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目的:评价人凝血酶对扁桃体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例行双侧扁桃体摘除手术的患者随机分为研究组和对照组,在研究组自身对照观察有效性,即右侧创面局部给予人,左侧0.9%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。对照组和研究组间比较观察凝血相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;明显低于使用生理盐水创面的(94.7±36.9)s,(7.3±13.4)g,(1.14±1.95)g.cm-2;两者比较均差异有统计学意义。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也不明显,且2组结果相似。10例研究组患者观察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 effect and safety of human thrombin on tonsil wounds. Methods: A prospective, randomized, controlled trial, 80 patients undergoing bilateral tonsillectomy were randomly divided into study group and control group. The effectiveness of the study in the control group was observed. % Sodium chloride solution, bleeding time to compare the bleeding time, bleeding and bleeding volume per unit area. Comparison of the control group and the study group to observe the clotting phase and liver and kidney function and other safety indicators. Results: The bleeding time of the human thrombin wound was (62.8 ± 24.6) s, the bleeding volume was (4.9 ± 6.7) g, the bleeding volume per unit area was 0.79 ± 0.98 g.cm-2, which was significantly lower than that of the saline wound (94.7 ± 36.9) s, (7.3 ± 13.4) g and (1.14 ± 1.95) g.cm-2, respectively. The differences between the two groups were statistically significant. During the study, all patients did not show any local or systemic adverse events; coagulation index and liver and kidney function of major organs such as change is not obvious, and the two groups of similar results. 10 cases of study group observed HBsAg, anti-HCV, HIV antibody and syphilis antibodies and other indicators were normal for 3 months. Conclusion: Human thrombin has a good hemostatic effect and safety on capillary wound hemorrhage of tonsils.