Kidd B, Frenzel W
St. Bartholomew's and Royal London School of Medicine, London, UK.
J Rheumatol. 1996 Sep;23(9):1605-11.
To compare the efficacy and tolerability of lornoxicam and diclofenac in the treatment of patients with osteoarthritis (OA) over 12 weeks and to assess the efficacy and tolerability of lornoxicam over a followup period of 40 weeks.
In a double blind, parallel group study, 135 patients (mean age 63 years) with OA of the hip and/or knee were randomized to receive lornoxicam 4 mg 3 times daily (tid), lornoxicam 8 mg twice daily (bid), or diclofenac 50 mg tid for 12 weeks. 85 patients who completed this 12 week treatment period subsequently received lornoxicam 4 mg tid or 8 mg bid for up to 40 weeks.
Over the initial 12 week treatment period, intention-to-treat analysis revealed improvements in the functional index of severity for OA in all 3 groups by -1.5 to -1.9 points and pairwise testing demonstrated significant intergroup equivalence (p < 0.033). Confirmatory analysis demonstrated the expected efficacy as outlined in the sample size calculation. The percentage of patients showing improvements in disease activity (about 46%) and pain intensity (42 to 48%) was also similar and a clear majority of patients also reported "some" or "excellent" pain relief (80 to 89%). A per protocol analysis produced similar results. During the 40 week lornoxicam followup treatment period there was slight deterioration in the functional index of severity of OA (0.3 to 1.1 points). This minor change may reflect the natural course of the disease rather than a loss of efficacy in lornoxicam. Disease activity and pain intensity continued to improve but in a lesser proportion of patients (< 23%) compared to the previous phase. Nevertheless, a similar high percentage of patients (78 to 89%) reported "some" or "excellent" pain relief. Adverse events in both phases of this study were consistent with those commonly reported during treatment with nonsteroidal antiinflammatory drugs and included headache and gastrointestinal events. There was no difference in the frequency or severity of adverse events between any of the treatment groups. Lornoxicam was well tolerated in the long term.
Lornoxicam 4 mg tid and 8 mg bid were as effective as diclofenac 50 mg tid for the treatment of OA. There was no significant difference in tolerability of these regimens. Thus, lornoxicam appears to be a useful therapeutic alternative to diclofenac in patients with OA.
比较氯诺昔康和双氯芬酸治疗骨关节炎（OA）患者12周的疗效和耐受性，并评估氯诺昔康在40周随访期的疗效和耐受性。
在一项双盲、平行组研究中，135例髋和/或膝关节OA患者（平均年龄63岁）被随机分为接受氯诺昔康4mg每日3次（tid）、氯诺昔康8mg每日2次（bid）或双氯芬酸50mg tid治疗12周。85例完成这12周治疗期的患者随后接受氯诺昔康4mg tid或8mg bid治疗长达40周。
在最初的12周治疗期，意向性分析显示所有3组OA严重程度功能指数改善了1.5至1.9分，两两检验显示组间等效性显著（p<0.033）。验证性分析证明了样本量计算中概述的预期疗效。疾病活动改善的患者百分比（约46%）和疼痛强度改善的患者百分比（42%至48%）也相似，并且绝大多数患者也报告“部分”或“显著”的疼痛缓解（80%至89%）。符合方案分析产生了相似的结果。在40周氯诺昔康随访治疗期，OA严重程度功能指数略有恶化（0.3至1.1分）。这种微小变化可能反映了疾病的自然病程，而非氯诺昔康疗效的丧失。疾病活动和疼痛强度持续改善，但与前一阶段相比，改善的患者比例较小（<23%）。然而，仍有相似高比例的患者（78%至89%）报告“部分”或“显著”的疼痛缓解。本研究两个阶段的不良事件与非甾体抗炎药治疗期间常见的不良事件一致，包括头痛和胃肠道事件。任何治疗组之间不良事件的频率或严重程度均无差异。氯诺昔康长期耐受性良好。
氯诺昔康4mg tid和8mg bid治疗OA与双氯芬酸50mg tid同样有效。这些治疗方案的耐受性无显著差异。因此，氯诺昔康似乎是OA患者双氯芬酸的一种有用的治疗替代药物。
