药用辅料在新生儿重症监护室患儿中的暴露分析  

Exposure Analysis of Excipients in Neonate Patients in a Neonatal Intensive Care Unit

作　　者：倪映华[1] 朱正怡[1] 高鹏[1] 张少燕 夏锦芳[1] 李彦红 黄凌斐[1] 王慧娟[1] 林慧佳[1] 方罗 NI Ying-hua;ZHU Zheng-yi;Gao Peng;ZHANG Shao-yan;XIA Jin-fang;LI Yan-hong;HUANG Ling-fei;WANG Hui-juan;LIN Hui-jia;FANG Luo(National Clinical Research Center for Child Health,The Childrenrs Hospital of the Zhejiang University School of Medicine,Hangzhou 310052,China;Cancer Hospital of University of Chinese Academy of Sciences,Zhejiang Cancer Hospital,Institute of Basic Medicine and Caricer,Chinese Academy of Sciences,Hangzhou 310022,China)

机构地区：[1]浙江大学医学院附属儿童医院,国家儿童健康与疾病临床医学研究中心,杭州310052 [2]中国科学院大学附属肿瘤医院,浙江省肿瘤医院,中国科学院基础医学与肿瘤研究所,杭州310022

出　　处：《中国药学杂志》2021年第15期1255-1259,共5页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金项目资助(81773819);浙江省自然科学基金项目资助(Y16H160129)。

摘　　要：目的阐述我国某三级甲等教学医院新生儿重症监护室中新生儿药用辅料暴露情况。方法回顾性收集2017年新生儿重症监护室患儿的基本信息和药品,分析统计辅料涉及的药品、暴露人数和暴露医嘱次数。结果纳入627例患儿的共17640份医嘱,共涉及238个药品,其中55.5%药品说明书中明确辅料成分,涉及辅料共171种,以注射用水、氯化钠和氢氧化钠为最常见。有害辅料共涉及16个药品(6.7%),以丙二醇涉及药品种类最多。人群中暴露百分比最高的有害辅料是丙二醇(90.4%),其次为对羟基苯甲酸甲酯(84.7%)和聚山梨酯80(82.1%)。从医嘱中分析,暴露次数最多的是对羟基苯甲酸甲酯,其次是丙二醇和聚山梨酯80。在不同出生体重新生儿中丙二醇对羟基苯甲酸甲酯、聚山梨酯80和乙醇的暴露人数百分比无显著差异。结论新生儿重症监护室患儿中有害辅料暴露比例高,有害辅料的日暴露量和累积暴露量有待进一步研究。OBJECTIVE To describe the exposure to the excipients in the neonatal intensive care unit of a class A teaching hospital in China.METHODS A prospective cross-sectional study recorded all neonates in neonatal intensive care unit in 2017.The following information was extracted from the hospital medical records:demographic data and prescriptions for all drugs.RESULTS A total of 627 subjects with 17640 prescriptions were collected.Water for injection was the most common excipient,followed by sodium chloride and sodium hydroxide.Sixteen of 238 drugs(6.7%)were involved in harmful excipients and propylene glycol was the most common harmful excipient in these drugs.Propylene glycol,methyl paraben and polysorbate 80 were the three most common harmful ex・cipients exposed to 90.4%,84.7%,and 82.1%of neonates,respectively.Methylparaben was the most prescribed harmful excipient in medication orders,followed by propylene glycol and polysorbate 80.There was no significant difference of the exposure rate of harmful excipients among infants with different birth weights.CONCLUSION Harmful excipients exposures are common among neonates in neonatal intensive care unit.Future researches should evaluate the daily dose and cumulative dose of harmful excipients.

关 键 词：药用辅料 新生儿重症监护室 新生儿 早产儿 

分 类 号：R969.3[医药卫生—药理学]