Mössner J, Koop H, Porst H, Wübbolding H, Schneider A, Maier C
Universitätsklinikum Leipzig, Germany.
Aliment Pharmacol Ther. 1997 Dec;11(6):1087-92. doi: 10.1046/j.1365-2036.1997.00242.x.
Pantoprazole is a benzimidazole derivative which selectively inhibits the proton pump H+. K+-ATPase necessary for the final step in gastric acid secretion.
To investigate the tolerability and the prophylactic effect of pantoprazole 40 mg once daily on relapse in patients whose reflux oesophagitis had been healed.
The safety of pantoprazole 40 mg once daily was assessed in an open 1-year trial on 222 patients whose reflux oesophagitis had been healed with omeprazole or pantoprazole. Relapse was defined as endoscopically-confirmed reflux oesophagitis (at least Grade I), with endoscopies being performed for patients experiencing 3 consecutive days of disease-specific symptoms.
Kaplan-Meier survival analysis at 6 and 12 months gave estimated treatment failure rates of 2% and 6% from confirmed relapses (per-protocol), and of 9% and 30% for a worst-case group (all withdrawals counted as failures). The only population shift in laboratory variables was a doubling of the median serum gastrin level over the first 6 months; thereafter it stabilized. Fifty-four (24%) patients experienced adverse events; 15 of these withdrew. Serious adverse events were reported for 12 patients.
Pantoprazole appears to be highly effective and to have a good safety profile for long-term prophylaxis of reflux oesophagitis.
泮托拉唑是一种苯并咪唑衍生物，可选择性抑制胃酸分泌最后一步所需的质子泵H⁺.K⁺-ATP酶。
研究每日一次服用40mg泮托拉唑对反流性食管炎已愈合患者复发的耐受性和预防效果。
在一项开放的1年试验中，对222例反流性食管炎已用奥美拉唑或泮托拉唑治愈的患者评估每日一次服用40mg泮托拉唑的安全性。复发定义为经内镜确认的反流性食管炎（至少I级），对出现连续3天疾病特异性症状的患者进行内镜检查。
6个月和12个月时的Kaplan-Meier生存分析显示，确诊复发（符合方案）的估计治疗失败率分别为2%和6%，最坏情况组（所有退出均计为失败）为9%和30%。实验室变量中唯一的群体变化是前6个月血清胃泌素中位数水平翻倍；此后稳定下来。54例（24%）患者发生不良事件；其中15例退出。报告了12例严重不良事件。
泮托拉唑似乎对反流性食管炎的长期预防非常有效且安全性良好。
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