| Objective: This study by observing Jianwei Zhitong Mixture in the treatment of chronic non-atrophic gastritis patients with spleen qi deficiency,to explore the clinical efficacy and safety of this medicine,to provide a basis for clinical treatment of this disease.Methods : 90 patients,from December 2019 to December 2020,who met the inclusion criteria in the outpatient department of spleen and stomach of Gansu Provincial Hospital of Traditional Chinese Medicine were collected and randomly divided into two groups:treatment group(n=46)and control group(n=44).The treatment group was treated with Jianwei Zhitong Mixture,and the control group was treated with Xiangsha Liujun Pill.Both groups were treated for 4 weeks.The TCM syndrome efficacy,TCM syndrome total score,each single symptom score,SF-36 scale score and safety index of the two groups were collected before and after treatment and 4 weeks after withdrawal.The results were statistically analyzed.Results: From the single symptom score,the single symptom score of the two groups after treatment was significantly lower than that before treatment(P<0.05),indicating that the two drugs can improve the clinical symptoms of patients with chronic non-atrophic gastritis(spleen deficiency type).The efficacy of the treatment group was significantly better than that of the control group(P<0.05),in improving gastric pain,reduced appetite,post-eating distension,fatigue and other symptoms,while the efficacy of the two groups was similar in loose stool and lazy speech(P>0.05).The scores of main symptoms and secondary symptoms of traditional Chinese medicine:After treatment,the scores of main symptoms in the two groups were significantly lower than those before treatment(P<0.05).Both groups can improve gastric pain and postprandial distention.The treatment group was better than the control group(P<0.05).After treatment,the secondary symptom scores of the two groups were significantly lower than those before treatment(P<0.05),indicating that the two drugs have a better effect on improving the four secondary symptoms of anorexia,fatigue,laziness and loose stool.After treatment,the curative effect of the treatment group was better than that of the control group(P<0.05).The total score of TCM syndromes: After 4 weeks of treatment,the total score of TCM syndromes in the two groups was significantly decreased compared with that before treatment(P<0.05).Both drugs can treat the disease,and the improvement of overall symptoms in the treatment group was better than that in the control group(P<0.05).The total effective rate was93.2% in the treatment group and 76.0% in the control group.The treatment group was better than the control group(P<0.05),indicating that the effective rate of the treatment group in the treatment of chronic non-atrophic gastritis(spleen qi deficiency type)was significantly higher than that of the control group.Quality of life score : the scores of the two groups after treatment were higher than those before treatment(P<0.05),and the difference was statistically significant,indicating that the two groups of drugs had good effects on the improvement of the quality of life of patients.The scores between the two groups were compared.After treatment,the scores of quality of life in the treatment group were significantly higher than those in the control group in four dimensions of physical pain,overall health,social function and mental healt(P<0.05),and the treatment group had obvious advantages in these aspects.In the dimensions of physiological function,physiological function,vitality and emotional function,the improvement effects of the two groups were similar(P>0.05).The improvement effect of the treatment group on the overall quality of life was better than that of the control group,and the treatment group was more effective in improving the quality of life of patients.Recurrence rate: There was no significant difference in the recurrence rate between the two groups 4 weeks after drug withdrawal(P>0.05),indicating that the long-term efficacy of the two drugs was equivalent.Safety: There was no significant change in the safety between the two groups after treatment(P>0.05).No adverse events occurred.It indicated that both drugs had good safety.Conclusion: Jianwei Zhitong Mixture can significantly improve the clinical symptoms and quality of life of chronic non-atrophic gastritis(spleen qi deficiency syndrome),such as stomach pain,post-eating distension,reduced appetite,and fatigue.The clinical efficacy and long-term efficacy are exact,safe and reliable,and it is worthy of further promotion in clinic. |