靶控输注国产与进口异丙酚药效学的比较

目的 比较靶控输注国产与进口异丙酚的药效学.方法 采用随机、双盲、交叉试验设计.择期拟行肌袢代瓣术的双下肢深静脉瓣膜功能不全患者18例,年龄45～55岁,体重指数18.5～22.9 kg/m2,ASA分级Ⅰ或Ⅱ级,采用随机数字表法,患者随机进人流程Ⅰ或流程Ⅱ,一期手术麻醉诱导时应用进口异丙酚,二期手术应用国产异丙酚为流程Ⅰ,反之为流程Ⅱ.异丙酚血浆靶浓度从0.5μg/ml开始,血浆浓度和效应室浓度平衡后,以0.5μg/ml递增,直至效应室浓度达3.5μg/ml,静脉注射瑞芬太尼2μg/kg、罗库溴铵0.6 mg/kg诱导气管插管后行机械通气.记录效应室浓度为0、0.5、1.0、1.5、2.0、2.5、3.0和3.5μg/ml时BIS值、呼吸频率、SpO2和血液动力学指标,患者意识消失时记录异丙酚用量和效应室浓度,采用概率单位法计算5%、50%及95%患者意识消失时的效应室浓度和BIS值,观察不良反应的发生情况.结果 相同效应室浓度国产和进口异丙酚靶控输注时,患者BIS值、呼吸频率、SpO2和血液动力学各指标差异无统计学意义(P＞0.05);5%、50%及95%患者意识消失时国产和进口异丙酚的BIS值和效应室浓度比较差异无统计学意义(P＞0.05);国产和进口异丙酚的药物用量及不良反应发生率比较差异无统计学意义(P＞0.05).结论 国产异丙酚与进口异丙酚具有临床生物等效性.

Abstract：

Objective To compare the clinical pharmacodynamics of domestic and imported propofol by target-controlled infusion. Methods This was a prospective,randomized,double-blind,cross-over study. Eighteen ASA Ⅰ or Ⅱ patients aged 45-55 yr undergoing substitute valve operation for severe deep venous were randomly divided into sequential Ⅰ and Ⅱ , in sequence Ⅰ , the imported propofol was applied in the first stage of surgery and then domestic propofol in the second stage surgery, while in sequence Ⅱ the order was reversed. The target plasma concentration of propofol was initially set at 0.5 μg/ml, followed by increments of 0.5 μg/ml when the effect-site concentration and plasma concentrations was balanced, until the predicted effect-site concentrations reached 3.5 μg/ml. BIS value, RR, SpO2 and hemodynamics were recorded at 0,0.5, 1.0,1.5,2.0,2.5,3.0 and 3.5 μg/ml effect-site concentration level, the predicted effect-site concentrations and the BIS value at loss of consciousness in 5%, 50% and 95% of the patients were calculated. Adverse reactions were recorded during the trial period.Results Under the same effect-site concentration,there was no significant difference in BIS value,RR, SpO2 and hemodynamic monitoring indicators between the two drugs( P ＞ 0.05). There was no significant difference in predicted effect-site concentrations of propofol, the BIS value at loss of consciousness in 5%, 50% and 95% of the patients and the incidence of adverse reaction between the two drugs ( P ＞ 0.05). Conclusion The domestic propofol and imported propofol have clinical bioequivalence.

Comparison of the clinical pharmacodynamics of domestic and imported propofol by target-controlled infusion

Objective To compare the clinical pharmacodynamics of domestic and imported propofol by target-controlled infusion. Methods This was a prospective,randomized,double-blind,cross-over study. Eighteen ASA Ⅰ or Ⅱ patients aged 45-55 yr undergoing substitute valve operation for severe deep venous were randomly divided into sequential Ⅰ and Ⅱ , in sequence Ⅰ , the imported propofol was applied in the first stage of surgery and then domestic propofol in the second stage surgery, while in sequence Ⅱ the order was reversed. The target plasma concentration of propofol was initially set at 0.5 μg/ml, followed by increments of 0.5 μg/ml when the effect-site concentration and plasma concentrations was balanced, until the predicted effect-site concentrations reached 3.5 μg/ml. BIS value, RR, SpO2 and hemodynamics were recorded at 0,0.5, 1.0,1.5,2.0,2.5,3.0 and 3.5 μg/ml effect-site concentration level, the predicted effect-site concentrations and the BIS value at loss of consciousness in 5%, 50% and 95% of the patients were calculated. Adverse reactions were recorded during the trial period.Results Under the same effect-site concentration,there was no significant difference in BIS value,RR, SpO2 and hemodynamic monitoring indicators between the two drugs( P ＞ 0.05). There was no significant difference in predicted effect-site concentrations of propofol, the BIS value at loss of consciousness in 5%, 50% and 95% of the patients and the incidence of adverse reaction between the two drugs ( P ＞ 0.05). Conclusion The domestic propofol and imported propofol have clinical bioequivalence.