国产纤维蛋白粘合胶临床应用观察

Clinical observation of the efficacy and safety of domestic fibrin adhesive gel in surgery

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。

Objectives:To observe the hemostatic effect and safety of domestic fibrin adhesive gel (FAG) for treating oozing of blood in surgical wounds.Methods:161 patients were randomly recruited according to the established criteria and data were collected and analyzed statistically.In the safety validation group,53 patients were treated with FAG in comparison with 48 patients treated with gelatin sponge. Of the efficacy validation group,sub-group A consisted of 30 patients,half wound of them was treated with FAG and half with gelatin sponge;sub-group B consisted of another 30 patients,half wound of them was treated with FAG and half with nebulizing Tisseel.Results:No side effects were observed in safety validation group and in the efficacy validation group,no significant difference in hemostatic time was observed between FAG and Tisseel and with significant difference between FAG and gelatin sponge.Conclusions:Domestic FAG is as effective as Tisseel in control of surface blooding in surgery and it is superior significantly to gelatin sponge.