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，the domestic instructions were found with poor integrity，normative and scientific.Conclusion Re1evant departments shou1d strengthen the instruction management and pay more attention to update and revise the instructions；the pharmacists shou1d pub1icize the importance of instructions；medica1 staffs and patients shou1d attach much weight to instructions，so as to promote the normative deve1opment of drug instructions and its supervision work，ensure the c1inica1 rationa1 drug use.

［Key words］Instruction；Ora1 drug；Domestic drug；Imported drug

药品说明书是经国家食品药品监督管理部门批准，由药品生产企业提供的具有法律效力的药品使用说明文件，包含药品安全性、有效性的重要科学数据、结论和信息，是指导医务人员和患者合理用药以及进行药品不良反应监测的重要参考资料［1］。药品说明书项目的完整性，内容的科学性、规范性，以及语言表述的标准性，都与临床药物治疗效果和患者的依从性密切相关。由于目前国内外（或合资）制药企业的生产和实验条件不同，其药品说明书也存在不同程度的差别。……