| Research objectiveTo assess the clinical efficacy and safety of the Formula which is named "Jianpi Tongluo Jiedu Fang" for chronic atrophic gastritis(CAG).Research contentUsing the randomized controlled clinical research method,CAG Patients who visited Guanganmen Hospital of the Chinese Academy of Chinese Medical Sciences from September 2021 to September 2022 were the research subjects(n=60),and they were randomly divided into 2 groups,each group had 30 patients,the treatment group was treated with the "Jianpi Tongluo Jiedu Fang",the control group was treated with chinese medicine named Weifuchun,and the course of medication in both groups was 6 months,and the histopathological changes of the gastric mucosa were taken as the main observation index,endoscopic signs,TCM symptom points,The quality of life score was used as secondary observation index,and liver and kidney function and adverse events were used as safety indicators,and the clinical efficacy and safety of the "Jianpi Tongluo Jiedu Fang" for intervention in CAG were objectively evaluated.Research results1 General informationA total of 60 patients were included in this study,including 40 males and 20 females,with a male-to-female ratio of 2:1,and the average age of participants was 54.15 ± 11.9 years,with a minimum age of 28 years and a maximum age of 73 years.Mainly middle-aged and elderly,mainly concentrated in 35-70 years old,of which patients in the 55-60 age group are the most distributed;The average BMI was 23.67±2.6 kg/m2;The median course distribution was 4(1,24)months from the first confirmed CAG on the subject’s pathological examination;9 patients had been previously infected with Hp,and 45 Patients had no previous Hp.The subjects’ pathological atrophy and intestinal epithelial metaplasia(IM)were mainly mild and moderate,chronic inflammation was mainly mild and moderate,and dysplasia(Dys)and active inflammation were less occurring.There were no significant differences between the treatment group and the control group in terms of sex,age,BMI,course and disease distribution,and the baseline data of the two groups were comparable.After 6 months of pharmacological intervention,the results of the treatment group of the"Jianpi Tongluo Jiedu Fang" intervention and the control group of the chinese medicine named Weifuchun intervention were as follows:2 Main efficacy evaluation indicators2.1 Histological changes in the gastric mucosaReferring to the "Consensus Opinions on the Diagnosis and Treatment of Traditional Chinese Medicine in Chronic Atrophic Gastritis",atrophy,IM and Dys were divided into the main variables,and the lesions were divided into 4 grades:none,mild,moderate and severe,and 0 points,3 points,6 points and 9 points were assigned respectively.Chronic inflammation and activity were divided into secondary variables,and 0,1,2 and 3 were assigned according to the degree of lesions.After drug intervention,the glandular atrophy score,IM score,Principal variable integral,secondary variable integral,and total variable integral of the two groups decreased compared with the pre-treatment(P<0.05).Among them,in terms of gland atrophy integration,IM integration,main variable integration,secondary variable integration and total variable integration,the treatment group improved more significantly than the control group,and there was a statistical difference in the integration difference between the two groups before and after treatment(P<0.05).3 Secondary efficacy evaluation indicators3.1 Endoscopic signsAfter 6 months of treatment,the endoscopic signs were reduced to varying degrees in both groups.The endoscopic effective rate of the treatment group was 70.0%,and the endoscopic effective rate of the control group was 46.7%,and there was a significant difference in the efficacy of endoscopic between the two groups(P<0.05).3.2 TCM symptom pointsThe analysis of variance measured by repeated measures showed that the scores of TCM symptoms decreased after 1 month,3 months and 6 months of treatment in the two groups compared with before treatment,and the difference was statistically significant(P<0.05).The simple effect analysis showed that after 3 months and 6 months of treatment,the score of Chinese medicine symptoms in the treatment group decreased more significantly than that in the control group,and the difference was statistically significant(P<0.05).In terms of main symptom relief,after 6 months of treatment,the scores of stomach fullness,stomach pain,belching,acid reflux heartburn,and diet reduction in the two groups decreased compared with before treatment,and the difference was statistically significant(P<0.05),and the treatment group decreased more significantly than that in the control group(P<0.05).The effective rate of TCM symptoms in the treatment group was 90%,and the overall efficacy of TCM symptoms in the control group was 70%,and there was a significant difference in the efficacy of TCM symptoms between the two groups(P<0.05).3.3 Quality of LifeThe European five-dimensional health scale was used to assess the physical,social and mental health indices of the subjects in terms of mobility,self-care ability,ability to perform daily activities,pain/discomfort conditions,and anxiety/depression states.Before treatment and 6 months after treatment,patients self-rated on the scale,with a score of 100 representing the best condition and 0 representing the worst.After treatment,the quality of life scores of the two groups increased compared with those before treatment,and the difference was statistically significant(P<0.05).Compared with the control group,the treatment group increased significantly,and there was a significant difference in the quality of life score between the two groups before and after treatment(P<0.05).4 Safety evaluation indicatorsAfter treatment,there were no clinically significant abnormalities in liver and kidney function in either group,and no adverse reactions related to the study drug were found.Research ConclusionThe intervention of CAG by the "Jianpi Tongluo Jiedu Fang" improved the histopathology,endoscopic signs,clinical symptoms and quality of life of the gastric mucosa,and the efficacy was better than that of chinese medicine named Weifuchun without adverse reactions. |
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