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血液透析患者中 SARS-CoV-2 疫苗的免疫原性和安全性:系统评价和荟萃分析。

Immunogenicity and safety of SARS-CoV-2 vaccine in hemodialysis patients: A systematic review and meta-analysis.

机构信息

Second Clinical Medical School, Zhejiang Chinese Medical University, Hangzhou, China.

Urology and Nephrology Center, Department of Nephrology, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou, China.

出版信息

Front Public Health. 2022 Sep 23;10:951096. doi: 10.3389/fpubh.2022.951096. eCollection 2022.

DOI:10.3389/fpubh.2022.951096
PMID:36211647
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9539993/
Abstract

RATIONALE AND OBJECTIVE

COVID-19 vaccination is the most effective way to prevent COVID-19. For chronic kidney disease patients on long-term dialysis, there is a lack of evidence on the pros and cons of COVID-19 vaccination. This study was conducted to investigate the immunogenicity and safety of COVID-19 vaccines in patients on dialysis.

METHODS

PubMed, MEDLINE, EMBASE, and the Cochrane Library were systemically searched for cohort, randomized controlled trials (RCTs), and cross-sectional studies. Data on immunogenicity rate, antibody titer, survival rate, new infection rate, adverse events, type of vaccine, and patient characteristics such as age, sex, dialysis vintage, immunosuppression rate, and prevalence of diabetes were extracted and analyzed using REVMAN 5.4 and Stata software. A random effects meta-analysis was used to perform the study.

RESULTS

We screened 191 records and included 38 studies regarding 5,628 participants. The overall immunogenicity of dialysis patients was 87% (95% CI, 84-89%). The vaccine response rate was 85.1 in hemodialysis patients (HDPs) (1,201 of 1,412) and 97.4% in healthy controls (862 of 885). The serological positivity rate was 82.9% (777 of 937) in infection-naive individuals and 98.4% (570 of 579) in patients with previous infection. The Standard Mean Difference (SMD) of antibody titers in dialysis patients with or without previous COVID-19 infection was 1.14 (95% CI, 0.68-1.61). Subgroup analysis showed that the immunosuppression rate was an influential factor affecting the immunogenicity rate ( < 0.0001). Nine studies reported safety indices, among which four local adverse events and seven system adverse events were documented.

CONCLUSIONS

Vaccination helped dialysis patients achieve effective humoral immunity, with an overall immune efficiency of 87.5%. Dialysis patients may experience various adverse events after vaccination; however, the incidence of malignant events is very low, and no reports of death or acute renal failure after vaccination are available, indicating that vaccine regimens may be necessary.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42022342565, identifier: CRD42022342565.

摘要

背景与目的

接种新冠疫苗是预防新冠病毒感染的最有效手段。对于长期接受透析治疗的慢性肾脏病患者,新冠疫苗接种的利弊尚缺乏相关证据。本研究旨在评估透析患者接种新冠疫苗的免疫原性和安全性。

方法

计算机检索 PubMed、MEDLINE、EMBASE 和 Cochrane 图书馆,纳入队列研究、随机对照试验(RCT)和横断面研究,提取有关免疫原性率、抗体滴度、生存率、新发感染率、不良事件、疫苗类型以及患者年龄、性别、透析龄、免疫抑制率、糖尿病患病率等特征的相关数据,采用 RevMan 5.4 和 Stata 软件进行数据分析。采用随机效应模型进行荟萃分析。

结果

共筛选出 191 篇文献,最终纳入 38 项研究,共计 5628 例患者。总体来看,透析患者的免疫原性为 87%(95%CI:84%89%)。血液透析患者的疫苗应答率为 85.1%(1201/1412),健康对照者为 97.4%(862/885)。无感染史患者的血清学阳性率为 82.9%(777/937),有感染史患者为 98.4%(570/579)。有或无新冠既往感染的透析患者间抗体滴度的标准化均数差值(SMD)为 1.14(95%CI:0.681.61)。亚组分析显示,免疫抑制率是影响免疫原性率的一个重要因素(<0.0001)。9 项研究报告了安全性指标,其中记录了 4 项局部不良事件和 7 项系统不良事件。

结论

疫苗接种有助于透析患者产生有效的体液免疫,总体免疫效率为 87.5%。透析患者接种疫苗后可能会出现各种不良反应,但恶性事件发生率很低,尚无接种疫苗后死亡或急性肾衰竭的报道,表明疫苗方案可能是必要的。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42022342565,识别码:CRD42022342565。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a245/9539993/efc1dfca1ab4/fpubh-10-951096-g0006.jpg
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