Use of fibrin glue in tracheal surgery. Experimental studies

The experimental studies were undertaken in order to estimate the suitability of fibrin sealant in tracheal surgery and the compare tissue reactivity after using cyanoacrylic and fibrin adhesives. 14 piglets of the Poland white breed, weighing up to 25 kg, were used in the study. Under general tracheal anesthesis the tracheal wall was cut open by incision on the mid-line on the neck between the III-IV tubular cartilages along 3/4 of its circumference. The lips of the incision were closed by one atraumatic suture and tightened by fibrin sealant. Piglets dissecting examinations were carried out after 24 hours, 3, 7, 14, 30, 60 and 90 days after the operation. The results were estimated by macro- and microscopic studies. Comparative studies were carried out on the basis of our own similar experimental studies by means of cyanoacrylates. It was found that the Immuno fibrin adhesive is a very useful new material for tightening the tracheal wounds. The Immuno fibrin adhesive, in comparison with cyanoacrylates, has very good biological qualities, does not cause marginal tissue necrosis and increased chronic inflammatory changes. Fibrin sealant undergoes complete elimination from the wound after 7-10 days and is replaced by connective tissue.     

Fibrin sealant in wound repair: a systematic survey of the literature

Fibrin sealants have recently been approved for clinical use in the US by the FDA and have been available for clinical use in Europe for years. The indication for use in the US is haemostasis. Nevertheless, both commercial and non-commercial fibrin sealant preparations are also for wound healing and for prevention of abdominal adhesions in the US and Europe. To the non-cognoscenti of fibrin sealants, their use to promote wound repair and to prevent abdominal adhesions appears contradictory since an agent that promotes connective tissue repair might be expected to promote abdominal adhesion rather than prevent them. In this systematic survey of the animal and clinical data evidence is presented that supports both off-label uses. However there is much inconsistency in the data secondary to the use of various fibrin sealant preparations, different animal models and clinical situations and different application techniques. It is clear from this survey that standard preparation and application of fibrin sealant for a particular surgical setting are needed to resolve the many apparent discrepancies in the literature. A corollary to this is the likelihood that different fibrin sealant preparations may be preferred for different clinical situations.     

Fibrin sealant in wound repair: a systematic survey of the literature

Fibrin sealants have recently been approved for clinical use in the US by the FDA and have been available for clinical use in Europe for years. The indication for use in the US is haemostasis. Nevertheless, both commercial and non-commercial fibrin sealant preparations are also for wound healing and for prevention of abdominal adhesions in the US and Europe. To the non-cognoscenti of fibrin sealants, their use to promote wound repair and to prevent abdominal adhesions appears contradictory since an agent that promotes connective tissue repair might be expected to promote abdominal adhesion rather than prevent them. In this systematic survey of the animal and clinical data evidence is presented that supports both off-label uses. However there is much inconsistency in the data secondary to the use of various fibrin sealant preparations, different animal models and clinical situations and different application techniques. It is clear from this survey that standard preparation and application of fibrin sealant for a particular surgical setting are needed to resolve the many apparent discrepancies in the literature. A corollary to this is the likelihood that different fibrin sealant preparations may be preferred for different clinical situations.     

Fibrin sealant (evicel® [quixil®/crosseal™]): a review of its use as supportive treatment for haemostasis in surgery

