摘要
目的:为促进国家基本药物说明书中老年用药信息规范化提供参考。方法:通过美康用药软件收集目前国内上市的各类说明书并参照《国家基本药物目录》(2010版)筛选出10 483份说明书,对其进行老年用药信息标注情况统计和分析。结果:3 197份中成药说明书中,标注老年用药信息的共38份(1.2%),单独标注老年用药项的说明书仅3份。7 287份化学药品与生物制剂说明书中,标注老年用药信息的共6 206份(85.2%),单独标注老年用药项共5 905份(81.0%),但其中597份(8.2%)标注内容为"尚不明确"。中成药说明书中除了老年用药项外,其余说明书各项中老年用药信息标注比例相对较低,主要是用法用量、禁忌、药物相互作用、药物过量和药动学(均为0%);不良反应和药理毒理(0.1%);适应症(或功能主治)(0.2%)、注意事项(0.9%)。而化学药品和生物制品说明书中除了老年用药项外,其余说明书各项中老年用药信息标注比例较中成药说明书较高些,但也不容乐观,主要是适应症(1.7%)、禁忌(0.3%)、药物相互作用(1.9%)、药物过量(0.6%)、药理毒理(0.3%)、用法用量(4.1%)、不良反应(6.0%)、注意事项(14.0%)和药动学(5.7%)。结论:国家基本药物说明书中普遍存在各项老年用药信息内容的缺失、表述不明确等问题,应进一步完善说明书各项中老年用药信息,加强药品说明书规范性。
Objective： To provide reference for standardization of drug information for the elderly in package inserts of national essential drugs. Methods： A total of 10 483 package inserts of national essential drugs were screened out from all domestic drugs by Medicom software, and analyzed statistically in respect of drug information for the elderly. Results： Among the 3 197 package inserts of traditional Chinese drugs, 38 （ 1.2% ） had drug information for the elderly and only 3 package inserts had independent item of medication for elderly patients. Among the 7 287 package inserts of chemical drugs and biological products 6 206 （85.2%） had drug information for the elderly and 5 905 （81.0%） had independent item of medication for elderly patients, but 597 （8.2%） marked ＂unclear＂. The traditional Chinese drugs had lower labelling rate, mostly were usage and dosage; the proportions of package inserts containing information on contraindieations, drug interactions, drug overdose and pharmacological activities were 0% ; the proportions of package inserts containing information on adverse reactions, pharmacology and toxicology were 0.1% ; that containing information on indications was 0.2% and on precaution was 0.9%. The situation of chemicals and biological package insert were better than traditional Chinese drugs. The labelling rates were as follows： indications （1.7%）, contraindications （0.3%） , drug interactions （1.9%） , drug overdose （0. 6% ） , pharmacology and toxicology （0. 3% ） , usage and dosage （4. 1% ） , adverse reactions （6.0%） , precaution （ 14.0% ） , pharmacological （ 5.7% ） , and medication for elderly patients （ 19. 0% ）. Conclusions： It is a common problem that there lack of medication information for the elderly in domestic drug package inserts, and some drug descriptions are not clear. Standardization of drug package inserts should be further strengthened.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第17期2036-2040,共5页
Chinese Journal of New Drugs
关键词
老年患者
国家基本药物
药品说明书
分析
elderly patient
national essential list
package insert
analysis
