某大型三甲医院1500份药品说明书老年人用药标注情况调查

Investigation on Drug Labeling in 1 500 drug Instructions for Elderly People in A Large Tertiary Hospital

目的:了解我院临床在用1 500种药品说明书中关于老年人用药信息的标注情况。方法:收集并阅读我院临床使用的1 500份药品说明书,对其中"老年人用药"、"适应症"、"用法用量"、"禁忌"、"注意事项"、"药代动力学"等项目老年人用药标注情况进行统计分析,并对不同药理作用、不同剂型、不同批文,以及国产进口药品说明书的标注情况进行比较。结果:1 500份药品说明书中,提到"老年"字样的说明书共1 260份(84%),其中"用法用量"、"药代动力学"、"注意事项"等项目中提到老年人用药的7份(0. 47%);而在列出的"老年人用药"项的说明书中有214份标注为"尚不明确"(20. 93%)。血液及抗肿瘤系统药物老年人用药标注居首位(15. 73%),其次是作用于中枢神经系统的药物(15. 53%),抗感染药物居第三位(13. 47%)。口服剂型未注明"老年人用药"占27. 80%,远高于注射剂的6. 10%(P <0. 05)。未注明老年人用药信息的中成药(82. 59%)远高于化学制剂(5. 85%)和生物制剂(6. 87%)(P <0. 05)。说明书中"老年人用药"标注较多的内容为"参照用法用量或无需调整剂量"(27. 20%)、"未作该项试验且无参考文献"(15. 60%)、"慎用"(13. 07%);"不适用"(1. 67%)。结论:我院在用1 500份药品说明书中关于老年人群的用药标注信息尚不完善,应进一步完善,以提高老年患者用药的合理性。

Objective：To investigate the drug labeling in 1 500 drug instructions on the use of drug information for elderly patients in our hospital. Methods：1 500 drug instructions in our hospital were collected and read. The description of the elderly medication item was extracted and analyzed statistically by SPSS 18. 0 in terms of ＂geriatric use＂,＂indications＂,＂usage and dosage＂,＂contraindications＂,＂warnings and precautions＂and＂pharmacokinetic＂. The different pharmacological effects,different dosage forms,different approval category and lable on the Instructions of domestic and imported drugs were compared. Results：Within the 1 500 drug instructions,1 260（84%） referred to the word ＂elderly＂,of which 7（0. 47%） referred to the use of drugs for the elderly in the items of＂usage and dosage＂,＂pharmacokinetics＂and＂matters needing attention＂and 214（20. 93%） were listed as＂not yet known＂. According to different pharmacological effects,the drug labeling of blood and anti-tumor drugs in the elderly ranked first（15. 73%）,followed by drugs acting on the central nervous system（15. 53%） and anti-infective drugs ranked third（13. 47%）. According to the different dosage forms,27. 80% of the oral dosage forms did not indicate＂medication items for the elderly＂,which was much higher than the 6. 10% of injections（ P 〈 0. 05）. The Chinese patent medicine of the elderly which didn’t labled（82. 59%） was far higher than that of the chemical preparations（5. 85%） and the biological preparations（6. 87%）（ P 〈 0. 05）. In the instructions,27. 20%,15. 60%,13. 07% and 1. 67% were marked as ＂reference dosage or no adjustment dosage＂,＂no test and no reference＂,＂caution＂and＂inapplicability＂respectively. Conclusion：The information about the drug labeling of the elderly patients in 1 500 copies of the drug instructions was not perfect and should be further improved to upgrade the rationality of drug use in elderly patients.