| Objective:To investigate the distribution of TCM syndromes of refractory gastroesophageal reflux disease(RGERD)and the correlation between TCM syndromes and psychological status,and to observe the clinical efficacy of regulating Qi and stomach Yin in the treatment of refractory gastroesophageal reflux disease with liver-stomach disharmony as to provide reference for TCM clinical treatment of RGERD.Methods:First Part: Used questionnaire investigation,description statistics,correlation analysis to collect standard RGERD TCM four diagnosis in patients with clinical data,self-evaluation of anxiety scale(SAS),depression self rating scale(SDS),combined with the patient's tongue and pulse condition,divided into different syndrome,including liver-stomach disharmony syndrome,syndrome of heat in liver and stomach,middle deficiency Qi adverse syndrome,Qi stagnated with phlegm syndrome,cold and heat complex syndrome,qi stagnated with blood stasis syndrome.SPSS 25.0 statistical software was used to calculate and analyze the general information of RGERD patients,the distribution of syndrome type,psychological status,and the correlation between syndrome type and psychological status.Second Part: A randomized and controlled clinical research was conducted.80 RGERD patients with disharmony between liver and stomach syndrome were randomly divided into treatment group and control group,40 cases in both groups,8 consecutive weeks of intervention therapy.Before treatment,all patients conduct the baseline data assessment.(1)The treatment group was given general intervention therapy;(2)Chinese medicine deoction granule,twice a day before meal with each time 150 ml.(2)The control group was given general intervention therapy;(2)Esomeprazole magnesium enteric-coated tablets: 20mg/ tablet,twice a day,before breakfast and dinner;and;(3)Mosapride citrate capsule: 5mg/ time,3 times /d,oral before three meals.Main outcome indicators is gastroesophageal reflux symptoms(RDQ scale and TCM syndrome quantitative measure table),the secondary outcome indicators including psychological status(by Hamilton anxiety scale(HAMA)and Hamilton depression scale(HAMD)to measure)and sleep status(via Pittsburgh sleep index(PSQI)measured),All outcome indicators were evaluated before,after,and between groups,and finally the safety and RDQ recurrence of this study were observed.The secondary outcome indicators three months follow-up after treatment,the whole process recorded cases of watch list.Result:First Part 1: A total of 197 RGERD patients were included.According to the general data,the youngest was 18 years old and the oldest was 85 years old.Among the patients,middleaged people,45-59 years old were more common,and female patients were slightly more than male patients.Most of the causes were disordered diet and emotional disorders,and most of the patients had a course of disease ?1 year.TCM syndromes: the frequency of syndrome type distribution was successively from high to low: disharmony between liver and stomach > heat stagnation in liver and stomach > Qi stagnated with phlegm > middle deficiency Qi adverse > Qi stagnated with blood stasis > cold and heat complex.There was no statistically significant difference between syndrome type and gender but the middle aged people in each syndrome had the most and patients with liver and stomach disharmony syndrome had the most in any age group except the elderly.In terms of the distribution of syndromes,the top ten symptoms are: dry and bitter mouth,poor appetite,belching or nausea,abdominal(stomach)distension,fatigue,rib distension,epigastric pain,sticky stool,loose stool and burning pain behind the sternum.In the aspect of tongue image,the tongue is mainly light red,the coating is mainly white and greasy with tooth marks.The pulse condition in the top three are stringy,slippery and thin pulse.More than half of people with anxiety,and depression were assessed.The average integral value of SAS and SDS shows that the overall psychological state is worse than ordinary people.The difference between gender and SDS was statistically significant,and female scores were significantly higher than male scores.The difference between SAS and different age groups was statistically significant.The correlation analysis between syndromes and psychological status showed that in terms of anxiety,the first syndrome of Qi stagnated with blood stasis was statistically significant(P < 0.05)compared with the other four syndromes.There were statistically significant differences(P < 0.05)in the scores of the four syndromes(cold and heat complex,disharmony between liver and stomach,stagnation heat in liver and stomach,middle deficiency Qi adverse and Qi stagnated with phlegm)and lower than the four syndromes(P < 0.05),while the differences between the other syndromes were not statistically significant(P > 0.05).In terms of depression,there were statistically significant differences(P < 0.05)between the first syndrome of Qi stagnated with blood stasis and the three syndromes of disharmony between liver and stomach,middle deficiency Qi adverse and Qi stagnated with phlegm(P < 0.05),and the score was lower than the three syndromes.There were statistically significant differences(P < 0.05)between the one syndrome of cold and heat complex and the four syndromes of disharmony between liver and stomach,stagnation heat in liver and stomach,middle deficiency Qi adverse and Qi stagnated with phlegm(P < 0.05),and the scores were lower than the four syndromes,while the differences between the other syndromes were not statistically significant(P > 0.05).Second part: There were 5 cases of abscission,75 cases in total,39 cases in the treatment group and 36 cases in the control group.After 8 weeks of treatment,scale scores of RDQ,TCM syndromes,HAMA,HAMD and PSQI were all decreased in both groups,and drugs in both groups could improve patients' symptoms of gastroesophageal reflux,psychological status and sleep status.RDQ: The total effective rate of the treatment group was 79.49%,and the total effective rate of the control group was 38.90%.The total score and the improvement of single symptoms such as heartburn,acid reflux and food reflux were better in the treatment group than in the control group.In terms of TCM syndromes,the treatment group was superior to the control group in terms of the total score of TCM syndromes,dry and bitter mouth,belching,uncomfortable throat,epigastric discomfort,fatigue,poor appetite,abdominal distension,emotional disturbance,and stool adhesion.The two treatment schemes had similar effects on the symptom of diarrhea.Psychological condition: HAMA and HAMD in the treatment group were better than those in the control group;The curative effect of the treatment group on sleep quality was significantly better than the control group.Follow-up: 3 patients in the control group were lost to follow-up.Three months after treatment,the psychological status and sleep quality of patients in both groups were followed up.The scores of both groups were decreased,and the therapeutic effect of the treatment group was significantly better than that of the control group.In terms of recurrence rate,the treatment group was significantly better than the control group in controlling the recurrence rate of RDQ symptoms.Conclusion:1.From the distribution of syndrome types,the symptom performance of the four clinics,the comparison with the domestic norms and the measurement of integral value,it is found that the TCM syndromes of refractory gastroesophageal reflux disease are closely related to the psychological status,including liver and stomach disharmony,stagnation heat in liver and stomach,Qi stagnated with phlegm and middle deficiency Qi adverse,the tendency of anxiety and depression is more obvious.The majority of anxiety states are liver and stomach disharmony and stagnation heat in liver and stomach.The majority of depression states are disharmony between liver-stomach and middle deficiency Qi adverse.Combined anxiety and depression,the patients with liver-stomach dishamory had the most2.Regulating Qi and stomach Yin are effective in the treatment of gastroesophageal reflux,psychological status and related symptoms of sleep quality in RGERD patients with liverstomach disharmony,with lesser side effects,low recurrence rate and advantages in prognosis,providing more research basis and choices for the treatment of traditional Chinese medicine. |
PDF Full Text Request