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5-氨基水杨酸(美沙拉嗪)治疗溃疡性结肠炎和克罗恩病的药物安全性、耐受性及有效性

[Drug safety, acceptance and effectiveness of 5-aminosalicylic acid (mesalazine) in the treatment of ulcerative colitis and Crohn disease].

作者信息

Bayerdörffer E, Bock H

机构信息

Medizinische Abteilung, Städtisches Krankenhaus München-Neuperlach.

出版信息

Leber Magen Darm. 1988 Apr;18(2):104-13.

PMID:3374251
Abstract

In an open clinical trial 71 patients with ulcerative colitis and 27 patients with Crohn's disease were treated with mesalazine (5-ASA). After four to eight weeks of acute phase treatment, maintenance therapy was ensued by treatment over a period of maximal 48 weeks. The activity of both inflammatory bowel disease clearly decreased. Relapse was not observed during maintenance treatment in ulcerative colitis. Pathological changes of clinical findings were not observed during treatment. Pathologic changes before treatment, which were associated with the disease, returned to normal during treatment. All potential side effects during treatment were recorded. The rate of side effects was low and all normalized when therapy was continued. The study confirms that mesalazine was safe, efficient and almost well tolerable.

摘要

在一项开放性临床试验中,71例溃疡性结肠炎患者和27例克罗恩病患者接受了美沙拉嗪(5-氨基水杨酸)治疗。在急性期治疗4至8周后,接着进行最长48周的维持治疗。两种炎症性肠病的活动度均明显降低。溃疡性结肠炎维持治疗期间未观察到复发。治疗期间未观察到临床检查结果的病理变化。治疗前与疾病相关的病理变化在治疗期间恢复正常。记录了治疗期间所有可能的副作用。副作用发生率较低,继续治疗时所有副作用均恢复正常。该研究证实美沙拉嗪安全、有效且耐受性良好。

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