| Objective:The failure of Helicobacterpylori eradication in patients with functional dyspepsia remedial treatment field, the cooperation of Chinese and western medicine is still blank. This clinical study emphatically in for these patients to explore a set of efficient and reasonable treatment.Methods:This study is divided into three parts. The first study is theoretical research. To explore the diagnosis and treatment of diseases of the digestive system of traditional Chinese medicine, especially in the treatment of patients with Hp positive FD solution, so as to provide theoretical support for clinical research. Study 2:This study participants included 50 cases of Hp positive FD patients, were randomly divided into traditional Chinese medicine, western medicine group. Observe each group Hp eradication rate and between groups of patients after treatment of symptoms, for statistical analysis. Study 3: Anti Hp Fang quadruple scheme for Hp eradication failure of remedial treatment of FD patients clinical studies.This study included 132 patients with Hp eradication treatment failure of patients with FD. Were randomly divided into standard of sanlian group (group A), the new antibiotics group (group B), anti Hp quad group (group C), bismuth agent quad group (group D), treatment for 10 days, contrast the above four groups of treatment differences, explore new therapies.Observe the indicators:Compare each group of Hp eradication rate. Evaluation between groups of patients after treatment of symptoms, abnormal changes of mucosa under gastroscope, pathological changes, tongue like, electrogastrogram, IL-8, the influence of IL-18, smoking, drinking, oral Hp infection and Hp eradication effect, the relationship between each group the occurrence of adverse reactions.Results:Study 1:"Stomach, liver, the heart-lung" and "stomach, spleen, lung and kidney" two metabolic pathways, and supplement each other, constitute the TCM zang-fu organs physiological model. Digestive disease of traditional Chinese medicine, the theoretical model can be summarized as "one core, two ways, three characteristic". A core, namely the spleen as the core; Two ways that is "the stomach, the liver-heart-lung" and "stomach, spleen, lung and kidney" two pathways; Three features:"Bupiwei sanyinhuo shengyangtang" mode, the digestive tract mucous membrane is the skin of visceral doctrine, astragalus membranaceus treating digestive system diseases special role. Anti Hp Fang according to the clinical treatment of diseases of the digestive system of traditional Chinese medicine formula theory model, made innovations in the field of pharmacology. Study 2:1. Breath test using chi-square test, chinese traditional medicine group of 10 cases were negative, clearance rate of 41.7%, western medicine group of 14 cases of negative, clearance rate of 60.9%. Breath test results showed that patients with breath test whether from conforms to the project data analysis or intentional analysis, western medicine group is slightly better than the traditional Chinese medicine, but not statistically significant (p> 0.05).2. From the point of symptom score, Chinese medicine group obviously improve the symptoms of patients with western medicine group, with statistical significance (p< 0.05).3. Chinese traditional medicine group of 25 cases,1 case lost, western medicine group of 25 cases, lost contact in 1 case, adverse reactions from the experiment in 1 case. Western medicine group of adverse drug reaction occurred 1 case of rash, doubt is panxi tora azole side effects. Two groups there were no obvious abnormal liver and kidney function before and after treatment, compared two groups of no statistical difference (p> 0.05). Study 3:1. Hp eradication:Group A clearance rate 41.9%, group B 72.7% clearance, group C clearance rate 87.5%, group D clearance rate 84.4%. Hp eradicate rate, according to the results from both conform to the plan data analysis or intentional analysis, C, D group result was better than control group (group A), the difference was statistically significant (p< 0.017). Group B compared with group A no statistical difference (p> 0.05).2. The clinical symptoms improved:According to the patients before treatment, the symptoms of the end, the end of the course of 1 month statistical results show that for gas, abdominal pain, bloating, heartburn symptoms, each symptom integral has a tendency to decline.Group C which improve the role of the gas, bloating, heartburn symptoms by the rank and analysis, compared with the control group with statistical significance (p< 0.017). Especially for abdominal distention, heartburn symptoms improved after treatment in January still obviously, prompt these patients can benefit in the long run. Group D to improve the effect of