Evicel? is a fibrin sealant consisting of two components, human clottable protein (predominantly human fibrinogen) and human thrombin. It is indicated as supportive treatment in patients undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Evicel? is a new formulation of the previously available fibrin sealant Quixil? (in the EU) or Crosseal? (in the US). Evicel? differs from Quixil?/Crosseal? in that its fibrinogen component does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, resulting in Quixil?/Crosseal? being contraindicated for use in neurosurgery. The removal of tranexamic acid did not affect the haemostatic efficacy or longevity of Evicel? fibrin clots and allowed the sealant to be granted an expanded indication. Evicel? and Quixil?/Crosseal? are easy to use and, since they do not contain synthetic or bovine aprotinin, have a reduced potential for hypersensitivity reactions. This article reviews the pharmacological properties, clinical efficacy and tolerability of Evicel? and its previous formulation as supportive treatment for haemostasis in surgery. In clinical studies, Evicel? and Quixil?/Crosseal? were generally well tolerated and effective haemostatic agents for adjunctive use in various types of surgeries when conventional methods were impractical or ineffective in controlling bleeding. Two pivotal, randomized studies showed that Evicel? was significantly more effective than manual compression in patients undergoing vascular surgery, and significantly more effective than Surgicel? in patients undergoing retroperitoneal or intra-abdominal surgery, as assessed by the proportion of patients achieving haemostasis. In another similarly designed pivotal study in patients undergoing liver resection, Crosseal? was significantly more effective than standard haemostatic agents (e.g. Surgicel?), as assessed by the mean time to haemostasis. The incidences of treatment-emergent adverse events in these studies were generally similar between the Evicel? or Crosseal? groups and the comparator groups. Quixil? was also generally well tolerated and an effective haemostatic agent in endonasal surgeries, and tonsillectomies and/or adenoidectomies, with some benefit of treatment with Evicel? or Quixil? also observed in orthopaedic surgeries. Although additional comparative studies with other haemostatic agents would help to definitively position Evicel? with respect to these agents, current evidence suggests that Evicel? is useful in surgeries for improving haemostasis where standard surgical techniques are insufficient.     

生物蛋白胶与过敏性休克

生物蛋白胶具有止血、促进创伤愈合等作用,在临床中应用广泛。但由于其含有异体蛋白成分——牛抑肽酶,具有一定的抗原性,可导致严重的过敏性休克发生,特别是在重复使用的情况下。文中就生物蛋白胶的组成成分、引起过敏性休克的相关机制及治疗措施进行综述。     

冻干人纤维蛋白胶在心血管外科手术中的应用

目的:评价冻干人纤维蛋白胶在心外科手术应用中的止血效果及安全性.方法:选取年龄为18～60岁,体外循环下行心脏直视手术,并有主动脉或右心室切口的病人共60例,随机分为试验组和对照组各30例,选择主动脉或右心室缝合后有渗血的切口为试验创面,局部使用试验药或对照药.以止血时间及出血量为主要疗效评价指标,比较试验药和对照药的临床疗效.试验组患者随机抽取7例进行3个月安全性随访.结果:用药前后生命体征变化及实验室检查结果的变化,两组之间无明显差异;试验组止血时间(14.67±6.18s)和渗血量(0.81±0.54g)等指标均明显优于对照组(分别为250.45±37.02s和15.39±2.69g);7例试验组病例术后3个月的安全性随访结果均为阴性.结论:冻干人纤维蛋白胶对心脏外科手术后的切口及创面渗血具有良好的止血和组织粘合作用,且具有可靠的病毒安全性.     

A New Fibrin Sealant From Crotalus durissus terrificus Venom: Applications in Medicine

Fibrin sealant, a widely available tissue adhesive, has been used since 1940 in a variety of clinical applications. Commercially available fibrin sealant products are synthesized from bovine thrombin and human fibrinogen, which may transmit infectious diseases, and recipients may also develop antibodies against bovine thrombin. Bearing these disadvantages in mind, a new fibrin sealant was developed in 1989 by a group of researchers from the Center for the Study of Venoms and Venomous Animals, in Sao Paulo State, Brazil. The main purpose was to produce an adhesive fibrin without using human blood, to avoid transmitting infectious diseases. The components of this novel sealant were extracted from large animals and a serine proteinase extracted from Crotalus durissus terrificus snake venom. The applicability of this sealant was tested in animals and humans with beneficial results. The new fibrin sealant can be a useful tool clinically due to its flexibility and diversity of applications. This sealant is a biological and biodegradable product that (1) does not produce adverse reactions, (1) contains no human blood, (3) has a good adhesive capacity, (4) gives no transmission of infectious diseases, and (5) may be used as an adjuvant in conventional suture procedures. The effectiveness of this new fibrin sealant is reviewed and its development and employment are described.     

