Seta Takeshi, Noguchi Yoshinori, Shikata Satoru, Nakayama Takeo
Department of Health Informatics, Kyoto University School of Public Health, Yoshida-Konoe, Sakyo-ku, Kyoto, Kyoto 606-8501, Japan.
BMC Gastroenterol. 2014 May 30;14:102. doi: 10.1186/1471-230X-14-102.
The intravenous use of protease inhibitors in patients with acute pancreatitis is still controversial. The purpose of this study was to evaluate the effectiveness of protease inhibitors intravenously administered to prevent pancreatitis-associated complications.
We updated our previous meta-analysis with articles of randomized controlled trials published from January 1965 to March 2013 on the effectiveness of protease inhibitors for acute pancreatitis. A systematic search of PubMed, EMBASE, the Cochrane Library, and Japana Centra Revuo Medicina was conducted. In addition, Internet-based registries (ClinicalTrials.gov, controlled-trials.com, UMIN, JMACCT, and JAPIC) were used to search for on-going clinical trials. Furthermore, references of review articles and previously published meta-analyses were handsearched. The main outcome of interest was the overall mortality rate from acute pancreatitis.
Seventeen trials were selected for analysis. Overall, protease inhibitors did not achieve a significant risk reduction in mortality (pooled risk difference [RD], -0.02; 95% Confidence Interval [CI], -0.05 to 0.01; number needed to treat [NNT], 74.8) with low heterogeneity. A subgroup analysis in moderate to severe pancreatitis (defined by control mortality rate [CMR] >0.10) did not show a significant effect of protease inhibitors to prevent death (pooled RD, -0.03; 95% CI, -0.07 to 0.01; NNT, 1603.9) with low heterogeneity. An additional subgroup analysis of two trials with CMR >0.20 (i.e., low quality) revealed a significant risk reduction.
The present meta-analysis re-confirmed that there is no solid evidence that supports the intravenous use of protease inhibitors to prevent death due to acute pancreatitis.
急性胰腺炎患者静脉使用蛋白酶抑制剂仍存在争议。本研究旨在评估静脉给予蛋白酶抑制剂预防胰腺炎相关并发症的有效性。
我们用1965年1月至2013年3月发表的关于蛋白酶抑制剂治疗急性胰腺炎有效性的随机对照试验文章更新了之前的荟萃分析。对PubMed、EMBASE、Cochrane图书馆和日本医学中央杂志进行了系统检索。此外,利用基于互联网的注册库(ClinicalTrials.gov、controlled-trials.com、UMIN、JMACCT和JAPIC)检索正在进行的临床试验。此外,还手工检索了综述文章和先前发表的荟萃分析的参考文献。主要关注的结局是急性胰腺炎的总体死亡率。
选择17项试验进行分析。总体而言,蛋白酶抑制剂在降低死亡率方面未取得显著风险降低(合并风险差[RD],-0.02;95%置信区间[CI],-0.05至0.01;需治疗人数[NNT],74.8),异质性较低。在中度至重度胰腺炎(由对照死亡率[CMR]>0.10定义)中的亚组分析未显示蛋白酶抑制剂预防死亡的显著效果(合并RD,-0.03;95%CI,-0.07至0.01;NNT,1603.9),异质性较低。对两项CMR>0.20(即低质量)试验的额外亚组分析显示有显著的风险降低。
本荟萃分析再次证实,没有确凿证据支持静脉使用蛋白酶抑制剂预防急性胰腺炎导致的死亡。