Objective:This current study aims to explore the approaches for constructing a professional clinical research system within the context of research ward development, with the ultimate objective of providing valuable guidance for the establishment and development of proficient clinical research teams.Methods:Through a comprehensive case analysis, integrating the practical experiences from clinical trials conducted in the research ward of a Class-A tertiary hospital in Beijing, along with an extensive review of relevant literature and policy studies, this paper examined the current state of domestic clinical research implementation teams. Subsequently, a series of strategies were devised to build and foster professional clinical research teams and to explore corrective measures for cultivating a dynamic professional clinical research talent ecosystem.Results:The development of full-time clinical research teams in China was rather slow, and there was a lack of mature clinical trial teams training blueprints. Drawing on the practical experience accumulated during the establishment of a professional clinical research team in a leading hospital in Beijing, it was crucial to attach utmost importance to the optimal allocation of human and material resources. This required the systematic training of principal investigators, coordinating researchers, and research assistants, as well as the setting up of a comprehensive support system, an advanced scientific research team, and a quality control unit. Moreover, the standardization of operational models of both domestic and foreign research institutions, along with the implementation of corresponding support and incentive mechanisms, and the strengthening of training and continuing education frameworks were equally significant.Conclusions:During the process of assembling a full-time clinical research team, it is of utmost significance to cultivate professional principal investigators, coordinating researchers, and research assistants. Complemented by the establishment of a comprehensive support team, a scientific research team, and a quality control team, along with corresponding support and incentive mechanisms, this is crucial for constructing a professional clinical research execution team and a sustainable talent ecosystem in the research ward. Eventually, this will drive the efficient and high-quality progress of China's pharmaceutical industry.

Objective:This current study aims to explore the approaches for constructing a professional clinical research system within the context of research ward development, with the ultimate objective of providing valuable guidance for the establishment and development of proficient clinical research teams.Methods:Through a comprehensive case analysis, integrating the practical experiences from clinical trials conducted in the research ward of a Class-A tertiary hospital in Beijing, along with an extensive review of relevant literature and policy studies, this paper examined the current state of domestic clinical research implementation teams. Subsequently, a series of strategies were devised to build and foster professional clinical research teams and to explore corrective measures for cultivating a dynamic professional clinical research talent ecosystem.Results:The development of full-time clinical research teams in China was rather slow, and there was a lack of mature clinical trial teams training blueprints. Drawing on the practical experience accumulated during the establishment of a professional clinical research team in a leading hospital in Beijing, it was crucial to attach utmost importance to the optimal allocation of human and material resources. This required the systematic training of principal investigators, coordinating researchers, and research assistants, as well as the setting up of a comprehensive support system, an advanced scientific research team, and a quality control unit. Moreover, the standardization of operational models of both domestic and foreign research institutions, along with the implementation of corresponding support and incentive mechanisms, and the strengthening of training and continuing education frameworks were equally significant.Conclusions:During the process of assembling a full-time clinical research team, it is of utmost significance to cultivate professional principal investigators, coordinating researchers, and research assistants. Complemented by the establishment of a comprehensive support team, a scientific research team, and a quality control team, along with corresponding support and incentive mechanisms, this is crucial for constructing a professional clinical research execution team and a sustainable talent ecosystem in the research ward. Eventually, this will drive the efficient and high-quality progress of China's pharmaceutical industry.

To improve patient-centered pharmaceutical management and pharmaceutical service capabilities in the pharmaceutical department of medical institutions,automation and information technology are indispensable.The Pharmacy Administration-Automation and Information Technology is one of the social organization standards of the Chinese Hospital Association as part 4-4 of Pharmaceutical Administration and Pharmaceutical Practice in Healthcare,which standardizes 32 key elements in four aspects:basic requirements for automation construction in medical institutions,construction of automation hardware equipment,construction of intelligent information platform,and quality management and continuous improvement.It can be used to guide medical institutions at all levels to select and optimize pharmacy automation equipment and information platforms.This article introduced the construction methods and contents of the pharmacy automation and information technology standards,to deepen the understanding of peers on this standard and promote its implementation.This article aimed to promote the modernization,informatization,and intelligence of pharmaceutical services in medical institutions,and improve the quality and efficiency of overall medical pharmaceutical administration and service.

