| Objective To observe and evaluate the clinical symptoms and psychological state of PDS patients with spleen deficiency and qi stagnation syndrome,and to verify efficacy and safety of Jiajianxiangsha Liujunzi Decoction.Summarize the experience of mentor Professor Liu Wanli in the treatment of functional dyspepsia postprandial discomfort syndrome,and provide a basis for the clinical application of Jiajianxiangsha Liujunzi Decoction.Methods A randomized,parallel controlled method was used to conduct clinical research.From April 2019 to December 2019,a total of 60 patients with functional dyspepsia postprandial discomfort syndrome(spleen deficiency and qi stagnation syndrome)were collected from the outpatient departments in the Department of Spleen-stomach Clinic of Nanjing Integrated Chinese and Western Medicine Hospital.Patients were randomly divided into treatment group and control group,every group include 30 cases.The treatment group used the Professor Liu’s self-prepared formula,Jiajianxiangsha Liujunzi Decoction,2 doses daily,and was taken 15 minutes after breakfast and dinner.The 4 weeks of medication were 1 course of treatment for a total of 2 courses.The control group was treated with moxapride citrate,and 4 weeks of medication was a course of treatment for a total of 2 courses.Observe and follow up the changes of clinical symptoms and anxiety and depression in the two groups of patients before and after treatment,analyze whether the data collected during the treatment are statistically different,and observe its clinical efficacy in the treatment of PDS.All data were analyzed by SPSS20.0.Result(1)Completion of cases:In this study,a total of 60 patients who met the criteria for admission were collected,the treatment group and the control group both include 30 cases,and 29 cases were completed in the two groups.Among the 29 patients in the treatment group,14 were males and 15 were females;the youngest in the treatment group was 21 years old,the oldest in the treatment group was 62 years old,the average age was 37.90±12.92 years,and the average disease duration was 31.24±10.15 months.Among the 29 patients in the control group,15 were males and 14 were females;the youngest in the treatment group was 19 years old,the oldest in the treatment group was 60 years old,the average age was 39.38±12.63 years,and the average disease duration was 33.24±9.51 months.The gender distribution,age distribution,and course distribution of the two groups of patients were not statistically different after examination(P>0.05).The treatment group and the control group were comparable.(2)Comparison of total scores of TCM syndromes:The comparison of the total scores of TCM syndromes before treatment in the treatment group and the control group showed no statistical difference after examination(P>0.05).The treatment group and the control group were comparable.After examination,the total scores of the TCM syndromes after treatment in the treatment group and control group were lower than before treatment,and there was a statistical difference(P<0.05)after examination,indicating that both groups of treatment can improve the spleen deficiency and Qi stagnation in PDS patients to a certain extent.TCM syndromes.After inspection,the total score comparison between the treatment group and the control group was statistically different(P<0.05),indicating that the treatment group was better than the control group in improving the overall TCM syndromes.(3)Comparison of scores of individual symptoms of TCM syndromes:Comparison of scores of individual symptoms of TCM syndromes before treatment in the treatment group and the control group.There was no statistical difference after examination(P>0.05).The treatment group and the control group were comparable.After treatment,the scores of the individual symptoms of the TCM syndromes in the treatment group and the control group were lower than before the treatment,and there was a statistical difference between the examination(P<0.05),indicating that the drugs in the treatment group and the control group can improve fullness after meals,early satiety,upper abdominal pain,diminished diet,nausea and suffocation,heartburn and acid reflux,fullness of both flank,chest tightness and sigh,diarrhea and uneasiness are effective.After examination,the scores of the individual symptoms of the treatment group and the control group were compared after treatment,and the treatment group was equivalent to the control group in improving the symptoms of diarrhea and uneasiness in the stool(P>0.05).In terms of fullness after meals,early satiety,upper abdominal pain,diminished diet,nausea and suffocation,heartburn and acid reflux,fullness of both flank,chest tightness and sigh,the treatment group was better than the control group(P<0.05).