Fibrin Tissue Adhesive

纤维蛋白组织粘连
  • 文章类型: Journal Article
    各种研究都集中在甲状腺手术中纤维蛋白封闭剂(FS)的应用上。利用荟萃分析,本系统综述分析了近期关于FS在甲状腺切除术患者中的安全性和有效性的随机对照试验的结果.科克伦图书馆,WebofScience,Embase,PubMed,和Medline数据库搜索相关研究,没有任何语言限制。在最初确定的69项研究中包括了7项随机对照试验。总的来说,652例患者在甲状腺手术期间接受FS;将其结果与常规治疗的患者进行比较。主要结果是伤口引流的总体积,住院时间,和手术时间。观察到伤口引流的总体积存在显着差异(平均偏差(MD):-29.75,95%置信区间(CI):-55.39至-4.11,P=0.02),住院时间(MD:-0.84,95%CI:-1.02至-0.66,P<0.00001),和手术时间(MD:-7.60,95%CI:-14.75至-0.45,P=0.04)。次要结果是血清肿和甲状旁腺功能减退。FS组和常规组之间甲状旁腺功能减退的风险没有差异(I=0%,相对危险度=1.31,P=0.38)。对“需要侵入性治疗的血清肿形成”的分析表明,FS显示出一定的益处(I2=8%,相对危险度0.44,P=0.15)。不同试验之间的异质性限制了他们的结论。荟萃分析显示,尽管使用FS并没有显着降低甲状腺切除术后患者的血清肿或甲状旁腺功能减退的发生率,它大大减少了总排水量,住院时间,和手术持续时间。
    Various studies have focused on the application of fibrin sealants (FS) in thyroid surgery. Utilizing a meta-analysis, this systematic review analyzed the findings of recent randomized controlled trials on the safety and efficacy of FS in patients who underwent thyroidectomy. The Cochrane Library, Web of Science, Embase, PubMed, and Medline databases were searched for relevant studies, without any language restrictions. Seven randomized controlled trials were included in the originally identified 69 studies. Overall, 652 patients received FS during thyroid surgery; their outcomes were compared with those of conventionally treated patients. The primary outcomes were total volume of wound drainage, length of hospitalization, and operative time. Significant differences were observed in the total volume of wound drainage (mean deviation (MD): -29.75, 95% confidence interval (CI): -55.39 to -4.11, P = 0.02), length of hospitalization (MD: -0.84, 95% CI: -1.02 to -0.66, P < 0.00001), and surgery duration (MD: -7.60, 95% CI: -14.75 to -0.45, P = 0.04). Secondary outcomes were seroma and hypoparathyroidism development. The risk of hypoparathyroidism did not differ between the FS and conventional groups (I = 0%, relative risk = 1.31, P = 0.38). Analysis of \"seroma formation that required invasive treatment\" indicated that FS showed some benefit (I2 = 8%, relative risk 0.44, P = 0.15). Heterogeneity among the different trials limited their conclusions. The meta-analysis showed that although FS use did not significantly reduce seroma or hypoparathyroidism incidence in patients after thyroidectomy, it significantly reduced the total drainage volume, length of hospitalization, and duration of surgery.
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  • 文章类型: Journal Article
    目的:尽管颅底重建原理的认识取得了重大进展,组织封闭剂在改善术后脑脊液(CSF)渗漏结局方面的作用仍存在争议.我们评估了内窥镜颅底手术(ESBS)期间颅底缺损修复中与组织密封剂使用相关的术后CSF泄漏发生率。
    方法:WebofScience,PubMed/MEDLINE,Scopus,科克伦图书馆
    方法:风险差异(RD)的系统评价和荟萃分析。搜索策略确定了报告ESBS后CSF泄漏的原始研究,并通过组织密封剂的使用和/或类型进行了解聚。
    结果:27项非随机研究(n=2,403)纳入了定性和荟萃分析。与不使用密封剂的重建相比,使用组织密封剂的重建并没有显着降低术后CSF泄漏的风险(RD[95%CI]=0.02[-0.01,0.05])。与无密封剂相比,硬脑膜密封剂(-0.02[-0.11,0.07])和纤维蛋白胶(0.00[-0.07,0.07])的亚分析同样不显著。在DuraSeal的进一步子分析中,术后CSF泄漏没有显著调节(0.02[-0.02,0.05]),Adherus(-0.03[-0.08,0.03]),或生物胶(-0.06[-0.23,0.12])与不使用硬脑膜密封剂相比,或Tisseel/Tissucol与未使用纤维蛋白胶(0.00[-0.05,0.05])。在成对(0.01[-0.03,0.05])或网络荟萃分析(-0.01[-0.05,0.04])上,比较硬脑膜密封剂的使用与纤维蛋白胶的使用没有显着关联。来源文献的局限性阻止了按泄漏特征分层的子分析,缺陷的大小和位置,和相应的重建材料。
    结论:与不使用组织密封剂相比,使用组织密封剂对术后脑脊液漏发生率没有影响。有必要进行更高质量的研究,以彻底阐明在内窥镜颅底重建中使用辅助密封剂的临床价值。
    方法:N/A喉镜,134:3425-3436,2024.
