BACKGROUND & AIMS:
:Histamine H2 antagonists are widely used in treating patients with hematemesis and melena, despite the lack of reliable evidence of benefit from any of the randomized trials, considered separately. Examination of the data from all 27 available randomized trials, in which over 2500 patients were entered, suggests that treatment may reduce the rates of rebleeding, surgery, and death by about 10, 20, and 30 per cent, respectively, although these results were only marginally significant for surgery and death. Any benefit appeared to be confined to patients with bleeding gastric ulcers, but since this subgroup analysis was prompted by preliminary examination of the data in some of the individual trials reviewed here, it should be treated with particular caution. The implications of this overview are that treatment with histamine H2 antagonists appears to be moderately promising, but its effects on important end points, such as death, still need to be assessed reliably. Prevention of "only" about 20 per cent of all deaths could well be worthwhile, for the condition is common, and the treatment widely practicable. To detect such a moderate effect reliably, however, might require the randomization of 10,000 patients (or more), which would be possible only in an extremely simple multicenter collaborative trial.
背景与目标:
: 组胺H2拮抗剂被广泛用于治疗呕血和黑便患者,尽管缺乏可靠的证据从单独考虑的任何随机试验中获益。对来自所有27个可用的随机试验的数据 (其中输入了2500多名患者) 的检查表明,治疗可将再出血,手术和死亡率分别降低约10%,20% 和30%,尽管这些结果仅对手术和死亡具有轻微意义。任何益处似乎都仅限于胃溃疡出血患者,但由于该亚组分析是通过对此处审查的一些单独试验中的数据进行初步检查而引起的,因此应特别谨慎对待。此概述的含义是,用组胺H2拮抗剂治疗似乎是适度有希望的,但仍需要可靠地评估其对重要终点 (例如死亡) 的影响。预防 “仅” 大约20% 的死亡是值得的,因为这种情况很普遍,并且治疗广泛可行。然而,为了可靠地检测这种中等效应,可能需要对10,000患者 (或更多) 进行随机化,这仅在极其简单的多中心协作试验中是可能的。