纤维蛋白粘合剂作为抗肿瘤等药物缓释载体的研究进展

纤维蛋白粘合剂作为药物缓释载体因其具有良好的缓释性、生物相容性和定向作用,已被广泛应用于临床;其可通过模拟机体凝血过程的最后阶段,形成海绵状纤维蛋白凝胶,凝胶呈三维结构的纤维蛋白多聚体,和抗肿瘤等药物联合使用时可以将药物包合在凝胶内,形成储药库,当喷射或涂布于创面后,随着凝胶被逐渐吸收和降解,药物被缓慢释放,产生理想的定向缓释作用。此作用机制特别适合局部肿瘤治疗、抗菌治疗及局麻镇痛药物等方面的联合使用;在减少给药次数,降低药物毒副作用,提高药物治疗效果等方面具有非常好的应用前景。近年来,纤维蛋白粘合剂的缓释作用越来越受到学者们的重视,成为研究的热点。本文将对纤维蛋白粘合剂联合抗肿瘤等药物形成缓释体系的机理及临床应用进行综述。     

医用生物蛋白胶在婴幼儿腭裂修复术中的应用

目的讨论减少腭裂修复术创面出血的方法.方法将腭裂修复术的患儿45例,随机分为实验组和对照组,除实验组手术创面喷洒生物蛋白胶外,两组间手术方式、性别、年龄无差异,记录手术创面负压引流管的出血量.结果实验组手术后创面出血,需输血的例数与对照组相比,经χ2检验,有差异.结论应用医用生物蛋白胶对于腭裂手术中剥离的创面有良好的止血效果.     

医用生物蛋白胶在胸腔镜食管癌切除术中的应用

目的探讨医用生物蛋白胶（biomedical fibrin sealant,BFS）在电视胸腔镜食管癌切除术中的应用优势及前景。方法62例患者随机分为治疗组和观察组各31例,治疗组应用医用生物蛋白胶封闭胸部创面和吻合口,对照组仅用医用生物蛋白胶封闭吻合口。结果治疗组31例患者术后第1天胸腔引流量为（190±53）ml,术后总引流量（370±87）ml;对照组31例患者术后第1天胸腔引流量为（280±91）ml,术后总引流量（490±124）ml,两组间在术后第1天引流量和总引流量有统计学意义（P〈0.01）。同时,62例患者仅有1例发生吻合口瘘（1.61%）,吻合口漏发生率明显降低。结论医用生物蛋白胶在胸腔镜食管癌切除手术中可以有效的减少创面的渗血,预防食管胃吻合口的＂针孔漏＂;促进组织愈合,为胸腔镜手术提供有效的安全保障。     

医用生物蛋白胶在腹腔镜下输卵管保守性手术中提高患者再孕率的应用

目的探讨医用生物蛋白胶在腹腔镜下输卵保守性手术中提高者再孕率的价值。方法回顾性分析本院3年间应用医用生物蛋白胶治疗输卵保守性手术150例的治疗效果及优越性,选择腹腔镜下异位始娠开窗取胚术150例（对照组）与在对照组的基础上再用医用生物蛋白胶150例为研究对象（观察组）。结果观察组均获成功,与对照组相比,加用医用生物蛋白胶组术中出血少,损伤少,术后随访患者持续异妊娠再次宫外孕率、不孕率均低于对照组,宫内妊娠率高。结论医用生物蛋白胶能提高异位妊娠手术的成功率及术后宫内妊娠率。     

Fibrin glue: a review of its preparation, efficacy, and adverse effects as a topical hemostat

Fibrin glue is composed of two separate solutions of fibrinogen and thrombin. When mixed together, these agents mimic the last stages of the clotting cascade to form a fibrin clot. Fibrin glue is available in Europe but is not commercially available in the U.S.; therefore, investigators have extemporaneously compounded their own fibrin glue. Fibrinogen can be obtained from pooled, single-donor, and autologous blood donors and is usually isolated by the process of cryoprecipitation. The thrombin component is generally derived from commercial bovine sources. Some investigators have added calcium chloride and/or antifibrinolytics (i.e., aminocaproic acid, aprotinin) to their preparations. Fibrin glue can be applied using a double-barrel syringe or by spray application. Although fibrin glue has been used in a variety of surgical procedures, it has been especially useful in heparinized patients undergoing cardiovascular procedures requiring extracorporeal circulation, as it does not require an intact hemostatic system to be effective. Fibrin glue also has been evaluated in presealing woven or knitted Dacron vascular grafts. The major drawback to its use is the risk of transmitted serological disease from pooled and single-donor blood donors. The safest preparations use the patient's own blood to prepare fibrin glue. Overall, fibrin glue is a useful adjunct to other methods to control bleeding in selected surgical patients.     