    OBJECTIVE: Despite significant advances in understanding of skull base reconstruction principles, the role of tissue sealants in modifying postoperative cerebrospinal fluid (CSF) leak outcomes remains controversial. We evaluate postoperative CSF leak incidence associated with tissue sealant use in skull base defect repair during endoscopic skull base surgery (ESBS).
    METHODS: Web of Science, PubMed/MEDLINE, Scopus, and Cochrane Library.
    METHODS: Systematic review and meta-analysis of risk differences (RD). A search strategy identified original studies reporting CSF leakage following ESBS with disaggregation by tissue sealant use and/or type.
    RESULTS: 27 non-randomized studies (n = 2,403) were included for qualitative and meta-analysis. Reconstruction with a tissue sealant did not significantly reduce postoperative CSF leak risk compared with reconstruction without sealant (RD[95% CI] = 0.02[-0.01, 0.05]). Sub-analyses of dural sealant (-0.02[-0.11, 0.07]) and fibrin glue (0.00[-0.07, 0.07]) compared with no sealant were similarly unremarkable. Postoperative CSF leakage was not significantly modulated in further sub-analyses of DuraSeal (0.02[-0.02, 0.05]), Adherus (-0.03[-0.08, 0.03]), or Bioglue (-0.06[-0.23, 0.12]) versus no dural sealant use, or Tisseel/Tissucol versus fibrin glue nonuse (0.00[-0.05, 0.05]). No significant association was seen comparing dural sealant use versus fibrin glue use on pairwise (0.01[-0.03, 0.05]) or network meta-analysis (-0.01[-0.05, 0.04]). Limitations in source literature prevented sub-analyses stratified by leak characteristics, defect size and location, and accompanying reconstruction materials.
    CONCLUSIONS: Tissue sealant use did not appear to impact postoperative CSF leak incidence when compared with nonuse. Higher quality studies are warranted to thoroughly elucidate the clinical value of adjunct sealant use in endoscopic skull base reconstruction.
    METHODS: N/A Laryngoscope, 134:3425-3436, 2024.
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  • 文章类型: Comparative Study
    以下问题指导了该研究:纤维蛋白胶在无引流的输卵管成形术中的使用是否可以降低血肿的患病率,与标准治疗相比,血清肿患病率增加了患者的满意度或减少了成年人群的住院时间?以下纳入和排除标准适用:两组均进行了隆胎成形术。参与者仅限于在研究期间没有进行任何其他手术的成年人。与对照组相比,干预措施包括使用无引流的纤维蛋白胶,其中应用了排水沟和/或压力敷料。数据库:clinicaltrials.gov,MEDLINE,Cochrane,mRCT,PubMed,谷歌学者,Scopus,Embase,VHL,GHL于2023年3月25日由2名不同的调查人员进行了搜索。使用Cochrane偏差风险工具2.0。纳入了五项研究,共有1277名参与者(2554名面侧)。使用纤维蛋白胶的累积血肿率为OR0.47(95%CI0.26-0.84)。没有足够的数据来评估血清肿率,患者满意度,和住院时间。研究偏倚的风险被判断为低和中等。使用纤维蛋白密封剂与引流的确定性很高,并且在GRADeproGDT工具中,结果的重要性被认为很重要。在血肿患病率方面,接受除皱术的患者与引流相比,使用纤维蛋白胶更有益。本研究在PROSPERO(CRD42023421475)注册。证据级别I本期刊要求作者为每篇文章分配一个级别的证据。对于这些循证医学评级的完整描述,请参阅目录或在线作者说明www。springer.com/00266.
