The Sterility Days of Compounding Parenteral Nutrition Solutions: A Prospective Study

調配靜脈營養液之無菌天數：前瞻性研究

10.6200/TCMJ.202003_17(1).0006

蔡芳佩(Fang-Pei Tsai)；彭姿蓉(Tzu-Rong Peng)；吳大圩(Ta-Wei Wu)；陳家輝(Jia-Hui Chen)

parenteral nutrition ； medication safety ； sterility ； 靜脈營養 ； 用藥安全 ； 無菌

北市醫學雜誌

17卷1期（2020 / 03 / 30）

59 - 70

英文

Objective: Keeping compounded parenteral nutrition sterile is critical to ensure drug safety for patients. However, no literature clearly indicated the number of days that sterility can be maintained after compounding of various parenteral nutrient solutions. The objective of this study was to investigate the sterility days of compounded parenteral nutrition. Methods: A prospective study was conducted from August 16th, 2017 to December 31st, 2017; pharmacists compounded the parenteral nutrient solution every day. Some finished products were taken as samples and placed into the liquid culture medium, and then the incubation was kept in the dark at room temperature. The other two pharmacists visually observed the clarity of incubation for at least 14 days. If the test medium showed cloud stratification, it would be considered that there was growth of microorganisms, and it will then be sent to the bacterial culture laboratory for incubation at 37°C to identify the species of the bacteria. The results of the culture were analyzed by Kaplan-Meier survival analysis. Results: A total of 258 parenteral nutrient solution products were prepared. 87 of them were sampled and taken for testing. Among them, only one sample (1.1%) stored at room temperature in the dark for 27 days had shown cloud stratification. The average sterility days of the compounding parenteral nutrition solutions was 130.5 days (95%CI 127.7-133.4). Conclusions: Under this settled environment, equipment, pharmacists and protocols, the samples were incubated at room temperature in the dark for at least 27 days and did not show any bacterial and fungal contaminations. In addition, the compounding parenteral nutrition solutions were able to maintain an average of 130.5 days without bacterial and fungal contaminations.

目的：維持調配靜脈營養製劑的無菌狀態對於確保病人的藥物安全性至關重要。然而，目前沒有文獻清楚地指出在混合調配各種靜脈營養溶液後可以保持無菌的天數。本研究之目的是探討調配靜脈營養液之無菌天數。方法：前瞻性研究設計，研究期間為2017年8月16日至2017年12月31日。藥師每日依據醫師處方調配靜脈營養溶液，將部分成品進行抽樣採檢並將檢體放入液體微生物培養基中，置於室溫暗處培養，每天由其他兩名藥師肉眼觀察檢體培養液的澄清度至少14天判斷是否為無菌，假如檢體培養液呈現雲霧分層，則視為有菌生長。並將其送至細菌室進行溫箱（37℃）培養，並鑑定菌別種類。此培養結果使用Kaplan-Meier survival進行分析。結果：研究期間調配靜脈營養溶液成品共258包，其中抽樣共87個檢體進行檢測，87個檢體中有1個檢體培養液（1.1%）在室溫暗處培養27天後出現雲霧分層；培養結果由Kaplan-Meier統計後，發現靜脈營養溶液檢體培養液的無菌平均天數為130.5天（95%CI 127.7-133.4）。結論：於此規格之環境、設備、藥師及作業程序下，檢體在室溫黑暗中培養至少27天，沒有顯示任何細菌和真菌污染。此外，靜脈營養溶液檢體培養液平均可維持130.5天沒有細菌和真菌污染。