0.5%左旋布比卡因用于产科麻醉的安全性研究

Safety of 0. 5% epidural levobupivacaine for cesarean section

目的评价0.5%左旋布比卡因用于硬膜外麻醉剖宫产手术的临床效果,及其在母体中血药浓度的变化与经胎盘转运的情况,并以0.5%布比卡因作为对照。方法选择行择期剖宫产手术足月单胎孕妇40例,硬膜外麻醉时随机分别接受0.5%左旋布比卡因(L组,n=20)或0.5%布比卡因(B组,n=20)15 mL,观察感觉阻滞(针刺法)、运动阻滞(改良Bromage评分)、镇痛和腹壁肌松质量、心电图变化、新生儿Apgar、适应能力和脐静脉血气及不良反应。并用高效液相色谱法测定母体和胎儿的血浆药物浓度。结果两组孕妇感觉和运动阻滞的起效时间和持续时间、最高阻滞平面、心电图变化、新生儿Apgar、适应能力评分和血气差异均无统计学意义,低血压的发生率在L组为75.0%,B组为90.0%(P=0.051),观察中无严重不良反应。L组和B组母体血浆药物浓度在30 min左右达高峰,分别为(896±86)ng/mL和(901±79)ng/mL,浓度时间曲线下面积分别为(3 167±132)和(2 935±96)h·ng·mL-1,脐静脉/母体静脉血药浓度比分别为0.300±0.091和0.279±0.116。结论 0.5%左旋布比卡因适用于产科硬膜外麻醉,麻醉效能与同等浓度和剂量的布比卡因相同,其镇痛和麻醉效果可以满足临床手术需要;对母体副作用少,对新生儿无不良反应;同时药代动力学参数及经胎盘的转运比率两组是相似的。

Objective To study the efficacy of 0.50% epidural levobupivacaine for cesarean section and its serum level in the parturients and transportation via the placenta by comparing with 0.5% bupivacaine. Methods Forty healthy parturients undergoing elective cesarean section with epidural anesthesia were randomized to receive 15 ml of either 0.5% levobupivacaine （group L） or 0.5% bupivacaine （group B） in a double-blind fashion. The efficacy endpoint measures included onset, offset, adverse effect, and quality of anesthesia. Neonatal blood gas analyses, Apgar score determinations, and neurobehavioral examinations were performed. The drug concentrations were determined by high performance liquid chromatography in the parturients and neonates; and the serial electrocardiograms were obtained. Results The onset and persistence of sensory block and motor block, maximal block level, electrocardiogram changes, Apgar score determinations, neurobehavioral examinations, and blood gas findings were similar between the two groups. The frequency of hypotension was 75.0% in the levobupivacaine group and 90. 0% in the bupivacaine group （P= 0. 051）, and there was no severe adverse reactions. The maximum drugconcentrations were seen 30 min later in the parturients, being（896±86） and （901±79） ng/mL in group L and B, respectively, with the areas under the concentration-time curve being （3 167±132） and （2 935±96） h/（h·ng·mL^-1）, and the umbilical veinto-maternal vein ratios being 0. 300±0. 091 and 0. 279 ± 0. 116, respectively. Conclusion Epidural 0.5 % levobupivacaine for cesarean section has similar efficacy with 0.5% bupivacaine, and can meet the demand of operation, with less adverse effect to the parturients and no effect to the neonates. The pharmacokinetic parameters and trans-placenta transportation rates are also similar to between levobupivacaine and bupivacaine.