Objective:To observe and evaluate the clinical efficacy and safety of Jian pi hua shi yu yang decoction combined with Pantoprazole Sodium Enteric-Coated Capsules in the treatment of gastric ulcer of Pi xu shi zu syndrome.Methods:All cases were collected from January 2016 to February 2018 in the affiliated Hospital of Nanjing University of Chinese Medicine and Nanjing first hospital,incorporated in the electronic gastroscope diagnosis of gastric ulcer(activity)in 59 cases of patients,who were diagnosed as Pi xu shi zu syndrome,and without serious complications.59 patients were randomly divided into treatment group of 30 cases,treated by Jian pi hua shi yu yang decoction combined with Pantoprazole Sodium Enteric-Coated Capsules(Pan Lisu 40mg qd);29 cases in the control group only received Pantoprazole Sodium Enteric-Coated Capsules(Pan Lisu 40mg qd)treatment,no significant difference between two groups in clinical symptoms integral factors,gender,age nor course of disease before treatment(P>0.05).Patients of two groups with Helicobacter pylori(Hp)infection would receive therapy for 14 days firstly with Pantoprazole Sodium Enteric-Coated Capsules(Pan Lisu,40 mg bid)+ Colloidal Bismuth Pectin for Suspension,300mg bid + Amoxicillin Capsules,1.0g bid,(or levofloxacin,0.5g qd for those who are allergic to penicillin)+ Clarithromycin Sustained-release Tablets,0.5g bid.Thereafter,they will continue to be treated in treatment or control group.Two groups were treated for 8 weeks,and the curative effects,symptoms,endoscopic healing rate,Hp eradication rate and adverse reaction of the patients would be observed and estimated after treatment.The two group of patients were observed and recorded scores in discomfort,symptoms,signs and adverse reactions in the end of the second week(±2 days),the sixth week(±2 days)and the eighth week(±2 days),then the differences would be analyzed.The efficiency were obtained in treatment group and observation group according to the integral index.Results:1.Comparison of TCM syndrome curative effect between the two groups:Treatment group's efficiency rate was 100%,control group's efficiency rate was 48.28%,statistical analysis indicated that the results of the two groups have remarkable difference(P<0.05),the treatment group was better than the control group.2.Comparison of TCM symptoms total score between the two groups:In the end of the second week,the sixth week and the eighth week of treatment,the total score of each group of patients with clinical symptoms significantly decreased compared with prior treatment(P<0.05);comparison between groups,the treatment group were significantly better than the control group in scores' improving of clinical symptoms(P<0.05).3.Comparison of single symptom of the two groups:Both groups of patients had good curative effect in alleviating epigastric pain,abdominal distension,sticky and greasy feeling in mouth,lassitude,anorexia,loose stool or diarrhea and so on(P<0.05).Comparison between groups showed that the treatment group was better than the control group(P<0.05).4.Hp eradication rate comparison:The eradication rates about treatment and control group were 95.45%,86.96%.The statistical analysis results showed that there was no significant difference between the two groups(P>0.05).5.Comparison about endoscopic healing rate of two groups:Each group of post-treatment patients had higher cure rates(P<0.05);the comparison between the two groups,showed no significant difference in the results(P>0.05).6.After treatment,evaluation and safety analysis about the two groups showed that there were no abnormal results and untoward effect.Conclusion:The clinical curative effect of traditional Chinese medicine Jian pi hua shi yu yang decoction combined with Pantoprazole Sodium Enteric-Coated Capsules in the treatment of gastric ulcer in Pi xu shi zu syndrome is superior to the single application of Pantoprazole Sodium Enteric-Coated Capsules.It proved that herbs combined with western medicine have much better therapeutic effect,and Jian pi hua shi yu yang decoctionin have significant clinical effects in alleviating symptoms,signs and improving the quality of patients' life. |