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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 medicine is widely used in China, but is placed under a different management system with Western medicine. Due to traditional medicine, proprietary Chinese medicines containing morphine and other opium poppy have the potential of causing substance abuse or addiction. The aim of this study was to assess the risk of drug substance abuse and addiction caused by proprietary Chinese medicines containing morphine from the perspective of pharmacy management. We selected from the relevant government documents 76 eligible morphine-containing proprietary Chinese medicines as a research group, and another 10 morphine-containing western medicines as a control group. Because there is currently no management tool for assessing the risks of drug abuse and addiction at home and abroad, we have created a five-item scale for scoring drugs in study and control groups to quantify their level of risk. We also used contingency table analysis of SPSS 15.0 to statistically analyze drug risk values and potential impact factors to find the factors that influence drug risk values. The results showed that the average risk for the study group was 2.04, which was five times that of the control group. More than four-fifths of study drug groups did not have the highest limit of morphine or codeine in their quality standards. 46.0% of the drug manual does not provide “long-term use may be addictive” or “no long-term use” warning. Drug composition, functional indications and drug risk values are related. This study concluded that proprietary Chinese medicines containing morphine present a higher risk than Western medicine containing morphine and may lead to abuse or addiction to consumers. This study suggests that: (1) control the composition of the drug, (2) set the maximum amount of morphine and codeine in the quality standard, (3) provide a clear warning of addiction in the drug’s instructions, and (4) Strict regulation of drugs containing both morphine and ephedrine.