Brain tumor

脑肿瘤
  • 文章类型: Journal Article
    背景:本研究旨在使用因子分析来识别原发性脑肿瘤患者中潜在的症状群。了解这些集群可以在开颅手术后进行更有针对性的干预。
    方法:选取2021年1月至2022年3月在上海市第十人民医院神经外科就诊的211例患者作为研究对象。开颅手术两周后,使用MDASI-BT(M.D.Anderson症状清单脑肿瘤模块)测量患者的症状,并进行因素分析以确定症状群。
    结果:总共三个症状群,即,确定了症状簇1、症状簇2和症状簇3。其中,症状群1代表疲劳相关症状群,包括疲劳,嗜睡,口干,疼痛,和睡眠障碍(Cronbach'sα=0.742);症状群2代表肠-脑轴症状群,包括食欲不振,身体一侧的弱点,以及排便习惯的改变(Cronbach'sα=0.532);症状群3代表自我形象症状群,包括外观的变化,悲伤,和痛苦(克朗巴赫的α=0.547)。
    结论:本研究确定了原发性脑肿瘤患者的三种潜在症状群。了解这些集群很可能有助于早期干预和提高护理质量。
    BACKGROUND: This study aimed to identify potential symptom clusters among primary brain tumor patients using factor analysis. Understanding these clusters enables better-targeted interventions post-craniotomy.
    METHODS: A total of 211 participants visiting Department of Neurosurgery at Shanghai Tenth People\'s Hospital for proposed surgical treatment between January 2021 and March 2022 were enrolled. Two weeks after craniotomy, the patients\' symptoms were measured using MDASI-BT (M.D. Anderson Symptom Inventory Brain Tumor Module), and factor analysis was performed to identify symptom clusters.
    RESULTS: A total of three symptom clusters, i.e., symptom cluster 1, symptom cluster 2, and symptom cluster 3, were identified. Among them, symptom cluster 1 represented the fatigue-related symptom cluster, including fatigue, lethargy, dry mouth, pain, and sleep disturbance (Cronbach\'s α = 0.742); symptom cluster 2 represented the gut-brain axis symptom cluster, including loss of appetite, weakness in one side of the body, and change in bowel habits (Cronbach\'s α = 0.532); and symptom cluster 3 represented the self-image symptom cluster, including change in appearance, sadness, and distress (Cronbach\'s α = 0.547).
    CONCLUSIONS: This study identified three potential symptom clusters among primary brain tumor patients. Understanding these clusters could well contribute to earlier interventions and improved quality of care.
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  • 文章类型: Journal Article
    对紧急神经成像的需求正在增加。甚至磁共振成像(MRI)也经常在办公时间以外进行,有时会发现更多不常见的实体,如脑肿瘤。研究人工智能(AI)方法在成像中对脑肿瘤进行分类的科学文献正在增长,但是关于放射科医生在这项任务上的表现的知识却出奇的缺乏。我们的研究旨在暂时填补这一知识空白。我们假设放射科医生可以在急诊科以临床上可接受的准确性对轴内脑肿瘤进行分类。我们回顾性检查了2013年至2021年的急诊脑MRI报告,纳入标准是(1)急诊脑MRI,(2)先前没有已知的轴内脑肿瘤,和(3)在紧急MRI报告中怀疑轴内脑肿瘤。将肿瘤类型提示和最终的临床诊断分为:(1)神经胶质肿瘤,(2)转移,(3)淋巴瘤,(4)其他肿瘤。最终的研究样本包括150名患者,其中108例具有组织病理学肿瘤类型确认。在组织病理学确认肿瘤类型的患者中,MRI报告对胶质瘤的肿瘤类型进行分类的准确性为0.86,而不是其他肿瘤类型,转移0.89,淋巴瘤为0.99。我们发现结果令人鼓舞,鉴于对紧急成像的大量需求。
    Demand for emergency neuroimaging is increasing. Even magnetic resonance imaging (MRI) is often performed outside office hours, sometimes revealing more uncommon entities like brain tumors. The scientific literature studying artificial intelligence (AI) methods for classifying brain tumors on imaging is growing, but knowledge about the radiologist\'s performance on this task is surprisingly scarce. Our study aimed to tentatively fill this knowledge gap. We hypothesized that the radiologist could classify intra-axial brain tumors at the emergency department with clinically acceptable accuracy. We retrospectively examined emergency brain MRI reports from 2013 to 2021, the inclusion criteria being (1) emergency brain MRI, (2) no previously known intra-axial brain tumor, and (3) suspicion of an intra-axial brain tumor on emergency MRI report. The tumor type suggestion and the final clinical diagnosis were pooled into groups: (1) glial tumors, (2) metastasis, (3) lymphoma, and (4) other tumors. The final study sample included 150 patients, of which 108 had histopathological tumor type confirmation. Among the patients with histopathological tumor type confirmation, the accuracy of the MRI reports in classifying the tumor type was 0.86 for gliomas against other tumor types, 0.89 for metastases, and 0.99 for lymphomas. We found the result encouraging, given the prolific need for emergency imaging.
