奥美拉唑碳酸氢钠胶囊治疗十二指肠溃疡119例
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摘要
目的观察奥美拉唑碳酸氢钠胶囊治疗活动性十二指肠溃疡的临床疗效和安全性。方法活动性十二指肠溃疡患者238例,随机分为治疗组与对照组各119例。治疗组给予奥美拉唑碳酸氢钠胶囊治疗,对照组给予奥美拉唑镁肠溶片治疗,疗程均为4周。比较两组治疗前后胃镜下溃疡分期和临床症状指标变化,及药物不良反应发生情况。结果治疗后,治疗组与对照组相比溃疡愈合显效率(86.73%比85.59%)与有效率(96.46%比97.30%)差异均无统计学意义(P>0.05)。两组临床症状均显著缓解,用药4周后治疗组嗳气评分下降值显著大于对照组[(1.36±0.76)比(1.09±0.60),P<0.05];用药2周及4周后,治疗组临床症状总分下降值均显著大于对照组[2周后(4.54±2.58)比(3.78±2.12),P<0.05];4周后[(5.33±2.77)比(4.53±1.93),P<0.05]。用药4周后,治疗组的疼痛消失率高于对照组(96.26%比95.19%),但差异无统计学意义(P>0.05)。两组不良反应差异无统计学意义。结论奥美拉唑碳酸氢钠胶囊治疗十二指肠溃疡疗效显著,效果确切,安全性好。
Objective To investigate the effect and safety of omeprazole/sodium bicarbonate capsule in treatment of active duodenal ulcer. Methods Totally, 238 patients with active duodenal ulcers were randomly divided into the treatment group and the control group with 119 patients in each group.The treatment group was treated with omeprazole/sodium bicarbonate capsule, and the control group treated with omeprazole magnesium enteric tablet.The treatment course was 4 weeks.The stage classification of ulcer under endoscopy and clinical symptoms were compared between the groups before and after the treatment. Results After treatment, the stage of ulcers under endoscopy was significantly improved in both groups, but the proportion of patients in stage S1 or S2, and patients with ulcer area reduction more than 50% had no statistical differences between the treatment group and the control group(86.73% vs.85.59%,and 96.46% vs.97.30%, respectively, P>0.05).The clinical symptoms were significantly improved in both groups.After 4 weeks of treatment, the decline of belching score was significantly greater in the treatment group than in the control group(1.36±0.76 vs.1.09±0.60,P<0.05).The decline of total symptom score was significantly greater in the treatment group than in the control group after 2 and 4 weeks(4.54±2.58 vs.3.78±2.12, and 5.33±2.77 vs. 4.53±1.93, respectively, P<0.05).After 4 weeks of treatment, the rate of pain disappearance in the treatment group was higher than that in the control group(96.26% vs.95.19%), but without statistical difference(P>0.05).There were no statistical differences in adverse drug reactions between the two groups. Conclusion Omeprazole/sodium bicarbonate capsule has definite therapeutic effect and good safety in treating active duodenal ulcer.
Objective To investigate the effect and safety of omeprazole/sodium bicarbonate capsule in treatment of active duodenal ulcer. Methods Totally, 238 patients with active duodenal ulcers were randomly divided into the treatment group and the control group with 119 patients in each group.The treatment group was treated with omeprazole/sodium bicarbonate capsule, and the control group treated with omeprazole magnesium enteric tablet.The treatment course was 4 weeks.The stage classification of ulcer under endoscopy and clinical symptoms were compared between the groups before and after the treatment. Results After treatment, the stage of ulcers under endoscopy was significantly improved in both groups, but the proportion of patients in stage S1 or S2, and patients with ulcer area reduction more than 50% had no statistical differences between the treatment group and the control group(86.73% vs.85.59%,and 96.46% vs.97.30%, respectively, P>0.05).The clinical symptoms were significantly improved in both groups.After 4 weeks of treatment, the decline of belching score was significantly greater in the treatment group than in the control group(1.36±0.76 vs.1.09±0.60,P<0.05).The decline of total symptom score was significantly greater in the treatment group than in the control group after 2 and 4 weeks(4.54±2.58 vs.3.78±2.12, and 5.33±2.77 vs. 4.53±1.93, respectively, P<0.05).After 4 weeks of treatment, the rate of pain disappearance in the treatment group was higher than that in the control group(96.26% vs.95.19%), but without statistical difference(P>0.05).There were no statistical differences in adverse drug reactions between the two groups. Conclusion Omeprazole/sodium bicarbonate capsule has definite therapeutic effect and good safety in treating active duodenal ulcer.
