Gardasil

Gardasil
  • 文章类型: Journal Article
    确定我们中心的人乳头瘤病毒(HPV)疫苗接种率,并确定围绕疫苗的常见负面看法,以指导更有效的HPV疫苗咨询。
    我们回顾了在布鲁克陆军医疗中心接受治疗的11至26岁患者的免疫接种记录。通过将完成HPV疫苗系列的患者数量除以总目标人群来确定疫苗摄取率。从2021年10月到2022年12月,在耳鼻喉科访问期间,向父母(11-17岁的患者)或患者本身(18-26岁)分发了一项临床调查,以调查疫苗接种状况和对疫苗的态度。
    在布鲁克陆军医疗中心,共有3038名年龄在11至26岁的患者参加了初级保健,但只有962(32%)的疫苗完成。在研究期间收集了35项调查。来自患者/父母的22项调查(63%)报告他们/他们的孩子已经接受了HPV疫苗。对疫苗安全的担忧,性行为,学校缺乏免疫接种要求,难以安排时间是患者未接种疫苗的最常见原因。
    考虑到围绕疫苗接种的常见误解,对HPV疫苗的患者进行咨询可能很困难,但是了解这些态度将使耳鼻喉科医生能够更有效地教育患者。这一点很重要,因为更了解HPV的患者更有可能接种疫苗。
    我们的诊所与初级保健部门合作制定了新的策略,为符合条件的患者提供更简化的疫苗接种。向前迈进,我们计划随着时间的推移改变HPV疫苗接种率的趋势,以确定我们对接种率的影响.
    UNASSIGNED: To determine our center\'s human papillomavirus (HPV) vaccination rate and identify common negative perceptions surrounding the vaccine to guide more effective HPV vaccine counseling.
    UNASSIGNED: We reviewed immunization records for patients ages 11 to 26 that receive care at Brooke Army Medical Center. Vaccine uptake rate was determined by dividing the number of patients who had completed the HPV vaccine series by the total target population. From October 2021 to December 2022, a clinic survey was distributed to parents (for patients ages 11-17) or patients themselves (ages 18-26) during otolaryngology visits to poll vaccination status and attitudes toward the vaccine.
    UNASSIGNED: A total of 3038 patients ages 11 to 26 are enrolled for primary care at Brooke Army Medical Center, but only 962 (32%) are vaccine complete. Thirty-five surveys were collected during the study period. Twenty-two surveys (63%) from patients/parents reported they/their child had received the HPV vaccine. Concerns about vaccine safety, sexual behaviors, lack of immunization requirement for school, and difficulty getting scheduled were the most common reasons patients were unvaccinated.
    UNASSIGNED: Counseling patients on the HPV vaccine can be difficult given the common misconceptions surrounding vaccination, but understanding these attitudes will allow otolaryngologists to educate patients more effectively. This matters since patients more knowledgeable about HPV are more likely to receive the vaccine.
    UNASSIGNED: Our clinic has developed new strategies in partnership with primary care departments to facilitate more streamlined vaccination for eligible patients, and moving forward we plan to trend HPV vaccination rates over time to determine our impact on uptake.
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  • 文章类型: Journal Article
    目的:了解少数民族成年人的疫苗接种知识和疫苗接种障碍。
    方法:横断面调查。
    方法:安全网医院和三级学术中心的耳鼻喉科诊所和头颈部癌症筛查事件。
    方法:对同意的患者进行调查。描述性统计和显著性检验用于表征数据,与非少数群体受访者作为对照。采用多因素logistic回归分析疫苗接种相关因素。
    结果:我们的241名受访者(n=41,17.67%)及其合格儿童(n=52,33.55%)的HPV疫苗接种率较低。未接种疫苗的少数民族更有可能对HPV疫苗接种表示兴趣(28.66%vs8.66%,p=0.016)。少数患者对HPV引起宫颈的知识明显较少(88.64%vs72.45%,p=0.024)和头颈部(68.18%vs44.90%,p=0.005)癌症,并且对HPV感染的了解也较少(95.45%vs81.12%,非女性中p=0.020)。缺乏对HPV疫苗的了解是少数患者对自己或子女的疫苗接种不感兴趣或不感兴趣的原因。在与HPV疫苗接种相关因素的多变量逻辑回归中,仅年龄增加与疫苗接种可能性显着相关(OR=0.91,95%CI=[0.88-0.95],p<0.001)。
    结论:报告的HPV疫苗接种率对于白人和少数民族患者均较低,但在单变量或多变量分析中没有显著差异。然而,少数受访者对HPV及其表现的了解明显较少;他们最常提到的原因是不接受HPV疫苗接种或对HPV疫苗不感兴趣.因此,HPV疫苗教育干预可能会提高少数人群的疫苗接种率。
    OBJECTIVE: Understand vaccination knowledge and barriers to vaccination among minority adults.
