Objective To prepare an influenza A(H1N1) split-virus vaccine and observe its safe-ty and effectiveness. Methods According to the process for preparing seasonal flu split-virus vaccine two batches of vaccine were prepared with the flu A (H1N1) vaccine virus strain recommended by WHO. The pilot products were tested against the requirements of flu split-virus vaccine. Results The quality of the pi-lot vaccine has been tested by National Control Laboratory and conformed to the requirements. Nine hundred and sixty volunteers received one dose of vaccine containing either 15 μg or 30 μg of hemagglutinin. The re-suits indicated the both seroconversion rate and protection rate were higher the 70%. The GMT of HIAb of the volunteers who received 1 dose of 15 μg increased significantly by 15, 39, 37 and 25 times compared to those before vaccination in the age groups of 3-11, 12-17, 18-59 and ≥60, respectively. And 26, 72, 68 and 36 times rise were found in the postvaccinated volunteers of 30 μg group. The total adverse reaction rates of 15 μg and 30 μg dose group were 29.38% and 43.75%, respectively. The grade 2 adverse reaction rates of 15 μg and 30 μg dose group were 6.25% and 15.42%, and the grade 3 adverse reaction rates of 15 μg and 30 μg dose group were 0.83% and 1.46%, respectively. No serious adverse reactions were found. Conclusion The influenza A (H1N1) split-virus vaccine prepared according to the requirements of season-al flu vaccine is safe and effective.

Objective:To systematically integrate the attitudes and experiences of medical staffs towards the family presence during resuscitation and provide a reference for the development of family presence during resuscitation clinical practice in China.Methods:To search PubMed, Embase, Web of Science, The Cochrane Library, CINAHL, CNKI, CBM and Wanfang database for qualitative studies on medical staff's attitudes and experiences of family presence during resuscitation since its inception to August 2022. The quality of the literature was evaluated using the Australian JBI Centre for Evidence-Based Health Care (2017) quality assessment criteria for qualitative studies, which were integrated using a pooled integration approach.Results:A total of 12 papers were included to distil the findings of 74 studies, which were summarized to form 10 new categories and 4 consolidated findings including medical staffs′ attitudes towards and reasons for family presence during resuscitation, the impact of family presence during resuscitation on the resuscitation team, the impact of family presence during resuscitation on patients and families, and the real-life dilemmas and recommendations for medical staffs to allow family presence during resuscitation.Conclusions:We should pay attention to the difficulties and needs of family presence during resuscitation by medical staff, take into account the medical context in China, and improve the humanistic care system in our hospitals by considering hospital management, clinical practice, and the demands of patients and their families, in order to improve the accessibility of family presence during resuscitation by the medical staff.

【Objective】 To evaluate the efficacy and safety of human coagulation factor Ⅷ developed by Shenzhen Weiguang Biological products Co, Ltd in the treatment of patients with hemophilia A. 【Methods】 A prospective, multi-center, open, single-group clinical study was conducted. A total of 65 subjects with hemophilia A were enrolled, and human coagulation factor Ⅷ(FⅧ) was injected according to the patients’ bleeding severity. The improvement score of bleeding symptoms and signs after the first infusion of the first bleeding event and the transfusion efficiency of FⅧ activity at 10 min and 1 hour after infusion were taken as the main efficacy indexes. The improvement scores of bleeding symptoms and signs after the first infusion and the increase of FⅧ activity at 10 min and 1 hour after infusion were the secondary efficacy indexes. 【Results】 The 65 subjects were enrolled in safety analysis set (SS) and full analysis set (FAS), and 58 of them were enrolled in protocol analysis set (PPS). Ten minutes and one hour after the first infusion, the level of factor Ⅷ activity in the subjects increased significantly, and the FⅧ activity increased by 100% or more in more than 79% of the subjects. The average infusion efficiency of FⅧ activity in all subjects was more than 100%. In 70% of the subjects, the pain was relieved rapidly and /or the bleeding symptoms were significantly improved 8 hours after each bleeding infusion, and the improvement rate of bleeding symptoms and signs reached 100% 72 hours after infusion. 【Conclusion】 After infusion of human coagulation factor Ⅷ, the activity level of factor Ⅷ in patients with hemophilia A significantly increased. The infusion efficiency can reach a optimal level, and the bleeding symptoms can be significantly improved.

