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Elective versus symptomatic intravenous antibiotic therapy for cystic fibrosis

  • Review
  • Intervention

Authors


Abstract

Background

Pseudomonas aeruginosa is the commonest micro-organism associated with respiratory infections in cystic fibrosis. Retrospective studies have suggested that using an aggressive policy of intravenous anti-pseudomonal antibiotics at regular intervals, irrespective of symptoms, increases survival.

Objectives

To determine whether there is evidence that an elective (regular) versus symptomatic intravenous antibiotic regimen is associated with an improvement in clinical status and survival rates in people with cystic fibrosis. To identify any adverse effects associated with the use of elective intravenous antibiotics, including an increase in the development of resistant organisms.

Search methods

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings.

Date of the most recent search of the Group's Trials Register: 22 April 2010.

Selection criteria

All randomised or quasi-randomised controlled trials describing the use of elective compared with symptomatic intravenous antibiotic policies for any duration or dose regimen. Elective versus symptomatic intravenous antibiotic regimens against any organisms were considered. People with cystic fibrosis of any age or disease severity were included.

Data collection and analysis

Both authors independently assessed trial eligibility and quality; both extracted the data.

Main results

Searches identified four studies. Two studies reporting results from a total of 79 participants were included in the review. Differences in study design and objectives meant that data could not be pooled for meta-analysis. Neither study demonstrated significant differences in outcome measures between intervention and comparison groups.

Authors' conclusions

Studies are insufficient to identify conclusive evidence favouring a policy of elective intravenous antibiotic administration, despite its widespread use, neither are the potential risks adequately evaluated. The results should be viewed with caution, as participant numbers are small. Clearly there is a need for a well-designed, adequately-powered, multicentred randomised controlled trial to evaluate these issues.

摘要

背景

比較選擇性(elective)或症狀性(symptomatic)給予囊狀纖維化(cystic fibrosis)患者靜脈抗生素治療

綠膿桿菌是囊狀纖維化患者呼吸道感染中最常見的微生物。回溯性(retrospective)研究顯示不論症狀而積極的定期使用靜脈抗綠膿桿菌抗生素會提高生存率。

目標

是否接受選擇性(定期)的靜脈注射抗生素療程的囊狀纖維化患者,相較於症狀性的靜脈注射抗生素療程者,其臨床症狀有改善和存活率有提高。為了要澄清有關於使用選擇性靜脈注射抗生素的任何副作用,包括抗藥性微生物的增加。

搜尋策略

我們搜尋了Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register,其主要是由廣泛搜尋電子資料庫所找到的參考書目,以及手動搜尋相關期刊及會議摘要冊所組成。最近搜尋Group's Register的時間:2006年8月。

選擇標準

凡描述比較選擇性或症狀性靜脈抗生素治療的所有隨機對照試驗(randomised controlled trials;RCTs)或半隨機對照試驗(quasirandomised controlled trials),不限任何療程或劑量。我們納入了針對任何微生物的選擇性或症狀性的靜脈抗生素治療。我們納入了任何年齡或疾病之嚴重程度的囊狀纖維化患者。

資料收集與分析

兩位作者各自評估試驗的資格和性質;兩位作者都參予資料的提取。

主要結論

總共找到4個研究。兩項研究報告來自共79個參加者的結果被納入在本回顧中。研究設計和目標的差異導致無法匯集二者的數據來進行統合分析(metaanalysis)。兩項研究都無法顯示試驗組和對照組之間結果的明顯差異。

作者結論

沒有足夠的研究證據指出選擇性靜脈注射抗生素療法較好,即使它已被廣泛的使用,而其潛在的風險也尚未經過充足的評估。我們對這些研究的結果持謹慎的態度,因為參加試驗人數不多。顯見一個設計良好,檢力足夠,多中心的隨機對照試驗的需要性, 以評估這些議題。

翻譯人

本摘要由臺灣大學附設醫院何天民翻譯。

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

總結

選擇性(定期)的靜脈抗綠膿桿菌抗生素療程在治療囊狀纖維化中可能有它的價值。囊狀纖維化患者的慢性綠膿桿菌造成常造成呼吸功能的衰退。靜脈注射抗生素是治療這種微生物所引起的肺功能急性惡化之標準療法。許多醫學中心提倡使用選擇性(定期)每3個月的靜脈注射抗生素療程來減少急性惡化的頻率,進而延緩肺功能的惡化。另一種療程則只在有症狀時才給予靜脈注射抗生素, 理由是選擇性療程有可能增加微生物對抗生素的多重抗藥性。本回顧的目的是找出針對這兩種不同的療法的隨機和半隨機對照試驗所得到的結果。目前並沒有明確的結論。

Plain language summary

Elective (regular) regimens of intravenous anti-pseudomonal antibiotics may have a place in the management of cystic fibrosis

Chronic infection of the airways by Pseudomonas aeruginosa in people with cystic fibrosis is associated with deterioration in respiratory function. Intravenous antibiotics are the standard therapy for pulmonary exacerbations caused by this micro-organism. Many centres advocate the use of elective (regular) three-monthly antibiotics to reduce the frequency of exacerbations and therefore slow the deterioration of lung function. Alternatively, intravenous antibiotics are only prescribed when symptoms indicate. Elective therapy may encourage multi-resistance to antibiotics. This review aimed to identify randomised and quasi-randomised controlled trials that evaluated the results of the two different approaches. No clear conclusions were identified.