multi-center study

  • 文章类型: Journal Article
    背景:这项工作的目的是开发一种深度学习(DL)系统,用于快速,准确地筛查眼内肿瘤(IOT),视网膜脱离(RD),玻璃体出血(VH),和后巩膜葡萄肿(PSS)使用眼部B超图像。
    方法:来自五个临床证实类别的超声图像,包括玻璃体出血,视网膜脱离,眼内肿瘤,后巩膜葡萄肿,正常的眼睛,用于开发和评估细粒度分类系统(双路径病变注意力网络,DPLA-Net)。图像来自不同超声检查者扫描的五个中心,并分为训练,验证,和测试集的比例为7:1:2。招募了两名高级眼科医生和四名初级眼科医生来评估系统的性能。
    结果:这项多中心横断面研究是在中国的六家医院进行的。共收集6054张超声图像;4758张图像用于系统的训练和验证,和1296张图像被用作测试集。DPLA-Net在测试集中实现了0.943的平均准确度,物联网的曲线下面积为0.988,0.997为RD,0.994用于PSS,对于VH为0.988,和0.993正常。在DPLA-Net的帮助下,四名初级眼科医生的准确性从0.696(95%置信区间[CI]0.684-0.707)提高到0.919(95%CI0.912-0.926,p<0.001),每幅图像的分类时间从16.84±2.34s减少到10.09±1.79s。
    结论:提出的DPLA-Net显示出使用跨多个中心的B超图像筛查和分类多种眼科疾病的高准确性。此外,该系统可以提高眼科医生的分类效率。
    BACKGROUND: The aim of this work is to develop a deep learning (DL) system for rapidly and accurately screening for intraocular tumor (IOT), retinal detachment (RD), vitreous hemorrhage (VH), and posterior scleral staphyloma (PSS) using ocular B-scan ultrasound images.
    METHODS: Ultrasound images from five clinically confirmed categories, including vitreous hemorrhage, retinal detachment, intraocular tumor, posterior scleral staphyloma, and normal eyes, were used to develop and evaluate a fine-grained classification system (the Dual-Path Lesion Attention Network, DPLA-Net). Images were derived from five centers scanned by different sonographers and divided into training, validation, and test sets in a ratio of 7:1:2. Two senior ophthalmologists and four junior ophthalmologists were recruited to evaluate the system\'s performance.
    RESULTS: This multi-center cross-sectional study was conducted in six hospitals in China. A total of 6054 ultrasound images were collected; 4758 images were used for the training and validation of the system, and 1296 images were used as a testing set. DPLA-Net achieved a mean accuracy of 0.943 in the testing set, and the area under the curve was 0.988 for IOT, 0.997 for RD, 0.994 for PSS, 0.988 for VH, and 0.993 for normal. With the help of DPLA-Net, the accuracy of the four junior ophthalmologists improved from 0.696 (95% confidence interval [CI] 0.684-0.707) to 0.919 (95% CI 0.912-0.926, p < 0.001), and the time used for classifying each image reduced from 16.84 ± 2.34 s to 10.09 ± 1.79 s.
    CONCLUSIONS: The proposed DPLA-Net showed high accuracy for screening and classifying multiple ophthalmic diseases using B-scan ultrasound images across mutiple centers. Moreover, the system can promote the efficiency of classification by ophthalmologists.