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  • 文章类型: Journal Article
    脑膜瘤是最常见的原发性脑肿瘤,在女性中有着明显的优势。肥胖被认为是脑膜瘤发展的危险因素。肥胖也是代谢综合征的临床标志,以葡萄糖不耐受为特征,血脂异常,和高血压。生活方式和代谢因素直接影响超重和肥胖,因此是脑膜瘤发展的潜在危险因素。这项研究的目的是评估女性脑膜瘤风险的生活方式和代谢因素。
    挪威队列(CONOR)是一项全国性的健康调查,在1994年至2003年期间进行,包括人体测量,验血,和健康问卷。与国家癌症登记处的联系使得在2018年12月之前的随访期间能够识别颅内脑膜瘤。
    总共对81,652名妇女进行了长达150万年的随访,并确认了238例颅内脑膜瘤。体力活动水平的增加(HR0.81;95%CI0.68-0.96;p趋势<0.02)和均等(HR0.83;95%CI0.71-0.97;p趋势<0.03)与脑膜瘤风险呈负相关。糖尿病或葡萄糖不耐受增加脑膜瘤的风险(HR2.54;95%CI1.60-4.05)。超重和肥胖与脑膜瘤风险无关,代谢综合征也是如此。然而,没有代谢功能障碍的参与者脑膜瘤风险降低,而存在所有5种代谢因素的参与者患脑膜瘤的风险增加了4倍(HR4.28;95%CI1.34~13.68).
    生活方式因素似乎显著影响脑膜瘤风险。然而,解开脑膜瘤危险因素之间的复杂关联和相互作用将是未来研究的一项具有挑战性的任务.
    UNASSIGNED: Meningioma is the most common primary brain tumor, with a clear preponderance in women. Obesity is considered a risk factor for the development of meningioma. Obesity is also the clinical hallmark of metabolic syndrome, characterized by glucose intolerance, dyslipidemia, and hypertension. Lifestyle and metabolic factors directly impact overweight and obesity and are therefore potential risk factors for meningioma development. The aim of this study is to assess lifestyle and metabolic factors for meningioma risk in women.
    UNASSIGNED: The Cohort of Norway (CONOR) is a nationwide health survey, conducted between 1994 and 2003, including anthropometric measures, blood tests, and health questionnaires. Linkage to the National Cancer Registry enabled the identification of intracranial meningioma during follow-up until December 2018.
    UNASSIGNED: A total of 81,652 women were followed for a combined total of 1.5 million years, and 238 intracranial meningiomas were identified. Increasing levels of physical activity (HR 0.81; 95% CI 0.68-0.96; p trend <0.02) and parity (HR 0.83; 95% CI 0.71-0.97; p trend <0.03) were negatively associated with meningioma risk. Diabetes mellitus or glucose intolerance increased the risk for meningioma (HR 2.54; 95% CI 1.60-4.05). Overweight and obesity were not associated with meningioma risk, nor was metabolic syndrome. However, participants without metabolic dysfunction had a reduced meningioma risk, while participants with all five metabolic factors present had a 4-fold risk increase for meningioma (HR 4.28; 95% CI 1.34-13.68).
    UNASSIGNED: Lifestyle factors seem to significantly influence meningioma risk. However, disentangling the complex associations and interactions between factors for meningioma risk will be a challenging task for future studies.
