| Objective: To observe the clinical effect of compound shenzhujianwei capsule combined with quadruple therapy in the treatment of Helicobacter pylon related spleen stomach deficiency cold type duodenal ulcer,and objectively evaluate its safety and effectiveness.Methods: 1.60 patients with duodenal ulcer stage a(including stage A1 and A2),Helicobacter pylori infection(detection method: 14 C urea breath test)and spleen stomach deficiency cold syndrome were selected and randomly divided into treatment group(Chinese and Western medicine group)and control group(Western medicine group).2.The control group was given rabeprazole sodium enteric coated tablets 10 mg twice a day;clarithromycin 0.5g twice a day;amoxicillin 1.0g twice a day;Bismuth Potassium Citrate Granules 2.0g twice a day.Bismuth and antibiotics were stopped after 2 weeks of continuous administration,PPI was continued for another 2 weeks,a total course of 4 weeks.In the treatment group,1.0g compound Shenzhu Jianwei capsule was added to the control group,three times a day for 4 weeks.The course of treatment in both groups was four weeks.3.Before and after treatment,the symptoms,physical signs and gastroscopy results of the patients were observed,and H.pylori eradication rate was observed.And the treatment group and the control group were statistically analyzed and compared.Result:1.Comparison of general conditions: there was no significant difference between the two groups in age,gender,stage of ulcer,diameter of ulcer,location of ulcer,total score of TCM symptoms and single score of TCM symptoms(P > 0.05).2.Comparison of total score of TCM symptoms: after 4 weeks of treatment,the difference between the two groups was statistically significant(P < 0.05).After the treatment,the treatment group was better than the control group in reducing the total score of TCM symptoms,the difference was statistically significant(P < 0.05).3.Comparison of single symptom scores of traditional Chinese medicine: after treatment,the difference between the two groups was statistically significant(P < 0.05)in the symptom scores of epigastralgia,decreased pain of getting food,tiredness of limbs,chilly limbs,slobbery,loose stools and less intake(P < 0.05);and the difference between the treatment group and the control group was statistically significant(P < 0.05))It shows that the treatment group and the control group have significant curative effect in improving TCM symptoms,and the curative effect of the treatment group is better than that of the control group.4.Comparison of gastroscope effect: after treatment,the difference between the two groups in gastroscope performance and before treatment was statistically significant(P < 0.05);after treatment,the difference between the treatment group and the control group in gastroscope effect was not statistically significant(P = 0.165 > 0.05).It shows that the treatment group and the control group have good curative effect on mucosal repair,and the curative effect is equivalent.5.Comparison of H.pylori eradication rate: the eradication rate of H.pylori in the treatment group was 96.67%,while that in the control group was 93.33%,there was no significant difference between the two groups(P = 0.554 > 0.05).It shows that the treatment group and the control group have good curative effect on eradicating H.pylori infection,and the curative effect is equivalent.6.Safety comparison: during the treatment,no obvious adverse reactions occurred in the two groups.Conclusion: the combination of compound shenzhujianwei capsule and quadruple therapy can significantly improve the symptoms of traditional Chinese medicine,relieve the discomfort of patients,and improve the quality of life of patients with Helicobacter pylon related DU.It is effective,safe and worthy of clinical application. |