| Objective This study mainly through observing the clinical effect of Jianpi Xiaozhang Decoction in the treatment of functional dyspepsia with spleen deficiency and Qi stagnation,calculating the recurrence rate,recording the safety index of patients and adverse reactions in the course of research in order to objectively evaluate the effectiveness and safety of Jianpi Xiaozhang Decoction,to provide reference for clinical treatment of functional dyspepsia.Methods This experiment adopts randomized,balanced,and controlled grouping principle,on the basis of determining the diagnostic criteria,admission criteria and exclusion criteria,74 patients with functional dyspepsia of spleen deficiency and Qi stagnation were randomly divided into 37 cases in the control group and 37 cases in the experimental group.By observing and comparing the overall curative effect of the two groups after treatment,the total score of TCM syndromes and the score of symptoms before and after treatment,the quality of life score,safety and adverse reactions to evaluate the effectiveness and safety of the Jianpi Xiaozhang Decoction.At last,by calling or returning to hospital after 4 weeks of treatment to evaluate the above scale to the assess the remote efficacy of the two groups.Results A total of 74 patients meeting the inclusion criteria were included in the study,and 66 cases were completed this study,including 34 in the experimental group and 32 in the control group,with a total shedding rate of 10.81%.Compared the general data of the two groups before treatment,the results showed no statistical difference(P>0.05),and the two groups were comparable.After 4 weeks of treatment:1.Comparison of overall curative effect:After treatment,the overall effective rate of the experimental group was 91.18%,and that of the control group was 68.75%.The comparison between the the overall effective rate of two groups showed a significant statistical difference(P<0.01),indicating that the clinical effect of Jianpi Xiaozhang decoction was significantly better than that of mosapride citrate dispersible tablets.2.Comparison of total scores of TCM syndromes:before treatment,there was no statistical difference in total scores of TCM syndromes between the two groups(P>0.05),which could be compared.The total score of TCM syndromes in the two groups was significantly lower than that before treatment(P<0.01),indicating that the treatment schemes of both groups had obvious curative effect.However,the total score of the experimental group was more superior than that of the control group(P<0.01),indicating that the overall effect of the test group was significantly better than that of the control group.3.Comparison of every symptom scores:before treatment,there was no significant difference(P>0.05)between the two groups.The scores of symptoms in the experimental group decreased significantly after 4 weeks of treatment(P<0.01).The scores of stomach distention,epigastric pain,belching,regurgitation,nausea and vomiting in the control group decreased significantly(P<0.01).The scores of fatigue and weakness decreased compared with those before treatment(P<0.05).There was no significant difference before and after treatment in diet reduction and loose stools(P<0.05).The results showed that the two groups had a good effect on other symptoms except diet reduction and loose stools.The scores of symptoms after treatment between the two groups were lower than those of the control group(P<0.05),and decreased more significantly in diet,fatigue and loose stools(P<0.01),but there was no significant difference in the scores of the above symptoms after treatment(P<0.05).The results showed that the experimental group had more advantages in improving the symptoms of epigastric distention than the control group,and had more significant curative effect in the treatment of diet reduction,fatigue weakness and loose stool symptoms.However,there was no significant difference in alleviating epigastric pain,belching,regurgitation,nausea and vomiting between the two groups.4.Comparison of quality of life score:there was no significant difference between the two groups before treatment(P>0.05),which could be compared.After 4 weeks of treatment,the quality of life score of both groups was significantly improved(P<0.01).These results indicated that both treatment methods could improve the quality of life of patients,but the effect of experimental group was better.5.Comparison of recurrence rate:After 4 weeks of treatment,the recurrence of the two groups was counted.Results the experimental group was followed up to 28 cases,the recurrence rate was 14.28%,the control group was followed up to 22 cases,the recurrence rate was 45.45%.The difference between the two groups was statistically significant(P<0.05).It shows that the long-term effect of the experimental group is better than that of the control group.6.Comparison of safety and adverse reactions:Blood routine,urine routine,stool routine,liver and kidney function and electrocardiogram were not abnormal and no adverse reactions occurred.It shows that in the course of this study,the treatment schemes of both groups are safe and reliable.Conclusion Jianpi xiaozhang decoction has a significant effect in the treatment of functional dyspepsia of spleen deficiency and qi stagnation,which can significantly reduce the discomfort symptoms of patients,improve the quality of life,reduce the recurrence rate,and has high safety without adverse reactions. |
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