Staunstrup H, Ovesen J, Larsen U T, Elbaek K, Larsen U, Krøner K
Department of Orthopedic Surgery, Aarhus University Hospital, Denmark.
J Clin Pharmacol. 1999 Aug;39(8):834-41. doi: 10.1177/00912709922008362.
This randomized double-blind study compared the analgesic efficacy and tolerability of intramuscular lornoxicam and tramadol in 76 patients with moderate to unbearable pain following arthroscopic reconstruction of the anterior cruciate ligament using the patella bone-tendon-bone technique. Patients receiving a single dose of lornoxicam 16 mg experienced significantly greater total pain relief than patients receiving tramadol 100 mg over the following 8 hours. Lornoxicam had greater analgesic efficacy than tramadol in patients with moderate baseline pain but was of equivalent efficacy in those with severe/unbearable baseline pain. Fewer patients in the lornoxicam group required rescue medication (58% vs. 77%, respectively). Patients' global impression of efficacy showed lornoxicam to be superior to tramadol with 82% and 49% of patients, respectively, rating treatment as good, very good, or excellent. Following multiple-dose administration of lornoxicam (8 mg tid) or tramadol (100 mg tid) for 3 days, efficacy profiles similar to those following a single dose were obtained. Thus, slightly fewer patients in the lornoxicam group required rescue medication, and patients' global impression of efficacy again favored lornoxicam. Adverse events were reported by 38 of the 76 patients and were mainly mild to moderate in severity. Significantly fewer patients reported one or more adverse events with lornoxicam than with tramadol (14 vs. 24, respectively). Thus, intramuscular lornoxicam offers a useful alternative to tramadol for the treatment of moderate to severe postoperative pain.
这项随机双盲研究比较了76例采用髌腱骨技术进行关节镜下前交叉韧带重建术后中度至难以忍受疼痛患者中，肌肉注射氯诺昔康和曲马多的镇痛效果和耐受性。在接下来的8小时内，接受单剂量16毫克氯诺昔康的患者比接受100毫克曲马多的患者总疼痛缓解程度明显更大。氯诺昔康在基线疼痛为中度的患者中镇痛效果优于曲马多，但在基线疼痛为重度/难以忍受的患者中二者效果相当。氯诺昔康组需要急救药物的患者更少（分别为58%和77%）。患者对疗效的总体印象显示，氯诺昔康优于曲马多，分别有82%和49%的患者将治疗评为良好、非常好或优秀。在氯诺昔康（8毫克，每日三次）或曲马多（100毫克，每日三次）多剂量给药3天后，获得了与单剂量给药后相似的疗效情况。因此，氯诺昔康组需要急救药物的患者略少，并且患者对疗效的总体印象再次倾向于氯诺昔康。76例患者中有38例报告了不良事件，严重程度主要为轻度至中度。报告一种或多种不良事件的氯诺昔康组患者明显少于曲马多组（分别为14例和24例）。因此，肌肉注射氯诺昔康为曲马多治疗中度至重度术后疼痛提供了一种有用的替代方法。
