brain tumor

脑肿瘤
  • 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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  • 文章类型: Journal Article
    目的:这项研究的目的是评估脑肿瘤切除术后谵妄的发生和诱发因素。
    方法:从国家住院患者样本(NIS)数据库中提取2016年至2019年接受脑肿瘤切除术患者的数据,并进行回顾性分析。两组之间的差异比较采用Wilcoxon秩和检验或卡方检验。单因素和多因素logistic回归分析用于确定脑肿瘤切除术后谵妄的危险因素。
    结果:从2016年到2019年,在NIS数据库中确定了28340例接受脑肿瘤切除术的患者,谵妄发生率为4.79%(1357/28340)。研究发现,谵妄发生率的增加与75岁以上的男性和男性显著相关(均P<0.001)。此外,谵妄患者更有可能出现多种合并症并接受择期手术(均P<0.001).Logistic回归分析结果显示,自我报酬(OR=0.51;CI=0.31-0.83;P=0.007),择期录取(OR=0.53;CI=0.47-0.60;P<0.001),肥胖(OR=0.77;CI=0.66-0.92;P=0.003),女性(OR=0.79;CI=0.71-0.88;P<0.001),和私人保险(OR=0.80;CI=0.67-0.95;P=0.012)与谵妄发生率较低相关。此外,谵妄与额外的总住院费用有关(P<0.001),住院时间增加(P<0.001),较高的住院死亡率(P=0.001),围手术期并发症(包括心力衰竭,急性肾功能衰竭,尿路感染,尿潴留,败血症,肺炎,输血,和脑水肿)(P<0.001)。
    结论:脑肿瘤切除术后谵妄的发生与多种因素有关。因此,临床医师应及时发现易发生谵妄的高危患者,并采取有效的管理措施,减少不良结局。
    OBJECTIVE: The aim of this study was to evaluate the occurrence and factors predisposing to delirium following brain tumor resection.
    METHODS: Data from patients who underwent brain tumor resection surgery from 2016 to 2019 were extracted from the National Inpatient Sample database and retrospectively analyzed. The difference between the 2 groups was compared by Wilcoxon rank test or χ2 test was used. Univariate and multivariate logistic regression analyses were used to identify the risk factors of delirium after brain tumor resection.
    RESULTS: From 2016 to 2019, 28,340 patients who underwent brain tumor resection were identified in the National Inpatient Sample database, with the incidence of delirium being 4.79% (1357/28,340). It was found that increased incidence of delirium was significantly associated with age over 75 years and males (all P < 0.001). Besides, patients with delirium were more likely to have multiple comorbidities and to receive elective surgery (all P < 0.001). The results of logistic regression analysis showed that self-pay (odds ratio [OR] = 0.51; confidence interval [CI] = 0.31-0.83; P = 0.007), elective admission (OR = 0.53; CI = 0.47-0.60; P < 0.001), obesity (OR = 0.77; CI = 0.66-0.92; P = 0.003), females (OR = 0.79; CI = 0.71-0.88; P < 0.001), and private insurance (OR = 0.80; CI = 0.67-0.95; P = 0.012) were associated with lower occurrence of delirium. Besides, delirium was related to extra total hospital charges (P < 0.001), increased length of stay (P < 0.001), higher inpatient mortality (P = 0.001), and perioperative complications (including heart failure, acute renal failure, urinary tract infection, urinary retention, septicemia, pneumonia, blood transfusion, and cerebral edema) (P < 0.001).
    CONCLUSIONS: Many factors were associated with the occurrence of delirium after brain tumor resection. Therefore, clinicians should identify high-risk patients prone to delirium in a timely manner and take effective management measures to reduce adverse outcomes.
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  • 文章类型: Journal Article
    红外热成像(IT)是一种非侵入性的实时成像技术,在神经外科的不同领域具有潜在的应用价值。尽管该领域的技术进步,术中IT(IIT)一直是一个被低估的工具,关于其在颅内肿瘤切除术中的有用性的报道很少。我们旨在通过静态和动态热成像图来评估高分辨率IIT对硬膜病变定位的有用性,和诊断,为了评估切除的程度,围手术期急性缺血的发生。
    在一项前瞻性研究中,15例受颅内肿瘤影响的患者(6例胶质瘤,四个脑膜瘤,和五个脑转移)在开颅手术后用高分辨率热成像相机检查,硬脑膜开放后,在肿瘤切除结束时。
    肿瘤经dural定位,敏感性为93.3%,特异性为100%(p<0.00001),以及皮质动脉和静脉.胶质瘤始终是低体温的,而转移瘤和脑膜瘤在静态(p=0.055)和动态(p=0.015)成像上表现出高度可变的热像图。残余肿瘤显示非特异性静态但特征性动态热像图。缺血性损伤显著低温(p<0.001)。
    高分辨率IIT是一种用于病变定位的无创替代术中成像方法,诊断,评估肿瘤切除的程度,用静态和动态热像图识别急性缺血的变化。
    UNASSIGNED: Infrared thermography (IT) is a non-invasive real-time imaging technique with potential application in different areas of neurosurgery. Despite technological advances in the field, intraoperative IT (IIT) has been an underestimated tool with scarce reports on its usefulness during intracranial tumor resection. We aimed to evaluate the usefulness of high-resolution IIT with static and dynamic thermographic maps for transdural lesion localization, and diagnosis, to assess the extent of resection, and the occurrence of perioperative acute ischemia.
