Kristine M Erlandson, Linda N Geng, Caitlin A Selvaggi, Tanayott Thaweethai, Peter Chen, Nathan B Erdmann, Jason D Goldman, Timothy J Henrich, Mady Hornig, Elizabeth W Karlson, Stuart D Katz, C Kim, Sushma K Cribbs, Adeyinka O Laiyemo, Rebecca Letts, Janet Y Lin, Jai Marathe, Sairam Parthasarathy, Thomas F Patterson, Brittany D Taylor, Elizabeth R Duffy, Monika Haack, Boris Julg, Gabrielle Maranga, Carla Hernandez, Nora G Singer, Jenny Han, Priscilla Pemu, Hassan Brim, Hassan Ashktorab, Alexander W Charney, Juan Wisnivesky, Jenny J Lin, Helen Y Chu, Minjoung Go, Upinder Singh, Emily B Levitan, Paul A Goepfert, Janko Ž Nikolich, Harvey Hsu, Michael J Peluso, J Daniel Kelly, Megumi J Okumura, Valerie J Flaherman, John G Quigley, Jerry A Krishnan, Mary Beth Scholand, Rachel Hess, Torri D Metz, Maged M Costantine, Dwight J Rouse, Barbara S Taylor, Mark P Goldberg, Gailen D Marshall, Jeremy Wood, David Warren, Leora Horwitz, Andrea S Foulkes, Grace A McComsey
{"title":"通过 RECOVER 群体中的标准临床实验室测量结果区分 SARS-CoV-2 前感染和急性后遗症。","authors":"Kristine M Erlandson, Linda N Geng, Caitlin A Selvaggi, Tanayott Thaweethai, Peter Chen, Nathan B Erdmann, Jason D Goldman, Timothy J Henrich, Mady Hornig, Elizabeth W Karlson, Stuart D Katz, C Kim, Sushma K Cribbs, Adeyinka O Laiyemo, Rebecca Letts, Janet Y Lin, Jai Marathe, Sairam Parthasarathy, Thomas F Patterson, Brittany D Taylor, Elizabeth R Duffy, Monika Haack, Boris Julg, Gabrielle Maranga, Carla Hernandez, Nora G Singer, Jenny Han, Priscilla Pemu, Hassan Brim, Hassan Ashktorab, Alexander W Charney, Juan Wisnivesky, Jenny J Lin, Helen Y Chu, Minjoung Go, Upinder Singh, Emily B Levitan, Paul A Goepfert, Janko Ž Nikolich, Harvey Hsu, Michael J Peluso, J Daniel Kelly, Megumi J Okumura, Valerie J Flaherman, John G Quigley, Jerry A Krishnan, Mary Beth Scholand, Rachel Hess, Torri D Metz, Maged M Costantine, Dwight J Rouse, Barbara S Taylor, Mark P Goldberg, Gailen D Marshall, Jeremy Wood, David Warren, Leora Horwitz, Andrea S Foulkes, Grace A McComsey","doi":"10.7326/M24-0737","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC).</p><p><strong>Objective: </strong>To investigate clinical laboratory markers of SARS-CoV-2 and PASC.</p><p><strong>Design: </strong>Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024).</p><p><strong>Setting: </strong>83 enrolling sites.</p><p><strong>Participants: </strong>RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection.</p><p><strong>Measurements: </strong>Participants completed questionnaires and standard clinical laboratory tests.</p><p><strong>Results: </strong>Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 10<sup>9</sup> cells/L [95% CI, 264.5 to 267.4 × 10<sup>9</sup> cells/L]) than participants without known prior infection (275.2 × 10<sup>9</sup> cells/L [CI, 268.5 to 282.0 × 10<sup>9</sup> cells/L]), as well as higher mean hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin-creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA<sub>1c</sub> levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero.</p><p><strong>Limitation: </strong>Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined.</p><p><strong>Conclusion: </strong>Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC.</p><p><strong>Primary funding source: </strong>National Institutes of Health.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":null,"pages":null},"PeriodicalIF":19.6000,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort.\",\"authors\":\"Kristine M Erlandson, Linda N Geng, Caitlin A Selvaggi, Tanayott Thaweethai, Peter Chen, Nathan B Erdmann, Jason D Goldman, Timothy J Henrich, Mady Hornig, Elizabeth W Karlson, Stuart D Katz, C Kim, Sushma K Cribbs, Adeyinka O Laiyemo, Rebecca Letts, Janet Y Lin, Jai Marathe, Sairam Parthasarathy, Thomas F Patterson, Brittany D Taylor, Elizabeth R Duffy, Monika Haack, Boris Julg, Gabrielle Maranga, Carla Hernandez, Nora G Singer, Jenny Han, Priscilla Pemu, Hassan Brim, Hassan Ashktorab, Alexander W Charney, Juan Wisnivesky, Jenny J Lin, Helen Y Chu, Minjoung Go, Upinder Singh, Emily B Levitan, Paul A Goepfert, Janko Ž Nikolich, Harvey Hsu, Michael J Peluso, J Daniel Kelly, Megumi J Okumura, Valerie J Flaherman, John G Quigley, Jerry A Krishnan, Mary Beth Scholand, Rachel Hess, Torri D Metz, Maged M Costantine, Dwight J Rouse, Barbara S Taylor, Mark P Goldberg, Gailen D Marshall, Jeremy Wood, David Warren, Leora Horwitz, Andrea S Foulkes, Grace A McComsey\",\"doi\":\"10.7326/M24-0737\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC).</p><p><strong>Objective: </strong>To investigate clinical laboratory markers of SARS-CoV-2 and PASC.</p><p><strong>Design: </strong>Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024).</p><p><strong>Setting: </strong>83 enrolling sites.</p><p><strong>Participants: </strong>RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection.</p><p><strong>Measurements: </strong>Participants completed questionnaires and standard clinical laboratory tests.</p><p><strong>Results: </strong>Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. 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引用次数: 0
摘要
背景：目前尚无有效的 SARS-CoV-2 感染后遗症（PASC）临床生物标志物：目前尚无有效的 SARS-CoV-2 感染急性后遗症（PASC）临床生物标志物：研究SARS-CoV-2和PASC的临床实验室标志物：设计：拟合倾向得分加权线性回归模型，评估先前感染和PASC指数（≥12 vs. 0）对平均实验室指标的影响。(临床试验：NCT05172024）：83个报名点：RECOVER-成人队列参与者，无论是否感染 SARS-CoV-2，均应在指数日期后 6 个月（如果指数日期后超过 6 个月，则在注册时）进行研究访问和实验室测量。如果 6 个月的就诊时间是在再感染后 30 天内，则排除参与者：测量：参与者填写调查问卷并进行标准临床实验室检测：在 10 094 名参与者中，8746 人曾感染过 SARS-CoV-2，1348 人未感染，1880 人的 PASC 指数达到或超过 12，3351 人的 PASC 指数为零。经过倾向得分调整后，曾感染者的平均血小板计数（265.9 × 109 cells/L [95% CI, 264.5 to 267.4 × 109 cells/L]）低于未感染者（275.2 × 109 cells/L [CI, 268.5 to 282.0 × 109 cells/L]），平均血红蛋白 A1c (HbA1c) 水平（5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]）和尿白蛋白-肌酐比值（81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]）也更高，但差异的临床意义不大。在剔除原有糖尿病患者后，HbA1c水平的差异有所减小。在既往有感染的参与者中，PASC 指数为 12 或更高的参与者与 PASC 指数为零的参与者之间的平均实验室值没有发现有意义的差异：局限性：无法确定实验室指标的差异是感染 SARS-CoV-2 的后果还是风险因素：总体而言，在本研究评估的 25 项常规临床实验室指标中，没有发现任何一项指标可作为 PASC 的临床有用生物标志物：主要资金来源：美国国立卫生研究院。
Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort.
Background: There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC).
Objective: To investigate clinical laboratory markers of SARS-CoV-2 and PASC.
Design: Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024).
Setting: 83 enrolling sites.
Participants: RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection.
Measurements: Participants completed questionnaires and standard clinical laboratory tests.
Results: Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 109 cells/L [95% CI, 264.5 to 267.4 × 109 cells/L]) than participants without known prior infection (275.2 × 109 cells/L [CI, 268.5 to 282.0 × 109 cells/L]), as well as higher mean hemoglobin A1c (HbA1c) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin-creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA1c levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero.
Limitation: Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined.
Conclusion: Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC.
Primary funding source: National Institutes of Health.
期刊介绍：
Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.
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