1.Brief Introduction on the Disclosure of FDA Information in US and Its Implication
China Pharmacy 2005;0(22):-
OBJECTIVE:To provide reference for food & drug regulatory authorities in China to disclose government information.METHODS:In the light of the development and status quo of the disclosure of information in US FDA,the access,content and procedure for the disclosure of information in FDA were discussed.RESULTS & CONCLUSIONS:There are many similarities between US and China in the disclosure of information.In view of the practical situation of governmental information disclosure in food and drug regulatory authorities in China,Chinese government should be able to find out such key issues as the human and financial support is much needed in FDA information disclosure,the disclosure level should be in line with our national condition,a three-dimensional publicity system of government information at different level should be established and emphasis should be laid to the key disclosed information etc based on the research on the development,access,content and procedure of information disclosure in FDA.
2.Applicability of Zebra Fish Thrombosis Model in Antithrombotic Activity Screening of Chinese Materia Medica
Jiaojiao FAN ; Yihan QIAO ; Chongjun ZHAO ; Yuanyuan NI ; Ran YANG ; Yaru FENG ; Zhiqiang MA ; Ruichao LIN
Chinese Journal of Information on Traditional Chinese Medicine 2017;24(7):58-61
Objective To investigate the applicability of zebra fish thrombosis model in antithrombotic activity screening of Chinese materia medica.Methods The living zebra fish thrombosis model was induced by adrenaline hydrochloride. Zebra fish were randomly divided into blank control group, model group, positive medicine group and medication group. Each group was given the corresponding medicine or embryo culture water. O-anisidine staining solution was used to stain and calculate the staining intensity of erythrocytes in zebra fish heart, and quantitative analysis was carried out. The platelet aggregation of transgenic zebra fish was observed and under qualitative analysis. Results Compared with the model group, 100μg/mL salvianolic acid B, 300, 900μg/mL aqueous extract of Salvia miltiorrhiza, 45μg/mL 95% ethanol extract and 400, 1200μg/mL hypothalamus could significantly inhibited the formation of zebra fish thrombosis (P<0.01).ConclusionZebra fish thrombosis model has good applicability in antithrombotic activity screening of Chinese materia medica.
3.Bone marrow stromal cells as a therapeutic treatment for cerebral ischemic
Yihan WANG ; Xu MA ; Suyuan LIU ; Jiayuan WANG
International Journal of Biomedical Engineering 2017;40(5):393-397
Bone marrow stromal cells (BMSCs) are a kind of stem cells with multiple differentiation potential in bone marrow.BMSCs have been widely used in tissue engineering,cell transplantation,gene therapy and organ transplantation,due to their characteristics of wide range of sources,weak immunogenicity weak,easily transfected by exogenous gene,long survival time in the host,multi-directional differentiation,etc.Cerebral ischemia is caused by neurological impairment,which is the most common cause of death and quality-of-life impairments.The clinical manifestations of the patients with cerebral ischemia are motor function failure,sensory dysfunction and abnormal mental consciousness.A large number of studies have reported that BMSCs transplantation has the therapeutic effects of body sensory and motor function recovery,and can treat ischemic stroke.BMSCs transplantation has brought new hope for the clinical treatment of ischemic cerebrovascular disease.In this paper,the recent progress in the study of BMSCs transplantation for ischemic stroke was reviewed.The mechanism,pathways,influencing factors and clinical application of BMSCs transplantation were summarized.