    METHODS: Cross-sectional survey.
    METHODS: Otolaryngology clinics at a safety net hospital and a tertiary academic center and a head and neck cancer screening event.
    METHODS: Survey was administered to consenting patients. Descriptive statistics and significance testing were used to characterize the data, with non-minority respondents as controls. Multivariate logistic regression was used to understand factors associated with vaccination.
    RESULTS: HPV vaccination among our 241 respondents (n = 41, 17.67 %) and their qualifying children (n = 52, 33.55 %) was low. Non-vaccinated minorities were significantly more likely to express interest in HPV vaccination (28.66 % vs 8.66 %, p = 0.016). Minority patients were significantly less knowledgeable about HPV causing cervical (88.64 % vs 72.45 %, p = 0.024) and head and neck (68.18 % vs 44.90 %, p = 0.005) cancer and were also less aware of HPV infection (95.45 % vs 81.12 %, p = 0.020) among non-women. Lack of knowledge about the HPV vaccine was the most cited reason why minority patients did not or were uninterested in vaccination for themselves or their children. In a multivariable logistic regression of factors associated with HPV vaccination, only increased age demonstrated a significant association with vaccination likelihood (OR = 0.91, 95 % CI = [0.88-0.95], p < 0.001).
    CONCLUSIONS: Reported HPV vaccination rates were low for both white and minority patients but did not significantly vary on univariate or multivariate analysis. However, minority respondents were significantly less knowledgeable about HPV and its manifestations; they most often cited inadequate knowledge as why did not receive or were uninterested in HPV vaccination. As such, HPV vaccination educational interventions may raise vaccination rates among minority populations.
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  • 文章类型: Journal Article
    医学伦理指南要求临床试验研究者和申办者告知前瞻性试验参与者与研究医疗产品相关的所有已知和潜在风险。并获得他们的自由知情同意。这些指南还要求临床研究的设计应尽量减少危害并最大化收益。
    研究默克公司在GardasilHPV疫苗许可前临床试验中使用含反应性铝的“安慰剂”的科学原理。
    我们检查了在丹麦进行的FUTUREIIGardasil疫苗试验的知情同意书和招募手册;我们采访了几位FUTUREII试验参与者及其治疗医生。我们还审查了与Gardasil疫苗批准过程相关的监管文件以及关于评估人类疫苗中使用的佐剂的指南。
    发现疫苗制造商默克公司向试验参与者做出了一些不准确的陈述,损害了他们的知情同意权。首先,尽管研究方案将安全性测试列为研究的主要目标之一,招聘手册强调FUTUREII不是一项安全研究,疫苗已经被证明是安全的。第二,试验的广告材料和知情同意书指出安慰剂是盐水或非活性物质,when,事实上,它含有默克公司专有的高反应性铝佐剂,该佐剂似乎没有经过适当的安全性评估。几个试验参与者经历了慢性致残症状,包括一些随机分配到佐剂“安慰剂”组。
    在我们看来,在Gardasil临床试验中使用反应性安慰剂没有任何可能的益处,不必要地将研究对象暴露在风险中,因此违反了医学伦理。在疫苗临床试验中常规使用铝佐剂作为“安慰剂”是不合适的,因为它阻碍了疫苗相关安全信号的发现。
    UNASSIGNED: Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits.
