| Research purposes:In order to observe the clinical efficacy,HP eradication rate and adverse reactions of Jinghuaweikang Capsule combined with expectorant tetracycline in the treatment of Helicobacter pylori(H pylori HP)-positive functional dyspepsia And evaluation of safety.research method:(1)Test design: randomized,parallel control design.(2)Test population: Western diagnostic criteria for functional dyspepsia with HP positive and TCM syndrome differentiation standards for cold and hot syndrome.(3)Number of cases: According to the principle of 1:1 control of clinical trials,considering the withdrawal rate of no more than 20%,the total number of cases was determined to be 72 cases,and the test group and the control group were 36 cases each.(4)Random grouping method: With the SAS statistical analysis system,a random number table is generated,that is,the treatment allocation corresponding to the serial number 001 to 072 is listed.Subjects were randomly assigned to the test group and the control group.(5)Control drug: refer to the "Fifth National Helicobacter Pylori Infection Consensus Report" [1] HP eradication program using PPI + sputum+ two antibiotics(esomeprazole magnesium + bismuth potassium citrate +furazolidone +amoxicillin).(6)Test course: 6 weeks.Research result:(1)Comparison of HP eradication rates: 32 cases in the experimental group,of which 29 cases were eradicated by HP,the eradication rate was90.6%,and 3 cases were not eradicated,accounting for 9.4%.There were33 cases in the control group,of which 26 cases were eradicated by HP,the eradication rate was 78.79%,and 7 cases were not eradicated,accounting for 21.21%.The chi-square test was used to compare the two groups,and the difference was not statistically significant(P=0.186>0.05).(2)Comparison of the efficacy of TCM syndromes: 1 Total effective rate comparison: The total effective rate of the experimental group and the control group were 96.87% and 78.79%,respectively.There were differences in the four therapeutic efficacy levels of healing,markedly effective,effective and ineffective.Statistical significance(P<0.05),indicating that the clinical symptoms of the experimental group were better than the control group.2 Comparison of total scores of TCM symptoms:The total scores of TCM symptoms before and after treatment were significantly lower than those before treatment.The difference was statistically significant(P<0.05).After treatment,the total scores of TCM symptoms were compared.Statistical significance(P <0.05).The above results showed that both groups of drugs were effective in the treatment of HP-positive FD,and the experimental group was superior to the control group.(3)Comparison of single symptoms: 1 main symptoms: before and after treatment,the two groups of drugs had significant improvement in symptoms such as stomach cramps,stomach cramps,mouth pain and dry mouth;the two groups were better than the control group.The difference wasstatistically significant(P<0.05).2 secondary symptoms: after treatment,the two groups were better than the control group in improving the symptoms of gastric nodules in the patients,the difference was statistically significant(P <0.01);improving the patient's symptoms such as poor appetite,nausea,vomiting,and loose stools There was no significant difference between the two groups(P>0.05).The above results show that the test group is better than the control group in improving the symptoms of stomach cramps,stomach cramps,mouth and mouth dryness,stomach discomfort,etc.In improving patients with symptoms such as poor appetite,nausea,vomiting,and loose stools,There were no statistical differences in the groups.(4)Comparison of recurrence rate: The patients were followed up for clinical symptoms after 3 months of treatment.The experimental group was successfully followed up in 25 cases,1 case recurred,the recurrence rate was 4%;the control group was successfully followed up in 23 cases,2 cases recurred,the recurrence rate was 13.04%;the FD symptom recurrence rate was statistically significant between the two groups(P <0.05).(5)Comparison of safety: During the two observations,no adverse reactions and side effects were found,and the safety was good,which deserves further study.Analysis conclusion:Jinghua Weikang Capsule combined with tincture quadruple therapy can significantly improve the clinical efficacy of patients with functional dyspepsia and HP-positive(cold fever and miscellaneous syndrome),significantly improve the clinical symptoms of patients,highlight the advantages of TCM syndrome differentiation,and have no significant effect on improving HP eradication rate..No obvious adverse reactions and side effects were found during the treatment,and the safety was good,which is worthy of further clinical research. |
PDF Full Text Request