目的 通過對2018年河南省6家醫(yī)院新生兒使用益生菌的超說明書用藥情況進行分析，為臨床合理用藥提供參考。方法 通過醫(yī)院信息系統(tǒng)，檢索河南省6家醫(yī)院2018年2、5、8、11月的住院新生兒患者使用益生菌的醫(yī)囑，參照說明書，對患兒一般信息、藥物使用情況和超說明書情況進行統(tǒng)計分析。結(jié)果 共抽取913條醫(yī)囑，發(fā)現(xiàn)益生菌在新生兒患者使用普遍存在超說明書用藥現(xiàn)象，主要表現(xiàn)為超適應癥（97.92%）、超給藥劑量（41.07%）和超年齡（25.52%）。其中超適應癥主要為新生兒高膽紅素血癥（黃疸）和早產(chǎn)兒。酪酸梭菌活菌片的超給藥劑量醫(yī)囑數(shù)最多，為355條；酪酸梭菌腸球菌三聯(lián)活菌片的超年齡醫(yī)囑數(shù)最多，為118條。結(jié)論 益生菌在新生兒中超說明書發(fā)生率較高，其中大部分超適應癥用藥有詢證醫(yī)學依據(jù)，但應盡可能規(guī)范處方；鼓勵開展相關(guān)臨床研究，完善藥品說明書，促進益生菌的合理用藥。

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

河南省科技攻關(guān)項目（182102310422）；白求恩·醫(yī)學科學研究基金資助項目（SCE131AN）