医用生物蛋白胶在眼睑裂伤中的临床应用

目的：考察医用生物蛋白胶在眼睑裂伤伤口修复中的临床应用效果。方法：将2009～2011年期间在我科门诊治疗的108例眼睑裂伤的患者分为生物蛋白胶实验组（A组56例）：患者在伤口清创处理后使用医用生物蛋白胶（FS）对伤口进行对合;以医用普通线缝合为对照组（B组52例）：在外伤清创后用普通5-0线丝缝合。统计比较A、B两组的伤口愈合时间、炎症反应、瘢痕以及其他并发症情况。结果：A组术中伤口清创缝合时间及术后伤口愈合时间均低于B组,P<0.01具有统计学意义,且眼睑伤口出血量明显减少,无伤口液化、组织挛缩、外观也能完美恢复。结论：在眼睑裂伤中应用医用生物蛋白胶优点很多,值得临床推广应用。     

Role of coagulation in glomerular injury

A role for coagulation in renal diseases is suggested by the presence of glomerular fibrin deposits in numerous experimental and human renal diseases, some of which are of toxic origin. Fibrin may exert detrimental effects by occluding glomerular capillaries, by attracting macrophages or by direct cytotoxicity to mesangial cells. Intraglomerular fibrin deposition or formation may result in part from changes in the normal multiple haemostatic properties of glomeruli. In glomerular clotting of systemic origin, e.g., glycerol-induced acute renal failure with intravascular coagulation, inhibition by drugs of glomerular fibrinolytic activity leads to persistent thrombi and permanent renal damage. In immune glomerulonephritis, fibrin formation may depend on activation of glomerular prothrombotic properties: for example, glomerular procoagulant (tissue factor-like) activity is enhanced at the peak of mercuric chloride-induced autoimmune glomerulonephritis, characterized by massive fibrin deposits. Finally, fibrin deposits probably contribute to the progressive renal lesions and chronic renal failure seen in rats with kidney damage, in which anticoagulant therapy has a beneficial effect.     

垂体后叶素结合腹腔镜肌瘤假包膜套扎法治疗壁间肌瘤的临床分析

目的探讨垂体后叶素结合腹腔镜下肌瘤假包膜套扎及镜下连续缝合技术在治疗子宫肌壁间肌瘤中的临床价值。方法回顾性分析2011年1月至2012年7月在我科住院的66例采用肌瘤假包膜套扎法和同期50例传统缝合行腹腔镜子宫肌瘤剔除术治疗肌壁间肌瘤患者的临床资料。比较两组的手术时间、术中出血量、并发症、术后恢复情况及子宫瘢痕愈合情况等。结果两组的手术时间、并发症及术后恢复情况差异无统计学意义,而肌瘤假包膜套扎组的术中出血量为(57.35±9.87)mL,明显少于传统缝合组(210.50±14.56)mL(P<0.001);术后(30±5)d子宫瘢痕减小指数,肌瘤假包膜套扎组为73.50%±3.46%,传统缝合组为64.56%±4.08%,两组比较差异具有统计学意义(P<0.001)。结论采用垂体后叶素结合肌瘤假包膜套扎及镜下连续缝合方法行腹腔镜子宫肌瘤剔除术疗效显著,尤其适用于肌壁间肌瘤,相对于传统缝合法,可减少术中出血,术后子宫瘢痕愈合快,具有一定的临床价值。     

Immunological safety evaluation of a horse collagen haemostatic pad.

