Reduction of the closure time of postoperative enterocutaneous fistulas with fibrin sealant

AIM: To assess whether the use of fibrin sealantshortens the closure time of postoperative enterocutaneous fistulas (ECFs). METHODS: The prospective case-control study included 70 patients with postoperative ECFs with an output of < 500 mL/d, a fistulous tract of > 2 cm and without any local complication. They were divided into study (n = 23) and control groups (n = 47). Esophageal, gastric and colocutaneous fistulas were monitored under endoscopic visualization, which also allowed fibrin glue application directly through the external hole. Outcome variables included closure time, time to resume oral feeding and morbidity related to nutritional support. RESULTS: There were no differences in mean age, fistula output, and follow-up. Closure-time for all patients of the study group was 12.5 ± 14.2 d and 32.5 ± 17.9 d for the control group (P < 0.001), and morbidity related to nutritional support was 8.6% and 42.5%, respectively (P < 0.01). In patients with colonic fistulas, complete closure occurred 23.5 ± 19.5 d after the first application of fibrin glue, and spontaneous closure was observed after 36.2 ± 22.8 d in the control group (P = 0.36). Recurrences were observed in 2 patients because of residual disease. One patient of each group died during follow-up as a consequence of septic complications related to parenteral nutrition. CONCLUSION: Closure time was significantly reduced with the use of fibrin sealant, and oral feeding was resumed faster. We suggest the use of fibrin sealant for the management of stable enterocutaneous fistulas.

Fibrin sealant for esophageal anastomosis:A phase II study

BACKGROUND Esophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer(EC or EJC).Postoperative anastomotic leakage(AL)remains problematic.The use of fibrin sealant(FS)may improve the strength of esophageal anastomosis and reduce the incidence of AL.AIM To assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC.METHODS In this single-arm,phase II trial(Clinicaltrial.gov identifier:NCT03529266),we recruited patients aged 18-80 years with resectable EC or EJC clinically staged as T1-4aN0-3M0.An open or minimally invasive McKeown esophagectomy was performed with a circular stapled anastomosis.After performing the anastomosis,2.5 mL of porcine FS was applied circumferentially.The primary endpoint was the proportion of patients with AL within 3 mo.RESULTS From June 4,2018,to December 29,2018,57 patients were enrolled.At the data cutoff date(June 30,2019),three(5.3%)of the 57 patients had developed AL,including two(3.5%)with esophagogastric AL and one(1.8%)with gastric fistula.The incidence of anastomotic stricture and other major postoperative complications was 1.8%and 17.5%,respectively.The median time needed to resume oral feeding after operation was 8 d(Interquartile range:7.0-9.0 d).No adverse events related to FS were recorded.No deaths occurred within 90 d after surgery.CONCLUSION Perioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or EJC.Further phase III studies are warranted.

Effect of implanting fibrin sealant with ropivacaine on pain after laparoscopic cholecystectomy

AIM:To investigate the safety and efficacy of implant-ing fibrin sealant with sustained-release ropivacaine in the gallbladder bed for pain after laparoscopic chole-cystectomy(LC).METHODS:Sixty patients(American Society of Anes-thesiologists physical status wasⅠorⅡand underwent LC)were randomly divided into three equal groups:group A(implantation of fibrin sealant in the gallbladder bed),group B(implantation of fibrin sealant carrying ropivacaine in the gallbladder bed),and group C(normal saline in the gallbladder bed).Postoperative pain was evaluated,and pain relief was assessed by visual analog scale(VAS)scoring.RESULTS:The findings showed that 81.7%of patients had visceral pain,50%experienced parietal,and 26.7% reported shoulder pain after LC.Visceral pain was significantly less in group B patients than in the other groups(P<0.05),and only one patient in this group experienced shoulder pain.The mean VAS score in group B patients was lower than that in the other groups.CONCLUSION:Visceral pain is prominent after LC and can be effectively controlled by implanting fibrin sealant combined with ropivacaine in the gallbladder bed.

Fibrin sealant for closure of mucosal penetration at the cardia during peroral endoscopic myotomy: A retrospective study at a single center

AIM To assess the efficacy and safety of fibrin sealant for closure of mucosal penetration at the cardia during peroral endoscopic myotomy(POEM).METHODS Twenty-four patients who underwent POEM and experienced mucosal injury of the cardia during the procedure were retrospectively identified. Of the 24 patients, 21 had mucosal penetration and 3 had only slight mucosal damage without penetration. The 21 patients with mucosal penetration received fibrin sealant for closure at the site of penetration. Penetration-related characteristics, treatment, and recovery were reviewed for all 21 patients to assess the efficacy and safety of fibrin sealant for closure of mucosal penetration at the cardia. Clinical data, including general characteristics, procedure-related parameters, Eckardt scores, lower esophageal sphincter pressures (LESP), and esophagogastroduodenoscopy(EGD) results, were analyzed to determine their influence on treatment success after mucosal penetration during POEM.RESULTS All 21 patients had a solitary mucosal penetration in the cardia (12 in esophageal region of the cardia, 9 in the stomach region of the cardia, and 1 in both the esophageal and stomach regions). Twelve had ahole-like penetration and 9 had a linear penetration. For those with a hole-like penetration, the mean size was 0.14 cm2 (0.02-0.32 cm2). For those with a linear penetration, the median size was 0.37 cm (0.10-1.00 cm). Closure of the mucosal penetration using fibrin sealant was performed successfully in all 21 patients(two patients required 5 m L fibrin sealant, and the remaining 19 patients required 2.5 mL). Two patients had a nasogastric tube placed for five days after POEM; the remaining 19 patients were kept fasting for 3 d. All 21 patients were discharged after a median of 5 d(range: 5-7 d) postoperatively. During a median 42 mo (range: 9-62 mo) follow-up, all 21 patients with a mucosal penetration successfully healed without the occurrence of infection, ulcer, or esophagitis. Furthermore, the median LESP decreased from 31.9 mm Hg (range: 21.9-67.1 mm Hg) preoperatively to 20.3 mm Hg (range: 6.0-41.0 mm Hg) postoperatively(P < 0.05). The median preoperative and postoperative Eckardt scores were 5.0(range; 4-10) and 1.0(range: 0-4), respectively (P < 0.05). Of the 21 patients with mucosal penetration, symptom remission, which is defined as a postoperative Eckardt score ≤ 3, was achieved in 20 patients(95.2%) indicating that mucosal penetration did not influence the success of POEM treatment if closed successfully using fibrin sealant.CONCLUSION Fibrin sealant is safe and effective for closure of mucosal penetration during POEM. Mucosal penetrations do not appear to influence the treatment success of POEM if closed successfully using fibrin sealant. Additional studies regarding the feasibility, efficacy, and safety of fibrin sealant for closure of larger mucosal penetrations is warranted.

Fibrin sealant use in pilonidal sinus: Systematic review

AIM: To review the current data about the success rates of fibrin sealant use in pilonidal disease.METHODS: Fibrin sealant can be used for different purposes in pilonidal sinus treatment, such as filling in the sinus tracts, covering the open wound after excision and lay-open treatment, or obliterating the subcutaneous dead space before skin closure. We searched Pubmed, Google-Scholar, Ebsco-Host, clinicaltrials, and Cochrane databases and found nine studies eligible for analysis; these studies included a total of 217 patients(84% male, mean age 24.2 ± 7.8). RESULTS: In cases where fibrin sealant was used to obliterate the subcutaneous dead space, there was no reduction in wound complication rates(9.8% vs 14.6%, P = 0.48). In cases where sealant was used to cover the laid-open area, the wound healing time and patient comfort were reported better than in previous studies(mean 17 d, 88% satisfaction). When fibrin sealant was used to fill the sinus tracts, the recurrence rate was around 20%, despite the highly selected grouping of patients.CONCLUSION: Consequently, using fibrin sealant to decrease the risk of seroma formation was determined to be an ineffective course of action. It was not advisable to fill the sinus tracts with fibrin sealant because it was not superior to other cost-effective and minimally invasive treatments. New comparative studies can be conducted to confirm the results of sealant use in covering the laid-open area.

Effects of primary suture and fibrin sealant on hemostasis and liver regeneration in an experimental liver injury