4.Effects of four types of perforator flaps pedicled with cutaneous neurotrophic vessels in repairing wounds on the volar side of hands
Hui WANG ; Tong ZHOU ; Yujie LIU ; Yihan ZHANG ; Ying LIU ; Tiepeng MA ; Xiaoxi YANG
Chinese Journal of Burns 2023;39(11):1038-1046
Objective:To investigate the effects of four types of perforator flaps pedicled with cutaneous neurotrophic vessels in repairing wounds on the volar side of hands.Methods:A retrospective observational study was conducted. From May 2012 to July 2021, 122 patients with wounds on the volar side of hands who met the inclusion criteria were admitted to the Department of Hand Surgery of the Second Hospital of Tangshan, including 74 males and 48 females, aged 18-76 years. There were 15 cases of palm injury alone, 101 cases of finger injury alone, and 6 cases of simultaneous palm and finger injury. The wounds with area ranging from 1.5 cm×1.2 cm to 15.0 cm×6.0 cm were all repaired by transplantation of perforator flaps pedicled with cutaneous neurotrophic vessels, including 16 cases of the ulnar artery perforator flap carrying the medial antebrachial cutaneous nerve, 20 cases of the dorsal metacarpal artery perforator flap carrying the dorsal metacarpal cutaneous nerve, 21 cases of the digital artery dorsal perforator flap of thumb carrying the terminal branch of lateral antebrachial cutaneous nerve, and 65 cases of the digital artery dorsal perforator flap of the 2 nd to 5 th finger carrying the dorsal branch of digital nerve, with the sizes of flaps ranging from 1.8 cm×1.4 cm to 20.0 cm×6.0 cm. High-frequency color Doppler ultrasonography was performed to locate and measure the perforators and cutaneous nerves of the flaps preoperatively. The cutaneous nerves carried by the flaps were all anastomosed with the nerves at the recipient sites during the operation. The donor sites were closed directly or repaired with split- or full-thickness free skin graft from the ipsilateral thigh or proximal medial forearm. The survival of the flaps and skin grafts at the flap donor sites, and the healing of incisions at the flap donor sites were observed postoperatively. The patients were followed up, and at the last follow-up, the static two-point discrimination distances of the flaps were measured, the degree of satisfaction of patients with the appearances of the flaps and flap donor sites were evaluated based on the evaluation criteria of Michigan Hand Function Questionnaire, and the functions of the affected hands were evaluated according to the trial criteria for upper limb function evaluation of the Hand Surgery Society of the Chinese Medical Association. Results:After surgery, the distal end of the ulnar artery perforator flap carrying the medial antebrachial cutaneous nerve transplanted in one patient and the digital artery dorsal perforator flap of the 2 nd to 5 th finger carrying the dorsal branch of digital nerve transplanted in two patients were partially necrotic but healed after dressing change; the flaps transplanted in the other 119 patients all survived. All skin grafts at the flap donor sites survived, and all incisions at the flap donor sites healed after surgery. The follow-up period was 10 to 36 months, with an average of 16 months. At the last follow-up, the static two-point discrimination distances of the ulnar artery perforator flaps carrying the medial antebrachial cutaneous nerve was 10 to 20 mm. Ten patients were strongly satisfied and 6 patients were satisfied in the evaluation of satisfaction with the appearance of the flaps. Seven patients were strongly satisfied and 9 patients were satisfied in the evaluation of satisfaction with the appearance of the flap donor sites. Functional evaluation of the affected hand was excellent in 7 cases, good in 7 cases, and fair in 2 cases. For the dorsal metacarpal artery perforator flap carrying the dorsal metacarpal cutaneous nerve, the static two-point discrimination distances of the flaps was 8 to 18 mm; 13 patients were strongly satisfied and 7 patients were satisfied in the evaluation of satisfaction with the appearance of the flaps; 10 patients were strongly satisfied and 10 patients were satisfied in the evaluation of satisfaction with the appearance of the flap donor sites; the functional evaluation of the affected hand was excellent in 11 cases, good in 7 cases, and fair in 2 cases. For the digital artery dorsal perforator flap of thumb carrying the terminal branch of lateral antebrachial cutaneous nerve, the static two-point discrimination distances of the flaps was 6 to 11 mm; 17 patients were strongly satisfied and 4 patients were satisfied in the evaluation of satisfaction with the appearance of the flaps; 13 patients were strongly satisfied and 8 patients were satisfied in the evaluation of satisfaction with the appearance of the flap donor sites; the functional evaluation of the affected hand was excellent in 15 cases and good in 6 cases. For the digital artery dorsal perforator flap of the 2 nd to 5 th finger carrying the dorsal branch of digital nerve, the static two-point discrimination distances of the flaps was 5 to 12 mm; 43 patients were strongly satisfied and 22 patients were satisfied in the evaluation of satisfaction with the appearance of the flaps; 47 patients were strongly satisfied and 18 patients were satisfied in the evaluation of satisfaction with the appearance of the flap donor sites; the functional evaluation of the affected hands were excellent in 39 cases, good in 21 cases, and fair in 5 cases. Conclusions:With the assistance of high-frequency color Doppler ultrasonography, four types of perforator flaps pedicled with cutaneous neurotropic vessels which are used to repair different types of wounds on the volar side of the hand can have reliable blood supply, are easy to cut, cause minimal secondary damage to the donor area, and have good recovery of the flap sensation after surgery.
