凝血酶与胶原蛋白海绵联合用于手术创面止血的临床应用观察

The Research of Efficacy and Safety about Combined Application of Thrombin and Absorb Hemostatic Materials in Operation Wound Hemostasis

目的评价外用人凝血酶与可吸收止血材料联合用于手术创面的止血作用和安全性。方法采用前瞻随机分组对照的方法,对例手术的患者随机分为试验组和两对照组。A组外科手术病人渗血创面,取冻干人凝血酶1000IU/支(用量根据手术创面面积),用灭菌氯化钠注射液溶解成50~200u/ml的溶液喷雾或用干粉喷洒于创面;B组手术创面经止血后渗血创面敷以胶原蛋白海绵,再覆盖干纱布并以适当力量加压;C组手术创面经止血后渗血创面先局部凝血酶,剂量同A组,表面再敷以胶原蛋白海绵。对比观察创面出血的止血时间出血量和单位面积出血量、24h和48h腹腔引流量以及凝血指标和肝肾功能等安全性指标。结果研究组创面止血时间为(61.4±18.5)s,创面出血量(13.7±2)g,创面单位面积出血量(0.6±0.4)g/cm^2;24h和48h腹腔引流量为(53±30)ml,(23±10)ml,明显低于两对照组,两者比较差异均有显著性。研究期间,所有患者未出现任何局部或全身不良事件;凝血指标和肝肾等主要脏器功能的变化不明显,未发现由药物相互作用引发的不良反应。结论凝血酶与可吸收止血材料联合应用于手术创面出血有较好的止血作用和安全性。

Objective To evaluate the efficacy and safety about cmnbined application of thrombin and absorb hemostatie materials in operation wound hemostasis. Methods With prospective randomized control method,all the eases were randomly divided into treatment group and two control group. Group A-for the ooze blood wound of surgery patient,lyophilized people thromhin 1000 lu/hraneh was taken, sterilization sodium chloride injection which was melt into 50 - 200units/ml solution was used,then spraiedor dried powder was sprayed on the wot,nd;（,roup B：ooze blood wound was applied with hemostatic collagen sponge and dry gauze combined with proper strength;group C：after the bleeding local thrombin was applied to wound ooze blood, the dose was the same with group A, eollagen sponge was applied to the wound surface. The amount of bleeding in the hemostatie time of wound bleeding and the amount of bleeding in unit area were observed eontrastly,celiac lead flow,bloud coagulation indexes and liver/kidney safety index,etc after 24h and 48h were observed. Results Bleeding time of the wound was （ 61.4 ± 18.5 ） s, the amount of bleeding was （ l 3.7 ± 2 ） g, the amount of bleeding in the unit area was （ O. 6 ± 0.4 ） g/cm2 ; celiac lead flow after 24h and 48h was （53± 30） ml and （23 ＋ 10） ml,less than two control groups significantly,there was statistical significance. During the study period,all the patients failed to show any loeal or systemic adverse events;there was not obvious change in blood coagulation indexes,liver, kidney and other major viscera function,there was also not adverse reactions caused by drug interaction. Conclusion Combined application of thrombin and absorb hemnstatic materials in operation wound hemostasis have better hemostatic effect and safety.