[Jinghuaweikang capsules combined with triple therapy in the treatment of Helicobacter pylori associated gastritis and duodenal ulcer and analysis of antibiotic resistance: a multicenter, randomized, controlled, clinical study].

Objective To explore the efficacy of Jinghuaweikang capsules plus triple therapy (LACJ) in treatment of Helicobacter pylori (H.pylori) associated gastritis or duodenal ulcer,compare it with bismuth-containing quadruple therapy ( LACB ) and standard triple therapy ( LAC ) and analyze the antibiotic sensitivity of gastric mucosal H.pylori strains from the failed patients.Methods A total of 565 patients with H.pylori infection were recruited from 11 hospitals from January 2010 to June 2011.There were 336 males and 229 females.They underwent gastroendoscopy examination due to upper gastrointestinal symptoms and had never received H.pylori eradication therapies. Duodenal ulcer patients were divided randomly into LACJ therapy group,LACB therapy group and LAC therapy group while gastritis patients LACJ therapy group and LACB therapy group.Group LAC received lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg,twice a day,for 7 d (d1 -7).Group LACJ:LAC therapy plus Jinghuaweikang,3 capsules,twice a day,for 7 d (d1 -7) then Jinghuaweikang,3 capsules,twice a day,for 14 d (d8 -21 ).Group LACB:LAC plus bismuth potassium citrate 220 mg,twice a day,for 7 d (d1 -7) and then bismuth potassium citrate 220 mg,twice a day,for 14 d (d8 -21 ). All duodenal ulcer patients received lansoprazole ( 30 mg,once a day) for 14 days after the first 7-day of treatment ( d 8 - 21 ).At least 28 days after the end of treatment,all patients underwent 13C urea breath test.Gastric mucosa was collected under endoscopy from the failed patients.The detection technique of gene chip was employed to detect antibiotics resistant gene from mucosa. Results The eradication rates of duodenal ulcer patients in groups LACJ,LACB and LAC were as follows:per-protocol ( PP),80.2％ (77/96),89.9％ (89/99) and 72.2％ (70/97) (P =0.007),intention-to-treat ( ITT),78.6％ (77/98),88.1％ (89/101) and 70.0％ (70/100)( P =0.007).No statistical differences existed between groups LACJ and LACB or LAC ( all P ＞ 0.05 ).But there were statistical differences between groups LACB and LAC ( both P =0.002 ).The eradication rates of PP and ITT of chronic gastritis patients in groups 1ACJ and LACB were as follows:75.8％ (97/128),74.6％ (97/130) vs 83.8％ ( 109/130),80.1％ (109/136) ( both P ＞ 0.05).The symptomatic improvements of abdominal pain,burning and acid reflux of duodenal ulcer patients in group LACJ were higher than those in groups LACB and LAC.There were statistical differences between groups LACJ and LAC (all P ＜ 0.05 ).The symptomatic improvements of bloating and belching for chronic gastritis patients in group LACJ were higher than those of group LACB.But no significant difference existed between two groups ( all P ＞0.05 ).Sixty samples of gastric mucosa were collected from the failed patients.The detection rates of antibiotic-resistant gene to clarithromycin and amoxicillin were 60.0％ ( 36/36 ) and 18.3％ ( 11/60 )respectively.Conclusions The efficacy of LACJ for the treatment of H.pyloriinfection patients is similar to LACB and superior to LAC. And the symptomatic improvement of patients is better than the other two regimens.The main cause of treatment failure is antibiotic resistance of H.pyloristrains. Key words: Helicobacter pylori;  Drug therapy, combination;  Drug resistance;  CHINESE PATENT DRUGS