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  • 文章类型: Journal Article
    本研究旨在评估经胸主动脉腔内修复术(TEVAR)治疗的钝性胸主动脉损伤(BTAI)患者的长期预后。
    从2010年1月至2019年12月,这项回顾性观察研究在3个中心进行,涉及62例接受TEVAR的连续BTAI患者。计划在术后6个月进行计算机断层扫描血管造影扫描,此后每年。
    在所有62个程序(100%)中都取得了技术成功,其中包括夹层病例(n=35,56.45%),假性动脉瘤(n=20,32.26%),和破裂(n=7,11.29%)。平均损伤严重程度评分为31.66±8.30。通过烟囱技术对21个弓上分支进行了血运重建,其中累及左锁骨下动脉(LSA)12例,累及左颈总动脉9例。此外,在手术过程中涵盖了11个LSA。住院死亡率为1.61%(n=1)。平均随访时间为86.82±30.58个月。全因随访死亡率为3.28%(n=2)。随访发现3个弓上分支狭窄或闭塞(4.92%),2例(3.28%)需要再次干预。无脊髓缺血,内漏,或观察到迁移。
    尽管只包括长期随访的患者,本研究证实了TEVAR治疗BTAI的长期安全性和有效性.对于年轻的BTAI患者,随着年龄的增长胸主动脉,需要更长的随访时间来观察移植物与主动脉之间的潜在错配.
    结论:这项研究证实了腔内治疗钝性胸主动脉损伤(BTAI)的长期安全性和有效性。对于年轻的BTAI患者,随着年龄的增长胸主动脉,需要更长的随访时间来观察移植物与主动脉之间的潜在错配.通过在中国多个中心进行的显著延长的随访期(86.82±30.58个月),本研究证实了血管内治疗BTAI的长期安全性和有效性.
    UNASSIGNED: This study aimed to assess the long-term outcomes in patients treated by thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injuries (BTAI).
    UNASSIGNED: From January 2010 to December 2019, this retrospective observational study was conducted at 3 centers, involving 62 consecutive BTAI patients who underwent TEVAR. Computed tomography angiography scans were planned to be conducted at 6 months post-procedure, and annually thereafter.
    UNASSIGNED: Technical success was achieved in all 62 procedures (100%), which included cases of dissection (n=35, 56.45%), pseudoaneurysm (n=20, 32.26%), and rupture (n=7, 11.29%). Mean injury severity score was 31.66±8.30. A total of 21 supra-arch branches were revascularized by chimney technique, with 12 cases involving the left subclavian artery (LSA) and 9 cases involving the left common carotid artery. In addition, 11 LSAs were covered during the procedure. The in-hospital mortality rate was 1.61% (n=1). The mean follow-up time was 86.82±30.58 months. The all-cause follow-up mortality rate was 3.28% (n=2). Stenosis or occlusion of 3 supra-arch branches (4.92%) was identified at follow-up, with 2 cases (3.28%) requiring re-intervention. No spinal cord ischemia, endoleak, or migration was observed.
    UNASSIGNED: Despite only including patients with long-term follow-up, this study confirms the long-term safety and effectiveness of TEVAR for BTAI. For young BTAI patients, as the thoracic aorta increases with age, longer follow-up is needed to observe the potential mismatch between the endograft and the aorta.
    CONCLUSIONS: This study confirms the long-term safety and effectiveness of endovascular treatment for blunt thoracic aortic injury (BTAI). For young BTAI patients, as the thoracic aorta increases with age, longer follow-up is needed to observe the potential mismatch between the endograft and the aorta. Through a remarkably extended follow-up period (86.82±30.58 months) conducted at multiple centers in China, this study confirms the long-term safety and effectiveness of endovascular treatment for BTAI.
