Wegman A C M, van der Windt D A W M, de Haan M, Devillé W L J M, Fo C T Chin A, de Vries Th P G M
Department of General Practice, Institute for Research in Extramural Medicine, VU University Medical Centre, Amsterdam, The Netherlands.
Ann Rheum Dis. 2003 Dec;62(12):1156-61. doi: 10.1136/ard.2002.002865.
To investigate for individual patients who have been using NSAIDs regularly, whether paracetamol is as effective as non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of pain and disability related to osteoarthritis of the hip or knee.
A series of n of 1 trials were conducted in general practices in Amsterdam and the surrounding area. Each patient was his or her own control and received five pairs of treatments comprising two weeks of an NSAID and two weeks of paracetamol. For each pair, the order of treatments was randomised. Outcome measures were severity of individual main complaints, intensity of pain, satisfaction with drugs, function test, and side effects.
Thirteen patients were selected. Six patients did not complete the study. For five patients completing the study little or no difference was found between NSAIDs and paracetamol, for one patient the results favoured the NSAID, and for one patient there was no association between outcome and type of drug. It was recommended that six patients changed to paracetamol; the others continued with NSAIDs. Three months after the end of the study, four of the six patients for whom paracetamol had been recommended were taking NSAIDs for practical reasons or perceived lack of efficacy.
The results of the n of 1 trials varied across patients. n of 1 trials can be used to investigate which treatment is best for any specific person, thus avoiding unnecessary prolonged treatment with NSAIDs. However, practical reasons may cause patients to switch from NSAIDs to paracetamol or not.
对于长期规律使用非甾体抗炎药(NSAIDs)的个体患者,研究对乙酰氨基酚在治疗与髋或膝骨关节炎相关的疼痛和功能障碍方面是否与NSAIDs同样有效。
在阿姆斯特丹及其周边地区的普通诊所进行了一系列单病例试验(n-of-1试验)。每位患者自身作为对照,接受五组治疗,每组包括两周的NSAIDs治疗和两周的对乙酰氨基酚治疗。每组治疗的顺序是随机的。观察指标包括个体主要症状的严重程度、疼痛强度、对药物的满意度、功能测试及副作用。
选取了13名患者。6名患者未完成研究。对于5名完成研究的患者,NSAIDs和对乙酰氨基酚之间几乎没有差异;对于1名患者,结果显示NSAIDs更优;对于1名患者,结果与药物类型无关。建议6名患者改用对乙酰氨基酚;其他患者继续使用NSAIDs。研究结束3个月后,被建议使用对乙酰氨基酚的6名患者中有4名因实际原因或感觉疗效不佳而改用NSAIDs。
单病例试验的结果因患者而异。单病例试验可用于研究哪种治疗方法对任何特定个体最有效,从而避免不必要地长期使用NSAIDs。然而,实际原因可能导致患者从NSAIDs改用对乙酰氨基酚或不换药。