herpes zoster vaccine

带状疱疹疫苗
  • 文章类型: Journal Article
    尽管重组带状疱疹疫苗(RZV)已证明可有效降低50岁及以上人群患带状疱疹(HZ)的风险,其在慢性阻塞性肺疾病(COPD)患者中的有效性仍不确定.本研究旨在评估RZV对COPD患者HZ风险的影响。使用TriNetXResearch网络进行了一项多机构倾向评分匹配的回顾性队列研究,包括2018年1月1日至2022年12月31日期间40岁或以上COPD患者。排除有HZ病史或既往带状疱疹疫苗接种史的患者。主要结果是HZ发生,次要结局包括严重和非严重HZ。在倾向得分匹配后,纳入接受RZV的患者和未接种疫苗的患者各17431例.与未接种疫苗组相比,接种疫苗组的HZ风险显着降低(HR,0.62;[95%置信区间]95%CI,0.51-0.75,p<0.01)。对于非严重HZ(HR,0.61;95%CI,049-0.75,p<0.01)和重度HZ(HR,0.53;95%CI,0.38-0.73,p<0.01)。进一步的亚组分析显示,不同年龄(50-59岁、60-69岁、70-79岁和≥80岁)的风险持续降低。性别,和合并症,40-49岁的个人除外。这项研究证实了RZV在降低50岁及以上COPD患者HZ风险方面的有效性。支持它在这个人群中的管理。然而,疫苗接种率仍然很低,强调在这一高危人群中需要改进疫苗接种策略.增强疫苗摄取的努力是必要的,以降低HZ发病率。
    Although the recombinant zoster vaccine (RZV) has demonstrated efficacy in reducing the risk of herpes zoster (HZ) for individuals aged 50 years and older, its effectiveness in patients with chronic obstructive pulmonary disease (COPD) remains uncertain. This study was conducted to assess the effect of RZV on the risk of HZ in COPD patients. A multi-institutional propensity score-matched retrospective cohort study was conducted using the TriNetX Research network, including individuals aged 40 years or older with COPD from January 1, 2018, to December 31, 2022. Patients with a history of HZ or prior zoster vaccination were excluded. The primary outcome was HZ occurrence, with secondary outcomes including severe and nonsevere HZ. After propensity score matching, each 17 431 patients receiving RZV and unvaccinated patients were included. The vaccinated group had a significantly lower risk of HZ compared to the unvaccinated group (HR, 0.62; [95% confidence intervals] 95% CI, 0.51-0.75, p < 0.01). Similar risk reductions were observed for nonsevere HZ (HR, 0.61; 95% CI, 049-0.75, p < 0.01) and severe HZ (HR, 0.53; 95% CI, 0.38-0.73, p < 0.01). Further subgroup analyses demonstrated consistent risk reductions across age (50-59, 60-69, 70-79, and ≥80 years), sex, and comorbidities, except for individual aged 40-49 years. This study confirms the effectiveness of RZV in reducing HZ risk in patients with COPD aged 50 years and older, supporting its administration in this population. However, vaccination rates remain low, highlighting the need for improved vaccination strategies in this high-risk group. Efforts to enhance vaccine uptake are warranted to reduce HZ morbidity.
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    文章类型: Case Reports
    牛皮癣是一种常见的慢性炎症性皮肤病,主要影响皮肤,指甲,和关节。除了它的皮肤表现,牛皮癣与几种全身性合并症有关。各种因素可以触发或加剧牛皮癣,包括压力,感染,药物,和疫苗接种。这篇文章报告什么是,据作者所知,已知的第一例斑块型银屑病急性加重病例,表现为点滴状银屑病(GP),带状疱疹疫苗接种后。一名52岁的男性,有长期斑块型牛皮癣病史,在接受重组带状疱疹疫苗2周后突然出现GP病变。医生应该警惕牛皮癣恶化的潜在诱因,重组带状疱疹疫苗就是其中之一。
    Psoriasis is a common chronic inflammatory skin disorder that primarily affects the skin, nails, and joints. Beyond its cutaneous manifestations, psoriasis is associated with several systemic comorbidities. Various factors can trigger or exacerbate psoriasis, including stress, infections, medications, and vaccinations. This article reports what is, to the best of the author\'s knowledge, the first known case of acute exacerbation of plaque-type psoriasis, presenting as guttate psoriasis (GP), following herpes zoster vaccination. A 52-year-old male with a history of longstanding plaque-type psoriasis developed a sudden flare of GP lesions 2 weeks after receiving the recombinant herpes zoster vaccine. Physicians should be vigilant for potential triggers of psoriasis exacerbation, with the recombinant herpes zoster vaccine being among them.