    UNASSIGNED: In a prospective study, 15 patients affected by intracranial tumors (six gliomas, four meningiomas, and five brain metastases) were examined with a high-resolution thermographic camera after craniotomy, after dural opening, and at the end of tumor resection.
    UNASSIGNED: Tumors were transdurally located with 93.3% sensitivity and 100% specificity (p < 0.00001), as well as cortical arteries and veins. Gliomas were consistently hypothermic, while metastases and meningiomas exhibited highly variable thermographic maps on static (p = 0.055) and dynamic (p = 0.015) imaging. Residual tumors revealed non-specific static but characteristic dynamic thermographic maps. Ischemic injuries were significantly hypothermic (p < 0.001).
    UNASSIGNED: High-resolution IIT is a non-invasive alternative intraoperative imaging method for lesion localization, diagnosis, assessing the extent of tumor resection, and identifying acute ischemia changes with static and dynamic thermographic maps.
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  • 文章类型: Journal Article
    缺乏关于恶性脑肿瘤患者及其亲属如何参与神经肿瘤临床试验的证据。同样,缺乏照顾这组患者的试验人员的见解。本研究旨在调查患者,相关人员和试验人员参与临床神经肿瘤试验的经验。
    在定性探索性研究中,对脑肿瘤患者进行29次半结构化访谈,使用Braun和Clarke的反身主题分析(RTA)对亲属和试验人员进行了分析。患者研究人员和患者理事会参与了数据分析和解释。
    开发了四个主题,反映了试验经验的重要方面:1.“一切都围绕着希望”;2。“审判参与:体验独特的医疗保健”;3。“每个人的角色都在改变”;4.\"通信作为可能的冲突区域\"。人们发现,经历试验参与和一般医疗是相互关联的,以至于患者和亲属往往无法对它们进行有意义的区分。
    除了评估患者预后的传统终点外,我们建议更加重视调查构成试验参与的"软"成分的影响.由于医疗和试验参与的相互联系,我们建议与常规护理经验进行进一步调查。需要对试验参与有更深入的了解,以改善患者体验和工作人员满意度以及医学和科学进步。
    (恶性)脑肿瘤患者的治疗选择目前非常有限。因此,患者有时会被邀请参加临床试验.这意味着他们接受了实验性治疗(例如新药),目前尚不清楚它是否比常规医疗更好。目前,对于这一组患者,他们的亲属和照顾他们的医院工作人员经历了这些临床试验的参与-这就是我们在这里报道的研究中旨在探索的。根据对患者的采访,亲戚和工作人员,我们发现:试验参与主要围绕着希望;试验参与需要体验独特的医疗服务;试验参与显著改变了患者以往的角色,亲属和工作人员;审判参与加强了沟通,这是一个可能的冲突领域。通过提供患者的信息,亲属和工作人员了解他们的审判经历,这项研究是对传统医学和科学终点(如无进展生存期)临床试验重点的重要补充.这可能有助于参与癌症研究和治疗的临床医生和研究人员理解为什么“不成功”的试验仍然可以被患者认为是积极的,或者即使从临床医生的角度被认为是“不现实的”,希望的沟通也可以支持他们的患者。需要从受影响者的角度深入了解试验参与情况,以改善护理体验,以及癌症治疗的医学和科学进展。
    UNASSIGNED: There is a lack of evidence regarding how patients with malignant brain tumor and their relatives experience participation in neurooncological clinical trials. Similarly, insights from the perspective of trial staff caring for this group of patients are missing. This study aims to investigate patient, relative and trial staff experiences regarding participation in clinical neurooncological trials.
    UNASSIGNED: Within a qualitative exploratory study, 29 semi-structured interviews with brain tumor patients, relatives and trial staff were conducted and analyzed using reflexive thematic analysis (RTA) by Braun and Clarke. A patient researcher and patient council were involved in data analysis and interpretation.
    UNASSIGNED: Four themes were developed reflecting significant aspects of the trial experience: 1. \"It all revolves around hope\"; 2. \"Trial participation: experiencing unique medical care\"; 3. \"Everyone\'s roles are changing\"; 4. \"Communication as a possible area of conflict\". Experiencing trial participation and general medical treatment were found to be interconnected to such a degree that they were often not meaningfully distinguished by patients and relatives.
