Magrini M, Rivolta G, Bolis C, Furiosi D
Anesthesiology and Intensive Care Division, Ospedale Maggiore, Lodi, Italy.
Int J Clin Pharmacol Res. 1998;18(2):87-92.
This controlled, completely randomized trial was designed to compare the efficacy and safety of tramadol and pentazocine in the treatment of postoperative pain. A total of 50 adults were admitted (31 males, 19 females, mean age 48 years) to undergo hemorrhoidectomy or traumatological or abdominal surgery. Following a randomization list, each patient was given one ampul of tramadol (100 mg/2 mL) or pentazocine (30 mg/mL) by intramuscular injection at 8-h intervals for 3 days. Efficacy was assessed on both the basis of severity of pain (rated using a visual analog scale in the 6th h after the first injection and during the 3 days of treatment), and quality of sleep (rated using a five-point scale). Local reactions at the injection site (pain, skin reactions) were also assessed, as were systemic reactions (vital parameters, blood and biochemistry tests), and any untoward events were reported. Both drugs had good antalgic activity, significantly relieving pain in the 3 days of treatment (p < 0.01 from baseline). The first dose of tramadol was significantly more effective than pentazocine after the 1st h and throughout the subsequent 5 h. Final judgments on efficacy and acceptability were in favor of tramadol (p < 0.01 from pentazocine). Local and systemic safety were good, with no reactions at the injection site and no changes in vital parameters or laboratory findings. No patient reported any adverse reactions.
这项对照、完全随机试验旨在比较曲马多和喷他佐辛治疗术后疼痛的疗效和安全性。共有50名成年人（31名男性，19名女性，平均年龄48岁）入院接受痔切除术、创伤外科手术或腹部手术。根据随机列表，每位患者每8小时肌肉注射一安瓿曲马多（100mg/2mL）或喷他佐辛（30mg/mL），持续3天。根据疼痛严重程度（在首次注射后第6小时以及治疗的3天内使用视觉模拟量表进行评分）和睡眠质量（使用五点量表进行评分）来评估疗效。还评估了注射部位的局部反应（疼痛、皮肤反应）、全身反应（生命体征参数、血液和生化检查），并报告了任何不良事件。两种药物均具有良好的镇痛活性，在治疗的3天内可显著缓解疼痛（与基线相比，p<0.01）。在第1小时及随后的5小时内，曲马多的首剂疗效显著优于喷他佐辛。在疗效和可接受性方面的最终判断有利于曲马多（与喷他佐辛相比，p<0.01）。局部和全身安全性良好，注射部位无反应，生命体征参数或实验室检查结果无变化。没有患者报告任何不良反应。
