Sulfonated Hydrogel Formed via CO2-in-Water Emulsion: Potential in Antibiotic Removal.

Herein, a green, carbon dioxide-in-water high-internal-phase emulsion (C/W HIPEs) was developed and stabilized with polyvinyl alcohol (PVA) for the formation of chitosan oligosaccharide/poly(acrylamide-co-sodium 4-styrene sulfonate) [COS/P(AM-co-SSS)] monolithic porous hydrogel. The obtained monolith was characterized via FT-IR and SEM. The SEM patterns depicted that the monoliths were interconnected, the void sizes were 78.5 µm, and the interconnected pore throats were 28 µm approximately. Mechanical measurement results indicated that the maximum compress stress of the monolith could reach 334.4 kPa at 90% strain, and it exhibited good mechanical stability. After 200 cycles of compression, it could still recover its original shape without cracking. The obtained COS-based monolith was selected to remove tetracycline (TC) for evaluating the adsorptive features of the interpenetrating pore-containing monolith. The monolithic COS/P(AM-co-SSS) hydrogel behaved with strong antibiotic adsorption capacity (1600.4 mg/g for TC). The adsorption process agreed well with the pseudo-second-order kinetic and Langmuir isothermal models. In addition, the porous monolith had a strong electrostatic force on TC according to the thermodynamic study. This work provides a green route for the development of novel monolithic hydrogels and highlights its potential application in the treatment of antibiotic-containing wastewater.

Heparin-Mimetic Chitooligosaccharides-Based Monoliths Obtained from C/W Emulsions: Hemocompatibility and Toxin Removal Ability.

Hemoperfusion (HP) is one of the most prominent therapies for treating uremia, hyperbilirubinemia, and acute drug toxicity. The comprehensive performance of currently used porous HP adsorbents needs to be improved due to the impediment to their synthesis strategy. Herein, green carbon dioxide-in-water high internal phase emulsions (C/W HIPEs) were utilized and emulsified with poly(vinyl alcohol) (PVA) for the formation of a heparin-mimetic chitosan oligosaccharides/poly(acrylamide-co-sodium 4-styrenesulfonate) [COS/P(AM-co-SSS)] monolith, which exhibited good mechanical properties, stable swelling performance, hydrophilic properties, anticoagulant effect, and low hemolysis. It showed a strong toxin adsorption capacity (415.2 mg/g for creatinine, 199.3 mg/g for urea, 279.5 mg/g for bilirubin, and 160 mg/g for tetracycline). The adsorption process of porous COS/P(AM-co-SSS) followed the pseudo-second-order kinetic and Langmuir isotherm models. Moreover, the porous materials had a strong electrostatic force on creatinine. The removal of creatinine by simulated in vitro blood perfusion was 80.2% within 30 min. This work provides a green preparation strategy for developing novel HP materials, highlighting their potential application value in blood and environmental purification.

A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and Giotrif® in healthy Chinese subjects.

OBJECTIVE: Afatinib is an oral, irreversible ErbB family blocker. It binds covalently to the kinase domains of epidermal growth factor (EGFR), HER2 and HER4, resulting in irreversible inhibition of tyrosine kinase autophosphorylation. Our trial compared the bioequivalence and safety between afatinib produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Giotrif® produced by Boehringer Ingelheim. METHODS: Healthy Chinese subjects (N = 36) were randomly divided into two groups at a ratio of 1:1. There was a single dose per period of afatinib and Giotrif®. The washout was set as 14 days. Plasma drug concentrations of afatinib and Giotrif® were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Statistical analysis of major pharmacokinetic (PK) parameters was conducted to assess drug bioequivalence. In addition, we evaluated the safety of the drugs throughout the trial. RESULTS: The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for afatinib and Giotrif® were 102.80%, 101.83%, and 101.58%, respectively. The 90% confidence intervals (CIs) were all within 80%-125%, meeting the bioequivalence standards. In addition, both drugs showed a good safety profile during the trial. CONCLUSION: This study showed that afatinib was bioequivalent to Giotrif® in healthy Chinese subjects with well safety. CHINESE CLINICAL TRIAL REGISTRY: This trial is registered at the Chinese Clinical Trial website ( http://www.chinadrugtrials.org.cn/index.html # CTR20171160).

A randomized, double-blind, single-dose, parallel phase I clinical trial to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar and bevacizumab in healthy Chinese subjects.