(4)Comparison of evaluation of single main symptoms:Efficacy evaluation of post-prandial discomfort symptoms in the treatment group and control group.Among the 29 patients in the treatment group,18 were significantly effective,2 were effective,9 were improved,0 were ineffective,and the effective rate was 100%.Among the 29 patients in the control group,11 cases were markedly effective,0 cases were effective,16 cases were improved,2 cases were ineffective,and the effective rate was 93.10%.After the rank sum test,the difference was statistically significant(P<0.05),indicating that the treatment group was better than the control group in improving the postprandial discomfort symptoms.Evaluation of curative effect of early satiety in the treatment group and control group.Among the 29 patients in the control group,13 showed significant effects,0 cases were effective,13 cases were improved,2 case was ineffective,and the effective rate was 93.10%.Among the 29 patients in the treatment group,7 cases were markedly effective,0 cases were effective,14 cases were improved,8 cases were ineffective.Cases,the effective rate is 72.41%.After the rank sum test,there was a statistical difference between the two groups(P<0.05),indicating that the treatment group was better than the control group in improving the efficacy of patients with early satiety.(5)Comparison of total FDDQL scores:After examination,there was no statistical difference in the total FDDQL scores between the treatment group and the control group before treatment(P>0.05),and the two groups were comparable.After inspection,the total scores of FDDQL after treatment in both groups increased compared with those before treatment,with a statistical difference(P<0.05),indicating that both groups of drugs can effectively improve the quality of life of patients.After inspection,the comparison between the total FDDQL scores of the treatment group and the control group after treatment was statistically different(P<0.05),indicating that the treatment group was better than the control group in improving the overall quality of life of the patients.(6)Comparison of FDDQL single scores:Before treatment,the treatment group and the control group compared each FDDQL single score.After examination,there was no statistical difference(P>0.05).The two groups were comparable.After treatment,the individual FDDQL scores of the treatment group and control group increased compared with those before treatment,and there was a statistical difference(P<0.05)after examination,indicating that the two groups of drugs have improved the individual FDDQL items(daily activities,worry,diet,sleep,discomfort,health sensation disease control,stress).After examination,the FDDQL scores of the treatment group and the control group were compared after treatment.In terms of discomfort,the treatment group was comparable to the control group(P>0.05);in improving daily activities,anxiety,diet,sleep,health feeling,and disease control In terms of stress,the treatment group was better than the control group(P<0.05).(7)Comparison of HAMA/HAMD scores:Compared with the HAMA/HAMD scores of the treatment group and the control group before treatment,there was no statistical difference after examination(P>0.05),and the two groups were comparable.After treatment,the HAMA/HAMD scores of the treatment group and the control group were lower than those before the treatment.The difference between the two groups was statistically significant(P<0.05),indicating that the two groups of drugs can improve the patient’s anxiety state.Comparing the HAMA/HAMD scores of the two groups after treatment,there was a statistical difference(P<0.05)after examination,indicating that the treatment group was better than the control group in the effect of improving anxiety.(8)Safety evaluation:58 patients participating in the experiment were monitored for vital signs such as breathing,pulse,blood pressure,heart rate before and after treatment,blood routine,urine routine,stool routine,liver and kidney function and electrocardiogram.No significant adverse reactions occurred during the period.Conclusion Modified Xiangsha Liujunzi Decoction can improve the total score of TCM syndromes,individual symptoms of TCM syndromes,overall quality of life,individual areas of quality of life,anxiety in patients with functional indigestion postprandial discomfort syndrome(spleen deficiency and qi stagnation syndrome)and depression have shown good results.Among them,the addition and subtraction of Xiangsha Liujunzi Decoction can improve the overall efficacy of TCM syndromes and individual symptoms of TCM syndromes(fullness after meals,early satiety,upper abdominal pain,diminished diet,nausea and suffocation,heartburn and acid reflux,fullness of both flank,chest tightness and sigh),overall quality of life,single item of quality of life assessment(daily activities,anxiety,diet,sleep,healthy feelings,disease control,stress),anxiety and depression were better than the mosapride citrate group.And there were no adverse reactions between the treatment group and control group during the treatment period.Modified Xiangsha Liujunzi Decoction is effective,safe and effective in the treatment of PDS,and is worthy of clinical application. |
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