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Changes to the UK childhood immunisation schedule. 英国儿童免疫接种计划的变化。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-26 DOI: 10.1136/archdischild-2023-326625
Oluwasefunmi Akeju, Emily A Lees, Gayatri Amirthalingam, Mary E Ramsay, Andrew J Pollard
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引用次数: 0
Trachoma prevention, azithromycin and reduced mortality. 预防沙眼、阿奇霉素和降低死亡率。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2024-327925
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引用次数: 0
Severity of acute phase reaction in children receiving the first dose of zoledronic acid and the impact of the underlying condition: a cross-sectional study. 接受首剂唑来膦酸治疗的儿童急性期反应的严重程度及基础疾病的影响:一项横断面研究。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2023-326287
Sapna Nayak, Lauren Rayner, Zulf Mughal, Georgia McKinney, Avril Mason, Sze Choong Wong, Raja Padidela, Amish Chinoy

Introduction: Zoledronic acid (ZA), used for treatment of children with osteoporosis, can cause acute phase reaction (APR) following the first infusion. Many institutions have a policy to admit and monitor all children for their first ZA infusion.

Objective: To determine if the APR with the first ZA dose warrants hospital-level care and evaluate if its severity correlates with the underlying condition.

Design: Retrospective cross-sectional analysis.

Settings: Two tertiary centres across the UK that run paediatric metabolic bone disease services.

Patients: Children who received first ZA infusion as inpatients at these centres.

Interventions: Nil.

Main outcome measures: The Paediatric Early Warning Score (PEWS) and length of hospital stay to assess the severity of APR.

Results: 107 patients were included. Peak PEWS≤3 was found in 85% of children. 83% required admission for <24 hours. The various patient populations (osteogenesis imperfecta (OI), immobility-induced osteoporosis, idiopathic juvenile osteoporosis, systemic inflammatory disorders and steroid-induced osteoporosis, Duchenne muscular dystrophy (DMD)) did not differ significantly in the mean peak PEWS and the length of hospital stay. However, when compared directly, the group with DMD and that with systemic inflammatory disorders and steroid-induced osteoporosis differed significantly in the mean peak PEWS (p=0.011) and the length of hospital stay (p=0.048), respectively, as compared with the OI group.

Conclusion: Most patients had a mild APR not requiring overnight hospital admission, after their first ZA dose. However, certain groups seem to suffer more severe APR and may warrant consideration of inpatient monitoring with the first infusion.

简介唑来膦酸(ZA)用于治疗儿童骨质疏松症,首次输注后可引起急性期反应(APR)。许多医疗机构规定,所有首次输注唑来膦酸的儿童都必须住院并接受监测:目的:确定首次输注ZA时出现的APR是否需要住院治疗,并评估其严重程度是否与潜在病情相关:设计:回顾性横断面分析:英国两家提供儿科代谢性骨病服务的三级医疗中心:干预措施:无:干预措施:无:主要结果测量:儿科早期预警评分(PEWS)和住院时间,以评估APR的严重程度:结果:共纳入107名患者。85%的患儿PEWS峰值≤3。83%的患者需要住院治疗:大多数患者在首次服用ZA后出现轻度APR,不需要住院治疗。然而,某些群体的 APR 似乎更为严重,可能需要考虑在首次输注时进行住院监测。
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引用次数: 0
Physical health and mental healthcare: each has its own evidence base but they need to be integrated. 身体健康和心理健康:两者都有自己的证据基础,但需要加以整合。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2024-326901
Isobel Heyman
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引用次数: 0
Visible damp in a child's bedroom is associated with increased respiratory morbidity in early life: a multicentre cohort study. 儿童卧室明显潮湿与幼年呼吸道发病率增加有关:一项多中心队列研究。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2024-326944
Tom Ruffles, Sarah K Inglis, Anjum Memon, Paul Seddon, Kaninika Basu, Stephen A Bremner, Heike Rabe, Somnath Mukhopadhyay, Katy J Fidler

Objective: Household damp exposure is an important public health issue. We aimed to assess the impact of the location of household damp on respiratory outcomes during early life.

Methods: Household damp exposure was ascertained in children recruited to the GO-CHILD multicentre birth cohort study. The frequency of respiratory symptoms, infections, healthcare utilisation and medication prescription for wheezing were collected by postal questionnaires at 12 and 24 months. Log binomial and ordered logistic regression models were fitted to the data.

