H_2受体拮抗剂预防应激性溃疡出血的系统评价  

H_2RA for Prevention of Stress Ulcer Bleeding:A Systematic Review of Randomized Controlled Trials

作　　者：曾超[1] 王一平[1] 

机构地区：[1]四川大学华西医院消化科,成都610041

出　　处：《中国循证医学杂志》2007年第9期658-668,共11页Chinese Journal of Evidence-based Medicine

摘　　要：目的评价H2受体拮抗剂(H2RA)对预防重危病人应激性溃疡出血(SUB)的有效性及安全性。方法按既定的检索策略,全面检索Cochrane临床对照试验数据库(2006年第4期)、MEDLINE光盘数据库(1980～2006年10月)、EMbase光盘数据库(1984～2006年10月)、中国生物医学文献数据库(1978～2006年10月)、维普中刊数据库(1989～2006年10月)和中文循证医学随机对照试验数据库。手工检索5种相关中文期刊、相关会议论文集及所有检索到试验的参考文献。纳入H2RA预防SUB的随机对照试验。由两位研究者独立地对纳入试验进行质量评价和资料提取,并交叉核对。如有分歧,通过讨论解决。结局指标包括SUB的发生率、医源性肺炎(nosocomial pneumonia,NP)发生率、病死率、药物不良反应的发生率、胃液pH值等指标评价药物预防SUB的效果和安全性。采用RevMan4.2.7软件进行Meta分析。结果共检索到18个可能符合纳入标准的临床试验,其中16个试验共包括2014例病人符合纳入标准,2个试验被排除。纳入试验的方法学质量高低不齐。提取数据后,进行Meta分析或描述性分析。①H2RA能降低SUB的发生率[RR0.39,95%CI(0.28,0.56);P<0.00001,NNT=6],H2RA(P=0.11),不能降低临床大出血的发生率[RR0.51,95%CI(0.17,1.53);P=0.11]。②H2RA与安慰剂相比较,NP发生率差别无统计学意义[RR1.02,95%CI(0.55,1.89);P=0.95]。③H2RA能降低病死率[RR0.68,95%CI(0.52,0.90);P=0.007,NNT=18]。④H2RA的安全性好。⑤药物预防SUB对胃内pH值的影响,由于所纳入的试验在pH值的测量方法、测量时间上的差异,无法提取资料进行合并分析。所有试验均未将住院时间作为观察指标。结论现有的有限证据表明,预防性使用H2RA均能降低SUB发生率、病死率但不能降低临床大出血的发生率。因所发表的临床研究方法学质量普遍不高,存在多种方法学局限性。故应谨慎看待以上结论。今后有必要进一步开展�Objective To assess the efficacy and safety of histamine H2 receptor antagonist （H2RA） for the prevention of stress ulcer bleeding （SUB） in critically ill patients. Methods Trials were identified by searching Cochrane Controlled Trials （Issue 4, 2006）, MEDLINE （1980 to October 2006）, EMbase （1984 to October 2006） and the Chinese Biological Medicine Database （1978 to October）, Chinese VIP Database （1989 to October 2006） and Chinese EBM Database. We also handsearched the proceedings of relevant conferences, 5 kinds of important Chinese journals and the references of all included trials. Two reviewers assessed the quality of studies and extracted data independently. Disagreement was resolved by discussion. The primary outcomes included were incidence of SUB, incidence of nosocomial pneumonia （NP）, mortality and adverse events. Secondary outcomes were gastric pH,length of hospital stay and length of ICU stay. RevMan4.2.7 software was used for meta-analyses. Results Sixteen trials involving 2 014 patients were included. Most of the trials were of poor quality. Meta-analyses showed that H2RA significantly less SUB compared with patients in the placebo or non-prophylaxis group （RR 0.39, 95%CI 0.28 to 0.56; P〈0.000 01, NNT=6）, but but there was no significant difference in the incidence of clinically important bleeding （RR 0.51,95%CI 0.17 to 1.53; P=-0.11）. No significant difference was observed in the incidence of NP（RR 1.02, 95%CI 0.55 to 1.89, P=0.95）. H2RA significantly decreased mortality in comparison with placebo or nonprophylaxis （RR 0.68, 95%CI 0.52 to 0.90; P=0.007, NNT=18）. H2RA had a good safety profile. We did not perform metaanalysis for gastric pH due to the methodological limitations. Conclusion H2RA may significantly reduce the incidence of SUB and mortality, but cannot reduce the incidence of clinically important bleeding. Due to the poor quality of included studies, the conclusion should be interpreted cautiously. More randomized controlled trial

关 键 词：应激性溃疡出血 H2受体拮抗剂 系统评价 META分析 

分 类 号：R573.1[医药卫生—消化系统]