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  • 文章类型: Journal Article
    背景:脑膜瘤与性腺类固醇激素之间的关系一直是争论的话题,对病人之间的联系了解有限,肿瘤特征,和孕激素受体(PGR)状态。
    方法:这项回顾性观察性研究旨在探讨PGR+与PGR-脑膜瘤的预后相关性,放射学,和手术预测因子。分析包括270名患者,分为两组:A组(PGR-,194名患者),和B组(PGR+,76名患者)。
    结果:分析显示在年龄方面没有显着差异,性别,临床首次亮相,术后并发症,全切除,两组之间的评分。然而,在所有随访阶段,平均Karnofsky表现状态(KPS)均存在显著差异.术前MRI测得的瘤周水肿显着影响术前两者的KPS值(ANOVA,p=0.05)和术后评估(术后方差分析,p=0.014)仅在A组中。在多变量分析中,没有与临床相关的显著因素,生物,和先前在每个测量时间检查的手术参数(p=0.826)。
    结论:研究发现,PGR+脑膜瘤患者术后恢复较好,临床初诊较早,与年龄患病率或分级无关。
    BACKGROUND: The relationship between meningiomas and gonadal steroid hormones has been the subject of debate, and there is limited understanding of the connection between patient, tumor characteristics, and progesterone receptor (PGR) status.
    METHODS: This retrospective observational study aims to explore the prognostic correlation between PGR+ and PGR- meningiomas in terms of various clinical, radiological, and surgical predictors. The analysis included 270 patients, divided into two groups: Group A (PGR-, 194 patients), and Group B (PGR+, 76 patients).
    RESULTS: The analysis showed no significant differences in terms of age, sex, clinical debut, post-surgical complications, total resection, and grading between the two groups. However, a significant difference was observed in the mean Karnofsky performance status (KPS) at all stages of follow-up. Peritumoral edema measured in preoperative MRI significantly influences the value of KPS in both preoperative (ANOVA, p= 0.05) and postoperative evaluation (Post-operative ANOVA, p= 0.014) only in the Group A. In the multivariate analysis, there are no significant factors related to the clinical, biological, and surgical parameters previously examined for each measurement time (p = 0.826).
    CONCLUSIONS: The study found that PGR+ meningioma patients tend to have better postoperative recovery and earlier clinical debut without any association with age prevalence or grading.
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  • 文章类型: Journal Article
    目的是探讨动态对比增强(DCE)MRI和扩散峰度成像(DKI)在区分成人型神经胶质瘤分子亚型中的性能。具有标准化成像协议的多中心MRI研究,包括81例WHO2-4级胶质瘤患者的DCE-MRI和DKI数据,在六个中心进行。在肿瘤组织和对侧正常白质的ROI中定量评估DCE-MRI和DKI参数值。进行二元逻辑回归分析以区分高级(HGG)与低级别胶质瘤(LGG),IDH1/2野生型vs.突变的神经胶质瘤,和高级别星形细胞肿瘤与高级别少突胶质细胞瘤.为每个参数和回归模型生成受试者工作特征(ROC)曲线,以确定曲线下面积(AUC)。灵敏度,和特异性。在DCE-MRI和DKI参数中发现肿瘤组之间存在显着差异。DCE-MRI和DKI参数的组合显示了HGG与HGG的最佳预测LGG(AUC=0.954(0.900-1.000)),IDH1/2野生型vs.突变的神经胶质瘤(AUC=0.802(0.702-0.903)),和星形细胞瘤/胶质母细胞瘤vs.少突胶质细胞瘤(AUC=0.806(0.700-0.912))具有最低的Akaike信息标准。根据2021年世界卫生组织(WHO)的分类,DCE-MRI和DKI的组合似乎有助于预测神经胶质瘤的类型。
    The aim was to explore the performance of dynamic contrast-enhanced (DCE) MRI and diffusion kurtosis imaging (DKI) in differentiating the molecular subtypes of adult-type gliomas. A multicenter MRI study with standardized imaging protocols, including DCE-MRI and DKI data of 81 patients with WHO grade 2-4 gliomas, was performed at six centers. The DCE-MRI and DKI parameter values were quantitatively evaluated in ROIs in tumor tissue and contralateral normal-appearing white matter. Binary logistic regression analyses were performed to differentiate between high-grade (HGG) vs. low-grade gliomas (LGG), IDH1/2 wildtype vs. mutated gliomas, and high-grade astrocytic tumors vs. high-grade oligodendrogliomas. Receiver operating characteristic (ROC) curves were generated for each parameter and for the regression models to determine the area under the curve (AUC), sensitivity, and specificity. Significant differences between tumor groups were found in the DCE-MRI and DKI parameters. A combination of DCE-MRI and DKI parameters revealed the best prediction of HGG vs. LGG (AUC = 0.954 (0.900-1.000)), IDH1/2 wildtype vs. mutated gliomas (AUC = 0.802 (0.702-0.903)), and astrocytomas/glioblastomas vs. oligodendrogliomas (AUC = 0.806 (0.700-0.912)) with the lowest Akaike information criterion. The combination of DCE-MRI and DKI seems helpful in predicting glioma types according to the 2021 World Health Organization\'s (WHO) classification.
