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Community Socioeconomic Status, Acute Cardiovascular Hospitalizations, and Mortality in Medicare, 2003 to 2019 2003 年至 2019 年医疗保险中的社区社会经济状况、急性心血管病住院率和死亡率
Pub Date : 2024-04-10 DOI: 10.1161/circoutcomes.123.010090
Rishi K. Wadhera, Eric A. Secemsky, Jiaman Xu, Robert W. Yeh, Yang Song, Samuel Z. Goldhaber
BACKGROUND:Socioeconomically disadvantaged communities in the United States disproportionately experience poor cardiovascular outcomes. Little is known about how hospitalizations and mortality for acute cardiovascular conditions have changed among Medicare beneficiaries in socioeconomically disadvantaged and nondisadvantaged communities over the past 2 decades.METHODS:Medicare files were linked with the Centers for Disease Control and Prevention’s social vulnerability index to examine age-sex standardized hospitalizations for myocardial infarction, heart failure, ischemic stroke, and pulmonary embolism among Medicare fee-for-service beneficiaries ≥65 years of age residing in socioeconomically disadvantaged communities (highest social vulnerability index quintile nationally) and nondisadvantaged communities (all other quintiles) from 2003 to 2019, as well as risk-adjusted 30-day mortality among hospitalized beneficiaries.RESULTS:A total of 10 942 483 Medicare beneficiaries ≥65 years of age were hospitalized for myocardial infarction, heart failure, stroke, or pulmonary embolism (mean age, 79.2 [SD, 8.7] years; 53.9% female). Although age-sex standardized myocardial infarction hospitalizations declined in socioeconomically disadvantaged (990–650 per 100 000) and nondisadvantaged communities (950–570 per 100 000) from 2003 to 2019, the gap in hospitalizations between these groups significantly widened (adjusted odds ratio 2003, 1.03 [95% CI, 1.02–1.04]; adjusted odds ratio 2019, 1.14 [95% CI, 1.13–1.16]). There was a similar decline in hospitalizations for heart failure in socioeconomically disadvantaged (2063–1559 per 100 000) and nondisadvantaged communities (1767–1385 per 100 000), as well as for ischemic stroke, but the relative gap did not change for both conditions. In contrast, pulmonary embolism hospitalizations increased in both disadvantaged (146–184 per 100 000) and nondisadvantaged communities (153–184 per 100 000). By 2019, risk-adjusted 30-day mortality was similar between hospitalized beneficiaries from socioeconomically disadvantaged and nondisadvantaged communities for myocardial infarction, heart failure, and ischemic stroke but was higher for pulmonary embolism (odds ratio, 1.10 [95% CI, 1.01–1.20]).CONCLUSIONS:Over the past 2 decades, hospitalizations for most acute cardiovascular conditions decreased in both socioeconomically disadvantaged and nondisadvantaged communities, although significant disparities remain, while 30-day mortality is now similar across most conditions.
