2.Study on the Effect of Drug Registration System Adjustment on New Drug Research and Development in China
Ailing FENG ; Fuli GUO ; Hua XING
China Pharmacy 2017;28(22):3025-3029
OBJECTIVE:To provide reference for improving the registration success rate of new drug research and develop-ment(R&D)enterprises after adjusting drug registration system in China. METHODS:The national drug policies,regulations and related documents were comprehensively studied and combed to explore the main contents of drug registration system adjustment and its effects on the R&D forms,drug patent and on-site verification. The suggestions were put forward. RESULTS & CONCLU-SIONS:The adjusted drug management system showed new definitions for new drugs and generic drugs in China,as well as de-tailed requirements and regulations for drug R&D conditions,process and on-site inspection. It enhanced the protection of patents and patentees. The new drugs should be assessed its market value and clinical advantages. Data contents and requirements for drug registration declaration were made the relevant adjustments. New drug R&D enterprises should develop drug listed license manage-ment system as early as possible based on the implementation of listed license management system pilot,improve its efficiency and benefit. The new drug R&D should notice the clinical efficacy and demand of market,focus on the drugs with good clinical effica-cy in common diseases,frequently-occurring diseases and major diseases;and those for treating rare diseases,the elderly and chil-dren disease can use easy access or fast track to accelerate the speed of drug registration. New drug R&D enterprises should im-prove the R&D conditions,and standardize the management of development process to ensure the effective and smooth develop-ment.
3.Confer Effect of Air Disinfection by Using Nanometer Light Catalysis Decontamination Machine in Operating Room
Feng SONG ; Xin DONG ; Caixia YIN ; Hua WEI ; Yubin XING
Chinese Journal of Nosocomiology 2006;0(06):-
OBJECTIVE To analysis the effect of air disinfection by using nanometer light catalysis decontamination machine in operating room. METHODS By compare the effectiveness of air disinfection both by using nanometer light catalysis decontamination machine and ultraviolet rays light. RESULTS The result of tests is 0 CFU/m~2 by nanometer light catalysis decontamination machine and 33.3 CFU/m~2 by ultraviolet rays light in unmanned environment;By different groups: F=220.423,P=0.000,P
4.Antibacterials in Patients Accepted Operation in Grass-roots Hospitals:Their Application and Cost Analysis
Xing-Hua ZHANG ; Hong-Qin SUN ; Feng-Xia XU ; Yan-Hua LV ; Xiao-Qin WANG ;
Chinese Journal of Nosocomiology 1994;0(01):-
OBJECTIVE To investigate the application of antibacterials in patients accepted operation in grass-roots(hospitals),so to standardize the application of antibacterials and cut down the medical cost.METHODS Full-time administrators for nosocomial infection investigated the application of antibacterials in patients who accepted(operation) in Sep 2004,and filled in the questionnaires.RESULTS In 1 383 cases of 11 hospitals the application rate of antibacterials was 98.63%;in which 86.50% were for prophylactic usage and 13.50% for therapeutic usage;(29.90%) for single antibiotics treatment and 50.15% for bigeminy,18.70% were for trigeminy.Time of(application) differentiated(6.90,7.00,6.60d) fromⅠto Ⅲ kinds of operation.Per capita cost of antibacterials was $956.50(47.60%).CONCLUSIONS High cost of antibacterials results from such factors as multiple kinds,long time and(combined) application.
6.Meta-analysis of blood system adverse events of Tripterygium wilfordii.
Zhi-xia LI ; Dong-mei MA ; Xing-hua YANG ; Feng SUN ; Kai YU ; Si-yan ZHAN
China Journal of Chinese Materia Medica 2015;40(2):339-345
A systematic review was undertaken, including studies that evaluated the incidence of the blood system adverse events of Tripterygium wilfordii (TWP). Medline, Embase and the Cochrane library were searched for relevant studies, including RCT, cohort studies and case series, of patients treated with TWP published in English and Chinese from inception up until May 25th, 2013 with the keywords including "Tripterygium wilfordii", "toxicity", "reproductive", "side effect", "adverse", "safety" and "tolerability". Relevant information was extracted and the incidence of the blood system adverse events was pooled with MetaAnalyst software. Besides, subgroup and sensitivity analyses were performed based on age, mode of medicine, observation time and disease system. According to inclusion and exclusion criteria, a total of 49 articles were included in the meta-analysis, they were split into 54 researches incorporated in the analysis. There is a large degree of heterogeneity among the studies, so data was analyzed using random-effects model and the summary estimates of incidence of the blood system adverse events was 6.1%. The weighted combined incidence of three major blood system adverse events were white-blood cells decreasing 5.6% (95% CI, 4.3% - 7.3%), hemoglobin decreasing 1.7% (95% CI, 0.5% - 5.0%) and platelet decreasing 1.8% (95% CI, 1.0% - 3.1%), respectively . Sensitivity analyses based on 45 studies with high quality showed the combined value was close to the summary estimate of total 54 studies. The current evidence indicates that the incidence of the blood system adverse events induced by TWP was high; attentions should be paid on to the prevention and treatment of the blood system adverse events.