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  • 文章类型: Journal Article
    中矢状区域肿瘤对上矢状窦(SSS)的慢性闭塞导致侧支静脉途径(CVP)。了解CVP的常见模式有助于减少手术并发症。本研究旨在探讨在SSS侵袭性肿瘤患者中发现的CVP,并提供有关预防手术静脉并发症的信息。这项回顾性研究从2015年1月至2022年12月,收集了肿瘤侵犯SSS并接受颅内血管数字减影血管造影的患者。收集的数据包括性别,年龄,肿瘤病理学,沿着SSS的肿瘤位置,肿瘤侧,SSS的阻塞程度,CVP的类型和路线模式,以及肿瘤和二倍体静脉(DV)之间的距离。20名患者(6名男性,招募了14名女性)。DV的CVP类型的患病率为90%,皮质浅静脉的端到端吻合术为35%,15%用于脑膜静脉,其他类型的CVP为20%。在肿瘤对侧的大脑半球发现的翼额顶和枕顶二倍体途径明显多于肿瘤同侧的大脑半球。在所有存在侧支DV的患者中,61%的人在最近的DV和SSS中的肿瘤附件之间具有非常接近(小于1cm)的距离。肿瘤对侧大脑半球的DV是肿瘤引起的SSS阻塞患者中最常见的CVP类型。大多数侧支DV位于非常靠近SSS肿瘤附件的位置。神经外科医生在计划开颅手术时应该意识到这些发现。
    Chronic occlusion of the superior sagittal sinus (SSS) by tumors in the midsagittal region causes the collateral venous pathway (CVP). Understanding common patterns of CVP is helpful in reducing surgical complications. This study aimed to investigate the CVP found in patients with SSS-invading tumors, and to provide information on the prevention of operative venous complications. From January 2015 to December 2022, this retrospective study collected patients with tumors that invaded the SSS and underwent digital subtraction angiography of intracranial vessels. Data collected included sex, age, tumor pathology, tumor location along the SSS, tumor side, degree of obstruction of the SSS, types and route patterns of the CVP, and the distance between the tumor and the diploic vein (DV). Twenty patients (6 males, 14 females) were recruited. The prevalence of CVP types was 90% for DV, 35% for end-to-end anastomosis of superficial cortical vein, 15% for meningeal vein, and 20% for other types of CVP. The pteriofrontoparietal and occipitoparietal diploic routes were found on the cerebral hemisphere contralateral to the tumor significantly more than in the cerebral hemisphere ipsilateral to the tumor. Of all patients with presence of collateral DV, 61% had a very close (less than 1 cm) distance between the nearest DV and tumor attachment in the SSS. DV in the cerebral hemisphere contralateral to the tumor was the most common type of CVP found in patients with tumor-induced SSS obstruction. Most of the collateral DV was located very close to the SSS tumor attachment. Neurosurgeons should realize these findings when planning a craniotomy.
