Mignon M, Pospai D, Forestier S, Vatier J, Vallot T
Department of Hepato-Gastroenterology, Bichat-Claude Bernard Hospital, Paris, France.
Clin Ther. 1993;15 Suppl B:22-31.
In the treatment of Zollinger-Ellison syndrome patients with severe disease and acid hypersecretion, proton pump inhibitors are the drugs of choice. Data have now been accumulated on lansoprazole treatment of 41 patients (21 treated at the National Institutes of Health [NIH], Bethesda, Maryland, USA, and 20 treated at the Bichat-Claude Bernard Hospital, Paris, France). Short-term studies of the inhibitory action of lansoprazole on acid secretion have been carried out in both institutions. Our group first performed a dose-response analysis of the efficacy of lansoprazole in reducing basal acid output (BAO) in four patients with severe Zollinger-Ellison syndrome (mean BAO 52 +/- 9 [SD] mmol H+/h) who had previously been treated with a mean omeprazole dosage of 75 mg/day. The maximum acid inhibitory effect was obtained with lansoprazole 60-90 mg/day. The 40-hour duration of action of lansoprazole appears equivalent to that of omeprazole. In a second study at the Bichat-Claude Bernard Hospital, nine Zollinger-Ellison syndrome patients underwent 24-hour intragastric pH monitoring while receiving lansoprazole (mean dosage 80 mg/day, range 30-165 mg/day) or omeprazole (mean dosage 75 mg/day, range 20-180 mg/day). The acid inhibitory activity of the two drugs was comparable. Those patients are currently receiving long-term maintenance treatment with lansoprazole, and satisfactory clinical and biological secretory control has been achieved. The long-term safety and efficacy of lansoprazole administration were studied in the 21 patients followed at the NIH. In those patients the initial maintenance dose was determined using acid inhibition studies; in all patients lansoprazole controlled gastric acid hypersecretion and peptic symptoms in both the short and long term. The mean initial maintenance dose was 60 mg QID, except for two patients who required 60 mg BID. During long-term treatment (mean duration 31 months, range 1-43 months), six patients required a dosage increase within the first year, while the lansoprazole dose could be reduced in six others. The safety profile of lansoprazole has been excellent. Comparable results have been noted in nine Zollinger-Ellison syndrome patients during an ongoing evaluation in our institution. These studies indicate that lansoprazole is an efficacious, well-tolerated antisecretory agent in patients with Zollinger-Ellison syndrome.
在治疗患有严重疾病且胃酸分泌过多的卓-艾综合征患者时,质子泵抑制剂是首选药物。目前已经积累了关于兰索拉唑治疗41例患者的数据(21例在美国马里兰州贝塞斯达的国立卫生研究院接受治疗,20例在法国巴黎的比夏-克劳德·贝尔纳医院接受治疗)。两个机构都进行了兰索拉唑对胃酸分泌抑制作用的短期研究。我们小组首先对4例严重卓-艾综合征患者(基础胃酸排量[BAO]平均为52±9[标准差]mmol H⁺/小时)进行了兰索拉唑降低基础胃酸排量疗效的剂量反应分析,这些患者此前平均使用奥美拉唑剂量为75mg/天。兰索拉唑60 - 90mg/天可获得最大胃酸抑制效果。兰索拉唑40小时的作用持续时间似乎与奥美拉唑相当。在比夏-克劳德·贝尔纳医院的第二项研究中,9例卓-艾综合征患者在接受兰索拉唑(平均剂量80mg/天,范围30 - 165mg/天)或奥美拉唑(平均剂量75mg/天,范围20 - 180mg/天)治疗时进行了24小时胃内pH监测。两种药物的胃酸抑制活性相当。这些患者目前正在接受兰索拉唑的长期维持治疗,并已实现了满意的临床和生物学分泌控制。在国立卫生研究院随访的21例患者中研究了兰索拉唑给药的长期安全性和疗效。在这些患者中,初始维持剂量通过胃酸抑制研究确定;在所有患者中,兰索拉唑在短期和长期内均能控制胃酸分泌过多和消化性症状。平均初始维持剂量为60mg每日四次,除了两名患者需要60mg每日两次。在长期治疗期间(平均持续时间31个月,范围1 - 43个月),6例患者在第一年内需要增加剂量,而另外6例患者的兰索拉唑剂量可以减少。兰索拉唑的安全性良好。在我们机构正在进行的一项评估中,9例卓-艾综合征患者也得到了类似结果。这些研究表明,兰索拉唑在卓-艾综合征患者中是一种有效且耐受性良好的抗分泌药物。