中国组织工程研究 ›› 2024, Vol. 28 ›› Issue (10): 1490-1496.doi: 10.12307/2024.370

• 功能性生物材料Functional biomaterials • 上一篇    下一篇

氧化再生纤维素止血材料在猪肝脏出血创面模型中的止血效果

霍  云,孙晓青   

  1. 杭州协合医疗用品有限公司,浙江省杭州市  310018
  • 收稿日期:2023-01-10 接受日期:2023-05-27 出版日期:2024-04-08 发布日期:2023-08-17
  • 作者简介:霍云,女,1989年生,安徽省宣城市人,汉族,硕士,中级工程师,主要从事可吸收生物材料改性研究与应用研究。

Hemostatic effect of oxidized regenerated cellulose hemostatic material on minipig liver hemorrhage models

Huo Yun, Sun Xiaoqing   

  1. Hangzhou Singclean Medical Products Co., Ltd., Hangzhou 310018, Zhejiang Province, China
  • Received:2023-01-10 Accepted:2023-05-27 Online:2024-04-08 Published:2023-08-17
  • About author:Huo Yun, Master, Intermediate engineer, Hangzhou Singclean Medical Products Co., Ltd., Hangzhou 310018, Zhejiang Province, China

摘要:


文题释义:

再生纤维素:是将木浆、棉浆等原料溶解后纺丝形成的直径均匀的纤维。与天然纤维素相比,再生纤维素具有优良的吸湿性、透气性、手感柔软和染色性等特点。
氧化再生纤维素:再生纤维素经可控的氧化反应制得,其止血机制是将创面血液中的血小板聚集在由氧化再生纤维素为成分的编织物或非编织物上,迅速形成凝胶状的棕黑色物质,使血块凝结,从而达到止血的目的。


背景:目前植物来源的可吸收止血材料以进口为主,研发出非劣于同类进口产品的国产替代非常有必要。

目的:观察氧化再生纤维素止血材料对猪肝出血模型的止血效果。
方法:选取巴马小型猪24只,采用随机数字表法分为3组:假手术组(n=6)只做开腹手术,将伤侧肝脏取出后放回原位;实验组(n=12)建立肝脏出血创面模型后将氧化再生纤维素止血材料敷于创面上;对照组(n=6)建立肝脏出血模型后将市售可吸收止血纱敷于创面上,记录止血时间和出血量。造模前及造模后不同时间点取猪前腔静脉血,进行血常规、肝肾功能分析;造模后2,6,14周,进行创面组织苏木精-伊红与Masson染色;造模后14周,进行主要脏器病理组织学观察;造模后不同时间点进行肝脏超声检查,观察材料降解吸收情况。

结果与结论:①实验组与对照组猪肝脏创面止血时间与出血量比较差异均无显著性意义(P > 0.05);②血液生化指标监测结果显示,3组猪造模后24 h的谷草转氨酶和谷丙转氨酶水平均高于造模前,造模后72 h这些指标基本恢复到造模前正常水平,3组间肝肾功能、血糖及炎症因子等血液生化指标值比较差异均无显著性意义(P > 0.05);③创面组织苏木精-伊红与Masson染色显示,造模后2周时,两组肝脏创面可见肉芽组织形成及大量的胶原纤维沉积,有明显的纤维增生带和炎症细胞浸润,创面愈合良好;造模后14周,两组猪肝脏创面有轻度的纤维增生带、胶原纤维沉积和少量炎症细胞浸润,材料降解完全,创面愈合;苏木精-伊红染色显示主要脏器无明显的病理组织变化;④超声检查显示,随着植入时间的延长,两组材料逐渐降解,至造模后56 d时已大部分降解吸收;⑤结果显示氧化再生纤维素止血材料能有效防止猪肝脏创面出血,且应用安全可靠。

https://orcid.org/0009-0001-8317-4617(霍云)

中国组织工程研究杂志出版内容重点:生物材料;骨生物材料口腔生物材料纳米材料缓释材料材料相容性组织工程

关键词: 氧化再生纤维素, 可吸收止血材料, 肝脏出血创面, 可吸收止血纱, 动物模型, 止血效果

Abstract: BACKGROUND: At present, plant-derived absorbable hemostats are mainly imported, so it is necessary to develop domestic alternatives that are not inferior to similar imported products.
OBJECTIVE: To investigate the hemostatic effect of oxidized regenerated cellulose hemostatic material on a model of minipig liver hemorrhage.
METHODS: A total of 24 Bama minipigs were selected and randomly divided into three groups. In the sham operation group (n=6), only an open operation was performed, and the damaged side of the liver was removed and put back in situ. In the experimental group (n=12), the liver hemorrhage model was established, and the oxidized regenerated cellulose hemostatic material was applied to the wound. In the control group (n=6), commercially available absorbable hemostatic gauze was used on the wound after establishing liver hemorrhage models. Hemostatic time and blood loss were recorded. The venous blood of the minipig anterior cavity was collected at different time points before and after modeling, and the blood routine and liver and kidney functions were analyzed. Hematoxylin-eosin staining and Masson staining were performed at 2, 6, and 14 weeks after modeling. The main organs were observed by histopathology at 14 weeks after modeling. A liver ultrasound examination was performed at different time points after modeling to observe the degradation and absorption of materials.
RESULTS AND CONCLUSION: (1) There was no significant difference in intraoperative hemostatic time and blood loss between the experimental group and the control group (P > 0.05). (2) The monitoring results of blood biochemical indexes demonstrated that the levels of aspartate transaminase and glutamic pyruvic transaminase in the three groups were higher 24 hours after modeling than before modeling, and the indexes basically recovered to the normal levels 72 hours after modeling. There were no significant differences in blood biochemical indexes such as liver and kidney functions, blood glucose and inflammatory factors among the three groups (P > 0.05). (3) Hematoxylin-eosin staining and Masson staining of histopathology revealed that 2 weeks after surgery, granulation tissue formation and a large amount of collagen fiber deposition were observed on the liver wounds of the two groups, and there were obvious fibrous hyperplasia zones and inflammatory cell infiltration, and the wound healed well. 14 weeks after modeling, the liver wounds of two groups of minipigs exhibited mild fibrous hyperplasia zone, collagen fiber deposition and a small amount of inflammatory cell infiltration, complete material degradation, and the healed wound. Hematoxylin-eosin staining showed no significant pathological changes in major organs. (4) Ultrasonic examination demonstrated that the materials of both groups were degraded gradually with the extension of implantation time, and most of them were degraded and absorbed by 56 days after molding. (5) The results confirm that the oxidized regenerated cellulose hemostatic material can effectively prevent liver wound hemorrhage in minipigs, and the hemostats are safe and reliable.

Key words: oxidized regenerated cellulose, absorbable hemostatic material, liver hemorrhage wound, absorbable hemostatic gauze, animal model, hemostatic effect

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