背景:在美国,社会经济处境不利的社区心血管疾病的治疗效果极差。过去 20 年来,社会经济弱势社区和非弱势社区的医疗保险受益人因急性心血管疾病住院和死亡的变化情况鲜为人知。方法:将医疗保险档案与美国疾病控制和预防中心的社会脆弱性指数联系起来,研究 2003 年至 2019 年期间,居住在社会经济弱势社区(全国社会脆弱性指数最高的五分位数)和非弱势社区(所有其他五分位数)、年龄≥65 岁的医疗保险付费服务受益人因心肌梗死、心力衰竭、缺血性中风和肺栓塞住院的年龄-性别标准化情况,以及住院受益人的风险调整后 30 天死亡率。结果:共有 10 942 483 名年龄≥65 岁的医疗保险受益人因心肌梗死、心力衰竭、中风或肺栓塞住院治疗(平均年龄 79.2 [SD, 8.7] 岁;53.9% 为女性)。虽然从 2003 年到 2019 年,社会经济条件较差社区(每 10 万人中有 990-650 人)和非较差社区(每 10 万人中有 950-570 人)的年龄-性别标准化心肌梗死住院率有所下降,但这些群体之间的住院率差距明显扩大(2003 年调整后的几率比为 1.03 [95% CI,1.02-1.04];2019 年调整后的几率比为 1.14 [95% CI,1.13-1.16])。在社会经济条件较差的社区(每 10 万人中有 2063-1559 人)和非较差社区(每 10 万人中有 1767-1385 人),心力衰竭以及缺血性中风的住院率下降幅度相似,但这两种疾病的相对差距没有变化。相比之下,弱势社区(每 10 万人中有 146-184 人)和非弱势社区(每 10 万人中有 153-184 人)的肺栓塞住院率都有所上升。到 2019 年,在心肌梗死、心力衰竭和缺血性中风方面,社会经济弱势社区和非弱势社区的住院受益人经风险调整后的 30 天死亡率相似,但肺栓塞的死亡率更高(赔率为 1.10 [95% CI, 1.01-1.20])。结论:在过去 20 年中,社会经济弱势社区和非弱势社区中大多数急性心血管疾病的住院率都有所下降,但仍存在显著差异,而大多数疾病的 30 天死亡率目前相似。
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引用次数: 0
Trends in Income Inequities in Cardiovascular Health Among US Adults, 1988–2018 1988-2018 年美国成年人心血管健康方面的收入不平等趋势
Pub Date : 2024-04-03 DOI: 10.1161/circoutcomes.123.010111
Nicholas K. Brownell, Boback Ziaeian, Nicholas J. Jackson, Adam K. Richards
BACKGROUND:Mean cardiovascular health has improved over the past several decades in the United States, but it is unclear whether the benefit is shared equitably. This study examined 30-year trends in cardiovascular health using a suite of income equity metrics to provide a comprehensive picture of cardiovascular income equity.METHODS:The study evaluated data from the 1988–2018 National Health and Nutrition Examination Survey. Survey groupings were stratified by poverty-to-income ratio (PIR) category, and the mean predicted 10-year risk of a major cardiovascular event or death based on the pooled cohort equations (PCE) was calculated (10-year PCE risk). Equity metrics including the relative and absolute concentration indices and the achievement index—metrics that assess both the prevalence and the distribution of a health measure across different socioeconomic categories—were calculated.RESULTS:A total of 26 633 participants aged 40 to 75 years were included (mean age, 53.0–55.5 years; women, 51.9%–53.0%). From 1988–1994 to 2015–2018, the mean 10-year PCE risk improved from 7.8% to 6.4% (P<0.05). The improvement was limited to the 2 highest income categories (10-year PCE risk for PIR 5: 7.7%–5.1%, P<0.05; PIR 3–4.99: 7.6%–6.1%, P<0.05). The 10-year PCE risk for the lowest income category (PIR <1) did not significantly change (8.1%–8.7%). In 1988–1994, the 10-year PCE risk for PIR <1 was 6% higher than PIR 5; by 2015–2018, this relative inequity increased to 70% (P<0.05). When using metrics that account for all income categories, the achievement index improved (8.0%–7.1%, P<0.05); however, the achievement index was consistently higher than the mean 10-year PCE risk, indicating the poor persistently had a greater share of adverse health.CONCLUSIONS:In this serial cross-sectional survey of US adults spanning 30 years, the population’s mean 10-year PCE risk improved, but the improvement was not felt equally across the income spectrum.
