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Screenshot Source: JAMA Internal Medicine In patients with COVID-19, it is not uncommon for the count of exosteonal lymphocytes to decline, and the magnitude and duration of the decline can predict the severity and death of the disease.
rhG-CSF has been widely used in clinical practice, and in mouse models and human studies, rhG-CSF can increase the count of exosteal leukocytes and lymphocytes.
but the potential therapeutic effect of rhG-CSF on COVID-19 patients is uncertain.
This is why, led by academician Zhong Nanshan, this open-label, multi-center, randomized clinical trial was conducted in three clinical centers in China (Guangzhou Eighth People's Hospital, Wuhan Concord Hospital and Wuhan Hankou Hospital) from February 18 to April 10, 2020.
trial included a total of 200 subjects who were diagnosed with the new coronavirus by nucleic acid testing, pneumonia, blood lymphocyte count of 800/μL, and no cogeneration (to eliminate rhG-CSF treatment taboos).
56 per cent of these patients were male, with a medium age of 45.
patients were randomly divided into control groups, followed by guidelines for routine treatment, and the trial group received 3 doses of rhG-CSF (5 μg/kg, subsulated injections on day 0-2) on the basis of conventional treatment.
21 days of observation, the main endpoint was the time it took to improve from random grouping to clinical symptoms by 1 point (based on a score of 7 on the severity of the disease).
results showed similar times for clinical improvement between the two groups, with a median of 12 days in the rhG-CSF group (IQR, 10-16 days) and a median of 13 days in the conventional treatment group (IQR, 11-17 days).
further subgroup analysis found that rhG-CSF had a greater impact on the rate of clinical improvement in patients with an exosteeric blood lymphocyte count of 400/μL (medium time 12 days vs14 days, HR:1.86), while the difference between rhG-CSF and routine treatment was further narrowed in patients with exosytolytic lymphocyte count of 400/μL.
(A) in patients with an exosycical blood lymphocyte count of 400/μL, rhG-CSF significantly accelerated clinical improvement, and in patients with an exosyclinic lymphocyte count of 400/μL (B), two Group differences were not significant (Photo Source: Resources) At the same time, patients in the rhG-CSF group had significantly less progression with acute respiratory distress syndrome (ARDS), sepsis, shock (2% vs 15%).
on the 21st day, 2 patients (2%) in the rhG-CSF group died, while 10 patients (10%) in the conventional treatment group died, significantly reducing the risk of death in the rhG-CSF group by 81%.
addition, on the 5th day of treatment, patients in the rhG-CSF group had higher lymphocyte counts (median 1050/μL vs 620/μL), with similar results on the 7th and 10th days.
of all subjects, 61 patients in the rhG-CSF group had available virological data, and oral swab test results showed no difference in RNA load between the two groups.
but on the 10th day, the viral RNA load in the rhG-CSF group dropped faster.
safety, 29 patients in the rhG-CSF group (14.5%) and 42 patients (21%) in the general care group experienced severe adverse events.
based on these data, the team suggests that rhG-CSF's treatment of PATIENT-19 patients with reduced lymphocytes but no cogeneration may reduce the risk of developing severe illness and death and deserve larger studies.
resources: s1. Cheng L, et al., (2020). Effect of Recombinant Human Granulocyte Colony -Requesting Factor for Patients With Coronavirus Disease 2019 (COVID-19) and Lymphopenia: AedEs random Clinical Trial. JAMA Intern Med, DOI: 10.1001/jamainternmed.2020.5503.