艾普拉唑肠溶片治疗十二指肠溃疡安全性和有效性的临床研究

Clinical Research of Safety and Effectiveness of Ilaprazole Enteric-coated Tablets in the Treatment of Duodenal Ulcer

目的:探讨艾普拉唑肠溶片治疗十二指肠溃疡的疗效及安全性。方法:将2012年1-12月在本院确诊为活动性十二指肠溃疡的62例患者随机分为观察组和对照组,每组各31例。观察组采用艾普拉唑肠溶片治疗,对照组采用奥美拉唑肠溶片治疗。对两组患者治疗过程中的临床症状、溃疡愈合情况、Hp根除率及不良反应发生情况进行对比分析。结果:观察组患者用药后的腹痛、烧灼感、反酸消失时间均明显短于对照组,差异均有统计学意义(P<0.05)。观察组患者治疗2周末临床症状消失率为80.65%,明显高于对照组的54.84%,差异有统计学意义(P<0.05)。观察组患者治疗4周末溃疡愈合率为96.77%,明显高于对照组的74.19%,差异有统计学意义(P<0.05)。治疗结束时,两组患者的Hp根除率及不良反应发生率比较差异均无统计学意义(P>0.05)。结论:艾普拉唑能有效改善十二指肠溃疡患者的临床症状,提高溃疡愈合率与症状消失率,其疗效确切,安全性高,值得在临床上推广应用。

Objective： To investigate the safety and effectiveness of Ilaprazole Enteric-coated Tablets in the treatment of duodenal ulcer.Method： 62 patients who diagnosed as active duodenal ulcer in our hospital from January 2012 to December 2012 were randomly divided into the observation group and the control group, 31 cases in each group.The observation group was treated with Ilaprazole Enteric-coated Tablets, the control group was treated with Omeprazolc Enteric-coated Tablets.The clinical symptoms in the process of treatment, the ulcer healing, Hp eradicate rate and adverse reactions between the two groups were compared and analyzed.Result： The disappearance time of abdominal pain, burning sensation, acid reflux in the observation group were significantly shorter than the control group, the difference was statistically significant （ P〈0.05 ） .Through two weeks therapy, the clinical symptom disappearance rate of the observation group was 80.65%, which was significantly higher than 54.84% of the control group, the difference was statistically significant （ P〈0.05 ） .After four weeks therapy, the ulcer healing rate of the observation group was 96.77%, which was significantly higher than 74.19% of the control group, the difference was statistically significant （ P〈0.05 ） .At the end of the treatment, there were no statistically significant differences in Hp eradicate rate and incidence of adverse reactions between the two groups （P〉0.05） .Conclusion： Ilaprazole can effectively improve the clinical symptoms of patients with duodenal ulcer, increase the rate of ulcer healing rate and symptoms disappear, its curative effect, high safety, is worth popularization and application in clinic.