    UNASSIGNED: To examine Merck\'s scientific rationale for using a reactogenic aluminum-containing \"placebo\" in Gardasil HPV vaccine pre-licensure clinical trials.
    UNASSIGNED: We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines.
    UNASSIGNED: It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study\'s primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck\'s proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant \"placebo\" group.
    UNASSIGNED: In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as \"placebos\" in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.
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  • 文章类型: Journal Article
    目的:主要目的是检查Gardasil系列疫苗接种前后45岁以上患者复发性呼吸道乳头状瘤病(RRP)的手术间隔(ISI)。
    方法:我们对2012年至2022年诊断为RRP的年龄>45岁的成年患者进行了回顾性图表回顾。如果患者未接受至少两剂Gardasil疫苗系列,或者在研究期间接受了两次或更少的手术,则将其排除在外。
    结果:13例患者符合纳入标准,11名男性和两名女性。最初诊断的年龄为46至80岁,平均59岁。平均ISI有显著增加,从接种前126±87天到接种后494±588天(p<0.01)。平均随访49.7±30.3个月,每位患者的平均手术次数为6.8±2.4。
    结论:45岁以上RRP患者使用辅助Gardasil显著增加了ISI。目前CDC的建议仅包括9至45岁的患者,但这项研究提供了证据表明,该年龄范围以外的RRP患者可能会从辅助HPV疫苗接种中受益。
    方法:4喉镜,2024.
    OBJECTIVE: The primary objective was to examine the intersurgical interval (ISI) of recurrent respiratory papillomatosis (RRP) in patients older than 45 years before and after a Gardasil vaccination series.
    METHODS: We conducted a retrospective chart review of adult patients >45 years of age diagnosed with RRP from 2012 to 2022. Patients were excluded if they did not receive at least two doses of the Gardasil vaccine series or if they underwent two or fewer surgeries during the study period.
    RESULTS: Thirteen patients met the inclusion criteria, 11 males and two females. The age at initial diagnosis ranged from 46 to 80 years, with a mean of 59 years. There was a significant increase in the average ISI, from 126 ± 87 days pre-vaccination compared to 494 ± 588 days post-vaccination (p < 0.01). The average number of surgeries per patient was 6.8 ± 2.4 over an average follow-up of 49.7 ± 30.3 months.
    CONCLUSIONS: Adjuvant Gardasil use in RRP patients older than 45 years significantly increases the ISI. Current CDC recommendations include only patients ages 9 to 45, but this study provides evidence that RRP patients outside this age range may benefit from adjuvant HPV vaccination.
    METHODS: 4 Laryngoscope, 134:3226-3229, 2024.
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  • 文章类型: Journal Article
    背景:同性恋和双性恋男性以及其他LGBTQ+群体更频繁地暴露于与人类乳头瘤病毒(HPV)获得风险增加相关的因素。疫苗接种对于预防HPV+头颈癌(HNC)至关重要。我们表征了感知的收缩风险水平与HPV知识的关系,和疫苗决策。
    方法:横断面队列。
    方法:LGBTQ和一般调查Reddit论坛(控制)。
    方法:在线论坛之间共享了一项调查。描述性统计对数据进行了表征。多变量logistic回归用于了解与疫苗接种相关的因素,自我感知的高风险,和HPV+HNC的知识。
    结果:在718名受访者中,大多数是女性(41.09%),高加索人(59.89%),受过大学教育(33.01%),和被保险人(77.15%),平均年龄为30.75岁。一半人接种了疫苗(49.16%),大多数未接种疫苗的认可兴趣(60.58%)。很少有家属接种疫苗(25.91%),未接种疫苗的儿童的父母对疫苗接种感兴趣(38.58%)。了解HIV与HPV的相关性(62.95%),HPV引起HNC(55.57%),疫苗对HNC的疗效(55.57%)也中等。识别女性(P=.042),自我感知的高风险(P<.001),接种疫苗的儿童(P<.001)增加了接种疫苗的可能性;变性者(P=.021),或女同性恋或男同性恋性认同(P<.001)降低的可能性。个人HNC诊断(P<.001),自我接种(P<.001),接种疫苗的儿童(P<.001),肛交(P=.001)或不了解过去的HPV状态(P<.001)增加了自我感知高风险的可能性。
    结论:需要努力改善关于HPV与HNC之间的关联和疫苗接种效力的公众教育,以更好地告知有HPV感染风险的个体的疫苗决策。
    BACKGROUND: Gay and bisexual males and other LGBTQ+ communities are more frequently exposed to factors associated with an increased risk of human papillomavirus (HPV) acquisition. Vaccination is critical to protect against HPV+ head and neck cancer (HNC). We characterized the association of perceived level of risk of contraction with HPV knowledge, and vaccine decision-making.
