Efficacy and safety of standard and anti-reflux self-expanding metal stent: A systematic review and meta-analysis of randomized controlled trials

BACKGROUND Self-expanding metal stents are the main palliative treatment modality for unresectable esophageal cancer. Gastroesophageal reflux is a common adverse outcome after placement of esophageal stent for cancer involving the gastroesophageal junction and the gastric cardia. Anti-reflux stents with valve have been designed to prevent the acid reflux. The superiority of anti-reflux stent over standard stent in preventing gastroesophageal reflux has not been established well. This study compares the anti-reflux stent and the standard stent in terms of their efficacy to prevent acid reflux.AIM To compare the standard and the anti-reflux stents in terms of their efficacy,safety, and complications.METHODS The meta-analysis included 8 randomized clinical trials(RCTs) to compare pooled outcomes of total 395 patients. Primary outcomes include improvement in reflux symptoms and dysphagia score. Secondary outcomes include complications of stent migration, occlusion, and bleeding.RESULTS A total of eight RCTs were included in the meta-analysis. Compared to the standard stent, the anti-reflux stent showed a trend towards reduction in the dysphagia score without reaching a statistical significance [Standardized mean difference(SMD):-0.33(-0.71, 0.05); P = 0.09, I2: 37%]. There was no statistical difference in the gastrointestinal reflux(GER) scores between the two types of stents [SMD:-0.17(-0.78, 0.45); P = 0.008, I2: 74%]. Compared to standard stent,anti-reflux stent showed no difference in the risk of stent migration [OR: 1.37(0.66, 2.83); P = 0.40, I2: 0 %], bleeding [OR: 1.43(0.40, 5.13); P = 0.59, I2: 0 %], and obstruction [OR: 1.66(0.60, 4.60); P = 0.33, I2: 0 %].CONCLUSION Traditional self-expanding standard esophageal stent and anti-reflux stent with valve are similar in terms of outcomes and complications.

Endoscopic stenting and concurrent chemoradiotherapy for advanced esophageal cancer:A case-control study

AIM:To evaluate the role of endoscopic stenting with or without concurrent 3-dimensional conformal chemoradiotherapy (3D-CRT) in patients with inoperable esophageal cancer.METHODS:Advanced esophageal cancer patients indicated for esophagectomy received esophageal stents.A part of patients completed 3D-CRT after stenting.Efficacy was assessed by endoscopy and computed tomographic scan before and 4 wk after completion of the treatment.The median survival,3D-CRT toxicity and complications were compared between 3D-CRT and control groups.RESULTS:From 1999 to 2008,99 consecutive patients with T3/T4 disease and unsuitable for esophagectomy were placed with esophageal stents.Sixty-seven patients received 3D-CRT,while 36 patients treated withendoscopic stents alone were recruited as controls.After 3D-CRT treatment,the median tumor volume of 3D-CRT patients were reduced significantly from 43.7 ± 10.2 cm 3 to 28.8 ± 8.5 cm 3 (P < 0.05).The complete and partial response rate was 85.1%,and no response was 14.9%.After 3D-CRT,the incidence rate of T2 and T3 disease evident on CT scan increased to 78.4% while T4 decreased from 66.7% to 21.6% (P < 0.05).3DCRT Karnofsky Performance Status improved in 3D-CRT patients compared with the control group (P=0.031).3D-CRT patients had a longer survival than the control group (251.7 d vs 91.1 d,P < 0.05).And the median half-year survival rate in 3D-CRT group (91%) was higher than in the control group (50%,P < 0.05).The most common toxicity was leukocytopenia in the 3D-CRT group (46.7% vs 18.8%,P=0.008).The control group had a higher rate of restenosis than the 3D-CRT group (81.3% vs 9.0%,P < 0.05).The rate of nephrotoxicity was increased in 3D-CRT as compared with the control group (31.3% vs 15.6%,P < 0.05).CONCLUSION:3D-CRT can improve dysphagia in patients with inoperable esophageal carcinoma.3D-CRT combined with stenting results in better survival as compared with endoscopic stents used alone.

Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial

AIM: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.

Acetylsalicylic acid for metal stent in malignant distal common bile duct obstruction:A randomized controlled trial

Background:Endoscopic biliary drainage is the treatment of choice for patients with malignant distal common bile duct obstruction.Self-expandable metal stents have clinical advantages including an increased duration of patency that may be prolonged by acetylsalicylic acid(ASA)use.The aim of this study was to investigate whether ASA had a positive effect on the patency of self-expandable metal stents compared with placebo.Methods:This prospective,multicenter,double-blinded,and randomized placebo-controlled trial was conducted from October 2017 to May 2020 in Korea.Patients who underwent palliative endoscopic biliary drainage with self-expandable metal stents for malignant distal bile duct obstruction were enrolled,and allocated to ASA treatment or placebo.The study outcomes were the rate of stent dysfunction at 6 months,duration of stent patency,risk factors for stent dysfunction,and any adverse events.Results:Interim analysis included 24 and 28 patients in the ASA and placebo groups,respectively.There was no significant difference between the ASA and placebo groups in stent dysfunction(25.0%vs.20.7%,P=0.761)or the duration of stent patency(150.97±10.55 vs.158.07±8.70 days,P=0.497).Six patients experienced suspected ASA-related adverse events,and there was one lethal case.Conclusions:ASA did not prolong stent patency.This study was terminated early because of the possibility of serious adverse events related to ASA treatment of these patients receiving palliative care.

释氧生物材料用于组织工程的研究进展

一定程度的局部缺氧会引起不同水平的组织细胞损伤,释氧生物材料能持续给移植细胞供氧。近年来,许多研究致力于开发更有应用价值的释氧生物材料和体系,来增加体内的氧气输送以保证植入组织的有效氧供。根据提供氧气的形式释氧生物材料可以分为携氧材料和产氧材料。前者基于特定条件下结合氧分子后提供治疗性氧合,后者则是借助氧源材料组合入聚合物内,通过在体内的水解达到氧气释放的效果。文章归纳和总结携氧材料发展现状与产氧材料的氧源供应、装载材料和控制释放等多方面的最新研究,论述释氧生物材料进行氧气递送的实践应用和控制缓释的一系列方案。

A“built-up”composite film with synergistic functionalities on Mg-2Zn-1Mn bioresorbable stents improves corrosion control effects and biocompatibility

Control of premature corrosion of magnesium(Mg)alloy bioresorbable stents(BRS)is frequently achieved by the addition of rare earth elements.However,limited long-term experience with these elements causes concerns for clinical application and alternative methods of corrosion control are sought after.Herein,we report a“built-up”composite film consisting of a bottom layer of MgF2 conversion coating,a sandwich layer of a poly(1,3-trimethylene carbonate)(PTMC)and 3-aminopropyl triethoxysilane(APTES)co-spray coating(PA)and on top a layer of poly(lactic-co-glycolic acid)(PLGA)ultrasonic spray coating to decorate the rare earth element-free Mg-2Zn-1Mn(ZM21)BRS for tailoring both corrosion resistance and biological functions.The developed“built-up”composite film shows synergistic functionalities,allowing the compression and expansion of the coated ZM21 BRS on an angioplasty balloon without cracking or peeling.Of special importance is that the synergistic corrosion control effects of the“built-up”composite film allow for maintaining the mechanical integrity of stents for up to 3 months,where complete biodegradation and no foreign matter residue were observed about half a year after implantation in rabbit iliac arteries.Moreover,the functionalized ZM21 BRS accomplished re-endothelialization within one month.

