Walan A
Dept. of Gastrointestinal Clinical Pharmacology and Medicine, AB Hässle, Mölndal, Sweden.
Scand J Gastroenterol Suppl. 1989;166:140-4; discussion 145. doi: 10.3109/00365528909091262.
More than 13,000 individuals with duodenal ulcer, gastric ulcer or reflux oesophagitis have now taken part in controlled clinical studies with omeprazole. In duodenal ulcer, treatment with omeprazole, 20 mg daily or more, has resulted in healing rates of 58%-83% after 2 weeks and 84%-100% after 4 weeks. In all of these studies, healing rates with omeprazole have been higher than with either ranitidine or cimetidine. Omeprazole has also had a more pronounced effect on ulcer symptoms. Although the first comparative study on gastric ulcer showed only marginally higher healing rates with omeprazole than with an H2-receptor antagonist, later studies have all shown significantly higher healing rates with omeprazole. Healing rates of the order of 70% or more have been achieved within 4 weeks, rising to over 88% after 8 weeks. Symptom relief has also been faster with omeprazole. In both duodenal ulcer and gastric ulcer, almost every patient can be healed, including those resistant to treatment with H2-receptor antagonists. The influence of omeprazole on the healing of reflux oesophagitis has been investigated in several studies comparing omeprazole with ranitidine. Healing rates have been markedly higher with omeprazole in all studies. These unprecedentedly high healing rates (81%-96% at 8 weeks) have also been accompanied by rapid symptom relief. In clinical studies with omeprazole, no clinically significant side-effects which could be ascribed to treatment, nor indeed any serious side-effects, have been observed, neither have any clinically significant changes in laboratory variables been seen. Furthermore, no pathological changes of the gastric mucosa have been detected after long-term treatment with omeprazole.
目前已有超过13000名患有十二指肠溃疡、胃溃疡或反流性食管炎的患者参与了奥美拉唑的对照临床研究。在十二指肠溃疡治疗中，每日服用20毫克或更高剂量的奥美拉唑，2周后的愈合率为58%-83%，4周后的愈合率为84%-100%。在所有这些研究中，奥美拉唑的愈合率高于雷尼替丁或西咪替丁。奥美拉唑对溃疡症状的影响也更为显著。虽然第一项关于胃溃疡的对比研究显示奥美拉唑的愈合率仅略高于H2受体拮抗剂，但后续研究均显示奥美拉唑的愈合率显著更高。4周内愈合率达到70%或更高，8周后升至88%以上。奥美拉唑缓解症状的速度也更快。在十二指肠溃疡和胃溃疡中，几乎每个患者都能治愈，包括那些对H2受体拮抗剂治疗耐药的患者。在几项将奥美拉唑与雷尼替丁进行比较的研究中，对奥美拉唑对反流性食管炎愈合的影响进行了调查。在所有研究中，奥美拉唑的愈合率均显著更高。这些前所未有的高愈合率（8周时为81%-96%）还伴随着症状的迅速缓解。在奥美拉唑的临床研究中，未观察到可归因于治疗的具有临床意义的副作用，实际上也未观察到任何严重副作用，实验室指标也未出现任何具有临床意义的变化。此外，长期使用奥美拉唑治疗后未检测到胃黏膜的病理变化。
