多孔止血淀粉的制备及其生物相容性

Preparation and biocompatibility of porous hemostatic starch

背景:目前临床应用的能对实质脏器迅速止血并且对其功能无影响的止血材料仍存在止血速度慢、具有毒性及价格昂贵等缺陷。目的:制备一种多孔止血淀粉,观察其在动物体内的生物相容性。设计、时间及地点:随机对照动物实验,于2008-03/04在解放军第三军医大学实验动物中心完成。材料:甘薯淀粉在淀粉酶作用下水解,并经交联、表面活性处理后,制成多孔止血淀粉。方法:健康KM小鼠60只随机分成实验组和对照组,每组30只。所有动物在右股划出长约1cm,深约0.5cm的条形切口,实验组将1g无菌多孔止血淀粉填入其中,对照组不填塞。主要观察指标:埋植后2,4,6,8,14d,2组各取6只,观察一般状况,检测血常规、肝肾功能及体液免疫学指标,并观察局部组织形态学变化。结果:制备的多孔止血淀粉为球径约15μm大小的白色球状颗粒,表面布满直径约为1μm的小孔,小孔由表面向中心深入,孔的容积占颗粒体积50%左右。实验组和对照组血生化和免疫学等指标无显著差异(P>0.05),肝肾组织切片显示无明显炎症反应,手术区肌肉组织第2天有少量炎性细胞浸润,4d后无明显炎症反应,未见明显纤维细胞包膜。结论:动物体内实验显示,多孔止血淀粉无急慢性毒性、无排斥反应、无免疫反应、无过敏反应,具有良好的生物相容性。

BACKGROUND： The hemostatic materials applied without any affection on the organ function have many shortages, such as slow hemostasis speed, toxicity and high cost. OBJECTIVE： To prepare the porous hemostatic starch （PHS）, and to analyze its biocompatibility in animals. DESIGN, TIME AND SETTING： The experiment was a randomized control animal study and carried out in the Centre of Laboratory Animals, the Third Military Medical University of Chinese PLA from March to April in 2008. MATERIALS： PHS was formed by reacting sweet potato starch granules with amylase, followed by cross-linking and surface modifying. METHODS： Sixty healthy K.M mice were randomized into the test group and control group, each group containing 30 animals. A strip-shaped incision was created in the right thigh, 1 cm length and 0.5 cm depth. PHS was implanted into the muscles of the mice in test group while the controlled mice were implated with nothing. MAIN OUTCOME MEASURES： The biocompatibility was evaluated by the detection of blood routine examination, liver and kidney function, body fluid immunology and histopathological observation in every 6 mice killed at 2, 4, 6, 8 and 14 days. RESULTS： The prepared PHS was a white granule with 15 μ m diameter, its surface was covered with nearly 1 μ m microbores, which penetrated from the surface to the core, the volume of the microbores was about 50% of the granules of PHS. There were not significant differences in blood biochemistry and immunology between two groups （P 〉 0.05） and the histopathological results of the test group did not show any inflammatory reaction in incisions of liver and kidney tissues. Muscular tissues allowed a little inflammatory cells infiltrate at two days, after four days, there was not inflammation or fibrous tissue envelope. CONCLUSION： The prepared PHS granules have good biocompatibility without any acute or chronic toxicity, reject reaction, immunological reaction and anaphylactic response in animals.