背景:过去几十年来,美国人的平均心血管健康状况有所改善,但目前尚不清楚这种益处是否得到了公平分享。本研究利用一系列收入公平指标对心血管健康的 30 年趋势进行了研究,以全面了解心血管收入公平情况。方法:本研究评估了 1988-2018 年全国健康与营养调查的数据。按照贫困收入比(PIR)类别对调查分组进行了分层,并根据集合队列方程(PCE)计算了10年重大心血管事件或死亡的平均预测风险(10年PCE风险)。结果:共纳入了 26 633 名 40 至 75 岁的参与者(平均年龄为 53.0-55.5 岁;女性为 51.9%-53.0%)。从 1988-1994 年到 2015-2018 年,平均 10 年 PCE 风险从 7.8% 降至 6.4%(P<0.05)。这种改善仅限于 2 个最高收入类别(PIR 5 的 10 年 PCE 风险:7.7%-5.1%,P<0.05;PIR 3-4.99:7.6%-6.1%,P<0.05):7.6%-6.1%,P<0.05)。最低收入类别(PIR <1)的 10 年 PCE 风险没有显著变化(8.1%-8.7%)。1988-1994 年,PIR <1 的 10 年 PCE 风险比 PIR 5 高出 6%;到 2015-2018 年,这种相对不平等增加到 70%(P<0.05)。当使用考虑到所有收入类别的指标时,成就指数有所改善(8.0%-7.1%,P<0.05);然而,成就指数始终高于平均 10 年 PCE 风险,这表明穷人持续承受着更大的不利健康份额。
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引用次数: 0
Impact of Local Tailoring on Acute Stroke Care in 21 Disparate Emergency Departments: A Prospective Stepped Wedge Type III Hybrid Effectiveness-Implementation Study 在 21 个不同急诊科进行局部调整对急性卒中护理的影响:前瞻性阶梯式楔形III型混合疗效实施研究
Pub Date : 2024-04-03 DOI: 10.1161/circoutcomes.123.010477
Kathleen E. McKee, Andrew J. Knighton, Kristy Veale, Julie Martinez, Cory McCann, Jonathan W. Anderson, Doug Wolfe, Robert Blackburn, Marilyn McKasson, Tyler Bardsley, Blessing Ofori-Atta, Tom H. Greene, Robert Hoesch, H. Adrian Püttgen, Rajendu Srivastava
BACKGROUND:Faster delivery of tPA (tissue-type plasminogen activator) results in better health outcomes for eligible patients with stroke. Standardization of stroke protocols in emergency departments (EDs) has been difficult, especially in nonstroke centers. We measured the effectiveness of a centrally led implementation strategy with local site tailoring to sustain adherence to an acute stroke protocol to improve door-to-needle (DTN) times across disparate EDs in a multihospital health system.METHODS:Prospective, type III hybrid effectiveness-implementation cohort study measuring performance at 21 EDs in Utah and Idaho (stroke centers [4]/nonstroke centers [17]) from January 2018 to February 2020 using a nonrandomized stepped-wedge design, monthly repeated site measures and multilevel hierarchical modeling. Each site received the implementation strategies in 1 of 6 steps providing control and intervention data. Co-primary outcomes were percentage of DTN times ≤60 minutes and median DTN time. Secondary outcomes included percentage of door-to-activation of neurological consult times ≤10 minutes and clinical effectiveness outcomes. Results were stratified between stroke and nonstroke centers.RESULTS:A total of 855 474 ED patient encounters occurred with 5325 code stroke activations (median age, 69 [IQR, 56–79] years; 51.8% female patients]. Percentage of door-to-activation times ≤10 minutes increased from 47.5% to 59.9% (adjusted odds ratio, 1.93 [95% CI, 1.40–2.67]). A total of 615 patients received tPA of ≤3 hours from symptom onset (median age, 71 [IQR, 58–80] years; 49.6% female patients). The percentage of DTN times ≤60 minutes increased from 72.5% to 86.1% (adjusted odds ratio, 3.38, [95% CI, 1.47–7.78]; stroke centers (77.4%–90.0%); nonstroke centers [59.3%–72.1%]). Median DTN time declined from 46 to 38 minutes (adjusted median difference, −9.68 [95% CI, −17.17 to −2.20]; stroke centers [41–35 minutes]; nonstroke centers [55–52 minutes]). No differences were observed in clinical effectiveness outcomes.CONCLUSIONS:A centrally led implementation strategy with local site tailoring led to faster delivery of tPA across disparate EDs in a multihospital system with no change in clinical effectiveness outcomes including rates of complication. Disparities in performance persisted between stroke and nonstroke centers.
