含吗啡中成药的滥用风险研究

摘要

中成药被广泛应用于中国,但被置于一个与西药不同的管理体系之下.基于传统医学的缘故,含有吗啡及其他罂粟成分的中成药存在导致药物滥用或成瘾的风险.本研究旨在从药事管理的角度评估含吗啡中成药导致药物滥用及成瘾的风险.我们从政府有关文件中挑选了76个符合条件的含吗啡中成药作为研究组,另外10个含吗啡的西药作为控制组.因为目前国内外并无评估药物滥用及成瘾风险的管理学工具,我们创建了一个包括5个问题的评分表,用于给研究组和控制组的药物打分,以量化评估它们的风险水平.我们还使用SPSS 15.0的列联表分析法,对药物风险值和潜在的影响因素进行统计学分析,以寻找影响药物风险值的因素.结果显示,研究组的平均风险值为2.04,是控制组的5倍.超过五分之四的研究组药物,其质量标准中没有吗啡或可待因的最高限量值.46.0％的药物说明书没有提供“长期服用可能上瘾”或者“禁止长期服用”的警告.药物成分数、功能主治与药物风险值存在相关性.本研究认为,跟含吗啡的西药相比,含吗啡的中成药存在更高的风险,可能导致消费者滥用或成瘾.本研究建议:(1)控制药物的成分数,(2)在质量标准中设定吗啡和可待因的最高限量值,(3)在药物说明书中提供清晰的成瘾警告,以及(4)对同时含有吗啡及麻黄碱的药物进行严格监管.%Chinese patent medicines (CPMs) are widely used across China,and they are differently administrated from chemical drugs.For traditional reasons,CPMs may contain opium-derived compounds,such as morphine,which may pose the issues of drug abuse and addiction.In the present study,we aimed to evaluate the present risk of morphine-containing CPMs in causing drug abuse and addiction,based on a questionnaire-based approach and from a medicinal administrative perspective.We chose 76 CPMs containing morphine from government document and set them as the study group,and 10 chemical drugs containing morphine were set as the control group.Because there is no ready-made method,we created an evaluation sheet consisting of five questions to evaluate each drug and generate a risk-value score.Crosstabs analysis using SPSS 15.0 was conducted to obtain the influencing factors.We found that the study group obtained a mean score of 2.04 for the risk value,which was five times of that of the control group.Specifically,no maximum limit of morphine or codeine was set in product quality standards for more than four-fifth of the drugs.Moreover,46.0％ of package inserts failed to show any warning about addiction or prohibition over the long-term use of the drugs.The number of ingredients,as well as the functions of the drugs,was found to correlate with the risk value.Our findings suggested that CPMs were more risky in causing drug abuse and addiction than chemical drugs.Approaches,such as i) controlling the number of ingredients,ii) setting up maximum limit of morphine or codeine in quality standard,iii) providing more information on the package insert of drugs and iv) monitoring the drug containing both morphine and ephedrine,will be effective in reducing the risk of drug abuse and addiction.