5.The Data Model Design and Intelligent Applications of Health Portrait
Chun FAN ; Jie MA ; Anqi XU ; Yihan XU ; Jinlong SHI
Journal of Medical Informatics 2024;45(6):13-18
Purpose/Significance To explore the data model design and intelligent applications of health portrait.Method/Process The paper analyzes the current situation and problems of health portrait applications,standardizes the data collection,legislation and gov-ernance of health portrait,systematically establishes the data model of health portrait,and explores potential application scenarios for health portrait.Result/Conclusion The data model of health portrait is designed to enhance the comprehensiveness and pertinence of health portrait.The data model management system is established to improve the standardized management efficiency of the model.Two application scenarios of health portrait are summarized,namely"health management and assessment"and"accurate diagnosis and per-sonalized diagnosis and treatment",which help to improve the quality and effect of medical treatment,and meet individual health needs.
6.Changes of cytokines IL-4 and IFN-γ of serum in patients with chronic insomnia and mild cognitive impairment
Xinwei ZHENG ; Dong LI ; Lijuan GENG ; Chenfei LIU ; Su MA ; Huimiao LIU ; Yihan LIU ; Sai ZHANG ; Ping GU
Chinese Journal of Behavioral Medicine and Brain Science 2020;29(8):700-705
Objective:To investigate the characteristics of serum cytokine IL-4 and IFN- γ levels in patients with chronic insomnia with mild cognitive impairment (MCI), and to further explore the relationship between cognitive function and IL-4 and IFN-γ in patients with chronic insomnia.Methods:Sixty-two patients with chronic insomnia were divided into MCI group( n=30) and non-MCI group( n=32) according to the scores of Montreal cognitive assessment(MoCA), mini-mental state examination(MMSE) score and chief complaint of cognitive decline. Pittsburgh sleep quality index(PSQI), Hamilton depression scale(HAMD 24) and Hamilton anxiety scale 14 item(HAMA 14) were evaluated. Serum IL-4 and IFN-γ were detected by flow fluorescence, correlation analysis and regression analysis were carried out. Results:The levels of IL-4 and IFN-γ in MCI group were significantly lower than those in non-MCI group (IL-4: 0.875(0.143, 1.655)μg/L, 1.855(0.813, 2.723)μg/L; IFN-γ: 0.450(0.173, 1.163)μg/L, 1.160(0.483, 3.075)μg/L, all P<0.05). There was no significant difference in IFN- γ/IL-4, PSQI, HAMA 14 and HAMD 24 scores between MCI group and non-MCI group. IL-4 was positively correlated with the total score of MoCA( r=0.318, P<0.05), orientation( r=0.324, P<0.05)and delayed recall( r=0.368, P<0.01). The results of multivariate regression showed that IL-4 had significant effects on MCI in patients with chronic insomnia( B=2.161, OR=8.682, 95% CI=2.058~36.633, P=0.003). Conclusion:The cognitive function of chronic insomnia is closely related to serum IL-4 and IFN-γ, and serum IL-4 has a protective effect on cognition in chronic insomnia patients. Therefore, it can be speculated that cytokines may be an important pathophysiological link of cognitive change in chronic insomnia patients.
7.Progress on economic evaluation of pneumococcal vaccine
Yuekun TANG ; Xiang GUO ; Xiaoying MA ; Hongli JIANG ; Yihan LU ; Zhuoying HUANG ; Jing QIU ; Jia REN ; Xiaodong SUN
Chinese Journal of Preventive Medicine 2021;55(7):896-902
Review the literature on the economic evaluation of PCV-10, PCV-13 and PPSV-23 for providing references for decision-making and research in China. A total of 17 literatures were included, and the basic information to descriptive characteristics, methodology, modeling and the results were extracted. The 14 studies adopted Markov model, 2 studies adopted decision tree model and 1 study adopted probabilistic model. The cost including vaccine price and administration costs, direct medical expenses and indirect lost. All the 17 studies use QALY as the outcome, some studies also use LYG as the outcome. 9 of 13 studies (69.2%) involving people over the age of 50 concluded that pneumococcal vaccination was cost-effective. To provide effective references for decision-makers, China should collect the relevant epidemiological parameters, vaccine effect of pneumococcal disease in the Chinese population and carry out the economic evaluation of pneumococcal vaccination.