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  • 文章类型: Journal Article
    本研究旨在探索住院碘克沙醇注射液引起的过敏反应的信号检测方法。
    使用处方序列对称分析(PSSA)方法对来自20家中国大型综合医院的3,719,217名住院患者的数据库进行了处理和分析。
    分析了126,680名使用碘克沙醇并同时接受抗过敏药物治疗的住院患者。在这些病人的医疗记录中,只有32人记录了碘克沙醇过敏.统计分析确定了4类钙制剂中的22种药物,肾上腺素能/多巴胺能药物,糖皮质激素,和抗组胺药-作为标记药物。时间间隔为3、7和28天,所有抗过敏药物和4个类别的调整序列比(aSR)均大于1.7天的aSR为2.12(95%CI:2.08-2.15),1.70(95%CI:1.68-1.73),3.85(95%置信区间[CI]:3.75-2.30),2.30(95%CI:2.26-2.35),和1.95(95%CI:1.89-2.02),分别。每个信号指示的不良药物事件的比例如下:所有抗过敏药(2.92%-3%),葡萄糖酸钙(0.19%-0.52%),肾上腺素能/多巴胺能药物(2.20%-3.37%),糖皮质激素(3.13%-3.76%),和抗组胺药(1.05%-1.32%)。
    这是第一个多中心的中国住院患者数据库研究,检测到碘克沙醇引起的过敏信号,揭示反应可能远高于收集的自发报告。碘克沙醇风险暴露更接近实际的药物护理结果。间隔≤7天的PSSA应用似乎更适合监测这些药物的晚期过敏反应信号。
    UNASSIGNED: This study aimed to explore the signal detection method for allergic reactions induced by inpatient iodixanol injection.
    UNASSIGNED: A database of 3,719,217 hospitalized patients from 20 large Chinese general hospitals was processed and analyzed using the prescription sequence symmetry analysis (PSSA) method.
    UNASSIGNED: 126,680 inpatients who used iodixanol and were concurrently treated with anti-allergic drugs were analyzed. In the medical records of these patients, only 32 had documented iodixanol allergies. Statistical analysis identified 22 drugs in 4 categories-calcium preparations, adrenergic/dopaminergic agents, glucocorticoids, and antihistamines-as marker drugs. With time intervals of 3, 7, and 28 days, the adjusted sequence ratios (aSRs) for all anti-allergics and the 4 categories were greater than 1. The 7-day aSRs were 2.12 (95% CI: 2.08-2.15), 1.70 (95% CI: 1.68-1.73), 3.85 (95% confidence interval [CI]: 3.75-2.30), 2.30 (95% CI: 2.26-2.35), and 1.95 (95% CI: 1.89-2.02), respectively. The proportions of adverse drug events indicated by each signal were as follows: all anti-allergics (2.92%-3%), calcium gluconate (0.19%-0.52%), adrenergic/dopaminergic agents (2.20%-3.37%), glucocorticoids (3.13%-3.76%), and antihistamines (1.05%-1.32%).
    UNASSIGNED: This first multi-center Chinese inpatient database study detected iodixanol-induced allergy signals, revealing that reactions may be much higher than those in collected spontaneous reports. Iodixanol risk exposure was closer to actual pharmaceutical care findings. PSSA application with ≤7-day intervals appears better suited for monitoring late allergic reaction signals with these drugs.
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  • 文章类型: Journal Article
    目的:全身麻醉下行妇科手术的患者体温过低是非常常见的,因此,住院时间甚至死亡风险都大大增加。我们的目的是开发一种简单实用的模型,在术前识别存在术中低体温风险的妇科手术患者。
    方法:在这项回顾性研究中,我们收集了2022年6月至2023年8月在三家医疗中心接受妇科手术的802例患者的数据.我们进一步将患者分配到一个训练组,内部验证组,或外部验证组。使用最小绝对收缩和选择操作员(LASSO)方法确定妇科患者术中低体温的初步预测因素。最终的预测因素随后通过多变量逻辑回归分析确定,并建立了预测体温过低发生的列线图。
    结果:共纳入802例患者,培训队列中有314名患者(平均年龄48.5±12.6岁),内部验证队列中的130名患者(平均年龄49.9±12.5岁),外部验证队列中有358名患者(平均年龄47.6±14.0岁)。LASSO回归和多变量逻辑回归分析表明,体重指数,微创手术,基线心率,基线体温,既往手术史,谷草转氨酶水平与妇科手术患者术中低体温有关。这个列线图是基于这六个变量构建的,训练队列的C指数为0.712。
    结论:我们建立了一个实用的预测模型,可用于预测妇科手术患者术前体温过低的发生。
    背景:chictr.org.cn,标识符ChiCTR2300071859。
    Hypothermia is highly common in patients undergoing gynecological surgeries under general anesthesia, so the length of hospitalization and even the risk of mortality are substantially increased. Our aim was to develop a simple and practical model to preoperatively identify gynecological surgery patients at risk of intraoperative hypothermia.