    The following questions guided the study: Can the use of fibrin glue in drainless rhytidoplasty reduce hematoma prevalence, seroma prevalence increase patient satisfaction or decrease the length of hospital in the adult population compared with standard treatment? The following inclusion and exclusion criteria apply: The procedure performed was rhytidoplasty for both groups. Participants were limited to adults who did not have any other procedure performed during the study. The intervention consisted of the use of fibrin glue without drains compared to the control group, in which drains and/or pressure dressing were applied. Databases: clinicaltrials.gov, MEDLINE, COCHRANE, mRCT, PubMed, Google Scholar, Scopus, Embase, VHL, GHL were searched on 03/25/2023 by 2 different investigators. The Cochrane Risk of Bias Tool 2.0 was used. Five studies were included with a total number of 1277 participants (2554 face sides). The cumulative hematoma rate was OR 0.47 (95% CI 0.26-0.84) in favor of using fibrin glue. Insufficient data were available to assess seroma rate, patient satisfaction, and length of hospital stay. The risk of study bias was judged to be low and moderate. The certainty for the use of fibrin sealant versus drainage is high and the importance of outcomes is rated as important in the GRADEpro GDT tool. Fibrin glue use is more beneficial comparing to drainage in patients undergoing rhytidectomy in terms of hematoma prevalence. This study was registered in PROSPERO (CRD42023421475).Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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  • 文章类型: Meta-Analysis
    文献描述了多种刺激伤口愈合以减轻患者对疼痛的感知的方法。本系统评价旨在评估与自然愈合相比,促进伤口愈合的方法是否可以减少患者从上颚区域去除游离牙龈移植物后的疼痛感觉。根据PRISMA检查表编写了系统审查方案。对五个数据库进行了电子搜索,以确定随机临床试验(RCT),这些试验评估了患者在从上颚去除游离牙龈移植物后对疼痛的感知。主要结果是视觉模拟量表(VAS)评分,评估患者在从上颚区去除游离牙龈移植物后7天的疼痛感觉。在从电子数据库检索到的1622篇潜在相关文章中,选择16个随机对照试验进行定性分析,其中,6项RCT纳入meta分析。RCT显示与使用增强伤口愈合的方法相关的显著的VAS降低。汇总估计显示,手术后7天,整体VAS显着降低2.20(95%CI2.32,2.07)。表现出最大的疼痛感知减少的方法是富含血小板的纤维蛋白,透明质酸,和自体纤维蛋白胶。增强伤口愈合的方法,包括富含血小板的纤维蛋白,透明质酸,和自体纤维蛋白胶,可以减少上颚区游离牙龈移植物去除后的疼痛感觉。然而,只有1个RCT调查了每种方法,这阻碍了关于减少疼痛感知的最佳程序的结论。
    The literature describes multiple ways to stimulate wound healing to reduce the patient\'s perception of pain. This systematic review aimed to evaluate if methods that enhance wound healing can reduce the patient\'s perception of pain after free gingival graft removal from the palate region compared to natural healing. A systematic review protocol was written following the PRISMA checklist. Electronic searches of five databases were performed to identify randomized clinical trials (RCTs) that assessed the patient\'s perception of pain after the removal of a free gingival graft from the palate. The primary outcome was the visual analog scale (VAS) score assessing the patient\'s perception of pain 7 days after the free gingival graft removal from the palate region. Of the 1,622 potentially relevant articles retrieved from the electronic databases, 16 RCTs were selected for qualitative analysis, and of these, 6 RCTs were included in the meta-analysis. RCTs showed a significant VAS reduction associated with the use of methods to enhance wound healing. The pooled estimates revealed a significant overall VAS reduction of 2.20 (95% CI 2.32, 2.07) 7 days after surgery. The methods that presented the greatest reduction in the perception of pain were platelet-rich fibrin, hyaluronic acid, and autologous fibrin glue. Methods that enhance wound healing, including platelet-rich fibrin, hyaluronic acid, and autologous fibrin glue, can reduce pain perception after free gingival graft removal in the palate region. However, only 1 RCT investigated each approach, which hinders the conclusion regarding the best procedure to reduce the perception of pain.
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  • 文章类型: Letter
    Wang等人的荟萃分析。(干细胞ResTher14(1):103,2023)旨在探索间充质干细胞是否对肛周瘘有效。作者指出,细胞类型的差异,细胞来源和细胞剂量不影响间充质干细胞的功效,这可能不准确。我认为用更高剂量的间充质干细胞进行局部治疗似乎不会导致更高的治愈率。And,考虑到过去的进一步自身免疫病史,未来的试验应该集中在供体特征上,及时,具有成本效益的治疗,以减轻优化的治疗目标。在未来,探讨纤维蛋白胶联合间充质干细胞注射治疗肛周瘘的安全性和可行性。
    The meta-analysis by Wang et al. (Stem Cell Res Ther 14(1):103, 2023) aims to explore whether mesenchymal stem cells are effective for perianal fistulas. The authors indicated that the difference in cell types, cell sources and cell dosages did not influence mesenchymal stem cells\' efficacy, which may not be accurate. I think that local treatment with higher dosages of mesenchymal stem cells seems to not result in a higher healing rate. And, future trials should focus on donor characteristics considering past medical history of further autoimmunity, timely and cost-effective treatment to lighten the optimized therapeutic goals. In the future, it will be interesting to assess the safety and feasibility of injection of fibrin glue combined with mesenchymal stem cells in perianal fistulas.
