由于药典标准透析溶液中的酸糖污染导致的无菌性周周炎
Leo Martis1, Mehul Patel, Joe Giertych
1Baxter Healthcare, McGraw Park, IL, USA.
Lancet (London, England)
|February 15, 2005
概括
透析患者的麻性腹膜炎是由透析剂中的细菌污染 (Alicyclobacillus) 引起的,尽管符合安全标准. 纠正措施解决了这个问题,突出了当前药典测试对亲肠道产品的局限性.
科学领域:
- 微生物学 微生物学
- 免疫学 免疫学 免疫学
- 腎臟病學 (nephrology) 是一種醫學.
背景情况:
- 亲肠溶液必须符合药典的安全性和无菌性标准.
- 2002年5月,由于无菌性腹膜炎病例,全球范围内召回了icodextrin透析剂.
- 这项研究调查了腹膜透析患者无菌性腹膜炎的原因.
研究的目的:
- 在腹膜透析患者中确定无菌性腹膜炎的致病因子.
- 调查为什么符合药典标准的透析剂会导致不良事件.
主要方法:
- 分析了186份无菌性腹膜炎报告 (2001年9月至2003年1月).
- 对被召回的透析液进行物理,化学和微生物学研究.
- 在人体细胞和老鼠无菌腹膜炎中,对糖甘诱导的介质素-6进行了剂量反应研究.
主要成果:
- 透析剂触发了尽管符合内毒素和化学规格的互白素-6反应.
- 来自Alicyclobacillusacidocaldarius的丁糖被确定为污染物.
- 透析甘水平和腹膜炎报告之间存在正相关性.
结论:
- 佩皮多格利坎被Alicyclobacillus污染导致了腹腔透析患者的无菌性腹腔炎.
- 疫情表明,在当前药典测试中安全的产品仍然可以引起不良影响.
- 纠正措施成功降低了腹膜炎的发病率,证实了确定的原因.
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