AIM: To investigate the effects of fibrin sealant on hemostasis and liver regeneration and intra-abdominal adhesions in an experimental liver injury. METHODS: Thirty-six Wistar rats were randomly divided into primary suture group (n = 15), fibrin sealant group (n = 15) and control group (n = 6). A wedge resection was performed on the left lobe of the liver. In primary suture group, liver was sutured using polypropylene material, while fibrin glue was administrated on the liver surface in fibrin sealant group. RESULTS: More intra-abdominal adhesions were observed in the primary suture group compared to the fibrin sealant group on 3rd (2.50 ± 0.5 vs 0.25 ± 0.5, P = 0.015), 10th (2.75 ± 0.5 vs 0.50 ± 0.6, P = 0.06) and 20th (1.75 ± 0.5 vs 0.70 ± 0.5, P = 0.015) postoperative days. Histopathological scores were better in the fibrin sealant group in comparison with the primary suture group on 3rd (8.75 ± 0.5 vs 6.75 ± 0.5, P = 0.006), 10th (7.50 ± 1.0 vs 5.5 ± 0.6, P = 0.021) and 20th (6.40 ± 1.7 vs 3.20 ± 1.6, P = 0.025) postoperative days. CONCLUSION: Out data suggest that fibrin sealant is preferred over primary suture in appropriate cases including liver trauma since it causes less intra-abdominal adhesions while allowing shorter hemostasis time as assessed in experimental liver trauma.

Influence of fibrin sealant on osteoinductive ability of inject-type bone morphogenetic protein

Objective To observe influence of fibrin seala nt (FS)on osteoinductive ability of inject-type BMP.Method The inject-type BMP power was dissolved in the main glue p art or thrombin part of FS,then mixed with the main glue part or thrombin pa rt of FS into gel,observe coagulating time,then implant comp osite into the thigh muscle pouch of m ice to evaluate their capacity to induce new bone formation,and compared to the single BMP implant gr oup.Result There was no difference in the coagul ating time between two mixing method,the osteoin-ductive ability of implants BMP dissolved in the main glue part or thrombin part of FS group was higher than that of simply BMP implant group.Conclusion FS was perfect carrier to inject-type BMP.

Fibrin Sealant Patch to Treat Dialysis-Associated Hemorrhagic Pericarditis

A 73-year-old male patient with a 3-year history of hemodialysis was admitted for the treatment of pericardial effusion. Echocardiography suggested a diagnosis of effusive pericarditis. Pericardiocentesis was performed several times. Six weeks after the admission, the patient developed cardiac tamponade. Surgical pericardiotomy showed the epicardium had a diffuse shaggy and hemorrhagic surface. To control diffuse oozing, fibrin sealant patches (Tachosil;CSL Behring, Tokyo, Japan) were attached to the epicardium. Oozing was then controlled.

Transplantation of neonatal cardiomyocytes plus fibrin sealant restores myocardial function in a rat model of myocardial infarction

Background Most cardiac regenerative approaches can restore injured heart muscles. In this study, we investigated if fibrin sealant could help neonatal cardiomyocytes restore myocardial function in a rat model of myocardial infarction. Methods The left anterior descending artery in adult female Sprague-Dawley （SD） rats was ligated to make a myocardial infarction model. Neonatal ventricular cardiomyocytes from one-day male SD rats were isolated, labeled and cultured. The cells were injected into the infarcted area three weeks later. The animals were randomized into four recipient groups： （1） cardiomyocytes plus fibrin sealant （group CF, n=10）; （2） cardiomyocytes alone （group C, n=10）; （3） fibrin sealant recipients alone （group F, n=10）; （4） control group （n=10）. Four weeks after transplantation, echocardiography and Langerdoff model were used to assess heart function. Immunohistochemical staining and polymerase chain reaction （PCR） were performed to track the implanted cardiomyocytes and detect the sex-determining region Y gene on Y chromosome. Results Echocardiography showed the fraction shortening （FS） in groups CF, C, F and control group was （27.80±6.32）%, （22.29±4.54）%, （19.24±6.29）% and （20.36±3.29）% respectively with statistically significant differences in group CF compared with the other groups （P〈0.05）. The Langendoff model revealed that the left ventricular development of peak pressure （LVDPmax, mmHg） in groups CF, C, F and control group was 104.81±17.05, 80.97±21.60, 72.07±26.17 and 71.42±17.55 respectively with statistically significant differences in group CF compared with the other groups （P〈0.05）. Pathological examination and PCR indicated that transplanted cardiomyocytes in group CF survived better than those in the other groups. Conclusion Transplanted neonatal cardiomyocytes plus fibrin sealant can survive in myocardial infarctioned area and improve heart function greatly in rat models.

