Gillessen Anton, Beil Winfried, Modlin Irvin M, Gatz Gudrun, Hole Ursula
Ruhr-Universität Bochum, Universitätsklinik Marienhospital Herne, Germany.
J Clin Gastroenterol. 2004 Apr;38(4):332-40. doi: 10.1097/00004836-200404000-00007.
Proton pump inhibitors are regarded as the most effective class of acid suppressive medication for gastroesophageal reflux disease treatment. There is considerable interest regarding the dose equivalence between various proton pump inhibitors.
To compare the efficacy of pantoprazole and esomeprazole with regard to healing and relief from gastroesophageal reflux disease-related symptoms.
Multicenter, randomized, double-blind study. Patients with gastroesophageal reflux disease grades B/C (Los Angeles classification) received 40 mg pantoprazole daily (n = 113) or 40 mg esomeprazole daily (n = 114). Healing (endoscopy) and relief from gastroesophageal reflux disease-related symptoms (direct questioning) were assessed at first and final visit (after 4, 6, 8, or 10 weeks of treatment).
Overall healing in both treatment groups was 88% of patients (intention-to-treat population), 95% (pantoprazole), and 90% (esomeprazole) (per-protocol population); statistically, this indicates "at least equivalence" between treatments. Overall relief from gastroesophageal reflux disease-related symptoms was similar for pantoprazole (55%) and esomeprazole (51%, per-protoco). No correlation between healing and symptom relief was seen. The majority of reported adverse events were assessed as "not related" to the study drug. Pantoprazole and esomeprazole have comparably good safety and tolerability.
In patients with gastroesophageal reflux disease, 40 mg pantoprazole daily and 40 mg esomeprazole daily are equally effective for healing of esophageal lesions and relieving gastroesophageal reflux disease-related symptoms.
质子泵抑制剂被认为是治疗胃食管反流病最有效的抑酸药物类别。人们对各种质子泵抑制剂之间的剂量等效性极为关注。
比较泮托拉唑和埃索美拉唑在治愈胃食管反流病及缓解相关症状方面方面的疗效。
多中心、随机、双盲研究。B/C级(洛杉矶分类法)胃食管反流病患者每日接受40毫克泮托拉唑治疗(n = 113)或每日接受40毫克埃索美拉唑治疗(n = 114)。在首次和末次就诊时(治疗4、6、8或10周后)评估食管愈合情况(通过内镜检查)以及胃食管反流病相关症状的缓解情况(直接询问)。
两个治疗组的总体愈合率在意向性治疗人群中为88%的患者,在符合方案人群中泮托拉唑为95%,埃索美拉唑为90%;从统计学角度看,这表明两种治疗方法“至少等效”。泮托拉唑(55%)和埃索美拉唑(符合方案人群为51%)缓解胃食管反流病相关症状的总体情况相似。未观察到愈合与症状缓解之间存在相关性。大多数报告的不良事件被评估为与研究药物“无关”。泮托拉唑和埃索美拉唑具有相当好的安全性和耐受性。
对于胃食管反流病患者,每日40毫克泮托拉唑和每日40毫克埃索美拉唑在食管病变愈合及缓解胃食管反流病相关症状方面同样有效。