    METHODS: Cross-sectional cohort.
    METHODS: LGBTQ and general survey Reddit forums (control).
    METHODS: A survey was shared amongst the online forums. Descriptive statistics characterized the data. Multivariable logistic regression was used to understand factors associated with vaccination, self-perceived high risk, and knowledge of HPV + HNC.
    RESULTS: Of 718 respondents, most were female (41.09%), Caucasian (59.89%), college-educated (33.01%), and insured (77.15%) with a mean age of 30.75 years. Half were vaccinated (49.16%), with most unvaccinated endorsing interest (60.58%). Few dependents were vaccinated (25.91%), with interest in vaccination among parents of unvaccinated children (38.58%). Knowledge of HIV\'s association with HPV (62.95%), HPV causing HNC (55.57%), and the vaccine\'s efficacy against HNC (55.57%) was also moderate. Identifying female (P = .042), a self-perceived high-risk (P < .001), and having vaccinated children (P < .001) increased vaccination likelihood; transgender (P = .021), or lesbian or gay sexual identity (P < .001) decreased likelihood. Personal HNC diagnosis (P < .001), self-vaccination (P < .001), having vaccinated children (P < .001), having anal sex (P = .001) or no knowledge of past HPV status (P < .001) increased likelihood of high self-perceived risk.
    CONCLUSIONS: Efforts to improve public education regarding the association between HPV and HNC and vaccination efficacy are required to better inform vaccine decision-making among individuals at risk for HPV infection.
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  • 文章类型: Journal Article
    背景:宫颈癌被认为是全球女性(15-44岁)最常见的癌症之一,但是人乳头瘤病毒(HPV)疫苗的出现提高了人们对宫颈癌根除可能在不久的将来实现的预期,因为目前已有几种预防性宫颈癌疫苗在多个国家获得许可.各国应该制定战略,实践和政策,以实现和维持更高水平的HPV免疫覆盖率,因为即使在第一个预防性HPV疫苗获得许可后17年,仍有68%的国家在其国家免疫计划中引入了HPV疫苗。
    方法:使用各种数据库和搜索引擎进行了全面的文献分析,纳入现有的最相关的研究文章和数据,并批判性地讨论了实现HPV疫苗接种的足够覆盖率所需解决的操作差距。
    结果:本综述重点介绍了现有的HPV疫苗接种策略,需要解决未满足的需求和挑战,以实现适当的实施框架以及实现体面的疫苗接种覆盖率所需的合作。协调良好的疫苗接种策略,重点是少女,如果可能的话,男孩会对世界各地的疾病减少产生巨大影响。
    BACKGROUND: Cervical cancer has been considered as one of the most common cancers in women (15-44 years) globally, but the advent of the human papilloma virus (HPV) vaccine has raised the anticipation that eradication of cervical carcinoma might be achieved in the near future as several prophylactic cervical carcinoma vaccines have already been currently licensed in various countries. Countries should devise strategies, practices and policies to attain and sustain higher levels of HPV immunization coverage as still 68% countries have introduced HPV vaccine in their national immunization programs even after 17 years following the licensure of the first prophylactic HPV vaccine.
