铝碳酸镁联合奥美拉唑治疗活动期胃溃疡的随机、平行对照、多中心临床研究

Evaluation of hydrotalcite combined with omeprazole in treatment of gastric ulcer:A multi-center.randomized,controlled clinical trial

目的比较铝碳酸镁咀嚼片(商品名:达喜(?))联用奥美拉唑或单用奥美拉唑治疗成人活动期胃溃疡患者的临床症状改善情况、内镜下溃疡愈合率以及组织学溃疡愈合质量。方法采用多中心、随机、平行对照研究,将88例经胃镜证实伴幽门螺杆菌感染的成人活动期胃溃疡患者,随机分为试验组(45例)和对照组(43例)。治疗第1周,两组均予幽门螺杆菌根除三联疗法,试验组同时给予铝碳酸镁咀嚼片每次1000mg,每日4次嚼服。第2～6周,试验组给予铝碳酸镁(剂量服法同前)联合奥美拉唑胶囊20 mg,每晨1次口服。对照组仅给予奥美拉唑胶囊20 mg,每晨1次口服。第7～8周,试验组继续给予铝碳酸镁咀嚼片(剂量服法同前),对照组停药。结果首次服药后上腹痛消失时间对照组为2 d,试验组仅0.5d,两组间差异有统计学意义(P<0.001)。治疗第1周末,试验组改善腹痛、腹胀、反酸、嗳气、呕吐的发生频率显著优于对照组(P<0.05),试验组改善腹痛程度亦显著优于对照组(P<0.01)。治疗8周后,两组内镜下溃疡愈合总有效率差异无统计学意义(P>0.05)。病理组织学检查显示试验组腺体密度和腺管形态恢复显著优于对照组(P<0.05)。结论治疗活动期胃溃疡,在质子泵抑制剂有效抑酸基础上,联合应有兼有抗酸、抗胆汁作用的胃黏膜保护剂铝碳酸镁,能更快缓解多种临床症状,尤其是迅速缓解胃痛。加用铝碳酸镁能显著促进胃黏膜组织形态结构的恢复,提高溃疡愈合质量。

Objective To evaluate the clinical symptoms relief, ulcer healing rate and the histologic quality of ulcer healing after the treatment of hydrotalcite （Talcid） combined with omeprazole oromeprazole alone in the patients with active gastrie ulcer. Methods A multi-center, randomized. parallel controlled clinical study was conducted. Eighty-eight patients with active gastric ulcer and Helicobacter pylori （H. pylori）infection were randomized into the study group （n=45） and controll group （n=43）. In the 1 st week, both of the two groups received H. pylori eradication regimen. The study group received hydrolalcite 1,0 g four times a day additionally. In the 2nd to 6th week, the study group received omeprazole 20 mg once a day with hydroxalcite 1.0 g four times a day . the control group only received omeprazole 20 mg onceaday. In the 7th to 8th week. the study group received hydrotalcite （dose as above） and the control group with no drugs. Results After the first dose. the study group relieved the abdominal pain in 0. 5 day. while the control group in 2 days （P〈0.001）. At the end of first week, the study group was significantly more effective than the control group in reducing frequencies of abdominal pain. abdominal distension, heartburn, acid reflux and belching. The study group wassignific antly more effective than the control group in reducing sexerity of abdominal pain as well. There was no significant difference between the two groups on the ulcer healing rate evaluated by endoscopy. A better nlucosa restoration on gland density and morphology was observed in the study group （P〈0.05） at the end of 8 weeks. Conclusion In active gastric ulcer, the treatment of combined with omeprazole can better relieve the dyspeptic symptoms and improve the quality of ulcer healing on histology as well.