To investigate the clinical efficacy and safety of the combination of Mailuo Shutong Pills and acupuncture in the treatment of pseudobulbar palsy dysphagia after cerebral infarction.Methods:A total of 186 patients who were diagnosed with pseudobulbar palsy in western medicine and apoplexy in Chinese medicine at the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from November 2018 to October 2021 were included and were classified into the observation group(n=113，Mailuo Shutong Pills+acupuncture+conventional treatment) and the control group(n=73，acupuncture+conventional treatment) according to the administration of Mailuo Shutong Pills.The pre-treatment and post-treatment water swallow test(WST) grade，Modified Mann Assessment of Swallowing Ability(MMASA) score，score of dysphagia-related items，and Swallowing Quality-of-Life(SWAL-QOL) score were recorded and analyzed.Results:There was no significant difference in the basic data between the two groups(P>0.05).The treatment and follow-up rates of the observation group were 90.27%(102/113) and 92.92%(105/113)，respectively，which were better than those of the control group[76.71%(56/73) and 80.82%(59/73)，separately](P<0.05).After treatment and during follow-up，WST grade，MMASA score，and SWAL-QOL score were higher than those before treatment in the two groups(P<0.05) and higher in the observation group than in the control group(P<0.05).After treatment，the observation group was superior to the control group in tongue muscle movement and saliva control(P<0.05).No serious adverse reactions occurred in either group and the incidence of adverse reactions showed no significant difference between the two groups(P>0.05).Conclusion:The combination of Mailuo Shutong Pills and acupuncture is superior to the control group in the treatment of pseudobulbar palsy dysphagia and the pills can effectively improve the swallowing function of patients and are safe.