Simancas-Racines Daniel, Franco Juan Va, Guerra Claudia V, Felix Maria L, Hidalgo Ricardo, Martinez-Zapata Maria José
Cochrane Ecuador, Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC), Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador.
Argentine Cochrane Centre, Instituto Universitario del Hospital Italiano, Potosí 4234, Buenos Aires, Buenos Aires, Buenos Aires, Argentina, C1199ACL.
Cochrane Database Syst Rev. 2017 May 18;5(5):CD002190. doi: 10.1002/14651858.CD002190.pub5.
The common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore throat, and fever (usually < 37.8º C). The widespread morbidity caused by the common cold worldwide is related to its ubiquitousness rather than its severity. The development of vaccines for the common cold has been difficult because of antigenic variability of the common cold virus and the indistinguishable multiple other viruses and even bacteria acting as infective agents. There is uncertainty regarding the efficacy and safety of interventions for preventing the common cold in healthy people. This is an update of a Cochrane review first published in 2011 and previously updated in 2013.
To assess the clinical effectiveness and safety of vaccines for preventing the common cold in healthy people.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (September 2016), MEDLINE (1948 to September 2016), Embase (1974 to September 2016), CINAHL (1981 to September 2016), and LILACS (1982 to September 2016). We also searched three trials registers for ongoing studies and four websites for additional trials (February 2017). We included no language or date restrictions.
Randomised controlled trials (RCTs) of any virus vaccines compared with placebo to prevent the common cold in healthy people.
Two review authors independently evaluated methodological quality and extracted trial data. We resolved disagreements by discussion or by consulting a third review author.
We found no additional RCTs for inclusion in this update. This review includes one RCT dating from the 1960s with an overall high risk of bias. The RCT included 2307 healthy participants, all of whom were included in analyses. This trial compared the effect of an adenovirus vaccine against placebo. No statistically significant difference in common cold incidence was found: there were 13 (1.14%) events in 1139 participants in the vaccines group and 14 (1.19%) events in 1168 participants in the placebo group (risk ratio 0.95, 95% confidence interval 0.45 to 2.02; P = 0.90). No adverse events related to the live vaccine were reported. The quality of the evidence was low due to limitations in methodological quality and a wide 95% confidence interval.
AUTHORS' CONCLUSIONS: This Cochrane Review was based on one study with low-quality evidence. We found no conclusive results to support the use of vaccines for preventing the common cold in healthy people compared with placebo. We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Any future trials on medical treatments for preventing the common cold should assess a variety of virus vaccines for this condition. Outcome measures should include common cold incidence, vaccine safety, and mortality related to the vaccine.
普通感冒是上呼吸道的一种自限性感染，其特征为流鼻涕、鼻塞、打喷嚏、咳嗽、不适、喉咙痛和发热（通常<37.8ºC）。普通感冒在全球范围内造成的广泛发病与它的普遍存在有关，而非其严重程度。由于普通感冒病毒的抗原变异性以及作为感染源的其他多种难以区分的病毒甚至细菌，普通感冒疫苗的研发一直很困难。对于健康人群预防普通感冒的干预措施的有效性和安全性存在不确定性。这是Cochrane系统评价的更新版，该评价首次发表于2011年，之前于2013年更新。
评估疫苗对健康人群预防普通感冒的临床有效性和安全性。
我们检索了Cochrane对照试验中心注册库（CENTRAL）（2016年9月）、MEDLINE（1948年至2016年9月）、Embase（1974年至2016年9月）、CINAHL（1981年至2016年9月）和LILACS（1982年至2016年9月）。我们还检索了三个试验注册库以查找正在进行的研究，并检索了四个网站以查找其他试验（2017年2月）。我们未设语言或日期限制。
将任何病毒疫苗与安慰剂进行比较以预防健康人群普通感冒的随机对照试验（RCT）。
两位综述作者独立评估方法学质量并提取试验数据。我们通过讨论或咨询第三位综述作者来解决分歧。
我们未找到可纳入本次更新的其他RCT。本综述纳入了一项始于20世纪60年代的RCT，其总体偏倚风险较高。该RCT纳入了2307名健康参与者，所有参与者均纳入分析。该试验比较了腺病毒疫苗与安慰剂的效果。未发现普通感冒发病率有统计学显著差异：疫苗组1139名参与者中有13例（1.14%）发病事件，安慰剂组1168名参与者中有14例（1.19%）发病事件（风险比0.95，95%置信区间0.45至2.02；P = 0.90）。未报告与活疫苗相关的不良事件。由于方法学质量的局限性和较宽的95%置信区间，证据质量较低。
本Cochrane系统评价基于一项证据质量较低的研究。我们未找到确凿结果支持在健康人群中使用疫苗预防普通感冒优于安慰剂。我们确定需要设计良好、样本量充足的RCT来研究健康人群预防普通感冒的疫苗。未来任何关于预防普通感冒的医学治疗试验都应评估针对这种情况的多种病毒疫苗。结局指标应包括普通感冒发病率、疫苗安全性以及与疫苗相关的死亡率。
