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1.
Annals of the Rheumatic Diseases ; 81:388, 2022.
Article in English | EMBASE | ID: covidwho-2008828

ABSTRACT

Background: BAT1806/BIIB800 is a proposed biosimilar to reference tocili-zumab (TCZ). A Phase III randomised, double-blind, active-controlled clinical trial was conducted as part of a biosimilar development programme. Objectives: To evaluate the efficacy, pharmacokinetics (PK), safety and immu-nogenicity of BAT1806/BIIB800 in comparison with EU-sourced TCZ in subjects with moderate to severe rheumatoid arthritis with inadequate response to meth-otrexate (MTX). Methods: The study was conducted at 55 centres in China and Europe, between June 2018 and January 2021. Eligible subjects were randomised in a 2:1:1 ratio to one of three treatment groups: (1) BAT1806/BIIB800 up to Week 48, (2) TCZ up to Week 48, or (3) TCZ up to Week 24, followed by BAT1806/BIIB800 from Week 24 to Week 48, administered intravenously every 4 weeks at a dose of 8mg/kg. The primary endpoint was the proportion of subjects achieving an ACR20 response at timepoints pre-specifed to meet the requirements of different Regulatory Agencies: Week 12, for EMA;Week 24, for FDA and NMPA. Equivalence margins applied to differences in ACR20 response rates in the BAT1806/BIIB800 and TCZ treatment groups were pre-specifed as follows: +/-14.5% for EMA (95% confdence interval (CI));-12.0%,15% for FDA (90% CI);+/-13.6% for NMPA (95% CI). Secondary endpoints included pharmacokinetics, safety and immunogenicity. The ICH E9(R1) estimands framework including intercurrent events (related or unrelated to the COVID19 pandemic) was implemented for the ACR20 evaluation. A logistic regression model including 'region' (China and Eastern Europe) and 'previous biologic or targeted synthetic DMARD use' (Yes/No) as captured in Interactive Web Response System as stratifcation factors was utilised to assess equivalence for the primary endpoint. The difference in response rates was estimated and corresponding confdence intervals were derived to assess equivalence for the primary endpoint. This presents results up to Week 24. Results: In total, 621 subjects were randomised to receive BAT1806/BIIB800 (N=312), TCZ (N=155), or TCZ followed by BAT1806/BIIB800 (N=154). The groups were comparable in terms of baseline demographics and disease characteristics, including age, gender, disease activity and disease duration. The estimated proportions of subjects achieving an ACR20 response in the BAT1806/BIIB800 vs. the TCZ groups, respectively, were 68.97% vs. 64.82% at Week 12 and 69.89% vs. 67.94% at Week 24. The estimated difference between ACR response rates was 4.15% (95% CI-3.63, 11.93) at week 12, and 1.94% (90% CI-4.04, 7.92;95% CI-5.18, 9.07) at Week 24. The CIs for the estimated differences between the treatment groups were within the pre-defned equivalence margins (Figure 1). The treatment groups were comparable in terms of serum trough levels, incidence of TEAEs and ADA/NAb positivity (Table 1). Conclusion: BAT1806/BIIB800 has demonstrated equivalent efficacy at Week 12 and Week 24 and a similar PK, safety and immunogenicity profile as reference tocilizumab up to Week 24.

2.
European Stroke Journal ; 7(1 SUPPL):124, 2022.
Article in English | EMBASE | ID: covidwho-1928084

ABSTRACT

Background and aims: COVID-19 pandemic is affecting triage of strokes in emergency. We aimed to find whether COVID-19 delayed the reperfusion treatment in acute ischemic stroke (AIS) patients. Methods: The Shanghai Stroke Service System (4S) is a regional network that prospectively registries AIS patients within 7 days. Data with COVID- 19 negetive was extracted from January 2018 to December 2020. Compared to quality measures in 2018-2019, the performance during COVID- 19 outbreak (mainly during 1st quarter of 2020) and post were analyzed. The primary outcome was door to needle time (DTN). The secondary outcomes included the rate of reperfusion treatment and hospitalization cost. Results: Our study included 69,258 patients from 64 stroke centers. During 1st quarter 2018 to 4th quarter 2019, there was an overall downward trend of DTN (P trend=0.006). However, during 1st and 2nd quarters 2020, there was a significant delay of DTN. After outbreak in China, the average DTN plus mandatory COVID-19 PCR test dropped back to <60 minutes. The drop of reperfusion rate was also associated to COVID-19 outbreak (57.92% pre vs 51.74% during, P<0.001), while improved after, compared to those of previous(57.92% pre vs 62.32% post, P<0.001). The cost was slightly declined in 1st quarter 2020 (-$125 USD), which reflected changes in reperfusion rates. Conclusions: In 2020, COVID-19 pandemic prolonged the DTN during COVID-19 outbreak but improved after in Shanghai. Although the prevention protocol and PCR test are still in place, acute stroke care in Shanghai has back to normal post pandemic. (Figure Presented).

