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非处方感冒药。对1950年至1991年间临床试验的批判性综述。

Over-the-counter cold medications. A critical review of clinical trials between 1950 and 1991.

作者信息

Smith M B, Feldman W

机构信息

Division of Pediatric Medicine, Izaak Walton Killam Children's Hospital, Halifax, Nova Scotia.

出版信息

JAMA. 1993 May 5;269(17):2258-63. doi: 10.1001/jama.269.17.2258.

Abstract

OBJECTIVE

To determine whether over-the-counter cold medications have been shown to be effective in relieving symptoms in children, adolescents, and adults.

DATA SOURCES

The MEDLINE database using the key words combined with medications and research and review articles. Articles were retrieved if they were written in English and published between January 1950 and January 1991.

STUDY SELECTION

Articles were selected if they described a controlled clinical trial on the treatment of the common cold. Forty-eight percent of 106 articles met the selection criteria, and these were grouped by age into child studies (< 5 years old and < 12 years old) and adolescent (aged 12 years and older)/adult studies.

DATA EXTRACTION

Each article was scored on 11 criteria to determine scientific validity. Those articles scoring above 70% were included in the final analysis. Two authors independently scored a sample of articles to determine interrater reliability.

DATA SYNTHESIS

Very few studies have been performed on children. Of those, two done on preschool children demonstrated no symptom relief, whereas two done on older children showed some benefit. In the adolescent/adult studies, chlorpheniramine maleate, pseudoephedrine hydrochloride, oxymetazoline hydrochloride, phenylpropanolamine hydrochloride, ipratropium bromide, and atropine methonitrate all improved nasal symptoms. Combination therapy (using an antihistamine-decongestant mix) was shown to relieve a variety of symptoms.

CONCLUSIONS

No good evidence has demonstrated the effectiveness of over-the-counter cold medications in preschool children. Further studies are required to clarify the role of these medications in children. Certain single over-the-counter medications and combinations have been shown to reduce cold symptoms in adolescents and adults.

摘要

目的

确定非处方感冒药是否已被证明对儿童、青少年和成人的症状缓解有效。

数据来源

使用关键词“药物”与“研究”及“综述文章”相结合检索MEDLINE数据库。若文章为英文撰写且发表于1950年1月至1991年1月之间,则予以检索。

研究选择

若文章描述了关于普通感冒治疗的对照临床试验,则予以选择。106篇文章中有48%符合选择标准,这些文章按年龄分为儿童研究(<5岁和<12岁)以及青少年(12岁及以上)/成人研究。

数据提取

每篇文章根据11项标准进行评分以确定科学有效性。得分高于70%的文章纳入最终分析。两位作者独立对部分文章样本进行评分以确定评分者间信度。

数据综合

针对儿童进行的研究极少。其中,两项针对学龄前儿童的研究显示症状未缓解,而两项针对大龄儿童的研究显示有一定益处。在青少年/成人研究中,马来酸氯苯那敏、盐酸伪麻黄碱、盐酸羟甲唑啉、盐酸苯丙醇胺、异丙托溴铵和硝酸甲胆碱均改善了鼻部症状。联合治疗(使用抗组胺药 - 减充血剂合剂)显示可缓解多种症状。

结论

没有充分证据表明非处方感冒药对学龄前儿童有效。需要进一步研究以阐明这些药物在儿童中的作用。某些单一非处方药物及其组合已被证明可减轻青少年和成人的感冒症状。

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