引文
[1] 刘腾,徐春敏,赵志刚.奥美拉唑碳酸氢钠制剂的研发与临床应用[J].药品评价,2016,13(22):13-16.
[2] 马桂凤,华建平,李俊美,等.荆花胃康胶丸治疗十二指肠球溃疡的疗效[J].中国新药杂志,2006,15(21):1874-1876.
[3] 毛煜,佘佳红,袁伯俊.苯并咪唑类质子泵抑制剂的药理和临床研究进展[J].中国新药杂志,2006,15(1):17-21.
[4] CASTELL D.Review of immediate-release omeprazole for the treatment of gastric acid-related disorders[J].Expert Opin Pharmacother,2005,6(14):2501-2510.
[5] ORBELO D M,ENDERS F T,ROMERO Y,et al.Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing[J].Dig Dis Sci,2015 ,60(1):146-162.
[6] PRATHA V S,MCGRAW T,TOBIN W.A randomized,crossover pharmacodynamic study of immediate-release omeprazole/sodium bicarbonate and delayed-release lansoprazole in healthy adult volunteers[J].Pharmacol Res Perspect,2016,4(3):e00238.
[7] HOWDEN C W.Review article:immediate-release proton-pump inhibitor therapy -potential advantages[J].Aliment Pharmacol Ther,2005,22(3):25-30.
[8] 梅亚君,勾忠平,秦永平,等.奥美拉唑碳酸氢钠干混悬剂和肠溶制剂在健康人体的药动学对比研究[J].中国新药杂志,2016,25(6):677-680,715.
[9] FDA.Label.ZEGERID(omeprazole/sodium bicarbonate) powder for oral suspension,ZEGERID(omeprazole/sodium bicarbonate) capsules for oral use [EB/OL].(2016-10-01)[2017-8-1].http://shared.salix.com/shared/pi/zegerid-pi.pdf.
[10] GERSON L B,MITRA S,BLEKER W F,et al.Control of intra-oesophageal pH in patients with Barrett's oesophagus on omeprazole-sodium bicarbonate therapy[J].Aliment Pharmacol Ther,2012,35(7):803-809.
[2] 马桂凤,华建平,李俊美,等.荆花胃康胶丸治疗十二指肠球溃疡的疗效[J].中国新药杂志,2006,15(21):1874-1876.
[3] 毛煜,佘佳红,袁伯俊.苯并咪唑类质子泵抑制剂的药理和临床研究进展[J].中国新药杂志,2006,15(1):17-21.
[4] CASTELL D.Review of immediate-release omeprazole for the treatment of gastric acid-related disorders[J].Expert Opin Pharmacother,2005,6(14):2501-2510.
[5] ORBELO D M,ENDERS F T,ROMERO Y,et al.Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing[J].Dig Dis Sci,2015 ,60(1):146-162.
[6] PRATHA V S,MCGRAW T,TOBIN W.A randomized,crossover pharmacodynamic study of immediate-release omeprazole/sodium bicarbonate and delayed-release lansoprazole in healthy adult volunteers[J].Pharmacol Res Perspect,2016,4(3):e00238.
[7] HOWDEN C W.Review article:immediate-release proton-pump inhibitor therapy -potential advantages[J].Aliment Pharmacol Ther,2005,22(3):25-30.
[8] 梅亚君,勾忠平,秦永平,等.奥美拉唑碳酸氢钠干混悬剂和肠溶制剂在健康人体的药动学对比研究[J].中国新药杂志,2016,25(6):677-680,715.
[9] FDA.Label.ZEGERID(omeprazole/sodium bicarbonate) powder for oral suspension,ZEGERID(omeprazole/sodium bicarbonate) capsules for oral use [EB/OL].(2016-10-01)[2017-8-1].http://shared.salix.com/shared/pi/zegerid-pi.pdf.
[10] GERSON L B,MITRA S,BLEKER W F,et al.Control of intra-oesophageal pH in patients with Barrett's oesophagus on omeprazole-sodium bicarbonate therapy[J].Aliment Pharmacol Ther,2012,35(7):803-809.