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  • 文章类型: Journal Article
    背景:目前,预防带状疱疹的重组亚单位疫苗和减毒活疫苗已在中国批准上市。本研究旨在评估重组亚单位疫苗和减毒活疫苗在中国人群中的成本-效果。
    方法:使用决策树-马尔可夫分析模型来估计预期成本和质量调整寿命年(QALYs),比较疫苗接种与重组亚单位疫苗的终生成本效益(伦敦,英国,Shingrix,GSK)对减毒活疫苗(长春,中国,干威,长春Bcht)在中国人口中,主要结果指标是增量成本效益比(ICER)。
    结果:在基本案例分析中,重组亚单位疫苗的ICER按年龄划分,从每QALY3428美元到5743美元不等,而减毒活疫苗的ICER在每QALY4017美元至18,254美元之间,与没有接种疫苗相比。在所有年龄组中,60至69岁是最佳接种年龄.结果对带状疱疹发病率的变化最敏感,疫苗功效,和贴现率。即使重组亚单位疫苗的两剂依从率达到20%,疫苗接种仍然具有成本效益。与RZV相比,ZVL需要将成本降低至少12.2%才能具有成本效益优势。
    结论:重组亚单位疫苗和减毒活疫苗在中国人群中都具有成本效益,但是,相对而言,在50岁以上的所有年龄组中,重组亚单位疫苗在疾病预防和成本效益方面具有更大的优势.
    BACKGROUND: Currently, the recombinant subunit vaccine and live attenuated vaccine in the prevention of herpes zoster are approved for marketing in China. This study aims to evaluate the cost-effectiveness of the recombinant subunit vaccine and the live attenuated vaccine in the Chinese population.
    METHODS: A decision tree-Markov analysis model was utilized to estimate expected costs and quality-adjusted life years (QALYs), comparing the lifetime cost-effectiveness of vaccination with the recombinant subunit vaccine (London, United Kingdom, Shingrix, GSK) to that of the live attenuated vaccine (Changchun, China, Ganwei, Changchun Bcht) in the Chinese population, with the primary outcome measure being the incremental cost-effectiveness ratio (ICER).
    RESULTS: In the base-case analysis, the ICERs for the recombinant subunit vaccine ranged by age from USD 3428 to USD 5743 per QALY, while the ICERs for the live attenuated vaccine ranged from USD 4017 to USD 18,254 per QALY, compared with no vaccination. Among all age groups, the category of 60 to 69 years was the optimal age for vaccination. The results were most sensitive to changes in herpes zoster incidence, vaccine efficacy, and discount rate. Even with a two-dose compliance rate of 20% for the recombinant subunit vaccine, vaccination remained cost-effective. ZVL would need to reduce costs by at least 12.2% compared to RZV to have a cost-effectiveness advantage.
    CONCLUSIONS: The recombinant subunit vaccine and the live attenuated vaccine were both cost-effective in the Chinese population, but, relatively, the recombinant subunit vaccine had a greater advantage in disease prevention and cost-effectiveness in all age groups above 50 years.