    In this retrospective study, we collected data from 802 patients who underwent gynecological surgery at three medical centers from June 2022 to August 2023. We further allocated the patients to a training group, an internal validation group, or an external validation group. The preliminary predictive factors for intraoperative hypothermia in gynecological patients were determined using the least absolute shrinkage and selection operator (LASSO) method. The final predictive factors were subsequently identified through multivariate logistic regression analysis, and a nomogram for predicting the occurrence of hypothermia was established.
    A total of 802 patients were included, with 314 patients in the training cohort (mean age 48.5 ± 12.6 years), 130 patients in the internal validation cohort (mean age 49.9 ± 12.5 years), and 358 patients in the external validation cohort (mean age 47.6 ± 14.0 years). LASSO regression and multivariate logistic regression analyses indicated that body mass index, minimally invasive surgery, baseline heart rate, baseline body temperature, history of previous surgery, and aspartate aminotransferase level were associated with intraoperative hypothermia in gynecological surgery patients. This nomogram was constructed based on these six variables, with a C-index of 0.712 for the training cohort.
    We established a practical predictive model that can be used to preoperatively predict the occurrence of hypothermia in gynecological surgery patients.
    chictr.org.cn, identifier ChiCTR2300071859.
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  • 文章类型: Journal Article
    多中心研究的设计越来越多地用于借用多个研究小组的力量,以获得广泛适用和可重复的研究结果。回归分析被广泛用于分析多组研究,然而,在许多大规模的合作研究中,大量的回归预测因子是非线性的和/或经常用批量效应来衡量。此外,非线性预测因子的组组成在不同中心之间可能是异质的。传统的汇总数据分析忽略了非线性和批量效应之间的相互作用,群体组成异质性,多中心设置中的测量误差和其他数据不一致,可能导致有偏差的回归估计和误导性结果。在本文中,我们提出了一个基于集成部分线性回归模型(IPLM)的分析来解释预测因子的非线性,一般批量效应,群体组成异质性,高维协变量,协变量中的潜在测量误差,同时这些复杂性的组合。采用基于局部线性回归的方法来估计非线性分量,并引入正则化程序来识别预测因子的影响,这些影响可以是同质的,也可以是异质的。特别是,当所有预测因子的影响在研究中心都是均匀的时,所提出的IPLM可以自动简化为所有中心的一个简单的部分线性模型。所提出的方法具有渐近估计和变量选择一致性,包括高维协变量。此外,它具有快速的计算算法,其有效性得到了数值模拟研究的支持。提供了一个多中心阿尔茨海默病研究项目来说明所提出的基于IPLM的分析。
    The design of multi-center study is increasingly used for borrowing strength from multiple research groups to obtain broadly applicable and reproducible study findings. Regression analysis is widely used for analyzing multi-group studies, however, some of the large number of regression predictors are nonlinear and/or often measured with batch effects in many large scale collaborative studies. Also, the group compositions of the nonlinear predictors are potentially heterogeneous across different centers. The conventional pooled data analysis ignores the interplay between nonlinearity and batch effect, group composition heterogeneity, measurement error and other data incoherence in multi-center setting that can cause biased regression estimates and misleading outcomes. In this paper, we propose an integrated partially linear regression model (IPLM) based analysis to account for the predictor\'s nonlinearity, general batch effect, group composition heterogeneity, high-dimensional covariates, potential measurement-error in covariates, and combinations of these complexities simultaneously. A local linear regression based approach is employed to estimate the nonlinear component and a regularization procedure is introduced to identify the predictors\' effects that can be either homogeneous or heterogeneous across groups. In particular, when the effects of all predictors are homogeneous across the study centers, the proposed IPLM can automatically reduce to one single parsimonious partially linear model for all centers. The proposed method has asymptotic estimation and variable selection consistency including high-dimensional covariates. Moreover, it has a fast computing algorithm and its effectiveness is supported by numerical simulation studies. A multi-center Alzheimer\'s disease research project is provided to illustrate the proposed IPLM based analysis.