8.Progress on economic evaluation of pneumococcal vaccine
Yuekun TANG ; Xiang GUO ; Xiaoying MA ; Hongli JIANG ; Yihan LU ; Zhuoying HUANG ; Jing QIU ; Jia REN ; Xiaodong SUN
Chinese Journal of Preventive Medicine 2021;55(7):896-902
Review the literature on the economic evaluation of PCV-10, PCV-13 and PPSV-23 for providing references for decision-making and research in China. A total of 17 literatures were included, and the basic information to descriptive characteristics, methodology, modeling and the results were extracted. The 14 studies adopted Markov model, 2 studies adopted decision tree model and 1 study adopted probabilistic model. The cost including vaccine price and administration costs, direct medical expenses and indirect lost. All the 17 studies use QALY as the outcome, some studies also use LYG as the outcome. 9 of 13 studies (69.2%) involving people over the age of 50 concluded that pneumococcal vaccination was cost-effective. To provide effective references for decision-makers, China should collect the relevant epidemiological parameters, vaccine effect of pneumococcal disease in the Chinese population and carry out the economic evaluation of pneumococcal vaccination.
9.Study on Secondary Metabolites of Endophytic Fungus Fusarium sp. HSL-3 from Hainan Mangrove
WANG Lixia ; LI Sihui ; MA Yihan ; WU Bin
Chinese Journal of Modern Applied Pharmacy 2023;40(13):1759-1764
OBJECTIVE To study the secondary metabolites of the endophytic fungus Fusarium sp. HSL-3 isolated from Hainan Mangrove and screen their anti-inflammatory and anti-tumor activities. METHODS This fungus was fermented statically by using rice medium, and the secondary metabolites of the fungus were isolated and purified by column chromatography and HPLC. Structures indentification of the ortained compounds was carried out through MS and NMR. RESULTS Eight compounds were respectively isolated and identified as follows:lateritin(1), 4-carbomethoxy-6-hydroxy- 2-quinolone(2), 3,5-dimethoxydihydro-fusarubin D(3), anhydrofusarbin(4), 3,3'-methylene-bis(4-hydroxybenzaldehyde)(5), crypticin B(6), vanillyl alcohol(7) and 3,4-dihydroxyphenylaceticacid(8), among which, compounds 2 and 5 were isolated from the genus Fusarium for the first time. Compounds 3 and 5 showed good anti-inflammatory activity on RAW264.7 cells with the inhibition rate of NO at 50 µmol·L-1 were 87% for compound 3 and 71% for compound 5, while compound 1 showed significant cytotoxic activity against human non-small cell lung cancer cell line A549, among which the IC50 value was (7.92±0.27) µmol·L-1. CONCLUSION Compounds 3 and 5 isolated from endophytic fungus Fusarium sp. HSL-3 isolated from Hainan Mangrove show strong anti-inflammatory activity, while compound 1 shows significant anti-tumor activity.
10.Study on p-Hydroxybenzoic Acid on Rheumatoid Arthritis Via Inhibiting NF-κB/caspase-1 Signaling Pathway
MA Yihan ; WEI Chengqiong ; XU Xiaotian ; LU Xi ; WANG Yuhui ; DUAN Xiaoqun
Chinese Journal of Modern Applied Pharmacy 2023;40(18):2519-2525
OBJECTIVE To investigate the therapeutic effect of natural phenolic compound p-hydroxybenzoic acid(HA) on adjuvant arthritis(AA) induced by the complete Freund's adjuvant(CFA), and to clarify the mechanism of HA preliminary. METHODS Apart from the normal group, all rats received 0.1 mL CFA by plantar subcutaneous injection to induce AA rats model. And rats with AA were randomized to the model group, the low-, medium-, and high-dose HA group(2.5, 5, and 10 mg·kg-1, respectively), the positive control group(indomethacine, 5 mg·kg-1). The rats in each group were orally treated with the corresponding drugs for therapeutic intervention. The volume and leg thickness of the rats in each group were recorded and an inflated articular score was obtained. Inflammation cytokine expression(TNF-α, IL-1β and IL-6) was determined by ELISA and qPCR. Radiographs and HE staining were used to observe histopathological and pathological changes in the foot. The expressions of caspase-1 and NF-κB were examined in Western blotting. RESULTS HA could significantly alleviate joint swelling in AA rat(P<0.05), inhibited the production of inflammatory factors(TNF-α, IL-1β and IL-6) from protein and mRNA levels(P<0.05), and decreased the expression levels of caspase-1 and NF-κB at protein level(P<0.05). HA alleviated ankle injury in rats by X-ray examination, and HE staining showed that HA could significantly inhibit the infiltration of inflammatory cells and the destruction of cartilage surface(P<0.05), and these results were dose-dependent. CONCLUSION HA may relieve rheumatoid arthritis by inhibiting the NF-κB/casepase-1 signaling pathway.