van Pinxteren Bart, Sigterman Kirsten E, Bonis Peter, Lau Joseph, Numans Mattijs E
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, Utrecht, Netherlands, 3508 GA.
Cochrane Database Syst Rev. 2010 Nov 10(11):CD002095. doi: 10.1002/14651858.CD002095.pub4.
Approximately 25% of adults regularly experience heartburn, a symptom of gastro-oesophageal reflux disease (GORD). Most patients are treated empirically (without specific diagnostic evaluation e.g. endoscopy. Among patients who have an upper endoscopy, findings range from a normal appearance, mild erythema to severe oesophagitis with stricture formation. Patients without visible damage to the oesophagus have endoscopy negative reflux disease (ENRD). The pathogenesis of ENRD, and its response to treatment may differ from GORD with oesophagitis.
Summarise, quantify and compare the efficacy of short-term use of proton pump inhibitors (PPI), H2-receptor antagonists (H2RA) and prokinetics in adults with GORD, treated empirically and in those with endoscopy negative reflux disease (ENRD).
We searched MEDLINE (January 1966 to November 2008), EMBASE (January 1988 to November 2008), and EBMR in November 2008.
Randomised controlled trials reporting symptomatic outcome after short-term treatment for GORD using proton pump inhibitors, H2-receptor antagonists or prokinetic agents. Participants had to be either from an empirical treatment group (no endoscopy used in treatment allocation) or from an endoscopy negative reflux disease group (no signs of erosive oesophagitis).
Two authors independently assessed trial quality and extracted data.
Thirty-two trials (9738 participants) were included: fifteen in the empirical treatment group, thirteen in the ENRD group and four in both. In empirical treatment of GORD the relative risk (RR) for heartburn remission (the primary efficacy variable) in placebo-controlled trials for PPI was 0.37 (two trials, 95% confidence interval (CI) 0.32 to 0.44), for H2RAs 0.77 (two trials, 95% CI 0.60 to 0.99) and for prokinetics 0.86 (one trial, 95% CI 0.73 to 1.01). In a direct comparison PPIs were more effective than H2RAs (seven trials, RR 0.66, 95% CI 0.60 to 0.73) and prokinetics (two trials, RR 0.53, 95% CI 0.32 to 0.87). In treatment of ENRD, the RR for heartburn remission for PPI versus placebo was 0.73 (eight trials, 95% CI 0.67 to 0.78) and for H2RA versus placebo was 0.84 (two trials, 95% CI 0.74 to 0.95). The RR for PPI versus H2RA was 0.78 (three trials, 95% CI 0.62 to 0.97) and for PPI versus prokinetic 0.72 (one trial, 95% CI 0.56 to 0.92).
AUTHORS' CONCLUSIONS: PPIs are more effective than H2RAs in relieving heartburn in patients with GORD who are treated empirically and in those with ENRD, although the magnitude of benefit is greater for those treated empirically.
约25%的成年人经常出现胃灼热症状，这是胃食管反流病（GORD）的一种症状。大多数患者接受经验性治疗（未进行如内镜检查等特定诊断评估）。在上消化道内镜检查的患者中，检查结果从外观正常、轻度红斑到伴有狭窄形成的严重食管炎不等。食管无可见损伤的患者患有内镜阴性反流病（ENRD）。ENRD的发病机制及其对治疗的反应可能与伴有食管炎的GORD不同。
总结、量化并比较质子泵抑制剂（PPI）、H2受体拮抗剂（H2RA）和促动力药在经验性治疗的GORD成年患者以及内镜阴性反流病（ENRD）患者中短期使用的疗效。
我们检索了MEDLINE（1966年1月至2008年11月）、EMBASE（1988年1月至2008年11月）以及2008年11月的循证医学数据库（EBMR）。
随机对照试验，报告使用质子泵抑制剂、H2受体拮抗剂或促动力药对GORD进行短期治疗后的症状性结局。参与者必须来自经验性治疗组（治疗分配中未使用内镜检查）或内镜阴性反流病组（无糜烂性食管炎体征）。
两位作者独立评估试验质量并提取数据。
纳入32项试验（9738名参与者）：经验性治疗组15项，ENRD组13项，两组均涉及的4项。在GORD的经验性治疗中，安慰剂对照试验中PPI缓解胃灼热（主要疗效变量）的相对风险（RR）为0.37（两项试验，95%置信区间（CI）0.32至0.44），H2RA为0.77（两项试验，95%CI 0.60至0.99），促动力药为0.86（一项试验，95%CI 0.73至1.01）。在直接比较中，PPI比H2RA更有效（七项试验，RR 0.66，95%CI 0.60至0.73），也比促动力药更有效（两项试验，RR 0.53，95%CI 0.32至0.87）。在ENRD的治疗中，PPI与安慰剂相比缓解胃灼热的RR为0.73（八项试验，95%CI 0.67至0.78），H2RA与安慰剂相比为0.84（两项试验，95%CI 0.74至0.95）。PPI与H2RA相比的RR为0.78（三项试验，95%CI 0.62至0.97），PPI与促动力药相比为0.72（一项试验，95%CI 0.56至0.92）。
在经验性治疗的GORD患者和ENRD患者中，PPI在缓解胃灼热方面比H2RA更有效，尽管经验性治疗患者的获益程度更大。
