高校学生对非处方药品说明书理解力调查

Study on University Students' Comprehension on the Package Inserts of the OTC Drugs

目的：了解在校大学生对非处方药（OTC）说明书的理解程度。方法：搜集国产OTC药品复方氯己定漱口水不同厂家的说明书8份,选取其中较为规范的主要项目作为测试内容制作测试问卷。对在校大学生进行问卷调查,应用SPSS 22.0进行统计分析。结果：共对370名大学生进行了问卷调查,有效问卷308份。对适应证的正确理解率最高为96.78%,其次是用法用量和药物相互作用,对不良反应的理解率最低为22.73%,全部理解错误率1.95%（95%CI：0.72%～4.19%）,全部正确理解率13.64%（95%CI：10.00%～17.98%）。结论：大学生对药品说明书的理解力有待提高。应加强卫生宣教,提高消费者安全用药意识。在OTC药品被批准上市前进行目标用药人群的说明书理解力测试很有必要,建议尽早制定适于国情的说明书理解力研究指南。

Objective： To probe into university students＇ comprehension on the package inserts of OTC drugs.Methods： The leaflets of the OTC drug compound chlorhexidine gargles produced in China were collected and the qualified main items were selected as the testing contents. A questionnaire was derived based on the contents of the investigation.The data were analyzed using SPSS 22. 0. Results： Altogether 370 university students responded to the survey and 308 questionnaires were valid for the analysis. The understanding rate of indication was 96. 78% which was the highest,while the understanding rate of adverse drug reactions was 22. 73% which was the lowest among the comprehension rates of main items of the package inserts. The all-wrong understanding rate was 1. 95%（ 95% CI： 0. 72%-4. 19%） and the all-correct comprehension rate was 13. 64%（ 95% CI： 10. 00%-17. 98%）. Conclusion： Comprehension on the package inserts of OTC drugs was not satisfied even for the university students. There is a need to strengthen the health education,improve consumers＇ caution on safe-medication and conduct insert＇s comprehension survey in target consumers before the OTC drug being approved to appear in the market. A national guideline on the study of comprehension of the package inserts is expected.