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  • 文章类型: Systematic Review
    目的:评估和汇编目前关于成功手术治疗膀胱阴道瘘的证据水平,以及这些围手术期干预措施如何影响解剖,以病人为中心,和不良后果。
    方法:从开始到2022年9月9日搜索PubMed和EMBASE。
    方法:本综述包括原发性或复发性膀胱阴道瘘的比较研究(任何样本量)和单组研究(1,000名或更多参与者)(即,膀胱阴道瘘,尿道阴道瘘,和膀胱颈阴道瘘)。我们评估了干预前的评估或管理,各种术中管理技术,和术后管理。感兴趣的结果包括解剖和客观结果(如成功修复,瘘管闭合,尿失禁,复发性瘘管,围手术期并发症)和主观结果(例如排尿症状和生活质量)。摘要和全文文章进行了一式两份的筛选,并将研究描述和发现提取到标准化的提取表格中。偏倚风险由两名调查人员独立评估,并由三分之一进行裁决。用标准化工具总结研究质量。当至少有三项研究比较了相似的干预措施并报告了相似的结果指标时,我们对相对风险进行了随机效应模型和限制性最大似然荟萃分析。
    结果:46项研究符合纳入标准。研究分为11个领域:1)术前评估,2)术前、术后物理治疗,3)手术路线,4)结合襟翼,5)修边,6)分层闭合,7)术中抗生素,8)纤维蛋白胶,9)筋膜吊带,10)术后Foley导尿管持续时间,11)生活质量。尽管数据的强度不足,术前非那唑吡啶,物理治疗,分层闭合,术中使用抗生素似乎可以提高瘘管修复的成功率。手术方式(阴道与腹部剖腹手术)主要由外科医生的偏好决定,在成功的瘘管修复中没有差异。此外,使用中间皮瓣,修剪瘘管边缘,纤维蛋白胶,筋膜吊带在瘘管治愈率方面没有显着改善。总的来说,术后生活质量评分改善,与修复途径和插入皮瓣的使用无关.
    结论:我们的发现强调了可用于指导膀胱阴道瘘修复的循证治疗的有限信息。总的来说,缺乏高质量的证据来提供指导方针;因此,专家意见仍然是瘘管修复建议的主要影响因素.
    背景:PROSPERO,CRD42021214948。
    OBJECTIVE: To assess and compile the current level of evidence regarding successful surgical treatment of vesicovaginal fistulae and how these perioperative interventions affect anatomic, patient-centered, and adverse outcomes.
    METHODS: PubMed and EMBASE were searched from inception through September 9, 2022.
    METHODS: This review included comparative studies (of any sample size) and single-group studies (1,000 or more participants) of primary or recurrent vesicovaginal fistula (ie, vesicovaginal fistula, urethrovaginal fistula, and bladder neck-vaginal fistula). We evaluated preintervention assessment or management, various techniques for intraoperative management, and postoperative management. Outcomes of interest included anatomic and objective outcomes (such as successful repair, fistula closure, urinary incontinence, recurrent fistula, perioperative complications) and subjective outcomes (such as voiding symptoms and quality of life). Abstracts and full-text articles were screened in duplicate, and study descriptions and findings were extracted into standardized extraction forms. Risk of bias was assessed independently by two investigators and adjudicated by a third. Study quality was summarized with standardized tools. We conducted random-effects model and restricted maximum-likelihood meta-analyses of relative risks when at least three studies compared similar interventions and reported similar outcome measures.
    RESULTS: Forty-six studies met the inclusion criteria. Studies were categorized into 11 domains: 1) preoperative assessment, 2) preoperative and postoperative physical therapy, 3) route of surgery, 4) incorporation of a flap, 5) trimming, 6) layered closure, 7) intraoperative antibiotics, 8) fibrin glue, 9) fascial sling, 10) postoperative Foley catheter duration, and 11) quality of life. Although the strength of the data is insufficient, preoperative phenazopyridine, physical therapy, layered closure, and intraoperative antibiotics seemed to improve the rate of successful fistula repair. Route of surgery (vaginal vs abdominal laparotomy) was determined primarily by surgeon preference and showed no difference in successful fistula repair. In addition, use of interpositional flaps, trimming fistula edges, fibrin glue, and fascial sling did not show significant improvement in rates of fistula cure. Overall, quality-of-life scores improved postoperatively regardless of route of repair and use of interpositional flaps.
