     

Surgical Treatment of Parotid Tumors

Treatment of parotid tumors, whether benign or malignant, is always early, total parotidectomy; aspiration biopsy permits definitive differentiation. If the tumor proves benign, as in the case illustrated, the surgeon is prepared for the detailed dissection that makes it possible to preserve all or almost all of the facial nerve and its branches. In malignancy, sacrifice of the nerve may become obligatory.     

雷帕霉素药物洗脱支架在冠心病介入治疗中长期随访研究

目的评价雷帕霉素药物洗脱支架(DES)在冠状动脉病变治疗后长期的有效性与安全性。方法从2005年度(2005-01-01～2005-12-31)和2010年度(2010-01-01～2010-12-31)在解放军总医院心血管内科行DES置入患者中各随机筛选135例患者,按随访时间将其分为术后1年随访组和术后6年随访组两组。所有患者采用电话随访、门诊检查、冠状动脉造影等方式,观察患者在DES支架置入后不同时间不良心血管事件(MACE)发生情况及冠状动脉造影复查情况。结果术后1年随访组与术后6年随访组随访率比较,差异无统计学意义(94.8%vs 92.6%,P>0.05);两组MACE发生率比较,差异有统计学意义(3.1%vs 11.2%,P<0.05),其中心源性死亡(0.1%vs 2.4%,P>0.05)、非致死性心肌梗死(0.0%vs 0.8%,P>0.05)、靶病变血运重建(2.4%vs 8.0%,P<0.05);其他不良事件包括血栓事件、出血事件、全因死亡均无统计学意义;两组造影复查,1年随访组复查造影26例(20%),共置入64枚支架,7枚支架再狭窄(10.9%),无支架贴壁不良、瘤样扩张、支架断裂及支架内血栓病例。6年随访组复查造影61例(48.8%),共置入134枚支架,25枚支架再狭窄(18.7%),两组支架再狭窄率比较,差异无统计学意义(P>0.05)。6年随访组有3例支架贴壁不良,均行血管内超声(IVUS)检查证实(P>0.05),2例靶血管瘤样扩张(P>0.05),1例支架断裂(支架置入后47个月,P>0.05),无支架内血栓病例。结论雷帕霉素药物洗脱支架在冠状动脉病变介入治疗后远期是有效、安全的。     

血管内超声指导下冠状动脉内旋磨术联合药物洗脱支架治疗严重钙化病变

目的：评价血管内超声指导下冠脉内旋磨术联合药物洗脱支架治疗严重钙化病变的疗效。方法：17例患者23处严重钙化病变在血管内超声指导下行旋磨术与药物洗脱支架治疗。观察治疗的即刻成功率及随访结果。结果：所有患者均成功进行了旋磨术与血管内超声指导下的药物洗脱支架植入,手术成功率100%。最小管腔直径由（0.71±0.28）mm增加到（3.24±0.48）mm（P〈0.05）;直径狭窄率由（88.40±7.82）%缩减到（5.26±10.41）%（P〈0.01）。21处病变只选择了1个磨头,占91.30%。9例患者（52.34%）完成了9个月造影复查,无明显支架内再狭窄。结论：血管内超声指导下,冠状动脉内旋磨术联合药物洗脱支架可安全用于冠状动脉严重钙化病变,提高介入治疗成功率。     

血管支架紧缩行为的非线性有限元分析

叙述了采用有限元方法系统研究血管支架的力学行为,对不同结构类型和几何尺寸的钴铬合金的血管支架在预装过程中的紧缩行为进行了精细的模拟,并与实际的测试结果进行了比较。研究表明,基于有限元方法的精细模型,可以真实地模拟出微小血管支架的力学行为。模拟结果显示,随着支架筋厚度的增加,支架的抗力增大,并且较小的金属表面积比将产生较小的轴向伸长率。这些结果对血管支架的合理设计和手术操作具有一定的启示作用。     

