Lansoprazole in the treatment of functional dyspepsia: Two double-blind, randomized, placebo-controlled trials
Lansoprazole in the treatment of functional dyspepsia: Two double-blind, randomized, placebo-controlled trials
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DOI：
10.1016/j.amjmed.2004.01.008
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发表时间：
2004-06-01
影响因子：
5.9
通讯作者：
Talley, NJ
中科院分区：
文献类型：
--
作者：
Peura, DA;Kovacs, TOG;Talley, NJ
目的：质子泵抑制剂治疗功能性消化不良患者症状缓解的疗效仍有争议。本研究旨在比较兰索拉唑与安慰剂在缓解功能性消化不良患者上腹部不适方面的疗效。方法：我们招募了921例功能性消化不良（定义为前3个月内持续或反复出现的上腹部不适）和至少30%筛查天数的中度上腹部不适的患者；所有患者均无提示胃食管反流的主要症状或胃镜下糜烂性或溃疡性食管炎、胃或十二指肠溃疡或糜烂的证据。患者被随机分配接受兰索拉唑15毫克（n = 305）、兰索拉唑30毫克（n = 308）或安慰剂（n = 308），每天8周。患者在日常日记中记录症状发生的频率和严重程度。结果：在第8周，与安慰剂组（19%）相比，接受兰索拉唑15 mg（35%）或30 mg（34%）治疗的患者报告的上腹部不适天数百分比的平均减少显著（P < 0.001）。同样，与安慰剂治疗的患者相比，使用兰索拉唑15 mg（44%）或30 rug（44%）治疗的患者在8周时报告症状完全缓解（定义为在研究访问前3天内没有上腹部不适发作）的患者更多（29%,P < 0.001）。然而，只有在入组时至少有一些胃灼热症状的患者才会出现上腹部不适的改善。结论：每日剂量为15mg或30mg的兰索拉唑在减轻持续或复发性上腹部不适症状并至少伴有某些胃灼热症状方面明显优于安慰剂。医学杂志2004；116:740 - 748。(C)2004年由摘录医疗公司。
PURPOSE: The efficacy of proton pump inhibitor therapy for symptom resolution in patients with functional dyspepsia remains controversial. This study was designed to compare the efficacy of lansoprazole with placebo in relieving upper abdominal discomfort in patients with functional dyspepsia.METHODS: We enrolled 921 patients with functional dyspepsia (defined as persistent or recurrent upper abdominal discomfort during the prior 3 months) and moderate upper abdominal discomfort on at least 30% of screening days; none of the patients had predominant symptoms suggestive of gastroesophageal reflux or endoscopic evidence of erosive or ulcerative esophagitis, or gastric or duodenal ulcer or erosion. Patients were assigned randomly to receive lansoprazole 15 mg (n = 305), lansoprazole 30 mg (n = 308), or placebo (n = 308) daily for 8 weeks. Patients recorded the frequency and severity of symptoms in daily diaries.RESULTS: At week 8, significantly (P < 0.001) greater mean reductions in the percentage of days with upper abdominal discomfort were reported in patients treated with lansoprazole 15 mg (35%) or 30 mg (34%) compared with those treated with placebo (19%). Similarly, more patients treated with lansoprazole 15 mg (44%) or 30 rug (44%) reported complete symptom resolution (defined as no episodes of upper abdominal discomfort in the 3 days before the study visit) at 8 weeks than did placebo-treated patients (29%, P < 0.001). Improvement of upper abdominal discomfort, however, was seen only in patients who had at least some symptoms of heartburn at enrollment.CONCLUSION: Lansoprazole, at a daily dose of 15 mg or 30 mg, is significantly better than placebo in reducing symptoms of persistent or recurrent upper abdominal discomfort accompanied by at least some symptoms of heartburn. Am J Med 2004; 116:740-748. (C)2004 by Excerpta Medica Inc.