Results: Follow-up was obtained in 1344 children between August 2010 and January 2016. Visible damp was present in a quarter of households (25.3%) with 1 in 12 children's bedrooms affected (8.3%). Damp in the bathroom, kitchen or living room was not associated with any respiratory or infection-related outcomes. Damp in the child's bedroom was associated with an increased risk of dry cough (8.7% vs 5.7%) (adjusted relative risk 1.56, 95% CI 1.07 to 2.27; p=0.021) and odds of primary care attendance for cough and wheeze (7.6% vs 4.4%) (adjusted OR 1.37, 95% CI 1.07 to 1.76; p=0.009). There were also increased risk of inhaled corticosteroid (13.3% vs 5.9%) (adjusted RR 2.22, 95% CI 1.04 to 4.74; p=0.038) and reliever inhaler (8.3% vs 5.8%) (adjusted RR 2.01, 95% CI 1.21 to 2.79; p=0.018) prescription.

Conclusion: Damp in the child's bedroom was associated with increased respiratory morbidity. In children presenting with recurrent respiratory symptoms, clinicians should enquire about both the existence and location of damp, the presence of which can help prioritise those families requiring urgent household damp assessment and remediation works.

目标:家庭受潮是一个重要的公共卫生问题。我们的目的是评估家庭潮湿位置对生命早期呼吸系统结果的影响。方法:对加入 GO-CHILD 多中心出生队列研究的儿童进行家庭潮湿暴露调查。在 12 个月和 24 个月时,通过邮寄问卷收集呼吸道症状、感染、医疗保健使用率和喘息处方药的频率。数据采用对数二项式和有序逻辑回归模型:2010年8月至2016年1月期间,对1344名儿童进行了随访。四分之一的家庭(25.3%)存在明显的潮湿现象,每12个儿童卧室中就有1个受到影响(8.3%)。浴室、厨房或起居室的潮湿与任何呼吸道或感染相关结果无关。儿童卧室潮湿与干咳风险增加(8.7% 对 5.7%)(调整后相对风险为 1.56,95% CI 为 1.07 至 2.27;p=0.021)以及因咳嗽和喘息而到初级保健机构就诊的几率增加(7.6% 对 4.4%)(调整后 OR 为 1.37,95% CI 为 1.07 至 1.76;p=0.009)有关。吸入皮质类固醇(13.3% vs 5.9%)(调整后RR为2.22,95% CI为1.04至4.74;P=0.038)和缓解吸入器(8.3% vs 5.8%)(调整后RR为2.01,95% CI为1.21至2.79;P=0.018)处方的风险也有所增加:结论:儿童卧室潮湿与呼吸系统发病率增加有关。对于反复出现呼吸道症状的儿童,临床医生应询问是否存在潮湿以及潮湿的位置。
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引用次数: 0
Children and young people's preferences and needs when using health technology to self-manage a long-term condition: a scoping review. 儿童和青少年在使用医疗技术自我管理长期疾病时的偏好和需求:范围界定综述。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2023-326044
Rosemary Jane Court, Veronica Swallow, Sarab El-Yousfi, Kara Gray-Burrows, Fiona Sotir, Gemma Wheeler, Ian Kellar, Jia Mang Lee, Robyn Mitchell, Wiktoria Mlynarczyk, Arnav Ramavath, Paul Dimitri, Bob Phillips, Lucy Prodgers, Madeleine Pownall, Marcin Kowalczyk, Jacob Branchflower, Lauren Powell, Sadiq Bhanbhro, Anna Weighall, Jacqueline Martin-Kerry

Background: The use of patient-facing health technologies to manage long-term conditions (LTCs) is increasing; however, children and young people (CYP) may have preferences about health technologies which they interact or engage with, that influence their decision to use these technologies.

Aims: To identify CYP's reported preferences about health technologies to self-manage LTCs.

Methods: We undertook a scoping review, searching MEDLINE, PsycINFO and CINAHL in July 2021. Searches were limited to papers published between January 2015 and July 2021. We included any health technologies used to manage physical and mental LTCs. Qualitative content analysis of study data was undertaken to categorise data into themes and quantitative data were described and visually represented. We engaged CYP with LTCs to support the review design, interpretation of findings and development of recommendations.