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  • 文章类型: Journal Article
    使用不同疫苗平台的异源免疫已被证明是增强抗原特异性免疫应答的有效策略。在这项研究中,我们对中年小鼠水痘-带状疱疹病毒(VZV)的mRNA疫苗和佐剂蛋白亚单位疫苗的不同初免-加强免疫方案诱导的体液和细胞免疫应答进行了正面比较,旨在更好地了解疫苗接种计划对免疫反应的影响。
    合成VZV糖蛋白(gE)mRNA并包封到基于SM-102的脂质纳米颗粒(LNP)中。然后使用VZVgEmRNA疫苗(RNA-gE)和蛋白质亚单位疫苗(PS-gE)对VZV引发的中年C57BL/6小鼠进行同源和异源引发加强免疫策略。使用酶联免疫吸附测定(ELISA)分析评估抗原特异性抗体。此外,使用ELISPOT测定和流式细胞术检测细胞介导的免疫(CMI)。此外,还评估并比较了体内安全性.
    负载mRNA的脂质纳米颗粒具有约130nm的流体动力学直径和0.156的多分散指数。总IgG抗体水平在不同免疫策略之间没有显着差异。然而,接受2×RNA-gE或RNA-gE>PS-gE的小鼠显示比接受2×PS-gE和PS-gE>RNA-gE的小鼠更低的IgG1/IgG2c比率。2×RNA-gE或RNA-gE>PS-gE诱导的CMI应答明显强于2×PS-gE和PS-gE>RNA-gE诱导的CMI应答。安全性评价表明mRNA疫苗和蛋白质疫苗均诱导小鼠短暂的体重减轻。此外,蛋白质疫苗在注射部位产生明显的炎症反应,而mRNA疫苗没有显示可观察到的炎症。
    异源初免-加强策略已经证明,在中年小鼠中,mRNA引发的免疫方案比蛋白质亚基引发的方案可以诱导更好的细胞介导的免疫应答。这些发现为VZV疫苗的设计和优化提供了有价值的见解,并有可能在未来扩大水痘疫苗接种策略。
    UNASSIGNED: Heterologous immunization using different vaccine platforms has been demonstrated as an efficient strategy to enhance antigen-specific immune responses. In this study, we performed a head-to-head comparison of both humoral and cellular immune response induced by different prime-boost immunization regimens of mRNA vaccine and adjuvanted protein subunit vaccine against varicella-zoster virus (VZV) in middle-aged mice, aiming to get a better understanding of the influence of vaccination schedule on immune response.
    UNASSIGNED: VZV glycoprotein (gE) mRNA was synthesized and encapsulated into SM-102-based lipid nanoparticles (LNPs). VZV-primed middle-aged C57BL/6 mice were then subjected to homologous and heterologous prime-boost immunization strategies using VZV gE mRNA vaccine (RNA-gE) and protein subunit vaccine (PS-gE). The antigen-specific antibodies were evaluated using enzyme-linked immunosorbent assay (ELISA) analysis. Additionally, cell-mediated immunity (CMI) was detected using ELISPOT assay and flow cytometry. Besides, in vivo safety profiles were also evaluated and compared.
    UNASSIGNED: The mRNA-loaded lipid nanoparticles had a hydrodynamic diameter of approximately 130 nm and a polydispersity index of 0.156. Total IgG antibody levels exhibited no significant differences among different immunization strategies. However, mice received 2×RNA-gE or RNA-gE>PS-gE showed a lower IgG1/IgG2c ratio than those received 2×PS-gE and PS-gE> RNA-gE. The CMI response induced by 2×RNA-gE or RNA-gE>PS-gE was significantly stronger than that induced by 2×PS-gE and PS-gE> RNA-gE. The safety evaluation indicated that both mRNA vaccine and protein vaccine induced a transient body weight loss in mice. Furthermore, the protein vaccine produced a notable inflammatory response at the injection sites, while the mRNA vaccine showed no observable inflammation.
    UNASSIGNED: The heterologous prime-boost strategy has demonstrated that an mRNA-primed immunization regimen can induce a better cell-mediated immune response than a protein subunit-primed regimen in middle-aged mice. These findings provide valuable insights into the design and optimization of VZV vaccines with the potentials to broaden varicella vaccination strategies in the future.
