国产氟吗西尼与进口氟吗西尼临床比较

Comparing the clinical effects between domestic and import flumazenil

目的与方法 :评价国产氟吗西尼在逆转咪唑安定的镇静催眠效果及安全性。选择ASA(I～II级 ) ,择期行下腹部手术 2 0 0例 ,随机双盲分组 :国产氟吗西尼组 (I组 )与进口氟吗西尼组 (II组 )各 10 0例。硬膜外麻醉满意后 ,均静脉注射咪唑安定 ,使病人处于睡眠状态。分别静脉注射国产与进口氟吗西尼 ,观察催醒效果及副作用 ,监测平均动脉压、心率、呼吸频率和血氧饱和度。结果 :氟吗西尼拮抗 5min后两组病人催醒程度相似无显著差异 ,血压、心率、呼吸频率稳定 ,不良反应小。结论 :术后早期适量应用国产氟吗西尼 ( 0 .1～ 1.0mg)可迅速安全的解除咪唑安定引起的镇静催眠作用 ,适合临床广泛应用。

Objective: To evaluate the effects and safeties of domestic flumazenil on inverting the calming and hypnotic effects of midazolam. Method: 200patients with elective lower abdominal surgery (ASA I～II) were chosen and classified randomly into domestic flumazenil group (100patients) and imported flumazenil group(100patients) according to double blind method when epidural blocks were completed all patients were keep in sleeping by intravenous injection of midazolam .then they were awaken by intravenous injection of domestic flumazenil or imported flumazenil respectively the effects and side effects of two drugs were observe and at same time average artery pressures rates of heart beating and breath ,and oxygen saturation were monitored .Results: there were no significant difference in analeptic effects between the two groups .blood pressures ,rates of heart beating and breath were stable ,and slight side effects were showed in both groups .Conclusion: domestic flumazenil can be used in early period of post operation to overcome the calming and hypnotic effects of midazolam .It come into action quickly and safety ,so can be used widely in clinical medicine.