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Title:: Evaluation of hemostatic effect and safety of absorbable hemostatic material in pulmonary hemorrhage model

Author(s):: HE Xiaohua; ZHENG Xiaoxia; HUANG Yanni ; LIU Chun; CHENG Yanling; Shandong Academy of Pharmaceutical Sciences, Jinan 250101,China

Keywords:: Hemostatic materia; Pulmonary hemorrhage model; Amount of bleeding; Hemostatic time; Safety evaluation

摘要:: 观察可吸收多糖止血材料对动物肺出血模型的止血效果和安全性评价，并与纱布对照组和外科术中止血装置(上市对照组)进行比较。建立巴马小型猪肺出血模型，观察止血材料和上市对照组对肺出血模型止血效果及安全性。与纱布对照组比较，止血材料能明显缩短出血时间，减少出血量，术中止血观察评价优良（P<0.01）；与上市对照组比较，止血效果相当，但样品用量明显减少（P<0.05），止血时间、出血量及术中止血效果观察具有一定的优势。各组血液临检指标自身对照及指标变化率无明显差异；术后7 d，巴马小型猪解剖脑体重占比降低。止血材料在胸腔肺出血创面具有优良的止血效果，不增加感染几率，不影响组织愈合，是一种较安全的止血材料。

Abstract:: To observe the hemostatic effect and safety of absorbable hemostatic material in pulmonary hemorrhage model and compare it with commercial reference. A model of pulmonary hemorrhage was established in Bama mini pig, and the hemostatic effect and safety of hemostatic materials were observed on this model. When compared with model group, the bleeding time and the amount of bleeding were significantly reduced in absorbable hemostatic material group, and the evaluation of hemostasis during surgery was excellent (P<0.01); when compared with the commercial reference, the hemostatic effect was comparable, but the sample usage was significantly reduced (P<0.05), the hemostasis time, bleeding volume and hemostasis during surgery were more advantage than that of reference. There was no significant difference in hematology examination, including the indicators compared with self-control and rate of change. The proportion of brain weight was decreased in 7 d after operation.The hemostasis material has excellent hemostasis in thoracic pulmonary hemorrhage wound, the probability of infection and tissue healing was not influenced during the whole test, it is a safety hemostasis material.