Platt P N
Department of Rheumatology, Freeman Hospital, Newcastle upon Tyne, England, U.K.
Clin Rheumatol. 1989 Mar;8 Suppl 1:54-62. doi: 10.1007/BF02214110.
Interim results are reported for three double-blind clinical trials comparing etodolac, a new nonsteroidal anti-inflammatory drug (NSAID), with piroxicam, diclofenac, or naproxen in patients with osteoarthritis (OA) of the knee. Patients assigned to receive etodolac were given 200 mg three times a day in the diclofenac comparison and 300 mg twice a day in the other two studies. The comparator groups in the three studies received piroxicam 20 mg once a day, diclofenac 50 mg three times a day, or naproxen 500 mg twice a day. The length of the studies ranged from 6 to 12 weeks, and patients were seen at baseline and every 2 weeks thereafter. Etodolac, piroxicam, and diclofenac treatment consistently resulted in similar and statistically significant changes from baseline, indicative of improvement, in all primary efficacy variables (physicians' and patients' global assessments of improvement, pain intensity, and night pain) at every evaluation. In the comparison with naproxen, patients who received etodolac showed statistically significant improvement at most evaluations, whereas significant changes were less frequent in the naproxen group. Response rates in the three studies (response was defined as a decrease of 1 or more units in the patient's overall global evaluation, which is based on a 5-point scale ranging from 1 = very good to 5 = very poor) were as follows: etodolac 72%, piroxicam 75%; etodolac 66%, diclofenac 56%; and etodolac 40%, naproxen 16%. These interim results suggest that the efficacy of etodolac compares favorably with that of other NSAIDs in the treatment of OA of the knee.
报告了三项双盲临床试验的中期结果,这些试验在膝骨关节炎(OA)患者中比较了一种新型非甾体抗炎药依托度酸与吡罗昔康、双氯芬酸或萘普生的疗效。在双氯芬酸比较试验中,分配接受依托度酸的患者每日三次服用200毫克,在另外两项研究中则为每日两次服用300毫克。三项研究中的对照 groups分别接受每日一次20毫克吡罗昔康、每日三次50毫克双氯芬酸或每日两次500毫克萘普生。研究时长从6周到12周不等,患者在基线时接受检查,此后每2周检查一次。在每次评估时,依托度酸、吡罗昔康和双氯芬酸治疗在所有主要疗效变量(医生和患者对改善情况的总体评估、疼痛强度和夜间疼痛)方面均导致与基线相比出现相似且具有统计学意义的变化,表明病情有所改善。在与萘普生的比较中,接受依托度酸的患者在大多数评估中显示出统计学意义上的改善,而萘普生组的显著变化则较少见。三项研究中的缓解率(缓解定义为患者总体总体评估下降1个或更多单位,该评估基于从1 =非常好到5 =非常差的5分制)如下:依托度酸72%,吡罗昔康75%;依托度酸66%,双氯芬酸56%;依托度酸40%,萘普生16%。这些中期结果表明,依托度酸在治疗膝OA方面的疗效与其他非甾体抗炎药相比具有优势。