比較選擇性剖腹產以0.5％Levobupivacaine或0.5％Bupivacaine進行硬膜外麻醉的安全性與有效性

A Comparative Study of the Safety and Efficacy of 0.5% Levobupivacaine and 0.5% Bupivacaine for Epidural Anesthesia in Subjects Undergoing Elective Caesarean Section

背景：Levobupivacaine是bupivacaine消旋複合物的左旋鏡像異構物。研究資料顯示levobupivacaine有較小的中樞神經及心臟毒性作用。此研究就是來比較這兩種藥物使用於剖腹生產的硬膜外麻醉的效力及安全性。方法：我們徵求45個健康的孕婦要接受硬膜外麻醉進行常規的剖腹生產手術進入這個研究。孕婦隨機分為二組，以雙盲方式接受25毫升的levobupivacaine或是bupivacaine。效力的評估包括開始作用時間、消退的時間、及麻醉的品質。安全性的評估包括新生兒的Apgar scores、孕婦的心電圖、孕婦及新生兒血液的酸驗值。結果：Levobupivacaine或是bupivacaine這二組在感覺阻斷開始作用的時間、麻醉藥消退到胸皮節第十節的時間、及完全恢復的時間均無統計學上明顯的差別。在運動神經的阻斷上，開始及恢復的時間也無統計學上的差別。比較二組在疼痛指數、產科醫師評估麻醉手術中肌肉的鬆弛效果、麻醉醫師評估麻醉的品質都無統計學上的差異。在安全性方面，在新生兒的Apgar scores、產婦的心電圖、產婦及新生兒血液的酸驗值、及不良反應都沒有統計學上的差異。最常見藥物所引起的不良反應為低血壓及顫抖。整個研究過程中，二組均無嚴重的藥物不良反應。結論：使用25毫升0.5％levobupivacaine與0.5％bupivacaine於剖腹生產硬膜外麻醉對於感覺及運動神經阻斷及麻醉的品質在臨床上是有效且類似。二組對於產婦及新生兒沒有明顯的不良反應。因此在剖腹生產的硬膜外麻醉，0.5％levobupivacaine與0.5％bupivacaine有同樣的效力及安全性。

Background: 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. The present study was undertaken to compare the safety and efficacy between levobupivacaine and bupivacaine in epidural anesthesia for Cesarean delivery. Methods: A prospective, controlled, double-blinded study was conducted in 45 ASA class I-II Taiwanese obstetric patients undergoing elective Caesarean Section under extradural anesthesia. Patients were randomized to receive either 25 ml of 0.5% bupivacaine or 0.5% levobupivacaine in a double-blinded fashion. The end points of measurements relevant to efficacy included onset, fade-out, and quality of anesthesia. The safety end-point measurements included Apgar scores, maternal ECG, maternal and neonatal blood pH, and adverse events. Results: There was no significant difference between groups in the profile of sensory and motor blockade produced. Comparison of visual analogue pain scores did not show significant differences between groups at the corresponding times. There were no significant differences between groups in muscle relaxation scores assessed by obstetricians as well as the overall assessment of block quality rated by anesthesiologists. Apgar scores, maternal and neonatal blood pH, maternal ECG, and adverse events did not differ between groups. The drug-related adverse events were hypotension and shivering which were equally seen in levobupivacaine and bupivacaine groups. There was no other serious adverse event that happened in both groups. Conclusions: The onset and fade-out of sensory and motor blockade, quality of anesthesia, muscle relaxation and overall quality of anesthesia as assessed were comparable between two groups. No significant maternal or neonatal adverse events were found between the treatment groups. In comparison, levobupivacaine had the efficacy and safety profile equivalent to bupivacaine in epidural anesthesia for Caesarean section.