左旋布吡卡因与消旋布吡卡因用于硬膜外麻醉的比较  

Levobupivacaine versus racemic bupivacaine for epidural anesthesia

作　　者：张亚军[1] 刘春霞[1] 赵诗斌[1] 贾乃光[1] 邱应海 

机构地区：[1]中日友好医院麻醉科,北京100029 [2]珠海经济特区民彤制药厂,珠海519041

出　　处：《中日友好医院学报》2005年第2期73-75,共3页Journal of China-Japan Friendship Hospital

摘　　要：目的:采用随机、双盲、平行对照的Ⅱ期临床试验,评价0.5%左旋布吡卡因与0.5%消旋布吡卡因用于硬膜外麻醉的安全性与有效性。方法:40例行下肢静脉曲张手术的患者随机分为两组,均实施连续硬膜外麻醉:试验组采用0.5%左旋布吡卡因,对照组采用0.5%的消旋布吡卡因。药物安全性通过血压、心率、脉搏氧饱和度、心电图、术前与术后24h的肝肾功能等指标进行评定。药物的有效性通过感觉阻滞起效时间、运动阻滞起效时间、感觉阻滞范围、运动阻滞程度与麻醉质量等指标评定。结果:0.5%左旋布吡卡因与消旋布吡卡因的感觉阻滞与运动阻滞起效时间相似,但左旋布吡卡因的感觉阻滞范围略宽,消旋布吡卡因的运动阻滞程度较左旋布吡卡因略强。结论:0.5%左旋布吡卡因用于硬膜外麻醉感觉和运动神经阻滞起效时间、阻滞范围、麻醉质量与消旋布吡卡因相似,且具有与消旋布吡卡因相同的安全性。Objective:Levobupivacaine is the S(-)-enantiomer of the racemic bupivacaine.Data of pharmacological studies suggest that levobupivacaine has a lower potential of toxicity for central nervous and cardiovascular systems than does bupivacaine.This study was undertaken to compare the safety and efficacy between levobupivacaine and bupivacaine in epidural anesthesia.Methods:A prospective randomized,parallel controlled and double-blind clinical study was conducted in 40 ASA Ⅰ-Ⅱpatients undergoing lower extremity surgery.Patients were randomized to receive either 0.5% bupivacaine(control group) or 0.5% levobupivacaine(study group) in a double-blinded fashion.Blood pressure,heart rate,pulse oxygen saturation,ECG,pre- and post-operative liver and kidney function were used to evaluate the safety.Onset time of sensory and motor blockade,sensory block level,degree of motor blockade and anesthesia quality were used to evaluate the efficacy.Results:Both groups of patients experienced smooth anesthesia.The onset time of sensory and motor block were similar between these two groups.The sensory block level reached T8 and T10 in levobupivacaine and bupivacaine group respectively.The motor blockade was deeper in bupivacaine group.There was no other serious adverse event that happened in both groups.Conclusion:The onset of sensory and motor blockade,quality of anesthesia,and overall quality of anesthesia as assessed were comparable between two groups.In comparison,levobupivacaine have the same efficacy and safety character as bupivacaine in epidural anesthesia.

关 键 词：布吡卡因 左旋布吡卡因 硬膜外麻醉 临床试验 Ⅱ期 

分 类 号：R614.42[医药卫生—麻醉学]