【Cochrane简语概要】呼吸道合胞性病毒肺部感染的药物治疗

系统综述问题 

与安慰剂（一种相似外观的假药，没有效果）相比，在患有呼吸道合胞病毒（RSV）肺部感染的非常年幼的儿童中使用免疫球蛋白，是否减少死亡和住院时间，而不增加不良事件？

研究背景 

呼吸道合胞病毒是一种常见的病毒，可感染肺部和气道。每年有数百万儿童在医院接受治疗，这可能导致严重的疾病和死亡。绝大多数死亡发生在低收入国家。在高收入国家，大多数与RSV肺部感染有关的死亡发生在患有其他疾病的婴儿和幼儿中。

免疫球蛋白，也称为抗体，通常是一类在感染时由白细胞产生的分子。免疫球蛋白可能识别和附着于病毒（如RSV），并帮助消灭它们。免疫球蛋白可以人工生产，并给予不能产生RSV抗体的儿童。一些研究表明，免疫球蛋白有助于预防感染高风险儿童的RSV感染。当已存在RSV感染时，免疫球蛋白也可以用作治疗，但有效性和安全性未知。 

（图片来源于网络）

检索日期 

检索时间更新至2018年11月6日。

研究特征 

我们纳入了七项随机对照试验（受试者使用随机方法被分配到两个或两个以上治疗组之一），比较免疫球蛋白与安慰剂在486名患有RSV肺部感染住院幼儿的效果。所有试验在美国各地进行；三项试验包括来自南美洲国家的一些儿童（智利和巴拿马）；一项试验同时包括来自新西兰和澳大利亚的儿童。所有研究均在1987至2014年之间发表。

研究资金来源 

五项试验的免疫球蛋白测试得到了制造商的支持。一项试验得到了一个政府机构的支持，一项试验没有说明它是如何获得资金的。

主要结局 

尽管在试验中很少出现死亡，但免疫球蛋白在减少RSV感染的幼儿死亡方面与安慰剂组相比没有更好的表现。因RSV肺部感染而住院的儿童服用免疫球蛋白并没有减少住院时间。接受免疫球蛋白治疗的儿童出现被认为是严重的不良反应事件（如：呼吸衰竭）与安慰剂组儿童没有差别。在试验测试中免疫球蛋白和安慰剂相比所有其他结果没有区别，例如需要氧气或进入重症监护病房。缺少来自RSV感染死亡率更高人群的数据。

证据质量 

证据的质量很低或非常低，这意味着在患有RSV肺部感染的住院幼儿的免疫球蛋白治疗的真正效果可能与本综述的结果大不相同。

结论: 

我们发现免疫球蛋白和安慰剂之间的差异证据不足以进行任何综述结果。我们评估了免疫球蛋白在住院婴儿和幼儿用于治疗RSV下呼吸道感染的效果的证据，由于存在偏倚和不精确的风险，因此具有低或极低的确定性。我们不确定免疫球蛋白对这些结果的影响，真实效果可能与本评价报道的效果大不相同。所有试验均在高收入国家进行，缺少来自RSV感染死亡率更高人群的数据。

译者：徐金鹏，东阳市人民医院；审校：李迅，北京中医药大学循证医学中心；编辑排版：张晓雯，北京中医药大学循证医学中心

相关文章链接

【Cochrane Plain Language Summary】Drug treatment for respiratory syncytial virus lung infections

Review question

Does the use of immunoglobulins in very young children hospitalised with a respiratory syncytial virus (RSV) lung infection reduce deaths and hospital stay without increased adverse events, compared with placebo (a similar-appearing fake drug that has no effect)? 

Background

Respiratory syncytial virus is a common virus that can infect lungs and airways. Millions of children are treated in hospital each year for RSV, which can result in severe illness and death. The majority of these deaths occur in low-income countries. In high-income countries, the majority of deaths associated with RSV lung infection occur in infants and young children with other illnesses. 

Immunoglobulins, also known as antibodies, are a type of molecule normally produced by white blood cells when an infection is present. Immunoglobulins may recognise and attach to viruses (such as RSV) and help destroy them. Immunoglobulins can be produced artificially and given to children who are not making their own RSV antibodies. Some studies have shown that immunoglobulins are helpful in preventing RSV infection in children at high risk of becoming infected. They may also be used as a treatment when an RSV infection is already present, but the effectiveness and safety of immunoglobulins for this use is unknown.

Search date

We searched for evidence up to 6 November 2018.

Study characteristics

We included seven randomised controlled trials (studies in which participants are assigned to one of two or more treatment groups using a random method) that compared the effects of immunoglobulins with placebo in 486 young children hospitalised with RSV lung infections. All trials were conducted at sites in the USA; three trials included some children from South American countries (Chile and Panama); and one trial also included children from New Zealand and Australia. The trials were published between 1987 and 2014.

Study funding sources

Five trials were supported by the manufacturer of the immunoglobulin tested in the studies. One trial was supported by a government agency, and one trial did not describe how it was funded.

Key results

Immunoglobulins did not appear to be more effective than placebo in preventing deaths among young children with RSV infection, although few deaths occurred in the trials. Immunoglobulins given to children hospitalised with RSV lung infection did not decrease the time spent in hospital. Children treated with immunoglobulins experienced adverse effects of any severity or seriousness and adverse effects considered to be serious (such as respiratory failure) as often as children treated with placebo. There was no difference between immunoglobulins and placebo for any other outcomes measured in the trials, such as the need for oxygen or admission to the intensive care unit. Data from populations in which the rate of death from RSV infection is higher are lacking. 

Quality of the evidence

The quality of the evidence was low or very low, which means that the true effect of immunoglobulin treatment for young children in hospital with RSV lung infection may be very different from the findings of this review.

Authors' conclusions: 

We found insufficient evidence of a difference between immunoglobulins and placebo for any review outcomes. We assessed the evidence for the effects of immunoglobulins when used as a treatment for RSV lower respiratory tract infection in hospitalised infants and young children as of low or very low certainty due to risk of bias and imprecision. We are uncertain of the effects of immunoglobulins on these outcomes, and the true effect may be substantially different from the effects reported in this review. All trials were conducted in high-income countries, and data from populations in which the rate of death from RSV infection is higher are lacking. 

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