基于中成药说明书探讨辨病用药的可行性

Feasibility exploration of disease differentiation based on the Chinese patent medicine instructions

目的对比国产、进口及港澳台地区中成药说明书内容,探讨中成药加强辨病用药的可行性。方法检索国家医保目录收载的国产中成药及国家药品监督管理局官网公示的进口及港澳台地区中成药,对中成药说明书“功能”和“主治”项的信息分别进行统计分析。结果最终筛选出1311份国产中成药说明书和43份进口及港澳台地区中成药说明书。中成药说明书“功能”项中,以中医类术语表述的国产、进口及港澳台地区中成药说明书分别占94.04%、87.50%;以中西医结合类术语表述的分别占4.89%、12.50%;国产中成药说明书“功能”项单独采用西医类术语的表述占1.07%,进口及港澳台地区中成药说明书“功能”项中多采用中西结合类表述,无单独采用西医类术语的表述方法。在“功能”项包含西医类术语的表述中,抗炎(消炎)占比最高,国产、进口及港澳台地区中成药说明书分别占37.18%、75.00%。国产中成药说明书“主治”项包含证候类信息的占72.39%,进口及港澳台地区中成药说明书未包含证候类信息的占74.42%;国产、进口及港澳台地区中成药说明书“主治”项包含疾病类信息的占比分别为78.34%、41.86%,且均以西医疾病表述为主,分别占64.85%、73.68%。结论国家医保目录中的国产中成药多数具备辨病使用的依据;进口及港澳台地区中成药多数具备辨病使用的依据。

OBJECTIVE To compare the contents of the instructions of domestic and imported Chinese patent medicines as well as those from Hong Kong,Macao and Taiwan,and to explore the feasibility of Chinese patent medicines to strengthen the use of medicine according to disease differentiation.METHODS The domestic Chinese patent medicines included in national medical insurance list as well as imported Chinese patent medicines and those from Hong Kong,Macao and Taiwan regions publicized on the official website of National Medical Products Administration were searched to statistically analyze the information of“functions”and“indications”in the instructions of Chinese patent medicines.RESULTS Finally,1 311 instructions of domestic Chinese patent medicine and 43 of imported Chinese patent medicine and those from Hong Kong,Macao and Taiwan regions were screened out.In the“functions”item contained in the instructions of Chinese patent medicines,94.04% domestic Chinese patent medicines,87.50% imported ones and those from Hong Kong,Macao and Taiwan regions were expressed using the terms of traditional Chinese medicine;4.89% and12.50% were expressed using the terms of integrated Chinese and western medicine.The “functions” item were only expressed using the terms of western medicine in 1.07% of the instructions of domestic Chinese patent medicines.The“functions”item was mostly expressed using the terms of integrated Chinese and western medicine in the instructions of imported Chinese patent medicines and those from Hong Kong,Macao,and Taiwan regions,but there was no expressed using the terms of western medicine alone.Among the expressions of“functions”item containing the terms of western medicine,anti-inflammatory medicines accounted for the highest proportion,and domestic Chinese patent medicines,imported Chinese patent medicines and ones from Hong Kong,Macao and Taiwan regions accounted for 37.18% and 75.00%,respectively.In the instructions of domestic Chinese patent medicines,the“indications”item of which contained syndrome information accounted for 72.39%,and the instructions of imported Chinese patent medicines and those from Hong Kong,Macao and Taiwan regions which did not include syndromes information accounted for 74.42%;in the instructions of domestic Chinese patent medicines,imported ones and those from Hong Kong,Macao and Taiwan regions,the“indications”item of which contained disease information,accounted for 78.34% and41.86%,respectively,and the“indications”item of which were mainly expressed using the terms of western medicine diseases,accounted for 64.85% and 73.68%,respectively.CONCLUSIONS Most of the domestic Chinese patent medicines included in the national medical insurance list have the basis for the use of disease differentiation;most of the imported Chinese patent medicines and those from Hong Kong,Macao and Taiwan regions have the basis for the use of disease differentiation.