| Part ⅠObjective:To evaluate the efficacy of 7 classical prescriptions compared with anti-hp in the treatment of HPAG.Methods:The databases of CNKI、Wanfang、VIP and Pub Med were searched for randomized controlled trials(RCTs)on the treatment of HPAG with spleen-stomach damp-heat with seven classical prescriptions.Two reviewers screened the literature,extracted the data,and evaluated the quality and risk of bias of the included literature.Stata15.0 software was used for network meta-analysis.Results:A total of 47 studies involving 4122 patients and 9 interventions were included.The results of network meta-analysis showed that,In terms of Hp eradication efficacy,the ranking from high to low of these 9 interventions was Banxiaxexin decoction + anti-HP > Simiao pill + anti-HP >Huanglian-Wendan decoction + anti-Hp > Sanren decoction + anti-Hp >Huopuo-Xia-ling decoction + anti-Hp > Lianpuyin + anti-Hp > Huanglian-Wendan decoction > anti-Hp > Huanglian decoction.Conclusion(1)The combination of traditional Chinese medicine and western medicine is superior to the triple or quadruple therapy alone in the eradication rate of Helicobacter pylori:traditional Chinese medicine alone may not be able to compete with the triple or quadruple therapy in the eradication of Helicobacter pylori,so the combination of traditional Chinese medicine and western medicine is necessary.These results suggest that traditional Chinese medicine combined with anti-hp therapy may be superior to Traditional Chinese Medicine and anti-hp therapy alone.(2)Banxia-Xiexin decoction combined with anti-HP was superior to other 8interventions in the eradication rate of helicobacter pylori.Part IIObjective:To compare the safety and efficacy of Banxiaxiexin decoction combined with quadruple therapy and quadruple therapy in the treatment of HP-associated CAG with spleen and stomach damp-heat type through a prospective randomized controlled trial.The total clinical efficacy,the improvement of TCM syndrome score,gastroscopic and pathological efficacy,Hp eradication rate and the incidence of adverse reactions of Banxiaxiexin decoction combined with quadruple therapy were observed.Methods:After sample size estimation by PASS15.0 software,110 patients who met the inclusion criteria and were diagnosed with Helicobacter Pylori associated Chronic Atrophic Gastritis of spleen and stomach damp-heat type in our hospital from August 2021 to December 2022 were selected as the subjects of this trial.The patients were divided into treatment group(55cases)and control group(55 cases)by using SPSS 25.0 software to set random seeds.The control group was treated with quadruple therapy.The treatment group was treated with Banxiaxiexin decoction.Both groups were treated for14 days,and13C-UBT was reexamined 4 weeks after the end of treatment.After treatment,the total clinical efficacy,gastroscopy and pathological efficacy,various symptom scores and total TCM syndrome score changes,Hp eradication rate,and adverse reaction rate were observed.The efficacy of Banxiaxiexin decoction combined with quadruple therapy in the clinical treatment of Hp associated CAG of spleen and stomach damp-heat type was discussed.The data were analyzed by SPSS25.0 software and the conclusions were drawn.Results:There was no significant difference in gender、age、course of disease、gastroscopy and pathological results between the two groups before treatment(P>0.05).After treatment,3 cases were dropped out or excluded from the two groups,and 104 cases were finally included,with 52 cases in each group.Efficacy analyses were as follows:(1)The total clinical efficacy:In the treatment group,only 5 cases were ineffective and 47 cases were effective,with an effective rate of 90.38%.In the control group,12 cases were ineffective and 40 cases were effective,with an effective rate of 76.92%.The Treatment group was better than the Control group,with a statistically significant difference in the total clinical efficacy between the two groups(P<0.05).(2)Curative effect of gastroscopy and pathology:in the improvement of gastroscopy and pathology,the effective rate of the treatment group was86.5%,which was better than that of the control group(71.2%),the difference between the two groups was statistically significant(P<0.05).(3)TCM syndrome score:(1)Intra-group comparison: compared with before treatment,the total symptom score and each symptom score after treatment were decreased,and the difference between the two groups before and after treatment was statistically significant(P<0.05).(2)Comparison between groups:compared with the control group,the total symptom score of the treatment group decreased significantly after treatment,and the difference between the two groups was statistically significant(P<0.05).After treatment,the symptom scores of epigastric pain,epigastric burning,bitter mouth and halitosis,belching and acid regurgitation,poor appetite and fatigue,nausea and vomiting,and defecation difficulty were compared between the two groups.The reduction of symptom scores in the treatment group was better than that in the control group,and the horizontal differences between the two groups after treatment were statistically significant(P<0.05).(4)Hp eradication rate:After treatment,only 3 cases were positive and 49 cases were negative in the treatment group,and the eradication rate was92.3%.In the control group,11 cases were positive and 41 cases were negative,and the eradication rate was 82.7%.The Hp eradication rate of the treatment group was higher than that of the control group,and the difference between the two groups was statistically significant(P<0.05).(5)Adverse reaction rate:During the treatment,2 of 52 patients in the treatment group had adverse reactions;In the control group,11 of 52 patients had adverse reactions.The adverse reaction rates were 3.8% and 21.2%respectively.The rate of adverse reactions in the treatment group was lower than that in the control group,and the difference between the two groups was statistically significant(P<0.05).(6)Adverse reactions:1 case of nausea and 1 case of diarrhea in the treatment group;In the control group,there were 1 case of poor appetite,1 case of fatigue,2 cases of abdominal distension,2 cases of dry mouth,2 cases of stomach pain,and 3 cases of constipation.The adverse reactions in the two groups were mild,without special treatment,and disappeared after the course of treatment,without affecting the treatment.Conclusion(1)The treatment group was better than the control group in terms of total clinical efficacy,gastroscopy and pathological improvement,Hp eradication and safety.(2)Compared with the quadruple therapy alone,Banxiaxiexin decoction combined with quadruple therapy in the treatment of patients with Hpassociated CAG of spleen and stomach dampness-heat type has a significant effect on the total TCM symptom score and the symptom scores of epigastric pain,epigastric burning,bitter mouth and halitosis,belching and acid regurgitation,poor appetite and fatigue,nausea and vomiting,and dyschezia.(3)Banxiaxiexin decoction combined with quadruple therapy is significantly better than quadruple therapy alone in the improvement of clinical symptoms and Hp eradication in patients with Hp associated CAG of spleen and stomach damp-heat type,indicating that the combination of Chinese and Western medicine has significant advantages over simple western medicine therapy,which can improve the Hp eradication rate,reduce adverse reactions and improve patient compliance. |
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