摘要
目的:比较中美处方药说明书中有关吸烟影响药效和药动学内容的差异。方法:收集中美颁布的药品研发及药品说明书编写相关指南和处方药说明书,检索截至2014年6月19日美国药品食品监督管理局药品说明书官方网站DailyMed和中国药智网中的吸烟影响药效和药动学的相关内容,比较两国相关规定以及说明书中描述的差异。结果与结论:两国颁布的指南均要求在新药研发过程中关注吸烟对药效和药动学的影响,且须在说明书中明确注明。在记录的62 857条药品中,美国说明书提示吸烟对34个药物的药效和药动学产生影响,其中9个药物需要调整用药剂量;上述药品在中国药品说明书中有6个药物提示须关注吸烟对其药效和药动学的影响,仅1个药物(盐酸厄洛替尼)提示需要调整剂量。与美国药品说明书比较,中国药品说明书在吸烟对药效和药动学方面影响的标注率明显偏低。建议药品监督管理部门规范和完善药品说明书在此方面内容的描述,对不适宜的内容作更正,对可能产生严重后果的项目进行修订,尽快建立能够提供所有药品说明书查询的官方网站;药品生产企业也应规范药品上市前的临床研究,重视药品说明书的科学性、完整性和规范性。
OBJECTIVE： To compare the difference of the information about smoking affecting pharmacodynamics and pharma- cokinetics in prescription drug instructions between US and China. METHODS： The US and Chinese guidance for drug R＆D and drug instructions editing, prescription drug instructions were collected; the information about smoking affecting pharmacodynamics and pharmacokinetics were retrieved from FDA drug instruction official website DailyMed and Yaozhi Network in China up to Jun. 19th, 2014. The difference in related regulations and drug instruction were compared between US and China. RESULTS ＆ CON- CLUSIONS： The guidance issued by US and China require that great importance should be attached to the effects of smoking on pharmacodynamics and pharmacokinetics, and it must be noted in drug instructions. Of 62 857 drugs recorded, smoking affected pharmacodynamics and pharmcokinetics of 34 drugs in US drug instructions, among which 9 drugs needed dose modifications; for above drugs, Chinese drug instructions pointed out great importance should be attached to the effect of smoking on pharmacodynam- ics and pharmacokinetics of 6 drugs, and only one drug （erlotinid hydrochloride） needed to be modified. The label rate of smoking affecting pharmacodynamics and pharmacokinetics was relatively low in Chinese drug instructions compared to US. It is suggested that the regulatory agent should standardize and improve related description in drug instruction, correct unsuitable content, revise the items which may result in severe consequence, and set up official website which can provide all drug instructions as soon as possible. Drug manufacturers should standardize clinical study of drugs before marketing, focus on the scientificity, completeness and normalization of drug instructions.
出处
《中国药房》
CAS
北大核心
2016年第25期3592-3595,共4页
China Pharmacy
基金
江苏省卫生国际(地区)交流支撑计划自选项目(No.苏卫国合[2012]36号)
关键词
处方药
药品说明书
吸烟
药效
药动学
Prescription drug
Drug instructions
Smoking
Pharmacodynamics
Pharmacokinetics