    CONCLUSIONS: Our findings highlight the limited information available to guide evidence-based treatment of vesicovaginal fistula repair. Overall, high-quality evidence is lacking to provide guidelines; therefore, expert opinion remains the primary influence for fistula repair recommendations.
    BACKGROUND: PROSPERO, CRD42021214948.
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  • 文章类型: Journal Article
    目的:本综述将探讨纤维蛋白封闭剂在接受头颈部手术的成年患者中的有效性。
    背景:控制出血在头颈部手术中很重要。涉及附近重要结构的并发症增加了发病率和死亡率的风险。除其他传统止血方法外,还使用手术组织粘合剂以减少手术部位出血。与其他组织粘合剂相比,纤维蛋白密封剂已显示出一些成功,但个别研究尚无定论。
    方法:我们将包括对18岁或以上接受过头颈部软组织手术并放置引流管的患者进行纤维蛋白封闭剂与安慰剂或常规治疗的比较研究。主要结果包括伤口并发症和手术引流时间。次要结果包括住院时间,排出体积输出,术后血肿的外科治疗,输血率,和不良反应。
    方法:我们将搜索电子数据库(PubMed,Embase,Cochrane对照试验数据库),用于1975年以来发表的研究。标题,摘要,全文文件将由两名独立审核员根据纳入标准进行评估。将进行研究筛选和选择,以及使用标准化JBI评估工具进行的关键评估。数据将由2名独立审阅者提取。在适当的情况下,将对所有结果进行荟萃分析,连续数据的加权平均差。风险比将用于二分数据。确定性将使用建议分级报告,评估,开发和评估(等级)方法。
    背景:PROSPEROCRD42023412820。
    OBJECTIVE: This review will investigate the effectiveness of fibrin sealants in adult patients who underwent head and neck surgery.
    BACKGROUND: Controlling bleeding is important in head and neck surgery. Complications involving nearby vital structures increase the risk of morbidity and mortality. Surgical tissue adhesives are used in addition to other traditional hemostatic methods to reduce surgical site bleeding. Fibrin sealants have shown some success compared with other tissue adhesives, but individual studies have been inconclusive.
    METHODS: We will include studies comparing fibrin sealants with placebo or usual care in patients 18 years or older who have undergone soft tissue surgery of the head and neck with drain placement. Primary outcomes include wound complications and time to surgical drain removal. Secondary outcomes include length of hospital stay, drain volume output, surgical management of postoperative hematoma, rate of blood transfusions, and adverse reactions.
    METHODS: We will search electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials CINAHL, Scopus, Web of Science) for studies published from 1975 onwards. Sources to be search for unpublished literature will include ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, MedNar, and ProQuest Dissertations and Theses. Titles, abstracts, and full-text papers will be assessed against the inclusion criteria by 2 independent reviewers. Study screening and selection will be performed, and critical appraisal conducted using the standardized JBI appraisal tools. Data will be extracted by 2 independent reviewers. Meta-analysis will be conducted for all outcomes where appropriate, with weighted mean differences for continuous data. Risk ratios will be used for dichotomous data. Certainty will be reported using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.
    BACKGROUND: PROSPERO CRD42023412820.
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  • 文章类型: Systematic Review
    目的:这篇综述的目的是描述和评估用生物材料覆盖结直肠吻合的现有方法及其在减少吻合口漏方面的临床影响。(AL).
    背景:结直肠手术中最严重的并发症是AL。尽管其诊断和管理有所改善,AL仍然是一个悬而未决的问题。为了防止其外观和临床后果,已经描述了使用合成或生物材料的不同外部增强技术。
    方法:对2022年6月之前的现有文献进行了系统综述搜索,寻找有关结肠或结肠直肠吻合的外部加固的所有文献。在审查过程之后,将材料分为固体和液体材料,并对其临床影响进行了评估.该研究方案已在PROSPERO注册,并根据PRISMA和AMSTAR指南10,11进行了报告。
    结果:97篇文章符合纳入标准,被识别和修改。总的来说,选定的文章中有18篇集中在人体临床试验上,而79篇集中在动物模型上。只有纤维蛋白密封剂,胶原蛋白贴片和网膜成形术在人类中显示出积极的结果。
    结论:纤维蛋白密封剂,胶原蛋白贴片和网膜成形术,到目前为止,研究最多的生物材料。然而,在提出明确的建议之前,需要进一步的研究来确认这些发现。
    OBJECTIVE: The aim of this review is to describe and assess the existing methods to cover colorectal anastomoses with biomaterials and their clinical impact in reducing anastomotic leakage (AL).
