| Objective:Our research made comparison among three groups of gastric ulcer patients,which contained group without mucosal-protective agent,group with bismuth and group with rebanipide.We could evaluation the safety and efficacy of rebamipide in therapy of gastric ulcer through observing healing of ulcer,histological changes of gastric mucosal,changes of clinical symptoms,eradication of Helicobacter pylori(Hp)and side effects.Through these we could optimize the selection of mucosal protective agents,and try to find the alternative of bismuth which may cure Hp well.Methods:180 patients with gastrointestinal ulcer were collected from Navy General Hospital,including 90 patients with Hp and 90 patients without Hp.Hp(+)gastric ulcer patients were randomly divided into triple group(30 patients),B quadruple group(30 patients),R quadruple group(30 patients).The treatment of these groups were Pantoprazole Sodium Enteric-Coated Tablets 40 mg 2 / day + Amoxicillin and Clavulanate Potassium Tablets 1500 mg 2 / day + Clarithromycin Tablets 500 mg 2 / day;Pantoprazole Sodium Enteric-Coated Tablets 40 mg 2 / Day + Amoxicillin and Clavulanate Potassium Tablets 1500 mg 2 / day + Clarithromycin Tablets 500 mg 2 / day + Bismuth Potassium Citrate capsules 0.3g 3 / day;Pantoprazole Sodium Enteric-Coated Tablets 40 mg 2 / day + Amoxicillin and Clavulanate Potassium Tablets 1500 mg 2 / day + Clarithromycin Tablets 500 mg 2 / day + Rebanipide Tablets 100 mg 3 / day.Start taking medication on day 0.Antibiotics were discontinued on day 14.Review the endoscopy on day 28.The symptoms,morphology of ulce and gastric mucosa were recorded on day 0 and day 28.The adverse events were recorded on day 28.The 13 C breath test was performed and the eradication of Hp was recorded.Finally,the differences among the three groups were compared.Hp(-)gastric ulcer patients were randomly divided into PPI group(31 patients),PPI+B group(26 patients),PPI+R group(33 patients).The treatment of these groups were Pantoprazole Sodium Enteric-Coated Tablets 40 mg 2 / day;Pantoprazole Sodium Enteric-Coated Tablets 40 mg 2 / Day + Bismuth Potassium Citrate capsules 0.3g 3 / day;Pantoprazole Sodium Enteric-Coated Tablets 40 mg 2 / day + Rebanipide Tablets 100 mg 3 / day.Start taking medication on day 0.Review the endoscopy on day 28.The symptoms,ulce morphology and gastric mucosa histological structure were recorded on day 0 and day 28.The adverse events were recorded on day 28.Finally,the differences among the three groups were compared.Results:1,After 28 days of treatment there was significantly difference among the three Hp(+)gastric ulcer groups in number of ulcers,AHS classification,number of patients with S level ulcer and ulcer healing(p <0.05),but no significant difference in ulcer diameter,Forrest classification and total efficiency(p> 0.05).We made comparison between two groups and find that in number of ulcers,R quadruple group(0.30±0.53),B quadruple group(0.40±0.72)were less than triple group(0.83 ± 0.87).The difference was significant(P<0.05,P<0.05).In AHS classification,there was significantly difference between R quadruple group and triple group(P<0.05).In the former group there were more ulcer patients out of acute period than the latter group.In the rate of patients with S level ulcer,R quadruple group(73.73%)was higher than triple group(40%).The difference was significant(P<0.017).In ulcer healing,there was significantly difference between R quadruple group and triple group(P<0.05).The former group was batter latter group.2,In the Hp eradication rate of Hp(+)gastric ulcer patients,there was significantly difference among the three groups(p<0.05).We made comparison between two groups and find that the rate of B quadruple group(96.67%)was higher than triple group(73.33%).The difference was significant(P<0.017).R quadruple group(86.67%)was compared with triple group(73.33%)and B quadruple group(96.67%),there was no significant difference between the two(P>0.017,P>0.017).3,After 28 days of treatment there was significantly difference among the three Hp(+)gastric ulcer groups in endoscopic mucosal injury scores(P<0.05).We made comparison between two groups and find R quadruple group(1.13±0.35),B quadruple group(1.40±0.56)were less than triple group(1.87±0.78).The difference was significant(P<0.05,P<0.05).4,After 28 days of treatment there was significantly difference among the three Hp(+)gastric ulcer groups in abdominal pain integration,heartburn integration and total integration(p <0.05),but no significant difference in gas integration,abdominal distention integration and anorexia integration(P>0.05).We made comparison between two groups and find that in abdominal pain integration,R quadruple group(0.17±0.38),B quadruple group(0.20±0.41)were less than triple group(0.57 ± 0.68).The difference was significant(P<0.05,P<0.05).In heartburn integration,R quadruple group(0.10±0.31)was lower than triple group(0.60 ± 0.67)and B quadruple group(0.40 ± 0.56).The difference was significant(P<0.05,P<0.05).In total integration,R quadruple group(0.93±0.98)was lower than triple group(1.93±1.87).The difference was significant(P<0.05).5,After 28 days of treatment of Hp(+)gastric ulcer patients,there were 3 diarrhea patients and 1 nausea patient appeared in the triple group.In B quadruple group there was 1 diarrhea patient,2 nausea patient and 2 bitter-taste patients.In R quadruple group there was 1 nausea patient.In side effects integration there was no significantly difference among three groups(P>0.05).6,After 28 days of treatment there was significantly difference among the three Hp(-)gastric ulcer groups in number of ulcers,AHS classification,number of patients with S level ulcer and ulcer healing(p <0.05),but no significant difference in ulcer diameter,Forrest classification and total efficiency(p> 0.05).We made comparison between two groups and find that in number of ulcers,PPI+R group(0.39±0.70),PPI+ B group(0.35±0.63)were less than PPI group(0.74 ± 0.63).The difference was significant(P<0.05,P<0.05).In AHS classification,there was significantly difference between PPI+R group and PPI group(P<0.05).In the former group there were more ulcer patients out of acute period than the latter group.In the rate of patients with S level ulcer,PPI+R group(69.70%)and PPI+B group(73.08%)were higher than PPI group(35.48%).The difference was significant(P<0.017,P<0.017).In ulcer healing,there was significantly difference between PPI+R group and PPI group(P<0.05).The former group was batter latter group.7,After 28 days of treatment there was significantly difference among the three Hp(-)gastric ulcer groups in endoscopic mucosal injury scores(P<0.05).We made comparison between two groups and find PPI+R group(1.18±0.39),PPI+B group(1.23±0.51)were less than PPI group(1.71±0.78).The difference was significant(P<0.05,P<0.05).8,After 28 days of treatment there was significantly difference among the three Hp(-)gastric ulcer groups in abdominal pain integration,heartburn integration and total integration(p<0.05),but no significant difference in gas integration,abdominal distention integration and anorexia integration(P>0.05).We made comparison between two groups and find that in abdominal pain integration,PPI+R group(0.21±0.48),PPI+B group(0.23±0.43)were less than PPI group(0.61 ± 0.72).The difference was significant(P<0.05,P<0.05).In heartburn integration,PPI+R group(0.15±0.36)、PPI+B group(0.15±0.37)were lower than PPI group(0.52±0.68).The difference was significant(P<0.05,P<0.05).In total integration,PPI+R group(0.94±1.54)was lower than PPI group(2.00±1.81).The difference was significant(P<0.05).9,After 28 days of treatment of Hp(-)gastric ulcer patients,there was 1 diarrhea patient in PPI group.In PPI+B group there was 1 bitter-taste patient.In side effects integration there was no significantly difference among these groups(P>0.05).Results:Among Hp(+)and Hp(-)gastric ulcer patients,according to the significance of treatment effect in the endoscopic performance and clinical symptoms,We sorted these drugs as rebamipide>bismuth>without mucosal-protective agent.In endoscopic mucosal injury scores,rebamipide≈bismuth>without mucosal-protective agent.In the Hp eradication rate,B quadruple group> R quadruple group> triple group.But there was statistical significance only between B quadruple group and triple group.There was no significant difference between any other two groups.All above suggested that rebamipide may have the effect of eradicating Hp.But this conclusion lacked significance. |
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