3.
8th International Conference on Dependable Systems and Their Applications, DSA 2021 ; : 639-646, 2021.
Article in English | Scopus | ID: covidwho-1672601

ABSTRACT

The quality of the dataset affects the accuracy of the artificial intelligence model, but it is a lot of work to manually detect errors related to the quality evaluation of the dataset, and it may not be possible to perform quality evaluation through simple viewing. Therefore, we propose an image dataset quality measurement model, including nine evaluation metrics, and analyze the evaluation metrics from three aspects: definition, calculation formula and description. Based on the label file, the quality of the dataset file and the content of the dataset is evaluated, and the evaluation standard is given to judge whether the quality of the dataset is qualified. The measurement model and evaluation criteria proposed in this article were verified against the Cifar-10 dataset and the COVID-CT dataset, and the problems of label accuracy and label category imbalance were found, which proved the effectiveness of the method in this paper. © 2021 IEEE.

4.
Mathematics ; 9(5):1-23, 2021.
Article in English | Scopus | ID: covidwho-1138741

ABSTRACT

Socio-economic development is undergoing changes in China, such as the recently proposed carbon peak and carbon neutral targets, new infrastructure development strategy and the Coronavirus disease 2019 (COVID-19) pandemic. Meanwhile, the new-round marketization reform of the electricity industry has been ongoing in China since 2015. Therefore, it is urgent to evaluate the risk of electric power grid investment in China under new socio-economic development situation, which can help the investors manage risk and reduce risk loss. In this paper, a hybrid novel multi-criteria decision making (MCDM) method combining the latest group MCDM method, namely, Bayesian best-worst method (BBWM) and improved matter-element extension model (IMEEM) is proposed for risk evaluation of electric power grid investment in China under new socio- economic development situation. The BBWM is used for the weights’ determination of electric power grid investment risk criteria, and the IMEEM is employed to rank risk grade of electric power grid investment. The risk evaluation index system of electric power grid investment is built, including economic, social, environmental, technical and marketable risks. The risk of electric power grid investment under new socio-economic development situation in Inner Mongolia Autonomous Region of China is empirically evaluated by using the proposed MCDM method, and the results indicate that it belongs to “Medium” grade, but closer to “High” grade. The main contributions of this paper include: (1) it proposes a hybrid novel MCDM method combining the BBWM and IMEEM for risk evaluation of electric power grid investment;and (2) it provides a new view for risk evaluation of electric power grid investment including economic, social, environmental, technical and marketable risks. The proposed hybrid novel MCDM method for the risk evaluation of electric power grid investment is effective and practical. © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

6.
Jiaotong Yunshu Xitong Gongcheng Yu Xinxi/Journal of Transportation Systems Engineering and Information Technology ; 20(6):57-62, 2020.
Article in Chinese | Scopus | ID: covidwho-1005185

ABSTRACT

In order to analyze the effects of risk perception attribute on the long-distance travel mode choice behavior under the duration of public health emergencies, a multivariate Logit model is built for travel mode choice considering residents' risk perception difference. According to the 1 643 effective questionnaires collected from the internet during the COVID-19 in March 2020, the model parameters are calibrated using SPSS. The main risk perception factors affecting travelers' travel mode choices were obtained, and the sensitivity analysis of each factor was carried out. The results show that the prevention and control measures and the understanding of the measures have a significant influence on the choice of travel mode. Compared with air transportation, the increased exposure rate has a negative influence on the choice probability of railway transportation and a positive influence on the choice probability of road transportation. Keeping low air prices during the COVID-19 and increasing publicity of prevention and control measures for air transport can improve the choice probability of air transportation. Copyright © 2020 by Science Press.

