新生儿用药中潜在有害的辅料：日本一项全国多中心观察性研究
Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan.
作者信息
Saito Jumpei, Nadatani Naomi, Setoguchi Makoto, Nakao Masahiko, Kimura Hitomi, Sameshima Mayuri, Kobayashi Keiko, Matsumoto Hiroaki, Yoshikawa Naoki, Yokoyama Toshihiro, Takahashi Hitomi, Suenaga Mei, Watanabe Ran, Imai Kinuko, Obara Mami, Hashimoto Mari, Yamamoto Kazuhiro, Fujiwara Naoko, Sakata Wakako, Nagai Hiroaki, Enokihara Takeshi, Katayama Sayaka, Takahashi Yuta, Araki Mariko, Iino Kanako, Akiyama Naoko, Katsu Hiroki, Fushimi Kumiko, Takeda Tomoya, Torimoto Mayumi, Kishi Rina, Mitsuya Naoki, Kihara Rie, Hasegawa Yuki, Hamada Yukihiro, Kimura Toshimi, Wada Masaki, Tanzawa Ayano, Yamatani Akimasa
机构信息
Department of Pharmacy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, 175-8535, Japan.
Department of Pharmacy, Saitama Medical Center, Kawagoe-shi, Saitama, Japan.
出版信息
J Pharm Health Care Sci. 2021 Jul 1;7(1):23. doi: 10.1186/s40780-021-00208-9.
BACKGROUND
A multicenter investigation of neonate exposure to potentially harmful excipients (PHEs) in neonatal intensive care units (NICUs) in Japan has not been conducted.
METHODS
A multicenter nationwide observational study was conducted. Neonate patient demographic data and information on all medicines prescribed and administered during hospitalization on 1 day between November 2019 and March 2021 were extracted from the medical records. Nine PHEs, paraben, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol, benzalkonium chloride, and aspartame, were selected. PHEs were identified from the package insert and the Interview Form. The quantitative daily exposure was calculated if quantitative data were available for each product containing the PHE.
RESULTS
Prescription data was collected from 22 NICUs in Japan. In total, 343 neonates received 2360 prescriptions for 426 products containing 228 active pharmaceutical ingredients. PHEs were found in 52 (12.2%) products in 646 (27.4%) prescriptions for 282 (82.2%) neonates. Benzyl alcohol, sodium benzoates, and parabens were the most common PHEs in parenteral, enteral, and topical formulations, respectively. Quantitative analysis showed that 10 (10%), 38 (42.2%), 37 (94.9%), and 9 (39.1%) neonates received doses exceeding the acceptable daily intake of benzyl alcohol, polysorbate 80, propylene glycol, and sorbitol, respectively. However, due to the lack of quantitative information for all enteral and topical products, accurate daily PHE exposure could not be quantified.
CONCLUSIONS
Neonates admitted to NICUs in Japan were exposed to PHEs, and several of the most commonly prescribed medicines in daily clinical practice in NICUs contained PHEs. Neonate PHE exposure could be reduced by replacing these medicines with available PHE-free alternatives.
背景
日本尚未开展关于新生儿重症监护病房（NICU）中新生儿接触潜在有害辅料（PHEs）的多中心调查。
方法
开展了一项全国性多中心观察性研究。从病历中提取了2019年11月至2021年3月期间某一天住院期间新生儿患者的人口统计学数据以及所有处方和使用药物的信息。选择了9种PHEs，即对羟基苯甲酸酯、聚山梨酯80、丙二醇、苯甲酸盐、糖精钠、山梨醇、乙醇、苯扎氯铵和阿斯巴甜。从药品说明书和访谈表中识别PHEs。如果每种含有PHE的产品有定量数据，则计算每日定量暴露量。
结果
收集了日本22个NICU的处方数据。总共343名新生儿接受了426种产品的2360张处方，这些产品含有228种活性药物成分。在282名（82.2%）新生儿的646张（27.4%）处方中的52种（12.2%）产品中发现了PHEs。苄醇、苯甲酸钠和对羟基苯甲酸酯分别是肠外制剂、肠内制剂和局部用制剂中最常见的PHEs。定量分析表明，分别有10名（10%）、38名（42.2%）、37名（94.9%）和9名（39.1%）新生儿接受的剂量超过了苄醇、聚山梨酯80、丙二醇和山梨醇的可接受每日摄入量。然而，由于所有肠内和局部用产品缺乏定量信息，无法准确量化每日PHE暴露量。
结论
日本NICU收治的新生儿接触了PHEs，NICU日常临床实践中几种最常用的药物含有PHEs。用现有的无PHE替代药物取代这些药物可以减少新生儿对PHEs的接触。
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