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  • 文章类型: Journal Article
    背景:带状疱疹(HZ)的发病率正在迅速增加,在中国造成临床和经济负担。关于中国居民对每种疫苗接种属性的疫苗偏好和支付意愿(WTP)知之甚少。
    目的:本研究旨在了解中国城市成年人(25岁或以上)对HZ疫苗接种计划的偏好,并计算每个疫苗接种属性的WTP。
    方法:在本研究中,我们采访了中国9个城市的2864名居民。进行了离散选择实验,以调查居民对HZ疫苗接种的偏好,并预测不同疫苗方案的摄取率。使用混合logit模型来估计每个属性的偏好和WTP。实验中包含了七个不同级别的属性,我们将其他属性的系数除以价格系数来衡量WTP。
    结果:疫苗有效性,保护持续时间,副作用的风险,原产地,事实证明,成本会影响中国成年人对HZ疫苗接种的偏好。HZ疫苗的有效性是对居民偏好产生最主要影响的属性,其次是保护期限。居民愿意支付974元人民币(145美元),将疫苗的有效性从45%提高到90%,他们几乎不会支付将疫苗接种时间表从2剂换成1剂。建议将保护率从45%增加到90%,可以最大程度地促进预期的吸收(20.84%)。
    结论:中国城市成年人在疫苗有效性之间进行了权衡,保护持续时间,原产地,副作用,和HZ疫苗接种的费用。疫苗的有效性是最重要的特征。居民的WTP最高(974元人民币;145美元),以提高疫苗的有效性。为了最大限度地吸收HZ疫苗,卫生当局应提高疫苗的有效性。
    BACKGROUND: The incidence of herpes zoster (HZ) is rapidly increasing, causing both clinical and economic burdens in China. Very little is known about Chinese residents\' HZ vaccine preferences and willingness to pay (WTP) for each vaccination attribute.
    OBJECTIVE: This study aims to elicit the preferences of Chinese urban adults (aged 25 years or older) regarding HZ vaccination programs and to calculate WTP for each vaccination attribute.
    METHODS: In this study, we interviewed 2864 residents in 9 cities in China. A discrete choice experiment was conducted to investigate the residents\' preferences for HZ vaccination and to predict the uptake rate for different vaccine scenarios. A mixed logit model was used to estimate the preferences and WTP for each attribute. Seven attributes with different levels were included in the experiment, and we divided the coefficients of other attributes by the coefficient of price to measure WTP.
    RESULTS: Vaccine effectiveness, protection duration, risk of side effects, place of origin, and cost were proven to influence Chinese adults\' preferences for HZ vaccination. The effectiveness of the HZ vaccine was the attribute that had the most predominant impact on residents\' preferences, followed by protection duration. The residents were willing to pay CN ¥974 (US $145) to increase the vaccine effectiveness from 45% to 90%, and they would barely pay to exchange the vaccination schedule from 2 doses to 1 dose. It is suggested that the expected uptake could be promoted the most (by 20.84%) with an increase in the protection rate from 45% to 90%.
    CONCLUSIONS: Chinese urban adults made trade-offs between vaccine effectiveness, protection duration, place of origin, side effects, and cost of HZ vaccination. Vaccine effectiveness was the most important characteristic. The residents have the highest WTP (CN ¥974; US $145) for enhancing the effectiveness of vaccines. To maximize HZ vaccine uptake, health authorities should promote vaccine effectiveness.
