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三种剂量的兰索拉唑(15毫克、30毫克和60毫克)与安慰剂治疗十二指肠溃疡的比较。兰索拉唑研究组。

A comparison of three doses of lansoprazole (15, 30 and 60 mg) and placebo in the treatment of duodenal ulcer. The Lansoprazole Study Group.

作者信息

Avner D L, Dorsch E R, Jennings D E, Greski-Rose P A

机构信息

Abbott Laboratories, Inc., Abbott Park, IL, USA.

出版信息

Aliment Pharmacol Ther. 1995 Oct;9(5):521-8. doi: 10.1111/j.1365-2036.1995.tb00415.x.

DOI:10.1111/j.1365-2036.1995.tb00415.x
PMID:8580272
Abstract

BACKGROUND

Lansoprazole is a new proton pump inhibitor for the treatment of peptic ulcer disease.

METHODS

A double-blind, multicentre study was undertaken in 296 patients with endoscopically proven duodenal ulcer to compare the efficacy and safety of lansoprazole 15, 30 or 60 mg with placebo. Ulcer healing was documented by endoscopy at 2 and 4 weeks; patients whose ulcers healed after 4 weeks were followed for up to 6 months post-treatment.

RESULTS

Four-week healing rates of 89.4%, 91.7% and 89.9% were obtained with lansoprazole 15, 30 and 60 mg, respectively, compared with 46.1% on placebo (P < 0.001). All three doses of lansoprazole produced rapid symptom relief, although patients taking 60 mg lansoprazole required fewer antacids than did those taking 15 mg. At 6 months, the percentages of patients healed were 45.3%, 40.0% and 38.4% in the lansoprazole 15, 30 and 60 mg dosage groups, respectively, and 25.3% for the placebo group. No significant adverse events were documented during the period of this trial.

CONCLUSION

Lansoprazole is an effective and safe treatment for duodenal ulcer and the 15 mg dose is as effective as 30 or 60 mg.

摘要

背景

兰索拉唑是一种用于治疗消化性溃疡疾病的新型质子泵抑制剂。

方法

对296例经内镜证实为十二指肠溃疡的患者进行了一项双盲、多中心研究,以比较15毫克、30毫克或60毫克兰索拉唑与安慰剂的疗效和安全性。在第2周和第4周通过内镜检查记录溃疡愈合情况;溃疡在4周后愈合的患者在治疗后随访长达6个月。

结果

兰索拉唑15毫克、30毫克和60毫克组的4周愈合率分别为89.4%、91.7%和89.9%,而安慰剂组为46.1%(P<0.001)。所有三种剂量的兰索拉唑均能迅速缓解症状,尽管服用60毫克兰索拉唑的患者比服用15毫克的患者需要的抗酸剂更少。在6个月时,兰索拉唑15毫克、30毫克和60毫克剂量组愈合的患者百分比分别为45.3%、40.0%和38.4%,安慰剂组为25.3%。在该试验期间未记录到显著的不良事件。

结论

兰索拉唑是治疗十二指肠溃疡的一种有效且安全的药物,15毫克剂量与30毫克或60毫克剂量一样有效。

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