BNT162b2疫苗对慢性肾病患者的有效性——一项观察性研究
BNT162b2 vaccine effectiveness in chronic kidney disease patients-an observational study.
作者信息
Bielopolski Dana, Libresco Gilad, Barda Noam, Dagan Noa, Steinmetz Tali, Yahav Dafna, Charytan David M, Balicer Ran D, Rozen-Zvi Benaya
机构信息
Department of Nephrology and Hypertension, Rabin Medical Center, Petah-Tikva, Israel.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
出版信息
Clin Kidney J. 2022 Jul 4;15(10):1838-1846. doi: 10.1093/ckj/sfac166. eCollection 2022 Oct.
BACKGROUND
Chronic kidney disease (CKD) is a risk factor for severe coronavirus disease 2019 (COVID-19). We aimed to evaluate the real-life effectiveness of the BNT162b2 messenger RNA vaccine for a range of outcomes in patients with CKD compared with matched controls.
METHODS
Data from Israel's largest healthcare organization were retrospectively used. Vaccinated CKD [estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m] and maintenance dialysis patients were matched to vaccinated controls without CKD (eGFR ≥60 ml/min/1.73 m) according to demographic and clinical characteristics. Study outcomes included documented infection with severe acute respiratory syndrome coronavirus 2, symptomatic infection, COVID-19-related hospitalization, severe disease and death. Vaccine effectiveness was estimated as the risk ratio (RR) at days 7-28 following the second vaccine dose, using the Kaplan-Meier estimator. Effectiveness measures were also evaluated separately for various stages of CKD.
RESULTS
There were 67 861 CKD patients not treated with dialysis, 2606 hemodialysis (HD) patients and 70 467 matched controls. The risk of severe disease {RR 1.84 [95% confidence interval (CI) 0.95-2.67]} and death [RR 2.00 (95% CI 0.99-5.20)] was increased in nondialysis CKD patients compared with controls without CKD following vaccination. For the subgroup of patients with eGFR <30 ml/min/1.73 m, the risk of severe disease and death was increased compared with controls [RR 6.42 (95% CI 1.85-17.51) and RR 8.81 (95% CI 1.63-13.81), respectively]. The risks for all study outcomes were increased in HD patients compared with controls.
CONCLUSION
Two doses of the BNT162b2 vaccine were found to be less efficient for patients with eGFR <30 ml/min/1.73 m. Risk in HD patients is increased for all outcomes. These results suggest prioritizing patients with eGFR <30 ml/min/1.73 m for booster shots, pre- and post-exposure prophylaxis and early COVID-19 therapy.
背景
慢性肾脏病（CKD）是2019冠状病毒病（COVID-19）重症的一个危险因素。我们旨在评估BNT162b2信使核糖核酸疫苗在CKD患者中针对一系列结局的实际有效性，并与匹配的对照进行比较。
方法
回顾性使用来自以色列最大医疗保健机构的数据。根据人口统计学和临床特征，将接种疫苗的CKD患者[估计肾小球滤过率（eGFR）<60 ml/min/1.73 m²]和维持性透析患者与未患CKD的接种疫苗对照者（eGFR≥60 ml/min/1.73 m²）进行匹配。研究结局包括严重急性呼吸综合征冠状病毒2的确诊感染、有症状感染、COVID-19相关住院、重症和死亡。使用Kaplan-Meier估计器将疫苗有效性估计为第二剂疫苗接种后7至28天的风险比（RR）。还分别评估了CKD各个阶段的有效性指标。
结果
有67861例未接受透析治疗的CKD患者、2606例血液透析（HD）患者和70467例匹配对照者。与未患CKD的对照者相比，接种疫苗后未透析的CKD患者发生重症的风险{RR 1.84[95%置信区间（CI）0.95 - 2.67]}和死亡风险[RR 2.00（95%CI 0.99 - 5.20）]增加。对于eGFR<30 ml/min/1.73 m²的患者亚组，与对照者相比，重症和死亡风险增加[分别为RR 6.42（95%CI 1.85 - 17.51）和RR 8.81（95%CI 1.63 - 13.81）]。与对照者相比，HD患者所有研究结局的风险均增加。
结论
发现两剂BNT162b2疫苗对eGFR<30 ml/min/1.73 m²的患者效果较差。HD患者所有结局的风险均增加。这些结果表明，应优先为eGFR<30 ml/min/1.73 m²的患者进行加强接种、暴露前和暴露后预防以及早期COVID-19治疗。
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