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左侧溃疡性结肠炎和溃疡性直肠炎的药物治疗:治疗试验的批判性评估

Medical management of left-sided ulcerative colitis and ulcerative proctitis: critical evaluation of therapeutic trials.

作者信息

Regueiro Miguel, Loftus Edward V, Steinhart A Hillary, Cohen Russell D

机构信息

Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania 15213, USA.

出版信息

Inflamm Bowel Dis. 2006 Oct;12(10):979-94. doi: 10.1097/01.mib.0000231495.92013.5e.

Abstract

BACKGROUND

The goal of this work was to critically evaluate the published studies on the treatment of ulcerative proctitis (UP) and left-sided ulcerative colitis (L-UC). The results of this review provided the content for the accompanying treatment guidelines, Clinical Guidelines for the Medical Management of Left-sided Ulcerative Colitis and Ulcerative Proctitis: Summary Statement.

METHODS

All English language articles published between 1995 and September 2005 were identified through a comprehensive literature search using OVID and PubMed. The quality of the data supporting or rejecting the use of specific therapies was categorized by a data quality grading scale. An "A+" grade was assigned to treatment supported by multiple high-quality randomized controlled trials with consistent results, whereas a "D" grade was given to therapy supported only by expert opinion. The therapeutic efficacy of a treatment was defined by its success in treating UP and L-UC compared with placebo. A medication was ranked as "excellent" if it was specifically studied for UP and L-UC and had consistently positive results compared with placebo or another agent. Quality and efficacy scores were agreed on by author consensus.

RESULTS

For the acute treatment of UP or L-UC, the rectally administered corticosteroids and mesalazine (5-ASA), either alone or in combination with oral 5-ASAs, are the most effective therapy: evidence quality, A+; efficacy, excellent. Only rectally administered 5-ASA received an A+/excellent rating for maintenance of remission. Infliximab received an A+ grade for induction and maintenance of remission but only a "good" rating because the studies were performed in all UC, not specifically UP or L-UC.

CONCLUSIONS

This critical evaluation of treatment provides a "report card" on medications available for the management of patients with UP and L-UC. The guidelines should provide a useful reference and supplement for physicians treating UC patients.

摘要

背景

本研究的目的是严格评估已发表的关于溃疡性直肠炎(UP)和左侧溃疡性结肠炎(L-UC)治疗的研究。本综述的结果为随附的治疗指南《左侧溃疡性结肠炎和溃疡性直肠炎医学管理临床指南:总结声明》提供了内容。

方法

通过使用OVID和PubMed进行全面的文献检索,确定了1995年至2005年9月期间发表的所有英文文章。支持或反对使用特定疗法的数据质量通过数据质量分级量表进行分类。由多项高质量随机对照试验支持且结果一致的治疗被评为“A+”级,而仅由专家意见支持的疗法被评为“D”级。一种治疗的疗效通过其与安慰剂相比治疗UP和L-UC的成功率来定义。如果一种药物专门针对UP和L-UC进行了研究,并且与安慰剂或另一种药物相比始终具有阳性结果,则被列为“优秀”。质量和疗效评分经作者共识确定。

结果

对于UP或L-UC的急性治疗,直肠给药的皮质类固醇和美沙拉嗪(5-氨基水杨酸),单独使用或与口服5-氨基水杨酸联合使用,是最有效的疗法:证据质量,A+;疗效,优秀。只有直肠给药的5-氨基水杨酸在维持缓解方面获得了A+/优秀评级。英夫利昔单抗在诱导和维持缓解方面获得了A+级,但仅获得“良好”评级,因为研究是在所有溃疡性结肠炎患者中进行的,而非专门针对UP或L-UC。

结论

这种对治疗的严格评估为可用于治疗UP和L-UC患者的药物提供了一份“成绩单”。该指南应为治疗溃疡性结肠炎患者的医生提供有用的参考和补充。

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