人凝血酶对扁桃腺手术创面止血作用的随机对照研究

Efficacy and safety of human thrombin on hemostasis in tonsillectomy

目的:评价外用人凝血酶对扁桃腺手术创面的止血作用和安全性。方法:采用前瞻随机对照的方法, 80例行双侧扁桃腺摘除手术的患者随机分为试验组(A组,n=40)和安全性对照组(B组,n=40),在A组自身对照观察有效性,即右侧创面局部给予人凝血酶,左侧予生理氯化钠溶液,对比观察创面出血的止血时间、出血量和单位面积出血量。B组双侧均给予生理氯化钠溶液,对比观察A组和B组的凝血指标和肝肾功能等安全性指标。结果:使用人凝血酶创面止血时间为(62．8±24．6)s,创面出血量(4．9±6．7)g,创面单位面积出血量(0．79±0．98) g·cm-2;明显低于使用生理氯化钠溶液创面的(94．7±36．9)s,(7．3±13．4)g,(1．14±1．95)g·cm-2;两者比较有统计学差异。A组与B组均无不良事件发生。两组凝血指标和肝肾等主要脏器功能也无明显变化。A组10例患者观察HBsAg,抗HCV,HIV抗体和梅毒抗体等指标3个月无异常。结论:人凝血酶对扁桃腺手术创面毛细血管出血有较好的止血作用和安全性。

Objective ： To evaluate the hemostatic efficacy and safety of a human thrombin in tonsillectomy. Methods： This was a prospective, randomized and controlled clinical trial, which enrolled 80 patients undergoing both tonsillectomies. The patients were randomized to assign to either self-control treatment group or safety-control treatment group. The patients in the self-control were locally applied with the human thrombin at right surface of wound and 0. 9% NS at left surface of wound after tonsil removal. The patients in the safety-control were locally applied with 0.9% NS alone at both sides after tonsil removal. The efficacy was assessed based on the hemostatic onset, hemorrhagic volume and hemorrhagic volume per square unit. The safety was evaluated based on the status of coagulation index and liver and kidney functions. Results ： The surface of wound applying human thrombin and NS had the average hemostatic onset at （62. 8 ± 24.6） versus （94.7 ±36.9） second, the hemorrhagic volume for （4.9 ± 6.7） versus （7.3 ±13.4 ） g and the hemorrhagic volume per square unit for （0.79 ± 0.98 ） versus （1.14 ± 1.95）g·cm^-2（P 〈0.05）. No adverse events were reported during the treatment. The indexes of HBsAg, HIV, HCV and syphilis in study group showed normalities when the patients receiving the human thrombin were followed up for 3 months. Conclusion： The human thrombin offered effective and safe hemostasis for patients with tonsillectomy.