Fibrin sealant for the prevention of anastomotic leakage after esophagectomy for esophageal or esophagogastric junction cancer:interim report of a prospective,phase III,randomized controlled study

Purpose Anastomotic leakage(AL)is one of the most pernicious complications after esophagectomy for patients with esophageal or esophagogastric junction cancer(EC or EJC).The application of fibrin sealant(FS)may be advantageous for reducing the incidence of AL.This study aims to evaluate the safety and effectiveness of FS in preventing AL in patients undergoing McKeown esophagectomy.Methods In this multicenter,prospective,randomized controlled trial,we planned to recruit 360 patients aged 18–75 years with resectable EC or EJC and the interim analysis was performed when the number of participants reaches 180.Patients assigned to the FS group received McKeown esophagectomy with 2.5ml FS applied to the cervical anastomosis,while patients in the control group received surgery alone.The primary endpoint was the incidence of cervical AL within the first 3 months postoperatively.Result From February 2019 to November 2021,180 patients were recruited,with 89 in the FS group and 91 in the control group.There was no statistically difference between the incidence of AL between the two groups[6.7%(6/89)in the FS vs.14.3%(13/91)in the control group,P=0.16].Complications was comparable(P=0.76)between the FS group(42 of 89,47.2%)and the control group(45 of 91,49.5%).No adverse events related to FS or deaths occurred postoperatively.Conclusion The application of FS intraoperatively is feasible and does not increase the risk of complications,and its effectiveness for the prevention of AL needs to be revalidated after the completion of patient enrollment.Trial registration This trial was registered at ClinicalTrials.gov(NCT03847857)on February 19th,2019.

可注射型骨修复材料对兔MSC增殖及分化的影响

目的 :观察以纤维蛋白胶为载体的骨修复材料对兔骨髓基质细胞 (marrowstromalcell,MSC)增殖及分化的影响。方法 :采用细胞培养及组织化学等方法对各材料组兔MSC的增殖、碱性磷酸酶 (alkalinephosphase ,ALP)的活性和染色、细胞贴壁率及Ⅰ型胶原表达进行研究。结果 :( 1)各组材料对细胞贴壁率及促增殖作用的影响总体上由强到弱依次是 :对照组 2→实验组→对照组 1[纤维蛋白胶 (fibrinsealant ,FS) ]→对照组 3→单纯对照组 ,差异有显著性 (p <0 .0 5 )。( 2 )各组细胞的Ⅰ型胶原表达水平和ALP活性由强到弱依次是 :实验组→对照组 3→对照组 1→对照组 2→单纯对照组 ,差异有显著性 ( p <0 .0 5 )。结论 :以纤维蛋白胶为载体的注射型骨修复材料可显著促进MSC贴壁率和向成骨细胞方向的分化水平。

纤维蛋白胶复合骨形成蛋白的注射型骨修复材料对兔骨髓基质细胞增殖和分化的影响

目的观察以纤维蛋白胶(fibrinsealant,FS)为载体复合骨形成蛋白(bonemorphogeneticprotein,BMP)的注射型骨修复材料对体外培养的兔骨髓基质细胞(marrowstromalcells,MSCs)增殖和分化的影响,为其临床应用提供实验依据。方法取3日龄新西兰兔骨髓进行培养传代,采用第3代细胞进行研究。实验分为3组,实验组以含1μg/mlrhBMP-2注射型FS培养细胞;FS对照组以单纯FS培养细胞;空白对照组不作任何处理。采用细胞培养、组织化学及电镜等方法对各组兔MSCs的增殖、贴壁率、碱性磷酸酶(alkalinephosphatase,ALP)活性及染色、型胶原表达、超微结构及细胞在材料中的生长情况进行观察。结果各组细胞促增殖作用由强到弱依次是FS对照组→实验组→空白对照组,各组间差异均有统计学意义(P<0.05);对细胞贴壁率的影响总体由强到弱依次是FS对照组→实验组→空白对照组,各组间差异均有统计学意义(P<0.05)。各组ALP活性由强到弱依次是实验组→FS对照组→空白对照组,各组间差异均有统计学意义(P<0.05);各组细胞的型胶原表达水平由高到低依次是实验组→FS对照组→空白对照组,差异均有统计学意义(P<0.05)。扫描电镜观察,材料表面粗糙,有微孔存在,FS对照组、实验组细胞与材料融合生长。透射电镜观察实验组细胞向成骨细胞分化程度高,但细胞增殖活性较FS对照组稍差;FS对照组细胞向成骨细胞分化的程度较实验组低,细胞增殖活性较好;空白对照组的细胞增殖活性较差,胞外基质少。结论以FS为载体复合BMP的注射型骨修复材料可显著提高MSCs向成骨细胞方向的分化水平,但对MSCs促增殖作用不明显。