肠道黏合吻合专用支架的研制

目的：研制一种新型肠道黏合吻合专用的辅助支架,并检测其性能。方法：利用生物力学机和模拟灌注系统在体外和体内分别检测支架的抗压强度和溶解时间。将43只新西兰白兔分为实验组和对照组,分别采用黏合法和缝合法进行小肠端端吻合术。术后3、14、60d观察吻合口狭窄程度、梗阻程度以及死亡率、手术时间等。结果：该支架具有一定的强度．能承受手术的操作并起到良好的支撑作用,能迅速溶解;动物实验表明,采用该支架的实验组吻合口狭窄程度、梗阻程度和手术时间均优于对照组;死亡率与对照组无显著差异。结论：课题组自行研制的组合式双支架对黏合吻合技术的发展有一定的帮助．为该技术的深入研究寻找到了一条新的思路。     

Cost-Effectiveness of Drug-Eluting Stents in a US Medicare Setting: A Cost-Utility Analysis with 3-Year Clinical Follow-Up Data

Background:  There is only limited information about cost-effectiveness of drug-eluting compared with bare metal stents (BMS) over a time horizon of more than 1 year.
Methods and Results:  We developed a Markov model based on clinical outcome data from a meta-analysis including 17 randomized controlled trials comparing drug-eluting versus BMS with a minimum follow-up of 1 (n = 8221) and a maximum follow-up of 3 years (n = 4105) in patients with chronic coronary artery disease. Costs were obtained as reimbursement rates for diagnosis related groups from the US Centers for Medicare and Medicaid Services. All costs and effects were discounted at 3% annually. All costs are reported in US dollars of the financial year 2007. The incremental effects are 0.002 (95% confidence interval −0.039 to 0.041) quality-adjusted life-years (QALYs) for the sirolimus- and −0.001 (−0.040 to 0.038) QALYs for the paclitaxel-eluting stents (PES). The incremental costs are $2790 for the sirolimus- and $3838 for the PES. The incremental cost-effectiveness ratio is >$1,000,000 per QALY for the sirolimus-eluting stent. PES are dominated by BMS (i.e., less effective and more costly). Among various sensitivity analyses performed, the model proved to be robust.
Conclusions:  Our analysis from a US Medicare perspective suggests that drug-eluting stents are not cost-effective compared with BMS when implanted in unselected patients with symptomatic ischemic coronary artery disease.     

食管支架置入术治疗晚期食管癌贲门癌疗效及并发症分析

目的探讨食管支架置入术在晚期食管癌贲门癌姑息治疗中的疗效,术后并发症及相关因素。方法27例晚期食管癌贲门癌患者,采用食管支架置入术治疗食管贲门恶性梗阻。结果食管支架置入术治疗吞咽困难、饮水呛咳的疗效100％,改善了患者生存质量。并发症主要为胸骨后疼痛和异物感、出血、胃食管反流、支架堵塞、支架移位和食管再狭窄。严重并发症为大出血。结论食管支架置入术可以有效治疗晚期食管癌贲门癌恶性狭窄和食管瘘,缓解吞咽困难,提高生活质量。预防术后大出血需要深入研究。     

治疗晚期食管癌狭窄的金属内支架

扼要综述了金属内支架在晚期良管癌狭窄治疗中的应用及临床并发症。     

Bilateral Subtotal Thyroidectomy for Multinodular Goiter

In hyperthyroid patients who are suitable candidates for a surgical approach, bilateral subtotal thyroidectomy offers a more predictable result than alternative modalities. It is the preferred approach in symptomatic nodular goiter, for it at once restores the euthyroid state, relieves any symptoms arising from the physical size of the thyroid, and carries little likelihood of recurrence.     

消化道药物洗脱支架的研究进展

目前支架在消化道梗阻性病变中的应用已经十分普遍,而其临床研究和应用历史实际上比较短,在近20年才迅速发展起来,有很多临床问题如支架的再狭窄、移位等还没有得到很好的解决.和消化道支架一样,心血管支架同样面临着再狭窄问题,目前已经有一些涂层支架上载药物来预防管腔内再狭窄,并且已经在临床上普遍应用.本文回顾了心血管药物洗脱支架(eluting durg stents DES)和消化道DES的现状并推测消化系统药物洗脱支架将来的发展.     

