| Objective: Through the observation of two different treatment perscription in the treatment of patients with deficiency of spleen and stomach of chronic atrophic gastritis with mild to moderate dysplasia,compare the changes of clinical symptoms,pathology,patient reported outcomes scale,and record the adverse reaction during the treatment and adverse events,to evaluate the efficacy and safety of which with dysplasia of two different treatment perscription for chronic intervention atrophic gastritis.Method: 64 cases of patients with chronic atrophic gastritis with dysplasia in accordance with the inclusion criteria were divided into 2 groups,Chinese medicine group and Western medicine group,according to the classification standard of randomized and controlled,with 32 cases in each group.The Chinese medicine group was treated with the combination of xiangsha liujun pills and panax notoginseng powder,and the folic acid tablets were treated in the western medicine group,and the treatment courses were 24 weeks in both groups.Observe and compare the total scores of traditional Chinese medicine symptoms of 2 groups before treatment and 4,8,12,16,20,24 weeks after medication.Both groups were required to undergo gastroscopy and pathological examination before and after 24 weeks of treatment.To observe the changes of histopathology,pathology total score,the integral of each dimension of the PRO scale and total score of the PRO scale after 24 weeks before and after treatment.All patients in the two groups were required to complete three safety tests after 12 weeks of treatment and 24 weeks after the treatment,including three routine,liver function,renal function and electrocardiogram examination.The combined medication,adverse reactions and adverse events of 2 groups were observed and recorded during 24 weeks of treatment.Result:(1)Comparison of total scores of TCM symptoms: before the treatment,there was no significant difference between the 2 groups of TCM symptoms(P>0.05),and there was a comparability among the groups.During the 24 weeks of treatment,the total score of TCM symptoms of Chinese medicine group showed a continuous downward trend,while the TCM symptom score of Western medicine group showed a downward trend at 4 weeks and 8 weeks,and it rebounded at 12 and 20 weeks.After treatment for 4,8,12,16,20 and 24 weeks,the total score of TCM symptoms in the 2 groups decreased significantly compared with the same group before treatment,and the difference was statistically significant(P<0.05).The follow-up period after treatment between the 2 groups,Chinese medicine group in 4,8,12,medication for 16 weeks and the western medicine group had no significant difference(P>0.05);after 20 weeks and 24 weeks after the Chinese medicine group total score of TCM symptoms improved significantly better than the western medicine group,the difference was statistically significant(P<0.05)(2)Comparison the curative effect of TCM symptoms: after 24 weeks of treatment,the cure rate of Chinese medicine group was 16.13%,the total effective rate was 83.87%,and the western medicine group's cure rate was 3.33%,and the total effective rate was 60%.The total effective rate of the Chinese medicine group was significantly higher than that in the western medicine group,the difference was statistically significant(P<0.05),and there was no significant difference between the 2 groups(P>0.05).(3)Comparison of pathological scores before and after treatment: there was no significant difference between the 2 groups in each individual pathological score and pathological total score before treatment(P>0.05),and the difference between groups was comparable.After 24 weeks of treatment,compared with the same group before treatment,traditional Chinese medicine group in atrophy,intestinal metaplasia,dysplasia,acute and chronic inflammation and pathological score compared with the same group before treatment decreased,the difference was statistically significant(P<0.05);the western medicine group in Dys,IM,atrophy and total pathological score scores were lower than the the treatment group decreased,the difference was statistically significant(P<0.05),in acute and chronic inflammation scores with the same group before treatment showed no significant difference(P>0.05).After 24 weeks of treatment,compared between the 2 groups,the 2 groups in terms of atrophy,intestinal metaplasia and dysplasia showed no significant difference(P>0.05);in chronic inflammation,inflammatory activity and pathological score,treatment group was better than control group,the difference was statistically significant(P<0.05).(4)Comparison of PRO scale before and after treatmen: before treatment,there was no significant difference between the 2 groups in the integral aspects of indigestion,reflux,defecation,body condition,psychological and social function,and the total integral of the PRO scale(P>0.05),and there was a comparability among the groups.After 24 weeks of medication,compared with the same group before the same group,the 2 groups of indigestion,reflux,defecation,body condition,psychological integral and PRO scale were significantly lower than the same group before treatment.The difference was statistically significant(P<0.05).The scores of social function in the 2 groups were all lower than those before the same group,and the difference was statistically significant(P<0.05).After 24 weeks of treatment,the total scores of reflux,indigestion,defecation and PRO scale in the 2 groups were significantly lower than those in the western medicine group(P<0.05),and there was no significant difference between the 2 groups(P>0.05)in the whole body condition,psychological and social function.(5)Combined medication comparison: in the course of the 24 week treatment,the 2 groups were not statistically significant(P>0.05)in the combination of the drugs.In the 24 weeks of treatment,compared with the western medicine group,the Chinese medicine group was significantly better than the western medicine group in the combination of improving the symptoms of gastrointestinal symptoms(acid suppressing drugs and driving power drugs),and the difference was statistically significant(P<0.05).(6)Safety comparison: during 24 weeks of treatment,2 groups of patients did not appear serious adverse reactions and adverse events caused by drugs.There were no three major routines,liver and kidney function,ECG abnormalities,drug safety was good.Conclusion: Traditional Chinese medicine(xiangsha liujun pills and panax notoginseng powder)can obviously improve the TCM symptoms of deficiency of spleen and stomach of chronic atrophic gastritis with mild to moderate dysplasia patients,indicating that the combination of xiangsha liujun pills and panax notoginseng powder has a significant therapeutic effect on the symptoms of Chinese medicine.The clinical symptoms of the western medicine folic acid group are also significantly improved,but the reasons for its improvement may be related to the treatment process to improve the symptoms of digestive tract in the middle of the treatment.In the 4,8,12 and 16 weeks of medication,the improvement of Chinese medicine was equal to that of Western medicine,but the improvement of the symptoms was obviously better than that of Western medicine after 20 weeks and 24 weeks of medication,and the total effective rate of the clinical symptoms was higher than that of western medicine after 24 weeks.In the course of the 24 weeks treatment,the total score of TCM symptoms was sustained.The decline of Western medicine group is larger than that of Western medicine group.The combination of the Chinese medicine group Xiang Sha six Jun pill combined with 37 powder has the therapeutic effect on the acute and chronic gastric mucosa inflammation,atrophy,intestinal metaplasia and dysplasia of the patients with chronic atrophic gastritis with mild and moderate dysplasia of the spleen and stomach.Western medicine folic acid group has therapeutic effect on atrophy,intestinal metaplasia and dysplasia,but it has no obvious effect on acute and chronic inflammation.In terms of atrophy,intestinal metaplasia and dysplasia,the therapeutic effects of both treatments are similar.Chinese medicine is superior to Western folic acid group in improving acute and chronic inflammation.Both Chinese medicine and Western medicine have improved the dimensions of the PRO scale and the total integral of the patients,but the traditional Chinese medicine is superior to the western medicine folic acid group in the indigestion,defecation,reflux and the total integral of the PRO scale,which is the same in the whole body condition,the psychological and social function.The use of Chinese medicine in combination with acid suppressive drugs and propulsion drugs is obviously better than western medicine.The drug safety of the two treatments was high. |
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