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  • 文章类型: Journal Article
    背景:预清洁是内窥镜再处理中的关键步骤。
    目的:通过使用一次性内窥镜床边预清洗套件,开发一种有效且经济的内窥镜清洗方法。
    方法:总之,从五个高容量内窥镜单元中选择228个使用过的胃肠内窥镜,并通过传统的预清洁桶(T组)或一次性内窥镜床边预清洁套件(D组)进行预清洁。每组根据清洗液的更换频率进一步细分,在T1和D1亚组中每次更换,在Ts和Ds亚组中每更换几次。测量三磷酸腺苷(ATP)水平和残留蛋白质三次:在预清洁之前和之后以及手动清洁之后。
    结果:预清洗后,预清洗试剂盒显著降低ATP水平(P=0.034),与传统预清洗桶相比,ATP清除率更稳定.预清洗试剂盒还节省了预清洗过程中使用的酶洗涤剂成本的四分之一。手动清洁后,预清洗试剂盒组的ATP水平也显著低于传统预清洗桶组(P<0.05)。同时,清洗液的使用次数(最多4次)对清洗效果无显著影响(P>0.05)。
    结论:考虑到其经济成本和清洁效果,使用一次性内窥镜床边预清洁套件可以是在预清洁阶段的最佳选择,在手动清洁阶段更换清洁溶液几次。
    BACKGROUND: Precleaning is a key step in endoscopic reprocessing.
    OBJECTIVE: To develop an effective and economic endoscope cleaning method by using a disposable endoscope bedside precleaning kit.
    METHODS: Altogether, 228 used gastrointestinal endoscopes were selected from five high-volume endoscopy units and precleaned by a traditional precleaning bucket (group T) or a disposable endoscope bedside precleaning kit (group D). Each group was further subdivided based on the replacement frequency of the cleaning solution, which was replaced every time in subgroups T1 and D1 and every several times in subgroups Ts and Ds. The adenosine triphosphate (ATP) level and residual proteins were measured three times: Before and after precleaning and after manual cleaning.
    RESULTS: After precleaning, the precleaning kit significantly reduced the ATP levels (P = 0.034) and has a more stable ATP clearance rate than the traditional precleaning bucket. The precleaning kit also saved a quarter of the cost of enzymatic detergent used during the precleaning process. After manual cleaning, the ATP levels were also significantly lower in the precleaning kit group than in the traditional precleaning bucket group (P < 0.05). Meanwhile, the number of uses of the cleaning solution (up to four times) has no significant impact on the cleaning effect (P > 0.05).
    CONCLUSIONS: Considering its economic cost and cleaning effect, the use of a disposable endoscope bedside precleaning kit can be an optimal option in the precleaning stage with the cleaning solution being replaced several times in the manual cleaning stage.
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  • 文章类型: Multicenter Study
    目的:确定与院前急救期间感觉安全有关的因素。
    方法:一个多中心,横断面研究。2021年4月至2022年3月的数据收集,在应急中心061(安达卢西亚,西班牙)。
    方法:通过紧急医疗服务见证医疗保健。
    方法:未成年人,或沟通障碍。
    方法:见证感知安全量表ESPT10。研究的变量与社会人口统计学数据相关,对医疗保健的要求,病人,医院转院和患者安全事件。构建了因变量的多元线性回归模型。这项研究遵循了STROBE声明。
    结果:回答来自1400名证人。线性回归模型显示,随着证人感到更满意,量表上的得分增加(B=1.302;p<0.001)。相反,当证人报告患者安全事件时,得分较低(B=-2.856;p<0.001,B=-3.166;p<0.001),或当援助发生在公共场所(B=-0.722;p=0.017)。
    结论:满意度,患者安全事件的发生,和医疗保健的地方是与证人的看法相关的因素。证人感知安全量表ESPT10可以被认为是有效且有用的患者安全指标。
    OBJECTIVE: To determine the factors related with the perception of feeling safe during pre-hospital emergency care.