Results: 161 journal articles were included, describing preferences of CYP. Most included studies were undertaken in high-income countries. CYP's main preferences and needs were: design and functionality; privacy and sharing; customisation and personalisation of the technology; and interaction options within the technology.

Conclusions: This review highlights important preferences and needs that CYP may have before using technologies to self-manage their LTC. These should be considered when developing technology for this population. Future research should involve CYP throughout the development of the technologies, from identifying their unmet needs through to final design, development, evaluation and implementation of the intervention.

背景:使用面向患者的健康技术来管理长期病症(LTCs)的情况越来越多;然而,儿童和青少年(CYP)可能对他们互动或参与的健康技术有偏好,从而影响他们使用这些技术的决定:我们在 2021 年 7 月对 MEDLINE、PsycINFO 和 CINAHL 进行了范围界定审查。检索仅限于 2015 年 1 月至 2021 年 7 月间发表的论文。我们纳入了任何用于管理身体和精神长期慢性病的医疗技术。我们对研究数据进行了定性内容分析,将数据归类为主题,并对定量数据进行了描述和直观表示。我们让患有 LTC 的儿童参与其中,以支持综述的设计、研究结果的解释和建议的制定:结果:共收录了 161 篇期刊文章,这些文章描述了 CYP 的偏好。大多数纳入的研究都是在高收入国家进行的。CYP 的主要偏好和需求包括:设计和功能;隐私和共享;技术的定制和个性化;以及技术中的交互选项:本综述强调了青少年在使用技术自我管理其长期护理之前可能会有的重要偏好和需求。在为这一群体开发技术时,应考虑到这些因素。未来的研究应让儿童青少年参与整个技术开发过程,从确定他们未满足的需求到最终设计、开发、评估和实施干预措施。
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引用次数: 0
Role of urine Gram stain in young febrile infants with a suspected urinary tract infection: a cohort study. 尿液革兰氏染色在疑似尿路感染的发热幼儿中的作用:一项队列研究。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2024-327182
Borja Gomez, Ana Mier, Alberto Ugedo, Amaia Aguirre-Quiñonero, Javier Benito, Santiago Mintegi

Objective: To analyse the performance of the urine Gram stain for predicting a positive urine culture (UC) in young infants with fever without source (FWS) and pyuria.

Design: Observational study; secondary analysis of a prospective registry-based cohort study.

Setting: Paediatric emergency department; tertiary teaching hospital.

Patients: Infants ≤90 days old with FWS, pyuria and urine Gram stain requested seen between 2010 and 2022.

Main outcome measure: Performance of the Gram stain, defined as positive if any bacteria were seen, for predicting urinary tract infection (UTI: UC by urethral catheterisation growing >10 000 CFU/mL of a single bacterial pathogen).

Results: Among 367 febrile infants with pyuria, 281 (76.6%) had a positive Gram stain and 306 (83.3%) had a positive UC (277; 90.5% Escherichia coli).Rates of positive UC in patients with positive and negative Gram stains were 97.2% and 38.4%, respectively (p<0.01), showing a sensitivity of 89.2% (95% CI: 85.2% to 92.2%) and a specificity of 86.9% (95% CI: 76.2% to 93.2%). Sensitivity was lower for diagnosing UTIs caused by bacteria other than E. coli (69.0% vs 91.3% for UTIs caused by E. coli; p<0.01).Two (2.1%) of the 86 infants with negative Gram stains were diagnosed with bacteraemia unrelated to a UTI (Streptococcus pneumoniae and Staphylococcus aureus).

Conclusions: Around a third of infants with pyuria and a negative Gram stain will eventually be diagnosed with a UTI. These patients have a higher rate of UTIs caused by bacteria other than E. coli. Bacterial infections other than UTIs should also be considered in such cases.

