《鼓励研发申报儿童药品清单》口服药品有效成分在某儿童专科医院住院患儿中药物剂型可接受性情况调查  

Study on the Acceptability of Dosage Forms of Commonly Used Oral Preparations for Inpatients in A tertiary Children's Specialized Hospital

作　　者：肖梦微 朱琳[1] 王广飞[1] 李智平[1] XIAO Mengwei;ZHU Lin;WANG Guangfei;LI Zhiping(Department of Clinical Pharmacy,Children's National Medical Center,Pediatrics Hospital of Fudan University,Shanghai 201102,China)

机构地区：[1]国家儿童医学中心,复旦大学附属儿科医院临床药学部,上海201102

出　　处：《中国医药指南》2024年第15期109-112,共4页Guide of China Medicine

基　　金：2022年东方英才计划(原上海领军人才),编号:EK00000861;儿童抗感染药物精准用药课题项目,编号:20221128。

摘　　要：目的 分析《鼓励研发申报儿童药品清单》中的口服药物成分在某三甲儿童专科医院不同年龄段患儿中的实际应用及该院目前配备剂型适宜性的情况。方法 从4批《鼓励研发申报儿童药品清单》中的口服液体制剂的有效成分中,选取某三级儿童专科医院目前有该活性成分的口服药物,分析2023年11月9日至2023年12月8日住院患儿使用这些药物的调剂频次及用药时的年龄。基于我国《儿童用药(化学药品)药学开发指导原则(试行)》提出的不同年龄段儿科人群用药可接受的剂型选择,针对不同年龄组(新生儿、婴幼儿、学龄前儿童、学龄儿童、青少年),评估各药物的剂型适宜性。结果 在2023年11月9日至2023年12月8日时间段内,该院住院患儿使用过含4批《鼓励研发申报儿童药品清单》中的口服液体制剂的有效成分的口服药物共14种。在14种药物(片剂或胶囊剂)的4542次调剂记录中,新生儿和婴幼儿均为剂型“不适宜”,分别为132次和1111次;此2个年龄段使用频次最高的药物为左甲状腺素钠片、螺内酯片、熊去氧胆酸胶囊。对于学龄前儿童,适宜程度为“适用但存在问题”的胶囊剂共992次,其余为可“适用但不优选”的片剂1327次;对于学龄儿童,均为“适用”;对于青少年,均为“最优选”。“不适宜”或“适用但存在问题”的用药次数占总次数的49.2%。对各药物的剂型适宜性得分计算加权平均,剂型适宜性最低的药物分别为左甲状腺素钠片、熊去氧胆酸胶囊、他克莫司胶囊。结论 《鼓励研发申报儿童药品清单》中的口服液体制剂对应的片剂或胶囊剂在该院新生儿和婴幼儿中均有一定的应用,且剂型适宜性较低。医疗机构应当进一步加强儿童用药遴选与配备。对于新生儿及婴幼儿,需要加急研发他们常用药物的剂型以及分剂量调配的相关规范。Objective To analyze the practical application of the oral drug with active ingredients in the four batches of List of Children's Drugs Encouraged for Research,Development and Declaration in children of different age groups in a tertiary children's specialized hospital and the appropriateness of the dosage forms currently available in the hospital.Methods From the active ingredients of the oral liquid preparations in the four lists of Children's Drugs Encouraged for Research and Development and Declaration,oral preparations with active ingredients in a tertiary children's specialized hospital were selected.The times of oral administration of these drugs in patients hospitalized from November 9,2023 to December 8,2023 were analyzed based on the patients'age at the time of administration.The dosage form appropriateness of each medication was assessed for the different age groups(neonates,infants,infants,preschool children,school-aged children,and adolescents),according to the acceptable dosage form choices for pediatric populations of different age groups proposed in China's Guidelines for Pharmaceutical Development of Medications(Chemicals)for Children(for Trial Implementation).Results From November 9,2023 to December 8,2023,among the active ingredients of the oral liquid preparations in the four batches of the Children's Drugs Encouraged for Research,Development and Declaration,14 oral preparations(tablets or capsules)were used.Among the 4542 times of administration,the dosage forms were inappropriate for 132 times in neonates,and for 1111 times in infants and young children.The most frequently used inappropriate oral preparations in these two age groups were levothyroxine sodium tablets,spironolactone tablets,and ursodeoxycholic acid capsules.For preschool children,the dosage forms were applicable but problematic(capsules)for 992 times,and applicable but not preferred(tablets)for 1327 times.For school-age children,all the dosage forms were applicable.For teenagers,all the dosage forms were preferred.The number o

关 键 词：剂型 口服给药 新生儿 婴儿 学龄前儿童 药物调剂 

分 类 号：R97[医药卫生—药品] R197.5[医药卫生—药学]