Observation On The Safety Of Digestive Rract In Patients With RA By Different Doses Of Kunxian Capsule

ObjectiveTo observe the adverse reaction events and incidence of patients with rheumatoid arthritis(RA)in two different medications of Kunxian capsule(at meals and after meals),in order to evaluate the gastrointestinal safety of Kunxian Capsule in the treatment of RA.MethodsBased on the 2009 US ACR classification criteria for rheumatoid arthritis,the clinic was selected from the Department of Rheumatology,the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from September 2017 to December 2018.A total of 60 patients with RA were randomly divided into three groups:the meal group and the postprandial group.The two groups of patients took Kunxian capsule 3 times a day,2 capsules each time.Oral Kunxian capsules are taken during eating;patients in the postprandial group take 0.5-1h after meals.The observation period was 2 weeks.The observation included the specific symptoms and extent of the upper gastrointestinal adverse events during the medication,the time,duration,interventions,and outcomes.The severity of adverse events and the causal association with the drug used by Kunxian Capsule were recorded.The number of cases of upper gastrointestinal adverse reactions occurred in the two groups,and the adverse reaction rate was calculated.ResultsTaking Kunxian capsule either at meals or post-meals did not affect the clinical efficacy of Kunxian capsule;In terms of safety,1 case of upper gastrointestinal adverse reactions in was observed in the meals group and the incidence of adverse reactions was 3.3%.The main performance was:nausea,acid reflux,without the burning sensation of the sternum or difficulty in swallowing,which can self-relieve after stopping the drug.There were 4 cases of upper gastrointestinal adverse reactions in the postprandial group,and the incidence of adverse reactions was 13.3%.The main manifestations were:3 cases showed post-sternal burning pain,no diet,difficulty swallowing.The degree were moderate,which could relief after stopping the drug.1 case of severe,manifested as post-sternal burning pain,accompanied by dysphagia;remission after stopping the drug is not obvious,gastroscopy found"esophageal ulcer",add gastric remedies can significantly relieve symptoms.In conclusion,the incidence of adverse reactions in the upper digestive tract of Kunxian Capsule was lower than that in the postprandial group,and the degree was lighter.There was no significant difference between the two independent sample rates(P=0.35>0.05).The incidence of severe adverse reactions in the two groups was compared,p=0.038<0.05.The incidence of severe adverse reactions in the postprandial group was higher than that in the meal group,and the difference was statistically significant.ConclusionsThe incidence of adverse reactions of upper digestive tract in Kunxian capsule meal was lower than that in the postprandial group,and the degree was lower.Although no statistically significant difference was observed,the incidence of moderate to severe adverse reactions was higher in the postprandial group than in the meal group and the trend of the effects of two medication methods on the safety of upper digestive tract was observed.Further research with more samples will be needed.