BACKGROUND: Bevacizumab, a humanized monoclonal antibody against VEGF, can be used as a target therapy for colorectal cancer. A phase I clinical trial was conducted to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Bevacizumab (Roche Diagnostics GmbH) in healthy Chinese males. RESEARCH DESIGN & METHOD: Healthy Chinese subjects (N = 98) were randomly divided into two groups. A single-dose bevacizumab biosimilar or Bevacizumab was given per cycle. Plasma drug concentrations were detected by liquid chromatography-tandem mass spectrometry (LC-MC/MS) assay. We detected the levels of anti-drug antibody (ADA) to evaluate drug immunogenicity and the safety of drugs throughout the study. RESULTS: The geometric mean ratios (GMRs) of AUC0-t, Cmax, and AUC0-∞ for bevacizumab biosimilar and Bevacizumab were 96.27%, 93.69%, and 97.01%, respectively. The 90% CIs were all within 80-125%, meeting the bioequivalence standards. The levels of ADA were similar. In addition, the two drugs both demonstrated excellent safety in the trial. CONCLUSION: This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects.

Whether Social Participation Can Affect the Central Government Public Policy Response to the COVID-19 in China.

Objective: The coronavirus disease 2019 (COVID-19) outbreak has threatened the state's governance and public safety. This study investigates whether and how public participation can affect central government policy response to this pandemic in the context of China. Methods: This study constructs the theoretical framework based on theoretical analysis, and Social Network Analysis is used to analyze data on the public participation, New Media, and the central government response in this pandemic. Results: Findings show that the Chinese central government does not always adopt top-down elitist governance strategies in risk management. The central government will also adopt the bottom-up governance strategy triggered by public participation. In this process, New Media acts as a catalyst. Specifically, when faced with a public emergency and needs a policy response from the central government, public participation firstly creates "participation" with the authority of the media, forms public opinion, and then the prompt policy response from the central government. Conclusion: This study confirms that the central government will refer to public participation to decide the policy response. It also shows that the theory of government response applies to both the local government and the central government.

A randomized, open-label, single-dose, two-cycle crossover study to evaluate the bioequivalence and safety of lenvatinib and Lenvima® in Chinese healthy subjects.

BACKGROUND: Lenvatinib is a tyrosine kinase receptor inhibitor that inhibits vascular and endothelial growth factor receptor kinase activity. This study evaluated the bioequivalence and safety of lenvatinib with Lenvima® . RESEARCH DESIGN AND METHODS: The fasting and postprandial groups were two independent trials. Subjects were randomly divided into two sequences at a ratio of 1:1 for two-cycle crossover administration. Subjects took 10 mg lenvatinib or Lenvima® once per cycle. The wash-out period was 14 days. Detected the plasma drug concentrations and assessed the bioequivalence of two drugs. Besides, we evaluated the safety of the drugs throughout the trial. RESULTS: In the fasting state, the GMRs of Cmax, AUC0-t, and AUC0-∞ were 99.89%, 102.98% and 103.19%, respectively. The 90% CIs were all within 80%-125%. In the postprandial state, the GMRs of Cmax, AUC0-t, and AUC0-∞ were 98.96%, 94.25% and 95.27%, respectively. The 90% CIs were all within 80%-125%. All results met the bioequivalence criteria. Both drugs had good safety and tolerance in this trial. CONCLUSION: This study showed that lenvatinib and Lenvima® had similar bioequivalence and safety in healthy Chinese subjects under fasting and postprandial conditions. CLINICAL TRIAL REGISTRATION: This trial is registered at the Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html # CTR20191172).

Regional Disparity and Patients Mobility: Benefits and Spillover Effects of the Spatial Network Structure of the Health Services in China.

BACKGROUND: The distribution of medical resources in China is seriously imbalanced due to imbalanced economic development in the country; unbalanced distribution of medical resources makes patients try to seek better health services. Against this backdrop, this study aims to analyze the spatial network characteristics and spatial effects of China's health economy, and then find evidence that affects patient mobility. METHODS: Data for this study were drawn from the China Health Statistical Yearbooks and China Statistical Books. The gravitational value of China's health spatial network was calculated to establish a network of gravitational relationships. The social network analysis method was used for centrality analysis and spillover effect analysis. RESULTS: A gravity correlation matrix was constructed among provinces by calculating the gravitational value, indicating the spatial relationships of different provinces in the health economic network. Economically developed provinces, such as Shanghai and Jiangsu, are at the center of the health economic network (centrality degree = 93.333). These provinces also play a strong intermediary role in the network and have connections with other provinces. In the CONCOR analysis, 31 provinces are divided into four blocks. The spillover effect of the blocks indicates provinces with medical resource centers have beneficial effects, while provinces with insufficient resources have obvious spillover effects. CONCLUSION: There is a significant gap in the geographical distribution of medical resources, and the health economic spatial network structure needs to be improved. Most medical resources are concentrated in economically developed provinces, and these provinces' positions in the health economic spatial network are becoming more centralized. By contrast, economically underdeveloped regions are at the edge of the network, causing patients to move to provinces with medical resource centers. There are health risks of the increasing pressure to seek medical treatment in developed provinces with abundant medical resources.