导航美国FDA咨询:在早产婴儿中使用益生菌
Sreekanth Viswanathan1, Kanekal Suresh Gautham2
1Division of Neonatology, Department of Pediatrics, Nemours Children's Hospital, Orlando, FL, USA. sreekanth.viswanathan@nemours.org.
概括
死性肠球炎 (NEC) 是早产婴儿的一种严重疾病. 益生菌显著降低了NEC的发病率和死亡率,但由于FDA的担忧,美国的使用量已经下降,造成了临床困境.
科学领域:
- 新生儿医学 新生儿医学
- 胃肠病学 胃肠病学
- 微生物学 微生物学
背景情况:
- 结核性肠球炎 (NEC) 是早产婴儿的关键胃肠道疾病,与高死亡率和长期健康问题有关.
- 益生菌在减少NEC发病率,全因死亡率和早产婴儿晚发性败血症方面表现出显著的有效性,通过众多研究.
- 最近的一份FDA咨询报告导致美国新生儿重症监护病房的益生菌使用量急剧下降,尽管存在证据和指导方针.
研究的目的:
- 审查支持益生菌在预防NEC方面的有效性证据.
- 检查FDA关于益生菌的建议所述的理由.
- 将美国政策与全球实践对比,并分析减少益生菌使用的影响.
主要方法:
- 随机试验和对NEC益生菌疗效的元分析的系统审查.
- 分析FDA的咨询声明和安全问题.
- 美国与国际临床实践和指导方针的比较评估.
主要成果:
- 多项研究证实,益生菌可显著降低早产婴儿的严重NEC,死亡率和败血症.
- 美国食品和药物管理局 (FDA) 引用了安全问题,质量控制问题和未经批准的药物地位作为其咨询的原因.
- 美国益生菌的使用量有所下降,与国际建议背道而,可能会影响婴儿的结果.
结论:
- 禁用益生菌可能会造成风险/益处不平衡,剥夺早产婴儿可能挽救生命的干预.
- 需要进行监管改革,继续进行研究和合作,以解决安全问题并确保获得益生菌.
- 重新审视美国政策至关重要,以与全球实践保持一致,并保护脆弱的早产人口.
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