Richter J E, Bochenek W
Cleveland Clinic Foundation, Department of Gastroenterology, OH 44195, USA.
Am J Gastroenterol. 2000 Nov;95(11):3071-80. doi: 10.1111/j.1572-0241.2000.03254.x.
The aim of this dose-response study was to compare the effectiveness of 10 mg, 20 mg, and 40 mg of pantoprazole with that of placebo tablets in the healing and symptom relief of gastroesophageal reflux disease associated with erosive esophagitis, and to determine the optimal dose.
A total of 603 patients with endoscopically confirmed (Hetzel-Dent scale) erosive esophagitis of grade 2 (64.5%) or grades 3 or 4 (35.3%) were enrolled in a double-blind, multicenter study and randomly assigned to receive pantoprazole (10 mg, 20 mg, or 40 mg) or placebo, administered once daily in the morning, for 4 or 8 wk depending on healing.
The healing rates after 4 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 14%, 42%, 55%, and 72%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). Cumulative healing rates after 8 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 33%, 59%, 78%, and 88%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). The 40-mg pantoprazole dose produced greater rates of healing and earlier healing of esophagitis than either the 10- or 20-mg dose, regardless of severity. Pantoprazole, at any dose, was significantly more effective than placebo in relieving reflux symptoms. Patients on pantoprazole 40 mg experienced relief of symptoms on day 1 of treatment. No serious treatment-related adverse events occurred.
Pantoprazole was safe and effective for healing erosive esophagitis and provided rapid symptomatic relief. These results indicate that pantoprazole offers a new option for treatment of erosive esophagitis. Among the three doses studied, the 40-mg dose was the most effective.
本剂量反应研究旨在比较10毫克、20毫克和40毫克泮托拉唑与安慰剂片剂对糜烂性食管炎相关胃食管反流病的愈合效果及症状缓解情况，并确定最佳剂量。
共有603例经内镜确诊（赫茨尔-登特量表）为2级（64.5%）或3级或4级（35.3%）糜烂性食管炎的患者参加了一项双盲、多中心研究，并随机分配接受泮托拉唑（10毫克、20毫克或40毫克）或安慰剂治疗，每天早晨服用一次，根据愈合情况治疗4周或8周。
安慰剂组以及泮托拉唑10毫克/天、20毫克/天和40毫克/天组4周后的愈合率分别为14%、42%、55%和72%（所有剂量泮托拉唑与安慰剂相比，p<0.001）。安慰剂组以及泮托拉唑10毫克/天、20毫克/天和40毫克/天组8周后的累积愈合率分别为33%、59%、78%和88%（所有剂量泮托拉唑与安慰剂相比，p<0.001）。无论食管炎严重程度如何，4毫克泮托拉唑剂量比10毫克或20毫克剂量产生更高的愈合率且食管炎愈合更早。任何剂量的泮托拉唑在缓解反流症状方面均显著优于安慰剂。服用40毫克泮托拉唑的患者在治疗第1天症状即得到缓解。未发生严重的治疗相关不良事件。
泮托拉唑治疗糜烂性食管炎安全有效，能迅速缓解症状。这些结果表明泮托拉唑为糜烂性食管炎的治疗提供了一种新选择。在所研究的三种剂量中，40毫克剂量最为有效。
