Leontiadis Grigoris I, Sharma Virender K, Howden Colin W
Division of Gastroenterology, 2nd Department of Internal Medicine, Democritus University of Thrace School of Medicine, Alexandroupolis, Greece.
Mayo Clin Proc. 2007 Mar;82(3):286-96. doi: 10.4065/82.3.286.
To evaluate the efficacy of proton pump inhibitors (PPIs) in treating peptic ulcer bleeding.
We searched the MEDLINE, EMBASE, CENTRAL, Cochrane Library, and metaRegister of Controlled Trials databases and published proceedings of major meetings through November 2004 for randomized controlled trials that compared oral or intravenous PPIs with placebo or a histamine2-receptor antagonist for peptic ulcer bleeding. Pharmaceutical companies and relevant experts were contacted. Data extraction and assessment of study validity were performed independently in duplicate. Assessed outcomes were 30-day all-cause mortality, rebleeding, surgery, and repeated endoscopic treatment. Influence of study characteristics on outcomes was examined by subgroup analyses and meta-regression.
We included 24 trials (4373 participants). Statistical heterogeneity was evident only for rebleeding. Treatment with PPIs had no significant effect on mortality (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.74-1.40; number needed to treat [NNT], incalculable) but significantly reduced rebleeding (OR, 0.49; 95% CI, 0.37-0.65; NNT, 13) and the need for surgery (OR, 0.61; 95% CI, 0.48-0.78; NNT, 34) and repeated endoscopic treatment (OR, 0.32; 95% CI, 0.20-0.51; NNT, 10). Results were similar when analysis was confined to trials with adequate allocation concealment. Treatment with PPIs significantly reduced mortality in Asian trials (OR, 0.35; 95% CI, 0.16-0.74; NNT, 34) and in patients with active bleeding or a nonbleeding visible vessel (OR, 0.53; 95% CI, 0.31-0.91; NNT, 50).
In ulcer bleeding, PPIs reduce rebleeding and the need for surgery and repeated endoscopic treatment. They improve mortality among patients at highest risk.
评估质子泵抑制剂(PPI)治疗消化性溃疡出血的疗效。
检索MEDLINE、EMBASE、CENTRAL、Cochrane图书馆以及截至2004年11月的对照试验元注册数据库,并查阅主要会议的发表论文集,以获取将口服或静脉注射PPI与安慰剂或组胺2受体拮抗剂用于治疗消化性溃疡出血的随机对照试验。联系了制药公司和相关专家。数据提取和研究有效性评估由两人独立重复进行。评估的结局指标为30天全因死亡率、再出血、手术以及重复内镜治疗。通过亚组分析和元回归研究研究特征对结局的影响。
我们纳入了24项试验(4373名参与者)。仅再出血方面存在明显的统计学异质性。PPI治疗对死亡率无显著影响(比值比[OR],1.01;95%置信区间[CI],0.74 - 1.40;需治疗人数[NNT],无法计算),但显著降低了再出血(OR,0.49;95% CI,0.37 - 0.65;NNT,13)、手术需求(OR,0.61;95% CI,0.48 - 0.78;NNT,34)以及重复内镜治疗(OR,0.32;95% CI,0.20 - 0.51;NNT,10)。当分析仅限于分配隐藏充分的试验时,结果相似。PPI治疗在亚洲试验中显著降低了死亡率(OR,0.35;95% CI,0.16 - 0.74;NNT,34),在有活动性出血或无出血可见血管的患者中也显著降低了死亡率(OR,0.53;95% CI,0.31 - 0.91;NNT,50)。
在溃疡出血中,PPI可降低再出血率以及手术和重复内镜治疗的需求。它们可改善高危患者的死亡率。