    METHODS: A multi-centred, cross-sectional study. Data collection from April 2021 to March 2022, in the Centro de Emergencias Sanitarias 061 (Andalusia, Spain).
    METHODS: witnesses of health care by emergency medical services.
    METHODS: minors, or communication barriers.
    METHODS: Witness Perceived Safety Scale ESPT10. The variables studied were related with sociodemographic data, the request for health care, the patient, the hospital transfer and patient safety incidents. A multivariate linear regression model was constructed for the dependent variable. The study followed STROBE statement.
    RESULTS: Responses were obtained from 1400 witnesses. The linear regression model showed that the score on the scale increased as the witnesses felt more satisfied (B = 1.302; p < 0.001). On the contrary, the score was lower when the witness reported a patient safety incident (B = -2.856; p < 0.001 and B = -3.166; p < 0.001), or when the assistance took place in a public space (B = -0.722; p = 0.017).
    CONCLUSIONS: The level of satisfaction, the occurrence of a patient safety incident, and the place of health care are related factors with the perception of the witnesses. The Witness Perceived Safety Scale ESPT10 could be considered a valid and useful patient safety indicator.
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  • 文章类型: Multicenter Study
    加替隐球菌(C.gattii)正在全球范围内成为一种威胁生命的真菌。然而,中国的数据很少。在这项研究中,从中国多家医院收集了27个分离株和32个患者信息,加上以前报告的数据(80例),来描述C.gattii的地理分布.采用多位点序列分型对分离株进行了分子鉴定和遗传多样性分析,同时通过体外表型测试和体内动物实验探讨了微生物学和毒力特征。研究结果表明,感染了C.gattii的患者主要是具有免疫能力的男性,大部分表现出中枢神经系统受累的症状。分离菌株主要分布在热带和亚热带地区,以VGI基因型为主。这些菌株表现出明显的遗传多样性,在57个分离株中识别25个不同的序列类型(ST)(可用数据),包括三个新颖的ST(ST565、ST567和ST568)。体外测定揭示了VGI和VGII在39°C下的生长能力之间的显着差异,胶囊直径,黑色素的产生,抗紫外线,和抗氧化能力,VGII表现出更大的弹性。结合动物实验和临床预后表明,致病性与体外毒力表型或分子基因型没有直接相关,强调毒力的复杂性。此外,组织病理学分析表明,肺组织损伤可能主要导致小鼠死亡,特别是更多的致病菌株引起广泛的肺组织损伤。我们的研究有可能为全面了解中国C.gattii的微生物学特性提供有价值的数据。重要性我们的研究表明,加替隐球菌的分子分型与毒力无关。动物实验和临床预后的整合表明,致病性与体外毒力表型或分子基因型没有直接相关性。强调毒力的错综复杂的性质。总之,我们的研究有可能提供有价值的见解,以了解中国的C.gattii的微生物属性。
    OBJECTIVE: Our study indicates that the molecular typing of Cryptococcus gattii is unrelated to virulence. The integration of animal experiments and clinical prognosis demonstrated that pathogenicity did not exhibit a direct correlation with in vitro virulence phenotypes or molecular genotypes, emphasizing the intricate nature of virulence. In conclusion, our research holds the potential to provide valuable insights into understanding the microbiological attributes of C. gattii in China.