背景:对符合条件的脑卒中患者而言,更快地提供 tPA(组织型纤溶酶原激活剂)可带来更好的医疗效果。急诊科(ED)卒中规范的标准化一直很困难,尤其是在非卒中中心。我们测量了在多医院医疗系统中,由中央领导的实施策略与地方医疗机构量身定制的急性卒中治疗方案的有效性,以改善不同急诊室的门到针(DTN)时间。方法:采用非随机阶梯式楔形设计、每月重复现场测量和多级分层建模,对犹他州和爱达荷州 21 家急诊室(卒中中心 [4] / 非卒中中心 [17])2018 年 1 月至 2020 年 2 月的绩效进行前瞻性、III 型混合有效性实施队列研究。每个医疗点在 6 个步骤中的 1 个步骤中接受实施策略,提供对照和干预数据。共同主要结果是 DTN 时间≤60 分钟的百分比和 DTN 时间中位数。次要结果包括从门诊到启动神经科会诊时间≤10 分钟的百分比和临床效果结果。结果:共有 855 474 例急诊患者就诊,其中 5325 例为卒中激活(中位年龄 69 [IQR,56-79]岁;51.8% 为女性患者)。门到启动时间≤10 分钟的比例从 47.5% 增加到 59.9%(调整后的几率比为 1.93 [95% CI,1.40-2.67])。共有 615 名患者在症状出现后 3 小时内接受了 tPA(中位年龄为 71 [IQR,58-80]岁;49.6% 为女性患者)。DTN时间≤60分钟的比例从72.5%增至86.1%(调整后的几率比为3.38,[95% CI,1.47-7.78];卒中中心(77.4%-90.0%);非卒中中心[59.3%-72.1%])。中位 DTN 时间从 46 分钟降至 38 分钟(调整后的中位差异为 -9.68 [95% CI, -17.17 to -2.20];卒中中心 [41-35 分钟];非卒中中心 [55-52 分钟])。结论:在多医院系统中,由中央领导的实施策略与地方医疗机构的量身定制使不同急诊室的 tPA 送达速度更快,但临床效果(包括并发症发生率)没有变化。卒中中心和非卒中中心之间的绩效差距依然存在。
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引用次数: 0
Utilizing Quality of Life Adjusted Days Alive and Out of Hospital in Heart Failure Clinical Trials 在心力衰竭临床试验中利用生活质量调整后的存活和出院天数
Pub Date : 2024-04-03 DOI: 10.1161/circoutcomes.123.010560
Pishoy Gouda, Sarah Rathwell, Eloisa Colin-Ramirez, G. Michael Felker, Heather Ross, Jorge Escobedo, Peter Macdonald, Richard W. Troughton, Christopher M. O’Connor, Justin A. Ezekowitz
BACKGROUND:In heart failure (HF) trials, there has been an emphasis on utilizing more patient-centered outcomes, including quality of life (QoL) and days alive and out of hospital. We aimed to explore the impact of QoL adjusted days alive and out of hospital as an outcome in 2 HF clinical trials.METHODS:Using data from 2 trials in HF (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT] and Study of Dietary Intervention under 100 mmol in Heart Failure [SODIUM-HF]), we determined treatment differences using percentage days alive and out of hospital (%DAOH) adjusted for QoL at 18 months as the primary outcome. For each participant, %DAOH was calculated as a ratio between days alive and out of hospital/total follow-up. Using a regression model, %DAOH was subsequently adjusted for QoL measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score.RESULTS:In the GUIDE-IT trial, 847 participants had a median baseline Kansas City Cardiomyopathy Questionnaire Overall Summary Score of 59.0 (interquartile range, 40.8–74.3), which did not change over 18 months. %DAOH was 90.76%±22.09% in the biomarker-guided arm and 88.56%±25.27% in the usual care arm. No significant difference in QoL adjusted %DAOH was observed (1.09% [95% CI, −1.57% to 3.97%]). In the SODIUM-HF trial, 796 participants had a median baseline Kansas City Cardiomyopathy Questionnaire Overall Summary Score of 69.8 (interquartile range, 49.3–84.3), which did not change over 18 months. %DAOH was 95.69%±16.31% in the low-sodium arm and 95.95%±14.76% in the usual care arm. No significant difference was observed (1.91% [95% CI, −0.85% to 4.77%]).CONCLUSIONs:In 2 large HF clinical trials, adjusting %DAOH for QoL was feasible and may provide complementary information on treatment effects in clinical trials.
