Intervention Review

Antibiotic prophylaxis for spontaneous bacterial peritonitis in cirrhotic patients with ascites, without gastro-intestinal bleeding

  1. Matan J Cohen1,*,
  2. Tali Sahar2,
  3. Shmuel Benenson3,
  4. Eran Elinav4,
  5. Mayer Brezis1,
  6. Karla Soares-Weiser5

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 15 APR 2009

Assessed as up-to-date: 6 FEB 2009

DOI: 10.1002/14651858.CD004791.pub2


How to Cite

Cohen MJ, Sahar T, Benenson S, Elinav E, Brezis M, Soares-Weiser K. Antibiotic prophylaxis for spontaneous bacterial peritonitis in cirrhotic patients with ascites, without gastro-intestinal bleeding. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD004791. DOI: 10.1002/14651858.CD004791.pub2.

Author Information

  1. 1

    Hadassah Medical Center, Center for Clinical Quality & Safety, Jerusalem, Israel

  2. 2

    Hebrew University, Department of Family practice, Jerusalem, Israel

  3. 3

    Hadassah - Hebrew University Medical Center, Clinical Microbiology and Infectious Diseases, Jerusalem, Israel

  4. 4

    Tel Aviv Sourasky Medical Center, Department of Gastroenterology and Hepatology, Tel Aviv, Israel

  5. 5

    Enhance Reviews, Kfar-Saba, Israel

*Matan J Cohen, Center for Clinical Quality & Safety, Hadassah Medical Center, Ein Kessem Campus, Box 53, POB12000, Jerusalem, 91120, Israel. matan.cohen@mail.huji.ac.il.

Publication History

  1. Publication Status: New
  2. Published Online: 15 APR 2009

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Spontaneous bacterial peritonitis is frequent among cirrhotic patients, associated with significant morbidity and mortality. Selective intestinal decontamination employing antibiotics is a proposed prophylactic measure. While data regarding this modality among cirrhotic patients with gastrointestinal bleeding exist, there is insufficient data synthesis regarding cirrhotic patients with ascites and no gastrointestinal bleeding.

Objectives

To assess whether antibiotic prophylaxis decreases spontaneous bacterial peritonitis and mortality among cirrhotic patients with ascites and no gastrointestinal bleeding.

Search methods

We identified relevant randomised trials by searching trial registries of The Cochrane Hepato-Biliary Group and The Cochrane Collaboration, medical literature search engines, and reviewing all literature we found on the topic until February 2009.

Selection criteria

We searched for randomised clinical trials assessing prophylactic treatment among adult cirrhotic patients with ascites and no gastrointestinal bleeding, comparing antibiotic therapy with no intervention, placebo, or with another antibiotic regimen.

Data collection and analysis

Three independent authors searched for and collected the trials and extracted relevant data. Four other independent authors validated the findings and assessed them. The studies were assessed for design, patient and intervention characteristics, and quality. A meta-analysis was performed to estimate measures of association between antibiotic prophylaxis and spontaneous bacterial peritonitis or mortality.

Main results

Nine trials were included in the review. Seven trials, comparing antibiotics to placebo or no treatment, were meta-analysed. Systematic bias in design or publication is suggested by trial results. The randomisation results suggest that the probability that true randomisation took place in all trials is very small and the report of most trials regarding design was poor. The proportion of participants with spontaneous bacterial peritonitis varied between the trials from 15% to 50%. The calculated relative risks (95% confidence interval) of spontaneous bacterial peritonitis and mortality among patients treated with antibiotics compared with no treatment/placebo were 0.20 (0.11 to 0.37) and 0.61 (0.43 to 0.87). There were very few reports of adverse events.

Authors' conclusions

The pooled estimates suggest that antibiotic prophylaxis might be prudent among cirrhotic patients with ascites and no gastrointestinal bleeding. However, poor trial methodology and report coupled with findings suggesting systematic bias in publication and design reflect the fragility of these findings. Potential hazard to society and the patients themselves from resistant pathogens should be considered when promoting long-lasting antibiotic prophylaxis. It seems that recommending antibiotic prophylaxis is still far from being a substantiated prevention strategy. Trials of better design, well reported, and of longer follow-up are greatly needed.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Existing trials, of poor quality, indicate that antibiotic prophylaxis reduces spontaneous bacterial peritonitis among cirrhotic patients with ascites and no gastrointestinal bleeding