基于神经模糊系统的电动泵自动化机架运行研究

本文的目的是建立电动泵自动化支架的运行优化模型,并研究其在标称运行模式下的特性。为了研究涡流电动泵自动化理论的主要概念以及线性和非线性对象的控制原理,建立了涡流电动泵的支架结构。根据实验数据,建立了涡流电动泵运行特性的数学模型,基于水泵特性神经模糊系统模型的最优控制极限,提出了一种新的模糊系统模型。结果表明,对于最优模态的发现,依赖于模型识别的智能方法。

Comparison of treatment outcomes between biliary plastic stent placements with and without endoscopic sphincterotomy for inoperable malignant common bile duct obstruction

AIM:Considerable controversy surrounds the adoption of endoscopic sphincterotomy(ES)to facilitate the placement of 10F plastic stents(PS)and to reduce the risk of pancreatitis The aim of the study was to assess the possible advantages of ES before PS placement. METHODS:From 3/1996 to 6/2001,172 consecutive patients, who underwent placement of a single 10F-polyethylene stent for inoperable malignant strictures of the common bile duct,were randomly assigned to 2 groups.In group A(96 patients),a ES was performed before PS placement In Group B,96 patients had PS directly.Early complications(within 30 d)and late effects(from 30 d to stent replacement)were assessed.Patency interval was defined as the period between PS placement and obstruction or death.The success of stent replacement in the 2 groups was evaluated. RESULTS:Stent insertion was successful in 95.8%(92/96) of the pts in group A and in 93.7%(90/96)of the patients in group B(P>0.05).Early complications were more frequent in patients who underwent ES(6.5% vs4.4%)but the data were not significant(P>0.05).In group A pancreatitis developed in two patients and bleeding in three;whereas pancreatitis occurred in 2 patients in group B.Complications were managed conservatively.No procedure related mortality occurred.All late complications were acute cholangitis due to stent occlusion.We performed a stent replacement in 87 patients that was successful in 84 cases without differences between groups. CONCLUSION:Sphincterotomy does not seem to be necessary for placement of 10F-PS in patients with malignant common bile duct obstruction.

Treatment of Atherosclerotic Disease of the Femoral Artery: Randomized Controlled Trials and Meta-Analyses. Should You Be Sceptical?

A narrative review of the data provided by Randomised Controlled clinical trials and meta-analyses was undertaken to assess how much reliance a clinician could place on these in selecting a treatment for patients with disease of the Femoral artery. An attempt was made to detect and review every clinical trial and meta-analysis published on treatments relating to disease of the femoral artery but not relating to drug treatment. Disease of the femoral artery in >65 years age group occurs in approximately 20% of the population but symptomatology was present in 40%. In almost all trials the predominant (>90%) indication for treatment was intermittent claudication. In this setting, clinical benefit was limited and did not extend beyond 12 months. Mortality, from co-morbidities was high. The Basil Trial was the only one to examine intervention for critical limb ischemia. The results for Bypass surgery and Percutaneous transarterial balloon angioplasty (PTA) were equivalent. There is little evidence to support the use of PTA or stenting other than in the treatment of patients with critical limb ischemia.

管控模式对产后妇女行输尿管支架取出术的影响

目的分析管控模式对产后妇女行输尿管支架取出术的影响。方法选取2020年3月1日至2022年10月31日福建医科大学附属第二医院收治的42例行输尿管支架取出术的产后妇女作为研究对象,根据不同管控模式分为普通组与管控组,每组各21例。通过分析比较两组患者诊疗时间、自费费用、接触人数、患者医疗满意度、护理质量、并发症等指标,评价输尿管支架取出术管控模式在管控期间对产后妇女的影响。结果管控组的诊疗时间和接触人数低于普通组,差异有统计学意义(P<0.05)。管控组的医疗满意度良好率、护理质量高于普通组,差异有统计学意义(P<0.05)。管控组与普通组的自费费用、并发症发生率比较差异无统计学意义(P>0.05)。结论管控期间对产后妇女行输尿管支架取出术,相对于普通模式,管控模式的诊疗时间和接触人数显著降低,有利于管控,同时自费费用、并发症无明显差异,提高了患者医疗满意度和护理质量。