7.
Chinese Journal of Radiological Medicine and Protection ; 40(10):783-788, 2020.
Article in Chinese | Scopus | ID: covidwho-961725

ABSTRACT

Objective: To investigate the application value of third-generation dual-source CT(3-G DSCT) low-dose scan mode combined with iterative reconstruction technology in the screening of COVID-19 and to evaluate the radiation dose. Methods: One hundred and twenty patients suspected of COVID-19 from December 2019 to February 2020 were retrospectively analysed and randomly divided into two groups (test group and conventional group, 60 patients in each). The parameters for test group included 3-G DSCT, Turbo Flash scan mode, CARE kV, with reference 90 kV, pitch 2.0, and ADMIRE algorithm, while those parameters for conventional group included the 128-slice CT, conventional spiral scan mode, 120 kV, pitch 1.2, and FBP algorithm. The CT values of aorta, spinal posterior muscle, and subcutaneous fat, the aortic noise, signal-to-noise ratio (SNR), and contrast noise ratio (CNR) were compared to evaluate the image quality between two groups. Two experienced doctors scored the image quality using a double-blind method, and compared the CT dose index volume (CTDIvol), dose-length product (DLP), and effective dose (E) of the two groups. Results: The CT value of the aorta and spinal posterior muscle and the aortic SNR in the test group were (45.38±4.77), (53.41±8.44) HU, and 2.82±0.59, and significantly higher than those in the conventional group [(39.68±6.26), (42.66±6.32) HU, 2.58±0.61, t=5.608, 7.897, 2.162, P<0.05]. The aortic noise, CNR and subjective scores between the two groups had no significant difference( P>0.05). The CTDIvol, DLP, and E in the test group were (3.09±1.02) mGy, (107.57±32.81) mGy•cm, (1.51±0.46) mSv, significantly lower than those in the conventional group [(7.00±1.80) mGy, (261.65±73.93) mGy•cm, (3.66±1.03) mSv;t=-14.680, -14.756, -14.756, P<0.05]. Conclusions: In the screening of COVID-19, using low-dose scanning mode of 3-G DSCT combined with iterative reconstruction technology would provide diagnostic quality images and meanwhile effectively reduce the radiation dose and improve the SNR of the image. Copyright © 2020 by the Chinese Medical Association.

8.
Epidemiol Infect ; 148: e174, 2020 08 07.
Article in English | MEDLINE | ID: covidwho-695910

ABSTRACT

Coronavirus disease 2019 (COVID-19) is a global health threat. A hospital in Zhuhai adopted several measures in Fever Clinic Management (FCM) to respond to the outbreak of COVID-19. FCM has been proved to be effective in preventing nosocomial cross infection. Faced with the emergency, the hospital undertook creative operational steps in relation to the control and spread of COVID-19, with special focuses on physical and administrative layout of buildings, staff training and preventative procedures. The first operational step was to set up triaging stations at all entrances and then complete a standard and qualified fever clinic, which was isolated from the other buildings within our hospital complex. Secondly, the hospital established its human resource reservation for emergency response and the allocation of human resources to ensure strict and standardised training methods through the hospital for all medical staff and ancillary employees. Thirdly, the hospital divided the fever clinic into partitioned areas and adapted a three-level triaging system. The experiences shared in this paper would be of practical help for the facilities that are encountering or will encounter the challenges of COVID-19, i.e. to prevent nosocomial cross infection among patients and physicians.


Subject(s)
Coronavirus Infections/therapy , Emergency Medical Services/methods , Hospital Design and Construction/methods , Pneumonia, Viral/therapy , COVID-19 , China/epidemiology , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Cross Infection/prevention & control , Disease Outbreaks , Emergency Medical Services/organization & administration , Emergency Medical Services/standards , Fever/diagnosis , Fever/etiology , Fever/therapy , Hospital Design and Construction/standards , Humans , Pandemics/prevention & control , Personal Protective Equipment , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Teaching , Time Factors , Triage/methods , Ventilation/standards , Workflow , Workforce/organization & administration , Workforce/standards
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