不同胎龄早产儿有害药用辅料暴露的回顾性分析  

Retrospective Analysis of Harmful Pharmaceutical Excipients Exposure in Preterm Neonates at Different Gestational Ages

作　　者：王方杰[1] 王婷[1] 吴运芹[2] 何莉梅[1] 赵昕[1] Wang Fangjie;Wang Ting;Wu Yunqin;He Limei;Zhao Xin(Department of Pharmacy,Hunan Children’s Hospital,Changsha 410007,China;Department of NICU,Hunan Children’s Hospital,Changsha 410007,China)

机构地区：[1]湖南省儿童医院药学部,长沙410007 [2]湖南省儿童医院新生儿科,长沙410007

出　　处：《中国药师》2022年第8期1409-1413,共5页China Pharmacist

基　　金：湖南省卫生健康委课题(编号:20200092)。

摘　　要：目的:研究某专科儿童医院新生儿重症监护室中早产儿药用辅料的暴露程度。方法:回顾性收集2020年1~12月新生儿重症监护室中早产儿的基本信息与所用药品,根据文献鉴定出有害辅料,对有害辅料涉及药品、暴露人数及医嘱次数等进行统计分析。结果:共纳入329例患儿15 061次医嘱,涉及药品130种,其中62.02%的药品说明书明确辅料成分,共涉及辅料32种,以注射用水、氯化钠、氢氧化钠最多。鉴定出其中有害辅料7种,涉及药品15种(11.5%),暴露人数百分比最高的为聚山梨酯80(96.4%)与对羟基苯甲酸甲酯(96.4%);暴露医嘱次数百分比最高为聚山梨酯80(49.7%)和对羟基苯甲酸甲酯(49.6%)。除山梨醇外,其他药用辅料对于不同胎龄患儿的暴露人数及医嘱次数百分比差异无统计学意义(P>0.05)。结论:重症监护室中早产儿暴露有害辅料的比例较高,有害辅料的暴露安全范围及毒理学评估有待进一步研究。Objective: To describe the excipients exposure degree in preterm neonates in the neonatal intensive care unit(NICU) of a specialized children’s hospital. Methods: The basic information and treatment drugs of preterm neonates in NICU from January to December in 2020 were retrospectively collected. Harmful excipients were identified according to the literature. Meanwhile, the drugs with harmful excipients, the number of exposure and the number of medical order were analyzed. Results: A total of 329 children who received 15 061 medical orders were analyzed. Totally 130 drugs were involved in the treatment, and the excipients were recorded in 62.02% of the drug instructions. Water for injection was the most common used excipient, followed by sodium chloride and sodium hydroxide. Seven kinds of harmful excipients were found involved in 15 drugs(11.5%). Polysorbate 80 and methylparaben were the two most common harmful excipients both exposed to 96.4% of preterm neonates. The highest exposure percentage of medical orders was polysorbate 80(49.7%), followed by methylparaben(49.6%). There were no significant differences in the number of exposure and exposure percentage of medical orders among different gestational ages except sorbitol. Conclusion: The high proportion of preterm neonates are exposed to harmful excipients in the intensive care unit, and the exposure safety range and toxicology assessment of harmful excipients need to be further studied.

关 键 词：有害药用辅料 早产儿 暴露 新生儿重症监护室 

分 类 号：R722[医药卫生—儿科]