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  • 文章类型: Journal Article
    目的:急性生理学和慢性健康评估II(APACHEII)基于重症监护病房(ICU)患者的数据,通常与疾病严重程度和预后相关。然而,根据脑肿瘤患者的ICU入院数据,不存在预后预测因子,并且没有研究报告APACHEII与脑肿瘤患者的预后之间存在关联。日本重症监护患者数据库(JIPAD)的建立是为了提高日本重症监护医学的护理质量。我们使用JIPAD根据ICU收治的脑肿瘤术后患者的可用数据来检查与院内死亡率相关的因素。
    方法:2015年4月至2018年3月,在脑肿瘤手术切除或脑肿瘤活检后,年龄≥16岁的患者纳入JIPAD。我们根据血液检查和ICU入住期间的医疗程序检查了与出院时结果相关的因素,肿瘤类型,和APACHEII得分。
    结果:在研究中的1454名患者中(男性:女性比例:1:1.1,平均年龄:62岁),32人(2.2%)在住院期间死亡。在多变量分析中,男性(优势比[OR]2.70,[95%置信区间,CI1.22-6.00]),恶性肿瘤(OR2.51[95%CI1.13-5.55]),APACHEII评分≥15(OR2.51[95%CI3.08-14.3])与住院死亡率显著相关.
    结论:通过在早期发现院内死亡风险较高的病例,改善治疗方法和对患者家属的支持是可能的。
    OBJECTIVE: Acute Physiology and Chronic Health Evaluation II (APACHE II) is based on the data of intensive care unit (ICU) patients and often correlates with disease severity and prognosis. However, no prognostic predictors exist based on ICU admission data for patients with brain tumors, and no studies have reported an association between APACHE II and prognosis in patients with brain tumors. The Japanese Intensive Care Patients Database (JIPAD) was established to improve the quality of care delivered in intensive care medicine in Japan. We used JIPAD to examine factors associated with in-hospital mortality based on available data of postoperative patients with brain tumors admitted to the ICU.
    METHODS: Patients aged ≥16 years enrolled in JIPAD between April 2015 and March 2018 after surgical brain tumor resection or biopsy of brain tumors. We examined factors related to outcomes at discharge based on blood tests and medical procedures performed during ICU admission, tumor type, and APACHE II score.
    RESULTS: Among the 1454 patients (male:female ratio: 1:1.1, mean age: 62 years) in the study, 32 (2.2 %) died during hospital stay. In multivariate analysis, male sex (odds ratio [OR] 2.70, [95 % confidence interval, CI 1.22-6.00]), malignant tumor (OR 2.51 [95 % CI 1.13-5.55]), and APACHE II score ≥15 (OR 2.51 [95 % CI 3.08-14.3]) were significantly associated with in-hospital mortality.
    CONCLUSIONS: By picking up cases with a high risk of in-hospital death at an early stage, it is possible to improve methods of treatment and support for the patient\'s family.
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  • 文章类型: Journal Article
    目的:原发性恶性脑肿瘤患者由于预后有限和症状负担较高而经历严重的健康相关痛苦。因此,神经肿瘤医护人员可能会受到负面情绪影响。这项研究的目的是分析护士和医生在面对这些患者的精神困扰时的态度和行为。
    方法:Neurospirit-DE是一种基于定性的小插图,多中心,在巴伐利亚进行的横断面在线调查,德国。数据分析采用自反性主题分析。
    结果:共有143名护士和医生在46家医院的神经和神经外科病房工作参与了调查。参与者质疑提供精神护理的能力是否可以学习或是一种自然技能。强调了精神关怀作为整个团队的责任,工作人员反映了让精神护理专家参与的适当方式。精神关怀的主要限制是缺乏时间,并且没有将精神参与视为专业角色的一部分。有些人能够从与患者的精神对话中受益,但是许多参与者批评了感知到的情感负担,同时表达了对特定培训和团队反思的迫切需求。
    结论:大多数神经肿瘤科护士和医生将精神关怀视为其职责的一部分,并知道如何减轻患者的精神困扰。尽管如此,神经肿瘤学精神评估工具的验证和患者痛苦的标准化文件,共享的跨专业培训,在面对神经肿瘤学的精神护理时,对专业和个人挑战的反思需要进一步改进和培训。
    OBJECTIVE: People with primary malignant brain tumors experience serious health-related suffering caused by limited prognosis and high symptom burden. Consequently, neuro-oncological healthcare workers can be affected emotionally in a negative way. The aim of this study was to analyze the attitudes and behavior of nurses and physicians when confronted with spiritual distress in these patients.
