| Purpose:To observe the clinical efficacy,ulcer healing and safety of "Sanhe Jianzhong Decoction" in treating duodenal ulcer with spleen deficiency and blood stasis,so as to provide clinical and theoretical basis for preventing and treating this disease with traditional Chinese medicine and improving the quality of ulcer healing.Method:In this study,68 patients with duodenal ulcer due to spleen deficiency and blood stasis were randomly divided into observation group and control group.The observation group was given the self-made prescription "Sanhe Jianzhong Decoction" and the control group was given "Rabeprazole Sodium Enteric-coated Tablets" for oral treatment.After four weeks of treatment,the ulcer healing situation and quality were observed by endoscopy,and the TCM syndrome scores,curative effect index,quality of life(PUDQ)scores,three routine tests,liver function,renal function and electrocardiogram results were recorded.The test results were statistically analyzed to evaluate the effectiveness and safety of Sanhe Jianzhong Decoction.Results:1.The experiment was finally completed in 63 cases,31 cases in the observation group and 32 cases in the control group,with a shedding rate of 7.35%.There was no significant difference in gender,age,course of disease between the two groups(P>0.05),which was comparable.2.The curative effect of TCM syndrome in observation group and control group was93.5% and 71.9% respectively,and the difference was statistically significant(P<0.05).The total scores of TCM syndromes in the two groups were different before and after treatment.(P<0.05),and there were also statistical differences between the two groups after treatment(P<0.05).In the comparison of patients’ single symptom scores,after treatment,there were significant differences in symptoms of bloating,mental fatigue,anorexia and loose stool between the two groups(P<0.05).3.Comparing the curative effect of ulcer healing under gastroscope between the two groups after treatment,the effective rates were 100%,and the healing rates of observation group and control group were 77.42% and 62.50% respectively,with no statistical significance(P>0.05).4.After treatment,the maturity stages of the regenerated mucosa in the two groups were as follows: 3 cases in R0 stage,4 cases in R1 stage,2 cases in Sa stage,5 cases in Sb stage and 17 cases in Sc stage in observation group;In the control group,there were 5 cases in R0 stage,7 cases in R1 stage,6 cases in Sa stage,6 cases in Sb stage and 8 cases in Sc stage.There was significant difference between the two groups(P<0.05).5.Compared with the PUDQ scores before and after treatment,the total scores of quality of life(including ulcer-related,psychological state and social ability scores)and individual scores of the two groups were significantly different(P<0.05).Compared between the two groups,there was a statistical difference in mental state score after treatment(P<0.05).6.There was no discomfort in the two groups during the treatment,and there were no abnormalities in WBC,RBC,PLT,TBIL,ALT,AST,BUN,Scr,urine and feces routine,fecal OB and electrocardiogram before and after the treatment.Conclusion:1."Sanhe Jianzhong Decoction" has obviously improved the clinical symptoms,TCM syndromes and quality of life of patients with duodenal ulcer of "spleen deficiency and blood stasis" syndrome,and the curative effect is better than Rabeprazole sodium enteric-coated tablets,and it has no obvious toxic or side effects.2.In promoting the healing of duodenal ulcer,"Sanhe Jianzhong Decoction" has the same curative effect as "Rabeprazole",but the treatment of "Sanhe Jianzhong Decoction" improves the healing quality of ulcer. |
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