Objective:As a newly emerging thing, the construction and operation management of research wards are still being explored. According to the previous practice, this study summarized and shared the key points of a demonstration research ward in Beijing, and provided a reference for the development of domestic research wards.Methods:Focusing on improving the efficiency and quality of clinical research, this article summarizes and shares the experience of research ward construction. In addition, this study explores how to maintain the high-quality sustainable development of research wards from the aspects of improving core competence, system construction, and talent training.Results:Professional teams, innovative operation modes, as well as intelligence and informatization could improve the quality of clinical research. Besides, the improvement of core competence, talent training, and policy support ensure sustainable development of research wards.Conclusions:As clinical research platforms, the development paths of research wards need to be clarified further. The standardized construction and sustainable development of research wards can effectively improve clinical research capability and promote the transformation of scientific achievements.

Objective:To explore the feasibility of pulse wave recording in the pharmacodynamics and safety evaluation in clinical trials of sedative-hypnotics.Methods:The subjects were male healthy subjects who were publicly recruited by the research ward of Beijing Friendship Hospital, Capital Medical University from April 11 to June 11, 2022. The pharmacokinetic parameters of the single or combined use of midazolam were calculated based on the pharmacokinetic parameter analysis set. The occurrence of adverse events during the trial were recorded. Healthy subjects wore pulse wave recording watches for 24 hours in states of without medication, midazolam alone, and midazolam combined with itraconazole, and the subjects′ heart rate and body movement data were recorded, and pharmacodynamic evaluation indicators such as sleep duration, sleep depth and multiple dreams were compared with safety evaluation indicators such as mental state, circadian rhythm and life vitality.Results:A total of 12 healthy male subjects were included, aged (34±6) years. When using midazolam alone, the median Tmax was 0.5 hour, Cmax was (19.10±5.35) μg/L, AUC 0-t was (45.41±13.88) min·μg/L, and AUC 0-∞ was (46.99±14.74) min·μg/L. After combination with itraconazole, the median Tmax was still 0.5 hour, Cmax was (61.05±19.0) μg/L, AUC 0-t was (394.36±60.26) min·μg/L, and AUC 0-∞ was (553.10±178.87) min·μg/L. The 90% confidence interval for the geometric mean ratio of the AUC 0-t between midazolam combined with itraconazole and midazolam alone was 735.24% to 1 061.57%. Among the 12 subjects, 9 had a total of 26 adverse events, all of which were mild. The results of pulse wave recording showed statistically significant differences in sleep duration[(5.40±1.35), (6.50±1.85), and (8.05±0.8) hours, P=0.001], sleep depth [(14.13±5.15), (19.00±4.62), and (24.32±3.66) points, P=0.005] and life vitality[40.00(38.00,41.00), 36.50(35.25,38.75), and 32.50(30.00,36.00) points, P<0.001] in subjects in states of without medication, midazolam alone, and midazolam combined with itraconazole. Conclusion:Pulse wave recording can be used for a real-time, objective, quantitative assessment of the pharmacodynamics and safety of sedative-hypnotics.

