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【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.
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【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.
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OBJECTIVE： Te analyze the problems of clinical use in pediatric drug in China， and to put forward related countermeasures and suggestions. METHODS： Using “children” and “pediatrics” as retrieval words， registered drug information were retrieved from the website of China Food and Drug Administration； the data of pediatric drug use prescription was retrieved from hospital prescription system of 9 hospitals； all drug information were retrieved from national drug data management system； off-label drug use investigation and the literatures of pediatric drug use in medical institutions （5 representative third grade general medical institutions） were retrieved from CNKI and Wanfang database. General information and problems of pediatric drug use in China were investigated. RESULTS： A total of 170 009 items of registered drug information were retrieved， including 2 784 drug information items labeled with ”children” or ”pediatrics”， accounting for 1.64％；320 000 drug prescriptions from hospital prescription system of 9 hospitals covered 22 treatment areas involving 1 186 drugs and 51 dosage forms. Only 10％ suitable for children. The retrieval results of database showed that the incidence of children off-label drug use in outpatients prescriptions of 5 hospitals was in high level， mainly manifesting as without the information of pediatric drug use， hyper-indication drug use， hyper-dosage drug use. There were many problems in clinical pediatric drug use in China， such as less variety for children， single dosage form and specification， widespread off-label drug use， lack of scientific reference for drug use， difficulty in developing pediatric drug clinical trials， etc. CONCLUSIONS： Although the policies to protect children’s clinical drug use have been introduced in China， the problems facing children’s clinical drug use in China are still very serious. While further implementing relevant policies， it is necessary to establish a linkage management system led by government departments， with the full participation and mutual cooperation of society， enterprises， medical institutions and patients so as to guaratee the safety of pediatric drug use in clinic.
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The paper analyzes the effect ofInternet +on the purchase of periodical resources for libraries of medical colleges based on the discussion of the concept of Internet + ,points out the current situation and problems of purchase of periodicals for libraries of medical college,puts forward the periodical purchase modes and scheme proposals that conform to the current trend,and lays a foundation for the development of libraries of medical colleges.
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Objective To construct the prokaryotic expression vector pET30a( +)-VH-mms13 and identification of its protein after induced with IPTG.Method Heavy chain variable region VH gene of typeⅣcollagenase monoclonal antibody and magnetosome membrane protein gene mms13 were amplified separately,the fusion gene VH-linker-mms13 were synthesized by SOE-PCR technique and inserted into pET30a ( +) plasmid, which was confirmed by restriction enzyme digest and sequencing.Then the recombinant plasmid pET30a ( +)-VH-mms13 was transform into E.coli DE3 and induced with 0.4 mmol/L IPTG.The fused protein was identified by SDS-PAGE and Western blot.Results The length of fusion gene VH-mms13 was 738 bp,and the sequence was correct.After induced with IPTG,the fused protein was found in the inclusion body and Western blot results suggested that the fused protein can bind with His-tag antibody specifically.Conclusion Expression vector pET30a ( +)-VH-mms13 is successfully constructed and the fusion protein has good immunogenicity,which lay the foundation for the development of biomagnetism-targeted drug.
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Aim To observe the protective effects of total saponi ns of tribulus (TST) on cerebral ischemia reperfusion injury in rats. Meth ods Rat cerebral ischemia-reperfusion injury was induced by middle cer ebral artery occlusion .The neurological outcome was evaluated. CK, LDH and NO a ctivity in serum,SOD and MDA levels of cerebral tissue were measured. Re sults The levels of CK,LDH,NO,SOD and MDA in TST(30 mg?kg -1,1 0 mg?kg -1) groups were significantly lower than those in model group. The level of cellular and intercellular edema was reduced markly in the pathomorpho logy examination. The neurological deficits was decreased by TST.Conclus ion TST has protective effects on cerebral ischemia reperfusion injur y in rats.