Arthritis Research UK Pain Centre, Academic Rheumatology, Nottingham City Hospital, UK.
Ann Rheum Dis. 2011 Sep;70(9):1534-41. doi: 10.1136/ard.2011.154047.
To compare the efficacy and safety of single versus combination non-prescription oral analgesics in community-derived people aged 40 years and older with chronic knee pain.
A randomised, double-blind, four-arm, parallel-group, active controlled trial investigating short-term (day 10) and long-term (week 13) benefits and side-effects of four regimens, each taken three times a day: ibuprofen (400 mg); paracetamol (1000 mg); one fixed-dose combination tablet (ibuprofen 200 mg/paracetamol 500 mg); two fixed-dose combination tablets (ibuprofen 400 mg/paracetamol 1000 mg).
There were 892 participants (mean age 60.6, range 40-84 years); 63% had radiographic knee osteoarthritis and 85% fulfilled American College of Rheumatology criteria for osteoarthritis. At day 10, two combination tablets were superior to paracetamol (p<0.01) for pain relief (determined by mean change from baseline in WOMAC pain; n=786). At 13 weeks, significantly more participants taking one or two combination tablets rated their treatment as excellent/good compared with paracetamol (p=0.015, p=0.0002, respectively; n=615). The frequency of adverse events was comparable between groups. However, by 13 weeks, decreases in haemoglobin (≥1 g/dl) were observed in some participants in all groups. Twice as many participants taking two combination tablets had this decrease compared with those on monotherapy (p<0.001; paracetamol, 20.3%; ibuprofen, 19.6%; one or two combination tablets, 24.1%, 38.4%, respectively).
Ibuprofen/paracetamol combination analgesia, at non-prescription doses, confers modest short-term benefits for knee pain/osteoarthritis. However, in this population, paracetamol 3 g/day may cause similar degrees of blood loss as ibuprofen 1200 mg/day, and the combination of the two appears to be additive. Study no ISRCTN77199439.
比较单药与非处方药联合使用非甾体抗炎药治疗 40 岁及以上慢性膝痛患者的疗效和安全性。
这是一项随机、双盲、四臂、平行组、阳性对照试验，旨在研究四种方案的短期（第 10 天）和长期（第 13 周）益处和副作用，每种方案均每日服用 3 次：布洛芬（400mg）；扑热息痛（1000mg）；一种固定剂量复方片剂（布洛芬 200mg/扑热息痛 500mg）；两种固定剂量复方片剂（布洛芬 400mg/扑热息痛 1000mg）。
共纳入 892 名参与者（平均年龄 60.6 岁，范围 40-84 岁）；63%的参与者有放射学膝骨关节炎，85%的参与者符合美国风湿病学会骨关节炎标准。在第 10 天，与扑热息痛相比，两种联合片剂在缓解疼痛方面均具有优势（根据 WOMAC 疼痛的平均基线变化来确定；n=786）。在 13 周时，与扑热息痛相比，服用一种或两种联合片剂的参与者中，有更多人认为其治疗效果为优/良（p=0.015，p=0.0002，n=615）。各组之间不良反应的发生频率相当。然而，到 13 周时，所有组中一些参与者的血红蛋白（≥1g/dl）均出现下降。服用两种联合片剂的参与者中，血红蛋白下降的比例是服用单药治疗的参与者的两倍（p<0.001；扑热息痛组为 20.3%；布洛芬组为 19.6%；一种或两种联合片剂组分别为 24.1%和 38.4%）。
非处方药剂量的布洛芬/扑热息痛联合镇痛可在短期内缓解膝关节疼痛/骨关节炎。然而，在该人群中，扑热息痛 3g/天可能会导致与布洛芬 1200mg/天相似程度的失血，而且两者联合使用似乎具有相加作用。研究注册号：ISRCTN77199439。
