质子泵抑制剂联合伊托必利治疗胃食管反流病18个月疗效观察

摘要

Objective To evaluate long-term outcomes of proton pump inhibitor combined with itopride on gastroesophageal reflux disease (GERD).Methods A total of 140 patients including 58 cases of non-erosive reflux disease (NERD),64 cases of erosive esophagitis (EE) and 18 cases of Barrett's esophagus (BE) were enrolled in this research.A prospective,randomized controlled and follow-up trial was conducted in these patients.They were randomly divided into three sub-groups according to maintenance therapy (reduction and maintain therapy,intermittent therapy,on-demand therapy).They accepted gastroesophageal reflux disease questionnaire (GerdQ) at four time points (before treatment,when the initial treatment was over,12 months and 18 months after maintenance treatment respectively),also endoscopic inspecting at 12 months and 18 months after maintenance treatment respectively.Each participant signed an informed consent before participating this research.Results After 8 weeks initial treatment,GerdQ scores of three groups descended than those before treatment (P =0.000) ; at 12 months after maintenance treatment,all scores of three groups descended than those at 8-week (P =0.000),at 18 months after maintenance treatment,scores of EE and BE groups descended further and were lower than those at 8-week (P =0.039 and P =0.032).After 12 months of maintenance treatment,score of reduction and maintain therapy subgroup in EE groups was lower than that of on-demand subgroup (P =0.008),after 18 months of maintenance treatment,scores of reduction and maintain therapy subgroup in NERD and EE groups were all lower than that of on-demand subgroup (P =0.042 and P =0.037).After 12 and 18 months of maintenance treatment,esophageal mucosal healing rate of EE group were all higher than those of before treatment (P =0.000).Conclusion Symptomatic improvement and mucosa healing degree of GERD will be further along with extending of maintenance treatment duration ; as regard of efficacy,reduction and maintain therapy is superior to ondemand therapy; PPI and ITO are proved to be better safety and toleration in long treatment on GERD.%目的 观察质子泵抑制剂+伊托必利联合维持治疗对胃食管反流病(GERD)患者的远期疗效.方法 经内镜、24 h食管pH测定或PPI试验确诊的GERD患者140例,其中非糜烂性反流病(NERD)58例、糜烂性食管炎(EE)64例、Barrett食管(BE)18例,采用前瞻性、随机对照随访研究,分别按维持治疗方案分为3个亚组,于治疗前、初始治疗结束时(8周)、治疗12个月、治疗18个月后进行GerdQ评分及内镜检查.结果 经8周初始治疗,NERD、EE及BE患者GerdQ评分均较治疗前降低(P=0.000);治疗12个月后,NERD、EE及BE患者平均GerdQ评分均较8周时下降(P=0.000);治疗18个月后,三组的GerdQ评分进一步下降,其中EE及BE患者的GerdQ评分与12个月时比较差异均有显著性(P=0.039及P=0.032).治疗12个月后,EE患者中减量维持亚组的GerdQ评分低于按需治疗组(P=0.008);治疗18个月后,NERD组及EE组中减量维持亚组的GerdQ评分均低于按需治疗组(P=0.042及P=0.037).维持治疗12个月及18个月后与治疗前比较,EE患者食管黏膜内镜下5种表现的构成比有极显著性差异(P =0.000).结论 GERD的症状改善及黏膜愈合程度随维持治疗时间的延长而更趋于明显并持续;就疗效而言,减量维持治疗优于按需治疗方案;18个月随访,PPI及ITO应用具有良好的安全性和耐受性.