大采高加长工作面液压支架选型及顶板控制技术研究

为研究大采高加长工作面在矿压显现规律方面发生的变化,实现采场围岩的有效支护,以王庄煤业15112工作面为研究及实践对象,基于工作面的具体地质生产条件,经过理论分析计算,对液压支架进行选型,验证了工作面支架选型的合理性,进而制定综合矿压观测方案,分别进行了采场矿压、巷道表面位移、工作面走向超前支承压力、工作面侧向支承压力等方面的观测,研究得出了工作面的矿压显现规律及具体的采场围岩控制重点,有力指导了工作面回采期间的顶板管理工作,保障了矿井安全生产。

尼可地尔预防冠脉内支架置入术后无再流效果的系统评价

目的系统评价尼可地尔预防冠脉内支架置入术后慢血流/无再流的临床疗效与安全性。方法电子检索Cochrane对照试验注册数据库(2009年第2期)、PubMed、MEDLINE、EMbase、CBM、CNKI、VIP、万方数据资源(截至2009年4月)。由2名评价者独立评价纳入研究的质量、提取资料并交叉核对,对同质研究采用RevMan5.0软件进行Meta分析。结果共纳入7个研究,包括630例患者。Meta分析结果显示:冠脉和静脉内注射尼可地尔可明显减少无再流/慢血流的发生,冠脉和静脉内注射尼可地尔可以改善TIMI计帧数(CTFC),静脉内注射尼可地尔可以增加左室射血分数;在不良反应方面,虽然尼可地尔组未减少心肌再梗死、死亡和靶血管重建的发生率,但可明显减少室颤/室速、心包积液及心衰的发生率,且尼可地尔可以明显减少总的心脏不良事件发生率。结论本系统评价结果显示,冠脉和静脉内注射尼可地尔均可以起到降低冠脉内支架置入术后无再流/慢血流的发生率和TIM计帧数的效果,且在提高左室射血分数和减少术后不良反应方面,均可获得较好的效果。但限于纳入研究在方法学方面的局限性,尚需开展大样本、高质量的RCT进一步论证其疗效和安全性。

颅内自膨式支架Enterprise治疗缺血性脑卒中颈内动脉狭窄的远期效果:随机对照临床试验方案

背景:研究已证实,闭环可回收自膨胀支架Enterprise支架对颅内动脉瘤有良好的治疗效果,但其在缺血性脑卒中颅内动脉狭窄的治疗应用方面则主要集中于系列病例分析或个案病例报告方面。目的:探讨Enterprise支架置入对动脉粥样硬化缺血性脑卒中颈内动脉狭窄治疗的有效性。方法:研究为单中心、双盲、随机平行对照试验。试验取得患者或其监护人的书面知情同意后,将纳入研究的100例动脉粥样硬化缺血性脑卒中颈内动脉狭窄患者随机分为支架组(n=50)和药物治疗组(n=50),分别给予Enterprise支架置入+抗血小板药物治疗或单纯抗血小板药物治疗。试验共设4个访视时间点:支架置入并药物治疗或药物治疗0.5,1,2,3年。主要结局为美国国立卫生研究院脑卒中量表评估的神经功能缺损程度,次要结局为Barthel指数和颈动脉直径狭窄率。研究方案取得中国北京首都医科大学附属北京朝阳医院伦理委员会的书面批准(批准号:GJCY16012),且符合世界医学会制订的《赫尔辛基宣言》。同时已在Clinical Trial.gov注册(NCT02802072)。讨论:目前尚缺乏Enterprise支架置入治疗缺血性脑卒中颈动脉狭窄的远期疗效的随机对照研究。此次试验拟以此为突破口,试图证实Enterprise支架置入在缺血性脑卒中颈动脉狭窄治疗中的临床意义。

