| Objective:The essay is designed to evaluate the efficacy of Wumei Wan through clinical observation in treating cold and heat mixed type of chronic superficial gastritis(CSG)and provide the effective proof for clinical treatment of cold and heat mixed type CSG.Methods:1.Research objects in such project include outpatients of spleen and stomach disease department and endoscopy room in Changzhou TCM Hospital affiliated to Nanjing University of Chinese Medicine from January of 2016 through December of 2016,amounting to 120 cases,confirmed as patients of CSG in clinical diagnosis,with cold-heat complication pursuant to syndrome differentiation of TCM.All the above patients are divided into TCM with 40 members,western medicine group with 40 members and TCM-western medicine group with 40 members respectively as per the random number table.There are no significant differences in such baseline comparison as gender composition,age,disease course,TCM symptom integral,pepsinogen,chronic gastritis PRO scale(GEDPRO-CG)for spleen-stomach diseases,electrogastrogram and Hp infection situation among the above three groups.2.Patients in TCM group take Wumei Wan as the basic prescription,with modification made as appropriate,and patients in western medicine group take 10 mg qd of Sodium Rabeprazole Enteric-coated Tablets,while patients in TCM-western medicine group take both Wumei Wan as the basic prescription(same as TCM group)with appropriate modification and 10 mg qd of Sodium Rebeprazole Enteric-coated Tablets(same as western medicine group),with four weeks as one course of treatment.3.Make comparison in terms of TCM symptom integral observation,TCM efficacy observation,clinical comprehensive efficacy observation,pepsinogen observation,chronic gastritis PRO scale(GEDPRO-CG)for spleen-stomach diseases,electrogastrogram and Hp infection situation before and after treatment for the three groups.Observe the recurrence cases 4 weeks after drug withdrawal and conduct the safety evaluation at the same time.Results:1.During the treatment process,three cases in TCM group are excluded,three cases in western medicine group are excluded and four cases in TCM-western medicine group are excluded.After the treatment,there are 37 cases in TCM group,37 cases in western medicine group and 36 cases in TCM-western medicine group.The relevant research data of 110 patients in total are listed in the research results after the treatment.2.The three treatment methods in TCM group,western medicine group and TCM-western medicine group all produce the sound clinical efficacy in terms of cold and heat mixed type CSG and the treatment in the three groups presents satisfactory safety,without any obvious adverse effect.3.In the respect of TCM symptom integral,for the individual symptom,TCM-western medicine group is superior to western medicine group for improvement of main symptom Ⅰ(namely dul stomachache and/or distension)and minor symptom Ⅱ(namely anorexia and loose stool),with statistical significance;as to the aggregate integral,TCM group and TCM-western medicine group are superior to western medicine group for improvement of TCM aggregate integral,with statistical significance;in the light of aggregate integral difference,judging from the comparison of aggregate integral difference for all symptoms,TCM-western medicine group is superior to TCM group and western medicine group,with the difference equal to the data change value before and after the treatment,directly reflecting the improvement of symptoms,the greater the difference,the better symptoms improve,showing that TCM-western medicine group is superior to TCM group and western medicine group for improvement of main symptom and minor symptom.4.In terms of curative effect:TCM-western medicine group is superior to TCM group and western medicine group in the aspect of TCM symptom efficacy,with statistical significance;TCM-western medicine group is superior to western medicine group in the aspect of clinical comprehensive efficacy,with statistical significance.5.In the respect of pepsinogen,there is no statistically significant conclusion among groups after treatment.According to the comparison within the group before and after treatment,PGⅠ/PGⅡ of TCM group and TCM-western medicine group after treatment is higher than the value before treatment,with statistical significance,showing that the secretion function of pepsin and gastric mucosa state of TCM group and TCM-western medicine group after treatment have been improved as compared with that before treatment.6.In terms of chronic gastritis PRO scale(GEDPRO-CG),such items as energy,shape and appearance,pain and discomfort,digestive function,psychological aspect,physiological and psychological field,the curative effects of the three groups after treatment are totally different,with statistical significance.As compared with western medicine group,TCM group is superior to western.medicine group in terms of energy,shape and appearance,pain and discomfort,digestive function,physiological field,with statistical significance.As compared with TCM group,TCM-western medicine group is superior to TCM group in terms of digestive function,psychological aspect,physiological and psychological field improvement,with statistical significance.As compared with western medicine group,TCM-western medicine group is superior to western medicine group in terms of energy,shape and appearance,pain and discomfort,digestive function,psychological aspect,physiological and psychological field improvement,with statistical significance.In the respect of psychological field and psychological aspect,TCM-western medicine group is superior to TCM group and western medicine group for improvement,showing that the regulating effect on the patients’ psychological state for the TCM-western medicine group after treatment is superior to TCM group and western medicine group.7.In the aspect of electrogastrogram,TCM-western medicine group presents greater improvement than TCM group and western medicine group for the post-meal/pre-meal power ratio,with statistical significance.As to the comparison between pre-treatment and post-treatment for all groups,the post-treatment post-meal/pre-meal power ratio of TCM group and TCM-western medicine group is higher than that of pre-treatment,with statistical significance.Post-meal/pre-meal power ratio mainly reflects stomach power situation,as the quantitative index for such symptoms as distention and fullness and eructation.The therapeutic outcomes show Wumei Wan with appropriate modification has advantages in improving such relevant gastric motility symptoms as eructation,distention and fullness.In the comparison between TCM group and TCM-western medicine group,the average amplitude(pre-meal and post-meal)of the waveform after treatment shows statistical significance,suggesting greater average amplitude change of waveform for TCM-western medicine group than that of TCM group after treatment and indirectly reflecting the greater stomach power for TCM-western medicine group than that of TCM group after treatment.8.In terms of Hp infection situation,no significant difference is shown among the three groups and within the groups before and after treatm.ent;Wumei Wan alone with appropriate modification has no obvious anti-Hp action and Wumei Wan with Sodium Rabeprazole Enteric-coated Tablets also has no obvious anti-Hp action.9.TCM-western medicine group has lower recurrence rate than western medicine group,with statistical significance,showing the synergistic effect of combined TCM-western medicine treatment,with low recurrence rate..Conclusion:Wumei Wan with appropriate modification has sound clinical efficacy in treating cold and heat mixed type CSG.In the comparison among TCM group,western medicine group and TCM-western medicine group,Wumei Wan with appropriate modification combined with Sodium Rabeprazole Enteric-coated Tablets(TCM-western medicine group)has a better curative effect,with lower recurrence rate.The comparison of relevant laboratory data for GEDPRO-CG,electrogastrogram and pepsinogen shows that the effective mechanism for Wumei Wan with appropriate modification in treating cold and heat mixed type of chronic superficial gastritis may have something to do with the ability of Wumei Wan with appropriate modification to adjust the patients’ psychological state,improve their gastric motility and gastric mucosa state. |