复方消化酶胶囊联合泮托拉唑治疗功能性消化不良的疗效观察

Clinical observation of Compound Digestive Enzyme Capsules combined with pantoprazole in treatment of functional dyspepsia

目的探讨复方消化酶胶囊联合泮托拉唑钠肠溶片治疗功能性消化不良的临床疗效。方法选取2014年12月—2016年12月周口市中医院消化内科收治的功能性消化不良患者161例,所有患者在随机分组的原则下分成对照组(80例)和治疗组(81例)。对照组早餐前口服泮托拉唑钠肠溶片,40 mg/次,1次/d。治疗组在对照组基础上餐前口服复方消化酶胶囊,1粒/次,3次/d。两组患者均治疗28 d。观察两组的临床疗效,比较两组消化系统症状、胃排空时间和不良反应情况。结果治疗后,对照组和治疗组的总有效率分别为83.75%、97.53%,两组比较差异有统计学意义(P<0.05)。治疗后,两组胃部烧灼感、上腹部疼痛、早饱和餐后饱胀的发生率明显降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组这些观察指标的发生率明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组胃排空时间明显缩短,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组胃排空时间明显短于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,对照组和治疗组的不良反应发生率分别为21.25%、8.64%,两组比较差异有统计学意义(P<0.05)。结论复方消化酶联合泮托拉唑钠肠溶片治疗功能性消化不良具有较好的临床疗效,可改善临床症状,缩短胃排空时间,安全性较好,具有一定的临床推广应用价值。

Objective To investigate the effect of Compound Digestive Enzyme Capsules combined with Pantoprazole Sodium Enteric-Coated Tablets in treatment of functional dyspepsia. Methods Patients（161 cases） with functional dyspepsia in Department of Gastroenterology of Zhoukou Hospital of TCM from December 2014 to December 2016 were randomly divided into the control group（80 cases） and the treatment group（81 cases）. Patients in the control group were po administered with Pantoprazole Sodium Enteric-Coated Tablets before breakfast, 40 mg/time, once daily. Patients in the treatment group were po administered with Compound Digestive Enzyme Capsules before meal on the basis of the control group, 1 grain/time, three times daily. Patients in two groups were treated for 28 d. After treatment, the clinical efficacies were evaluated, and digestive system symptoms, gastric emptying time, and adverse reactions in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 83.75% and 97.53%, respectively, and there was difference between two groups（P〈0.05）. After treatment, the incidence rates of stomach burning, upper abdominal pain, early satiety, and postprandial fullness in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the gastric emptying times in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the gastric emptying times in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the incidence rates of adverse reactions in the control and treatment groups were 21.25% and 8.64%, respectively, and there was difference between two groups（P〈0.05）. Conclusion Compound Digestive Enzyme Capsules combined with Pantoprazole Sodium Enteric-Coated Tablets has clinical curative effect in treatment of functional dyspepsia, can improve clinical symptoms, and shorten the gastric emptying time, with good safety, which has a certain clinical application value.