Merckle GmbH, Abteilung Medizinische Wissenschaft, Ulm, Germany.
Clin Drug Investig. 2004;24(4):227-36. doi: 10.2165/00044011-200424040-00004.
Impaired mobility and pain mean a loss of quality of life for patients with rheumatic diseases. Therefore the initial aim of therapy is rapid and efficient analgesia in order to achieve the best possible result for these patients. Lornoxicam is a strong analgesic and anti-inflammatory NSAID with balanced cyclo-oxygenase (COX)-1/COX-2 inhibition and excellent tolerability. In the course of the development of selective COX-2 inhibitors, it was maintained that COX-2 inhibitors decrease the risk of injury to the upper gastrointestinal (GI) tract with a similar efficacy to that of classic NSAIDs. However, a clinical trial comparing both substances has never been performed. In the present study we investigated the treatment of patients with osteoarthritis with lornoxicam in comparison with treatment with the selective COX-2 inhibitor rofecoxib. This multicentre clinical investigation focused on efficacy and tolerability.
A total of 2520 patients (most of them with osteoarthritis) were treated over 25 days on average. Before and after treatment patients documented their individual scores for pain on movement, at rest and during the night, and their individual duration of morning stiffness as well as the consequent grade of restriction. At the end of the study all individuals involved judged the efficacy and safety of the therapy.
All improvements in each efficacy parameter were clinically relevant in each treatment group and significantly superior (p < 0.001) in the lornoxicam group. Pain on movement (-45.3%), at rest (-42.0%) and at night (-42.5%) was reduced by rofecoxib, whereas improvements after treatment with lornoxicam exceeded those effects significantly (-55.8%, -55.8% and -59.9%, respectively). Shortening of the duration of morning stiffness was significantly (p < 0.001) more pronounced with lornoxicam (-66.6%) than with rofecoxib (-50.2%). Nearly three times as many patients discontinued rofecoxib treatment because of lack of efficacy compared with lornoxicam treatment (8.9% versus 3.4%). Physicians judged lornoxicam to be markedly superior to rofecoxib, since excellent efficacy was observed in 40.9% of all cases versus 20.1% with rofecoxib. Serious adverse events did not occur. Adverse events were reported in 5.4% of all lornoxicam patients compared with 12.0% of the rofecoxib recipients (p < 0.001). GI symptoms showed a slight trend of being less frequent following rofecoxib therapy.
The results of this study confirmed the efficacy and safety of both drugs. Lornoxicam and rofecoxib are effective in the treatment of patients with activated osteoarthritis; the analgesic and anti-inflammatory effects of lornoxicam are significantly superior to those of rofecoxib without inferiority in tolerability.
行动不便和疼痛意味着风湿性疾病患者生活质量下降。因此，治疗的首要目标是快速有效地缓解疼痛，以便为这些患者取得最佳效果。氯诺昔康是一种强效的镇痛抗炎非甾体抗炎药，具有平衡的环氧化酶（COX）-1/COX-2抑制作用和良好的耐受性。在选择性 COX-2 抑制剂的开发过程中，人们认为 COX-2 抑制剂降低了经典 NSAIDs 类似的上胃肠道（GI）损伤风险。然而，从未进行过比较这两种药物的临床试验。在本研究中，我们比较了氯诺昔康治疗骨关节炎患者与选择性 COX-2 抑制剂罗非昔布的治疗效果。这项多中心临床研究主要关注疗效和耐受性。
共有 2520 名患者（大多数为骨关节炎患者）接受了平均 25 天的治疗。治疗前后，患者记录了他们的运动时疼痛、休息时疼痛和夜间疼痛的个人评分，以及他们的早晨僵硬持续时间和随之而来的限制程度。研究结束时，所有参与的个体都对治疗的疗效和安全性进行了判断。
每个治疗组的每个疗效参数的所有改善均具有临床意义，且在氯诺昔康组显著优于（p < 0.001）。运动时疼痛（-45.3%）、休息时疼痛（-42.0%）和夜间疼痛（-42.5%）均因罗非昔布而减轻，而氯诺昔康治疗后的改善效果明显优于这些效果（分别为-55.8%、-55.8%和-59.9%）。晨僵持续时间的缩短明显（p < 0.001），氯诺昔康组（-66.6%）优于罗非昔布组（-50.2%）。由于疗效不佳而停止罗非昔布治疗的患者几乎是氯诺昔康治疗的三倍（8.9%对 3.4%）。医生认为氯诺昔康明显优于罗非昔布，因为所有病例中疗效显著的比例为 40.9%，而罗非昔布为 20.1%。未发生严重不良事件。所有接受氯诺昔康治疗的患者中有 5.4%报告了不良反应，而接受罗非昔布治疗的患者中有 12.0%（p < 0.001）。胃肠道症状显示罗非昔布治疗后发生频率略有下降。
本研究结果证实了这两种药物的疗效和安全性。氯诺昔康和罗非昔布均能有效治疗活动期骨关节炎患者；氯诺昔康的镇痛和抗炎作用明显优于罗非昔布，且耐受性无差异。
