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兰索拉唑治疗卓-艾综合征患者的长期疗效和安全性的前瞻性研究。

Prospective study of the long-term efficacy and safety of lansoprazole in patients with the Zollinger-Ellison syndrome.

作者信息

Jensen R T, Metz D C, Koviack P D, Feigenbaum K M

机构信息

Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892.

出版信息

Aliment Pharmacol Ther. 1993;7 Suppl 1:41-50, discussion 61-6. doi: 10.1111/j.1365-2036.1993.tb00588.x.

Abstract

The long-term safety and efficacy of lansoprazole were studied in 21 patients with Zollinger-Ellison syndrome. The initial maintenance dose was determined by acid inhibition studies. In all patients lansoprazole controlled gastric acid hypersecretion and peptic symptoms in both the short and long term. Patients were treated for a mean of 31 months (range 1-43 months) with all but 4 patients followed for > 18 months. The mean initial dose was 60 mg/day, with 2 patients requiring a twice daily dose and the others a single daily dose. During long-term treatment 6 patients required an increased dosage, 5 within the first year. Long-term maintenance doses were reduced in 5 of the 6 patients in whom this was attempted. No changes in serum gastrin concentration, haematological parameters, liver function studies or other biochemical parameters occurred due to lansoprazole. No patient developed a gastric carcinoid tumour while being treated with lansoprazole. These results demonstrate that long-term treatment with lansoprazole is both safe and effective in patients with Zollinger-Ellison syndrome, and suggest that this drug will be useful in such patients. Furthermore, maintenance doses of lansoprazole, determined by the currently recommended method of acute acid titration studies in patients with Zollinger-Ellison syndrome, are too high.

摘要

对21例卓-艾综合征患者进行了兰索拉唑的长期安全性和有效性研究。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均能控制胃酸分泌过多和消化性症状。患者平均接受治疗31个月(范围1 - 43个月),除4例患者外,其余患者随访时间均超过18个月。平均初始剂量为60毫克/天,2例患者需要每日两次给药,其余患者每日一次给药。在长期治疗期间,6例患者需要增加剂量,其中5例在第一年就需要增加剂量。在尝试减少剂量的6例患者中,有5例患者的长期维持剂量降低。兰索拉唑未导致血清胃泌素浓度、血液学参数、肝功能研究或其他生化参数发生变化。接受兰索拉唑治疗的患者均未发生胃类癌肿瘤。这些结果表明,兰索拉唑长期治疗对卓-艾综合征患者既安全又有效,并提示该药物对此类患者有用。此外,通过目前推荐的卓-艾综合征患者急性酸滴定研究方法确定的兰索拉唑维持剂量过高。

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