Landsberg P G, Pillans P I, Radford J M
Department of Clinical Pharmacology, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Queensland 4102, Australia.
Intern Med J. 2003 May-Jun;33(5-6):225-8. doi: 10.1046/j.1445-5994.2003.00392.x.
The heavy usage of coxibs in Australia far outstrips the predicted usage that was based on the treatment of patients with risk factors for upper gastro-intestinal adverse events from conventional anti-inflammatory agents. This raises questions regarding the appropriateness of prescribing.
To determine: (i) the relationship between prescriptions for cyclooxygenase 2 (COX-2) inhibitors and objective evidence of inflammatory arthritis, (ii) prior experience with paracetamol and/or conventional non-steroidal anti-inflammatory drugs (NSAIDs), and (iii) contraindications to the use of NSAIDs.
Drug utilization evaluation and rheumatological assessment was conducted on 70 consecutive patients admitted on COX-2 inhibitors to a 480-bed metropolitan hospital. The main outcome measures were: the indication for COX-2 inhibitor; objective evidence of inflammatory arthritis; previous trial of paracetamol or conventional NSAIDs; and patient satisfaction.
Only 11 patients (16%) had symptoms or signs of an inflammatory arthropathy, and met Pharmaceutical Benefits Schedule criteria for prescribing a COX-2 inhibitor. Fifty-nine patients (84%) had chronic osteoarthritis, degenerative spinal disease, injury or malignancy, without overt active inflammation. Fourteen patients (20%) had trialled regular paracetamol prior to using any NSAID treatment. Conventional NSAIDs had been previously used by 51 patients (73%). Eleven patients (16%) reported previous adverse gastrointestinal effects from conventional NSAIDs. On the basis of significant renal impairment (creatinine clearance <50 mL/min) or cardiac failure, cautions or contraindications applied to the use of any form of NSAID in 49% of patients. Fifteen patients (21%) had demonstrable worsening of their renal function after commencement of a COX-2 inhibitor. Thirty-one percent of patients considered the drug was effective (rated >5/10).
Drug utilization data indicate that COX-2 inhibitors are frequently used first line for degenerative osteoarthritis in the absence of overt inflammation, without prior adequate trial of paracetamol and with disregard for the cautions and contraindications of these agents. These findings may explain the unprecedented Pharmaceutical Benefits Schedule expenditure on COX-2 inhibitors in Australia.
在澳大利亚,昔布类药物的大量使用远远超过了基于对具有传统抗炎药上消化道不良事件风险因素患者进行治疗所预测的用量。这引发了关于处方合理性的问题。
确定:(i)环氧化酶2(COX - 2)抑制剂处方与炎性关节炎客观证据之间的关系,(ii)对乙酰氨基酚和/或传统非甾体抗炎药(NSAIDs)的既往使用经验,以及(iii)NSAIDs使用的禁忌证。
对一家拥有480张床位的大都市医院中连续70例接受COX - 2抑制剂治疗的患者进行药物利用评估和风湿病学评估。主要结局指标包括:COX - 2抑制剂的适应证;炎性关节炎的客观证据;对乙酰氨基酚或传统NSAIDs的既往试验情况;以及患者满意度。
只有11例患者(16%)有炎性关节病的症状或体征,且符合药品福利计划中开具COX - 2抑制剂的标准。59例患者(84%)患有慢性骨关节炎、退行性脊柱疾病、损伤或恶性肿瘤,无明显的活动性炎症。14例患者(20%)在使用任何NSAID治疗之前曾试用过常规剂量的对乙酰氨基酚。51例患者(73%)曾使用过传统NSAIDs。11例患者(16%)报告既往使用传统NSAIDs时有胃肠道不良反应。基于严重肾功能损害(肌酐清除率<50 mL/分钟)或心力衰竭,49%的患者在使用任何形式的NSAIDs时存在注意事项或禁忌证。15例患者(21%)在开始使用COX - 2抑制剂后肾功能出现明显恶化。31%的患者认为该药物有效(评分>5/10)。
药物利用数据表明,在没有明显炎症的情况下,COX - 2抑制剂经常被作为退行性骨关节炎的一线用药,在没有对乙酰氨基酚的充分前期试验且无视这些药物的注意事项和禁忌证的情况下使用。这些发现可能解释了澳大利亚在COX - 2抑制剂上史无前例的药品福利计划支出。