背景:在心力衰竭(HF)试验中,人们一直在强调使用更多的以患者为中心的结果,包括生活质量(QoL)、存活天数和出院天数。方法:我们利用两项心力衰竭试验(心力衰竭生物标记物强化治疗指导循证疗法[GUIDE-IT]和心力衰竭100毫摩尔以下饮食干预研究[SODIUM-HF])的数据,以18个月时根据QoL调整的存活和出院天数百分比(%DAOH)作为主要结果,确定治疗差异。每位参与者的存活和出院天数百分比计算为存活和出院天数与总随访天数之比。结果:在 GUIDE-IT 试验中,847 名参与者的基线堪萨斯城心肌病问卷总分中位数为 59.0(四分位间范围为 40.8-74.3),在 18 个月内没有变化。生物标志物指导组的DAOH%为90.76%±22.09%,常规治疗组为88.56%±25.27%。调整后的 QoL %DAOH 无明显差异(1.09% [95% CI, -1.57% to 3.97%])。在 SODIUM-HF 试验中,796 名参与者的基线堪萨斯城心肌病问卷总体汇总得分中位数为 69.8(四分位间范围为 49.3-84.3),18 个月内没有变化。低钠治疗组的脱氧血症发生率为 95.69%±16.31%,常规治疗组的脱氧血症发生率为 95.95%±14.76%。结论:在两项大型 HF 临床试验中,根据 QoL 调整 %DAOH 是可行的,可为临床试验中的治疗效果提供补充信息。
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引用次数: 0
Transformational Journey of Outcomes Research: Looking Back From the Future 成果研究的转型之旅:从未来回望
Pub Date : 2024-01-01 DOI: 10.1161/CIRCOUTCOMES.123.010007
H. Krumholz
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引用次数: 0
Abstract 261: Improving Hypertension Control Among an Underserved Urban Patient Population 摘要 261:改善服务不足的城市患者群体的高血压控制情况
Pub Date : 2020-05-01 DOI: 10.1161/hcq.13.suppl_1.261
S. Anand, Yeriko Santillan, Ameesh Isaath, T. Goldberg, Dipal Patel
Needs and Objectives: Poorly-controlled hypertension is associated with increased risk of adverse cardiovascular outcomes and thus is an important healthcare quality metric for primary care practices. Yet achieving blood pressure goals among socially-complex, economically-disadvantaged patient populations can be challenging due to cost-related non-adherence, poor health literacy and other social determinant barriers. Indeed, by early 2019, only 59% of hypertensive patients at our inner-city community health clinic had a blood pressure less than 140/90. The goal of this resident-driven quality improvement (QI) project was to increase blood pressure control among our hypertensive patients to a network target of 75% over 6 months. Setting and Participants: Our project was implemented at the Ryan Adair Center, a Federally Qualified Health Center located in Central Harlem that serves as a primary care practice site for Internal Medicine residents. The patient population consists predominantly of Black and Latino patients, most of whom are on Medicaid and live well below the federal poverty line. Our target population was hypertensive patients. Intervention: We used the Plan-Do-Study-Act method to carry out our clinic-based project. PGY1’s at the site served as the QI project leaders with faculty oversight. Cycle 1 focused on nurse education regarding proper blood pressure measurement. Cycle 2 focused on home blood pressure monitoring including patient education on proper technique and the importance of maintaining a daily log. Cycle 3 focused on assessment of health literacy via a patient questionnaire. Cycle 4 focused on provider education by ensuring that our patients were prescribed an appropriate medication regimen based on ACC/AHA Guidelines. Cycle 5 focused on referring patients with continued poor control to community health coaches to identify barriers like nutrition, medication access, and health literacy. Evaluation: Using our clinic’s online hypertensive registry (DRVS), we tracked on a monthly basis the percentage of hypertensive patients who had controlled blood pressure (<140/90). Percent of patients at goal went from 59% in February 2019 to 73% in July 2019. Discussion/lessons learned: Through this project, we demonstrated a meaningful improvement in hypertensive control among an economically-disadvantaged, racially diverse urban patient population. Accurate nurse measurements, engagement of patients in self-management, and resident education on evidence-based medication standards have all contributed to this success. Future directions will explore the impact of community health coaches in hypertension control and use of standard questionnaire to assess health literacy.
