中国临床医学2025，Vol.32Issue(5)：768-775,8.DOI:10.12025/j.issn.1008-6358.2025.20250402
新型消化道黏膜隆起凝胶的临床前有效性与安全性评价——活体猪模型实验
Preclinical efficacy and safety evaluation of a novel gastrointestinal mucosal elevation gel in vivo porcine model
摘要
Abstract
Objective To evaluate the efficacy and safety of a novel gastrointestinal mucosal elevation gel in vivo porcine model.Methods Eight healthy white pigs were selected,which were uesd to bump height evaluation(n=2)and safety evaluation(n=6).The sample(alimentary canal mucosa bump gel sample)and the control sample(disposable endoscopic submucosal filler of alimentary canal)were respectively injected into the submucosa of pig gastric antrum and gastric body.In the evaluation of elevation height,the morphology,persistence,and clinical safety of mucosal elevation were observed and recorded immediately and 30 minutes after injection.In safety evaluation,endoscopic mucosal resection was performed after injection,and the mucosal protrusion shape,product efficacy,and clinical safety were observed and recorded at immediate and 7-day time points.After observation,all animals were euthanized and tissue samples were collected and excised for histopathological evaluation.Results In elevation height evaluation,sample group showed a steep elevation immediately after surgery,exhibiting a more pronounced elevation morphology compared to control group(P=0.019).Only two(25%)sites of the elevation showed slight collapse in 30 minutes after surgery,and the durability notably increased compared to control group(8 all collapsed,P＜0.001).In safety evaluation,the average trauma area of sample group was 1.77 mm2,which was significantly lower than control group(2.65 mm2,P＜0.001).There was no statistical difference among average injection dose per unit area,surgical time per unit area,and en bloc resection rate.Sample group showed mild ulcers and only 1(12.5%)site of mild bleeding at immediate time point after surgery.No bleeding,perforation,ulcer or edema was observed in sample group 7 days after surgery,and no statistical difference was identified compared to control group.Histopathological evaluation found that the gastric antrum and body tissues exhibited moderate injury and mild edema at immediate time point,accompanied by mild inflammatory cellular infiltration.At 7-day time point,gastric antrum tissues demonstrated moderate injury,mild edema and mild inflammatory cellular infiltration,with 1(12.5%)site of tissues infected,while in gastric body tissues,no bleeding was observed,whereas moderate injury and mild edema were evident,accompanied by mild inflammatory cellular infiltration and 3(37.5%)sites of tissues infected,all of which were not statistically different from control group.Conclusion The novel gastrointestinal mucosal elevation gel exhibited steep elevation morphology,long-lasting elevation height,and favorable efficacy and safety in preclinical animal trials,showing enormous clinical application potential.关键词
内镜手术/消化道黏膜隆起凝胶/临床前安全性/黏膜下隆起/活体猪模型Key words
endoscopic surgery/gastrointestinal mucosal elevation gel/preclinical safety/submucosal elevation/in vivo porcine model分类
医药卫生引用本文复制引用
田怿成,加沙尔·巴合提努尔,诸炎,夏玮,周平红,蔡明琰..新型消化道黏膜隆起凝胶的临床前有效性与安全性评价——活体猪模型实验[J].中国临床医学,2025,32(5):768-775,8.基金项目
上海市卫生健康委员会卫生行业临床研究专项(202340178),2023年度复旦大学附属中山医院临床研究专项基金(ZSLCYJ202350).Supported by Shanghai Municipal Health Commission Health Industry Clinical Research Special Project(202340178),2023 Clinical Research Special Fund of Zhongshan Hospital,Fudan University(ZSLCYJ202350). （202340178）
