泮托拉唑钠肠溶胶囊治疗反流性食管炎疗效观察

Clinical observation of Pantoprazole sodium enteric-coated capsules for treatment of reflux esophagitis

目的评价泮托拉唑钠肠溶胶囊治疗反流性食管炎的疗效和安全性。方法将138例反流性食管炎患者随机分为治疗组和对照组,每组各69例。治疗组给予泮托拉唑钠肠溶胶囊、枸橼酸莫沙必利分散片和铝碳酸镁片口服治疗,对照组仅给予枸橼酸莫沙必利分散片和铝碳酸镁片口服治疗。2组均治疗8周后观察疗效。结果就总体疗效而言,意向性分析结果显示2组总有效率分别为94.20%,84.06%,方案数据分析结果显示2组总有效率分别为96.92%,88.52%,疗效差异均有统计学意义P(<0.05),意向性分析与方案数据分析结果一致。临床观察中未发现明显毒副作用和不良反应。结论泮托拉唑钠肠溶胶囊治疗反流性食管炎安全有效,值得临床推广应用。

Objective To assess the efficacy and safety of Pantoprazole sodium enteric-coated capsules in the treatment of reflux esophagitis.Methods 138 patients of reflux esophagitis were randomly divided into treatment group and control group.There were 69 patients in each group.The treatment group were treated with Pantoprazole sodium enteric-coated capsules and Mosapride citrate tablets and Hydrotalcite tablets.The control group with tablets Mosapride citrate and tablets Hydrotalcite.8 weeks later,their therapeutic effects were observed.Results All the results were analyzed on the basis of intention-to-trea（tITT）and per-protocol population（PP）,the total effective rate was 94.20% or 96.92% in the treatment group and 84.06% or 88.52% in the control group with the significant difference between the two groups,P0.05.ITT and PP analysis revealed similar results.No adverse effect was found in the observation.Conclusion Pantoprazole sodium enteric-coated capsules is effect and safe for treatment of reflux esophagitis.