Spontaneous bacterial peritonitis (infection and inflammation of the membrane lining the abdominal cavity) is a frequent complication among cirrhotic patients (patients with end-stage liver disease marked by irreversible scarring of liver tissue) and is associated with significant morbidity and mortality. Selective intestinal decontamination, employing antibiotics, is a proposed prophylactic (preventive) measure. This systematic review of randomised clinical trials assesses whether antibiotic prophylaxis prevents spontaneous bacterial peritonitis and mortality among cirrhotic patients with ascites (excess fluid in the abdominal cavity) and no gastrointestinal bleeding. Nine trials are included in the review. The pooled rates of spontaneous bacterial peritonitis and mortality indicate that antibiotic prophylaxis reduces both. There are very few reports of adverse events. Reviewing these trials, we found poor methodology, evidence suggesting publication bias, and limited follow-up periods. Thus, the recommendation to prescribe prophylactic antibiotics to cirrhotic patients without gastrointestinal bleeding is hampered by quality of the trials that generated the data. Due to potential hazards, both to society as a whole and the patients, as individuals, before antibiotic prophylaxis can be confidently recommended, trials of better design, well reported, and of longer follow-up are required.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

預防性抗生素治療有腹水但無胃腸道出血的肝硬化病人的自發性細菌腹膜炎

自發性細菌腹膜炎經常發生在肝硬化病人,並具有極高的發病率和死亡率。使用抗生素作為選擇性腸道淨化方法當成一種預防措施使用。雖然對此種方法對於胃腸道出血的肝硬化病人存有相關資料,但是卻缺乏治療有腹水但胃腸道出血的無肝硬化病人的數據。

目標

評估是否使用預防性抗生素可以降低有腹水但無胃腸道出血的肝硬化病人的自發性細菌腹膜炎發生的機率和死亡。

搜尋策略

透過搜尋The Cochrane HepatoBiliary Group,Cochrane Collaboration和醫學文獻搜索引擎,我們搜尋了相關隨機試驗,並回顧有關此話題的文獻資料,搜索截止到2009年2月。

選擇標準

我們搜尋相關隨機臨床試驗針對評估預防治療對照抗生素療法,無干預法, 安慰劑, 無抗生素方案治療對於有腹水但無胃腸道出血的成年肝硬化病人。

資料收集與分析

3位作者獨立研究並收集試驗,摘錄相關數據。 另外4位作者驗證發現並且作出評估。從設計,病人和干預特性,品質等方面,評估研究。利用 metaanalysis 評估抗生素預防和自發性細菌腹膜炎之間的關聯測量值或死亡率。

主要結論

本次綜述共包括9po 試驗。7po 試驗透過 metaanalysis分析比較抗生素 安慰劑或無干預法。 試驗結果表明設計或發表存在系統性偏誤。 隨機化結果指出,所有試驗真正的隨機化比率非常小,而且多數試驗設計有缺陷。有自發性細菌腹膜炎的受試者比例為15% – 50%。和無干預法/安慰劑相比,計算接受抗生素治療自發性細菌腹膜炎的病人得到的相對風險 (95% CI)和死亡率分別是 0.20 (0.11 0.37) 和 0.61 (0.43 0.87)。 有關不良反應的報導較少。

作者結論

合併結果估計指出,應謹慎對有腹水但無胃腸出血的肝硬化病人使用抗生素預防。 但是,由於試驗方法學品質較差,有上述發現結果的報告指出發表文章和設計存在系統性偏誤,反應出這些發現並不十份定。在推動長期使用預防性抗生素的同時,也要考慮抗藥性病原菌對社會以及病人本身造成的潛在危害。似乎預防性抗生素的建議不屬於有事實證明的預防策略。我們需要有實驗設計更好,結果更佳確認以及追蹤時間更長的試驗。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

自發性細菌腹膜炎 (腹膜感染和發炎) 是在肝硬化病人常見的併發症(末期肝病的病人在肝臟組織中出現不可逆化的傷疤),具有極高的發病率和死亡率。使用抗生素作為選擇性腸道淨化方法當成一種預防(預防)措施使用。本次系統性文獻回顧了是否抗生素預防可以降低有腹水(腹腔液體過多)但無胃腸道出血的肝硬化病人的自發性細菌腹膜炎機率和死亡的隨機臨床試驗。 本次文獻回顧包括9個試驗。自發性細菌腹膜炎和死亡的合併比率指出,預防性抗生素可以降低2者的比例。有關不良反應的報導較少。回顧這些試驗,我們發現由於研究方法不良,缺乏證據,指出文章存在一定的誤差,而且追蹤時間有限。因此,抗生素預防治療無胃腸道出血的肝硬化病人的建議根據目前資料試驗品質不佳。在推薦抗生素預防療法時,應考慮對整個社會和病人、個體造成的潛在危害。我們需要實驗設計更好,結果更佳確認且追蹤時間更長的試驗。