人凝血酶对扁桃体手术创面止血的安全性和有效性研究

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。

Study the safty and effectivity of human thrombin after tonsillectomy

OBJECTIVE: To evaluate the safty and effectivity of human thrombin after tonsillectomy. METHOD: This was a prospective, randomized and controlled clinical trial. 80 cases of both tonsillectomies were divided into study group and control group. We evaluated the hemostatic role in study group: human thrombin has been insufflated locally in right side; physiological saline was in lift side. Observed the effects on the hemostatic time, hemorrhagic volume and hemorrhagic volume per square unit. RESULT: After two sides received different drugs in both tonsillectomies, in study group and control group, the average hemostatic time was (62.8 +/- 24.6) S and (94.7 +/- 36.9) S, the hemorrhagic volume was (4.9 +/- 6.7) g and (7.3 +/- 13.4) g, the hemorrhagic volume per square unit was (0.79 +/- 0.98) g/cm and (1.14 +/- 1.95) g x cm(-2), respectively. Two sides had the significant difference (P < 0.05). During the study, no adverse event was reported in two groups. The index of HBsAg, HIV, HCV and Syphilis in study group (10 cases) were not abnormalities after the thrombin had been insufflated 3 months. CONCLUSION: Human thrombin had the better hemostatic role and security on the hemorrhage of capillary of tonsillectomy wound.