Williams H J, Ward J R, Egger M J, Neuner R, Brooks R H, Clegg D O, Field E H, Skosey J L, Alarcón G S, Willkens R F
Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City 84132.
Arthritis Rheum. 1993 Sep;36(9):1196-206. doi: 10.1002/art.1780360904.
To compare the relative safety and efficacy of naproxen and acetaminophen in the treatment of osteoarthritis (OA) of the knee. The major outcome measures were radiographic progression and withdrawal from the trial due to lack of efficacy.
One hundred seventy-eight patients with OA of the knee were enrolled in a 2-year prospective, controlled, double-blind multicenter trial and were randomly assigned to receive acetaminophen (ACT) or naproxen (NPX) treatment.
After 6 weeks of treatment, modest improvement in pain on motion and in physician's global assessment was seen in both the ACT and the NPX groups, and the NPX group also had modest improvement in pain at rest and in 50-foot walk time. Sixty-two patients completed the 2-year study. Among these patients, radiographic progression was similar in the 2 treatment groups. Withdrawal from the trial due to lack of drug efficacy was slightly more frequent among patients in the ACT group (22% versus 16%), but withdrawal due to adverse drug effects was slightly more common in the NPX group (23% versus 18%).
The efficacy of ACT treatment and NPX treatment was similar, although it was slightly better for NPX. The toxicity rate was slightly lower with ACT. However, the high rate of withdrawal in both treatment groups suggests that neither is satisfactory for the treatment of OA.
比较萘普生和对乙酰氨基酚治疗膝骨关节炎(OA)的相对安全性和疗效。主要结局指标为影像学进展和因疗效不佳退出试验。
178例膝骨关节炎患者参加了一项为期2年的前瞻性、对照、双盲多中心试验,随机分配接受对乙酰氨基酚(ACT)或萘普生(NPX)治疗。
治疗6周后,ACT组和NPX组在运动疼痛和医生整体评估方面均有适度改善,NPX组在静息疼痛和50英尺步行时间方面也有适度改善。62例患者完成了2年研究。在这些患者中,两个治疗组的影像学进展相似。因药物疗效不佳退出试验的患者在ACT组略多(22%对16%),但因药物不良反应退出试验的患者在NPX组略常见(23%对18%)。
ACT治疗和NPX治疗的疗效相似,尽管NPX略好。ACT的毒性率略低。然而,两个治疗组的高退出率表明,两者对OA的治疗均不令人满意。