需求和目标:高血压控制不佳与不良心血管后果的风险增加有关,因此是初级保健实践中一项重要的医疗质量指标。然而,由于与费用相关的非依从性、健康知识匮乏以及其他社会决定因素的障碍,在社会复杂、经济条件不利的患者群体中实现血压目标可能具有挑战性。事实上,到 2019 年初,我们市内社区卫生诊所只有 59% 的高血压患者血压低于 140/90。这个由居民推动的质量改进(QI)项目的目标是在 6 个月内将高血压患者的血压控制率提高到 75% 的网络目标。 地点和参与者:我们的项目在瑞安-阿代尔中心(Ryan Adair Center)实施,该中心是位于哈林区中心的联邦合格医疗中心,是内科住院医师的初级保健实践基地。这里的病人主要是黑人和拉丁裔病人,其中大多数人都享受医疗补助,生活水平远远低于联邦贫困线。我们的目标人群是高血压患者。 干预措施我们采用 "计划-实施-研究-行动 "的方法开展诊所项目。医疗点的 PGY1 担任 QI 项目负责人,并由教师进行监督。周期 1 的重点是对护士进行有关正确测量血压的教育。周期 2 侧重于家庭血压监测,包括向患者传授正确的测量技巧和保持每日记录的重要性。周期 3 的重点是通过患者问卷评估健康素养。周期 4 的重点是对医疗服务提供者进行教育,确保根据 ACC/AHA 指南为患者开具适当的药物治疗方案。第 5 个周期的重点是将血压控制仍然不佳的患者转介给社区健康指导员,以识别营养、用药和健康知识等方面的障碍。 评估:我们利用诊所的在线高血压登记系统 (DRVS),每月跟踪血压得到控制(<140/90)的高血压患者比例。达到目标的患者比例从 2019 年 2 月的 59% 上升到 2019 年 7 月的 73%。 讨论/经验教训:通过该项目,我们展示了在经济条件较差、种族多元化的城市患者群体中,高血压控制情况得到了显著改善。护士的精确测量、患者的自我管理以及住院医师对循证用药标准的教育都为这一成功做出了贡献。未来将探索社区健康指导对高血压控制的影响,并使用标准问卷评估健康素养。
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引用次数: 2
Abstract 241: Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept 摘要 241:复发性心包炎患者的健康相关生活质量:利洛那普的2期研究结果
Pub Date : 2020-05-01 DOI: 10.1161/hcq.13.suppl_1.241
D. Lin, A. Klein, D. Cella, A. Beutler, F. Fang, M. Magestro, P. Cremer, M. LeWinter, S. Luis, A. Abbate, A. Ertel, L. Litcher-Kelly, B. Klooster, J. Paolini
Background: Recurrent pericarditis (RP) episodes and conventional treatments result in morbidity, but the impact on patient health-related quality of life (HRQoL) has not been quantified. The Phase 2 trial NCT03980522 of rilonacept (IL-1α/IL-1β inhibitor) evaluated HRQoL. Methods: Patients with active RP who were symptomatic at Baseline (A-RP, n=16) and RP patients who were not currently experiencing a recurrence but were corticosteroid-dependent at Baseline (CSD-RP, n=9) were enrolled. All received rilonacept weekly for 6 weeks to end of base treatment period (TP) plus an optional 18-week extension treatment period (EP). Corticosteroid tapering occurred in the EP. Physical and mental HRQoL (PROMIS Global Health v1.2 Physical and Mental Component Scores [PCS/MCS]) were assessed at