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

作　　者：李春晓[1,2] 王盼盼[1,2] 凌霄 杨梦 李学林[1,2] 杨玉晴 郭静 LI Chunxiao;WANG Panpan;LING Xiao;YANG Meng;LI Xuelin;YANG Yuqing;GUO Jing(Dept.of Pharmacy,the First Affiliated Hospital of Henan University of Chinese Medicine/Henan Province Engineering Research Center for Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine/Henan Provincial Key Laboratory for Clinical Pharmacy of Traditional Chinese Medicine,Zhengzhou 450099,China;Provincial and Ministry Co-constructed Collaborative Innovation Center for the Prevention and Treatment of Respiratory Diseases with Traditional Chinese Medicine,Henan University of Chinese Medicine,Zhengzhou 450006,China;Dept.of Pharmacy,Nanyang Zhang Zhongjing Hospital,Henan Nanyang 473004,China;College of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]河南中医药大学第一附属医院药学部/河南省中药临床应用、评价与转化工程研究中心/河南省中药临床药学中医药重点实验室,郑州450099 [2]河南中医药大学呼吸疾病中医药防治省部共建协同创新中心,郑州450006 [3]南阳张仲景医院药学部,河南南阳473004 [4]河南中医药大学药学院,郑州450046

出　　处：《中国药房》2022年第19期2309-2313,共5页China Pharmacy

基　　金：国家重点研发计划中医药现代化研究重点专项(No.2017YFC1703400);河南省重点研发与推广专项-科技攻关类(No.202102310182);河南省中医药科学研究专项课题(No.2016ZY1006);河南省中医药拔尖人才培养项目(No.豫卫中医函[2021]15号);中国药学会科普项目(No.CMEI2020KPYJ00534)。

摘　　要：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 whi

关 键 词：辨病用药 中成药 说明书 国家医保目录 

分 类 号：R242[医药卫生—中医临床基础]