Zheng Ming-Hua, Bai Jian-Ling, Meng Mao-Bin, Chen Yong-Ping
Department of Infection and Liver Diseases, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China.
Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China.
Curr Ther Res Clin Exp. 2008 Aug;69(4):288-304. doi: 10.1016/j.curtheres.2008.08.001.
Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP), and the benefit of pharmacologic treatment of the condition is unclear. Although prophylactic use of gabexate mesylate (GM) for the reduction of pancreatic injury after ERCP has been evaluated, uncertainty remains regarding the effectiveness of GM treatment in post-ERCP pancreatitis (PEP).
The aim of this study was to determine through systematic review and meta-analysis the effectiveness and tolerability of GM in the prophylaxis of PEP.
MEDLINE (January 1966-July 2007), EMBASE (January 1966- July 2007), the Cochrane Controlled Trials Register on The Cochrane Library (Issue 2, 2007), and the China Biological Medicine Database (January 1978-July 2007) were searched. We used the method recommended by The Cochrane Collaboration to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) of GM in the prevention of PEP.
Of the 38 studies identified, 31 were excluded for the following reasons: they were reviews or editorials (9 articles); were meta-analyses (4); had differences in cointerventions (4); were nonrandomized controlled trials or had incorrect randomization (4); were repeat publications (2); lacked a placebo group (1); or other (7). Seven RCTs, totaling 2883 patients, conducted in a variety of languages were included in the meta-analysis. When the RCTs were analyzed, odds ratios for GM were 0.65 (95% CI, 0.36-1.18; P 0.16) for PER 1.90 (95% CI, 0.54-6.65; P 0.32) for severe PEP, 0.55 (95% CI, 0.17-1.77; P 0.32) for the case-fatality ratio of PEP, 0.88 (95% CI, 0.74-1.05; P 0.16) for post-ERCP hyperamylasemia, and 0.78 (95% CI, 0.49 1.25; P 0.30) for post-ERCP abdominal pain. No evidence of publication bias was found.
No beneficial effects of GM on acute pancreatitis, the PEP mortality rate, or post-ERCP abdominal pain or hyperamylasemia were found; therefore, GM cannot be recommended for the prophylaxis of PEP.
急性胰腺炎是内镜逆行胰胆管造影术（ERCP）的常见并发症，药物治疗该疾病的益处尚不清楚。尽管已评估了预防性使用甲磺酸加贝酯（GM）以减少ERCP术后胰腺损伤的情况，但GM治疗在ERCP术后胰腺炎（PEP）中的有效性仍存在不确定性。
本研究旨在通过系统评价和荟萃分析确定GM预防PEP的有效性和耐受性。
检索MEDLINE（1966年1月至2007年7月）、EMBASE（1966年1月至2007年7月）、Cochrane图书馆的Cochrane对照试验注册库（2007年第2期）以及中国生物医学数据库（1978年1月至2007年7月）。我们采用Cochrane协作网推荐的方法，对GM预防PEP的随机对照试验（RCT）进行系统评价和荟萃分析。
在检索到的38项研究中，31项因以下原因被排除：它们是综述或社论（9篇文章）；是荟萃分析（4篇）；存在联合干预差异（4篇）；是非随机对照试验或随机化不正确（4篇）；是重复发表（2篇）；缺乏安慰剂组（1篇）；或其他原因（7篇）。纳入荟萃分析的有7项RCT，共2883例患者，这些研究以多种语言发表。对这些RCT进行分析时，GM预防轻度PEP的比值比为0.65（95%CI，0.36 - 1.18；P = 0.16），预防重度PEP的比值比为1.90（95%CI，0.54 - 6.65；P = 0.32），PEP病死率的比值比为0.55（95%CI，0.17 - 1.77；P = 0.32），ERCP术后高淀粉酶血症的比值比为0.88（95%CI，0.74 - 1.05；P = 0.16），ERCP术后腹痛的比值比为0.78（95%CI，0.49 - 1.25；P = 0.30）。未发现发表偏倚的证据。
未发现GM对急性胰腺炎、PEP死亡率、ERCP术后腹痛或高淀粉酶血症有有益作用；因此，不推荐使用GM预防PEP。
