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布洛芬和对乙酰氨基酚在儿童和成人中的疗效和安全性:荟萃分析和定性评价。

Efficacy and safety of ibuprofen and acetaminophen in children and adults: a meta-analysis and qualitative review.

机构信息

Critical Care Specialty Residency Department of Pharmacy, Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157, USA.

出版信息

Ann Pharmacother. 2010 Mar;44(3):489-506. doi: 10.1345/aph.1M332. Epub 2010 Feb 11.

DOI:10.1345/aph.1M332
PMID:20150507
Abstract

OBJECTIVE

To evaluate the analgesic and antipyretic efficacy and safety of ibuprofen compared to acetaminophen in children and adults.

DATA SOURCES

Literature searches were performed using PubMed/MEDLINE (through August 2009) and EMBASE (through January 2008) and were restricted to the English language. In PubMed/MEDLINE, search terms used were ibuprofen, acetaminophen, paracetamol, clinical trials, and randomized controlled trials. EMBASE search terms included ibuprofen and acetaminophen, restricted to human and clinical trials.

STUDY SELECTION AND DATA EXTRACTION

All English-language articles identified from the data sources were reviewed. Multiple review articles were studied for any pertinent references and this yielded additional articles. Only articles that directly compared ibuprofen and acetaminophen were eligible for this review.

DATA SYNTHESIS

Eighty-five studies that directly compared ibuprofen to acetaminophen were identified; 54 contained analgesic efficacy data, 35 contained antipyretic/temperature reduction data, and 66 contained safety data (some articles contained more than 1 type of data). Qualitative review of the literature revealed that, for the most part, ibuprofen was more efficacious than acetaminophen for the treatment of pain and fever in both pediatric and adult populations, and that these 2 drugs were equally safe. Meta-analyses on the subset of randomized clinical trial articles that reported sufficient quantitative information to calculate either an odds ratio (adverse event [AE]) or standardized mean difference (pain and fever) confirmed the qualitative results for adult (standardized mean difference [SMD] 0.69; 95% CI 0.57 to 0.81) and pediatric (SMD 0.28; 95% CI 0.10 to 0.46) pain at 2 hours postdose and pediatric fever (SMD 0.26; 95% CI 0.10 to 0.41) at 4 hours postdose. Conclusions regarding adult fever/temperature reduction could not be made due to a lack of evaluable data. The combined odds ratio for the proportion of adult subjects experiencing at least 1 AE slightly favored ibuprofen; however, the difference was not statistically significant (1.12; 95% CI 1.00 to 1.25). No significant difference between drugs in AE incidence was found for pediatric patients (0.82; 95% CI 0.60 to 1.12).

CONCLUSIONS

Ibuprofen is as or more efficacious than acetaminophen for the treatment of pain and fever in adult and pediatric populations and is equally safe.

摘要

目的

评估布洛芬相对于对乙酰氨基酚在儿童和成人中的镇痛和解热疗效和安全性。

资料来源

使用 PubMed/MEDLINE(截至 2009 年 8 月)和 EMBASE(截至 2008 年 1 月)进行文献检索,并仅限于英文文献。在 PubMed/MEDLINE 中,使用的检索词是布洛芬、对乙酰氨基酚、扑热息痛、临床试验和随机对照试验。EMBASE 的检索词包括布洛芬和对乙酰氨基酚,仅限于人类和临床试验。

研究选择和数据提取

对从数据源中识别出的所有英文文章进行了审查。对多篇综述文章进行了研究,以寻找任何相关的参考文献,这又产生了其他文章。只有直接比较布洛芬和对乙酰氨基酚的文章才有资格进行这项综述。

数据综合

共确定了 85 项直接比较布洛芬和对乙酰氨基酚的研究;54 项研究包含镇痛疗效数据,35 项研究包含退热/体温降低数据,66 项研究包含安全性数据(一些文章包含多种类型的数据)。对文献的定性综述表明,在大多数情况下,布洛芬在治疗儿科和成人人群的疼痛和发热方面比对乙酰氨基酚更有效,而且这两种药物同样安全。对报告有足够数量信息以计算比值比(不良反应[AE])或标准化均数差(疼痛和发热)的随机临床试验文章子集进行的荟萃分析证实了 2 小时时成人(标准化均数差[SMD]0.69;95%CI0.57 至 0.81)和儿科(SMD0.28;95%CI0.10 至 0.46)疼痛和 4 小时时儿科发热(SMD0.26;95%CI0.10 至 0.41)的定性结果。由于缺乏可评估的数据,无法得出关于成人退热/体温降低的结论。成人受试者至少经历 1 种不良反应的比例的综合比值比稍微有利于布洛芬;然而,差异无统计学意义(1.12;95%CI1.00 至 1.25)。在儿科患者中,两种药物的不良反应发生率无显著差异(0.82;95%CI0.60 至 1.12)。

结论

布洛芬在治疗成人和儿科人群的疼痛和发热方面与对乙酰氨基酚一样有效或更有效,且安全性相当。

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