质子泵抑制剂联合依托必利对胃食管反流病的疗效评价

Combination therapy of proton pump inhibitor and prokinetic agent in gastroesophageal reflux disease

目的观察质子泵抑制剂(proton pump inhibitor,PPI)联合盐酸伊托必利(itopride hydrochloride,ITO)对胃食管反流病(gastroesophageal reflux disease,GERD)的疗效,并评价该治疗方案的安全性及耐受性。方法经内镜、24 h食管pH测定或PPI试验确诊的GERD患者93例,按治疗方案随机分为PPI联合ITO治疗组及PPI单药治疗组,PPI联合ITO治疗组:糜烂性食管炎(EE)16例,非糜烂性反流病(NERD)21例,Barrett食管(BE)14例,共51例;PPI单药治疗组:EE 14例,NERD 16例,BE 12例,共42例。采用前瞻性、随访对照研究,于治疗前、治疗8周后、24周后进行GerdQ评分及内镜检查。结果 8周初始治疗后,两组内的3个亚型患者GerdQ评分均较治疗前明显降低,差异有统计学意义(P<0.01),24周后两组内EE及BE患者GerdQ评分较8周时进一步降低,差异有统计学意义(P<0.05);治疗8周及24周后两组EE患者食管黏膜愈合率分别为81.3%、71.4%(8周,P=0.00047)及93.8%、85.7%(24周,P=0.00036),PPI联合ITO治疗组食管黏膜愈合率高于PPI单药治疗组,差异有统计学意义(P<0.05)。结论就改善反流相关症状及食管黏膜愈合率而言,PPI联合ITO维持治疗方案优于PPI单药治疗,具有良好的安全性和耐受性。

Objective To observe the efficacy of proton pump inhibitor （PPI） combined with prokinetic agent in gastroesophageal reflux disease （GERD） and to evaluate the safety and toleration of this therapy.Methods A total of 93 patients were enrolled in this investigation,and randomly divided into two group：PPI combined with ITO treatment group （including 16 cases of EE,21 cases of NERD and 14 cases of BE） and PPI ammunition treatment group （including 14 cases of EE,16 cases of NERD,and 12 cases of BE）.A prospective,randomized controlled and follow-up trial was conducted.Gastroesophageal reflux disease questionnaire （Gerd Q） and gastroscopy were performed in all participants at three time points （before treatment,8-week initial treatment,and 24 weeks maintenance treatment,respectively）.Results After 8-week initial treatment,GerdQ scores of three subtypes in the two groups were significantly descended than those before treatment （P ＜0.01） ; at 24 weeks after maintenance treatment,GerdQ scores of EE and BE in the two group were descended further and were significantly lower than those at 8-week （P ＜ 0.05） ; after 8 weeks and 24 weeks maintenance treatment,esophagus mucosal healing rates of EE in PPI combined with ITO treatment group were higher than those in PPI ammunition treatment group （all P ＜ 0.001）.Conclusion Efficacy of PPI combined with ITO therapy is superior to PPI monotherapy in regard to improve reflux-related symptoms as well as esophagus mucosal healing rate; PPI and ITO are all proved to be safety and toleration in maintenance treatment of GERD.