Caldwell J R, Roth S H
Florida Arthritis and Allergy Institute, Daytona Beach 32114.
J Rheumatol. 1994 Apr;21(4):689-95.
To compare efficacy and gastrointestinal (GI) tolerability of a new enteric coated formulation of naproxen (NAP-EC) with standard immediate release naproxen (NAP-STD).
One hundred seventy-nine patients with osteoarthritis (OA) and one hundred seventy-six patients with rheumatoid arthritis (RA) at high risk for developing GI side effects to nonsteroidal antiinflammatory drug (NSAID) therapy were enrolled in a double blind, parallel, multicenter study. All patients had either discontinued as NSAID during the previous one year or required cotreatment with antiulcer drugs for control of GI complaints related to NSAID use. The treatments were evenly divided in both diagnostic cohorts.
Except for minor differences in alcohol consumption, baseline characteristics of patients in both treatment groups were statistically similar. Both naproxen formulations were highly efficacious by all variables of disease activity when changes were measured from baseline. No statistically significant between formulation difference was found in the primary efficacy variable, overall disease activity. Overall, between formulation differences in efficacy measures were few, though most favored NAP-STD. GI complaints were reduced by 15% (51% NAP-EC vs 60% NAP-STD, p = 0.077) and GI complaints thought to be drug related were reduced by 36% (16% NAP-EC vs 25% NAP-STD, p = 0.024). Withdrawals due to GI complaints were reduced by 37% in the NAP-EC group (12% NAP-EC vs 19% NAP-STD, p = 0.054), and withdrawals due to GI complaints judged to be drug related were reduced by 55% in the NAP-EC group (6% NAP-EC vs 12% NAP-STD, p = 0.025).
Enteric coated naproxen is an effective treatment for OA and RA. All observed differences in GI tolerability favor NAP-EC over NAP-STD.
比较新型肠溶包衣萘普生制剂（NAP-EC）与标准速释萘普生（NAP-STD）的疗效及胃肠道（GI）耐受性。
179例骨关节炎（OA）患者和176例类风湿关节炎（RA）患者因非甾体抗炎药（NSAID）治疗出现胃肠道副作用的风险较高而被纳入一项双盲、平行、多中心研究。所有患者在过去一年中要么停用了NSAID，要么需要联合使用抗溃疡药物来控制与NSAID使用相关的胃肠道不适。两个诊断队列中的治疗分配均衡。
除饮酒量存在微小差异外，两个治疗组患者的基线特征在统计学上相似。从基线开始测量变化时，两种萘普生制剂在所有疾病活动变量方面均具有高度疗效。在主要疗效变量总体疾病活动方面，未发现制剂之间存在统计学显著差异。总体而言，尽管大多数有利于NAP-STD，但两种制剂在疗效测量上的差异很少。胃肠道不适减少了15%（NAP-EC为51%，NAP-STD为60%，p = 0.077），被认为与药物相关的胃肠道不适减少了36%（NAP-EC为16%，NAP-STD为25%，p = 0.024）。NAP-EC组因胃肠道不适导致的停药减少了37%（NAP-EC为12%，NAP-STD为19%，p = 0.054），NAP-EC组因被认为与药物相关的胃肠道不适导致的停药减少了55%（NAP-EC为6%，NAP-STD为12%，p = 0.025）。
肠溶包衣萘普生是OA和RA的有效治疗方法。在胃肠道耐受性方面观察到的所有差异均表明NAP-EC优于NAP-STD。