Objective:To explore the feasibility of pulse wave recording in the pharmacodynamics and safety evaluation in clinical trials of sedative-hypnotics.Methods:The subjects were male healthy subjects who were publicly recruited by the research ward of Beijing Friendship Hospital, Capital Medical University from April 11 to June 11, 2022. The pharmacokinetic parameters of the single or combined use of midazolam were calculated based on the pharmacokinetic parameter analysis set. The occurrence of adverse events during the trial were recorded. Healthy subjects wore pulse wave recording watches for 24 hours in states of without medication, midazolam alone, and midazolam combined with itraconazole, and the subjects′ heart rate and body movement data were recorded, and pharmacodynamic evaluation indicators such as sleep duration, sleep depth and multiple dreams were compared with safety evaluation indicators such as mental state, circadian rhythm and life vitality.Results:A total of 12 healthy male subjects were included, aged (34±6) years. When using midazolam alone, the median Tmax was 0.5 hour, Cmax was (19.10±5.35) μg/L, AUC 0-t was (45.41±13.88) min·μg/L, and AUC 0-∞ was (46.99±14.74) min·μg/L. After combination with itraconazole, the median Tmax was still 0.5 hour, Cmax was (61.05±19.0) μg/L, AUC 0-t was (394.36±60.26) min·μg/L, and AUC 0-∞ was (553.10±178.87) min·μg/L. The 90% confidence interval for the geometric mean ratio of the AUC 0-t between midazolam combined with itraconazole and midazolam alone was 735.24% to 1 061.57%. Among the 12 subjects, 9 had a total of 26 adverse events, all of which were mild. The results of pulse wave recording showed statistically significant differences in sleep duration[(5.40±1.35), (6.50±1.85), and (8.05±0.8) hours, P=0.001], sleep depth [(14.13±5.15), (19.00±4.62), and (24.32±3.66) points, P=0.005] and life vitality[40.00(38.00,41.00), 36.50(35.25,38.75), and 32.50(30.00,36.00) points, P<0.001] in subjects in states of without medication, midazolam alone, and midazolam combined with itraconazole. Conclusion:Pulse wave recording can be used for a real-time, objective, quantitative assessment of the pharmacodynamics and safety of sedative-hypnotics.

Objective To study the effect of paeoniflorin on inflammatory chemokines and their receptor in a rat model of ovalbumin-induced asthma.Methods Sixty 6-week old SPF female BALB/c mice were used in this study.To es-tablish a mouse model of asthma by sensitizing and challenging with ovalbumin.ELISA was used to analyze the serum IL-6 and TNF-α, and the specific IgE against ovalbumin ( OVA-IgE ) , CCL19 and CCL21 in bronchoalveolar lavage fluid (BALF).RT-PCR was performed to determine CCR7mRNA and protein expression of chemokine receptor CCR7, and the level of NF-κB was tested by Western blot.ResultsIn In the paeoniflorin groups, the serum IL-6 and TNF-αlevels were significantly lower, and the OVA-IgE, CCL19 and CCL21 levels in BALF were significantly reduced, compared with that in the control group.CCR7mRNA and protein expression of chemokine receptor CCR7 and NF-κB in the lung were significant-ly reduced by paeoniflorin.Conclusions Paeoniflorin has a remarkably inhibitory effect on the airway inflammatory chemo-kines CCL19/CCL21 and the receptor CCR7 in the mouse model of asthma.

Objective To observe if fluoxetine has a potency to inhibit the progression of Lewis lung cancer by combining the fluoxetine and cisplatin to treat the mice bearing Lewis lung cancer with depression .Methods We devel-oped a mouse model of Lewis lung cancer with depression which was intervened with cisplatin and fluoxetine , and the indi-cators related to cancer and depression were tested .Social interaction test was used to measure the behavioral changes of the depressed model mice .The serum cortisol and IL-6, BDNF mRNA in the hippocampus , and NF-κB and VEGF in the tumor tissue were selected for investigation and comparison .Results The mice which were induced by social defeat exhib-ited social avoidance behavior in the social interaction test .The cortisol and IL-6 level in both combination groups was de-creased compared with that in the model group (P<0.05), and the cortisol and BDNF mRNA in the combination group in-creased signifuicantly ( P <0.05 ) .There were no statistically significant differences in the tumor weight , NF-κB and VEGF in tumor tissues between the single and combination groups (P>0.05).Conclusions Fluoxetine has antidepres-sant effect by decreasing the high level of serum cortisol and promoting the BDNF mRNA expression in the hippocampus . However , fluoxetine is not found to have the potency to inhibit the expression of NF -κB related with the progression of tumor.

