薬典の標準透析溶液のペプチドグリカン汚染によるアセプティック・ペリトニティス
Leo Martis1, Mehul Patel, Joe Giertych
1Baxter Healthcare, McGraw Park, IL, USA.
Lancet (London, England)
|February 15, 2005
まとめ
透析患者における無菌性腹膜炎は,安全基準を満たしているにもかかわらず,透析液中の細菌汚染 (Alicyclobacillus) によって引き起こされました. 矯正措置によって問題は解決され,親腸用医薬品の現在の薬典検査の限界が明らかになった.
科学分野:
- 微生物学 微生物学とは
- 免疫学 免疫学とは
- ネフロロジーはネフロロジーを用います.
背景:
- 親腸内溶液は,安全性および不妊性に関する製薬書の基準を満たさなければならない.
- 2002年5月に,アセプティックな炎の症例のために,イコデクストリン透析剤の世界的なリコールが発生しました.
- この研究では,腹膜透析患者における無菌性腹膜炎の原因を調査した.
研究 の 目的:
- 腹膜透析患者における無菌性腹膜炎の原因を特定する.
- 薬典の基準を満たす透析剤が有害事象を引き起こす原因を調査する.
主な方法:
- アセプティック・ペリトニティスの報告186件 (2001年9月~2003年1月) の分析.
- リコールされた透析液の物理的,化学的,微生物学的調査.
- ペプチドーグリカン誘発のインタールユーキン-6のヒト細胞とネズミの不妊腹膜炎の投与量反応に関する研究.
主要な成果:
- 透析剤は,エンドトキシンおよび化学物質の仕様を満たしたにもかかわらず,インタールイキン-6反応を誘発した.
- Alicyclobacillus acidocaldariusからのペプチドグリカンは,汚染物質として特定されました.
- 透析ペプチドグリカン濃度と腹膜炎との正の相関が報告されています.
結論:
- Alicyclobacillusによるペプチドグリカンの汚染は,腹膜透析患者の無菌性腹膜炎を引き起こしました.
- この疫病の発生は,現在の薬典の試験で安全である製品は,依然として有害な影響を及ぼす可能性があることを示した.
- 矯正措置は,周周炎の発生率を成功裏に低下させ,特定された原因を確認しました.
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