摘要目的 探讨荆花胃康胶丸(主要成分:土荆芥和水团花)联合三联疗法治疗幽门螺杆菌(Hp)相关十二指肠溃疡或胃炎的疗效,并观察Hp根除失败患者耐药情况.方法 采用前瞻性随机对照多中心临床研究,对象为因上胃肠道症状而接受胃镜检查且伴有Hp感染的患者,于2010年1月至2011年6月全国11个中心565例符合入选标准的患者被纳入,其中男336例.采用分层随机方法分别将299例十二指肠溃疡患者分为荆花胃康组(98例)、含铋四联组(101例)和标准三联组(100例),将266例胃炎患者分为荆花胃康组(130例)和含铋四联组(136例).标准三联组:兰索拉唑30 mg+阿莫西林1000 mg+克拉霉素500 nmg,2次/d,疗程7d(d1～7)；荆花胃康组:标准三联组方案加荆花胃康胶丸3粒,2次/d,疗程7d(d1～7),之后荆花胃康胶丸3粒,2次/d,14 d(d8～ 21)；含铋四联组:标准三联组方案加枸橼酸铋钾220 mg,2次/d,疗程7d(d1～7),之后枸橼酸铋钾220 mg,2次/d,14d( d8～21)；各组入选的十二指肠溃疡患者在Hp根除治疗7d后继续兰索拉唑30mg,1次/d,治疗14d(d8 ～ 21).治疗结束至少28 d后所有患者均接受13C-尿素呼气试验检测Hp,并对治疗后Hp未根除患者应用Hp耐药基因芯片检测技术检测胃黏膜Hp菌株对抗生素的耐药情况.结果 十二指肠溃疡患者荆花胃康组、含铋四联组及标准三联组的Hp根除率符合方案数据分析(PP)分别为80.2％(77/96)、89.9％(89/99)、72.2％( 70/97)(P=0.007),意向性分析(ITT)分别为78.6％ (77/98)、88.1％(89/101)、70.0％ (70/100)(P=0.007),其中含铋四联组与标准三联组比较差异均有统计学意义(均P =0.002),而与荆花胃康组差异均无统计学意义(均P＞0.05).慢性胃炎患者荆花胃康组和含铋四联组Hp根除率PP和ITT分别为75.8％(97/128)、83.8％(109/130),74.6％ (97/130)、80.1％(109/136),差异均无统计学意义(均P＞0.05).荆花胃康组上腹痛、烧灼和反酸的症状改善均高于标准三联组(均P＜0.05).对60例治疗失败患者的胃黏膜Hp菌株对克拉霉素和阿莫西林的耐药基因检出率分别为60.0％( 36/60)和18.3％ (11/60).结论 荆花胃康胶丸联合三联疗法治疗Hp感染疗效明显高于标准三联疗法,与含铋四联疗法相近.Hp对抗生素耐药是导致治疗失败的主要原因.

abstractsObjective 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.