Remschmidt Cornelius, Wichmann Ole, Harder Thomas
BMC Med. 2015 Mar 17;13:53. doi: 10.1186/s12916-015-0295-6.
Patients with diabetes are at increased risk of severe influenza disease; influenza vaccination for these patients is therefore recommended by the World Health Organization and several National Immunization Technical Advisory Groups. However, no systematic review has evaluated the effects of influenza vaccines for patients with diabetes.
We conducted a systematic review and meta-analysis by searching Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from inception until November 2014. We included all types of studies reporting on the efficacy, effectiveness, and/or safety of influenza vaccination in patients with type 1 and type 2 diabetes of all ages. We used the Newcastle-Ottawa scale to assess risk of bias in observational studies. Residual confounding was addressed by comparing estimates of vaccine effectiveness (VE) during influenza seasons to those obtained during off-seasons. Quality of the evidence for each outcome was assessed using the GRADE methodology.
Following review of 1,444 articles, 11 observational studies with a total of 170,924 participants were included. In diabetic patients of working-age (18-64 years), influenza vaccination prevented all-cause hospitalization with a pooled VE of 58% (95% CI, 6-81%) and hospitalization due to influenza or pneumonia (VE 43%; 95% CI, 28-54%), whereas no effects on all-cause mortality and influenza-like illness (ILI) were observed. In the elderly (65+), influenza vaccination prevented all-cause mortality (VE 38%; 95% CI, 32-43%), all-cause hospitalization (VE 23%; 95% CI, 1-40%), hospitalization due to influenza or pneumonia (VE 45%; 95% CI, 34-53%), and ILI (VE 13%; 95% CI, 10-16%). However, significant off-season estimates for several outcomes indicated residual confounding, particularly in elderly patients. Quality of the evidence was low to very low for all outcomes. Laboratory-confirmed influenza infections were not reported.
Due to strong residual confounding in most of the identified studies, the available evidence is insufficient to determine the magnitude of benefit that diabetic people derive from seasonal influenza vaccination. Adequately powered randomized controlled trials or quasi-experimental studies using laboratory-confirmed influenza-specific outcomes are urgently needed.
糖尿病患者出现严重流感疾病的风险增加；因此，世界卫生组织及多个国家免疫技术咨询小组建议这些患者接种流感疫苗。然而，尚无系统性综述评估流感疫苗对糖尿病患者的影响。
我们通过检索Medline、Embase、Cochrane对照试验中心注册库及ClinicalTrials.gov，从建库至2014年11月进行了一项系统性综述和荟萃分析。我们纳入了所有报告流感疫苗对各年龄段1型和2型糖尿病患者疗效、有效性及/或安全性的各类研究。我们使用纽卡斯尔-渥太华量表评估观察性研究中的偏倚风险。通过比较流感季节与非流感季节的疫苗有效性（VE）估计值来解决残余混杂问题。使用GRADE方法评估每个结局的证据质量。
在对1444篇文章进行综述后，纳入了11项观察性研究，共170924名参与者。在工作年龄（18 - 64岁）的糖尿病患者中，流感疫苗预防全因住院的合并VE为58%（95%CI，6 - 81%），预防因流感或肺炎住院的VE为43%（95%CI，28 - 54%），而未观察到对全因死亡率和流感样疾病（ILI）的影响。在老年人（65岁及以上）中，流感疫苗预防全因死亡率（VE 38%；95%CI，32 - 43%）、全因住院（VE 23%；95%CI，1 - 40%）、因流感或肺炎住院（VE 45%；95%CI，34 - 53%）及ILI（VE 13%；95%CI，10 - 16%）。然而，几个结局的显著非流感季节估计值表明存在残余混杂，尤其是在老年患者中。所有结局的证据质量均为低至极低。未报告实验室确诊的流感感染情况。
由于在大多数已识别研究中存在强烈的残余混杂，现有证据不足以确定糖尿病患者从季节性流感疫苗接种中获得的益处程度。迫切需要开展有足够效力的随机对照试验或使用实验室确诊的流感特异性结局的准实验研究。