    BACKGROUND: The most serious complication in colorectal surgery is AL. Despite improvements in its diagnosis and management, AL remains an unresolved issue. To prevent its appearance and clinical consequences, different external reinforcement techniques with synthetic or biomaterials have been described.
    METHODS: A systematic review search of the available literature until June 2022 was performed, looking for all literature regarding external reinforcement of colonic or colorectal anastomoses. After the review process, a classification of materials was proposed into solid and liquid materials, and an assessment of their clinical impact was performed. The study protocol has been registered at PROSPERO and has been reported in the line with PRISMA and AMSTAR Guidelines 11,12 .
    RESULTS: Ninety-seven articles that fulfilled inclusion criteria, were identified and revised. Overall, 18 of the selected articles focused on human clinical trials and 79 on animal models. Only fibrin sealants, collagen patches, and omentoplasty have shown positive results in humans.
    CONCLUSIONS: Fibrin sealants, collagen patches, and omentoplasty are, so far, the most studied biomaterials. However, further studies are required to confirm these findings before definite recommendations can be made.
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  • 文章类型: Journal Article
    背景:由于手术止血不足,血管手术后可能会发生内出血,异常凝血,或手术并发症。出血范围从轻微开始,没有输血要求,到巨大的,需要多次输血。有很多药物,系统给定或局部应用,这可能会减少输血的需要。
    目的:评估抗纤维蛋白溶解和止血药物和药物在减少出血和需要输血方面的有效性和安全性。
    方法:我们搜索:Cochrane中央对照试验登记册;MEDLINE;Embase;CINAHL,输血证据库。我们还检索了WHOICTRP和ClinicalTrials.gov试验登记处的正在进行的和未发表的试验。从数据库开始到2022年3月31日,搜索使用MeSH和自由文本术语的组合,没有语言或出版状态的限制。
    方法:我们纳入了成人药物治疗的随机对照试验(RCT),以减少由于大血管手术或有中度或重度失血风险的血管手术引起的出血。使用安慰剂,常规护理或其他药物方案作为对照。
    方法:我们使用标准Cochrane方法。我们的主要结果是红细胞输注单位和全因死亡率。我们的次要结果包括接受同种异体血液制品的风险,因出血而再次手术或重复手术的风险,血栓栓塞事件的风险,严重不良事件的风险和住院时间。我们使用等级来评估证据的确定性。
    结果:我们纳入了22项RCT,分析了3393名参与者,其中有69名参与者的一项RCT仅以抽象形式报告,没有可用的数据。七个RCT评估了全身药物治疗(三个抑肽酶,两种去氨加压素,两种氨甲环酸)和15种RCT评估了局部药物治疗(含药物的生物可吸收敷料或胶水),包括纤维蛋白,凝血酶,胶原蛋白,明胶,合成密封剂和一种研究性新剂。大多数试验是在高收入国家进行的,大多数试验仅包括接受选择性手术的参与者。我们还确定了两个正在进行的RCT。由于与本综述相关的结果报告很少,我们无法进行计划的网络荟萃分析。系统性药物治疗我们确定了三种系统性药物的七项试验:抑肽酶,去氨加压素和氨甲环酸,所有的安慰剂对照。抑肽酶和去氨加压素的试验规模很小,我们所有结果的确定性证据都很低。氨甲环酸与安慰剂是与参与者数量最多的全身性药物比较(2项试验;1460名参与者),两者的偏见风险都很低。其中最大的包括总共9535名接受不同的高风险手术的个体,并报告了关于血管亚组的有限信息(1399名参与者)。两项试验均未报告每位参与者在30天内输注的红细胞单位数。三个结果与非常低的确定性证据相关,这是由于研究规模小和事件数量少导致的非常宽的置信区间(CI)。这些是:全因死亡率长达30天;需要同种异体输血长达30天的参与者人数;以及由于出血而需要重复手术或手术的风险。氨甲环酸可能对30天内血栓栓塞事件的风险没有影响(风险比(RR)1.10,95%CI0.88至1.36;1项试验,1360名参与者;由于不精确而导致的低确定性证据)。有一项正在进行的大型试验(8320名参与者)比较氨甲环酸与安慰剂在接受非心脏手术的人中需要输注红细胞的高风险。计划在2023年4月完成招聘。该试验的主要结果是输注红细胞的参与者比例和静脉血栓栓塞(DVT或PE)的发生率。局部药物治疗由于其开放标签设计,大多数局部药物治疗试验存在较高的偏倚风险(与常规治疗相比,或将液体与海绵进行比较)。所有的试验都很小,大多数都很小,并且在术后期间很少报道临床相关结果。纤维蛋白密封剂与常规治疗是与参与者数量最多的局部药物比较(5项试验,784名参与者)。将纤维蛋白密封剂与常规护理进行比较的五项试验都存在较高的偏倚风险,由于开放标签试验设计,没有采取措施将报告偏差降至最低。所有的试验都是由制药公司资助的。五项试验均未报告每位参与者在30天内输注的红细胞数量或在30天内需要进行同种异体输血的参与者数量。由于样本量小和事件数量少,其他三个结果与具有宽置信区间的极低确定性证据相关。这些因素包括:长达30天的全因死亡率;因出血而需要重复手术的风险;以及长达30天的血栓栓塞性疾病风险.我们确定了一项大型试验(500名参与者),比较了接受腹主动脉瘤修复术的参与者的纤维蛋白密封剂与常规治疗。尚未开始招聘。该试验将动脉疾病导致的死亡和再干预率列为主要结果。
    结论:由于缺乏数据,我们不确定任何用于减少大血管手术所致出血的全身或局部治疗是否对以下方面有影响:长达30天的全因死亡率;因出血需要重复手术或手术的风险;每位参与者长达30天的红细胞输注数或需要同种异体输血长达30天的参与者数量.氨甲环酸可能对血栓栓塞事件的风险没有影响,直到30天。这很重要,因为有人担心这种风险可能会增加。需要针对数千名参与者的样本量目标和临床相关结果的试验,我们期待着在未来看到正在进行的试验的结果。
    Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor, with no transfusion requirement, to massive, requiring multiple blood product transfusions. There are a number of drugs, given systemically or applied locally, which may reduce the need for blood transfusion.
    To assess the effectiveness and safety of anti-fibrinolytic and haemostatic drugs and agents in reducing bleeding and the need for blood transfusion in people undergoing major vascular surgery or vascular procedures with a risk of moderate or severe (> 500 mL) blood loss.
    We searched: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL, and Transfusion Evidence Library. We also searched the WHO ICTRP and ClinicalTrials.gov trial registries for ongoing and unpublished trials. Searches used a combination of MeSH and free text terms from database inception to 31 March 2022, without restriction on language or publication status.
