【摘要】 探讨质子泵抑制剂联合复方消化酶片治疗伴腹胀上腹痛综合征型功能性消化不良患者的临床疗效和安全性。方法将138例伴腹胀上腹痛综合征型功能性消化不良患者,按照随机双盲法分为两组,每组69例,均予以早餐前0.5 h口服质子泵抑制剂埃索美啦唑肠溶片治疗,观察组在此基础上联合口服复方消化酶片治疗,观察14 d。治疗前后参照《功能性消化不良的中西医结合诊治方案》评定临床症状,检测胃蛋白酶原Ⅰ、胃蛋白酶原Ⅱ水平变化,随时记录两组患者治疗过程中出现的不良反应。结果治疗后两组上腹部疼痛、上腹部灼热感评分及临床症状总分均较治疗前显著下降(P<0.01),观察组评分显著低于对照组(P<0.01);两组胃蛋白酶原Ⅰ、胃蛋白酶原Ⅱ水平均较治疗前显著升高(P<0.05或0.01),观察组胃蛋白酶原Ⅰ、胃蛋白酶原Ⅱ水平均显著高于对照组(P<0.01)。观察组总有效率(89.9%)显著高于对照组(72.5%)(P<0.05),不良反应发生率与对照组比较差异无统计学意义(P>0.05)。结论质子泵抑制剂联合复方消化酶片治疗伴腹胀上腹痛综合征型功能性消化不良患者具有协同增效作用,能有效抑制患者体内胃酸的分泌,改善或缓解临床症状,疗效显著,安全性高。更多还原

【Abstract】 Objective To investigate the clinical efficacy and safety of proton pump inhibitor combined with compound digestive enzyme tablets on treatment of functional dyspepsia(FD) with upper abdominal pain syndrome(EPS) and abdominal distension. Methods 138 cases of FD with EPS and abdominal distension were randomly divided into control group and observation group, 69 cases in each group. They were all given oral proton pump inhibitor esomprazole enteric coating, and the observation group was given oral compound digestive enzyme tablets on this basis, patients were observed for 14 d. Integrative medicine diagnosis and therapy project of functional dyspepsia was used to evaluate the clinical symptoms before and after treatment, PG-Ⅰ, PG-Ⅱ level changes were detected, adverse reactions of the two groups during therapeutic process were recorded at any time. Results After treatment, the upper abdominal pain score,the upper abdominal burning sensation score and the clinical symptom total score of the two groups were all significantly declined(P<0. 01), the scores of the observation group was significantly lower than that of the control group(P<0. 01); the level of pepsinogen Ⅰ(PG-Ⅰ) and pepsinogen Ⅱ(PG-Ⅱ) of the two groups were significantly increased compared with those before treatment(P<0. 05 or 0. 01), PG-Ⅰ, PG-Ⅱlevels of the observation group were significantly higher than those of the control group(P<0. 01). Total efficiency of the observation group(89. 9%) was significantly higher than that of the control group(72. 5%)(P<0. 05),the difference of adverse reaction rate between the two groups had no statistic significance(P>0.05). Conclusion Proton pump inhibitor combined with compound digestive enzyme tablets on treatment of functional dyspepsia with upper abdominal pain syndrome and abdominal distension have synergistic interaction, it can effectively inhibit acid secretion, improve or relieve clinical symptoms, the curative effect is significant and with higher safety.更多还原