Clinical Rearearch Of Jianpi Yangwei Ointment In Treating Helicobacter Pylori Positive Chronic Non-atrophic Gastritis Of Spleen-deficiency And Dampness-heat Syndrome

ObjectjveThe purpose is to explore the the TCM syndrome curative effect,Heli cobacter pylori eradication rate,quality of life and safety of Jianpi Yangwei Ointment in the treat of Helicobacter Pylori positive Chronic Non-atrophic Gastritis of Spleen-deficiency and Dampness-heat Syndrome,to provied the clinical evidence for this disease with TCM.MethodIn this randomized controlled trial,72 patients with Helicobacter Pylori positive chronic non-atrophic gastritis of Spleen-deficiency and Dampness-heat syndrome were selected as the research object and were divided into two groups with 36 cases each.The treatment group was treated with Jianpi Yangwei Ointment for one month,while the control group was treated with quadruple therapy for 2 weeks and then with esomeprazole enteric-coated tablets till one month.The improvement of TCM symptoms and quality of life were observed after one month for medication and drug withdrawal for 3 months,and detect the Hp eradication rate after one month of withdrawal to evaluate clinical effect and safety.ResultsTCM spmptom total score:After one month intervened the total score of TCM spmptom of two group was decreased,in which the trial group was decreasesd more obviously than the control group(P<0.05).It means the trial group was superior than control group.After withdrawal 3 months,the total score of TCM spmtom in control group was not much change compared to after one month treatment(P>0.05),but which was significant decreased in the trial group(P<0.05).There were many uncontrollable factors during the period from one month to 3 months after treatment,so the result may suggest that Jianpi Yangwei Ointment can improve the digestive tract symptoms,and the curative effect can be maintained steadily and the recurrence rate is low compared with the control group.TCM symptom monoidal score:After one month of treatment,all the monoidal sore of TCM symptoms in the trial group were decreased(P<0.05),which suggested that the trial group could obviously improve the symptoms of TCM.In the control group,the scores of stomach distension,stomachache,heartburn or burning sensation,belching,bitterness of mouth and nausea were all decreased after one month treatment(P<0.05),but the other two symptoms had no significant change(P>0.05).The results suggest that the control group can obviously improve the symptoms of stomachache and other TCM symptoms.After one month of treatment,the trial group was superior to the control group in improving the integral degree of stomachache,bitterness of mouth,physical drowsiness,nausea and stool viscosity(P<0.05).After 3 months of withdrawal,the TCM symptom scores of stomachache,heartburn or burning sensation,bitterness of mouth and nausea,physical drowsiness in trail group was significantly lower than that after one month of treatment,while the scores of stomach distension and stool viscosity obviously increased(P<0.05).In the control group,the scores of stomach distension,belching,and nausea were significantly increased,while the scores of bitterness of mouth,physical drowsiness and stool viscosity were significantly decreased than that after one month of treatment(P<0.05),and a slight increase in the sore of stomachache,heartburn or burning sensation.After 3 months of withdrawal,all the TCM symptom scores other than stool viscosity in the trial group were superior than that in the control group(P<0.05).TCM syndrome effectiveness:After one month of treatment,the total effective rates of trial group and control group were 88.9%and 66.7%respectively(P<0.05).After 3 months of withdrawal,the total effective rates of trial group and control group were 94.4%and 50.0%(P<0.05).It suggests that the short-term and long-term curative effects of trial group are better than those of conrol group,and the clinical curative effect of trial group can be maintained after withdraw,while that of control group decreased.4.quality of life score:After 3 months of withdrawal,the pain score in the control group decreased significantly,the diet score increased significantly(P<0.05),and the other six aspects did not change significantly.In the trial group,except for urine and mood,the other six aspects decreased signifieantly(P<0.05).After 3 months of withdrawal,the improvement of energy,diet,stool and sleep in the trial group was significantly better than that in the control group(P<0.05).There was no differences in the improvement of pain,urine,mood and constitution between the two groups.5.Helicobacter pylori eradication rate:One month after drug withdrawal,the eradication rates of Hp in the trial group and the control group were 69.4%and 91.7%(P<0.05),which suggested that the eradication ability of Hp in the control group was better than that in the trial group.6.Analysis of adverse reactions:In the trial group,1 case had dry mouth and pharyngalgia and these can disappear and recovered well after proper treatment.In the control group,there were 4 cases of adverse reactions,of which 2 cases had black tongue coating and the other 2 cases suffered from physical fatigue.But adverse reactions above did not affect the progress of treatment and could be relieved after the withdrawal of the drug.Conclusion:Jianpi Yangwei Ointment can obviously improve the clinical efficacy,improve TCM symptoms and quality of life in the treatment of Hp-related chronic non-atrophic gastritis of Spleen-deficiency and Dampness-heat Syndrome.It is safe and worthy for application and promotion.