    METHODS: A comprehensive literature analysis was conducted using various databases and search engines, to include the most relevant research articles and data available and critically discussed the operational gaps that need to be answered to achieve adequate coverage of HPV vaccination.
    RESULTS: The present review highlights the existing HPV vaccination strategies, unmet needs and challenges needed to be addressed for proper implementation framework as well as the collaborations required to achieve decent vaccination coverage. Well-coordinated vaccination strategy with focus on adolescent girls and if possible, boys can lead to dramatic impact on disease reduction around the world.
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  • 文章类型: Journal Article
    背景:人乳头瘤病毒(HPV)是一种流行的STI(性传播感染),估计几乎所有性活跃的患者在其生命的某个阶段都会被病毒感染。虽然大多数HPV感染自发消退,有些会导致健康并发症,如生殖器疣和几种癌症。这项研究分析了感染人群中女性和男性HPV基因型的多样性。
    方法:从口服,阴道,研究参与者的生殖器部位和样本进行DNA提取,随后使用实时PCR进行扩增。使用HPVREALQUALITYRQ-Multi诊断试剂盒进行高风险(HR)和低风险(LR)HPV基因型的识别,并与统计病毒学数据一起分析人口统计信息。
    结果:在936个样本中,发现324例(34.6%)HPV阳性,阴性612例(65.4%)。在我们的参与者中,70个男性样本(27.5%)和254个女性样本(37.3%)为HPV阳性。常见的基因型包括16、6、11和18,而基因型59、56、31、45和52也被检测到。
    结论:根据本研究的结果,在男性和女性中发现了HPV感染的显着患病率,男性高危基因型的发病率更为多样化。虽然疫苗可以有效预防某些类型的HPV,例如16、18、6和11,其他基因型引起的感染似乎有所增加,并应采取预防措施,以防止未来的健康问题。
    Human Papillomavirus (HPV) is a prevalent STI (Sexually Transmitted Infection) that is estimated almost all sexually active Patients at some stage of their life will be infected by the virus. Although most HPV infections resolve spontaneously, some can result in health complications, such as genital warts and several types of cancer. This study analyzed the variety of HPV genotypes in females and males among the infected population.
    Samples were obtained from the oral, vaginal, and genital sites of study participants and the samples underwent DNA extraction and subsequently amplified using Real-Time PCR. The recognition of high-risk (HR) and low-risk (LR) HPV genotypes was carried out using the HPV REALQUALITY RQ-Multi diagnostic kit and demographic information was analyzed alongside statistical virological data.
    Out of 936 samples, 324 cases (34.6%) were found to be positive for HPV, while 612 cases (65.4%) were negative. Of our participants, 70 samples of males (27.5%) and 254 samples of females (37.3%) were HPV-positive. Common genotypes included 16, 6, 11, and 18, while genotypes 59, 56, 31, 45, and 52 were also detected.
    According to the findings of this study, a significant prevalence of HPV infection was seen in males and females, and the incidence of high-risk genotypes was more diverse in males. While the vaccine was effective in preventing some types of HPV, such as 16, 18, 6, and 11, there seems to be an increase in infections caused by other genotypes, and precautions should be taken to prevent future health problems.