BACKGROUNDBu-Shen-Yi-Qi-Tang (BSYQT), which is prescribed on the basis of clinical experience, is commonly used in clinics of traditional Chinese medicine (TCM) for asthma treatment. The components of BSYQT include Radix Astragali (RA), Herba Epimedii (HE) and Radix Rehmanniae (RR). The aim of this study was to compare the effect of granules and herbs of BSYQT on airway inflammation in asthmatic mice.

METHODSSixty female BALB/c mice were randomly divided into the normal control (NC) group, asthmatic group (A), decoction of granules of BSYQT treatment group (GD), decoction of herbs of BSYQT treatment group (HD), and dexamethasone treatment group (DEX). The mouse asthmatic model was induced by ovalbumin (OVA) sensitization and challenge. GD and HD of BSYQT as well as DEX were prepared and administered by intragastric infusion. Airway hyperresponsiveness (AHR) to methacholine (Mch), lung histopathology analysis, inflammatory mediators in serum (IL-4, IL-5, IL-17A, IFN-γ, and eotaxin) and in lung (IL-4, IL-5, IFN-γ, and eotaxin) were selected for investigation and comparison.

RESULTSBoth GD and HD treatment could decrease airway resistance (RL) and increase dynamic compliance (Cdyn) to Mch compared with the A group (P < 0.05). HD treatment was more effective in RL reduction than Mch at doses of 3.125 and 6.25 mg/ml (P < 0.05) and in Cdyn increase at Mch doses of 6.25 and 12.5 mg/ml (P < 0.05). There were no marked differences in RL reduction and Cdyn improvement between mice in HD and DEX groups (P > 0.05). Both GD and HD treatment markedly attenuated lung inflammation (P < 0.05), and HD treatment demonstrated more significant therapeutic function in alleviating lung inflammation than that of GD and DEX treatment (P < 0.05). Both GD and HD treatment resulted in a significant reduction in IL-4 and IL-17A levels and an increase in the IFN-γ level in serum compared with the A group (P < 0.05). The effect of HD in lowering the IL-4 and IL-17A level was significantly greater than that of GD (P < 0.05), and was not significantly different from DEX (P > 0.05). HD treatment significantly reduced the serum level of IL-5 and eotaxin compared with the A group (P < 0.05), however, mice in the GD treatment group did not demonstrate this effect. GD and HD treatment significantly reduced IL-4 and eotaxin mRNA expression compared with the A group (P < 0.05). HD treatment significantly reduced IL-5 mRNA expression compared with the A group (P < 0.05). There was a significant difference between the GD and HD treatment groups in reducing IL-5 and eotaxin mRNA expression (P < 0.05). HD treatment was more effective in down-regulation of IL-5 in serum and eotaxin level both in serum and lung than DEX (P < 0.05). Compared with the A group, an obvious increase in mRNA expression of IFN-γ was observed in both the GD and HD treatment groups (P < 0.05). However, the effect of HD treatment on increase of IFN-γ mRNA expression was more apparent than GD and DEX treatment (P < 0.05).

CONCLUSIONSBoth GD and HD treatment could decrease AHR, attenuate lung inflammation, reduce IL-4, IL-5, IL-17A, and eotaxin levels and increase IFN-γ levels in asthmatic mice. HD treatment manifests more remarkable inhibitory effects on asthmatic inflammation than GD treatment, which could provide a guide for further research on the screening of the material basis of the best anti-inflammatory effect of BSYQT.

Animals ; Asthma ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Inflammation ; drug therapy ; Medicine, Chinese Traditional ; Mice ; Mice, Inbred BALB C

Chronic obstructive pulmonary disease ( COPD) is a prevalent disease which is the fourth leading cause of death worldwide and will be the major economic burden of diseases according to the World Bank /World Health Organization .However , the pathogenesis of COPD is inadequately understood , oxidative stress and chronic inflammation are considered to be two independent path -ogenetic factors , but the epigenetic put them together because of changes of the environment lead to gene abnormal expression .This ar-ticle summarizes the relationship between histone modifications of genes induced by oxidative stress and the inflammation , antioxidant response, apoptosis, autophagy and the differentiation of T cell subsets in the pathogenesis of COPD .The work will provide more choices for clinical treatment of COPD .