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  • 文章类型: Journal Article
    探讨急性淋巴细胞白血病(ALL)患儿治疗后死亡的可能危险因素。采用多因素竞争风险分析对中国ALL患儿CCCG-ALL-2015治疗后死亡资料进行回顾性分析,确定ALL患儿治疗后死亡的可能危险因素。首次诊断年龄≥10岁;高风险的最终风险水平;D19微小残留病(MRD)(≥0.01%)和D46MRD(≥0.01%);遗传异常,如KMT2A重排,c-Myc重排,和PDGFRB重排;以及CNS3的存在(所有P值,<0.05)被确定为独立危险因素,而首次诊断为低危(LR)和ETV6时的风险水平::RUNX1阳性被认为是ALL患儿死亡的独立保护因素.在471例死亡病例中,45例仅接受CCCG-ALL-2015治疗,163人(34.61%)与治疗相关,62.42%是由于严重感染。55.83%的治疗相关死亡率(TRM)发生在治疗早期(诱导期)。TRM对小儿ALL患者的总体生存率有显著影响。此外,CCCG-ALL-2015方案治疗儿童ALL具有更好的安全性,率接近发达国家(注册编号:ChiCTR-IPR-14005706;注册日期:2014年6月4日)。
    To investigate the possible risk factors for death at post-treatment in children with acute lymphoblastic leukemia (ALL). A multivariate competing risk analysis was performed to retrospectively analyze the data of children with ALL who died after treatment with CCCG-ALL-2015 in China and to determine the possible risk factors for death at post-treatment in children with ALL. Age at the first diagnosis of ≥10 years; final risk level of high-risk; D19 minimal residual disease (MRD) (≥0.01%) and D46 MRD (≥0.01%); genetic abnormalities, such as KMT2A-rearrangement, c-Myc rearrangement, and PDGFRB rearrangement; and the presence of CNS3 (all P values, <0.05) were identified as independent risk factors, whereas the risk level at the first diagnosis of low-risk (LR) and ETV6::RUNX1 positivity was considered as independent protective factors of death in children with ALL. Among the 471 cases of death, 45 cases were treated with CCCG-ALL-2015 only, and 163 (34.61%) were treatment-related, with 62.42% due to severe infections. 55.83% of treatment-related mortality (TRM) occurred in the early phase of treatment (induction phase). TRM has a significant impact on the overall survival of pediatric patients with ALL. Moreover, the CCCG-ALL-2015 regimen has a better safety profile for treating children with ALL, with rates close to those in developed countries (registration number: ChiCTR-IPR-14005706; date of registration: June 4, 2014).
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  • 文章类型: Journal Article
    儿童中风从出生到18岁,在儿童死亡的十大原因中,并留下终生的神经损伤。婴儿期和儿童期的动脉缺血性中风是由于大脑中的动脉闭塞而发生的,导致局灶性病变.我们对发育中的大脑中与局灶性损伤相关的损伤和修复机制的理解仍然是初步的。神经成像可以揭示对这些机制的重要见解。在成人中风人群中,多中心神经影像学研究很常见,并加速了翻译过程,从而改善了治疗和预后.这些研究集中在越来越多的证据上,即神经影像学测量和其他生物标志物(例如,来自血液和脑脊液)可以增强我们对风险和损伤机制的理解,并用作补充结果标志物。这些因素尚未在小儿中风中进行研究,因为该人群中的大多数神经影像学研究都是以单一中心进行的,小群。通过汇集多个站点的神经成像数据,更大的患者队列可以显着提高研究的可行性和权力,阐明脑损伤的机制,修复和结果。这些目标在小儿中风中特别相关,因为发病率降低和缺乏机制靶向试验。为了这些目标,我们在2015年开发了儿科卒中神经成像平台(PEDSNIP),由加拿大大脑平台支持资助,专注于三个确定的神经影像学优先事项。这些是:开发和协调多点临床方案,创建要导入的基础设施和方法,通过国际小儿中风研究(IPSS)存储和组织来自多个站点的大型临床神经影像学数据集,并实现中央可搜索性。要做到这一点,开发了一种双管齐下的方法,包括构建1)与临床数据和纵向结果相关的临床MRI数据存储库(护理成像标准)和2)通过我们广泛的合作获得的研究MRI神经成像数据集,多中心,多学科网络。该数据集前瞻性地在八个北美中心收集,以测试协调的高级研究MRI的可行性和实施。随着临床信息的增加,遗传和蛋白质组学研究,在一组出现急性缺血性卒中的儿童中。在这里,我们描述了能够开发PEDSNIP的过程,该过程旨在提供支持儿科中风神经影像学研究重点的基础设施。建立了这个平台,我们现在能够利用全球范围内最大的儿童卒中神经影像学和临床数据池进行假设驱动的研究.我们正在积极研究生物信息学方法,以开发风险预测模型,损伤和修复,加速突破性发现,导致机制靶向治疗,改善预后,最大限度地减少儿童卒中后的负担。这种科学家和研究人员独特的转型资源有可能导致管理的范式转变,中风儿童及其家庭的结局和生活质量,在整个生命周期中对人们的其他大脑状况具有深远的好处。