腹腔镜联合胆道镜胆管可控式自脱支架治疗胆总管结石合并胆管炎的临床观察

目的:比较双镜(腹腔镜+胆道镜)联合胆总管探查取石胆管可控式自脱支架置入一期缝合与T管引流治疗胆总管结石合并胆管炎的临床疗效;探讨其可行性与安全性。方法:回顾分析2015年2月至2018年8月因胆囊结石、胆总管结石合并胆管炎行双镜联合胆囊切除、胆总管探查取石术的84例患者的临床资料,按术中胆总管引流方式分为可控式自脱支架置入胆管内引流一期缝合组(观察组,n=54)与T管引流组(对照组,n=30),比较两组手术时间、术中出血量、术后肛门排气时间、术后腹腔引流管留置时间、胆漏发生率、住院时间、降钙素原、C反应蛋白、总胆红素、谷丙转氨酶;记录支架管脱落时间与T管拔除时间。结果:84例患者均顺利完成手术;观察组与对照组手术时间[(117.9±45.2)min vs.(138.4±52.7)min]、住院时间[(8.1±2.2)d vs.(10.6±3.1)d]、术后腹腔引流管留置时间[(6.6±1.4)d vs.(8.6±2.6)d]差异有统计学意义(P<0.05)。对照组2例因取石困难术后8周经T管窦道再次取石成功,两组均无术后出血。可控式自脱落支架排出时间为2~6周,拔除T管时间8周。随访12个月,两组均无残余结石、胆管狭窄及支架管残留。结论:腹腔镜联合胆道镜胆总管探查取石胆管可控式自脱支架置入一期缝合术可作为治疗胆总管结石合并胆管炎的常规术式,效果确切,可达到胆道引流的目的,而且避免了留置T管带来的治疗周期长及患者生活不便、水电解质失衡等问题,具有手术创伤小、安全、治疗周期短、操作简便等优势,值得临床推广应用。

靶控输注依托咪酯应用于颅内支架成形术的对比研究

目的:比较靶控输注依托咪酯与丙泊酚应用于颅内支架成形术的麻醉效果和不良反应。方法:择期行颅内支架成形术患者40例,随机分为依托咪酯组(E组)和丙泊酚组(P组),每组20例。E组靶控输注依托咪酯麻醉诱导并维持,P组靶控输注丙泊酚诱导并维持。记录入室时(T0),放置喉罩前(T1)、放置喉罩即刻(T2)、放置喉罩后5min(T3)、股动脉穿刺置管时(T4)、介入支架植入时(T5)、拔除喉罩后1min(T6)的SBP、DBP、HR、PETCO2及术毕自主呼吸恢复时间(T7)、苏醒时间(T8)、拔除喉罩时间(T9)。观察两组患者不良反应情况。结果:P组患者诱导后SBP、DBP、HR明显下降,尤其是SBP、DBP在T1、T3、T53个时间点均显著低于基础值且两组差异有统计学意义(P<0.05)。循环抑制、注射痛发生率P组多于E组,而肌颤、恶心呕吐发生率E组多于P组。E组苏醒时间显著长于P组(P<0.05)。结论:靶控输注依托咪酯应用于颅内支架成形术血流动力学稳定,麻醉效果满意,不良反应少,为一种安全的麻醉方法。

胰管支架置入术预防内镜逆行胰胆管造影术后胰腺炎的系统评价

目的 评价胰管支架置入术能否降低内镜逆行胰胆管造影 (endoscopicretryradecholangiopancre atograph ,ERCP)术后胰腺炎 (post ERCPpancredtitis ,PEP)高危患者PEP的发生率、严重程度及其临床应用的安全性。方法 计算机检索Cochrane上消化道和胰腺专业临床试验资料库 ( 2 0 0 4年第 1期 )、Cochrane临床对照试验资料库 ( 2 0 0 4年第 1期 )、MEDLINE( 196 6～ 2 0 0 4 4 )、EMBASE( 1985～ 2 0 0 4 4 )、中国生物医学文献数据库 ( 1970～ 2 0 0 4 4 )以及中国循证医学中心随机对照试验资料库 ,手工检索 8种相关中文期刊及所获文献的参考文献 ,全面收集全世界关于胰管支架置入术预防PEP的临床随机对照试验 ,并按Cochrane协作网推荐的方法进行系统评价。结果 共 6篇RCT包括 4 6 8例PEP高危患者被纳入评价。Meta分析结果显示 ,胰管支架置入术可降低PEP高危患者PEP的发生率 [PetoRR 0 31,95 %CI ( 0 19,0 5 2 ) ;P <0 0 0 0 0 1;NNT=6 ]及重度PEP的发生率 [PetoOR 0 13,95 %CI ( 0 0 4 ,0 4 7) ;P =0 0 0 2 ;NNT =2 4 ]。上述结果均与敏感性分析的结果一致。结论 胰管支架置入术可降低PEP高危患者PEP的发生率和重度PEP的发生率 ,可能是预防PEP的有效方法。