    METHODS: Neurospirit-DE is a qualitative vignette-based, multicenter, cross-sectional online survey that was conducted in Bavaria, Germany. Reflexive thematic analysis was used for data analysis.
    RESULTS: A total of 143 nurses and physicians working in neurological and neurosurgical wards in 46 hospitals participated in the survey. The participants questioned if the ability to provide spiritual care can be learned or is a natural skill. Spiritual care as a responsibility of the whole team was highlighted, and the staff reflected on the appropriate way of involving spiritual care experts. The main limitations to spiritual care were a lack of time and not viewing spiritual engagement as part of the professional role. Some were able to personally benefit from spiritual conversations with patients, but many participants criticized the perceived emotional burden while expressing the imminent need for specific training and team reflection.
    CONCLUSIONS: Most neuro-oncological nurses and physicians perceive spiritual care as part of their duty and know how to alleviate the patient\'s spiritual distress. Nonetheless, validation of spiritual assessment tools for neuro-oncology and standardized documentation of patients\' distress, shared interprofessional training, and reflection on the professional and personal challenges faced when confronted with spiritual care in neuro-oncology require further improvement and training.
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  • 文章类型: Journal Article
    目的:为了检查潘帕奈尔(PER)对卒中后癫痫(PSE)患者的疗效和安全性,脑肿瘤相关癫痫(BTRE),和创伤后癫痫(PTE)使用日本现实世界的数据。
    方法:前瞻性上市后观察性研究纳入了接受PER联合治疗的局灶性癫痫发作伴或不伴双侧强直阵挛性癫痫发作的患者。观察期为初次PER给药后24或52周。安全性和有效性分析包括3716例和3272例患者,分别。这个事后分析检查了应答率(癫痫发作频率减少50%),无癫痫发作率(实现无癫痫发作的患者比例),以及上市后研究中患有PSE的患者的安全性,BTRE,和PTE在最后一次观察前4周。
    结果:总体而言,402、272和186名患者被纳入PSE,BTRE,和PTE亚群,和“其他”人群中的2867名对照(PSE以外的病因,BTRE,或PTE)。PSE在52周时的平均模式剂量(最常给药剂量)值为3.38、3.36、3.64和4.04mg/天,BTRE,PTE,和“其他,“;PER保留率为56.2%,54.0%,52.6%,和59.7%,分别。响应者比率(%[95%置信区间])为82%(76.3%-86.5%),78%(70.8%-83.7%),67%(56.8%-75.6%),和50%(47.9%-52.7%)的PSE,BTRE,PTE,和“其他,\"分别,无癫痫发生率为71%(64.5%-76.5%),62%(54.1%-69.0%),50%(40.6%-60.4%),和28%(25.8%-30.1%),分别。药物不良反应在PSE中发生频率较低(14.7%),BTRE(16.5%),和PTE(16.7%)亚群比“其他”群体(26.3%)。
    结论:在现实世界的临床条件下,在PSE的低PER剂量下观察到PER联合治疗的疗效和耐受性,BTRE,和PTE亚群。
    结论:为了了解药物perampanel的效果,以及对中风后癫痫患者是否安全,脑肿瘤,或者头部受伤,我们使用了来自日本真实医疗情况的信息。我们查看了约3700名接受perampanel治疗的日本癫痫患者的数据。我们发现perampanel的剂量较低,在控制癫痫发作方面效果更好,与对照组相比,由这些病因引起的癫痫患者的副作用更少。
    OBJECTIVE: To examine the efficacy and safety of perampanel (PER) in patients with post-stroke epilepsy (PSE), brain tumor-related epilepsy (BTRE), and post-traumatic epilepsy (PTE) using Japanese real-world data.
    METHODS: The prospective post-marketing observational study included patients with focal seizures with or without focal to bilateral tonic-clonic seizures who received PER combination therapy. The observation period was 24 or 52 weeks after the initial PER administration. The safety and efficacy analysis included 3716 and 3272 patients, respectively. This post hoc analysis examined responder rate (50% reduction in seizure frequency), seizure-free rate (proportion of patients who achieved seizure-free), and safety in patients included in the post-marketing study who had PSE, BTRE, and PTE in the 4 weeks prior to the last observation.
