顺苯磺酸阿曲库铵临床有效剂量测定

The determination of clinical effective dose of cisatracurium besilate for injection

目的测定1倍95%有效量(ED95)顺阿曲库铵对神经肌肉接头的阻滞时程和恢复过程。方法择期全麻手术患者30例,随机均分为Ⅰ、Ⅱ和Ⅲ组。Ⅰ组:顺苯磺阿曲库铵(批号:1067,葛兰素史克公司)稀释到10ml,1mg/ml;Ⅱ组:将顺苯磺酸阿曲库铵(批号:11111213,恒瑞医药股份有限公司)溶解到10ml,认为顺苯磺阿曲库铵浓度为1mg/ml;Ⅲ组:将顺苯磺酸阿曲库铵(同Ⅱ组)溶解到7.5ml,假设顺阿曲库铵浓度为1mg/ml。丙泊酚和舒芬太尼麻醉诱导后分别静脉注射1倍ED95顺阿曲库铵。用TOFWatchSX加速度仪对近腕尺神经行TOF透皮刺激,观察与记录给予肌松药的起效时间、第一次反应(T1)最大阻滞程度(Tmax)和临床有效时间。结果三组起效时间差异无统计学意义。Ⅰ组Tmax和临床有效时间与Ⅲ组比较差异无统计学意义;Ⅱ组Tmax和临床有效时间明显低于Ⅰ组和Ⅲ组(P<0.01或P<0.05)。结论恒瑞医药股份有限公司的顺苯磺酸阿曲库铵每瓶含顺阿曲库铵约7.5mg。使用时溶解成7.5ml,能使顺阿曲库铵浓度达到1mg/ml。

Objective To investigate the time-course-of-action and the process of recovery from neuromuscular block with 1 X 95% effect dose （ED95） of cisatracurium besilate for injection. Methods Thirty adult patients scheduled for elective surgery under general anesthesia were randomly allocated to three groups （n= 10）. In group I , 10 mg cisatracurium besilate （GlaxoSmithKline ） were diluted to 10 ml with normal saline. In group Ⅱ and group Ⅲ, cisatracurium besilate for injection （Heng-Rui ）, were dissolved to 10 ml or 7. 5 ml with normal saline, respectively. The above concentration of cisatracurium was all considered to be 1 mg/ml. After inducing with propofol and sufentanil, patients were randomized to receive 1 × ED95 of either cisatracurium. Neuromuscular transmission of ulnar nerve was monitored at the wrist with train-of-four stimulation by TOF Watch SX acceleromyographs, onset time, maximum depression degree of T1 （Tmax） and clinical duration of either cisatracuriaum were recorded. Results The onset time of the three groups showed no difference. Tmax and clinical duration of group Ⅱ was significantly lower than those in group I and group Ⅲ （P〈0.01 or P〈0.05）, but there was no difference between group I and group Ⅲ. Conclusion Heng-Rui cisatracurium besilate for injection contains cisatracuriaum 7.5 mg per vial, reasonable neuromuscular block can be achieved by dissolving it with 7.5 ml solution to the effective close of 1 mg/ml.