尼龙12肺动脉支架球囊导管成型温度优化

通过分析肺动脉支架球囊导管成型过程中温度变化对其成型后近端性能的影响,来确定最适宜的成型温度。首先用尼龙12制成的原料管,通过逐步改变球囊成型的温度,得到不同温度下的肺动脉支架球囊导管;然后测量其近端直径、双层壁厚、爆破压、顺应性等性能,选择符合性能要求的参数,用以确定其成型温度范围。

扰动作用下深部岩巷长期大变形机制及控制技术

巷道围岩本身存在一个抗扰动强度,当深部较高的集中应力超过其抗扰动强度时围岩会对外部扰动变得敏感,在围岩内会形成扰动影响区,围岩扰动影响区不断向内部的发育是扰动作用下深部岩巷长期大变形失稳的本质。针对深部开拓岩石巷道,提出以钢管混凝土支架为主体的复合支护技术。钢管混凝土支架具有承载力高、结构稳定等优点,能够给围岩提供一个较大的支护阻力,提高扰动影响区围岩的抗扰动强度,从而保持巷道长期稳定。根据某矿具体地质条件,设计了合理的支护技术措施,选用钢管混凝土支架型号为?194×8的钢管配合C40强度等级的核心混凝土,该支护体系能够给巷道围岩提供1.26 MPa以上的支护强度,工程应用效果良好。

颅内动脉狭窄支架置入术后预防高灌注综合征的护理

[目的]探讨预防颅内动脉狭窄支架置入术后病人高灌注综合征的护理措施。[方法]将2015年10月─2016年10月在我院诊断明确并接受支架置入术后接受传统护理的328例病人纳入传统组,2016年10月─2017年10月诊断明确并接受支架置入术的接受综合护理的352例病人纳入综合护理组,观察并记录两组高灌注综合征的发生率。[结果]传统护理组共发生高灌注综合征13例,其中脑出血4例,脑水肿4例,癫痫/谵妄5例,发生率为3.96%;综合护理组发生高灌注综合征5例,其中脑出血1例,脑水肿2例,癫痫/谵妄2例,发生率为1.42%。两组比较差异有统计学意义(P<0.05)。[结论]通过有效护理干预措施,使血压控制在合理的范围,可以有效降低颅内动脉狭窄支架置入术后病人高灌注综合征的发生。

尼卡地平与硝普钠用于主动脉腔内修复术控制性降压效果的比较

目的:观察尼卡地平用于覆膜支架主动脉腔内修复术中控制性降压的效果,并与传统降压药物硝普钠进行比较。方法:选用40例Standford B型主动脉夹层拟经股动脉行覆膜支架主动脉腔内修复手术患者,随机分为尼卡地平(N)组和硝普钠(S)组。观察2组降压前、降压4 min和停止降压后10 min、20 min的心率(HR)、收缩压(SBP)、舒张压(DBP)、中心静脉压(CVP)和收缩压与心率乘积(RPP)的变化。结果:应用两种方法均呈现较明显的降压效果。与降压前比较,SBP、DBP明显下降(P<0.01),N组HR无显著变化,S组HR明显增快(P<0.05)。停止用药后,N组血压变化平稳,缓慢回升;S组有血压反跳现象(P<0.05)。降压4 min时,N组RPP明显下降(P<0.05),S组RPP无显著变化。CVP无显著变化。结论:尼卡地平用于夹层动脉瘤覆膜支架主动脉腔内修复术中的控制性降压作用迅速,用药后对心率无显著影响,其效果优于硝普钠,特别适用于伴有冠心病行主动脉夹层腔内修复术的患者。