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  • 文章类型: Journal Article
    带状疱疹(HZ),老年人的常见疾病,影响他们的生活质量。因此,这项研究旨在研究社交媒体平台上HZ相关信息的博客文章,以分析居民对健康信息传播的态度和行为。本研究采用内容分析的方法来关注微博,中国有代表性的社交媒体,分析1866篇与带状疱疹(HZ)和带状疱疹疫苗(HZV)相关的博文内容。根据科恩·卡帕的一致性检验,确定了四个主题:(A)来源,(b)音调,(c)流行病学信息,和(D)扩展的并行过程模型元素。调查结果显示,微博上的大部分信息来自非专业人士,用中性的音调,并通过流行病学信息中的预防和老年保护两个最大方面显示了HZ的无形疼痛和HZV的有效性。然而,当前的博客文章将老年人视为看不见的个体,未能承认他们是信息的接收者。此外,疫苗的成本是无形的经济障碍,有助于传播有关民间疗法的错误信息。这影响了老年人对与HZV相关的健康信息的接受。因此,未来与老年人分享健康信息的方式需要改进,并应注意不正确信息的传播,以提高其疫苗接种率和健康管理意识。
    Herpes zoster (HZ), a common disease in older adults, affects their quality of life. Therefore, this study aimed to examine the blog posts of HZ-related information on social media platforms to analyze the attitudes and behaviors of residents toward the dissemination of health information. This research used content analysis to focus on Weibo, a representative social media in China, to analyze the content of 1866 blog posts related to herpes zoster (HZ) and herpes zoster vaccine (HZV). According to the consistency test by Cohen\'s Kappa, four themes were identified: (a) sources, (b) tones, (c) epidemiological information, and (d) extended parallel process model elements. The findings showed that most information on Weibo came from non-professionals, with a neutral tone, and showed the invisible pain of HZ and the effectiveness of HZV through the two largest aspects of prevention and aged protection in epidemiological information. However, current blog posts treat the older adult as invisible individuals, failing to acknowledge them as recipients of the information. Additionally, the cost of the vaccine acts as an invisible economic barrier, contributing to the dissemination of incorrect information about folk remedies. This impacts the older adult\'s acceptance of health information related to HZV. Thus, the way to share health information with the older adult needs to be improved in the future, and attention should be paid to the transmission of incorrect information to improve their vaccination rates and awareness of health management.
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  • 文章类型: Journal Article
    带状疱疹(HZ),也被称为带状疱疹,仍然是一个重要的全球健康问题,最常见于有水痘-带状疱疹病毒(VZV)早期接触史的老年人。目前,许可的疫苗Shingrix,它包含与强效佐剂AS01B配制的重组VZV糖蛋白E(gE),是市场上最有效的带状疱疹疫苗。然而,不希望的反应原性和全球需求的增加导致疫苗短缺,促使新型带状疱疹疫苗的开发。这里,我们开发了新的候选疫苗利用多个纳米颗粒(NP)平台来展示重组gE抗原,在MF59生物仿制药佐剂中配制。在幼稚的小鼠中,所有测试的NP疫苗都比Shingrix诱导更高的体液和细胞免疫反应,其中,gEM候选者诱导最高的细胞反应。在活减毒VZV(VZVLAV)引发的小鼠和恒河猴模型中,gEM候选物引起优于Shingrix的细胞介导免疫(CMI)。总的来说,我们证明了NP技术仍然是开发带状疱疹疫苗的合适工具,报道的gEM构建体是下一代带状疱疹疫苗开发中非常有希望的候选者。
    Herpes zoster (HZ), also known as shingles, remains a significant global health issue and most commonly seen in elderly individuals with an early exposure history to varicella-zoster virus (VZV). Currently, the licensed vaccine Shingrix, which comprises a recombinant VZV glycoprotein E (gE) formulated with a potent adjuvant AS01B, is the most effective shingles vaccine on the market. However, undesired reactogenicity and increasing global demand causing vaccine shortage, prompting the development of novel shingles vaccines. Here, we developed novel vaccine candidates utilising multiple nanoparticle (NP) platforms to display the recombinant gE antigen, formulated in an MF59-biosimilar adjuvant. In naïve mice, all tested NP vaccines induced higher humoral and cellular immune responses than Shingrix, among which, the gEM candidate induced the highest cellular response. In live attenuated VZV (VZV LAV)-primed mouse and rhesus macaque models, the gEM candidate elicited superior cell-mediated immunity (CMI) over Shingrix. Collectively, we demonstrated that NP technology remains a suitable tool for developing shingles vaccine, and the reported gEM construct is a highly promising candidate in the next-generation shingles vaccine development.
