微孔真空多聚糖止血粉有效性及安全性实验

Effectiveness and biological safety of microporous vacuum polysaccharide hemostatic microspheres

目的:研究微孔真空多聚糖止血粉的止血效果及生物安全性,为临床实验研究提供有效性依据。方法:采用巴马小型猪建立肝脏出血创面模型,分别用微孔真空多聚糖止血粉和Arista^(TM)止血微球进行止血;对SD大鼠经腹腔和肌肉注射1.2%微孔真空多聚糖止血粉悬浊液。评价微孔真空多聚糖止血粉的止血效果、组织吸收以及生物安全性。结果:微孔真空多聚糖止血粉和Arista^(TM)止血微球均能在3 min内有效止血,前者最短止血时间为10 s,后者最短止血时间为30 s。微孔真空多聚糖止血粉悬浊液在SD大鼠腹腔和肌肉内5 h降解所剩原物质浓度分别为(0.000 9±0.000 4)和(0.000 9±0.000 5)mg/ml。术后24 h、7 d、14 d、21 d解剖小型猪未发现腹腔内有积液、血块以及组织粘连情况;小型猪术后24 h血性(纤维素性)荚膜形成,术后7 d创面表面血性荚膜消失,术后14 d肝组织恢复正常形态。结论:微孔真空多聚糖止血粉止血效果好,具有良好的生物相容性,是一种安全的可吸收止血材料。

Objective To observe the hemostasis effect and biosafety of the microporous vacuum polysaccharide blood clotting powder so as to provide an effective basis for clinical experimental research. Methods The model of liver hemorrhage was established by using the Bama minipigs, and the hemostasis was performed by using the MVPH and the control product Arista（TM）. SD rats were administred with 1.2% microporous vacuum polysaccharide homostatic microspheres by peritoneal and imtramascular injection MVPH hemostatic effect, tissue absorption and biosafety were evaluated. Results The test product and control product were able to stop the bleeding effectively within 3 min, and the shortest hemostasis time by the test product was 10s, and the shortest hemostasis time by the control product was 30 s. The concentrations of the remaining substances in the abdominal cavity and tissue（muscle） were（0.000 9 ＋ 0.000 4） and（0.000 9 ＋ 0.000 5）mg/ml respectively.Postoperatively all miniature pigs were dissected at 24 h, 7 d, 14 d and 21 d according to the set time points. No effusion,blood clots and tissue adhesion were observed in abdominal cavity. Postoperative 24 h hemorrhagic（fibrous） capsular came into being, postoperative 7 d wound surface hemorrhagic capsule disappeared, postoperative 14 d liver tissue returned to normal form. Conclusion MVPH has good hemostasis and good biocompatibility. It proves a safe and absorbable hemostatic material.