【Objective】 To evaluate the clinical efficacy and safety of one kind of human prothrombin complex concentrate in treatment of patients with hemophilia B. 【Methods】 The clinical data of 36 patients with hemophilia B treated with human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. from May 2018 to April 2019 were retrospectively analyzed, and its clinical efficacy and safety were analyzed. 【Results】 A total of 35 subjects entered the full analysis set (FAS)and safety set (SS), 33 subjects entered the per protocol Set (PPS). Thirty minutes after the first infusion of FAS subjects, the activity of coagulation factor Ⅸ increased from (3.93±0.975) IU/dL to (25.61±9.337) IU/dL, and the infusion efficiency was (96.43±22.007)%. The increased value of coagulation factor Ⅱ activity was (73.25±14.874) IU/dL. The activity of coagulation factor Ⅶ was (42.79±16.847) IU/dL. The increased value of coagulation factor Ⅹ activity was (65.29±17.042) IU/dL. The increased value of coagulation factor Ⅸ activity was (21.68±9.434%) IU/dL. Twenty-four hours after the first infusion of FAS subjects, the improvement of bleeding symptoms and signs was excellent in 21 cases (60%), improved in 14 cases (40.0%), and the effective rate was 100%. The incidence of adverse reactions was 2.9%(1/35), and there was no antibody to human coagulation factor Ⅸ and new virus infection. 【Conclusion】 Infusion of human prothrombin complex concentrate produced by Shenzhen Weiguang Biological Products Co. Ltd. in the treatment of hemophilia B has significant clinical efficacy and good safety.

ObjectiveTo explore the mechanism of Buzhong Yiqitang in ameliorating inflammatory injury in autoimmune thyroiditis (AIT) mice based on the Toll-like receptor 4（TLR4）/nuclear transcription factor-kappa B（NF-κB）/absent in melanoma 2（AIM2）inflammasome signaling pathway. MethodThe 120 genetically susceptible 8-week-old NOD.H-2^h4 mice were selected and randomly divided into control group， model group， low， medium and high dose groups of Buzhong Yiqitang （4.78， 9.56， 19.12 g·kg^-1）， and western medicine group （selenium yeast tablets， 3.033×10^-5 g·kg^-1）. The AIT model mice in each group drank ad libitum 0.05% sodium iodide aqueous solution for 8 weeks to establish the AIT model， and the control group drank ad libitum distilled water. Eight weeks later， the mice in each dosing group were divided into groups and gavage. The swelling of thyroid tissue was observed with the naked eye， and the weight of spleen was weighed. The content of serum inflammatory factors interleukin-1β （IL-1β）， interleukin-6 （IL-6）， tumor necrosis factor-α （TNF-α） was measured by enzyme-linked immunosorbent assay （ELISA）， and Real-time PCR was used to detect the expression of HMGB1， TLR4， AIM2， NF-κB p65，apoptosis-associated speck-like protein（ASC），cysteinyl aspartate-specific protease-1（Caspase-1）， IL-1β mRNA. Western blot was used to detect the expression of high motility group protein 1 （HMGB1）， TLR4， AIM2， NF-κB p65， phosphorylation（p）-NF-κB p65， ASC， Caspase-1， and IL-1β proteins in thyroid tissue， and immunofluorescence staining was used to observe the protein expression of HMGB1， AIM2， and NF-κB p65 in thyroid tissue of mice. ResultCompared with the control group， the thyroid tissue of mice in the model group was significantly swollen， the spleen quality was significantly increased， and the expression of HMGB1， TLR4， NF-κB p65， AIM2， ASC， Caspase-1， IL-1β in thyroid tissue was significantly increased （P<0.01）. Compared with the model group， the swelling of thyroid tissue in mice in each dose group of Buzhong Yiqitang was improved， the quality of spleen was significantly reduced， and the expression of HMGB1， TLR4， AIM2， NF-κB p65， p-NF-κB p65， ASC， Caspase-1， IL-1β in thyroid tissue was significantly reduced （P<0.05， P<0.01）. ConclusionBuzhong Yiqitang can effectively improve the inflammatory injury of AIT， and regulating the abnormal activation of the TLR4/NF-κB/AIM2 inflammasome signal pathway may be one of its intervention mechanisms.