Clinical Evidence of Chinese Patent Medicines in Treatment of Respiratory Diseases in Children： A Scoping Review / 中国实验方剂学杂志

ABSTRACT

ObjectiveThis study performed a scoping review to comprehensively analyze and report the information on the instructions of Chinese patent medicines and clinical research evidence for the treatment of respiratory diseases in children. MethodChinese patent medicines against respiratory diseases in children were obtained by searching the three major drug catalogues. The Chinese and English databases were searched for relevant literature，followed by data statistics and visualized analysis. ResultAfter screening and analysis，52 Chinese patent medicines were included，involving nine dosage forms. The main drugs were Scutellariae Radix，Armeniacae Semen Amarum，Forsythiae Fructus，etc. The main functions included clearing heat and releasing exterior syndrome，and relieving cough and dissipating phlegm. The indications mainly included common cold with wind-heat syndrome and cough in children. Adverse drug reactions and contraindications were only specified in 19.23% （10/52） of Chinese patent medicines，and the rest only displayed "unclear". A total of 279 articles were included，including 277 articles from Chinese Core Periodicals and two articles from SCIE. In terms of research type，those articles included 253 randomized controlled trials （RCTs，with six dosage form/dose comparisons involved），11 retrospective analyses based on Hospital Information System （HIS） data，one case series，13 systematic reviews/Meta-analyses （with two network Meta-analyses involved），and one economic evaluation article. Among them，72.76% （203/279） of the articles were published in the Core Journals of Chinese Science and Technology. Only 33 Chinese patent medicines were involved，and Xiaoer Feire Kechuan Oral Liquid was the top 1 under investigation，accounting for 15.71% （44/280）. The indicated diseases were mainly infantile pneumonia，bronchitis，respiratory tract infection，cough，asthma，and other western medicine diseases. Xiaoer Chiqiao Qingre Granules and Xiaoer Dingchuan Oral Liquid were used off-label. The sample size was concentrated in 51-150 cases，accounting for 67.17% （178/265）. The interventions in the experimental group were mainly Chinese patent medicine + western medicine + basic treatment or Chinese patent medicine + western medicine. The main outcomes were the effective rate and the improvement of clinical symptoms. The adverse reactions were mainly gastrointestinal reactions，drug-induced skin symptoms，etc.，and two studies have shown that drug doses were associated with adverse reactions. ConclusionIn research years，the research on Chinese patent medicines in the treatment of respiratory diseases in children has advanced rapidly. However，there are still some problems that need to be resolved in the future，such as incomplete information on drug content in the instruction，concentrated drugs to be studied，limited indications，failure to highlight the characteristics of traditional Chinese medicine （TCM） syndromes，unstandardized research design，and an incomplete reflection of Chinese patent medicine.