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  • 文章类型: Journal Article
    宫颈癌是世界上15-44岁女性最常见的癌症之一,超过四分之三的病例诊断为局部晚期临床阶段,生存率较低。尽管只有一小部分人乳头瘤病毒(HPV)的女性会发展为宫颈癌,并且大多数HPV感染随后在初发阶段就被清除。但血清转换并不总是保证个体对HPV免疫。宫颈癌疫苗的出现提高了人们的期望,即在不久的将来可能根除宫颈癌,因为它在幼稚妇女中对疫苗特异性类型表现出非常高的功效,而没有严重的疫苗相关不良事件。目前,在100多个国家中,很少有预防性HPV疫苗获得许可。也有人提出,给男性和女性接种疫苗比仅给女性接种疫苗更有益。与基于癌症治疗成本的不接种疫苗相比,接种疫苗是一种具有成本效益的策略,可以降低宫颈癌的发病率和死亡率。协调良好的疫苗接种策略,重点是少女,如果可能的话,男孩会对世界各地的疾病减少产生巨大影响。
    Cervical cancer is one of the most common cancers in women aged 15-44 years in the world, with more than three-quarters of cases diagnosed at a locally advanced clinical stage with minor prospects of survival. Although only a small percentage of women with Human Papilloma Virus (HPV) develop cervical cancer and most of the HPV infections are cleared subsequently at primary stage itself, but seroconversion not always guarantees that the individual is immune to HPV. The advent of the cervical carcinoma vaccine has raised the expectations that eradication of cervical carcinoma might be possible in the near future as it exhibited remarkably high efficacy against the vaccine-specific types in naive women with no serious vaccine-related adverse events. Few prophylactic HPV vaccines are currently licensed in over 100 countries. It has also been suggested that vaccinating both men and women is more beneficial than vaccinating only females. Vaccination is a cost-effective strategy to reduce the incidence of cervical cancer and mortality compared to no vaccination based on the cost of cancer treatment. Well-coordinated vaccination strategy with focus on adolescent girls and if possible, boys can lead to dramatic impact on disease reduction around the world.
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  • 文章类型: Journal Article
    背景从9岁开始,用人类乳头瘤病毒(HPV)疫苗对女孩和男孩进行常规免疫是目前的建议。这项使用国家健康和营养检查调查数据的回顾性研究的目的是评估社会人口统计学因素对2011年至2020年HPV疫苗系列启动和完成的影响。方法使用卡方检验来检验分类变量与HPV疫苗的接收之间的关联的统计学显著性。采用Cochran-Armitage趋势检验来评估与HPV疫苗接种率相关的危险因素的时间趋势的统计学显著性。通过将这些趋势与最近的调查年份进行比较,以显著的比率进一步量化了这些趋势。结果在调查年份中,9-14岁年龄组的HPV疫苗摄入量较高,并且在此期间男性和女性均有所增加。11-18岁年龄组最有可能接受第一剂HPV疫苗。在2017-2020年的最新调查中,Gardasil®完成的疫苗接种系列数量最高。结论改进了医生为男性接种疫苗的努力和策略,低社会经济阶层患者,需要更多的少数民族。
    Background Routine immunization of both girls and boys starting from nine years of age with the human papillomavirus (HPV) vaccine is the current recommendation. The objective of this retrospective study using National Health and Nutrition Examination Survey data was to evaluate the influence of sociodemographic factors on the series initiation and completion of the HPV vaccine from 2011 to 2020. Methodology The chi-square test was used to examine the statistical significance of the association between categorical variables and receipt of the HPV vaccine. The Cochran-Armitage test for trend was employed to assess the statistical significance of temporal trends in risk factors associated with rates of HPV vaccination. These trends were further quantified by a significant rate ratio by comparing them against the most recent survey years. Results HPV vaccine uptake was higher in the 9-14-year age group across survey years and had increased for both males and females over that time. The first dose of the HPV vaccine was most likely to be received by the 11-18-year age group. In the most recent survey of 2017-2020, the highest number of vaccination series completion was achieved for Gardasil®. Conclusions Improved physician efforts and strategies to vaccinate males, low socioeconomic strata patients, and ethnic minorities in more numbers are needed.
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  • 文章类型: Case Reports
    急性播散性脑脊髓炎是一种罕见的自身免疫性脱髓鞘疾病,与先前的感染或疫苗接种有关。在这里,我们报道了一例难治性暴发性急性播散性脑脊髓炎病例,该病例发生在Gardasil疫苗接种后25天(Merck).
    Acute disseminated encephalomyelitis is a rare autoimmune demyelinating disease associated with preceding infection or vaccination. Herein, we report a case of refractory fulminant acute disseminated encephalomyelitis that occurred 25 days after Gardasil vaccination (Merck).
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