Stamer U M, Maier C, Grond S, Veh-Schmidt B, Klaschik E, Lehmann K A
Department of Anaesthesiology and Intensive Care Medicine, University of Kiel, Schwanenweg, Germany.
Eur J Anaesthesiol. 1997 Nov;14(6):646-54. doi: 10.1046/j.1365-2346.1994.00214.x.
A double-blind, randomized, placebo- and drug-controlled study in which the analgesic efficacy and safety of intravenous (i.v.) tramadol in patients with post-operative pain is reported. One hundred and eighty patients recovering from gynaecological or abdominal surgery were assigned to one of three treatment groups. After titration of an individual loading dose, patients could self-administer tramadol 20 mg, morphine 2 mg or placebo using a patient-controlled analgesia (PCA) device throughout a 48-h period. Criteria of efficacy were a decrease in pain intensity within the first 30 min of at least 20 on a visual analogue scale (VAS) (0 denotes no pain, 100 worst pain imaginable) and satisfactory analgesia in the patient's opinion during the study period. Patients treated with tramadol, morphine and placebo were assessed as responders at 66.7%, 75.0% and 18.3% (P < 0.0001). VAS after the initial bolus were 39.2 +/- 22.1, 35.9 +/- 21.6 and 50.0 +/- 24.2 (P = 0.002), the initial loading dose amounted to tramadol 144.9 +/- 51.2 mg, morphine 12.3 +/- 5.1 mg and placebo 17.2 +/- 4.9 mL. No serious opioid-related adverse events occurred in the patients given tramadol while two patients given morphine developed an impaired respiratory rate and a decreased oxygen saturation to 80% or less. Tramadol proved to be efficacious for PCA treatment of post-operative pain following gynaecological and abdominal surgery.
一项双盲、随机、安慰剂和药物对照研究报告了静脉注射曲马多对术后疼痛患者的镇痛效果和安全性。180名从妇科或腹部手术中恢复的患者被分配到三个治疗组之一。在滴定个体负荷剂量后，患者可在48小时内使用患者自控镇痛（PCA）装置自行给药曲马多20mg、吗啡2mg或安慰剂。疗效标准为在视觉模拟量表（VAS）上最初30分钟内疼痛强度至少降低20分（0表示无疼痛，100表示可想象的最严重疼痛），且患者认为在研究期间镇痛效果满意。接受曲马多、吗啡和安慰剂治疗的患者作为有效应答者的比例分别为66.7%、75.0%和18.3%（P<0.0001）。初始推注后的VAS分别为39.2±22.1、35.9±21.6和50.0±24.2（P=0.002），初始负荷剂量曲马多为144.9±51.2mg，吗啡为12.3±5.1mg，安慰剂为17.2±4.9mL。接受曲马多治疗的患者未发生严重的阿片类药物相关不良事件，而两名接受吗啡治疗的患者出现呼吸频率受损和氧饱和度降至80%或更低。曲马多被证明对妇科和腹部手术后的术后疼痛PCA治疗有效。
