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对有上腹部疼痛或烧灼感的未经检查的消化不良患者进行为期一周的抑酸试验,以预测对埃索美拉唑8周治疗的反应:一项随机、安慰剂对照研究。

One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study.

作者信息

van Zanten S V, Flook N, Talley N J, Vakil N, Lauritsen K, Bolling-Sternevald E, Persson T, Björck E, Svedberg L-E

机构信息

Dalhousie University, Halifax, Canada.

出版信息

Aliment Pharmacol Ther. 2007 Sep 1;26(5):665-72. doi: 10.1111/j.1365-2036.2007.03409.x.

DOI:10.1111/j.1365-2036.2007.03409.x
PMID:17697200
Abstract

BACKGROUND

While empiric acid-suppressive therapy for uninvestigated dyspepsia patients with symptoms of epigastric pain or burning is standard practice, it is unknown whether an early response to therapy predicts outcome.

AIM

To evaluate whether a 1-w acid suppression trial is effective for predicting 8-w response in such patients.

METHODS

Helicobacter pylori-negative patients (aged 18-50 years) in primary care with uninvestigated epigastric pain or burning were randomized to esomeprazole 40 mg q.d.s. or b.d. for 1w, followed by esomeprazole 40 mg q.d.s. or placebo for 7w. Each day, patients rated the severity of their symptoms.

RESULTS

Based on the last 3d, 1-w response rates were 39% (231 of 588) and 43% (258 of 596) with esomeprazole 40 mg q.d.s. and b.d., respectively. Based on the last 7d, response rates at 4w were 38% (283 of 738) and 25% (93 of 380) for esomeprazole and placebo, respectively, and 47% (339 of 716) and 34% (124 of 368), respectively, at 8w (both P < 0.001 vs. placebo). The sensitivity and specificity of esomeprazole treatment were 58% and 70%, respectively, at 8w.

CONCLUSION

A 1-w acid suppression trial is of limited clinical value for predicting 8-w response in patients with symptoms of epigastric pain or burning. Esomeprazole provides greater symptom control than placebo at 4w and 8w.

摘要

背景

对于有上腹部疼痛或烧灼感症状但未经检查的消化不良患者,经验性抑酸治疗是标准做法,但治疗的早期反应能否预测结局尚不清楚。

目的

评估为期1周的抑酸试验对预测此类患者8周反应是否有效。

方法

基层医疗中年龄在18至50岁、有未经检查的上腹部疼痛或烧灼感且幽门螺杆菌阴性的患者,随机分为接受埃索美拉唑40毫克每日一次或每日两次治疗1周,随后接受埃索美拉唑40毫克每日一次或安慰剂治疗7周。患者每天对其症状严重程度进行评分。

结果

基于最后3天,埃索美拉唑40毫克每日一次和每日两次治疗的1周反应率分别为39%(588例中的231例)和43%(596例中的258例)。基于最后7天,埃索美拉唑组和安慰剂组在4周时的反应率分别为38%(738例中的283例)和25%(380例中的93例),在8周时分别为47%(716例中的339例)和34%(368例中的124例)(与安慰剂相比,P均<0.001)。埃索美拉唑治疗在8周时的敏感性和特异性分别为58%和70%。

结论

为期1周的抑酸试验对预测有上腹部疼痛或烧灼感症状患者的8周反应临床价值有限。埃索美拉唑在4周和8周时比安慰剂能更好地控制症状。

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