ABSTRACT
Background The outbreak of COVID-19 in Xi'an between 2021 and 2022 was a large-scale local epidemic in a large city with a huge number of cases. It is necessary to analyze and summarize the contents of this outbreak. Objective To analyze the disease characteristics of patients with COVID-19，and to explore the risk factors as well as predictors of serious cases. Methods General data and laboratory parameters were retrospectively collected from patients diagnosed with a new coronavirus pneumonia who were admitted to the Fourth People's Hospital of Xi'an between December 2021 and January 2022. Based on the the ratios of total IgG to lymphocyte percentage （IgG∶L%），total IgM to lymphocyte percentage （IgM∶L%），total IgG to lymphocyte count ratio （IgG∶L#），and total IgM to lymphocyte count ratio （IgM∶L#），patients were divided into three groups: mild and common，severe and critical. Multivariate Logistic regression analysis was used to explore the risk factors of developing severe and critically new coronavirus；then the ROC curve was drawn to analyze the predictive indexes and predictive value of severe and critical COVID-19，the area under the ROC curve （AUC） was calculated，and the AUC of each index was compared using the Delong test. Results A total of 699 patients with identified COVID-19 were finally included，and divided into two groups: the mild and common（n=678） and the severe and critical （n=21） forms，with the mild and common forms having younger age，and less underlying disease，D-dimer，IgM ∶ L%，IgM ∶ L#，and higher lymphocyte percentage and lymphocyte count than the severe and critical forms （P<0.05）. Multivariate Logistic regression analysis showed that age〔OR=1.068，95%CI（1.031，1.105），P<0.001〕，D-dimer 〔OR=1.612，95%CI（1.026，2.533），P=0.038〕as well as IgM ∶L#〔OR=1.034，95%CI（1.006，1.063），P=0.018〕 were risk factors for the development of severe and dangerous new coronavirus，and lymphocyte percentage 〔OR=0.918，95%CI（0.844，0.997），P=0.043〕was a protective factor for the development of severe and critical new coronavirus. To establish a joint prediction model for severe and critical novel coronavirus infection，P=-5.031+0.065×age-0.086× lymphocyte percentage +0.738× lymphocyte count +0.477× D-dimer +0.034×IgM∶L#，and the cutoff value for combined detection to predict severe and critical COVID-19 was 0.04，with a sensitivity of 90.00%，a specificity of 83.18%，and its AUC of 0.912〔95%CI（0.858，0.965）〕，which was greater than that for age （Z=5.314，P<0.001），lymphocyte percentage （Z=-1.987，P=0.047），D-dimer （Z=2.273，P=0.023），and IgM∶L# （Z=0.161，P<0.001），with statistically significant differences. Conclusion In the acute phase of COVID-19，there is an imbalance between inflammatory response and cellular immune function，and this imbalance，along with age and D-dimer，are all risk factors for severe COVID-19. Combined indicators including age，D-dimer，lymphocyte percentage and IgM∶L# can effectively predict severe and critical COVID-19. © 2023 Chinese General Practice. All rights reserved.
ABSTRACT
After COVID-19, patients, medical workers and the whole society in COVID-19 were faced with the challenge of how to quickly return to normal life. Patients cured in COVID-19 would face mental or psychological barriers, or be discriminated against, or face problems such as overweight of local epidemic prevention policies. The front-line medical personnel experienced job burnout and a variety of mental and psychological disorders, with some even developing physical symptoms. During the epidemic, ordinary people were in a state of psychological stress, education, production and economic activities were affected, and the incidence of mental or psychological disorders increases. It was necessary to provide COVID-19 patients with mental health monitoring and counseling. Give professional guidance to front-line medical staff, arrange rotation reasonably, and pay attention to their mental health status. Local governments should strictly implement the national epidemic prevention system, formulate epidemic prevention policies with humanistic care, actively publicize epidemic related knowledge and safeguard the rights and interests of the people. © 2022, Editorial department of Chinese Medical Ethics. All rights reserved.
ABSTRACT
Background: DARA, a human anti-CD38 IgGκ monoclonal antibody, is approved in many countries as monotherapy in relapsed/refractory MM (RRMM) and in combination with standard of care (SoC) in RRMM and NDMM. However, no clinical studies have yet compared DARA maintenance versus SoC maintenance. The ongoing phase 3 AURIGA study will evaluate the addition of DARA to lenalidomide maintenance among pts with NDMM who are MRD positive after SoC induction and ASCT. The primary endpoint is the conversion rate to MRD negativity after 1 year of maintenance therapy. Methods: This openlabel, multi center, randomized phase 3 study will enroll approximately 214 pts in the United States aged 18-79 years with NDMM who receive ≥4 cycles of induction followed by ASCT. Pts must enroll within 6 months of ASCT, be naïve for anti-CD38 treatment, have a very good partial response or better per IMWG criteria, and be MRD positive at a threshold of 10-5 by next generation sequencing (NGS) within 30 days of screening. Pts will be stratified by cytogenetic risk (high vs standard/unknown) and randomized 1:1 to 28-day cycles of lenalidomide maintenance (10 mg PO;D1-28 [dose increasing to 15 mg if tolerated]) ± DARA SC (DARA 1,800 mg co-formulated with recombinant human hyaluronidase PH20 [rHuPH20;2,000 U/mL;ENHANZE®drug delivery technology, Halozyme, Inc., San Diego, CA, USA;QW Cycle 1-2, Q2W Cycles 3-6, Q4W C7+). Treatment will continue for up to 36 cycles or until disease progression, unacceptable toxicity, or patient withdrawal. The primary endpoint is MRD conversion rate after 12months of maintenance treatment, defined as the proportion of pts who achieve MRD negativity (10-5) by NGS. Additional MRD assessments occur after 18, 24, and 36 months of maintenance. While MRD negativity is associated with improved long-term outcomes for pts with MM and is an emerging, validated prognostic factor, this study is among the first to use MRD negativity as a primary study endpoint. Importantly, MRD negativity allows for earlier efficacy assessment than traditional endpoints such as progression-free survival (PFS) and overall survival (OS). Secondary endpoints include overall MRD conversion rate at any time, sustained MRD negativity lasting ≥12 months, PFS, OS, response rates, duration of complete response, changes in health-related quality of life, and safety. Due to the COVID-19 pandemic, this study has been amended to improve enrollment access by allowing up to 12 months from start of induction therapy to ASCT to mitigate against ASCT delays and to allow greater flexibility for screening and laboratory assessments.