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荟萃分析:直肠吲哚美辛预防 ERCP 后胰腺炎。

Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis.

机构信息

Division of Gastroenterology, McGill University Health Sciences, Montreal, QC, Canada; Division of Gastroenterology, Jewish General Hospital, Montreal, QC, Canada; Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA.

出版信息

Aliment Pharmacol Ther. 2013 Nov;38(9):995-1001. doi: 10.1111/apt.12488. Epub 2013 Sep 16.

Abstract

BACKGROUND

Despite initial evidence in the literature, nonsteroidal anti-inflammatory drugs (NSAIDs) have not been widely used to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).

AIM

To complete a meta-analysis of high-quality RCTs that included the latest available literature published after past meta-analytical efforts

METHODS

A comprehensive electronic literature search was carried out for RCTs comparing peri-procedural rectal indomethacin and placebo in preventing PEP. Methodological quality was assessed by the Cochrane risk of bias tool. Fixed model Mantel-Haenszel meta-analysis, Q test and I(2) index were used. Several subgroup and sensitivity analyses were planned.

RESULTS

A total of four of 61 retrieved trials between 2007 and 2012 (n = 1470) were included. No significant publication bias existed. All studies used similar criteria to detect pancreatitis. The pooled proportion estimate of the rate of pancreatitis was 5.1% with indomethacin and 10.3% with placebo. After excluding the high-risk patients, the rates were 3.9% and 7.9% respectively. Fixed model meta-analysis showed that the rate of pancreatitis was significantly lower using indomethacin as compared with placebo [OR = 0.49(0.34-0.71); P = 0.0002]. Number needed to treat was 20. There was no significant statistical or clinical heterogeneity. In subgroup analysis, the difference remained unchanged for average-risk population [OR = 0.49(0.28-0.85); P = 0.01] or in preventing severe PEP [OR = 0.41(0.21-0.78); P = 0.007]. The result of the main outcome remained robust in multiple sensitivity analyses.

CONCLUSIONS

Rectal indomethacin used immediately before or after ERCP significantly reduces the risk of PEP to half in both low- and high-risk patients, and with both statistically and clinically significant conclusions. These results suggest that a possible change in routine practice for patients at both low and high risk of developing PEP should be advocated.

摘要

背景

尽管文献中有初步证据,但非甾体抗炎药(NSAIDs)并未广泛用于预防内镜逆行胰胆管造影(ERCP)后胰腺炎(PEP)。

目的

对包括过去荟萃分析后发表的最新文献在内的高质量 RCT 进行荟萃分析。

方法

对比较 ERCP 术前和术后直肠使用吲哚美辛和安慰剂预防 PEP 的 RCT 进行全面的电子文献检索。使用 Cochrane 偏倚风险工具评估方法学质量。采用固定模型 Mantel-Haenszel 荟萃分析、Q 检验和 I² 指数进行分析。计划进行多项亚组和敏感性分析。

结果

共纳入 2007 年至 2012 年的 61 项研究中的 4 项(n=1470)。不存在显著的发表偏倚。所有研究均采用相似的标准来检测胰腺炎。使用吲哚美辛的胰腺炎发生率估计合并率为 5.1%,安慰剂组为 10.3%。排除高危患者后,发生率分别为 3.9%和 7.9%。固定模型荟萃分析显示,与安慰剂相比,吲哚美辛可显著降低胰腺炎的发生率[OR=0.49(0.34-0.71);P=0.0002]。需要治疗的人数为 20。无显著统计学或临床异质性。亚组分析显示,对于平均风险人群,差异保持不变[OR=0.49(0.28-0.85);P=0.01],或预防严重 PEP[OR=0.41(0.21-0.78);P=0.007]。主要结局的结果在多次敏感性分析中仍然稳健。

结论

ERCP 术前或术后立即直肠使用吲哚美辛可使低危和高危患者的 PEP 风险降低一半,且具有统计学和临床意义。这些结果表明,对于低危和高危发生 PEP 的患者,应提倡改变常规实践。

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