Müller P, Simon B, Khalil H, Lühmann R, Leucht U, Schneider A
Krankenhaus Schwetzingen, Bundesrepublik Deutschland.
Z Gastroenterol. 1992 Nov;30(11):771-5.
Pantoprazole is a newly developed benzimidazole derivative with strong inhibitory actions on gastric acid secretion by blocking H(+)-K(+)-ATPase. This randomized double-blind multicenter trial investigated the efficacy of 20 mg, 40 mg and 80 mg pantoprazole o.m. on ulcer healing and symptomatic relief in 219 out-patients with endoscopically assessed acute duodenal ulcer. After 2 weeks complete ulcer healing was achieved in 58%, 89% and 82% of the patients with 20 mg, 40 mg and 80 mg pantoprazole o.m., respectively. After 4 weeks, corresponding figures were 93%, 99% and 100%; the difference of the healing rates between the 20 mg and 40 mg groups at 2 weeks was statistically significant (p < 0.0001). A rapid pain relief was achieved in all treatment groups: 72% of the 20 mg group, 89% of the 40 mg group, and 84% of the 80 mg group were pain-free after 2 weeks. The difference between 20 mg and 40 mg was statistically significant (p < 0.05). Pantoprazole was well tolerated. Adverse events occurred in 13 patients; headache, skin alterations, and diarrhea were reported most frequently. Severity and frequency of adverse events did not reveal any dose-dependence. In conclusion, pantoprazole provides fast healing of acute duodenal ulcer as well as rapid improvement of ulcer symptoms. For further clinical trials in peptic ulcer disease a daily dose of pantoprazole 40 mg o.m. is recommended.
泮托拉唑是一种新开发的苯并咪唑衍生物，通过阻断H(+)-K(+)-ATP酶对胃酸分泌有强烈的抑制作用。这项随机双盲多中心试验研究了20毫克、40毫克和80毫克口服泮托拉唑对219例经内镜评估为急性十二指肠溃疡的门诊患者溃疡愈合和症状缓解的疗效。2周后，分别有58%、89%和82%口服20毫克、40毫克和80毫克泮托拉唑的患者实现了溃疡完全愈合。4周后，相应的数据分别为93%、99%和100%；2周时20毫克组和40毫克组的愈合率差异具有统计学意义（p<0.0001）。所有治疗组均实现了快速的疼痛缓解：2周后，20毫克组72%、40毫克组89%和80毫克组84%的患者疼痛消失。20毫克组和40毫克组之间的差异具有统计学意义（p<0.05）。泮托拉唑耐受性良好。13例患者出现不良事件；最常报告的是头痛、皮肤改变和腹泻。不良事件的严重程度和频率未显示出任何剂量依赖性。总之，泮托拉唑能使急性十二指肠溃疡快速愈合，并能迅速改善溃疡症状。对于消化性溃疡疾病的进一步临床试验，建议口服泮托拉唑的日剂量为40毫克。
