| Objective:The purpose of this study is to observe the effect and safety of Jianpi Tongluo Decoction on chronic atrophic gastritis(spleen deficiency with blood stasis syndrome)in the aspects of TCM syndrome scores,gastroscopy findings,gastric mucosal histopathology and Safety.Methods:According to the inclusion criteria and exclusion criteria,63 patients were randomly divided into the treatment group(32 cases)and the control group(31 cases)by random number table.The treatment group was treated with Jianpi Tongluo Decoction for 6 months,and the control group was treated with Weifuchun Tablets for 6 months also.Patients with H.pylori infection in both groups were treated with Livzon Triplet and Pantoprazole enteric-coated capsules for 14 days.The TCM syndrome scores,security index and the results of gastroscopy,histopathological examinations,Carbon-14 urea breath test were collected before and after treatment in both groups,and adverse reactions were also recorded.Use SPSS 21.0 to analyze datas about the treatment effects,efficacy and safety differences between the two groups.Results:(1)It’s comparable that there was no statistically significant difference between the two groups before treatment in terms of age,gender,total scores of histopathology and TCM syndrome(P>0.05).(2)The total pathological scores decreased after treatment in both groups(P<0.05),indicating that both groups were effective,while the treatment group was more effective than the control group(P<0.05).The scores in aspects of chronic inflammation,active,atrophy and intestinal integral in the treatment group decreased after treatment(P<0.05),and the pathological integral scores of the control group also fell after treatment,there was statistically significant in aspect of chronic inflammation scores(P<0.05),while there was no statistical significance in aspects of active,atrophy and intestinal integral scores(P>0.05).In terms of atrophy and intestinal metastasis,the total effective rates of the treatment group were 67.67%and 76.00%,respectively,both of the control group were 50.00%and 44.80%,and the total effective rates of the treatment group in terms of atrophy and intestinal metastasis were higher than those of the control group,while there was no significant difference between the two groups(P>0.05).Due to the small sample size,the effect about atypical hyperplasia can not be counted.In terms of the cure rate of gastroscopy,the endoscopic cure rates of the treatment group and the control group were 3.33%and 6.67%,while there was no significant difference between the both groups(P>0.05).In Hp eradication,the eradication rate of the treatment group was 86.9%,and the control group was 80.9%,while there was no statistical significance(P>0.05).In the overall efficacy,the total effective rate of the treatment group was 86.67%,while the control group was 53.33%,and the difference between them was statistically significant(P<0.05).(3)Total scores of TCM syndrome and each individual symptoms scores in both groups all fell after treatment compared with the previous(P<0.05),indicating that both groups were effective.The scores of TCM syndrome integral,abdominal distension,acid reflux,loose stools in the treatment group were lower than those of the control group after treatment,and the difference between them is statistically significant(P<0.05).(4)Adverse reaction analysis:No serious adverse events occurred in the process of treatment of the two groups.One adverse reaction occurred in the treatment group and 2 in the control group,and the incidence of adverse reactions of the two group were 3.3%and 6.7%.(5)Safety evaluation:Because there was no serious adverse reaction,the security level was level 2.Conclusion:Using Jian Pi Tong Luo Decoction to treat chronic atrophic gastritis(spleen deficiency with blood stasis syndrome)can effectively improve the clinical symptoms and pathological changes such as chronic inflammation,active,atrophy and intestinal pathological changes to some extent,and also the security is well. |
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