Henoch Schonlein Purpura and Corticosteroid Treatment

过敏性紫癜和皮质类固醇治疗

• 批准号: 7275644
• 负责人: Pamela Fitch Weiss
• 金额: $ 6.82万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7275644
• 关键词: Abdominal Pain; Accounting; Acute; Admission activity; Adrenal Cortex Hormones; Affect; Applications Grants; Arthritis; Bacterial Infections; Benign; Child; Childhood; Clinical; Clinical Management; Clinical Trials; Data; Development; Disease; Early treatment; End stage renal failure; Exanthema; Future; Glomerulonephritis; Hematuria; Hemorrhage; Henoch Purpura; Henoch-Schoenlein Purpura; Hospitalization; Hospitals; Hypertension; Incidence; Inflammation; Injury; Intractable Pain; Intravenous; Intussusception; Kidney; Kidney Diseases; Kidney Failure; Length; Length of Stay; Morbidity - disease rate; Nephritis; Nephrotic Syndrome; Numbers; Operative Surgical Procedures; Oral; Outcome; Patients; Pediatric Hospitals; Phase; Physicians; Pre-Eclampsia; Pregnancy; Prevention therapy; Prospective Studies; Proteinuria; Psychotic Disorders; Randomized Controlled Trials; Rapidly Progressive Glomerulonephritis; Rate; Recording of previous events; Recurrence; Reporting; Resolution; Retrospective Studies; Safety; Sample Size; Score; Secondary to; Severity of illness; Steroid therapy; Steroids; Supportive care; Therapeutic Human Experimentation; United States; Variant; Vasculitis; Woman; base; day; design; gastrointestinal; hospital readmission; improved; indexing; preference; prevent; prospective; time use

DESCRIPTION: Should children presenting to the hospital with new-onset Henoch Schonlein purpura (HSP) be treated with systemic corticosteroids in order to prevent the common subsequent complications, including renal injury? A rigorous answer to this question would have substantial clinical implications. We hypothesize, as have others, that corticosteroids ameliorate inflammation, hasten the resolution of acute manifestations of HSP, and protect the kidneys from long-term injury. The proposed study will use data collected from more than 30 children's hospitals in the United States over a 4 year period. It will be the first to use propensity score matched analysis to examine the difference between patients treated either with or without steroids in rates of hospital readmission, and development of co-morbidities necessitating readmission including nephritis, hypertension, recurrent abdominal pain, and intussusception. Data from this study will clarify the effect of corticosteroids on patients hospitalized with HSP, and will inform the design of future clinical investigations. We specifically aim to: 1) Describe the prevailing clinical management of children with HSP, specifically assessing the use and timing of corticosteroid treatment for patients with different manifestations of HSP and examining the variation in the use of corticosteroids among hospitals. 2) Compare outcomes of children with HSP who receive supportive care versus corticosteroids, with adjustment (through propensity score matching) for the likelihood of having received corticosteroids. 3) Determine the short-term safety of corticosteroid treatment for children with HSP by determining the rate of corticosteroid-associated complications during the initial admission and any subsequent readmissions. Relevance: HSP is the most common vasculitis of childhood affecting approximately 8-10/100,000 children annually and accounting for 49% of all childhood vasculitides in the United States. Approximately 40% of these children require hospitalization secondary to glomerulonephritis, hypertension, intractable pain or gastointestinal bleeding. Beyond the acute phase the major morbidity is prolonged urenal disease. How best to treat the acute manifestations and prevent the long-term complications of HSP remains controversial. Improvement in therapy and prevention requires better designed retrospective studies, such as the study proposed herein, and larger prospective randomized controlled trials. Such studies may provide evidence in support of early corticosteroid treatment for HSP, or may more firmly reveal this to be an ineffective means to improve these patients' outcomes, and thus spur therapeutic research in a different direction, focusing perhaps on other immunomodulatory or renal-protective treatments.

描述：是否应该用全身性皮质类固醇来治疗新发henoch schonlein purpura（HSP）的儿童，以防止常见的随后并发症，包括肾脏损伤？对这个问题的严格答案将具有重大的临床意义。我们和其他人一样假设皮质类固醇可以改善炎症，加快HSP急性表现的分辨率，并保护肾脏免受长期损伤。拟议的研究将在4年内使用美国30多家儿童医院收集的数据。这将是第一个使用倾向得分匹配分析的人来检查接受或没有类固醇的患者在住院率上接受或没有类固醇的患者之间的差异，以及需要再入院的合并症的发展，包括肾炎，高血压，高血压，复发性腹部疼痛和Intussusception。这项研究的数据将阐明皮质类固醇对HSP住院的患者的影响，并将为未来的临床研究设计。我们专门针对以下目的：1）描述HSP儿童的主要临床管理，专门评估了皮质类固醇治疗的使用和时机对HSP不同表现的患者的使用和时机检查，并检查了医院中皮质类固醇的使用变化。 2）比较接受支持性护理与皮质类固醇的HSP儿童的结果，并根据接受皮质类固醇的可能性进行调整（通过倾向得分匹配）。 3）通过确定与皮质类固醇相关的并发症的率和任何随后的再入院，确定皮质类固醇对HSP儿童的短期安全性。相关性：HSP是最常见的儿童血管炎，每年影响约8-10/100,000名儿童，占美国所有儿童血管菌的49％。这些儿童中约有40％需要继发于肾小球肾炎，高血压，顽固性疼痛或过胸骨结肠出血的住院。除了急性阶段，主要发病率是长时间的肾上腺病。如何最好地治疗急性表现并防止HSP的长期并发症仍然存在争议。治疗和预防的改进需要更好地设计的回顾性研究，例如本文提出的研究以及更大的前瞻性随机对照试验。这样的研究可能提供证据，以支持早期皮质类固醇治疗HSP，或者更牢固地揭示这是改善这些患者结果的一种无效手段，因此可以朝着不同方向刺激治疗性研究，也许将重点放在其他免疫调节或肾脏保护性治疗上。