目的分析尿液革兰氏染色法在预测无发热源(FWS)和脓尿的幼儿尿培养(UC)阳性方面的性能:观察性研究;基于前瞻性登记的队列研究的二次分析:儿童急诊科;三级教学医院:主要结果指标:主要结果指标:革兰氏染色预测尿路感染(UTI:通过尿道导管检查发现尿路感染中单个细菌病原体的CFU含量大于10 000 CFU/mL)的效果(若发现任何细菌则定义为阳性):在367名发热的脓尿婴儿中,281人(76.6%)革兰氏染色阳性,306人(83.3%)UC阳性(277人;90.5%为大肠埃希菌)。革兰氏染色阳性和阴性患者的UC阳性率分别为97.2%和38.4%(大肠埃希菌(69.0% vs 91.3%为大肠埃希菌引起的UTI;肺炎链球菌和金黄色葡萄球菌):结论:约有三分之一的脓尿和革兰氏染色阴性的婴儿最终会被诊断为尿毒症。这些患者患由大肠杆菌以外的细菌引起的尿毒症的比例较高。在这种情况下,还应考虑UTI 以外的细菌感染。
{"title":"Role of urine Gram stain in young febrile infants with a suspected urinary tract infection: a cohort study.","authors":"Borja Gomez, Ana Mier, Alberto Ugedo, Amaia Aguirre-Quiñonero, Javier Benito, Santiago Mintegi","doi":"10.1136/archdischild-2024-327182","DOIUrl":"10.1136/archdischild-2024-327182","url":null,"abstract":"<p><strong>Objective: </strong>To analyse the performance of the urine Gram stain for predicting a positive urine culture (UC) in young infants with fever without source (FWS) and pyuria.</p><p><strong>Design: </strong>Observational study; secondary analysis of a prospective registry-based cohort study.</p><p><strong>Setting: </strong>Paediatric emergency department; tertiary teaching hospital.</p><p><strong>Patients: </strong>Infants ≤90 days old with FWS, pyuria and urine Gram stain requested seen between 2010 and 2022.</p><p><strong>Main outcome measure: </strong>Performance of the Gram stain, defined as positive if any bacteria were seen, for predicting urinary tract infection (UTI: UC by urethral catheterisation growing >10 000 CFU/mL of a single bacterial pathogen).</p><p><strong>Results: </strong>Among 367 febrile infants with pyuria, 281 (76.6%) had a positive Gram stain and 306 (83.3%) had a positive UC (277; 90.5% <i>Escherichia coli</i>).Rates of positive UC in patients with positive and negative Gram stains were 97.2% and 38.4%, respectively (p<0.01), showing a sensitivity of 89.2% (95% CI: 85.2% to 92.2%) and a specificity of 86.9% (95% CI: 76.2% to 93.2%). Sensitivity was lower for diagnosing UTIs caused by bacteria other than <i>E. coli</i> (69.0% vs 91.3% for UTIs caused by <i>E. coli</i>; p<0.01).Two (2.1%) of the 86 infants with negative Gram stains were diagnosed with bacteraemia unrelated to a UTI (<i>Streptococcus pneumoniae</i> and <i>Staphylococcus aureus</i>).</p><p><strong>Conclusions: </strong>Around a third of infants with pyuria and a negative Gram stain will eventually be diagnosed with a UTI. These patients have a higher rate of UTIs caused by bacteria other than <i>E. coli</i>. Bacterial infections other than UTIs should also be considered in such cases.</p>","PeriodicalId":8150,"journal":{"name":"Archives of Disease in Childhood","volume":" ","pages":"801-805"},"PeriodicalIF":4.3,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141436561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Semaglutide treatment for children with obesity: an observational study. 塞马鲁肽治疗儿童肥胖症:一项观察性研究。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2023-326687
Elizabeth-Jane van Boxel, Saqib Rahman, Karen Lai, Nabil Boulos, Nikki Davis

Objective: To assess efficacy and tolerability of semaglutide as a weight loss treatment for children living with comorbid obesity.

Design: Retrospective observational study of the first 50 children from a weight management service treated with semaglutide for at least 6 months.

Setting: A tertiary paediatric multidisciplinary weight management clinic in a UK hospital.

Patients: Aged 10-18 years old with a body mass index (BMI) SD score (SDS) >2 with a weight-related comorbidity (including insulin resistance (defined as homeostatic model assessment for insulin resistance >4), type 2 diabetes, metabolic-associated fatty liver disease, obstructive sleep apnoea or hypertension).

Interventions: Once-weekly injectable semaglutide titrated over 8 weeks to a final dose of 1 mg in addition to dietary and lifestyle advice.

Main outcome measures: Primary outcome measures were change in weight, BMI SDS and percentage body weight. Secondary outcomes were side effects and cessation of treatment.

