目的 通过对2018年河南省6家医院新生儿使用益生菌的超说明书用药情况进行分析，为临床合理用药提供参考。方法 通过医院信息系统，检索河南省6家医院2018年2、5、8、11月的住院新生儿患者使用益生菌的医嘱，参照说明书，对患儿一般信息、药物使用情况和超说明书情况进行统计分析。结果 共抽取913条医嘱，发现益生菌在新生儿患者使用普遍存在超说明书用药现象，主要表现为超适应症（97.92%）、超给药剂量（41.07%）和超年龄（25.52%）。其中超适应症主要为新生儿高胆红素血症（黄疸）和早产儿。酪酸梭菌活菌片的超给药剂量医嘱数最多，为355条；酪酸梭菌肠球菌三联活菌片的超年龄医嘱数最多，为118条。结论 益生菌在新生儿中超说明书发生率较高，其中大部分超适应症用药有询证医学依据，但应尽可能规范处方；鼓励开展相关临床研究，完善药品说明书，促进益生菌的合理用药。

Objective To investigate and analyze the off-label use of probiotics in neonates at 6 hospitals of Henan province in 2018, so as to provide reference for rational use of probiotics in clinic. Methods The hospital information system was used to retrieve the doctor’s orders on the use of probiotics in hospitalized newborn patients from 6 hospitals in Henan province in February, may, August, and November of 2018. The general information, drug use and off-label conditions of the patients were statistically analyzed by referring to the instructions. Results A total of 913 doctor’s orders were extracted, and it was found that probiotics were commonly used in neonatal patients with off-label phenomenon, mainly manifested as over-indication (97.92%), over-dose (41.07%), and over-age (25.52%). The off-label indications were neonatal hyperbilirubinemia (jaundice) and premature infants. The number of overdose orders of Clostridium Caseinate Viable Tablets was the highest with 355 pieces. The number of overage medical orders for Clostridium Butyricum Enterococcus Tri-viable Bacteria Tablets was the highest with 118 pieces. Conclusion The off-label incidence of probiotics in neonates is high, and most of the off-label drugs have the evidence-based medical basis, but should be prescribed as standardized as possible. Relevant clinical research would be encouraged, and drug instructions should be improved, in order to promote the rational use of probiotics.

R969.3

河南省科技攻关项目（182102310422）；白求恩·医学科学研究基金资助项目（SCE131AN）