国产0.5%盐酸左旋布比卡因用于硬膜外麻醉的可行性被引量：27

Feasibility study of using levobupivacaine 0.5% during epidural anesthesia

导出

摘要目的采用多中心、随机、双盲、平行对照Ⅱ期临床试验,评价国产0.5％盐酸左旋布比卡因用于硬膜外麻醉的可行性。方法 120例行下腹部或下肢手术的患者,随机分为两组:对照组使用0.5％布比卡因连续硬膜外麻醉,试验组使用0.5％盐酸左旋布比卡因连续硬膜外麻醉,每组60例。药物有效性的观察指标包括:感觉阻滞起效时间、运动阻滞起效时间、感觉阻滞平面上界、运动阻滞程度及麻醉质量。安全性的观察指标包括:血压(BP)、心率(HR)、脉搏血氧饱和度(SpO2)、术前及术后24h血清谷丙转氨酶(ALT)、天门冬氨酸氨基转移酶(AST)、肌酐(Cr)、尿素氮(BUN)浓度等,并观察自用药后至出院前的不良事件。结果两组患者感觉起效时间和运动阻滞起效时间差异无显著性(P>0.05)。试验组患者感觉阻滞上界略低于对照组(P.<0.05),但两组患者最高感觉阻滞平面均达到T3水平。试验组患者运动阻滞程度达2-3分者约占46.7％,而对照组则为78.3％,试验组低于对照组( p<0.05)。两组患者麻醉质量差异无显著性(p>0.05)。两组患者的BP、HR和SpO2在各时间点差异无显著性(p>0.05)。两组患者手术前、后血清ALT、AST、Cr、BUN浓度差异无显著性(P>0.05)。两组患者不良事件发生率差异无显著性(P>0.05)。结论国产0.5％盐酸左旋布比卡因用于连续硬膜外麻醉可? Objective A multicenter prospective clinical study was done at 3 medical centers to evaluate the efficacy and safety of using 0.5% levobupivacaine for epidural anesthesia in a double-blind fashion. Methods After hospital' s ethic committee approval and informed consent,120 ASA Ⅰ-Ⅱ patients of either sex, aged 18-65 yrs, undergoing lower abdominal or lower extremity surgery were enrolled in this study. Their body weight was standard body weight (SBW)±15% (SBW=height (cm)-100) . An epidural catheter was placed at L2-3 and advanced approximately 2.5-3.0 cm in the epidural space toward head. The patients were randomized to receive in a double-blind fashion either 0.5% levobupivacaine (study group, n = 60) or 0.5% bupivacaine (control group, n = 60) . The efficacy variables included the onset time of sensory and motor block, the degree of motor block, the height of sensory block and the quality of anesthesia. The safety variables included the changes in BP, HR, SpO2 during surgery and the pre- and post- operative liver and kidney functions. Results The onset time of both sensory and motor block were similar between the two groups (P>0.05) . The sensory block reached T7 in levobupivacaine group and T6 in bupivacaine group respectively. The motor blocked was somewhat more intense in bupivacaine group. Conclusion The efficacy and safety of epidural anesthesia with levobupivacaine and bupivacaine are comparable.

作者朱波龚志毅叶铁虎吴新民孟美金王庚贾乃光张亚军刘春霞

机构地区中国医学科学院中国协和医科大学北京协和医院麻醉科北京大学第一医院麻醉科中日友好医院麻醉科

出处《中华麻醉学杂志》 CAS CSCD 北大核心 2004年第8期582-584,共3页 Chinese Journal of Anesthesiology

关键词患者运动阻滞左旋布比卡因对照组起效时间连续硬膜外麻醉 SPO2 显著性差异结论 Bupivacaine Anesthesia, epidural Feasibility studies

分类号 R614 [医药卫生—麻醉学] R446 [医药卫生—诊断学]

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参考文献9

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