Department of Gastroenterology and Hepatology, University Hospital of Essen, Essen, Germany.
Clin Ther. 2010 Apr;32(4):678-90. doi: 10.1016/j.clinthera.2010.03.020.
Systematic assessments of the onset of symptom relief in the treatment of gastroesophageal reflux disease (GERD) are lacking.
This work evaluated the time interval until complete symptom relief from heartburn (including both daytime and nighttime heartburn) and acid regurgitation in patients with GERD or endoscopy-negative GERD (NERD) during the first 7 days of treatment with pantoprazole, nizatidine, or ranitidine.
This was a post hoc reanalysis of data from 2 previously published, multicenter, randomized, double-blind, active-controlled, parallel-group studies. Male and female patients aged >or=18 years with endoscopically proven GERD or NERD (Hetzel-Dent grade >or= [trial 1] or Savary-Miller grade 0 or 1 [trial 2]) were enrolled. Patients were required to have had reflux symptoms for the previous >or=3 months, with >or=1 symptom (ie, daytime heartburn, nighttime heartburn, or acid regurgitation) for >or=4 of the past 7 days in trial 1 or >or=1 symptom (ie, heartburn, acid eructation, or painful swallowing) of at least moderate intensity for the past 3 days in trial 2. The treatments were pantoprazole 20 mg once daily in both trials, nizatidine 150 mg BID in trial 1, or ranitidine 150 mg BID in trial 2. Presence and severity of symptoms were recorded on daily diary cards using a 4-point Likert-type scale.
In total, 114 patients from trial 1 and 307 patients from trial 2 were evaluable for heartburn, and 58 patients from trial l and 271 patients from trial 2 were evaluable for acid regurgitation. In both studies, there were no significant differences in baseline characteristics between pantoprazole recipients and nizatidine or ranitidine recipients, with the exception of more men than women in trial 1 compared with trial 2 (P < 0.001). On day 2 of trial 1, 23 (39.0%) and 8 (14.5%) of pantoprazole and nizatidine recipients, respectively, experienced complete relief from heartburn (P < 0.01). The differences between groups remained statistically significant through day 7, when 28 (47.5%) and 8 (14.5 %) of pantoprazole and nizatidine recipients had no heartburn (P < 0.001). There were no differences in control of acid regurgitation over 7 days with pantoprazole compared with nizatidine or ranitidine, except at days 2 and 4 of trial 1, when significantly more patients receiving pantoprazole experienced relief from acid regurgitation than those receiving nizatidine (day 2: 60.6% [n = 20] vs 20.0% [n = 5], P < 0.01; day 4: 48.5% [n =16] vs 24.0% [n = 6], P < 0.05).
In this post hoc reanalysis of data from 2 previously published clinical trials, use of pantoprazole 20 mg once daily was associated with effective early relief from heartburn and acid regurgitation among these patients with GERD and NERD; relief occurred as fast as and, in some cases, even faster than that seen with nizatidine or ranitidine.
缺乏对胃食管反流病（GERD）治疗中症状缓解开始时间的系统评估。
本研究评估了在治疗 GERD 或内镜阴性 GERD（NERD）患者中，患者在接受泮托拉唑、尼扎替丁或雷尼替丁治疗的前 7 天内，烧心（包括白天和夜间烧心）和胃酸反流完全缓解的时间间隔。
这是之前发表的两项多中心、随机、双盲、活性对照、平行组研究数据的事后重新分析。纳入年龄≥18 岁的男性和女性患者，内镜证实为 GERD 或 NERD（Hetzel-Dent 分级≥[试验 1]或 Savary-Miller 分级 0 或 1 [试验 2]）。患者需要有≥3 个月的反流症状，在试验 1 中过去 7 天中有＞4 天有＞1 个症状（即白天烧心、夜间烧心或胃酸反流），或在试验 2 中有≥1 个症状（即烧心、胃酸呃逆或疼痛吞咽），且至少为中度强度，过去 3 天内。试验 1 中两种治疗方法均为每日一次泮托拉唑 20mg，试验 1 中尼扎替丁 150mg 每日两次，试验 2 中雷尼替丁 150mg 每日两次。使用 4 分李克特量表在每日日记卡上记录症状的存在和严重程度。
在试验 1 中，共有 114 名患者可评估烧心，58 名患者可评估胃酸反流；在试验 2 中，共有 307 名患者可评估烧心，271 名患者可评估胃酸反流。在两项研究中，接受泮托拉唑和尼扎替丁或雷尼替丁的患者之间的基线特征没有显著差异，除了试验 1 中男性多于女性（与试验 2 相比，P＜0.001）。在试验 1 的第 2 天，分别有 23（39.0%）和 8（14.5%）名泮托拉唑和尼扎替丁的患者烧心完全缓解（P＜0.01）。两组之间的差异在第 7 天仍具有统计学意义，此时分别有 28（47.5%）和 8（14.5%）名泮托拉唑和尼扎替丁的患者没有烧心（P＜0.001）。与尼扎替丁或雷尼替丁相比，泮托拉唑在控制胃酸反流方面在 7 天内没有差异，除了在试验 1 的第 2 和第 4 天，接受泮托拉唑的患者比接受尼扎替丁的患者更能缓解胃酸反流（第 2 天：60.6%[n=20]比 20.0%[n=5]，P＜0.01；第 4 天：48.5%[n=16]比 24.0%[n=6]，P＜0.05）。
在这两项已发表的临床试验数据的事后重新分析中，每日一次使用泮托拉唑 20mg 可有效快速缓解 GERD 和 NERD 患者的烧心和胃酸反流；缓解速度与尼扎替丁或雷尼替丁相当，在某些情况下甚至更快。
