国产与进口罗库溴铵的药效学及对循环功能影响的比较

Comparison of pharmacodynamics and circulatory function of domestic and imported rocuronium

目的 比较国产和进13罗库溴铵的药效学及对循环功能的影响。方法择期全麻手术患者210例，年龄18～65岁，ASA分级Ⅰ或Ⅱ级。采用随机数字表法，将患者随机分为2组（n=105）：国产罗库溴铵组（I组）和进口罗库溴铵组（Ⅱ组）。采用TOF-Watch。SX型加速度肌松监测仪刺激尺神经，观察拇内收肌颤搐情况。记录静脉注射插管剂量（0．6mg／kg）的罗库溴铵后气管插管条件、肌松起效时间、临床作用时间、最大肌颤搐抑制程度、75％恢复时间、恢复指数、循环指标完全恢复时间、血液动力学指标及不良事件的发生情况。结果两组肌松起效时间、临床作用时间、恢复指数、肌颤搐最大抑制程度、气管插管条件、循环指标完全恢复时间、给肌松药前后血液动力学指标及不良事件发生率比较差异无统计学意义（P〉0．05），11组75％恢复时间长于Ⅰ组（P〈0．05）。结论国产罗库溴铵与进口罗库溴铵具有相似的药效学特性，对循环功能无明显不利影响。

Objective To compare the pharmacodynamics and circulatory function of domestic and imported rocurenium.Methods This is a five center study of rocurenium. Two hundred and ten ASA Ⅰor Ⅱ patients aged 18-65 yr undergoing elective surgery under general anesthesia were randomly divided into 2 groups （ n = 105 each） ： domestic group （group I ） and imported group （group Ⅱ）. Anesthesia was induced and maintained with TCI of propofol （target plasma concentration = 3 mg/L） and remifentanil （target effect-site concentration = 2-4 μg/L）. Trachcal intubation was facilitated with intravenous rocuronium 0.6 mg/kg. The N-M function was assessed by accelerography （TOF-Watch SX, Organon, Netherlands） using TOF stimulation of ulnar nerve. Onset time, clinical dttralion, 75% recovery time,recovery indexes, the extent of maximal N- M blockade and intubation conditions （ease ,）f laryngoscopy, position of vocal cords and airway reaction） were monitored and recorded. BP and HR were also recorded. Results There were no significant differences in the onset time, clinical duration, recovery indexes, the extent of maximal N-M blockade, the intubation conditions, BP, HR and adverse reactions between groups Ⅰ and Ⅱ （P 〉 0.05）. The 75% recovery time was significantly longer in group n than in group Ⅰ （ P 〈 0.05）. Conclusion The pharmacodynamics of domestic and imported is comparable. The two drugs have no adverse effect on the circulatory function.