泮托拉唑钠肠溶片联合盐酸伊托必利片治疗反流性食管炎伴2型糖尿病患者的临床研究

Clinical trial of pantoprazole sodium enteric-coated tablets combined with itopride hydrochloride tablets in the treatment of patients with reflux esophagitis and type 2 diabetes mellitus

目的观察泮托拉唑钠肠溶片联合盐酸伊托必利片治疗反流性食管炎伴2型糖尿病患者的临床疗效及安全性。方法将120例反流性食管炎伴2型糖尿病患者随机分为对照组和试验组,每组60例。对照组给予伊托必利每次50 mg,tid,于三餐前15 min口服+法莫替丁每次20 mg,bid,口服;试验组给予伊托必利每次50 mg,tid,于三餐前15 min口服+泮托拉唑钠每次40 mg,qd,晨起顿服。2组均连续治疗4周。比较2组患者的临床疗效、胃肠激素和白细胞介素-17(IL-17)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为88.33%(53例/60例)和73.33%(44例/60例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的胃泌素分别为(114.47±31.66)和(142.65±36.51)ng·L^(-1),胃动素分别为(405.84±65.44)和(367.36±57.68)ng·L^(-1),IL-17分别为(31.02±4.75)和(36.89±5.44)μg·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有胃肠道反应和头晕,对照组发生的药物不良反应有口干、胃肠道反应和头晕。试验组和对照组的总药物不良反应发生率分别为6.67%和11.67%,差异无统计学意义(P>0.05)。结论泮托拉唑钠肠溶片联合盐酸伊托必利片治疗反流性食管炎伴2型糖尿病患者的临床疗效确切,其能有效地调节胃肠激素和IL-17的表达水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of pantoprazole sodium enteric-coated tablets combined with itopride hydrochloride tablets in the treatment of reflux esophagitis with type 2 diabetes mellitus.Methods A total of 120 patients with reflux esophagitis and type 2 diabetes were randomly divided into control group and treatment group with 60 cases per group.The control group was given itopride 50 mg,tid,15 minutes before meal,oral+famotidine 20 mg,bid,orally.The treatment group was given itopride 50 mg,tid,15 minutes before meal,oral+pantoprazole sodium 40 mg,qd,orally in the morning.Two groups were treated for 4 weeks.The clinical efficacy,levels of gastrointestinal hormone and interleukin-17(IL^(-1)7),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 88.33%(53 cases/60 cases)and73.33%(44 cases/60 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:the levels of gastrin were(114.47±31.66)and(142.65±36.51)ng·L^(-1),the levels of motilin were(405.84±65.44)and(367.36±57.68)ng·L^(-1),the levels of IL^(-1)7 were(31.02±4.75)and(36.89±5.44)μg·L^(-1),all the differences were statistically significant(all P<0.05).The adverse drug reactions in the treatment group were gastrointestinal reaction and dizziness,while those in control group were dry mouth,gastrointestinal reaction and dizziness.The total incidences of adverse drug reactions were 6.67%and 11.67%without significant difference(P>0.05).Conclusion Pantoprazole sodium enteric-coated tablets combined with itopride hydrochloride tablets have a definitive clinical efficacy in the treatment of patients with reflux esophagitis and type 2 diabetes,which can effectively regulate the expression of gastrointestinal hormones and IL^(-1)7,without increasing the incidence of adverse drug reactions.