| Objective: The aim of this study was to evaluate the effects and related adverse reaction of Compound Radix Linderae Tablets treat peptic ulcer and discussed its Pharmacological mechanism and provide scientific basis for drug promotion.Methods: Random allocation was taken to averagely divide patients who meet the inclusion criteria of peptic ulcer into Compound Radix Linderae Tablets group and Lansoprazole group.Compound Radix Linderae Tablets group treatment for the Compound Radix Linderae Tablets,5 slices a time,3times daily.Lansoprazole group treatment for Lansoprazole,30 mg a time,2times daily.All of the patients take pills respectively for 4 weeks.The helicobacter pylori positive patients,On the basis of the original drug,combine with bismuth potassium citrate,amoxicillin,clindamycin for helicobacter pylori eradication treatment,the treatment for 14 days.The evaluate of clinical manifestations,traditional Chinese medicine syndrome,mucosal damage under gastroscope and Helicobacter pylori before and after treatment.The research of patients relapse within 6 months and record the occurrence of adverse reactions in the process of treatment.The indicators data were analyzed using the statistical software.A total of 84 patients in this research.Results: There were no significant difference in age,sex distribution,the course of disease,the type of ulcer,the stage of ulcer activity,the size of ulcer,TCM symptoms properties,the infection of helicobacter pylori and clinical symptoms before treatment(every P>0.05).Patients of Compound Radix Linderae Tablets group and Lansoprazole group both have significant curative in the improvement of symptoms and the mucosal healing after treatment,the results have statistic difference(every P<0.05).Compared with the Lansoprazole group,the Compound Radix Linderae Tablets group had significantly better effect on relieving symptoms,such as abdominal distension,belching.Compared with the Compound Radix Linderae Tablets group,the Lansoprazole group had significantly better effect on relieving symptoms,such as burning senseation and acid regurgitation.The results are statistically significant difference(every P<0.05).There is no significant difference on relieving symptoms of stomachache,poor appetite,nausea and vomiting(P>0.05).The total effective rate were 90.7% and 82.9% on relieving symptoms of Compound Radix Linderae Tablets group and Lansoprazole group.There is no significant difference in total effective rate of improving symptom(P>0.05).Compound Radix Linderae Tablets had significantly better effect,when TCM syndrome type belonging to "insufficiency of spleen-yang,syndrome of static blood in stomach collaterals or sydrome of liver-qi stagnation".The results are statistically significant difference(P<0.05).The total effective rate were 81.4% and 87.8% in the improving of the healing of ulcer mucous.There is no significant difference in the improving of the healing of ulcer mucous(P>0.05).There is no significant difference in the eradication of helicobacter pylori between Compound Radix Linderae Tablets and Lansoprazole combined with bismuth potassium citarte,amoxicillin and clarithromycin.Compound Radix Linderae Tablets was better than Lansoprazole in reduce the recurrence rate of clinical symptoms and Ulcer recurrence within 6 weeks.The results are statistically significant difference(every P<0.05).Compound Radix Linderae Tablets group and Lansoprazole group do not adverse reaction during the period of treatment.Conclusion: Compound Radix Linderae Tablets had significantly better effect on relieving symptoms of patients with peptic ulcer and Promote the healing of mucosal.Compound Radix Linderae Tablets have characteristics of Less adverse reaction and low recurrence rate,So it can widely used in clinical treatment of peptic ulcer. |