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奥沙拉嗪与柳氮磺胺吡啶用于溃疡性结肠炎维持治疗的对照试验。

Controlled trial comparing olsalazine and sulphasalazine for maintenance treatment of ulcerative colitis.

作者信息

Jewell D P, Ireland A

机构信息

Gastroenterology Unit, Radcliffe Infirmary, Oxford, U.K.

出版信息

Scand J Gastroenterol Suppl. 1988;148:45-7. doi: 10.3109/00365528809101547.

DOI:10.3109/00365528809101547
PMID:2906477
Abstract

Olsalazine and sulphasalazine were compared in a double-blind, double-dummy trial in the prevention of relapse of ulcerative colitis over 6 months. The majority were taking sulphasalazine. They were randomized to receive either olsalazine, 500 mg b.d., or sulphasalazine, 1 g b.d. Of 82 patients, 16 relapsed on olsalazine compared with 10 of 82 on sulphasalazine. This difference was not statistically significant (p = 0.16). Twenty-one patients reported adverse events in the olsalazine group, of whom 16 were withdrawn, while 20 patients reported adverse events in the sulphasalazine group, with 9 of them being withdrawn. The differences were not statistically significant. No major haematological or biochemical abnormalities occurred. Thus, olsalazine is similar to sulphasalazine for the prevention of relapse of ulcerative colitis.

摘要

在一项为期6个月预防溃疡性结肠炎复发的双盲、双模拟试验中,对奥沙拉嗪和柳氮磺胺吡啶进行了比较。大多数患者服用的是柳氮磺胺吡啶。他们被随机分为两组,分别接受每日两次、每次500毫克的奥沙拉嗪,或每日两次、每次1克的柳氮磺胺吡啶。82名患者中,服用奥沙拉嗪的有16人复发,而服用柳氮磺胺吡啶的82人中有10人复发。这种差异无统计学意义(p = 0.16)。奥沙拉嗪组有21名患者报告了不良事件,其中16人退出试验,而柳氮磺胺吡啶组有20名患者报告了不良事件,其中9人退出试验。差异无统计学意义。未出现重大血液学或生化异常。因此,在预防溃疡性结肠炎复发方面,奥沙拉嗪与柳氮磺胺吡啶相似。

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Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: a randomised double blind trial.
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