Blood Cells
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drug effects
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Hemoglobins
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analysis
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Humans
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Tripterygium
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adverse effects
7.Optimum harvest study of Gentiana crassicaulis in Ludian.
Yu ZENG ; Xing-Fu CHEN ; Yuan-Feng ZOU ; Jiu-Hua SONG ; Wen-Yu YANG ; Tao CHENG
China Journal of Chinese Materia Medica 2014;39(14):2635-2639
The paper is aimed to study the difference in yield and quality at different harvest time and determine the optimum harvest of planting Gentiana in Ludian traditional harvest period. The authors analyzed the variation in fresh weight, dry weight, dry discount rate, length, diameter, volume and the content of gentiopicroside, loganin acid, alcohol-soluble extract and total ash and made a comprehensive appraisal of yield, appearance quality and intrinsic quality by gray relational distance ideal Comprehensive Evaluation method. The results showed that there is a big difference in yield and quality both 2-year-old and 3-year-old Gentiana harvested in traditional harvest period and the comprehensive evaluation more better when harvested more later. It can be seen, Gentiana harvested the later had a better yield and quality in Ludian traditional harvest period. The harvest of Gentiana can be appropriate delayed depending on the particular circumstances of production.
Agriculture
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methods
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China
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Gentiana
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anatomy & histology
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growth & development
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metabolism
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Iridoid Glucosides
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metabolism
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Organ Size
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Quality Control
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Time Factors
8.Application value of three-dimensional female pelvic visualization modeling on transvaginal gynecological ultrasound imaging
Feng ZHANG ; Liwen TAN ; Yanli GUO ; Haiyun HUANG ; Jun DING ; Xing HUA ; Li PENG
Chinese Journal of Obstetrics and Gynecology 2014;49(2):100-103
Objective To explore the application value of three-dimensional (3D) female pelvic visualization model on transvaginal gynecological ultrasound imaging.Methods The second digital Chinese woman visible human datasets was selected,and a female pelvicvoxel-based model was constructed in Amira software for analog simulation combined with transvaginal gynecological ultrasound.The main structures and the space position variation of female pelvic cavity were observed,and the comparison study with conventional section of ultrasound was carried out.Results A high accuracy 3D visualization model of female pelvic was successfully constructed,and the anatomy structures can be dynamically and clearly displayed in any section orientation.An analog simulation research was carried out according to the scan mode of gynecological ultrasound,and a series of high resolution images consistent with scan sections of dynamic ultrasound were obtained,which had provided the optimal scan pathway for the fast inspection of the uterus,fallopian tubes and ovaries.Conclusion The 3D female pelvic visualization model based on digital Chinese woman human datasets has provided detailed and accurate anatomy information for transvaginal gynecological ultrasound imaging,which could be the benefit for doctors to understand the ultrasound images of female pelvic,as well as the accurate positioning ability to the lesions of female pelvic cavity.
9.Soluble Expression and Purification of Snake Venoms Fihrino(geno)lytic Emzyme Alfimeprase in E.coli
Shou-Tao ZHANG ; Yan-Sheng ZHOU ; Xue-Hua LAI ; Xing-Feng BAO ; Ai-Guang GUO ;
China Biotechnology 2006;0(03):-
Fibrolase is a non-hemorrhagic zinc metalloproteinase isolated from southern copperhead snake venom (Agkistrodon contortrix contortrix) and is capable of degrading fibrin clots resulting from purified fibrinogen or from blood plasma. Alfimeprase, a truncated form of fibrolase, as a clinical agent was successfully completed PhaseII clinical trials.The cDNA of alfimeprase was amplified by recursive PCR, digested with BamHI and HindII, and cloned into pET43.1a, pMALp2X and pMALc2X vectors to generate fusions with NusA, MBP and sMBP(with signal peptide), respectively. Nus/alfimeprase was expressed in soluble form by co-expressing with chaperone FkpA and inducing with1mmol/L IPTG. The fusion protein accounted for about 25 % of total protein following cell lysis. Alfimeprase was successfully purifiesd by Ni-NTA affinity chromatography and cleaved by enterokinase. The results demonstrate the fibrinolytic activity of recombinant alfimeprase using fibrin plate assays and fibrinogen hydrolysis.
10.About AIDS Control Knowledge:An Investigation among Medical Staff at a Low Infected Area
Xing-Hua ZHANG ; Feng-Xia XU ; Mu-Rong WANG ; Lei TIAN ; Dong-Xiao LV ;
Chinese Journal of Nosocomiology 2005;0(11):-
OBJECTIVE To provide gists for educations about AIDS control through finding out the knowledge among medical staff at a low infected area.METHODS The questionnaires including 30 questions of 5 kinds were analyzed.RESULTS The awareness rate of total knowledge among medical staff was 64.94%.The positive rate about common knowledge was upon 88%.But the rate about comprehensive knowledge such as diagnosis standard,therapy way,disinfection measure,career defending,law function,and so on was law.The correct answers on 17 questions among nurses were higher than doctors(P