Cook D J, Reeve B K, Guyatt G H, Heyland D K, Griffith L E, Buckingham L, Tryba M
Department of Medicine, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.
JAMA. 1996;275(4):308-14.
To resolve discrepancies in previous systematic overviews and provide estimates of the effect of stress ulcer prophylaxis on gastrointestinal bleeding, pneumonia, and mortality in critically ill patients.
Computerized search of published and unpublished research, bibliographies, pharmaceutical and personal files, and conference abstract reports.
Independent review of 269 articles identified 63 relevant randomized trials for inclusion.
We made independent, duplicate assessment of the methodologic quality, population, intervention, and outcomes of each trial.
The source of discrepancies between prior meta-analyses included incomplete identification of relevant studies, differential inclusion of non-English language and nonrandomized trials, different definitions of bleeding, provision of additional information through direct correspondence with authors, and different statistical methods. The current overview demonstrates that prophylaxis with histamine2-receptor antagonists decreases the incidence of overt gastrointestinal bleeding (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.42 to 0.79) and clinically important bleeding (OR, 0.44; 95% CI, 0.22 to 0.88). There is a trend toward decreased overt bleeding when antacids are compared with no therapy (OR, 0.66; 95% CI, 0.37 to 1.17). Histamine2-receptor antagonists and antacids are associated with a trend toward lower clinically important bleeding rates than sucralfate is. There is a trend toward an increased risk of pneumonia associated with histamine2-receptor antagonists as compared with no prophylaxis (OR, 1.25; 95% CI, 0.78 to 2.00). Sucralfate is associated with a lower incidence of nosocomial pneumonia when compared with antacids (OR, 0.80; 95% CI, 0.56 to 1.15) and histamine2-receptor antagonists (OR, 0.77; 95% CI, 0.60 to 1.01). Sucralfate is also associated with a reduced mortality rate (OR, 0.73; 95% CI, 0.54 to 0.97) relative to antacids and to histamine2-receptor antagonists (OR, 0.83; 95% CI, 0.63 to 1.09).
Our results emphasize the need for registries to include all randomized trials and demonstrate the importance of explicit methodology for systematic reviews. There is strong evidence of reduced clinically important gastrointestinal bleeding with histamine2-receptor antagonists. Sucralfate may be as effective in reducing bleeding as gastric pH-altering drugs and is associated with lower rates of pneumonia and mortality. However, the data are insufficient to determine the net effect of sucralfate compared with no prophylaxis.
解决以往系统综述中的差异,并提供应激性溃疡预防对危重症患者胃肠道出血、肺炎和死亡率影响的估计。
对已发表和未发表的研究、参考文献、制药公司和个人档案以及会议摘要报告进行计算机检索。
对269篇文章进行独立评审,确定63项相关随机试验纳入研究。
我们对每项试验的方法学质量、研究对象、干预措施和结局进行了独立的、重复的评估。
以往荟萃分析之间存在差异的原因包括相关研究识别不完整、非英语语言和非随机试验的纳入差异、出血定义不同、通过与作者直接通信提供额外信息以及统计方法不同。当前综述表明,使用组胺2受体拮抗剂进行预防可降低显性胃肠道出血的发生率(优势比[OR],0.58;95%置信区间[CI],0.42至0.79)和具有临床意义的出血发生率(OR,0.44;95%CI,0.22至0.88)。与不进行治疗相比,使用抗酸剂时显性出血有减少趋势(OR,0.66;95%CI,0.37至1.17)。与硫糖铝相比,组胺2受体拮抗剂和抗酸剂具有降低具有临床意义出血率的趋势。与不进行预防相比,使用组胺2受体拮抗剂有增加肺炎风险的趋势(OR,1.25;95%CI,0.78至2.00)。与抗酸剂(OR,0.80;95%CI,0.56至1.15)和组胺2受体拮抗剂(OR,0.77;95%CI,0.60至1.01)相比,硫糖铝与医院获得性肺炎发生率较低相关。与抗酸剂和组胺2受体拮抗剂相比,硫糖铝还与死亡率降低相关(OR,0.73;95%CI,0.54至0.97)(抗酸剂和组胺2受体拮抗剂的OR为0.83;95%CI,0.63至1.09)。
我们的结果强调登记处需要纳入所有随机试验,并证明系统评价明确方法学的重要性。有强有力的证据表明组胺2受体拮抗剂可减少具有临床意义的胃肠道出血。硫糖铝在减少出血方面可能与改变胃pH值的药物同样有效,并且与较低的肺炎和死亡率相关。然而,数据不足以确定硫糖铝与不进行预防相比的净效应。