Results: After 6 months of treatment, statistically significant decreases in BMI SDS (0.32±0.27, p<0.001) and body weight (7.03±7.50 kg, p<0.001) were seen. Mean percentage total weight loss was 6.4±6.3% (p<0.001). For the 14 patients for whom 12-month data were available, statistically significant decreases were seen in mean BMI SDS (0.54±0.52, p<0.001). Mean body weight decreased by 9.7±10.8 kg (p<0.001). Percentage total weight loss at 12 months was 8.9±10.0% (p<0.001). Mild gastrointestinal side effects were common. One patient developed gallstones. Five patients discontinued treatment due to side effects.

Conclusion: Semaglutide appears to be a safe and effective weight loss adjunct when used in a multidisciplinary weight management clinic.

目的目的:评估塞马鲁肽作为一种减肥疗法对合并肥胖症儿童的疗效和耐受性:对体重管理服务机构的前50名儿童进行回顾性观察研究,这些儿童接受了至少6个月的semaglutide治疗:地点:英国一家医院的三级儿科多学科体重管理诊所:患者:10-18岁,体重指数(BMI)SD评分(SDS)大于2,患有与体重相关的合并症(包括胰岛素抵抗(定义为胰岛素抵抗的稳态模型评估大于4)、2型糖尿病、代谢相关性脂肪肝、阻塞性睡眠呼吸暂停或高血压):干预措施:每周一次注射塞马鲁肽,8周内滴定至最终剂量1毫克,同时提供饮食和生活方式建议:主要结果指标:体重变化、BMI SDS 和体重百分比。次要结果为副作用和停止治疗:治疗 6 个月后,BMI SDS 有统计学意义的显著下降(0.32±0.27,p):在多学科体重管理诊所中使用塞马鲁肽似乎是一种安全有效的减肥辅助疗法。
{"title":"Semaglutide treatment for children with obesity: an observational study.","authors":"Elizabeth-Jane van Boxel, Saqib Rahman, Karen Lai, Nabil Boulos, Nikki Davis","doi":"10.1136/archdischild-2023-326687","DOIUrl":"10.1136/archdischild-2023-326687","url":null,"abstract":"<p><strong>Objective: </strong>To assess efficacy and tolerability of semaglutide as a weight loss treatment for children living with comorbid obesity.</p><p><strong>Design: </strong>Retrospective observational study of the first 50 children from a weight management service treated with semaglutide for at least 6 months.</p><p><strong>Setting: </strong>A tertiary paediatric multidisciplinary weight management clinic in a UK hospital.</p><p><strong>Patients: </strong>Aged 10-18 years old with a body mass index (BMI) SD score (SDS) >2 with a weight-related comorbidity (including insulin resistance (defined as homeostatic model assessment for insulin resistance >4), type 2 diabetes, metabolic-associated fatty liver disease, obstructive sleep apnoea or hypertension).</p><p><strong>Interventions: </strong>Once-weekly injectable semaglutide titrated over 8 weeks to a final dose of 1 mg in addition to dietary and lifestyle advice.</p><p><strong>Main outcome measures: </strong>Primary outcome measures were change in weight, BMI SDS and percentage body weight. Secondary outcomes were side effects and cessation of treatment.</p><p><strong>Results: </strong>After 6 months of treatment, statistically significant decreases in BMI SDS (0.32±0.27, p<0.001) and body weight (7.03±7.50 kg, p<0.001) were seen. Mean percentage total weight loss was 6.4±6.3% (p<0.001). For the 14 patients for whom 12-month data were available, statistically significant decreases were seen in mean BMI SDS (0.54±0.52, p<0.001). Mean body weight decreased by 9.7±10.8 kg (p<0.001). Percentage total weight loss at 12 months was 8.9±10.0% (p<0.001). Mild gastrointestinal side effects were common. One patient developed gallstones. Five patients discontinued treatment due to side effects.</p><p><strong>Conclusion: </strong>Semaglutide appears to be a safe and effective weight loss adjunct when used in a multidisciplinary weight management clinic.</p>","PeriodicalId":8150,"journal":{"name":"Archives of Disease in Childhood","volume":" ","pages":"822-825"},"PeriodicalIF":4.3,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140109026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is montelukast helpful in managing obstructive sleep apnoea in children with Down syndrome? 孟鲁司特有助于控制唐氏综合征儿童的阻塞性睡眠呼吸暂停吗?
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2023-326706
Doireann Pereira, Irwin Gill
{"title":"Is montelukast helpful in managing obstructive sleep apnoea in children with Down syndrome?","authors":"Doireann Pereira, Irwin Gill","doi":"10.1136/archdischild-2023-326706","DOIUrl":"10.1136/archdischild-2023-326706","url":null,"abstract":"","PeriodicalId":8150,"journal":{"name":"Archives of Disease in Childhood","volume":" ","pages":"861-863"},"PeriodicalIF":4.3,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140317692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetic and pharmacodynamic data from the NEOLEV1 and NEOLEV2 studies. 来自 NEOLEV1 和 NEOLEV2 研究的药代动力学和药效学数据。
IF 4.3 3区 医学 Q1 PEDIATRICS Pub Date : 2024-09-25 DOI: 10.1136/archdischild-2022-324952
Cynthia Sharpe, Derek Z Yang, Richard H Haas, Gail E Reiner, Lilly Lee, Edmund V Capparelli

