Leontiadis G I, Sharma V K, Howden C W
Cochrane Database Syst Rev. 2006 Jan 25(1):CD002094. doi: 10.1002/14651858.CD002094.pub3.
Randomised controlled trials (RCTs) evaluating the clinical effect of proton pump inhibitors (PPIs) in peptic ulcer (PU) bleeding yield conflicting results.
To evaluate the efficacy of PPIs in acute bleeding from PU using evidence from RCTs.
We searched CENTRAL, The Cochrane Library (Issue 4, 2004), MEDLINE (1966 to November 2004), EMBASE (1980 to November 2004), proceedings of major meetings to November 2004, and reference lists of articles. We contacted pharmaceutical companies and experts in the field.
RCTs of PPI treatment (oral or intravenous) compared with placebo or H(2)-receptor antagonist (H(2)RA) in acute bleeding from PU.
Two reviewers extracted data independently, assessed study validity, summarised studies and undertook meta-analysis. The influence of study characteristics on the outcomes was examined by subgroup analyses and meta-regression.
Twenty-four RCTs comprising 4373 participants in total were included. Statistical heterogeneity was found among trials for rebleeding (P = 0.04), but not for all-cause mortality (P = 0.24) or surgery (P = 0.45). There was no significant difference in all-cause mortality rates between PPI and control treatment; pooled rates were 3.9% on PPI versus 3.8% on control (odds ratio (OR) 1.01; 95% CI 0.74 to 1.40). PPIs significantly reduced rebleeding compared to control; pooled rates were 10.6% with PPI versus 17.3% with control treatment (OR 0.49; 95% CI 0.37 to 0.65). PPI treatment significantly reduced surgery compared with control; pooled rates were 6.1% on PPI versus 9.3% on control (OR 0.61; 95% CI 0.48 to 0.78). There was no evidence to suggest that results on mortality and rebleeding were dependent on study quality, route of PPI administration, type of control treatment or application of initial endoscopic haemostatic treatment. PPIs significantly reduced surgery compared with placebo but not when compared with H(2)RA. There was no evidence to suggest that study quality, route of PPI administration or application of initial endoscopic haemostatic treatment influenced results on surgery. PPI treatment appeared more efficacious in studies conducted in Asia compared to studies conducted elsewhere. All-cause mortality was reduced only in Asian studies; reductions in rebleeding and surgery were quantitatively greater in Asian studies. Among patients with active bleeding or non-bleeding visible vessel, PPI treatment reduced mortality (OR 0.53; 95% CI 0.31 to 0.91), rebleeding and surgery.
AUTHORS' CONCLUSIONS: PPI treatment in PU bleeding reduces rebleeding and surgery compared with placebo or H(2)RA, but there is no evidence of an overall effect on all-cause mortality.
评估质子泵抑制剂（PPI）对消化性溃疡（PU）出血临床疗效的随机对照试验（RCT）结果相互矛盾。
利用随机对照试验的证据评估PPI对PU急性出血的疗效。
我们检索了考克兰系统评价数据库（CENTRAL）、《考克兰图书馆》（2004年第4期）、医学文献数据库（MEDLINE，1966年至2004年11月）、荷兰医学文摘数据库（EMBASE，1980年至2004年11月）、截至2004年11月的主要会议论文集以及文章的参考文献列表。我们还联系了制药公司和该领域的专家。
比较PPI治疗（口服或静脉注射）与安慰剂或H2受体拮抗剂（H2RA）治疗PU急性出血的随机对照试验。
两名评价员独立提取数据，评估研究的有效性，总结研究并进行荟萃分析。通过亚组分析和荟萃回归研究研究特征对结果的影响。
共纳入24项随机对照试验，总计4373名参与者。各试验在再出血方面存在统计学异质性（P = 0.04），但在全因死亡率（P = 0.24）或手术方面不存在异质性（P = 0.45）。PPI治疗与对照治疗的全因死亡率无显著差异；PPI组的合并死亡率为3.9%，对照组为3.8%（比值比（OR）1.01；95%可信区间0.74至1.40）。与对照相比，PPI显著降低了再出血率；PPI组的合并再出血率为10.6%，对照治疗组为17.3%（OR 0.49；95%可信区间0.37至0.65）。与对照相比，PPI治疗显著减少了手术；PPI组的合并手术率为6.1%，对照组为9.3%（OR 0.61；95%可信区间0.48至0.78）。没有证据表明死亡率和再出血的结果取决于研究质量、PPI给药途径、对照治疗类型或初始内镜止血治疗的应用。与安慰剂相比，PPI显著减少了手术，但与H2RA相比则不然。没有证据表明研究质量、PPI给药途径或初始内镜止血治疗的应用会影响手术结果。与其他地区开展的研究相比，PPI治疗在亚洲开展的研究中似乎更有效。仅在亚洲研究中全因死亡率有所降低；亚洲研究中再出血和手术的减少在数量上更大。在活动性出血或可见非出血血管的患者中，PPI治疗降低了死亡率（OR 0.53；95%可信区间0.31至0.91）、再出血率和手术率。
与安慰剂或H2RA相比，PPI治疗PU出血可降低再出血率和手术率，但没有证据表明对全因死亡率有总体影响。