baseline and follow-up. Results: Figure 1 presents the PROMIS PCS/MCS and pain scale scores (both patient-reported) as well as C-reactive protein levels over time. Mean PCS/MCS scores at baseline were 39.9/44.5 and 43.3/46.5 for A-RP and CSD-RP groups respectively (versus the norm mean of 50). In A-RP, PCS/MCS scores improved by 11.4/5.6 points by end of base TP, and this improvement was sustained throughout the EP (increase of 11.4/6.0 points from baseline at end of EP). In CSD-RP, PCS/MCS scores increased by 1.8/1.4 points by end of TP and improved by 3.5/4.2 points at end of study, after tapering or discontinuation of corticosteroid without disease recurrence. Conclusion: Impaired baseline HRQoL suggests negative impact of RP. For A-RP, rilonacept rapidly improved pericarditis signs and symptoms which was associated with HRQoL improvements. For CSD-RP, rilonacept supported tapering/withdrawal of corticosteroids without recurrence, with maintained/improved HRQoL. These results suggest rilonacept can improve RP patient HRQoL while providing an alternative to corticosteroids.
背景:复发性心包炎(RP)发作和常规治疗会导致发病,但对患者健康相关生活质量(HRQoL)的影响尚未量化。利龙赛普(IL-1α/IL-1β抑制剂)的 2 期试验 NCT03980522 对 HRQoL 进行了评估。 研究方法纳入基线时有症状的活动性 RP 患者(A-RP,16 人)和目前未复发但基线时依赖皮质类固醇的 RP 患者(CSD-RP,9 人)。所有患者每周接受利龙赛普治疗 6 周,直至基础治疗期(TP)结束,并可选择接受为期 18 周的延长治疗期(EP)。在延长治疗期,皮质类固醇逐渐减少。在基线和随访期间对患者的身体和心理 HRQoL(PROMIS Global Health v1.2 身体和心理成分评分 [PCS/MCS])进行评估。 结果图 1 显示了随时间变化的 PROMIS PCS/MCS 和疼痛量表评分(均由患者报告)以及 C 反应蛋白水平。A-RP 组和 CSD-RP 组基线时的 PCS/MCS 平均分分别为 39.9/44.5 和 43.3/46.5(标准平均分为 50)。在 A-RP 组中,PCS/MCS 分数在基础 TP 结束时提高了 11.4/5.6 分,而且这种提高在整个 EP 中一直持续(EP 结束时比基线提高了 11.4/6.0 分)。在 CSD-RP 中,PCS/MCS 评分在 TP 结束时提高了 1.8/1.4 分,在研究结束时提高了 3.5/4.2 分,在减量或停用皮质类固醇后疾病没有复发。 结论基线 HRQoL 受损表明 RP 有负面影响。对于A型RP,利隆钠肽能迅速改善心包炎的体征和症状,这与心率质生活改善有关。对于 CSD-RP,利隆塞普支持皮质类固醇的减量/停药,且不会复发,同时还能维持/改善 HRQoL。这些结果表明,利龙赛普可以改善RP患者的HRQoL,同时提供皮质类固醇的替代品。
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引用次数: 9
期刊
Circulation: Cardiovascular Quality and Outcomes
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