需要重新考虑红细胞成分的国家质量标准:从回顾性观察分析的证据
Indranil Das1, Dheeraj Khetan1, Anupam Verma1
1Department of Transfusion Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.
The Indian journal of medical research
|October 9, 2024
概括
红细胞缩剂 (RCC) 质量控制显示,大多数单位未能达到国家体积和血液度标准. 然而,RCCs符合国际标准,这表明需要修订国家质量控制标准,以提高红细胞产品质量.
科学领域:
- 输血医学 输血医学
- 血液成分质量控制 血液成分质量控制
背景情况:
- 红细胞缩剂 (RCC) 需要严格的质量控制 (QC) 才能获得治疗效果.
- 评估组件制备对RCC质量和QC合规性的影响至关重要.
研究的目的:
- 评估组件制备方法对RCC质量的影响.
- 评估RCC是否符合国家和国际质量控制标准.
主要方法:
- 在10年的时间里 (2009-2019) 对5218个RCC单元进行了回顾性分析.
- 评估QC参数:体积,血红素 (Hct),血红蛋白 (Hb),白细胞 (WBC) 含量,以及血解的%.
- 与三个国家和三个国际质量控制标准进行比较.
主要成果:
- 超过50%的RCC未能达到国家数量和Hct标准.
- 超过75%的RCC满足了国际对体积,Hct和Hb的标准.
- 布菲外套方法显示了比富血小板血 (PRP) 方法更好的QC遵守.
- 组件制备方法影响了Hb,WBC和血液溶解;男性捐赠者有更好的Hb.
结论:
- 研究中心的RCC更符合国际质量控制标准,而不是国家标准.
- 对红细胞的国家质量控制标准可能需要修订,考虑到全血体积和制备方法.
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