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36 至 48 周龄婴儿每周两次用葡萄糖酸氯己定沐浴的安全性。

Safety of Biweekly Chlorhexidine Gluconate Bathing in Infants 36 To 48 Weeks' Postmenstrual Age.

机构信息

Celeste J. Chandonnet is an infection preventionist at Boston Children's Hospital, Boston, Massachusetts. Cheryl Toole is director of nursing patient services and Stephanie Wild is a staff nurse II in the neonatal intensive care unit, Cardiovascular and Critical Care Nursing Patient Services, Boston Children's Hospital. Vanessa Young is a clinical coordinator in the Division of Newborn Medicine, Boston Children's Hospital. Henry A. Feldman is principal biostatistician in the Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, and an associate professor of pediatrics at Harvard Medical School, Boston, Massachusetts. Mark Kellogg is associate director of chemistry in the Department of Laboratory Medicine, Boston Children's Hospital and an assistant professor of pathology at Harvard Medical School. Jenny Kim is a clinical pharmacist and Michael Scoville is lead pharmacy technician for the investigational drug service in the Department of Pharmacy, Boston Children's Hospital. Courtney Porter is a program administrative manager III in Cardiovascular and Critical Care Nursing Patient Services, Boston Children's Hospital. Malika Weekes is a staff nurse I in the cardiac intensive care unit, Cardiovascular and Critical Care Nursing Patient Services, Boston Children's Hospital. Michele DeGrazia is director of nursing research in the neonatal intensive care unit, Cardiovascular and Critical Care Nursing Patient Services, Boston Children's Hospital, and an assistant professor of pediatrics at Harvard Medical School.

出版信息

Am J Crit Care. 2019 Nov;28(6):451-459. doi: 10.4037/ajcc2019967.

DOI:10.4037/ajcc2019967
PMID:31676520
Abstract

BACKGROUND

Little evidence supports use of chlorhexidine gluconate (CHG) baths to reduce health care-associated infections, including central catheter-associated bloodstream infections in infants less than 2 months old.

OBJECTIVE

To describe the safety of biweekly CHG baths in infants less than 2 months old by measuring blood levels of CHG, liver and renal function, skin reactions, and adverse events.

METHODS

Study participants received twice-weekly 2% CHG baths, weekly blood tests, and twice-daily skin assessments. Adverse events were monitored.

RESULTS

Ten infants 36 to 48 weeks' postmenstrual age with central venous catheters admitted to the neonatal or cardiac intensive care unit were enrolled before the study was closed by the Food and Drug Administration. The 9 patients contributing data had 83 CHG exposures; 31 CHG levels were analyzed. All patients had evidence of CHG absorption. Seven patients had CHG levels of 100 ng/mL or greater. Findings did not support accumulation of CHG but did show evidence of higher absorption than previously reported. Results of liver and renal function studies remained within reference limits. No patient had any adverse events, including skin reactions.

CONCLUSIONS

Although no adverse events were observed, our patients had evidence of CHG absorption. The effects of this absorption remain unknown. More research is needed to determine safe blood levels of CHG in infants less than 2 months of age.

摘要

背景

几乎没有证据支持使用葡萄糖酸氯己定(CHG)浴来减少与医疗保健相关的感染,包括小于 2 个月大的婴儿中心静脉导管相关的血流感染。

目的

通过测量 CHG、肝肾功能、皮肤反应和不良事件的血液水平,描述小于 2 个月大的婴儿使用两周一次 CHG 浴的安全性。

方法

研究参与者接受每周两次 2%CHG 浴、每周血液检查和每天两次皮肤评估。监测不良事件。

结果

在食品和药物管理局关闭研究之前,10 名胎龄 36 至 48 周的患有中心静脉导管的婴儿入住新生儿或心脏重症监护病房。有数据的 9 名患者接受了 83 次 CHG 暴露;分析了 31 个 CHG 水平。所有患者均有 CHG 吸收的证据。7 名患者的 CHG 水平为 100ng/ml 或更高。研究结果不支持 CHG 的积累,但确实表明吸收程度高于之前的报告。肝肾功能研究结果仍在参考范围内。没有患者出现任何不良事件,包括皮肤反应。

结论

尽管没有观察到不良事件,但我们的患者有 CHG 吸收的证据。这种吸收的影响尚不清楚。需要进一步研究以确定小于 2 个月大的婴儿 CHG 的安全血液水平。

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