Pincus T, Koch G G, Sokka T, Lefkowith J, Wolfe F, Jordan J M, Luta G, Callahan L F, Wang X, Schwartz T, Abramson S B, Caldwell J R, Harrell R A, Kremer J M, Lautzenheiser R L, Markenson J A, Schnitzer T J, Weaver A, Cummins P, Wilson A, Morant S, Fort J
Division of Rheumatology and Immunology, Vanderbilt University, Nashville, Tennessee 37232-4500, USA.
Arthritis Rheum. 2001 Jul;44(7):1587-98. doi: 10.1002/1529-0131(200107)44:7<1587::AID-ART282>3.0.CO;2-X.
To perform a randomized, double-blind, crossover clinical trial of diclofenac + misoprostol versus acetaminophen in ambulatory patients with osteoarthritis of the hip or knee.
Patients in 12 ambulatory care settings were eligible if they were age >40 years and if they had Kellgren/Lawrence radiographic grade 2-4 osteoarthritis of the knee or hip and a score of > or =30 mm on a 100-mm visual analog pain scale. Patients were randomized to one of two groups, 75 mg diclofenac + 200 microg misoprostol twice daily or 1,000 mg acetaminophen 4 times daily (each for 6 weeks), and were then crossed over to the other treatment for 6 weeks. A placebo was included in each treatment regimen to enable double blinding. The primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index and the visual analog pain scale of the Multidimensional Health Assessment Questionnaire. Safety was assessed using a standard form to review adverse events.
We enrolled 227 patients, of whom 218 provided data for the first treatment period and 181 provided data for both treatment periods. Significantly higher levels of improvement in the primary outcomes were seen for diclofenac + misoprostol than for acetaminophen (P < 0.001). Adverse events were more common when patients took diclofenac + misoprostol (P = 0.046). Diclofenac + misoprostol was rated as "better" or "much better" by 57% of the 174 patients who provided such ratings for both treatment periods, while acetaminophen was rated as "better" or "much better" by 20% of these patients, and 22% reported no difference (P < 0.001). Differences favoring diclofenac + misoprostol over acetaminophen were greater in patients with more severe osteoarthritis according to baseline pain scores, radiographs, or number of involved joints.
Patients with osteoarthritis of the hip or knee had significantly greater improvements in pain scores over 6 weeks with diclofenac + misoprostol than with acetaminophen, although patients with mild osteoarthritis had similar improvements with both drugs. Acetaminophen was associated with fewer adverse events.
对双氯芬酸+米索前列醇与对乙酰氨基酚用于髋或膝骨关节炎门诊患者进行一项随机、双盲、交叉临床试验。
12个门诊护理机构中年龄>40岁、膝关节或髋关节Kellgren/Lawrence放射学分级为2-4级且在100毫米视觉模拟疼痛量表上得分≥30毫米的患者符合入选条件。患者被随机分为两组，一组每日两次服用75毫克双氯芬酸+200微克米索前列醇，另一组每日4次服用1000毫克对乙酰氨基酚（每组均为6周），然后交叉接受另一种治疗6周。每个治疗方案中均包含安慰剂以实现双盲。主要结局指标为西安大略和麦克马斯特大学骨关节炎指数以及多维健康评估问卷的视觉模拟疼痛量表。使用标准表格评估安全性以审查不良事件。
我们纳入了227例患者，其中218例提供了第一个治疗期的数据，181例提供了两个治疗期的数据。双氯芬酸+米索前列醇在主要结局方面的改善水平显著高于对乙酰氨基酚（P<0.001）。患者服用双氯芬酸+米索前列醇时不良事件更为常见（P=0.046）。在两个治疗期均提供此类评级的174例患者中，57%将双氯芬酸+米索前列醇评为“更好”或“好得多”，而20%的患者将对乙酰氨基酚评为“更好”或“好得多”，22%的患者报告无差异（P<0.001）。根据基线疼痛评分、X线片或受累关节数量，骨关节炎更严重的患者中，双氯芬酸+米索前列醇相对于对乙酰氨基酚的优势更大。
髋或膝骨关节炎患者使用双氯芬酸+米索前列醇在6周内疼痛评分的改善显著大于使用对乙酰氨基酚，不过轻度骨关节炎患者使用两种药物的改善情况相似。对乙酰氨基酚的不良事件较少。
