Can hydroxychloroquine prevent preeclampsia and preterm delivery in lupus pregnancy?

羟氯喹可以预防狼疮妊娠中的先兆子痫和早产吗？

• 批准号: 10417134
• 负责人: Julia F Simard
• 金额: $ 53.5万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10417134
• 关键词: Accounting; Address; Adherence; Affect; Ambulatory Care; Antiphospholipid Antibodies; Award; Behavioral Sciences; Benefits and Risks; Blindness; California; Cerebral Palsy; Child; Clinical; Clinical Data; Clinical Trials; Complication; Data; Databases; Diagnosis; Discipline of obstetrics; Disease; Disease Management; Documentation; Epidemiologist; Epidemiology; Female of child bearing age; Focus Groups; Foundations; Funding; Future; General Population; Gestational Diabetes; Glucocorticoids; Goals; Guideline Adherence; Heterogeneity; Hydroxychloroquine; Hypertension; Infant; Infection; Inflammatory; International; Interruption; Intervention; Israel; Link; Lupus; Maternal Mortality; Mediating; Mediation; Mediator of activation protein; Medical; Mentored Research Scientist Development Award; Methodology; Methods; Modification; Outcome; Oxidative Stress; Pathogenesis; Patients; Pharmaceutical Preparations; Pharmacoepidemiology; Phenotype; Placentation; Population; Population Study; Pre-Eclampsia; Pregnancy; Pregnant Women; Premature Birth; Premature Infant; Primary Health Care; Production; Proteinuria; Provider; Recommendation; Research; Research Personnel; Residual state; Rheumatology; Risk; Selection Bias; Serology; Stroke; Sweden; Systemic Lupus Erythematosus; Toll-like receptors; United States; Universities; Woman; Work; adverse outcome; adverse pregnancy outcome; chronic autoimmune disease; clinical care; cohort; comparative effectiveness study; compliance behavior; cytokine; design; early onset; effective therapy; experience; health care availability; health care service organization; high risk population; improved; innovation; inpatient service; lens; medical schools; multidisciplinary; novel; parity; phenotyping algorithm; population based; pregnant; premature; prevent; programs; provider adherence; recruit; reproductive; working group

This is a new application for an R01 award for epidemiologist Dr. Julia Simard, at Stanford University School of Medicine, who brings an innovative lens to the field as an early stage investigator building a research program focused on adverse pregnancy outcomes in patients with systemic lupus erythematosus. For her K01 award, Dr. Simard and colleagues showed that pregnant women with lupus are a highly-medicated group, who experience more adverse outcomes, including early-onset preeclampsia, preterm delivery, infection, and stroke. In recent pilot work, Dr. Simard found that hydroxychloroquine (HCQ), which is used to manage lupus during pregnancy, may prevent preeclampsia and preterm delivery. In two populations (one US and one in Sweden), Dr. Simard also found that fewer than half of pregnant women with lupus use HCQ, despite recommendations. This has been corroborated by others as well. Dr. Simard builds upon this work in the present application via three large international populations to determine whether HCQ reduces the risk of these adverse outcomes in lupus pregnancies. Dr. Simard will partner with colleagues in Sweden, Israel, and Kaiser Permanente of Northern California’s Division of Research in the United States. These data include details on ordered and filled prescriptions, and often unavailable data on antiphospholipid antibody status and parity, two critical factors in lupus reproductive research. In aim 1, Dr. Simard will determine whether preeclampsia risk is reduced in women who use HCQ during pregnancy. In aim 2, Dr. Simard will examine preterm delivery, partitioning spontaneous from medically-indicated, to examine overall risks and medication by preeclampsia and other factors such as glucocorticoid use and gestational diabetes. In aim 3, Dr. Simard’s team will identify barriers and facilitators of HCQ use in pregnant women with lupus using an innovative mixed methods design. After evaluating patient adherence and guideline adherence by clinicians in the large US and Israeli databases, they will identify subsets less likely to adhere and examine how they differ from adherent patients. Then partnering with patients and providers, they will use these quantitative findings to identify barriers and facilitators of adherence from the patient and provider perspectives using focus groups. This aim will provide key information on HCQ use and prescription practices to improve the analytic paradigm and inform our clinical understanding HCQ use in lupus pregnancy, and provide foundational support for clinical care and possibly, a future clinical trial.

这是斯坦福大学流行病学家Julia Simard博士的R01奖的新申请 他将一种创新的透镜作为早期阶段引入该领域 研究者建立了一个研究项目，重点关注患者的不良妊娠结局 系统性红斑狼疮对于她的K01奖，Simard博士和同事们表明， 患有狼疮的孕妇是一个高度用药的群体， 结果，包括早发性先兆子痫，早产，感染和中风。近几 在试点工作中，Simard博士发现，用于治疗狼疮的羟氯喹（HCQ） 在怀孕期间，可以预防先兆子痫和早产。在两个人群中（一个美国 Simard博士还发现，只有不到一半的狼疮孕妇 使用HCQ，尽管建议。其他人也证实了这一点。 博士Simard在本申请中通过三个大的国际专利申请建立在这项工作的基础上。 以确定HCQ是否降低狼疮患者发生这些不良结局的风险 怀孕。Simard博士将与瑞典、以色列和凯撒医疗机构的同事合作 美国北方加州研究部的研究员。这些数据包括以下详细信息： 订购和填写的处方，以及抗磷脂抗体状态的数据往往不可用 和产次，狼疮生殖研究中的两个关键因素。在目标1中，Simard博士将确定 妊娠期间使用HCQ的妇女是否降低了先兆子痫的风险。在目标2中，博士 Simard将检查早产，将自发性早产与医学指征早产区分开来， 检查先兆子痫和其他因素（如糖皮质激素）的总体风险和药物治疗 使用和妊娠糖尿病。 在目标3中，Simard博士的团队将确定孕妇使用HCQ的障碍和促进因素 使用创新的混合方法设计治疗狼疮。在评估患者依从性和 在美国和以色列的大型数据库中，他们将确定临床医生遵守的指南， 不太可能粘附的亚群，并检查它们与粘附患者的差异。然后 与患者和提供者合作，他们将使用这些定量结果来确定 从患者和提供者的角度来看，使用焦点的依从性的障碍和促进因素 组这一目标将提供关于HCQ使用和处方实践的关键信息，以改善 分析范式，并告知我们的临床理解HCQ用于狼疮妊娠， 为临床护理提供基础支持，并可能为未来的临床试验提供基础支持。