老年慢性病治疗药物中美药品说明书适老化信息对比分析

Comparative Analysis of Aging-appropriate Information in Chinese and American drug Instruction for the Treatment of Chronic Diseases in the Elderly

目的分析常见老年慢性病治疗药物的中国药品说明书和美国药品说明书中适老化信息相关内容之间的差异,为中国药品说明书适老化提出政策建议。方法选取10种老年患者常见的慢性疾病治疗药物,通过随机抽样调查法,每种药物用随机数法随机抽取1个国产厂家的药品说明书,在dailymed网站选取1个美国药品说明书作为样本,对药品说明书各项目中老年人相关信息利用Excel进行统计、对比分析。使用Readability Formulas可读性评分系统,计算美国药品说明书患者版本的平均阅读水平;通过健康教育文本材料适用性量表评定中国药品说明书的可读性。结果与美国药品说明书相比,中国常见老年慢性疾病治疗药物的药品说明书更新次数少、更新节奏慢;涉及老年患者用药信息的药品说明书项目少于美国药品说明书,且内容记载欠完备;药品说明书的可读性差,不利于老年患者理解。结论中国亟需药品说明书的适老化改革,对于老年患者慢性病治疗药物,建议通过增加开展对老年群体的临床试验,完善完备药品说明书中各个涉及老年人用药信息的项目;并制作适于老年人阅读和理解的“老年患者版本药品说明书”。

Objective To analyze the differences in aging-related information between Chinese and American drug instruction for common chronic disease in the elderly,and to propose policy recommendations for the aging-related drug instruction in China.Methods Ten common chronic disease treatment drugs for elderly patients were selected,and through the random sampling method,the drug manuals of one domestic manufacturer were randomly selected for each drug by the random number method,and one American drug manual was selected as a sample from the dailymed website,and the information related to elderly people in the various items of the drug manuals was statistically analyzed by using Excel for comparative analysis.The average reading level of the patient version of the U.S.drug instructions was calculated using the Readability Formulas Scoring System;the readability of the Chinese drug instructions was assessed by the Health Education Text Material Suitability Scale.Results Compared with the U.S.drug instruction,the drug instruction for common chronic diseases of the elderly in China were updated less frequently and at a slower pace;the drug instruction with information on medication for elderly patients were fewer than those of the U.S.drug instruction,and the content of the drug instruction was not well documented;and the drug instruction were poorly readable,which was not conducive to the comprehension of the elderly patients.Conclusion China is in urgent need of reforming the aging of drug instructions,and it is recommended that,for chronic disease medications for elderly patients,we should increase the number of clinical trials conducted on the elderly,improve and complete the drug information for the elderly in the drug instructions,and produce"drug instructions for elderly patients"that are suitable for the elderly to read and understand.