    We included randomised controlled trials (RCTs) in adults of drug treatments to reduce bleeding due to major vascular surgery or vascular procedures with a risk of moderate or severe blood loss, which used placebo, usual care or another drug regimen as control.
    We used standard Cochrane methods. Our primary outcomes were units of red cells transfused and all-cause mortality. Our secondary outcomes included risk of receiving an allogeneic blood product, risk of reoperation or repeat procedure due to bleeding, risk of a thromboembolic event, risk of a serious adverse event and length of hospital stay. We used GRADE to assess certainty of evidence.
    We included 22 RCTs with 3393 participants analysed, of which one RCT with 69 participants was reported only in abstract form, with no usable data. Seven RCTs evaluated systemic drug treatments (three aprotinin, two desmopressin, two tranexamic acid) and 15 RCTs evaluated topical drug treatments (drug-containing bioabsorbable dressings or glues), including fibrin, thrombin, collagen, gelatin, synthetic sealants and one investigational new agent. Most trials were conducted in high-income countries and the majority of the trials only included participants undergoing elective surgery. We also identified two ongoing RCTs. We were unable to perform the planned network meta-analysis due to the sparse reporting of outcomes relevant to this review. Systemic drug treatments We identified seven trials of three systemic drugs: aprotinin, desmopressin and tranexamic acid, all with placebo controls. The trials of aprotinin and desmopressin were small with very low-certainty evidence for all of our outcomes. Tranexamic acid versus placebo was the systemic drug comparison with the largest number of participants (2 trials; 1460 participants), both at low risk of bias. The largest of these included a total of 9535 individuals undergoing a number of different higher risk surgeries and reported limited information on the vascular subgroup (1399 participants). Neither trial reported the number of units of red cells transfused per participant up to 30 days. Three outcomes were associated with very low-certainty evidence due to the very wide confidence intervals (CIs) resulting from small study sizes and low number of events. These were: all-cause mortality up to 30 days; number of participants requiring an allogeneic blood transfusion up to 30 days; and risk of requiring a repeat procedure or operation due to bleeding. Tranexamic acid may have no effect on the risk of thromboembolic events up to 30 days (risk ratio (RR) 1.10, 95% CI 0.88 to 1.36; 1 trial, 1360 participants; low-certainty evidence due to imprecision). There is one large ongoing trial (8320 participants) comparing tranexamic acid versus placebo in people undergoing non-cardiac surgery who are at high risk of requiring a red cell transfusion. This aims to complete recruitment in April 2023. This trial has primary outcomes of proportion of participants transfused with red blood cells and incidence of venous thromboembolism (DVT or PE). Topical drug treatments Most trials of topical drug treatments were at high risk of bias due to their open-label design (compared with usual care, or liquids were compared with sponges). All of the trials were small, most were very small, and few reported clinically relevant outcomes in the postoperative period. Fibrin sealant versus usual care was the topical drug comparison with the largest number of participants (5 trials, 784 participants). The five trials that compared fibrin sealant with usual care were all at high risk of bias, due to the open-label trial design with no measures put in place to minimise reporting bias. All of the trials were funded by pharmaceutical companies. None of the five trials reported the number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. The other three outcomes were associated with very low-certainty evidence with wide confidence intervals due to small sample sizes and the low number of events, these were: all-cause mortality up to 30 days; risk of requiring a repeat procedure due to bleeding; and risk of thromboembolic disease up to 30 days. We identified one large trial (500 participants) comparing fibrin sealant versus usual care in participants undergoing abdominal aortic aneurysm repair, which has not yet started recruitment. This trial lists death due to arterial disease and reintervention rates as primary outcomes.
