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Analgesic technique on pain and biomarkers during sickle pain crisis

镰状痛危象期间疼痛和生物标志物的镇痛技术

基本信息

批准号：
8015271
负责人：
GAILEN D. MARSHALL
金额：
$ 18.65万
依托单位：
UNIVERSITY OF MISSISSIPPI MED CTR
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-12-01 至 2012-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8015271
关键词：
Absence of pain sensation Accident and Emergency department Acute Acute Pain Address Admission activity Adult Affect Agmatine Ambulatory Care Facilities Analgesics Back Biological Markers Blood Child Child Care Clinic Clinic Visits Clinical Complex Complication Consumption Data Development Disease Emergency Situation Employment Enrollment Evaluation Exploratory/Developmental Grant Functional disorder Future Heat-Shock Proteins 70 Hematology Hospitals Inflammatory Interleukin-12 Intervention Ischemia Laboratories Link Maintenance Measures Medical Methods NIH Program Announcements Nitric Oxide Synthase Nitrites Opiates Oral Outcome Outpatients Pain Parents Patient Discharge Patients Plasma Process Refractory Regimen Research Role Schedule Serum Severities Sickle Cell Sickle Cell Anemia Substance P Syndrome TNF gene Techniques Testing Time Tissues Translational Research Treatment outcome Visit base experience follow-up hospital admission rate improved inflammatory pain novel programs public health relevance sickle cell crisis sickling tool treatment effect vascular inflammation

项目摘要

DESCRIPTION (provided by applicant): Although extensive research has been conducted with children who have sickle cell disease, there is a paucity of studies on adults with the disease. Many adult patients with sickle cell disease (SCD) experience daily pain. Although the pathophysiology of sickle cell related pain is complex, microcirculatory occlusion with tissue ischemia and activation of inflammatory cascades are believed to be involved. Acute vasoocclusive crises are responsible for most sickle cell related medical visits. Despite strong evidence for a role of tissue and vascular inflammation in the initiation and maintenance of acute vasoocclusive crises, no specific serum biomarkers have been identified which correlate with the intensity or duration of the acute crisis. An effective mode of analgesic treatment that can be assessed by serum biomarker and improved has not been methodically investigated in SCD pain crisis. Therefore, the objective of this R21 proposal is to test the hypothesis that quality and method of analgesia affect the level of specific blood biomarkers and can be correlated with pain levels. Thus, this study would provide a unique opportunity to understand the treatment effects of sickle cell crisis on pain and provide a basis for future interventions and clinical use of specific serum biomarkers. The first aim is to test the hypothesis that the mode of analgesia technique affects the outcome of pain crisis as determined by pain scores, analgesic consumption and hospital admission rates in SCD pain crisis. The SCD subjects will be enrolled during a regular hospital visit (total target of 75 subjects) and followed up during the emergency visit for the acute pain crisis. The standard analgesic technique of parenteral and oral opiate treatment will used. The aim is to assess the effect of analgesic treatment on acute and subacute pain levels during and after an acute sickle pain crisis and to identify serum inflammatory/pain molecules as biomarkers for pain severity in SCD pain crisis and to test the hypothesis that serum biomarkers can be used to predict need for admission, increased need for analgesics, and possibly disease complication rates in SCD. Furthermore, to determine if the analgesic treatment influence serum biomarkers and can be used as a predictor of analgesic efficacy. The baseline levels of plasma IL-12, TNF-1, Substance P (SP), heat shock protein 70 (HSP70), nitrite levels (measure of nitric oxide synthase activity) and agmatine will be determined in all enrolled subjects during the regular hospital visit. The levels of these plasma markers will be measured during the emergency visit for acute pain crisis and before discharge. The final analysis of the biomarkers will be made during the scheduled visit at 2 to 4 weeks after the acute pain crisis. At the conclusion, this study will produce two basic sets of preliminary data both of which will allow a more in-depth evaluation of the mechanisms of SCD pain syndrome and other treatment options. PUBLIC HEALTH RELEVANCE: One of the objectives of this R21 program announcement is to develop translational research program where laboratory-based scientific discoveries are applied into practical/clinical settings in pain conditions. Accordingly, the objective of this Proposal is to evaluate the standard analgesic treatment option during sickle cell disease (SCD) pain crisis and to identify serum biomarkers that will predict the occurrences and for treatment outcome during pain crisis. Thus, this Proposal is well under the scope of the PA-06-542 as an exploratory proposal in attempting to understand the efficacy of analgesic treatment and whether novel serum biomarkers can be identified as useful tools for future studies in SCD pain crisis.

描述（由申请人提供）：尽管对患有镰状细胞病的儿童进行了广泛的研究，但对患有该病的成人的研究却很少。许多患有镰状细胞病 (SCD) 的成年患者每天都会经历疼痛。尽管镰状细胞相关疼痛的病理生理学很复杂，但据信与组织缺血和炎症级联激活的微循环闭塞有关。急性血管闭塞危象是大多数镰状细胞病相关就诊的原因。尽管有强有力的证据表明组织和血管炎症在急性血管闭塞危象的发生和维持中发挥作用，但尚未发现与急性危象的强度或持续时间相关的特定血清生物标志物。尚未对 SCD 疼痛危象进行系统研究，以通过血清生物标志物评估并改进有效的镇痛治疗模式。因此，该 R21 提案的目的是检验镇痛质量和方法影响特定血液生物标志物水平并与疼痛水平相关的假设。因此，这项研究将为了解镰状细胞危象对疼痛的治疗效果提供一个独特的机会，并为未来的干预措施和特定血清生物标志物的临床使用提供基础。第一个目的是检验以下假设：镇痛技术模式影响疼痛危象的结果，该结果由 SCD 疼痛危象的疼痛评分、镇痛药用量和入院率决定。 SCD 受试者将在定期医院就诊期间入组（总目标为 75 名受试者），并在针对急性疼痛危机的紧急就诊期间进行随访。将使用胃肠外和口服阿片治疗的标准镇痛技术。目的是评估镇痛治疗对急性镰状痛危象期间和之后的急性和亚急性疼痛水平的影响，并确定血清炎症/疼痛分子作为 SCD 疼痛危象中疼痛严重程度的生物标志物，并检验血清生物标志物可用于预测 SCD 中入院需求、镇痛药需求增加以及可能的疾病并发症发生率的假设。此外，确定镇痛治疗是否影响血清生物标志物并可用作镇痛功效的预测因子。所有入组受试者的血浆 IL-12、TNF-1、P 物质 (SP)、热休克蛋白 70 (HSP70)、亚硝酸盐水平（一氧化氮合酶活性的测量）和胍丁胺的基线水平将在定期医院访视期间测定。这些血浆标志物的水平将在急性疼痛危机紧急就诊期间和出院前进行测量。生物标志物的最终分析将在急性疼痛危机后 2 至 4 周的预定访视期间进行。最后，这项研究将产生两组基本的初步数据，这两种数据都将有助于更深入地评估 SCD 疼痛综合征的机制和其他治疗方案。公共健康相关性：R21 计划公告的目标之一是开发转化研究计划，将基于实验室的科学发现应用于疼痛状况的实际/临床环境中。因此，本提案的目的是评估镰状细胞病（SCD）疼痛危机期间的标准镇痛治疗方案，并确定可预测疼痛危机期间发生情况和治疗结果的血清生物标志物。因此，该提案完全属于 PA-06-542 的范围，作为一项探索性提案，试图了解镇痛治疗的功效以及是否可以将新型血清生物标志物确定为未来 SCD 疼痛危机研究的有用工具。