Talley N J, Vakil N, Lauritsen K, van Zanten S V, Flook N, Bolling-Sternevald E, Persson T, Björck E, Lind T
Mayo Clinic College of Medicine, Rochester, MN, USA.
Aliment Pharmacol Ther. 2007 Sep 1;26(5):673-82. doi: 10.1111/j.1365-2036.2007.03410.x.
Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment.
To evaluate whether a 1-w acid suppression trial is useful for identifying true responders in this population.
Patients (18-70 years) were randomized to either esomeprazole 40 mg q.d.s., b.d. or placebo for 1w, and then esomeprazole 40 mg q.d.s. or placebo for 7w. Epigastric pain and/or burning were recorded on a 4-point scale (0 = none, 3 = severe). Trial-week response was defined as symptom score sum < or = 1 on last 3d of therapy; response at 8w was symptom score sum < or = 1 over preceding 7d.
1-w response rates were 33% (199 of 597), 29% (188 of 629) and 23% (71 of 315) with esomeprazole q.d.s., esomeprazole b.d. and placebo, respectively (P = 0.002 for esomeprazole groups vs. placebo). At 8w, trial week sensitivity and specificity were 46% and 80%, respectively, for esomeprazole (40 or 80 mg), and 33% and 87%, respectively, for placebo. The positive and negative predictive values for esomeprazole were 60% and 69%.
Response to a 1-w acid suppression trial is of limited use for predicting symptom response at 8w in patients with unexplained epigastric pain or burning.
对于有上腹部疼痛或烧灼感症状的功能性消化不良患者，早期识别真正对抑酸治疗有反应者可使临床医生优化治疗方案。
评估为期1周的抑酸试验对识别该人群中真正有反应者是否有用。
将年龄在18至70岁的患者随机分为三组，分别接受埃索美拉唑40毫克每日一次、每日两次或安慰剂治疗1周，然后接受埃索美拉唑40毫克每日一次或安慰剂治疗7周。上腹部疼痛和/或烧灼感采用4分制记录（0 = 无，3 = 严重）。试验周反应定义为治疗最后3天症状评分总和≤1；8周时的反应定义为前7天症状评分总和≤1。
接受埃索美拉唑每日一次、埃索美拉唑每日两次和安慰剂治疗的患者1周反应率分别为33%（597例中的199例）、29%（629例中的188例）和23%（315例中的71例）（埃索美拉唑组与安慰剂组相比，P = 0.002）。在8周时，埃索美拉唑（40或80毫克）的试验周敏感性和特异性分别为46%和80%，安慰剂的敏感性和特异性分别为33%和87%。埃索美拉唑的阳性预测值和阴性预测值分别为60%和69%。
对于有不明原因上腹部疼痛或烧灼感的患者，为期1周的抑酸试验对预测8周时的症状反应作用有限。
