王维娜 沈 素

    首都医科大学附属北京友谊医院西药剂科，北京 100050

    我院35种常用口服药物国产与进口药品说明书对比分析

    王维娜沈素

    首都医科大学附属北京友谊医院西药剂科，北京100050

    目的调查首都医科大学附属北京友谊医院(以下简称“我院”)进口和国产药品说明书的编写情况，为促进药品说明书及其监管工作的科学化、合理化和规范化提供参考。 方法对我院35种口服药物的进口和国产说明书进行对比分析，提出修改和完善建议。结果 35组说明书存在不同程度的差异，其中16组说明书差别较大，有4个或以上的差异项目。相比于进口药品，国产说明书往往存在完整性、规范性和科学性较差等问题。结论相关部门应加强管理，重视说明书的定期修订和更新；药学人员应大力宣传说明书的重要性；其他医务人员和患者应提高对说明书的重视程度，以促进药品说明书及其监管工作的规范化，确保临床安全合理用药。

    说明书；口服药物；国产药品；进口药品

    [Abstract]Objective To investigate the status of preparation of the domestic and imported drug instructions in Beijing Friendship Hospita1，Capita1 Medica1 University(“our hospita1”for short)，so as to provide references for scientific，reasonab1e and standardized deve1opment of the drug instructions and its supervision work.Methods The domestic and imported instructions of 35 kinds of ora1 drugs in our hospita1 were compared and ana1yzed，and some modification and improvement suggestions were put forward.Results 35 groups of instructions had different degrees of difference.Large differences were found in 16 groups，with 4 or more different items.Compared with the imported instructions ......