以纤维蛋白胶为载体复合BMP和bFGF的注射型骨修复材料诱导异位成骨的实验研究

目的 :了解以纤维蛋白胶 (Fibrinsealant,FS )为载体的注射型骨修复材料异位诱导成骨的作用 ,为其临床的应用提供实验依据。方法 :实验分组为 :实验组b (FS +bFGF+bBMP)、对照组b1(FS +bBMP)、对照组b2 (bBMP)、实验组r (FS +bFGF +rhBMP 2 )、对照组r1(FS +rhBMP)、对照组r2 (rhBMP)、对照组FS及空白对照组。将各组材料注射或植入小鼠肌袋内 ,采用放射学、形态学、碱性磷酸酶 (ALP)检测等方法对其成骨效应进行研究。结果 :在以bBMP为成骨因子的实验区中 ,实验组b具有高效的骨诱导活性 ,其成骨量显著高于对照组b1、对照组b2、对照组FS及空白对照组(P <0 .0 1) ;在以rhBMP 2为成骨因子的实验区中 ,实验组r同样具有高效的骨诱导活性 ,其成骨量也显著高于对照组r1、对照组r2、对照组FS及空白对照组 (P <0 .0 1)。结论 :以FS为载体复合BMP和bFGF的注射型骨修复材料具有高效的骨诱导活性 ,bFGF可明显增强BMP的骨诱导活性。

骨髓间充质干细胞复合纤维蛋白封闭剂体内构建可注射性组织工程软骨

目的探讨利用人骨髓间充质干细胞(marrowmesenchymalstemcells,MSCs)与可注射性纤维蛋白封闭剂(fibrinsealant,FS)复合,在裸鼠体内构建组织工程软骨的可行性。方法体外分离扩增健康人MSCs,以含有转化生长因子β1(transforminggrowthfactorβ1,TGF-β1)、地塞米松、维生素C的培养基进行成软骨诱导,诱导第7、14天分别检测软骨细胞特异的生物学特性。将诱导7d的MSCs与FS复合,接种于裸鼠背部皮下作为实验组,同时设单纯只注射FS或MSCs的支架对照组和细胞对照组。分别于接种后6、12周取材进行大体观察,行HE、阿尔新蓝染色和型胶原免疫组织化学染色评价其成软骨能力。结果MSCs以特定的培养基诱导后由纺锤形变为多角形,并表达软骨细胞分泌的基质。复合物接种6和12周后,实验组均可形成软骨样组织块,6周时形成的组织块较小而质地柔韧,陷窝清楚,可检测到阳性阿尔新蓝及型胶原表达;12周形成的组织块较大,质地较硬,表面光滑,软骨细胞位于成熟的陷窝中,阿尔新蓝及型胶原免疫组化阳性染色较6周增强。两个对照组均无软骨样组织块形成。结论MSCs复合FS可以作为一种较优良的可注射性组织工程软骨的构建方法。

椎体内注射医用生物蛋白胶对松质骨创面出血影响的实验研究

目的:探讨椎体内注射医用生物蛋白胶减少松质骨创面出血的有效性与安全性。方法:10只成年家犬全麻下前路暴露L2～L5椎体,其中6只动物L2～L5椎体随机分为实验组与对照组,每组每只2个椎体。实验组椎体内注射医用生物蛋白胶,对照组未注射给药,给药30s后同时于L2～L5椎体前方作直径8mm、深6mm的骨缺损,记录骨创面的控制出血时间、止血时间、出血量及各组10min内止血百分比。另4只动物L2～L5椎体内注入医用生物蛋白胶与欧乃派克混合物,给药30min后行CT扫描计算椎体内药物扩散体积百分比,观察药物局部渗漏及静脉渗漏情况。所有动物实验前后检测血浆凝血酶原时间(PT),术后3d拍胸部X线片后处死,剖胸探查有无肺梗死灶。结果:实验组和对照组的控制出血时间分别为97±48s和417±101s(P<0.001),止血时间分别为291±167s和890±237s(P<0.001),出血量分别为0.80±0.67g和4.39±1.84g(P<0.001),10min内止血百分比分别为91.67%和16.67%(P=0.001)。药物扩散体积百分比为72.1%±11.2%。药物造影组CT扫描未发现静脉渗漏,椎间孔渗漏1个(6.25%),椎管内渗漏5个(31.25%)。所有动物实验前、后PT转异率无显著性差异(P=0.628)。所有动物术后未发现神经损伤症状,胸片未见肺梗死征象,剖胸探查未发现肺梗死灶。结论:成年家犬椎体内注射医用生物蛋白胶可明显减少松质骨创面出血,安全性较好。