Objectives: To confirm that levetiracetam (LEV) demonstrates predictable pharmacokinetics(PK) at higher doses and to study the pharmacodynamics(PD) of LEV.

Design: Pharmacokinetic data from the NEOLEV1 and NEOLEV2 trials were analysed using a non-linear mixed effects modelling approach. A post hoc analysis of the effect of LEV on seizure burden was conducted.

Setting: Neonatal intensive care unit.

Patients: Term neonates with electrographically confirmed seizures.

Interventions: In NEOLEV1, neonates with seizures persisting following phenobarbital (PHB) received LEV 20 or 40 mg/kg bolus followed by 5 or 10 mg/kg maintenance dose(MD) daily. In NEOLEV2, patients received a 40 mg/kg intravenous LEV load, followed by 10 mg/kg doses 8 hourly. If seizures persisted, a further 20 mg/kg intravenous load was given. If seizures persisted, PHB was given. PK data were collected from 16 NEOLEV1 patients and 33 NEOLEV2 patients. cEEG data from 48 NEOLEV2 patients were analysed to investigate onset of action and seizure burden reduction.

Main outcome measures: Clearance (CL) and volume of distribution (Vd) were determined. Covariates that significantly affected LEV disposition were identified.

Results: Primary outcome: The median initial LEV level was 57 µg/mL (range 19-107) after the first loading dose and at least 12 µg/mL at 48 hours in all infants. CL and Vd were estimated to be 0.0538 L/hour and 0.832 L, respectively. A direct relationship between postnatal age and CL was observed. The final population pharmacokinetic(PopPK) model described the observed data well without significant biases. CL and Vd were described as CL (L/hour)=0.0538×(weight in kg/3.34)0.75×(postnatal age in days/5.5) 0.402 and Vd (L)=0.832×(weight in kg/3.34).Seizure burden reduced within 30 min of LEV administration. 28% of patients were completely seizure free after LEV. In an additional 25% of patients, seizure burden reduced by 50%.

Conclusions: LEV pharmacokinetics remained predictable at higher doses. Very high-dose LEV can now be studied in neonates.

Trial registration number: NCT01720667.

