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恶丙嗪与阿司匹林治疗类风湿关节炎的多中心双盲比较

A multicentre double-blind comparison of oxaprozin aspirin therapy on rheumatoid arthritis.

作者信息

Hubsher J A, Ballard I M, Walker B R, Gold J A

出版信息

J Int Med Res. 1979;7(1):69-76. doi: 10.1177/030006057900700111.

DOI:10.1177/030006057900700111
PMID:369925
Abstract

Preliminary clinical studies showed that oxaprozin (4,5 Diphenyl-2-oxazolepropionic acid) has anti-inflammatory and analgesic properties with a plasma half-life of about 40 hours. Consequently, a multicentre, double-blind parallel trial was conducted for 12 weeks at thirteen investigator sites, utilizing 212 patients with classic rheumatoid arthritis and comparing oxaprozin 600 mg/day, oxaprozin 1200 mg/day and aspirin 3900 mg/day. Both the oxaprozin and aspirin-treated patients had statistically significant improvement from baseline periods, in most key categories evaluated. Oxaprozin administered twice a day (b.i.d.) was as effective as aspirin administered four times a day (q.i.d.) and caused significantly less tinnitus (p less than 0.001). Fewer patients receiving high dose oxaprozin (2%) dropped out of the study because of unsatisfactory response than did those receiving aspirin (10%). There were no clinically significant laboratory abnormalities in the gastro-intestinal, renal, hepatic or haematological parameters monitored. This study suggests that oxaprozin is effective and well tolerated in the treatment of rheumatoid arthritis.

摘要

初步临床研究表明,恶丙嗪(4,5-二苯基-2-恶唑丙酸)具有抗炎和镇痛特性,血浆半衰期约为40小时。因此,在13个研究地点进行了一项为期12周的多中心、双盲平行试验,纳入212例典型类风湿关节炎患者,比较恶丙嗪600毫克/天、恶丙嗪1200毫克/天和阿司匹林3900毫克/天的疗效。在大多数评估的关键指标中,恶丙嗪治疗组和阿司匹林治疗组患者与基线期相比均有统计学显著改善。每日两次给药(bid)的恶丙嗪与每日四次给药(qid)的阿司匹林疗效相当,且耳鸣发生率显著更低(p<0.001)。因疗效不佳而退出研究的高剂量恶丙嗪治疗患者(2%)少于阿司匹林治疗患者(10%)。所监测的胃肠道、肾脏、肝脏或血液学参数均无临床显著的实验室异常。本研究表明,恶丙嗪治疗类风湿关节炎有效且耐受性良好。

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A multicentre double-blind comparison of oxaprozin aspirin therapy on rheumatoid arthritis.恶丙嗪与阿司匹林治疗类风湿关节炎的多中心双盲比较
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引用本文的文献

1
Oxaprozin. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy.奥沙普秦。对其药效学、药代动力学特性及治疗效果的初步综述。
Drugs. 1986 Oct;32(4):291-312. doi: 10.2165/00003495-198632040-00001.
2
Double-blind study on the interaction of oxaprozin with metoprolol in hypertensives.奥沙普秦与美托洛尔在高血压患者中相互作用的双盲研究。
Cardiovasc Drugs Ther. 1989 Jun;3(3):441-3. doi: 10.1007/BF01858116.