Abstract：Objective：To systematically evaluate the clinical effect and safety of modified Ganlu Xiaodu Pellets combined with western medicine on hand， foot and mouth disease. Methods： The randomized controlled trials(RCT) on treating hand，foot and mouth disease by modified Ganlu Xiaodu Pellets combined with western medicine were retrieved from China National Knowledge Infrastructure(CNKI)，Wanfang Med Online，VIP database，China Biology Medicine(CBM)，PubMed，Cochrane Library，Web of Science and Embase databases， with a time limit from the establishment of the database to January 2022. Two reviewers independently screened the literature，extracted the data，and evaluated the risk of bias in the included studies. RevMan 5.4 software was used for Meta- analysis and publication bias evaluation， and GRADEpro GDT online tool was used to grade the quality of evidence for the outcome indicators. Results： A total of 11 studies involving 1 253 patients were included. Meta-analysis showed that the total effective rate in the experiment group was significantly higher than that in the control group[RR=1.15，95%CI(1.10， 1.20)，P＜0.000 01]，and the following time were all shorter：body temperature recovery time[MD=-0.58， 95%CI(-0.84，-0.32)，P＜0.000 1]，patients recover time[RR=-2.60，95%CI(-3.02，-2.19)，P＜0.000 01]， and the regression time of rashes and oral herpes，including the total regression time [MD=-0.78，95%CI (-1.15，-0.41)，P＜0.000 1]，regression time of rashes [MD=-1.31，95%CI(-1.85，-0.78)，P＜0.000 01] and regression time of herpes[MD=-0.94，95%CI(-1.24，-0.64)，P＜0.000 01]. The improvement of blood routine recovery time， mental state， appetite state and other related indicators in the experiment group were better than those in the control group(P＜0.05). No adverse reactions were reported in the two groups. According to the GRADE quality of evidence， the evidence level of total clinical rate was considered as moderate，and the evidence level of body temperature recovery time and the regression time of rashes and oral herpes was considered as low. Conclusion：The clinical effect of the therapy of modified Ganlu Xiaodu Pellets combined with western medicine has a better therapeutic effect on treating hand，foot and mouth disease than western medicine alone， with high safety and no serious adverse reactions. However， in view of the relatively-low quality of the literature，multicenter and well-designed RCT with a large sample size are still needed to further verify the conclusion.