    RESULTS: Overall, 402, 272, and 186 patients were included in the PSE, BTRE, and PTE subpopulations, and 2867 controls in the \"Other\" population (etiologies other than PSE, BTRE, or PTE). Mean modal dose (the most frequently administered dose) values at 52 weeks were 3.38, 3.36, 3.64, and 4.04 mg/day for PSE, BTRE, PTE, and \"Other,\" respectively; PER retention rates were 56.2%, 54.0%, 52.6%, and 59.7%, respectively. Responder rates (% [95% confidence interval]) were 82% (76.3%-86.5%), 78% (70.8%-83.7%), 67% (56.8%-75.6%), and 50% (47.9%-52.7%) for PSE, BTRE, PTE, and \"Other,\" respectively, and seizure-free rates were 71% (64.5%-76.5%), 62% (54.1%-69.0%), 50% (40.6%-60.4%), and 28% (25.8%-30.1%), respectively. Adverse drug reactions tended to occur less frequently in the PSE (14.7%), BTRE (16.5%), and PTE (16.7%) subpopulations than in the \"Other\" population (26.3%).
    CONCLUSIONS: In real-world clinical conditions, efficacy and tolerability for PER combination therapy were observed at low PER doses for the PSE, BTRE, and PTE subpopulations.
    CONCLUSIONS: To find out how well the medication perampanel works and whether it is safe for people who have epilepsy after having had a stroke, brain tumor, or head injury, we used information from real-life medical situations in Japan. We looked at the data of about 3700 Japanese patients with epilepsy who were treated with perampanel. We found that perampanel was used at lower doses and better at controlling seizures, and had fewer side effects for patients with epilepsy caused by these etiologies than the control group.
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  • 文章类型: Journal Article
    复发性高级别胶质瘤(rHGs)预后不佳,其中IVterameprocol的最大耐受剂量(MTD)(5天/月),特异性蛋白1(Sp1)调节蛋白的转录抑制剂,为1,700mg/天,血浆浓度-时间曲线下的中位面积(AUC)为31.3μg*h/mL。鉴于持续的全身暴露和每日静脉治疗的挑战性后勤可能会增加疗效,在这里,我们研究多中心口服terameprocol治疗rHGs,第一阶段试验(GATOR)。使用3+3剂量递增设计,我们招募了20名患者,中位年龄60岁(范围31-80岁),70%男性,和中位数1次复发(范围1-3)。空腹患者耐受1,200毫克/天(n=3),2,400毫克/天(n=6),3,600毫克/天(n=3),和6,000毫克/天(n=2)口服剂量,无主要毒性。然而,增加剂量不会导致全身暴露增加,包括在美联储州(6,000毫克/天,n=4),最大AUC<5μg*h/mL。这些发现保证了研究提供持续全身水平的转录抑制剂以利用其治疗潜力的方法的试验。本研究在ClinicalTrials.gov(NCT02575794)注册。
    Recurrent high-grade gliomas (rHGGs) have a dismal prognosis, where the maximum tolerated dose (MTD) of IV terameprocol (5 days/month), a transcriptional inhibitor of specificity protein 1 (Sp1)-regulated proteins, is 1,700 mg/day with median area under the plasma concentration-time curve (AUC) of 31.3 μg∗h/mL. Given potentially increased efficacy with sustained systemic exposure and challenging logistics of daily IV therapy, here we investigate oral terameprocol for rHGGs in a multicenter, phase 1 trial (GATOR). Using a 3 + 3 dose-escalation design, we enroll 20 patients, with median age 60 years (range 31-80), 70% male, and median one relapse (range 1-3). Fasting patients tolerate 1,200 mg/day (n = 3), 2,400 mg/day (n = 6), 3,600 mg/day (n = 3), and 6,000 mg/day (n = 2) oral doses without major toxicities. However, increased dosage does not lead to increased systemic exposure, including in fed state (6,000 mg/day, n = 4), with maximal AUC <5 μg∗h/mL. These findings warrant trials investigating approaches that provide sustained systemic levels of transcription inhibitors to exploit their therapeutic potential. This study was registered at ClinicalTrials.gov (NCT02575794).
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