液态可吸收生物止血材料的安全性及有效性研究

Study on the safety and effectiveness of liquid absorbable biomaterial for hemostasis

目的研究新型液态可吸收生物止血材料羧甲基纤维素钠和海藻酸钠共混液应用于神经外科领域的安全性及有效性。方法建立家兔脑脊液穿刺置换模型,对比脑室弧弦长、第四脑室前后径宽度、中脑导水管宽度,结合家兔行为学、血液学、生化学、病理学结果,评估新型共混液应用于神经外科的安全性。建立巴马小型猪额叶部分切除模型,统计分析有效止血率,评估新型共混液应用于神经外科的有效性。结果实验组家兔脑室无明显扩张,行为学及血液学、生化学、病理学检验结果均未见明显异常。新型共混液有效止血率为100%,与阳性对照组止血效果无显著差异(P>0.05)。结论新型液态可吸收生物止血材料羧甲基纤维素钠和海藻酸钠共混液应用于神经外科领域安全、有效。

Objective To study the safety and effectiveness of a new type of liquid absorbable biological hemostatic material,a blend of sodium carboxymethyl cellulose and sodium alginate,used in the field of neurosurgery.Methods The cerebrospinal fluid puncture replacement model was established in rabbits.The length of the ventricle arc string,width of anteroposterior diameter in the fourth ventricle and width of midbrain aqueducts were compared,and combined with rabbit behavioral,hematological,biochemical,and pathological results,the safety of new blend used in the neurosurgery was assessed.Partial resection of the frontal lobe model was established in Bama mini-pigs.The effective hemostasis rate was statistically analyzed,and the effectiveness of the new blend used in neurosurgery was evaluated.Results There was no obvious dilatation of the ventricle in rabbits in the experimental group,and there were no obvious abnormalities in the results of behavioral,hematological,biochemical and pathological tests.The effective hemostasis rate of the new blend was 100%,which is not significantly different from the hemostatic effect in the positive control group(P>0.05).Conclusion It is safe and effective that the new liquid absorbable biological hemostatic material,a blend of sodium carboxymethyl cellulose and sodium alginate,is used in the field of neurosurgery.