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目的 :观察国产纤维蛋白粘合胶对手术创面渗血的止血效果和安全性。方法 :16 1例择期外科手术患者参加临床验证。安全性验证组 10 1例 ,分为验证组 5 3例 ,喷涂纤粘胶 ,用量 1.2～ 1.8ml;对照组 48例 ,明胶海绵敷贴。有效性验证组 6 0例 ,分为A组 30例 ,1/ 2创面喷涂纤粘胶 ,另 1/ 2创面明胶海棉敷贴 ;B组 30例 ,1/ 2创面喷涂纤粘胶 ,另 1/ 2创面喷涂Tisseel。结果 :安全性验证结果显示 ,用药后未发现不良反应 ;有效性试验结果显示 ,国产纤维蛋白粘合胶与Tisseel的止血时间无显著差异 (P >0 .0 5 ) ,与明胶海绵的止血时间有显著差异 (P <0 .0 1)。结论 :国产纤维蛋白粘合胶对手术渗血创面有止血作用 ,与国外同类产品Tisseel相似 ,并明显优于明胶海绵 ,且未发现严重不良反应。
Objective: To observe the hemostatic effect and safety of domestic fibrin glue in the surgical wound bleeding. Methods: One hundred and sixteen patients undergoing elective surgery were enrolled in the clinical trial. Safety verification group 10 1 cases, divided into verification group 53 cases, spraying viscose, dosage 1.2 ~ 1.8ml; control group of 48 cases, gelatin sponge application. A total of 60 validated patients were divided into group A (n = 30), 1/2 wound plaster and 1/2 wound gelatin sponge. Group B (n = 30) 1/2 wound spray Tisseel. Results: The results of safety verification showed that no adverse reactions were found after treatment. The results of validity test showed that there was no significant difference between Chinese fibrin glue and Tisseel in bleeding time (P> 0.05) There was a significant difference (P <0.01). CONCLUSION: The domestic fibrin glue has a hemostatic effect on the oozing blood of surgical operation, which is similar to Tisseel of similar foreign products and obviously superior to gelatin sponge. No serious adverse reactions were found.