Archimandritis Athanasios J, Nikolopoulou Vassiliki, Kouklakis Georgios, Paraskevas Emanouil, Avgerinos Alexandros, Tsianos Epaminontas, Triantafillidis John K
Department of Pathophysiology, Laiko Gen Hospital, University of Athens Medical School, Greece.
Curr Med Res Opin. 2005 Apr;21(4):603-10. doi: 10.1185/030079905X41444.
In controlled clinical trials, rabeprazole effectively improves symptoms and heals oesophageal erosions in patients with gastro-oesophageal reflux disease (GORD).
To examine symptom relief during week 1 of rabeprazole therapy, in addition to GORD healing, in a clinical practice setting.
In this 8-week, prospective, multicentre, postauthorisation surveillance study conducted in Greece, patients with GORD (intent-to-treat: efficacy, 272; safety, 273) were treated with rabeprazole 20 mg once daily. The primary efficacy end point was the change from baseline in GORD symptom severity on day 1, 2, 3 and 7 using a 5-point Likert scale (1 = no symptoms; 5 = severe symptoms). Oesophageal healing was also evaluated by comparing the results of endoscopic findings at baseline and after 4 and 8 weeks of treatment.
On day 1 of treatment, rabeprazole relieved GORD symptoms across all grades of oesophagitis, with statistically significant (p = 0.0001) improvement in heartburn, regurgitation, epigastric pain and dysphagia. Oesophageal healing was achieved in 77% of patients at week 4 and in 90% at week 8 and treatment was well tolerated.
In a clinical practice setting, rabeprazole provided rapid relief of GORD symptoms, confirming results seen in controlled clinical trials.
在对照临床试验中，雷贝拉唑可有效改善胃食管反流病（GORD）患者的症状并治愈食管糜烂。
在临床实践环境中，除了观察GORD的愈合情况外，还要研究雷贝拉唑治疗第1周内症状的缓解情况。
在希腊进行的这项为期8周的前瞻性、多中心、上市后监测研究中，GORD患者（意向性治疗：疗效分析272例；安全性分析273例）接受每日1次20 mg雷贝拉唑治疗。主要疗效终点是使用5级李克特量表（1 = 无症状；5 = 症状严重）评估第1、2、3和7天GORD症状严重程度相对于基线的变化。还通过比较基线以及治疗4周和8周后的内镜检查结果来评估食管愈合情况。
在治疗第1天，雷贝拉唑缓解了所有食管炎分级的GORD症状，烧心、反流、上腹痛和吞咽困难有统计学显著改善（p = 0.0001）。4周时77%的患者实现食管愈合，8周时为90%，且治疗耐受性良好。
在临床实践环境中，雷贝拉唑能迅速缓解GORD症状，证实了对照临床试验中的结果。
