Department of General Practice, Erasmus MC, University Medical Center Rotterdam, Netherlands.
BMC Musculoskelet Disord. 2010 Jan 12;11:7. doi: 10.1186/1471-2474-11-7.
Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac) compared with acetaminophen in new consulters with knee osteoarthritis in general practice.
METHODS/DESIGN: Patients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher (on a 0-10 scale), will be randomly allocated to either diclofenac (maximum daily dose of 150 mg) or acetaminophen (maximum daily dose of 3000 mg) for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions.
The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis.
Dutch trial registry NTR1485.
骨关节炎是最常见的慢性关节疾病，尤其会导致髋关节和膝关节疼痛和功能障碍。根据国际指南和荷兰全科医生治疗非创伤性膝关节症状的指南，对骨关节炎患者，应首选扑热息痛作为止痛药物。然而，在全科医疗实践中，所有开具的止痛药物中，90%为非甾体抗炎药，而扑热息痛仅占 10%。由于全科医生可能缺乏证据表明扑热息痛和非甾体抗炎药具有相似的疗效，我们设计了一项随机、开放标签试验，以比较非甾体抗炎药（双氯芬酸）与扑热息痛在新就诊的膝关节骨关节炎患者中的疗效。
方法/设计：年龄在 45 岁或以上、因非创伤性膝关节疼痛就诊全科医生、符合临床美国风湿病学会标准、疼痛严重程度评分为 2 或更高（0-10 分）的患者，将被随机分配到双氯芬酸（最大日剂量 150mg）或扑热息痛（最大日剂量 3000mg）治疗组，持续 2 周，如果需要，再延长 1-2 周，总随访期为 12 周。主要结局指标为使用每日日记记录的膝关节疼痛，以及在基线、第 3、6、9 和 12 周随访时使用膝关节损伤和骨关节炎结局评分（KOOS）测量的疼痛和功能。次要结局指标为患者感知的恢复情况、生活质量、医疗、患者和生产力成本、治疗依从性、合并干预措施和不良反应。
成功完成这项试验将有助于更好地了解应在初级保健患者中使用哪种药物治疗轻度膝关节骨关节炎。
荷兰试验注册 NTR1485。
