Bosch H C, Sigmund R, Hettich M
Boehringer Ingelheim GmbH, Ingelheim, Germany.
Curr Med Res Opin. 1997;14(1):29-38. doi: 10.1185/03007999709113340.
In this controlled, randomised, parallel-group, multicentre study, the efficacy and tolerability of an intramuscular (i.m.) dose of meloxicam (15 mg) on Day 1 followed by seven days of oral meloxicam (15 mg/day) were compared with those of an i.m. dose of piroxicam (20 mg) on Day 1 followed by seven days of oral piroxicam (20 mg/day) therapy in a total of 169 outpatients with acute lumbago. Time to onset of analgesic action after i.m. injection was determined, and overall efficacy, pain on movement, limitation of daily activities, local tolerability at the injection site and overall tolerability were assessed by investigators and patients on verbal rating scales (VRSs). Adverse events and laboratory assessments were documented. Meloxicam and piroxicam showed a rapid onset of action after i.m. injection (40 and 45 minutes median time, respectively), overall efficacy of both therapies was highly rated, and limitations to daily life were greatly reduced in the majority of patients in both groups. There were no statistically significant differences in efficacy between meloxicam and piroxicam. Local and overall tolerabilities were equally good for the two drugs, but there were fewer gastrointestinal (GI) adverse events among meloxicam patients (1.2% of patients) than piroxicam patients (7.0% of patients). The improved tolerability profile of meloxicam may be explained by its selectivity towards cyclooxygenase-2.
在这项对照、随机、平行组、多中心研究中，将169例急性腰痛门诊患者中第1天肌内注射美洛昔康（15毫克）随后7天口服美洛昔康（15毫克/天）的疗效和耐受性，与第1天肌内注射吡罗昔康（20毫克）随后7天口服吡罗昔康（20毫克/天）治疗的疗效和耐受性进行了比较。测定了肌内注射后镇痛作用开始的时间，研究者和患者通过语言评定量表（VRS）评估了总体疗效、运动时疼痛、日常活动受限情况、注射部位局部耐受性和总体耐受性。记录了不良事件和实验室评估结果。美洛昔康和吡罗昔康肌内注射后起效迅速（中位时间分别为40分钟和45分钟），两种治疗的总体疗效均得到高度评价，两组大多数患者的日常生活受限情况均有大幅减轻。美洛昔康和吡罗昔康在疗效上无统计学显著差异。两种药物的局部和总体耐受性同样良好，但美洛昔康组患者的胃肠道（GI）不良事件（占患者的1.2%）比吡罗昔康组患者（占患者的7.0%）少。美洛昔康耐受性改善的情况可能是由于其对环氧化酶-2的选择性所致。