    UNASSIGNED: In addition to assessing traditional endpoints for patient outcomes, we recommend increased emphasis on investigating the impact of the \"soft\" components constituting trial participation. Due to the interconnectedness of medical treatment and trial participation, we recommend further investigation in comparison to experiences in regular care. A deeper understanding of trial participation is needed to inform improvements for patient experiences and staff satisfaction alongside medical and scientific progress.
    The treatment options available to patients with (malignant) brain tumors are currently very limited. Therefore, patients are sometimes offered to participate in a clinical trial. This means that they receive an experimental treatment (eg new medicine) for which it is not yet clear whether it works better than regular medical care. Currently, little is known about how this group of patients, their relatives and the hospital staff who care for them experience the participation in these clinical trials – which is what we aimed to explore in our study reported here. Based on interviews with patients, relatives and staff, we found that: trial participation mainly revolves around hope;trial participation entails experiencing unique medical care;trial participation significantly changes the previous roles of patients, relatives and staff;trial participation intensifies communication as a possible area of conflict. By providing information on how patients, relatives and staff make sense of their trial experiences, this study constitutes an important addition to the traditional focus of clinical trials on medical and scientific endpoints (eg progression-free survival). This may help clinicians and researchers involved in cancer research and treatment to understand why “unsuccessful” trials can still be perceived as positive by patients or how hopeful communication may support their patients even when perceived as “unrealistic” from the clinicians’ perspective. An in depth understanding of trial participation from the perspective of those affected is needed for improved care experiences alongside medical and scientific progress for cancer treatment.
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  • 文章类型: Journal Article
    与肿瘤体积的增加有关,患有高级别神经胶质瘤的患者有发生颅内高压(ICHT)增加的风险。ICP变化不能通过侵入性方法测量,但可以通过使用常规临床体征来估计。结合标准成像方法,磁共振成像(MRI)。ICP的非侵入性监测可能对高级别神经胶质瘤感兴趣,特别是在放射治疗后,主要副作用是脑水肿。
    这项前瞻性临床研究旨在比较ICP变化(通过基于畸变产物耳声发射(DPOAE)监测的非侵入性方法估算)与MRI上观察到的体积变化接受放射治疗的高级别神经胶质瘤。放疗结束后一个月进行DPOAE测量,然后每3个月进行一次,为期一年。每次访问,患者还接受了MRI检查以及临床体征评估.
    每次随访时测量的颅内压读数估计值的变化(相对于基线测量的绝对值)与T2/FLAIR体积的变化显着相关(n=125;p<0.001),ICP读数的变化截止值为40.2度(例如,估计的变化为16mmHg)。
    GMaPIC试验证实了以下假设:使用非侵入性医疗设备通过DPOAEs测量估计的ICP变化与放疗后高级别神经胶质瘤的肿瘤或水肿变化相关。因此,该设备可以成为这些患者的易于使用且无创的颅内压监测工具。
    Clinicaltrials.gov,标识符(NCT02520492)。
    UNASSIGNED: Patients with high-grade gliomas are at risk of developing increased intracranial hypertension (ICHT) in relation to the increase in volume of their tumor. ICP change cannot be measured by invasive method but can be estimated by using routine clinical signs, in combination with a standard imaging method, magnetic resonance imaging (MRI). A non-invasive monitoring of ICP could be of interest in high-grade glioma, in particular after radiotherapy treatment with as major side effect a cerebral oedema.
    UNASSIGNED: This prospective clinical study aimed to compare the ICP changes (estimated by a non-invasive method based upon distortion product otoacoustic emissions (DPOAE) monitoring) with volume changes observed on MRI in patients with high-grade gliomas treated with radiotherapy. DPOAE measurements were performed one month after the end of radiotherapy and then every 3 months for one year. At each visit, the patient also underwent MRI as well as an evaluation of clinical signs.
    UNASSIGNED: The variation in the estimate of intracranial pressure readout measured at each follow-up visit (in absolute value with respect to the baseline measurements) was significantly associated with the variation of T2/FLAIR volume (n=125; p<0.001) with a cut off value of change ICP readout of 40.2 degrees (e.i. an estimated change of 16 mm Hg).
    UNASSIGNED: The GMaPIC trial confirm the hypothesis that the ICP change estimated by DPOAEs measurement using a non-invasive medical device is correlated with the change of the tumor or edema in high grade glioma after radiotherapy. The device could thus become an easy-to-use and non-invasive intracranial pressure monitoring tool for these patients.
    UNASSIGNED: Clinicaltrials.gov, identifier (NCT02520492).
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