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撤回:免疫球蛋白治疗呼吸道合胞病毒感染。

WITHDRAWN: Immunoglobulin treatment for respiratory syncytial virus infection.

作者信息

Fuller Hannah L, Del Mar Chris B

机构信息

16 Sweetbrier Lane, Exeter, Devon, UK, EX13AF.

出版信息

Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD004883. doi: 10.1002/14651858.CD004883.pub3.

Abstract

BACKGROUND

Respiratory syncytial virus (RSV) bronchiolitis and pneumonia hospitalise hundreds of thousands of infants every year. Treatment is largely supportive therapy, (for example, oxygen, fluids and occasionally mechanical ventilation). Ribavirin, an antiviral agent, is licensed for severe RSV infection, although systematic reviews find it of no benefit. Passive protection against RSV can be achieved through monthly intramuscular injections of the humanised monoclonal anti-RSV antibody palivizumab (Synagis), and yields a 55% reduction in RSV hospitalisation in susceptible infants. This review assesses immunoglobulin treatment of RSV infection rather than its role as a prophylactic measure.

OBJECTIVES

To assess the efficacy of adding human or humanised immunoglobulin therapy to supportive therapy in infants hospitalised with laboratory-determined RSV infection.

SEARCH STRATEGY

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2006, issue 1) which contains the Acute Respiratory Infections Group's specialized regsiter, MEDLINE (1966 to Week 4, January 2006) and EMBASE (1980 to September 2005). We also ran searches of reference lists of relevant trials and review articles and searches of personal files. We did not impose any language restrictions.

SELECTION CRITERIA

We selected randomised controlled trials (RCTs) that compared immunoglobulin treatment with a placebo control in children hospitalised for RSV infection with bronchiolitis or pneumonia or other lower respiratory tract infection (LRTI) with laboratory-documented RSV infection. The primary outcomes of interest were mortality, length of hospitalisation, length of ventilation and oxygen dependence. Secondary outcome measures were pulmonary function and re-hospitalisations for recurrent breathing difficulties in subsequent years. Any adverse effects of the treatments were also noted, for example, hypersensitivity reactions.

DATA COLLECTION AND ANALYSIS

Data were extracted but cross-comparison was not possible due to the shortage of studies and lack of comparative measurements.

MAIN RESULTS

Four papers fitted the search criteria. None demonstrated statistically significant benefit of intravenous immunoglobulin (IVIG) treatment added to supportive care compared with supportive care alone. The evidence does not support a role for RSVIG in such a setting, with the doses used in the studies.

AUTHORS' CONCLUSIONS: The evidence on the role of respiratory syncytial virus immunoglobulin (RSVIG) in treating RSV severe infections is limited. Future research might consider using stronger titres of neutralising antibodies; and further analyse severely ill children (who might respond differentially compared to those less ill, but yet hospitalised).

摘要

背景

呼吸道合胞病毒(RSV)引起的细支气管炎和肺炎每年导致数十万婴儿住院。治疗主要是支持性疗法(例如吸氧、补液,偶尔进行机械通气)。抗病毒药物利巴韦林虽被批准用于严重RSV感染,但系统评价发现其并无益处。通过每月肌肉注射人源化抗RSV单克隆抗体帕利珠单抗(Synagis)可实现对RSV的被动保护,能使易感婴儿的RSV住院率降低55%。本综述评估免疫球蛋白对RSV感染的治疗作用,而非其作为预防措施的作用。

目的

评估在因实验室确诊为RSV感染而住院的婴儿中,在支持性治疗基础上加用人或人源化免疫球蛋白治疗的疗效。

检索策略

我们检索了Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》,2006年第1期),其中包含急性呼吸道感染组的专业注册库、MEDLINE(1966年至2006年1月第4周)和EMBASE(1980年至2005年9月)。我们还检索了相关试验和综述文章的参考文献列表以及个人文件。我们未设置任何语言限制。

选择标准

我们选择了随机对照试验(RCT),这些试验比较了在因RSV感染导致细支气管炎或肺炎或其他有实验室记录的RSV感染的下呼吸道感染(LRTI)而住院的儿童中,免疫球蛋白治疗与安慰剂对照的效果。主要关注的结局是死亡率、住院时间、通气时间和氧依赖情况。次要结局指标是肺功能以及随后几年因反复呼吸困难再次住院的情况。还记录了治疗的任何不良反应,例如过敏反应。

数据收集与分析

提取了数据,但由于研究数量不足且缺乏比较性测量,无法进行交叉比较。

主要结果

有4篇论文符合检索标准。与单纯支持性治疗相比,没有一篇论文显示在支持性治疗基础上加用静脉注射免疫球蛋白(IVIG)治疗有统计学意义的益处。就研究中使用的剂量而言,证据不支持RSV免疫球蛋白(RSVIG)在此种情况下的作用。

作者结论

关于呼吸道合胞病毒免疫球蛋白(RSVIG)在治疗RSV严重感染中作用的证据有限。未来的研究可考虑使用效价更强的中和抗体;并进一步分析重症儿童(他们可能与病情较轻但仍住院的儿童反应不同)。

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