abdominal pain by the rank and analysis, compared with the control group with statistical significance (p< 0.017). The difference at the end of the course, the most obvious disappeared in 1 month after treatment.3. For the improvement of gastroscope images:Groups of bile reflux, congestion, edema, erosion improved obviously, the group C of bile reflux, congestion, edema, erosion is most obvious improvement, efficiency reached 71.4%,72.7% and 68.4% respectively, compared with the control group with statistical significance (p< 0.017); Group B, group D and no statistical difference compared with the control group. Groups for rough mucosa and submucosal vessels through see, abnormal movements, improve the poor, the overall curative effect is no statistical difference (p> 0.05).4. The pathological changes:Each group has effect on inflammatory change, The group C of the therapeutic effect of inflammation,improve obviously efficiency reached 61.3%, compared with the control group with statistical significance (p< 0.017). Group B and group D is not statistically significant compared with control group (p> 0.05).Groups for atrophy, intestinal metaplasia, hyperplasia improvement is poorer, the overall curative effect is not statistically significant.5. On the improvement of the tongue like:Group C on the tongue, tongue coating efficiency reached 67.9% and 61.5% respectively, compared with the control group with statistical significance (p< 0.017). Group B and group D on the tongue, tongue coating improved, compared with the control group no significant difference (p> 0.05).6. Electrogastrogram change:Results showed that each group of electrogastrogram in patients with primary function, frequency are i improved, the most obvious change in group C, compared with group A, group C of electrogastrogram main power, frequency, and abnormal electrogastrogram improved statistically significant (p< 0.017). Before treatment group C electrogastrogram 7 cases (21.9%), normal 24 cases (75%), normal after treatment compared with group A, p= 0.002< 0.017, statistically significant change.7. Interleukin change:Statistical results show that each group of IL 8, IL-18 were obviously improved. Group C and group D on IL-8-to reduce the result was better than control group (group A), the difference was statistically significant (p< 0.017). Group C and group D on the results of the IL-18 lower rank and inspection, A rank higher in group A and group B, but no statistical difference between groups (p> 0.05).8. Smoking, drinking, oral Hp infection with Hp eradication effect relationship:Logistic regression analysis showed that smoking and drinking factor has nothing to do with stomach Hp eradication results, P> 0.05, no statistical significance. And oral Hp infection and gastric inside there are correlation between Hp infection eradication, P< 0.05, with statistical significance.9. Adverse reactions:This experiment fall off 4 cases, group A fall off in 2 cases, group C and group D fall off in 1 case. Group D fall off of the adverse reactions occurred in 1 case, characterized by nausea, vomiting, dizziness, skin rash, considered to be the side effects of bismuth potassium citrate. Groups of liver and kidney function before and after treatment were in normal range, groups of liver and kidney function was no statistical difference (p> 0.05).10. After six months follow-up results:After six months to get the Hp eradication of follow-up, in patients with recurrence of each quantity is less, and the comparison between groups did not statistical difference, (p> 0.05). In retrospect it was found that in seven of the nine patients with recurrent oral Hp positive patients.Conclusion:The results above, we believe that the Anti Hp Fang formula precise, rational theoretical support fully. Anti Hp Fang used alone can achieve the same as the western medicine standard three transmitte Hp removal effect. And in the aspect of clinical symptoms improved compared with the western medicine standard three transmitte have an advantage. Anti Hp Fang quadruple solution can increase the rate of the eradication of Hp eradication failure patients,improve the clinical symptoms, gastroscope mucosal abnormalities, pathological inflammation, improve the gastrointestinal dynamics, correcting gastrointestinal rhythm disorders, eliminate local inflammation, reduce inflammatory factor, improve local circulation, speed up the glue the film repair. Regression analysis and oral Hp infection after six months follow-up results indicate there are correlation between Hp infection eradication and the stomach. Anti Hp Fang quadruple safety is good. Anti Hp Fang quadruple ideal solution scheme for Hp eradication failure of FD patients. |
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