    Childhood stroke occurs from birth to 18 years of age, ranks among the top ten childhood causes of death, and leaves lifelong neurological impairments. Arterial ischemic stroke in infancy and childhood occurs due to arterial occlusion in the brain, resulting in a focal lesion. Our understanding of mechanisms of injury and repair associated with focal injury in the developing brain remains rudimentary. Neuroimaging can reveal important insights into these mechanisms. In adult stroke population, multi-center neuroimaging studies are common and have accelerated the translation process leading to improvements in treatment and outcome. These studies are centered on the growing evidence that neuroimaging measures and other biomarkers (e.g., from blood and cerebrospinal fluid) can enhance our understanding of mechanisms of risk and injury and be used as complementary outcome markers. These factors have yet to be studied in pediatric stroke because most neuroimaging studies in this population have been conducted in single-centred, small cohorts. By pooling neuroimaging data across multiple sites, larger cohorts of patients can significantly boost study feasibility and power in elucidating mechanisms of brain injury, repair and outcomes. These aims are particularly relevant in pediatric stroke because of the decreased incidence rates and the lack of mechanism-targeted trials. Toward these aims, we developed the Pediatric Stroke Neuroimaging Platform (PEDSNIP) in 2015, funded by The Brain Canada Platform Support Grant, to focus on three identified neuroimaging priorities. These were: developing and harmonizing multisite clinical protocols, creating the infrastructure and methods to import, store and organize the large clinical neuroimaging dataset from multiple sites through the International Pediatric Stroke Study (IPSS), and enabling central searchability. To do this, developed a two-pronged approach that included building 1) A Clinical-MRI Data Repository (standard of care imaging) linked to clinical data and longitudinal outcomes and 2) A Research-MRI neuroimaging data set acquired through our extensive collaborative, multi-center, multidisciplinary network. This dataset was collected prospectively in eight North American centers to test the feasibility and implementation of harmonized advanced Research-MRI, with the addition of clinical information, genetic and proteomic studies, in a cohort of children presenting with acute ischemic stroke. Here we describe the process that enabled the development of PEDSNIP built to provide the infrastructure to support neuroimaging research priorities in pediatric stroke. Having built this Platform, we are now able to utilize the largest neuroimaging and clinical data pool on pediatric stroke data worldwide to conduct hypothesis-driven research. We are actively working on a bioinformatics approach to develop predictive models of risk, injury and repair and accelerate breakthrough discoveries leading to mechanism-targeted treatments that improve outcomes and minimize the burden following childhood stroke. This unique transformational resource for scientists and researchers has the potential to result in a paradigm shift in the management, outcomes and quality of life in children with stroke and their families, with far-reaching benefits for other brain conditions of people across the lifespan.
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