Vaccines for preventing influenza in people with cystic fibrosis

 

Abstract

Background

Viral respiratory tract infections in people with cystic fibrosis have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for people with cystic fibrosis.

Objectives

To assess the effectiveness of influenza vaccination for people with cystic fibrosis.

Search methods

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also contacted the companies which market the influenza vaccines used in the trials to obtain further information about randomised controlled trials.

Date of the most recent search of the Cystic Fibrosis Trials Register: 14 March 2011.

Selection criteria

All randomised and quasi-randomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine.

Data collection and analysis

Two authors independently assessed study quality and extracted data. Additional information was obtained by contacting the investigators when it was indicated.

Main results

Four studies enrolling a total of 179 participants with cystic fibrosis (143 (80%) were children aged 1 to 16 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a subunit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and the other two studies compared a split virus to a subunit vaccine and a virosome to a subunit vaccine (all intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48 out of 201 participants (24%) for the intranasal live vaccine to 13 out of 30 participants (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No study reported other clinically important benefits.

Authors' conclusions

There is currently no evidence from randomised studies that influenza vaccine given to people with cystic fibrosis is of benefit to them. There remains a need for a well-constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.

 

Plain language summary

Vaccines for preventing influenza in people with cystic fibrosis

People with cystic fibrosis have blocked airways which results in frequent airway infections. Infections with viral diseases like influenza ("the flu") can worsen lung damage. Doctors therefore often advise people with cystic fibrosis to be vaccinated against influenza every year. We searched for studies which compared different vaccines or compared vaccination to placebo. We were able to include four studies with 179 people in the review. Most (143) were under 16 years old. No study compared one vaccine to placebo. There were a high number of drop outs in two of the studies. Vaccination does result in an immune system response to the types of influenza used in the vaccine. However, this response may not result in protection against influenza infection or lung damage. There were a high number of adverse events, but none were serious or persistent. There is no evidence to show if regular influenza vaccine benefits people with cystic fibrosis.

 

摘要

背景

疫苗對囊狀纖維化患者流行性感冒的預防

病毒性呼吸道感染對囊狀纖維化患者的肺功能及疾病進展，具有不良的負面影響。因此通常建議囊狀纖維化患者患者每年定期接受流行性感冒疫苗的接種。

目標

評估囊狀纖維化患者患者接種流行性感冒疫苗的成效

搜尋策略

我們搜尋Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials資料庫；包括了各廣泛的電子資料庫搜索系統，並實際查詢相關的期刊文獻以及會議議程的摘要手冊。我們也連繫在試驗中登記的製造流行性感冒疫苗的廠商，以取得隨機採樣試驗中更進一步的資料。 最近一次進入Cystic Fibrosis Trials Register檢索的日期為2009年3月5日。

選擇標準

比較接受流行性感冒疫苗或安慰劑或其他流行性感冒疫苗，採隨機或準隨機取樣方法(包括已發表或未發表)的研究試驗結果。

資料收集與分析

兩位作者各自獨立的評估相關研究的合適性及研究方法的品質，並各自獨立的與其同事商議，以擷取所需資料。

主要結論

4項試驗共收納179名囊狀纖維化受試患者(143名(80%)為1至16歲的兒童)納入本篇評論。未有研究進行接種疫苗與安慰劑，或全病毒疫苗與次單位或裂解病毒疫苗進行比較。2項研究鼻腔內接種活毒疫苗與肌肉內死毒疫苗進行比較，另2項研究則就裂解病毒疫苗與次單位病毒疫苗進行比較(均採肌肉注射)。 依據不同種類的流行性感冒疫苗，其不良反應回報的頻率都相當高。在201位受試者中有48位(24%)發生不良反應，在30位接受裂解病毒疫苗接受的受試者中則有13位(43%)。受限於統計效力的不足，各項疫苗接種的研究之間並無顯著的差異。無嚴重不良事件。所有流行性感冒疫苗接種在血清抗體上均產生良好的反應。沒有研究報告其他臨床上的重要效益。

作者結論

根據隨機研究試驗，目前沒有足夠證據提出流行性感冒疫苗對囊狀纖維化患者的助益。仍需有完整架構的臨床研究，以就流行性感冒疫苗在臨床上重要的成效進行評估。

翻譯人

本摘要由臺灣大學附設醫院蕭雅慧翻譯。

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

總結

疫苗對囊狀纖維化患者流行性感冒的預防 囊狀纖維化患者因呼吸道經常性的感染而造成呼吸道的阻塞。病毒性疾病像是流行性感冒的感染，將使肺部損傷更為惡化。因此醫師通常建議患者每年定期接種流行性感冒疫苗。 本研究主要就不同的疫苗或疫苗與安慰劑進行比較。本篇評論納入4項179位受試者的研究分析結果。多數受試者(143位)的年齡小於16歲。無一項研究針對疫苗與安慰劑進行比較。其中2項研究的個案有相當高的流失數。 經由疫苗接種，確實能產生特定的免疫反應，然而此反應不一定能產生抵抗流行性感冒或肺部損傷。雖然有相當比例的個案發生不良反應，但並沒有產生嚴重或恆久性的傷害。目前還沒有足夠的證據證明，常規的流行性感冒疫苗接種對囊狀纖維化患者有所助益。