To analyze the effectiveness and safety of Pudilan Oral Liquid combined with western medicine in the treatment of children with hand,foot and mouth disease.Methods:Common database of CNKI，Wanfang，VIP，SinoMed，PubMed，and Cochrane Library for clinical RCTs of Pudilan Oral Liquid combined with Western medicine in the treatment of pediatric hand-foot-mouth disease were searched.A total of 2 researchers retrieved literature and extracted data，and RevMan 5.3 was used to evaluate the quality of the literature，and the analysis was carried out in accordance with the Meta-analysis standard.Results:A total of 271 papers were retrieved，and 63 papers were finally included.The total effective rate，clinical symptom resolution time，and the 3 outcome indicators of adverse reactions were selected for analysis.The results showed that the effectiveness and safety of Pudilan Oral Liquid alone or combined with Western medicine were selected for analysis.However，the incidence of adverse reactions of Pudilan Oral Liquid combined with ribavirin WAS higher than that of ribavirin alone，and the safety of the combination of the 2 drugs needs to be taken seriously and further verified.Conclusion:The clinical efficacy and safety of Pudilan Oral Liquid or Pudilan Oral Liquid combined with Western medicine is better than Western medicine.However，due to the low quality of the included literature and the large heterogeneity，the results cannot be used as clinical reference evidence，and more multi-centers，large samples，high-quality RCTs are needed to obtain more evidence.