Research situation on rational use of Chinese patent medicines for childhood asthma
Objective To systematically review the varieties,package inserts and clinical studies of Chinese patent medicines for asthma in children,and analyze the research situation on rational drug use.Methods The Chi-nese patent medicines listed in the National Medical Products Administration(NMPA)national essential drugs 20018 items in the record of listed proprietary Chinese patent medicines were searched systematically,with the registration time limited to December 31,2023 since the establishment of the database,and the drug type limited to Chinese pat-ent medicines,and the package inserts of Chinese patent medicines were sorted out.The four major databases of Chi-nese National Knowledge Infrastructure(CNKI),WanFang Data(Wangfang),China Science and Technology Journal Database(VIP)and PubMed Database were searched,and the studies on pediatric asthma Chinese patent medicines from the establishment of the database to December 31,2023 were collected.The Chinese patent medicines instruction combing method and bibliometric analysis were applied to identify and summarize the Chinese patent medicines litera-ture on childhood asthma.Results There were 14 kinds of Chinese patent medicines for children asthma listed in NMPA national essential drugs 20018 items in the record of listed proprietary Chinese patent medicines,among which 11 kinds were shared between children and adults,and only 3 kinds were special for children.Combing the package in-serts of Chinese patent medicines,it showed that 64％of the package inserts did not clearly describe the age-specific dosage of children,and more than 70％of the package inserts did not detail the items of the safe use of medication,and the adverse reactions,contraindications and precautions were described as"not clear",resulting in the lack of a serious basis for the rational use of clinical medication.A total of 16 related clinical studies were included in literature search of Chinese patent medicines for children with asthma,and all of them verified their effectiveness,however,most of them were observational indicators in terms of safety testing,and only 2 of them tested safety indicators such as hepatic and renal functions,and the other studies only had a macro"adverse reaction"indicator in terms of the rational use of medication.The specific analysis of adverse reaction events found that compared with western medicine alone,western medicine combined with Chinese patent medicine will not increase the incidence of adverse reactions.Conclusion Chinese patent medicine incombination with western medicine will not increase adverse reactions,but there are many missing items in their package inserts,resulting in serious lack of basis for the rational use of medication,and the cur-rent clinical research pays little attention to rational use of drugs.It is suggested that more safety-related endpoints should be added in later studies,and the relevant regulatory authorities should supervise the standardization and updating of the package inserts of children's Chinese patent medicines,so as to promote the rational use of Chinese patent medi-cines in childhood asthma.
ChildrenAsthmaChinese patent medicinesRational use of medicationPackage insertAdverse re-action
万方数据
维普
