Risk and Safety of Probiotics
Risk and Safety of Probiotics
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DOI：
10.1093/cid/civ085
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发表时间：
2015-05-15
影响因子：
11.8
通讯作者：
Snydman, David R.
中科院分区：
文献类型：
--
作者：
Doron, Shira;Snydman, David R.
益生菌已安全使用多年。已发表的临床试验中报告的安全性结局不一致。2011年，美国医疗保健研究和质量机构发布的一份报告得出结论，尽管现有的益生菌临床试验没有显示风险增加的证据，但“目前的文献并没有很好地回答益生菌在干预研究中的安全性问题。“批评者指出，大量证据，包括益生菌安全使用的悠久历史以及临床试验数据，动物和体外研究都支持益生菌对大多数人群通常是安全的假设。在病例报告、临床试验结果和实验模型中描述了理论风险，包括全身感染、有害代谢活动、易感个体的过度免疫刺激、基因转移和胃肠道副作用。需要更多的研究来正确描述与益生菌相关的不良事件的发生率和严重程度。
Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, "the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence." Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics.