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目的回顾关于质子泵抑制剂治疗溃疡出血患者的随机对照研究,确定该治疗对于死亡率、再出血和外科干预措施的影响。设计系统评价和汇总分析。资料来源包括Cochrane协作网的临床试验注册库、Medline、Embase、手工检索的和制药公司。评价方法在经内镜证实存在溃疡出血并至少有以下事件之一——死亡、再出血、外科干预的患者中,进行随机对照研究,比较质子泵抑制剂与安慰剂或H2受体拮抗剂的疗效。所有临床试验依据方法学质量来进行分级。由2个评定者独立回顾每个临床试验,将分歧按照多数人的意见来统一。结果我们选出了21项随机对照研究,包括2915例患者。质子泵抑制剂治疗对于死亡率没有显著影响[比值比1.11,95%可信区间0.79～1.57;需要治疗的人数(NNT)无法计算]。但是质子泵抑制剂可以降低再出血的发生(0.46,0.33～0.64;NNT为12)和外科治疗的比例(0.59,0.46～0.76;NNT为20)。对其中10项具有高质量方法学的临床试验进行汇总分析,得到相似的结论死亡率的OR值为0.96(0.46～2.01);再出血的OR值为0.41(0.25～0.68),NNT为10;外科手术的OR值为0.62(0.46～0.83),NNT为25。结论质子泵抑制剂的治疗可以降低溃疡的再出血风险,减少对外科手术的需要,但患者的总体死亡率没有改善。
Objective To review a randomized controlled trial of proton pump inhibitors in the treatment of patients with ulcer bleeding to determine the impact of the treatment on mortality, rebleeding and surgical interventions. Design system evaluation and summary analysis. Sources include the Cochrane Collaboration’s Clinical Trials Registry, Medline, Embase, Hand searched, and Pharmaceutical companies. METHODS OF EVALUATION Randomized controlled studies were performed in patients who had been confirmed by endoscopic ulcer bleeding and who had at least one of the following events - death, rebleeding, and surgical intervention. Proton pump inhibitors were compared with placebo or H2 receptor antagonist Efficacy. All clinical trials are based on methodological quality. Independent reviews of each clinical trial by two reviewers align disagreement with the majority opinion. Results We selected 21 randomized controlled studies, including 2915 patients. Proton pump inhibitor treatment had no significant effect on mortality [odds ratio 1.11, 95% confidence interval 0.79 to 1.57; number of patients requiring treatment (NNT)]. However, proton pump inhibitors decreased the incidence of rebleeding (0.46, 0.33-0.64; NNT 12) and surgical treatment (0.59, 0.46-0.76; NNT 20). A meta-analysis of 10 clinical trials with high-quality methodologies resulted in a similar OR of 0.96 (range, 0.46 to 2.01) for OR and 0.41 (0.25-0.68) for OR and 10 for NNT. The odds ratio for surgery was 0.62 (0.46-0.83) and NNT was 25. Conclusions The treatment of proton pump inhibitors can reduce the risk of rebleeding ulcers and reduce the need for surgery, but overall patient mortality has not improved.