对比分析无聚合物紫杉醇涂层支架与可降解聚合物雷帕霉素涂层支架治疗冠心病的效果

目的对比分析无聚合物紫杉醇涂层支架(垠艺)与可降解聚合物雷帕霉素涂层支架(Excel)治疗冠心病的疗效与安全性。方法选择某院收治的125例冠心病患者,随机分为垠艺组和Excel组,接受PCI治疗。临床随访1年,观察两组支架内有无血栓形成、主要心脏不良事件(MACE)、死亡原因及再次入院情况。结果两组患者均没有发生晚期肯定性支架血栓。共有6例患者死亡,垠艺组2例,Excel组4例。垠艺组的主要心脏不良事件和再次入院率与Excel组的数据近似,差异均没有统计学意义(P﹥0.05)。结论无聚合物紫杉醇涂层支架与可降解聚合物雷帕霉素涂层支架在治疗冠心病及预防心血管疾病作用相当,均有良好的效果。     

支架相关卫生技术评估研究是否对中国卫生政策有影响：基于文献研究的结果

目的：了解国内外与支架相关的技术评估研究,初步探索研究结论与我国卫生政策之间的关联。方法：采用文献复习法,在CNKI和PubMed数据库中检索文献和指南,并在卫生部和北京、上海、广州三地的相关网站查找与支架相关的政策,据此分析文献结论和政策内容的契合程度。结果：支架相关中英文文献数量逐年增加。中文相关系统综述类文献较少,大多聚焦于安全性和有效性,缺乏对成本效果的研究。中华医学会颁布的指南对支架,尤其是药物洗脱支架的适应症做了相关的说明,与文献结论相一致。与支架相关的政策共有6项,可分为集中招标采购政策、价格管理政策和技术管理规范等三类。前两类政策与成本相关的技术评估研究之间可能存在一定联系;技术管理规范则没有相应的研究证据。结论：尽管中国目前的支架相关文献量不算小,但对成本这一重点问题仍缺乏研究。指南内容和文献结论基本一致,但其他政策相对缺乏循证依据。     

Use of Drug-eluting Stents Versus Bare-metal Stents in Korea: A Cost-minimization Analysis Using Population Data

Objectives

The goal of this study was to perform an economic analysis of a primary stenting with drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with acute myocardial infarction (AMI) admitted through an emergency room (ER) visit in Korea using population-based data.

Methods

We employed a cost-minimization method using a decision analytic model with a two-year time period. Model probabilities and costs were obtained from a published systematic review and population-based data from which a retrospective database analysis of the national reimbursement database of Health Insurance Review and Assessment covering 2006 through 2010 was performed. Uncertainty was evaluated using one-way sensitivity analyses and probabilistic sensitivity analyses.

Results

Among 513 979 cases with AMI during 2007 and 2008, 24 742 cases underwent stenting procedures and 20 320 patients admitted through an ER visit with primary stenting were identified in the base model. The transition probabilities of DES-to-DES, DES-to-BMS, DES-to-coronary artery bypass graft, and DES-to-balloon were 59.7%, 0.6%, 4.3%, and 35.3%, respectively, among these patients. The average two-year costs of DES and BMS in 2011 Korean won were 11 065 528 won/person and 9 647 647 won/person, respectively. DES resulted in higher costs than BMS by 1 417 882 won/person. The model was highly sensitive to the probability and costs of having no revascularization.

Conclusions

Primary stenting with BMS for AMI with an ER visit was shown to be a cost-saving procedure compared with DES in Korea. Caution is needed when applying this finding to patients with a higher level of severity in health status.     

药物涂层支架技术临床应用中的患者参与决策研究

目的:研究药物涂层支架技术临床应用中的患者参与决策现况,分析患者在治疗决策中的参与及其对患者技术使用行为的影响,为相关理论研究和临床实践提供参考。方法:采用横断面设计和多阶段分层抽样方法,选取上海市、福建省、四川省医院心内科冠心病患者进行问卷调查。结果:冠心病患者参与决策量表总得分为32.93±8.235,聚类分析显示92位(61.33%)患者量表得分为"较高";患者量表得分对患者治疗技术选择有显著影响(P0.05),对患者决策满意度有显著影响(P0.05),患者决策满意度对患者治疗技术选择也有显著影响(P0.05),此三者间两两相关。结论:冠心病患者多偏好医患共同决策,但其参与决策的实际程度仍有待提高;患者参与决策正向影响冠心病患者决策满意度,并影响患者是否选择应用药物支架;应当鼓励医患共同决策模式,提升患者满意度并改善医患关系;建议加强技术全方位监督管理,促进药物支架技术的适宜推广。