    Because of a lack of data, we are uncertain whether any systemic or topical treatments used to reduce bleeding due to major vascular surgery have an effect on: all-cause mortality up to 30 days; risk of requiring a repeat procedure or operation due to bleeding; number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. There may be no effect of tranexamic acid on the risk of thromboembolic events up to 30 days, this is important as there has been concern that this risk may be increased. Trials with sample size targets of thousands of participants and clinically relevant outcomes are needed, and we look forward to seeing the results of the ongoing trials in the future.
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  • 文章类型: Systematic Review
    脑脊液(CSF)渗漏是众所周知的开颅手术并发症,有几种硬脑膜闭合技术。作为硬脑膜闭合的辅助物的一种常用的商业产品是胶原结合的纤维蛋白密封剂TachoSil®。我们分析了添加TachoSil是否对术后并发症和结局有有益影响。我们的未来,机构数据库进行了回顾性查询,纳入662例接受开颅手术的患者.三百五十二只用硬脑膜缝合治疗,在310中,在初次缝合后添加TachoSil。我们的主要终点是与脑脊液漏相关的术后并发症的发生率。次要终点包括功能性,残疾和神经系统的结果。根据PRISMA指南进行了系统评价,以确定比较有和没有其他密封剂的原发性硬脑膜闭合的研究。24例(7.74%)和28例(7.95%)手术伴或不伴TachoSil,发生与脑脊液漏相关的术后并发症。分别(p=0.960)。多因素分析证实两组间并发症发生率无显著差异(aOR0.97,95%CI0.53-1.80,p=0.930)。术后功能无显著差异,残疾或神经评分。系统评价确定了661项,并在定性综合中包括了8项研究。在并发症方面,没有一个显示出额外密封剂优于标准技术的显著优势,翻修手术率或结果。根据我们的发现,我们总结说,颅内外科手术后常规使用TachoSil和类似产品作为原发性硬膜缝合的辅助手段是安全的,但在避免并发症或预后方面没有明显优势。未来的研究应该调查它们在高风险环境中的使用是否有益。
    Cerebrospinal fluid (CSF) leakage is a well-known complication of craniotomies and there are several dural closure techniques. One commonly used commercial product as adjunct for dural closure is the collagen-bound fibrin sealant TachoSil®. We analysed whether the addition of TachoSil has beneficial effects on postoperative complications and outcomes. Our prospective, institutional database was retrospectively queried, and 662 patients undergoing craniotomy were included. Three hundred fifty-two were treated with dural suture alone, and in 310, TachoSil was added after primary suture. Our primary endpoint was the rate of postoperative complications associated with CSF leakage. Secondary endpoints included functional, disability and neurological outcome. Systematic review according to PRISMA guidelines was performed to identify studies comparing primary dural closure with and without additional sealants. Postoperative complications associated with CSF leakage occurred in 24 (7.74%) and 28 (7.95%) procedures with or without TachoSil, respectively (p = 0.960). Multivariate analysis confirmed no significant differences in complication rate between the two groups (aOR 0.97, 95% CI 0.53-1.80, p = 0.930). There were no significant disparities in postoperative functional, disability or neurological scores. The systematic review identified 661 and included 8 studies in the qualitative synthesis. None showed a significant superiority of additional sealants over standard technique regarding complications, rates of revision surgery or outcome. According to our findings, we summarize that routinary use of TachoSil and similar products as adjuncts to primary dural sutures after intracranial surgical procedures is safe but without clear advantage in complication avoidance or outcome. Future studies should investigate whether their use is beneficial in high-risk settings.
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