Division of Infectious Diseases, Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO; Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, MO.
RTI Health Solutions, Research Triangle Park, NC.
Am J Kidney Dis. 2020 Jan;75(1):72-83. doi: 10.1053/j.ajkd.2019.05.018. Epub 2019 Aug 1.
RATIONALE & OBJECTIVE: Studies of patients on maintenance dialysis therapy suggest that standard-dose influenza vaccine (SDV) may not prevent influenza-related outcomes. Little is known about the comparative effectiveness of SDV versus high-dose influenza vaccine (HDV) in this population.
Cohort study using data from the US Renal Data System.
SETTING & PARTICIPANTS: 507,552 adults undergoing in-center maintenance hemodialysis between the 2010 to 2011 and 2014 to 2015 influenza seasons.
SDV and HDV.
All-cause mortality, hospitalization due to influenza or pneumonia, and influenza-like illness during the influenza season.
Patients were eligible for inclusion in multiple yearly cohorts; thus, our unit of analysis was the influenza patient-season. To examine the relationship between vaccine dose and effectiveness outcomes, we estimated risk differences and risk ratios using propensity score weighting of Kaplan-Meier functions, accounting for a wide range of patient- and facility-level characteristics. For nonmortality outcomes, we used competing-risk methods to account for the high mortality rate in the dialysis population.
Within 225,215 influenza patient-seasons among adults 65 years and older, 97.4% received SDV and 2.6% received HDV. We observed similar risk estimates for HDV and SDV recipients for mortality (risk difference, -0.08%; 95% CI, -0.85% to 0.80%), hospitalization due to influenza or pneumonia (risk difference, 0.15%; 95% CI, -0.69% to 0.93%), and influenza-like illness (risk difference, 0.00%; 95% CI, -1.50% to 1.08%). Our findings were similar among adults younger than 65 years, as well as within other subgroups defined by influenza season, age group, dialysis vintage, month of influenza vaccination, and vaccine valence.
Residual confounding and outcome misclassification.
The HDV does not appear to provide additional protection beyond the SDV against all-cause mortality or influenza-related outcomes for adults undergoing hemodialysis. The additional cost and side effects associated with HDV should be considered when offering this vaccine. Future studies of HDV and other influenza vaccine strategies are warranted.
对维持性透析治疗患者的研究表明，标准剂量流感疫苗（SDV）可能无法预防与流感相关的结局。对于该人群中 SDV 与高剂量流感疫苗（HDV）的比较效果知之甚少。
使用美国肾脏数据系统的数据进行队列研究。
2010 至 2011 年和 2014 至 2015 年流感季节期间，507552 名接受中心维持性血液透析的成年人。
SDV 和 HDV。
全因死亡率、因流感或肺炎住院以及流感季节的流感样疾病。
患者有资格纳入多个年度队列；因此，我们的分析单位是流感患者-季节。为了研究疫苗剂量与有效性结局之间的关系，我们使用倾向评分加权 Kaplan-Meier 函数估计风险差异和风险比，同时考虑了广泛的患者和设施特征。对于非死亡率结局，我们使用竞争风险方法来考虑透析人群的高死亡率。
在年龄 65 岁及以上的成年人的 225215 个流感患者-季节中，97.4%接受了 SDV，2.6%接受了 HDV。我们观察到 HDV 和 SDV 接受者的死亡率（风险差异，-0.08%；95%CI，-0.85%至 0.80%）、因流感或肺炎住院（风险差异，0.15%；95%CI，-0.69%至 0.93%）和流感样疾病（风险差异，0.00%；95%CI，-1.50%至 1.08%）的风险估计值相似。在年龄小于 65 岁的成年人以及根据流感季节、年龄组、透析年限、流感疫苗接种月份和疫苗效价定义的其他亚组中，我们的发现也相似。
残余混杂和结局错误分类。
对于接受血液透析的成年人，HDV 似乎不能提供比 SDV 更多的保护，以预防全因死亡率或与流感相关的结局。在提供这种疫苗时，应考虑 HDV 相关的额外成本和副作用。需要进一步研究 HDV 和其他流感疫苗策略。
