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Particulate and microbial contamination in in-use admixed parenteral nutrition solutions.

机译:使用中的混合肠胃外营养液中的微粒和微生物污染。

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We evaluated particulate and microbial contamination in a total of 192 samples of in-use admixed and unadmixed parenteral nutrition solutions remaining in infusion bags in 10 hospitals. The mean numbers (range) of drug glass ampoules, plastic ampoules, and vials used in a total of 192 admixed solutions were 3.38 (1-13), 0.79 (0-7), and 1.2 (0-8), respectively. The mean number of particles (range) contained in the 192 samples according to the particle size (diameter) was 960.9 (30-9,539)/ml for particles >or=1.3 microm, 42.8 (0-587)/ml for those >or=5 microm, 6.4 (0-146)/ml for those >or=10 microm, and 0.09 (0-1)/ml for those >or=50 microm. The number of particles >or=1.3 microm in diameter was significantly higher in the 192 samples than in 7 samples (controls) of solutions not mixed with any ampoule or vial (p<0.0001). In addition, the number of particles >or=1.3 microm in diameter was significantly higher in samples of solutions mixed with 4-13 glass ampoules than in those of solutions mixed with 1-3glass ampoules (p<0.01). On the other hand, none of the 199 samples showed bacteria or fungi/5 ml residual solution. Measures against particulate contamination of admixed parenteral nutrition solutions are necessary.
机译:我们评估了10家医院输液袋中剩余的192种使用中的混合和非混合肠胃外营养液样品中的微粒和微生物污染。总共192种混合溶液中使用的药物玻璃安瓿瓶,塑料安瓿瓶和小瓶的平均数(范围)分别为3.38(1-13),0.79(0-7)和1.2(0-8)。根据粒径(直径),192个样品中包含的平均颗粒数(范围)对于大于或等于1.3微米的颗粒为960.9(30-9,539)/ ml,对于大于或等于1.3微米的颗粒为42.8(0-587)/ ml = 5微米,大于或等于10微米的那些为6.4(0-146)/ ml,大于或等于50微米的那些为0.09(0-1)/ ml。在192个样品中,直径大于或等于1.3微米的颗粒数量明显高于未与任何安瓿瓶或小瓶混合的溶液的7个样品(对照)中的颗粒数量(p <0.0001)。另外,与4至13个玻璃安瓿混合的溶液的样品中,直径大于或等于1.3微米的颗粒数目明显高于与1至3个玻璃安瓿混合的溶液的样品(p <0.01)。另一方面,199个样品中没有一个显示出细菌或真菌/ 5 ml的残留溶液。必须采取措施防止混合肠胃外营养液的颗粒污染。

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