Согласно данным от
16 августа 2021 г. Европейское агентство по лекарственным
средствам (EMA) начало оценку эффективности применения тоцилизумаба
(противовоспалительного препарата) в лечении пациентов, госпитализированных по
поводу тяжелой коронавирусной инфекции, которые уже получают терапию
кортикостероидами и нуждаются в оксигенотерапии, а также вспомогательной или
искусственной вентиляции легких.
Тоцилизумаб был впервые одобрен для применения на территории
Европейского союза в 2009 г. Тоцилизумаб может быть перспективным
вариантом лечения пациентов с коронавирусной инфекцией, поскольку он блокирует
действие интерлейкина-6 — вещества, вырабатываемого иммунной системой
в ответ на воспаление и играющего решающую роль при COVID-19.
Комитет по лекарственным
средствам для медицинского применения EMA (CHMP) проведет ускоренную
оценку данных, представленных в приложении, включая результаты 4 крупных
рандомизированных исследований у лиц, госпитализированных по поводу COVID-19,
для определения необходимости включения новых показаний.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related hypertension
and its complications (0.77; 95% confidence interval, 0.41-1.43). Pregnant
patients without comorbidities need to be reassured that asymptomatic/mild
SARS-CoV-2 infection does not increase the risk of preterm delivery. Preterm
birth and severe Coronavirus disease-19 share common risk factors (i.e., body
mass index > 24.9, asthma, chronic hypertension), which may explain the high
rate of indicated preterm birth due to maternal conditions reported in the
literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related hypertension
and its complications (0.77; 95% confidence interval, 0.41-1.43). Pregnant
patients without comorbidities need to be reassured that asymptomatic/mild
SARS-CoV-2 infection does not increase the risk of preterm delivery. Preterm
birth and severe Coronavirus disease-19 share common risk factors (i.e., body
mass index > 24.9, asthma, chronic hypertension), which may explain the high
rate of indicated preterm birth due to maternal conditions reported in the
literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related hypertension
and its complications (0.77; 95% confidence interval, 0.41-1.43). Pregnant
patients without comorbidities need to be reassured that asymptomatic/mild
SARS-CoV-2 infection does not increase the risk of preterm delivery. Preterm
birth and severe Coronavirus disease-19 share common risk factors (i.e., body
mass index > 24.9, asthma, chronic hypertension), which may explain the high
rate of indicated preterm birth due to maternal conditions reported in the
literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Заключение от CHMP
вместе с требованиями о проведении дополнительных исследований и мониторинге
безопасности будут направлены в Европейскую комиссию. После этого будет
опубликовано окончательное имеющее обязательную юридическую силу решение,
действительное во всех государствах-членах Европейского союза. Если
дополнительные данные не потребуются, то, как ожидается, EMA завершит оценку
эффективности терапии
тоцилизумабом к середине октября.
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