Safety of sulfamethoxazole-trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis.

IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Rebecca Preyra, Lujain Ez Eddin, Fatemeh Ahmadi, Atefeh Jafari, Flory T Muanda
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引用次数: 0

Abstract

Aims: Sulfamethoxazole-trimethoprim (SMX-TMP) is a widely used antibiotic for treating bacterial infections, but its safety in adult outpatients remains understudied. This systematic review and meta-analysis evaluated the safety profile of SMX-TMP and identified critical research gaps. The pharmacovigilance study aimed to validate and extend findings from meta-analyses to better understand the real-world safety of SMX-TMP.

Methods: We searched MEDLINE and Embase up to 12 August 2024, to identify studies comparing adverse drug events (ADEs) following SMX-TMP vs. other antibiotics in adult outpatients. Meta-analyses were performed where data allowed. A pharmacovigilance study using the Food and Drug Administration Adverse Event Reporting System was conducted to supplement our findings.

Results: Our review, which included 43 studies, found SMX-TMP had a nearly 3-fold higher risk of rash compared to other antibiotics (pooled risk ratio 2.56, 95% confidence interval [1.69, 3.89], I2 = 0%, n = 4458 participants, 24 randomized control trials). Pharmacovigilance data confirmed a higher frequencies of skin disorders and other ADEs compared to various comparator drugs. Compared to azithromycin, SMX-TMP was associated with a 5-fold increase in Stevens-Johnson syndrome, a 3-fold increase in toxic epidermal necrolysis, and a 10-fold increase in drug reaction with eosinophilia and systemic symptoms. Additionally, SMX-TMP showed a 10-fold increase in reports of pancytopenia, a 6-fold increase in neutropenia, a 4-fold increase in both thrombocytopenia and aplastic anaemia, a 56-fold increase in hyperkalaemia, and a 10-fold increase in hyponatraemia.

Conclusion: Our meta-analyses and pharmacovigilance study suggested SMX-TMP was associated with increased risk of ADEs compared to other antibiotics including amoxicillin/clavulanate, azithromycin and nitrofurantoin. Further robust research is essential to confirm these safety signals and guide clinical practice.

磺胺甲恶唑-甲氧苄啶治疗门诊细菌感染的安全性:一项系统评价和采用活性比较物歧化分析的荟萃分析。
目的:磺胺甲恶唑-甲氧苄啶(SMX-TMP)是一种广泛用于治疗细菌感染的抗生素,但其在成人门诊患者中的安全性仍有待研究。本系统综述和荟萃分析评估了SMX-TMP的安全性,并确定了关键的研究空白。药物警戒研究旨在验证和扩展meta分析的结果,以更好地了解SMX-TMP的实际安全性。方法:检索截至2024年8月12日的MEDLINE和Embase,以确定比较成人门诊患者使用SMX-TMP与其他抗生素的不良药物事件(ADEs)的研究。在数据允许的情况下进行meta分析。一项使用美国食品和药物管理局不良事件报告系统进行的药物警戒研究补充了我们的发现。结果:我们的综述包括43项研究,发现与其他抗生素相比,SMX-TMP的皮疹风险高出近3倍(合并风险比2.56,95%可信区间[1.69,3.89],I2 = 0%, n = 4458名受试者,24项随机对照试验)。药物警戒数据证实,与各种比较药物相比,皮肤疾病和其他ade的发生率更高。与阿奇霉素相比,SMX-TMP与Stevens-Johnson综合征增加5倍、中毒性表皮坏死松解增加3倍、嗜酸性粒细胞增多和全身性症状的药物反应增加10倍相关。此外,SMX-TMP显示全血细胞减少症报告增加10倍,中性粒细胞减少症报告增加6倍,血小板减少症和再生障碍性贫血报告增加4倍,高钾血症报告增加56倍,低钠血症报告增加10倍。结论:我们的荟萃分析和药物警戒研究表明,与阿莫西林/克拉维酸、阿奇霉素和呋喃妥因等其他抗生素相比,SMX-TMP与ade的风险增加有关。进一步强有力的研究对于确认这些安全信号和指导临床实践至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.30
自引率
8.80%
发文量
419
审稿时长
1 months
期刊介绍: Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.
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