The safety of a haemostatic and wound dressing collagen pad (Antema) obtained from horse Achilles tendon treated with pepsin, has been studied from the immunological point of view. A sensitizing activity test and maximization test in guinea pig has been performed and its capacity of inducing antibodies has been tested in rabbit and man. In guinea pig the collagen pad tested did not show any symptom of allergic reaction, in rabbit it induced a weak immunological response, without any clinical symptoms, detectable with the ELISA method only at very high serum concentration levels (1:20). In a clinical trial, 20 patients submitted to different types of surgery in which the product had been used as haemostatic pad and left in the surgery area until absorption, did not develop any immunological clinical reaction. One year after the operation no traces of anti-collagen antibodies have been found with the ELISA method in the sera of those patients.     

局部应用生物蛋白胶和加替沙星对手及前臂屈肌腱粘连及感染的预防

目的评价生物蛋白胶和加替沙星对肌腱吻合后预防粘连及局部感染的作用。方法12例肌腱断裂患者肌腱吻合后喷涂生物蛋白胶和加替沙星混合剂,观察患指功能恢复及伤口愈合情况,术后随访2~10个月。结果应用生物蛋白胶和加替沙星混合剂的患指功能恢复优良率为83.33%,较好为16.67%。结论生物蛋白胶和加替沙星对肌腱吻合后功能恢复和伤口愈合有良好疗效。     

纤维蛋白胶在猪心脏移植手术中的应用

目的 :评价从正常健康献血员血浆来源的自制的SD病毒灭活型人纤维蛋白胶 ,对猪心脏移植过程中各吻合口的止血效果及封闭作用。方法 :在肝素化低凝状态下行猪心脏移植手术 ,在心脏和血管缝合处的外部的渗血部位 ,以常规的压迫止血和使用经病毒灭活处理的人血纤维蛋白胶作比较 ,观察缝合后伤口的渗血量和止血时间。结果 :2组对比 ,纤维蛋白胶在吻合口起到立即止血、封闭伤口和减少心包渗出的效果 ,止血时间和渗血量较压迫止血对照组有显著性差异 ,P均 <0 0 1。结论 :人纤维蛋白胶对于缝合后的猪心脏、血管和伤口有明显的止血 ,封闭伤口和减少渗出的作用 ,为在心血管手术应用提供了可能     

Use of fibrin glue to treat a persistent pneumothorax with bronchopleural fistula.

PURPOSE: A case of spontaneous pneumothorax with a subsequent bronchopleural fistula (BPF) treated with endoscopically administered fibrin glue is presented. SUMMARY: A 76-year-old white man with a history of a benign lung mass and chronic obstructive pulmonary disease was admitted to the hospital with right-sided, anterior, pleuritic chest pain for the past three days and shortness of breath at rest, which worsened during exertion. Initial chest radiograph revealed a right 95% spontaneous tension pneumothorax. A chest tube was immediately placed in the right pleural space, resulting in reinflation of the lung. However, air leaks continued to be present, requiring the need for surgical intervention. The patient required both coronary artery bypass graft surgery and right blebectomy with pleurodesis. Postsurgery, the patient required two pleural chest tubes for the persistence of a BPF. A critical care clinical pharmacist was consulted regarding potential use of an endoscopic fibrin seal. Fiberoptic bronchoscopy was performed, and diffuse bronchiectasis was noted in all right lower respiratory airways. The day after the fibrin sealant was administered, one of the pleural chest tubes was removed because the air leak was significantly reduced in size. The patient was discharged home two days later with a Heimlich chest valve. One week postdischarge, a chest radiograph revealed no pneumothorax. CONCLUSION: Use of a fibrin sealant injected through a fiberoptic bronchoscope was effective in reducing an air leak associated with a spontaneous pneumothorax and subsequent BPF.     

肝硬化食管静脉曲张出血血管硬化剂联合套扎术的远期疗效观察

目的：研究肝硬化食管静脉曲张破裂大出血，出血量＞1000ml，经注射血管硬化剂联合皮圈套扎术治疗三年后，观察其无期疗效。方法：先急诊注射硬化剂，出血停止二周后再行套扎术，剩余少许曲张静脉再注射硬化剂。并与单独注射硬化剂组远期疗效进行对比观察。结果：远期再出血率单独组35．4％，联合组7．5％。结论：出血期间注射硬化剂能急诊止血，再皮圈套扎能使曲张静脉消失，远期疗效观察，可预防和减少再出血。与单独注射血管硬化剂相比（P＜0．05）。具有操作简便、并发症少