目的:确认左乙拉西坦(LEV)在较大剂量时表现出可预测的药代动力学(PK),并研究其药效学(PD):证实左乙拉西坦(LEV)在较大剂量时具有可预测的药代动力学(PK),并研究左乙拉西坦的药效学(PD):设计:采用非线性混合效应建模方法分析了来自NEOLEV1和NEOLEV2试验的药代动力学数据。环境:新生儿重症监护室:新生儿重症监护室:干预措施:在NEOLEV1中,苯巴比妥(PHB)治疗后癫痫持续发作的新生儿每天接受20或40毫克/千克的LEV注射,然后服用5或10毫克/千克的维持剂量(MD)。在 NEOLEV2 中,患者接受 40 毫克/千克的 LEV 静脉注射,之后每 8 小时一次,每次 10 毫克/千克。如果癫痫持续发作,则再静脉注射 20 毫克/千克的剂量。如果癫痫持续发作,则给予 PHB。收集了 16 名 NEOLEV1 患者和 33 名 NEOLEV2 患者的 PK 数据。分析了 48 名 NEOLEV2 患者的 cEEG 数据,以研究起效时间和癫痫发作负担的减轻情况:测定清除率(CL)和分布容积(Vd)。主要结果测量:测定清除率(CL)和分布容积(Vd),确定对LEV处置有显著影响的协变量:主要结果所有婴儿在首次负荷剂量后的LEV初始水平中位数为57微克/毫升(范围19-107),48小时后至少为12微克/毫升。估计CL和Vd分别为0.0538升/小时和0.832升/小时。出生后的年龄与CL之间存在直接关系。最终的群体药代动力学(PopPK)模型很好地描述了观察到的数据,没有明显偏差。CL和Vd的描述为:CL(升/小时)=0.0538×(体重(千克/3.34))0.75×(出生后年龄(天/5.5))0.402,Vd(升)=0.832×(体重(千克/3.34))。28%的患者在服用 LEV 后完全摆脱了癫痫发作。另有25%的患者癫痫发作减少了50%:结论:LEV的药代动力学在较大剂量时仍可预测。现在可以在新生儿中研究超大剂量 LEV:NCT01720667.
{"title":"Pharmacokinetic and pharmacodynamic data from the NEOLEV1 and NEOLEV2 studies.","authors":"Cynthia Sharpe, Derek Z Yang, Richard H Haas, Gail E Reiner, Lilly Lee, Edmund V Capparelli","doi":"10.1136/archdischild-2022-324952","DOIUrl":"10.1136/archdischild-2022-324952","url":null,"abstract":"<p><strong>Objectives: </strong>To confirm that levetiracetam (LEV) demonstrates predictable pharmacokinetics(PK) at higher doses and to study the pharmacodynamics(PD) of LEV.</p><p><strong>Design: </strong>Pharmacokinetic data from the NEOLEV1 and NEOLEV2 trials were analysed using a non-linear mixed effects modelling approach. A post hoc analysis of the effect of LEV on seizure burden was conducted.</p><p><strong>Setting: </strong>Neonatal intensive care unit.</p><p><strong>Patients: </strong>Term neonates with electrographically confirmed seizures.</p><p><strong>Interventions: </strong>In NEOLEV1, neonates with seizures persisting following phenobarbital (PHB) received LEV 20 or 40 mg/kg bolus followed by 5 or 10 mg/kg maintenance dose(MD) daily. In NEOLEV2, patients received a 40 mg/kg intravenous LEV load, followed by 10 mg/kg doses 8 hourly. If seizures persisted, a further 20 mg/kg intravenous load was given. If seizures persisted, PHB was given. PK data were collected from 16 NEOLEV1 patients and 33 NEOLEV2 patients. cEEG data from 48 NEOLEV2 patients were analysed to investigate onset of action and seizure burden reduction.</p><p><strong>Main outcome measures: </strong>Clearance (CL) and volume of distribution (V<sub>d</sub>) were determined. Covariates that significantly affected LEV disposition were identified.</p><p><strong>Results: </strong>Primary outcome: The median initial LEV level was 57 µg/mL (range 19-107) after the first loading dose and at least 12 µg/mL at 48 hours in all infants. CL and V<sub>d</sub> were estimated to be 0.0538 L/hour and 0.832 L, respectively. A direct relationship between postnatal age and CL was observed. The final population pharmacokinetic(PopPK) model described the observed data well without significant biases. CL and V<sub>d</sub> were described as CL (L/hour)=0.0538×(weight in kg/3.34)0.75×(postnatal age in days/5.5) 0.402 and V<sub>d</sub> (L)=0.832×(weight in kg/3.34).Seizure burden reduced within 30 min of LEV administration. 28% of patients were completely seizure free after LEV. In an additional 25% of patients, seizure burden reduced by 50%.</p><p><strong>Conclusions: </strong>LEV pharmacokinetics remained predictable at higher doses. Very high-dose LEV can now be studied in neonates.</p><p><strong>Trial registration number: </strong>NCT01720667.</p>","PeriodicalId":8150,"journal":{"name":"Archives of Disease in Childhood","volume":" ","pages":"854-860"},"PeriodicalIF":4.3,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141431247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Archives of Disease in Childhood
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