A controlled study comparing the effects of nabumetone, ibuprofen, and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa.

A controlled study comparing the effects of nabumetone, ibuprofen, and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa.
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一项对照研究比较了萘丁美酮、布洛芬和布洛芬加米索前列醇对上胃肠道粘膜的影响。

DOI:
10.1001/archinte.1993.00410220073008
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发表时间:
1993
影响因子:
--
通讯作者:
R. Fleischmann
R. Fleischmann
中科院分区:
--
文献类型:
--
作者:
S. Roth;E. Tindall;A. Jain;F. Mcmahon;P. April;B. Bockow;S. Cohen;R. Fleischmann

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背景 这项研究旨在比较服用萘丁美酮、布洛芬或同时服用布洛芬/米索前列醇的老年患者经内窥镜诊断的溃疡发生率。进一步的研究表明,更好地建立这些内窥镜检查结果的临床相关性。 方法 我们进行了一项前瞻性、多中心、随机、内窥镜盲法、为期12周的研究,研究对象为171名60岁及以上的骨关节炎患者。患者被随机分成三组,分别接受纳布美酮1000 mg(n=58)、布洛芬600 mg每日四次(n=53)或布洛芬600 mg每日四次与米索前列醇200微克每日四次(n=60)治疗。在基线、2周、6周和12周进行内窥镜检查。内窥镜检查结果按1到9分进行评分。显著溃疡被定义为黏膜破裂大于5 mm且深度可察觉。 结果 在171名随机分组的患者中,148人完成了这项研究。在萘丁美酮组和布洛芬/米索前列醇组之间,显著溃疡的发生率没有显著差异(1比0)。萘丁美酮和布洛芬/米索前列醇组的显著溃疡明显少于布洛芬单一治疗组(1和0 vs8;P<0.01)。发生溃疡的时间也有显著差异,布洛芬治疗(P<.01)比那丁美酮或布洛芬/米索前列醇治疗更早发生溃疡的风险更大。根据医生的评估,骨性关节炎的严重程度在服用萘丁美酮组、布洛芬组和布洛芬/米索前列醇组的患者中,分别有55%和63%的患者得到改善。 结论 萘丁美酮与布洛芬/米索前列醇具有相同的致溃性,但其致溃性明显低于单独使用布洛芬。
BACKGROUND This study was developed to compare the incidence of endoscopically diagnosed ulcers in elderly patients taking nabumetone, ibuprofen, or concomitant ibuprofen/misoprostol. Further research is indicated to better establish the clinical relevance of these endoscopy findings. METHODS We conducted a prospective, multicenter, randomized, endoscopist-blinded, 12-week study involving 171 patients with osteoarthritis aged 60 years and older. Patients were randomized to receive nabumetone, 1000 mg (n = 58); ibuprofen, 600 mg four times daily (n = 53); or ibuprofen, 600 mg four times daily, administered concomitantly with misoprostol, 200 micrograms four times daily (n = 60). Endoscopy was performed at baseline and at weeks 2, 6, and 12. Endoscopy results were scored on a scale of 1 to 9. Significant ulcers were defined as breaks in the mucosa greater than 5 mm with appreciable depth. RESULTS Of the 171 randomized patients, 148 completed the study. There was no significant difference in the incidence of significant ulcers between the nabumetone group and the ibuprofen/misoprostol group (one vs zero). There were significantly fewer significant ulcers in the nabumetone and ibuprofen/misoprostol groups than in the ibuprofen monotherapy group (one and zero vs eight; P < .01). There also was a significant difference in the time to ulcer development, with a greater risk of developing an ulcer sooner with ibuprofen treatment (P < .01) than either nabumetone or ibuprofen/misoprostol treatment. The severity of osteoarthritis, based on physicians' assessments, improved in 64% of patients in the nabumetone group, 55% of those in the ibuprofen group, and 63% of those in the ibuprofen/misoprostol group. CONCLUSIONS Nabumetone is equivalent in ulcerogenicity to concomitant ibuprofen/misoprostol and is significantly less ulcerogenic than ibuprofen alone.
DOI: 10.1002/art.1780341103
发表时间: 1991
影响因子: --
作者:
Fries,JF;Williams,CA;Bloch,DA
通讯作者: Bloch,DA