| Objectives:1.To explore the clinical efficacy and safety of Banxia Xiexin Decoction combined with quadruple theraphy in the treatment of Hp-related CAG(Cold-Heat Complication).2.To study the effects of Banxia Xiexin Decoction on the overall behavior,gastric mucosa morphology,and effect factor levels of Cag A+Hp-infected chronic atrophic gastritis mouse model,and to explore the mechanism of Banxia Xiexin Decoction.Methods:1.Clinical researchSixty patients met the diagnostic criteria for Hp-related CAG(Cold-Heat Complication),were divided into a treatment group and a control group by using stratified block randomization.The control group was given quadruple therapy(Rabeprazole Enteric-coated Capsules 20 mg + Compound Bismuth Aluminate Granules 2.6 g,two times a day,orally half an hour before meals;Amoxicillin Capsules 1000 mg + Clarithromycin Dispersible Tablets500 mg,2 times a Day,oral administration half an hour after meals;Course for 14 days);The treatment group was treated with quadruple therapy+Banxia Xiexin Decoction(2 times a day,half an hour after meals;Course for 12 weeks).TCM symptom score evaluation,13 C urea breath test,electronic gastroscopy and pathological examination were performed before and after treatment.Compared theclinical symptomimprovements,gastroscopy pathological efficacy,H.pylori eradication rate and medication safety after the course of treatment.SPSS23.0 was used for all data for statistical analysis.2.Animal experiment10 of the 48 SPF-grade healthy C57BL/6 mice were randomly selected as the normal group,the other 38 mice were given Hp bacteria solution for 2 weeks and MNNG solution freely consumed for 8 weeks formodeling.At the end of each stage of modeling,4 mice were randomly selected and sacrificed,a total of 8 mice,were killed for confirm the successful modeling.30Hp-related CAG model mice were randomly divided into a quadruple therapy group,a Banxia Xiexin group,and a model group,10 mice in each group.The quadruple therapy group was given quadruple therapy drug solution;The Banxia Xiexin group wastreated with Banxia Xiexin Decoction and decoction;The mice in the normal group and the model group were given physiological saline;Each group was administrated with gavage at10ml/kg once a day for 14 days.Observing of behavior and general condition in mice,sacrificing mice at the end and observing the mucosal appearanceshape,taking HE staining of gastric tissue,observing histopathological changes under light microscope,gastric tissue IL-10 and IL-17 A were measured by enzyme-linked immunosorbent assay(ELISA).All the data were statistically analyzed using SPSS 23.0.Results:1.Clinical research(1)General information: According to the date analysis,there were no statistical differences in gender,age,and course of disease between the two groups(P>0.05);Before treatment,there were no statistical differences in gastroscopy,pathological examination,and TCM symptom scores between the two groups,which had comparability(P>0.05).(2)Efficacy analysis: In terms of TCM symptom score,excepte the symptom scores ofstomachache(P=0.059)and dry-bitter mouth(P=0.056)of control group showed no significant improvement after treatment(P>0.05),two groups had significantly improved before treatment(P<0.05).The symptom scores of stomachache,belching,fatigue,exacerbationof cold,diarrha,and general symptom were improve better in the treatment group than in the control group(P<0.05).In terms of syndrome efficacy(P=0.009),gastroscopic efficacy(P=0.042),pathological efficacy(P=0.046),the treatment group was significantly better than the control group(P<0.05).In terms of Hp eradication rate,the treatment group(93.33%)was higher than the treatment group(80%),and the difference was not statistically significant(P>0.05),suggesting that Banxia Xiexin Decoction could increase the Hp eradication ratetrend,which needs a large sample research.(3)Safety evaluation: 2 cases of adverse events occurred in the control group,with an incidence of 6.67%,and 1 case in the treatment group,with an incidence of 3.33%.The difference was not statistically significant(P>0.05).The data suggest Banxia Xiexin Decoction and quadrupletherapy did not cause obvious adverse reactions during the test.2.Experimental research(1)Overall behavior: In the modeling stage,the mice in the model group lost weight,somasthenia,reduce activity,lossofappetite,diarrhea,and had partial abdominal distension.At the drug intervention stage,the weight and body size of the mice in both groups increased compared with the previous ones.The mice in the Banxiaxiexin group had increased fur gloss,sensitivity,activity and food intake,and formed the stool.(2)Pathological indexes of gastric mucosa: Observation under the naked eye and light microscope showed pathological changes of gastric mucosa and gastric tissue in the model group mice.The mucosal color,granular hyperplasia,cell morphology,glandular structure,etc.,the degree of lesions in two medication administration groups were lighter than the model group.(3)Contents of IL-10 and IL-17A: The contents of IL-10 and IL-17 A in gastric tissues of model mice were significantly higher than those in the normal group.The contents of two medication administration groups was significantly lower than the model group,but higher than the normal group.The levels of IL-10 and IL-17 A in the Banxia Xiexin group were higher than those in the quadruple theraphy group,and the differences between all above groups were statistically significant(P <0.01).Conclusions:1.Clinical researchBanxia Xiexin Decoction combined with quadruple therapy can significantly improve the clinical symptoms of patients with Hp-related CAG,especially in the improvement of stomache,belching,fatigue,exacerbation of coldand diarrha,the curative effect were better than use the quadruple therapy alone.Concomitant therapy can effectively control and reverse the gastric mucosal inflammatory and histological pathological changes,and improve the efficacy of gastroscopy and pathology on the basic of quadruple therapy;Banxia Xiexin Decoction has a certain trend in improving the eradication rate of Hp and reducing the incidence of adverse reactions.Due to the small sample size in this experiment,the difference of data was not statistically significant.2.Experimental researchBanxia Xiexin Decoction can effectively improve the general conditions of Hp-infected CAG mice,including weight,food intake,activity,fur gloss,fecal traits,etc.,and the effect is better than quadruple therapy.Banxia Xiexin Decoction and quadruple therapy are effective inimproving gastric mucosal lesions.Both two therapies significantly down-regulate the content of immunosuppressive factor IL-10 and proinflammatory factor IL-17 A in the gastric tissue of mice,and the effect of quadruple therapy is lower than that of Banxia Xiexin Decoction.It is considered that the efficacy of the drug is related to this regulation mechanism. |
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