医用生物蛋白胶及其主体成分纤维蛋白原的免疫原性研究

研究医用生物蛋白胶及其主体成分纤维蛋白原的潜在免疫原性。采用SDS-PAGE电泳、Western blot分离确定主体胶成分中的纤维蛋白原蛋白,建立间接ELISA法检测抗体条件;新西兰白兔创伤实验及BALB/c小鼠实验考察医用生物蛋白胶及纤维蛋白原的免疫原性。结果表明,生物蛋白胶主体成分以0.5μg/ml包被时,可有效检测抗纤维蛋白原抗体。新西兰白兔创伤实验中,实验组兔血清1周后出现抗体,2周后抗体水平明显升高,6周后抗体水平下降,呈先升后降的动态变化趋势;小鼠实验中,NBT试验未发现阳性中性粒细胞,MTT检测到T细胞呈现弱增殖能力。研究表明,医用生物蛋白胶主体胶成分中的纤维蛋白原在兔出现一过性抗体,医用生物蛋白胶对小鼠未表现出明显的免疫原性。

子宫中隔电切术后宫腔放置医用生物蛋白胶和水囊的临床疗效

目的:探讨腹腔镜监视下子宫中隔电切术后宫腔放置医用生物蛋白胶和水囊代替宫内节育器(IUD)的临床疗效。方法:将子宫中隔患者69例,随机分成3组,实施腹腔镜监视下子宫中隔电切术治疗,术后治疗组1宫腔内放置弗莱氏尿管,注入4 ml生理盐水形成水囊并经尿管注入生物蛋白胶封管,留置1 d后取出并使用雌孕激素人工周期序贯疗法;治疗组2方法同治疗组1,但水囊留置3 d;对照组放置IUD并使用雌孕激素人工周期序贯疗法。比较3组患者术后阴道流血时间、腰腹部疼痛和3月后宫腔镜检查宫腔情况。结果:宫腔放置医用生物蛋白胶和水囊的治疗组1有1例宫腔膜状粘连,治疗组2与放置IUD的对照组宫腔均无粘连,三者两两比较无显著性差异(P>0.05);患者阴道流血时间治疗组2较对照组明显缩短,治疗组1和2腰腹部疼痛时间较对照组明显延长,比较均有显著性差异(均为P<0.05);而治疗组1和治疗组2之间比较无显著性差异(P>0.05)。结论:腹腔镜监视下子宫中隔电切术后放置医用生物蛋白胶和水囊与宫内放置IUD疗效相同,而阴道流血时间和腰腹部疼痛时间短,是宫腔放置IUD的有效替代治疗方式。

多孔羟基磷灰石、纤维蛋白和金葡液复合物修复骨缺损的实验研究

目的 探讨珊瑚多孔羟基磷灰石 (CHAP)、纤维蛋白 (FS)及金葡液 (SAI)复合物修复骨缺损的作用 ,以及作为人工骨移植替代材料的可行性。 方法 采用新西兰大白兔 5 4只在双侧桡骨制备骨缺损模型后分成实验组、对照组及空白组。将 CHAP- FS- SAI复合物植入骨缺损处作为实验组 ,自体骨植入作为对照组 ,空白组不植入任何物质 ;术后 2、4、8和 12周分别取 2只兔行大体标本观察、组织学、X线片观察及生物力学测试 ,比较各组修复骨缺损的能力。 结果 实验组术后 2周见植入物与骨端形成紧密的纤维性连接 ,镜下可见 CHAP周围大量成纤维细胞、软骨细胞及毛细血管增生 ;对照组有少量骨痂形成 ,有软骨细胞、骨母细胞及破骨细胞。 4、8周两组均见大量骨痂形成 ,镜下见软骨细胞钙化 ,组织骨和板层骨。 12周实验组及对照组均见大量成熟的骨细胞及板层骨 ;实验组见植入物完全骨化 ,塑形完全 ,CHAP未完全降解。空白组 12周骨缺损区为纤维瘢痕组织填充 ,镜下主要为大量成纤维细胞。 X线片 2周实验组与对照组有骨痂影 ,4周骨痂影增多。 8周实验组骨缺损消失 ,CHAP分散在骨痂中 ;对照组骨折线消失 ,髓腔开始形成。 12周实验组和对照组骨皮质连续 ,髓腔复通 ,塑形完全。空白组 12周骨缺损区无骨性连接。