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  • 文章类型: Journal Article
    目的:评估重组带状疱疹疫苗(RZV)是否与50岁以上美国成年人新发痛风的风险增加有关。
    方法:我们进行了一个真实世界,使用行政索赔数据进行自我控制风险间期(SCRI)设计的回顾性安全性研究.我们包括年龄≥50岁的RZV暴露的健康计划成员,接下来是60天内的痛风事件。RZV暴露后第1-30天被认为是风险窗口(RW),第31-60天被认为是控制窗口(CW)。我们估计了RW与CW的痛风风险比(RR),使用条件泊松模型。主要分析估计了任何RZV剂量后发生痛风的风险。敏感性分析评估了剂量1-和剂量2-特定风险,符合60-183天推荐剂量间隔的患者的风险,季节性调整,并限制在COVID-19之前的时代(2019年12月1日之前)。
    结果:在SCRI分析中,共有461,323名个体接受了≥1次RZV剂量;我们纳入了302名个体(平均年龄72.5岁;66%为男性),在60天内有新发痛风的证据。共有153人(50.7%)在RW和149人(49.3%)在CW(RR1.03;95%置信区间0.81,1.29)发生痛风事件。所有敏感性分析都有一致的结果,RZV与痛风事件无关。
    结论:在50岁以上的美国成年人中,在RZV暴露后的30天内,痛风风险没有统计学上的显着增加,与随后的30天CW相比。
    OBJECTIVE: To assess whether recombinant zoster vaccine (RZV) is associated with an increased risk of new-onset gout among US adults aged ≥50 years.
    METHODS: We conducted a real-world, retrospective safety study with a self-controlled risk interval (SCRI) design using administrative claims data. We included health plan members aged ≥50 years with RZV exposure, followed by incident gout within 60 days. Days 1-30 following RZV exposure were considered the risk window (RW), and days 31-60 were considered the control window (CW). We estimated the risk ratio (RR) of gout in the RW versus CW, using a conditional Poisson model. The primary analysis estimated the risk of incident gout following any RZV dose. Sensitivity analyses evaluated dose 1- and dose 2-specific risks, risk among patients compliant with recommended dose spacing of 60-183 days, adjustment for seasonality, and restriction to the pre-COVID-19 era (before December 1, 2019).
    RESULTS: A total of 461,323 individuals received ≥1 RZV dose; we included 302 individuals (mean age 72.5 years; 66 % male) with evidence of new-onset gout within 60 days in SCRI analyses. A total of 153 (50.7 %) individuals had gout events in the RW and 149 (49.3 %) in the CW (RR 1.03; 95 % confidence interval 0.81, 1.29). All sensitivity analyses had consistent results, with no association of RZV with incident gout.
    CONCLUSIONS: In a population of US adults aged ≥50 years, there was no statistically significant increase in the risk of gout during the 30 days immediately after RZV exposure, compared with a subsequent 30-day CW.
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  • 文章类型: Journal Article
    水痘-带状疱疹病毒(VZV)是负责水痘和带状疱疹(HZ)的人亲神经疱疹病毒。在儿童期的原发性感染之后,VZV表现为水痘(水痘),并在背根神经节内进入潜伏期。由于老化或免疫抑制引起的细胞免疫应答受损触发病毒再激活和HZ(带状疱疹)的发展。由于与疾病本身相关的免疫缺陷和/或使用免疫抑制剂,患有自身免疫性疾病的患者患HZ的风险更高。具有独特机制的新型免疫抑制剂的引入扩大了自身免疫性疾病的治疗选择,但也增加了HZ的风险。具体来说,Janus激酶(JAK)抑制剂和anifrolumab引起了对HZ的关注。尽管治疗进展,相当多的患者长期患有并发症,如带状疱疹后神经痛。佐剂化重组带状疱疹疫苗(RZV)被认为即使在免疫受损的患者中也是安全和有效的。RZV的广泛采用可以减轻HZ患者的健康和社会经济负担。这篇综述涵盖了VZV与自身免疫性疾病之间的联系,评估与使用免疫抑制剂相关的HZ风险,并讨论了在自身免疫性疾病患者中使用RZV的益处和风险。
    The varicella-zoster virus (VZV) is a human neurotropic herpes virus responsible for varicella and herpes zoster (HZ). Following primary infection in childhood, VZV manifests as varicella (chickenpox) and enters a period of latency within the dorsal root ganglion. A compromised cellular immune response due to aging or immunosuppression triggers viral reactivation and the development of HZ (shingles). Patients with autoimmune diseases have a higher risk of developing HZ owing to the immunodeficiency associated with the disease itself and/or the use of immunosuppressive agents. The introduction of new immunosuppressive agents with unique mechanisms has expanded the treatment options for autoimmune diseases but has also increased the risk of HZ. Specifically, Janus kinase (JAK) inhibitors and anifrolumab have raised concerns regarding HZ. Despite treatment advances, a substantial number of patients suffer from complications such as postherpetic neuralgia for prolonged periods. The adjuvanted recombinant zoster vaccine (RZV) is considered safe and effective even in immunocompromised patients. The widespread adoption of RZV may reduce the health and socioeconomic burdens of HZ patients. This review covers the link between VZV and autoimmune diseases, assesses the risk of HZ associated with immunosuppressant use, and discusses the benefits and risks of using RZV in patients with autoimmune diseases.
