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评估美国批准用于治疗过敏性鼻炎的药物:按类别评估对鼻部症状疗效的循证综述。

Evaluating approved medications to treat allergic rhinitis in the United States: an evidence-based review of efficacy for nasal symptoms by class.

机构信息

Head and Neck Institute, The Cleveland Clinic, Celeveland, OH 44195, USA.

出版信息

Ann Allergy Asthma Immunol. 2010 Jan;104(1):13-29. doi: 10.1016/j.anai.2009.11.020.

DOI:10.1016/j.anai.2009.11.020
PMID:20143641
Abstract

OBJECTIVE

To evaluate how well the medications currently approved in the United States for allergic rhinitis (AR) treat nasal symptoms when examined according to Food and Drug Administration-indicated uses and dosages.

DATA SOURCES

MEDLINE (1966 onward), EMBASE (1974 onward), and the Cochrane Library (2007) were systematically searched according to the following criteria defined at a roundtable meeting of the authors: randomized controlled trial, at least a 2-week duration, and approved indication and dosage in the United States.

STUDY SELECTION

Data from studies that met the inclusion criteria were extracted into evidence tables, which were reviewed twice by the full panel of authors. Individual panel members also were asked to comment on abstracts, articles, and summary tables based on their known expertise. The entire faculty approved the selection of studies included in this review.

RESULTS

Fifty-four randomized, placebo-controlled studies involving more than 14,000 adults and 1,580 children with AR met the criteria for review: 38 studies of seasonal allergic rhinitis (SAR; n = 11,980 adults and 946 children) and 12 studies of perennial allergic rhinitis (PAR; n = 3,800 adults and 366 children). The median percentage changes from baseline for total nasal symptom score for SAR were as follows: nasal antihistamines, -22.2%; oral antihistamines, -23.5%; intranasal steroids (INSs), -40.7%; and placebo, -15.0%. For PAR, the changes were as follows: oral antihistamines, -51.4%; INSs, -37.3%; and placebo, -24.8%. Data for mediator antagonists were limited.

CONCLUSIONS

The data, although limited, confirm that INSs produce the greatest improvements in nasal symptoms in patients with SAR. In addition, INSs are effective for PAR, but the data were of variable quality, and oral antihistamines may be equally effective for some patients. The reporting of published data should be standardized to permit better comparisons in future studies.

摘要

目的

评估根据美国食品和药物管理局(FDA)规定的适应证和剂量,评估目前批准用于治疗过敏性鼻炎(AR)的药物在治疗鼻部症状方面的效果。

数据来源

根据作者圆桌会议定义的以下标准,系统地检索了 MEDLINE(1966 年以后)、EMBASE(1974 年以后)和 Cochrane 图书馆(2007 年):随机对照试验,至少 2 周的疗程,以及在美国获得批准的适应证和剂量。

研究选择

符合纳入标准的数据被提取到证据表中,由全体作者小组进行了两次审查。个别小组成员还根据他们的专业知识对摘要、文章和汇总表发表了评论。全体教员批准了本次综述中包含的研究选择。

结果

54 项随机、安慰剂对照研究涉及 14000 多名成年人和 1580 名儿童的 AR,符合审查标准:38 项季节性过敏性鼻炎(SAR)研究(n=11980 名成年人和 946 名儿童)和 12 项常年性过敏性鼻炎(PAR)研究(n=3800 名成年人和 366 名儿童)。SAR 患者总鼻部症状评分的基线中位数变化百分比如下:鼻用抗组胺药,-22.2%;口服抗组胺药,-23.5%;鼻内用皮质类固醇(INSs),-40.7%;安慰剂,-15.0%。对于 PAR,变化如下:口服抗组胺药,-51.4%;INSs,-37.3%;安慰剂,-24.8%。介质拮抗剂的数据有限。

结论

尽管数据有限,但证实 INSs 可使 SAR 患者的鼻部症状得到最大改善。此外,INSs 对 PAR 有效,但数据质量参差不齐,口服抗组胺药对某些患者可能同样有效。应标准化发表数据的报告,以便在未来的研究中进行更好的比较。

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