新生儿药物不良反应监察

Adverse drug reactions monitoring in neonates

对６５７名新生儿进行药物不良反应的医院内集中监察。监察期间共有６８名新生儿发生药物不良反应７３次，发生率约为１０％。严重的不良反应包括上消化道出血、肾功能衰竭、心律失常、钙盐沉积和肺损害。抗生素、脂肪乳剂、地高辛和镇静药为最常涉及的药物。本课题首次提供前瞻性药物流行病学报告，以促进新生儿安全用药。

An intensive hospital monitoring from February to October 1992 was performed on 657 neonates consecutively admitted to the neonatal unit of Pediatric Hospital,Shanghai Medical University.There were 73 verified adverse drug reactions(ADR) identified in 68 babies(10%),51 ADR were moderate or severe and 62 were type A reactions.Causality assessment using standardized algorithm revealed that definite or probable causality were established in 33 of total ADR.Most commonly suspected drugs associated with the ADR were antibiotics,fat emulsions,digoxin,and sedatives. The number of drugs administered and the duration of hospitalization were closely related to ADR.This study provides data for the pharmaco-epidemiological studies in neonatal unit.