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  • 文章类型: Journal Article
    目的:评估暴露于重组带状疱疹疫苗(RZV)后发生痛风的风险。
    方法:仅适用于此案例,自我控制风险区间研究包括一组美国按服务付费医疗保险(A部分,B,D)受益人年龄≥65岁。暴露是在2018年或2019年接受至少一剂双剂量RZV方案。风险和控制窗口分别为第1-30天和第31-60天,接种疫苗后。痛风事件定义为风险或控制窗口期间痛风的第一次发作,在过去的365天里没有痛风的证据。我们估计了相对于控制窗口的风险窗口中痛风事件的相对风险(RR)和95%置信区间(CI),使用条件泊松回归模型。敏感性分析包括在剂量1后60-183天接受剂量2的个体的剂量依从性亚分析;剂量特异性分析;季节性调整;以及由于大流行而导致的潜在检测偏差的COVID-19调整。
    结果:发生痛风的1290名RZV暴露者主要是白人(86.98%),男性(61.16%),和年龄70-79岁(55.82%)。痛风事件的RR为1.00(95%CI0.90,1.12)。在剂量依从性敏感性分析中(n=959例痛风事件),痛风事件的RR为0.99(95%CI0.87,1.13).这些发现在剂量特异性上没有变化,季节性,和COVID-19敏感性分析。
    结论:研究结果表明,在≥65岁的Medicare人群中,RZV与痛风发作风险的增加没有显著相关。
    OBJECTIVE: Assess the risk of incident gout following exposure to recombinant zoster vaccine (RZV).
    METHODS: This case-only, self-controlled risk interval study included a cohort of US fee-for-service Medicare (Part A, B, and D) beneficiaries aged ≥65 years. The exposure was receipt of at least one dose of the two-dose RZV regimen in 2018 or 2019. The risk and control windows were days 1-30 and days 31-60, respectively, following vaccination. Incident gout was defined as the first episode of gout during the risk or control window, with no evidence of gout in the last 365 days. We estimated the relative risk (RR) and 95 % confidence interval (CI) of incident gout in the risk window relative to the control window, using conditional Poisson regression models. Sensitivity analyses included a dose-compliant subanalysis of individuals who received dose 2 60-183 days after dose 1; dose-specific analysis; seasonality adjustment; and COVID-19 adjustment for potential detection bias due to the pandemic.
    RESULTS: The 1290 RZV-exposed individuals with incident gout were primarily White (86.98 %), male (61.16 %), and aged 70-79 years (55.82 %). The RR of incident gout was 1.00 (95 % CI 0.90, 1.12). In the dose-compliant sensitivity analysis (n = 959 cases of incident gout), the RR of incident gout was 0.99 (95 % CI 0.87, 1.13). The findings were unchanged in the dose-specific, seasonality, and COVID-19 sensitivity analyses.
    CONCLUSIONS: The findings suggest that RZV is not significantly associated with an increased risk of incident gout in the Medicare population aged ≥65 years.
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