| ObjectivesTo evaluate the clinical efficacy, advantages and disadvantages of fortifying the spleen, dispelling dampness and clearing heat method on eradicating the helicobacter pylori (Hp) comparing with pure western medicine by a prospective study. To analyze the mechanism of eradicating the helicobacter pylori with fortifying the spleen, dispelling dampness and clearing heat method by in vitro bacteriostasis experiments and animal experiments.MethodsⅠ. Clinical study part72 cases of patients with Hp infection were divided into triple antibiotic therapy combine with Chinese herbs group and quadruple antibiotic group by using the random single blind method. Making a questionnaire survey and record of the age, sex, symptom score, PRO scale scores and SF-36 quality of life scale scores of the patients before accepting an eradication treatment. Patients in triple antibiotic therapy combine with Chinese herbs group were given amoxicillin capsules (1g, bid, after meals), clarithromycin(0.5g bid, after meals), esomeprazole magnesium enteric-coated tablets(20mg, bid, before meals) and Jianpiqishiqingre formula (one dose per day, bid). Patients in quadruple antibiotic group were given amoxicillin capsules (1g, bid, after meals), clarithromycin (0.5g bid, after meals), esomeprazole magnesium enteric-coated tablets (20mg, bid, before meals) and bismuth potassium citrate capsules (0.22g, bid, before meals). All the patients in each group accepted 10 day treatment for 1 course. To evaluate clinical significance by making a 13C/14C breath test, Hp serum antibody detection at least 4 weeks after completing a given treatment for all subjects. And then collecting and analyzing the symptom score, PRO scale scores and SF-36 quality of life scale scores in two groups.Ⅱ. Experimental study partAgar diffusion method (AGAR) and broth dilution method were used to analyze the minimal inhibitory concentration (MIC) and Minimal bactericidal concentration (MBC) of Qingre huashi shuwei formula and its compatibility of not-cold and cold on eradicating the Hp. And then using KM mouse to copy an animal model infected by Hp, divided this mice into Jianpiqishiqingre formula group, triple antibiotic group, Jianpiqishiqingre formula combine with triple antibiotic group and model group. The normal animals were used as control group. Content of nitric oxide in serum of different groups were detected by nitrate reduction method and levels of inducible nitric oxide synthase (iNOS) in gastric tissue of different groups were tested by immunohistochemistry (IHC).ResultsⅠ.Clinical study partOnly 67 cases finished the treatment, reexamination and questionnaire, while 5 cases of patients with Hp infection fell off. Eradication rate of Hp in triple antibiotic therapy combine with Chinese herbs group was 91.7%, in quadruple antibiotic group was 93.5%, which showed no significantly difference (P>0.05).Symptom score decreased significantly both in triple antibiotic therapy combine with Chinese herbs group and quadruple antibiotic group (P<0.05), while it decreased more obvious in triple antibiotic therapy combine with Chinese herbs group than that in quadruple antibiotic group (P<0.05). All symptoms were relieved in triple antibiotic therapy combine with Chinese herbs group while quadruple antibiotic therapy could only relieve the symptoms of belching, acid reflux and heartburn, gasteremphraxis. The improvements and overall response rate (ORR) in triple antibiotic therapy combine with Chinese herbs group showed significantly better than that in quadruple antibiotic group (P<0.05).PRO scale scores showed that the overview, regurgitation, dyspepsia, defecation and self-evaluation decreased significantly in both two groups comparing with prior treatment (P<0.05). Statistic analysis result shows that there’s no obvious difference in psychological function dimension and social function dimension between two groups after treatment (P>0.05). Meanwhile, we found that it was better to using triple antibiotic therapy combine with Chinese herbs to improve the overview, dyspepsia, defecation than quadruple antibiotic therapy.SF-36 quality of life scale scores showed that BP, GH, VT, SF, RE, MH increased significantly in triple antibiotic therapy combine with Chinese herbs group comparing with prior treatment (P<0.05) while PF decreased and RP showed no change. The variation trend of PF, BP, GH, SF, RE and MH in quadruple antibiotic group were in keeping with triple antibiotic therapy combine with Chinese herbs group, and VT, RE showed no change. PF, RP, SF showed no significant difference in two groups after treatment while BP, GH, VT and MH was higher in triple antibiotic therapy combine with Chinese herbs group than in quadruple antibiotic group (P<0.05).Adverse reactions (ADR) of patients in the two groups mainly bitter taste and melena. There were no skin rash and symptom increased in treating process.Ⅱ.Experimental study partBacteriostatic ring diameter of Jianpiqishiqingre formula group, not cold group, cold group and triple antibiotic group was (14.30±1.12) mm, (3.13 ±0.82)mm, (13.93±0.95)mm and (23.25±1.33) mm, respectively. MIC and MBC of Jianpiqishiqingre formula was 7.81mg/ml and 15.63mg/ml.Histomorphology showed that there was a serious colonization of Hp in gastric tissue and chronic inflammatory change with different degrees of damage in gastric mucosa of KM mouse infected by Hp. The content of NO in serum and expression level of iNOS in gastric mucosa of model group increased significantly comparing with control groups (P<0.05). When given Jianpiqishiqingre formula, chronic inflammatory, content of NO in serum and expression level of iNOS in gastric mucosa decreased significantly (P<0.05). And these effects showed nothing to do with antibiotics.ConclusionTriple antibiotic therapy combine Jianpiqishiqingre formula has a good clinical efficacy on eradicating the Hp, which may have something to do with decreasing the content of NO in serum and expression level of iNOS in gastric mucosa to reduce the chronic inflammatory. As well, Jianpiqishiqingre formula has a good growth inhibitory effect on Hp in vitro, the bacteriostatic ability may mainly come from the characteristics of cold medicines. |
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