| Objective: This topic intends to study the safety of Shaozhujianwei Granules in clinical application,and reasonably evaluate its clinical efficacy in the treatment of liver-stomach disharmony CSG,so as to provide a strong basis for its subsequent clinical application.Methods: According to the 2017 edition of "Consensus Opinions on Diagnosis and Treatment of Chronic Gastritis in China" and the Ministry of Health's "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine for Chronic Gastritis" and combined with TCM syndrome differentiation criteria,patients were all hospitalized and outpatients in the Department of Digestive Internal Medicine of Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine from June 2018 to March 2019,with a total of 90 cases,36 males and 54 females.The patients were divided into two groups by random number table method,with 60 cases in the treatment group and 30 cases in the control group.The control group was given omeprazole enteric-coated capsule(Ox 20mg)orally,one capsule each time on an empty stomach starting in the morning.The treatment group was given Shaozhu Jianwei Granules orally,one bag each time(9g)after breakfast and dinner every day for eight weeks.During the treatment period,follow-up was conducted every two weeks to record the improvement of clinical symptom scores and TCM syndrome scores.SF-36 scores were recorded before and after treatment and safety indicators were monitored.Finally,statistical analysis was used to compare the changes of TCM syndrome score,clinical symptom score and SF-36 score before and after treatment between the two groups,as well as the related safety indexes before and after treatment,so as to reasonably evaluate the clinical effectiveness and safety of Shaozhujianwei Granules in treating liver-stomach disharmony CSG.Results: before treatment,there was no significant difference in clinical symptom scores,TCM syndrome scores and SF-36 scores between the two groups(P<0.05).after eight weeks of continuous treatment,by evaluating the improvement of patient syndrome scores,it was concluded that the significant efficiency of the treatment group was80.0%,and that of the control group was 50.0%.The treatment group was better than the control group in improving syndrome scores(P<0.05).at the same time,the treatment group was also significantly better than the control group in treating various clinical symptoms,such as fullness in the epigastrium or hypochondrium,dry mouth,emotional depression,belching,sighing,and preference for warm food(P<0.05).Statistical analysis of SF-36 scores before and after treatment showed that the improvement of physical health,physical pain,emotional role function and overall health in the treatment group was better than that in the control group(P<0.05).Conclusion: Shaozhujianwei Granules are safe in clinical application.Its clinical comprehensive curative effect is better than that of the control group,which can better improve the TCM syndromes and quality of life of CSG patients with liver-stomach disharmony,and is worthy of further clinical research and popularization. |
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