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.Influence of Simple Obesity on Kidney Function in Children
shu-hua, CUI ; guang-yao, LI ; yan-jun, XING ; feng, WANG
Journal of Applied Clinical Pediatrics 2004;0(07):-
0.05).In simple obesity group,there was positive correlation between BMI and urinary 24 h-Alb content(r=0.626,P
7.Working process in elimination of iodine deficiency disorders and related issues from 2003 to 2010
Shu-hui, XU ; Cai-yun, CHANG ; Xing-yi, GENG ; Hua-ru, XU ; Xue-feng, BIAN
Chinese Journal of Endemiology 2012;31(4):434-436
Objective To find out the status of prevention and control of iodine deficiency disorders and evaluate the iodine nutritional status of Jinan residents,to explore appropriate iodine level in drinking water,and to provide a scientific basis for adjustment of intervention strategies.MethodsAccording to the Monitoring Program of the National Iodine Deficiency Disorders (Trial),qualified iodized salt consumption rate,drinking water iodine content and urinary iodine levels of women of childbearing age were determined in iodine deficiency areas from 2003 to 2010.Salt iodine was detected by direct titrimetry,urinary iodine by As-Ce catalytic spectrophotometric assay and iodine in drinking water by cerous sulfate catalytic spectrophotometric method.Results Intake rate of qualified iodized salt was up to 90% and above from 2003 to 2010,median water iodine was 13.65 μg/L in the 10 counties(cities,districts),of which less than 100 μg/L accounted for 79.82%(4560/5713 ) and > 150 μg/L accounted for 12.73%(727/5713).With the increase of water iodine(0 ~ < 10,10 ~ < 50,50 ~ < 100,100 ~ < 150,150 ~ < 300 and ≥300 μg/L),urinary iodine levels of women of childbearing age increased successively(median 156.56,175.81,267.04,349.00,524.22,583.20 μg/L,respectively,x2 =121.20,P < 0.05),while the ratio of urinary iodine < 100 μg/L was significantly lower.The ratio of urinary iodine between 100 and 300 μg/L was decreased gradually,but the ratio of great than 300 μg/L was gradually increased.ConclusionsIodine deficiency areas in Jinan have reached the standard of elimination of iodine deficiency disorders.We should insist to carry out our measures to suit local conditions,classified guidances and scientific principals of iodine supplementation.
8.Biomechanical property changes following rat cornea collagen crosslinking using glyceraldehyde
Ying, WANG ; Feng-mei, HAN ; Yan-hua, CHU ; Quan-hong, HAN ; Kan-xing, ZHAO
Chinese Journal of Experimental Ophthalmology 2012;30(5):414-417
BackgroundSeveral cornea collagen crosslinking methods have been used to treat keratoconus.However,the safety of these methods is dissatisfactory.Glyceraldehyde is a very potent and highly reactive crosslinking agent,with little toxicity,but its effect on corneal biomechanical property is poorly clear.ObjectiveThe aim of this study was to evaluate the biomechanical effects of glyceraldehyde collagen crosslinking on rats cornea.Methods Fifteen clean SD rats were randomly divided into 0.005 mol/L glyceraldhyde group,0.050 mol/L glyceraldhyde group and blank control group.Glyceraldhyde drops was topically administered in the right ryes 2 times per day for consecutive 7 days in the 0.005 mol/L and 0.050 mol/L glyceraldhyde groups,and no any eye drops was used in the blank control group.Seven days later,the rats were sacrificed.Transparency of corneal buttons in these different groups was evaluated.The central corneal strips of 2 mm×6 mm with 2 mm scleral tiasue were obtained for the biomeehanical stress-strain measurement,including ultimate stress ( MPa),ultimate strain (%) and 6% elastic modulus (MPa).Corneal collagen fibril density was assessed by histological examination under a light microscopy.The use of the animals followed the Regulations for the Administration of Affair Concerning Experimental Animals by State Science and Technology Commission.ResultsThe words could be clearly displayed transcorneally in all the three groups.When strain was 6%,the stress was (0.463±0.065 ) MPa in 0.005 mol/L glyceraldehyde group,(0.846±0.240) MPa in 0.050 mol/L glyceraldehyde group,both showing a significant increase in comparison with (0.195±0.103 ) MPa of the blank control group (P=0.029,0.000 ).Following the crosslinking treatment,the ultimate stress was significant elevated in 0.050 mol/L glyceraldehydes group compared with the blank control group ( ( 10.759 ± 3.337 ) MPa vs.(5.295± 1.313 ) MPa,P =0.007 ),but no significant change between the 0.005 mol/L glyceraldehydes group and the blank control group ( ( 6.043 ±2.084) M Pa vs.(5.295 ± 1.313 ) MPa,P =0.660 ).Corneal ultimate strain was lower in the 0.005 mol/L glyceraldehyde group and 0.050 mol/L glyceraldehyde group than the blank control group (36.57% ±3.09% vs.43.87% ± 1.89%,P =0.009;28.53% ±1.89% vs.43.87% ± 1.89%,P =0.000).However,significantly increased 6% elastic modulus were seen in the 0.005 mol/L glyceraldehyde group and 0.050 moL/L glyceraldehyde group compared with the blank control group ( ( 7.718 ± 1.076 ) MPa,( 14.102 ± 4.011 ) MPa vs.( 3.252 ± 1.717 ) M Pa),with statistically significant differences ( P =0.029,0.000).Histological examination showed a increase of collagen fiber density in the 0.050 mol/L glyceraldehyde group.Conclusions Corneal collagen crosslinking induced by glyceraldehyde strengthens biomechanical intensity and increases the density of corneal collagen fiber.But the safety of glyceraldehyde crosslinking for keratoconus needs further study.
9.The genomic sequence analysis of human astrovirus in Shanghai
Xiaogui SHANG ; Wei GUO ; Xing FENG ; Lianru YANG ; Zhibiao YANG ; Jianguo ZHU ; Li CUI ; Xiuguo HUA
Chinese Journal of Microbiology and Immunology 2010;30(1):23-26
Objective To study the genomic molecular organization and genotype of human astro-virus infected infants in Shanghai of China. Methods Based on the published genomic sequence of HAstV (GenBank), the whole genome of one isolate human astrovirus was sequenced by specific primers. The PCR-products were cloned to pMD18-T vector and sequenced, phylogenetic tree was constructed by the Neighbor-Joining method with MEGA 4 software. Results The genome of HAstV-SH is 6807 hp, contains three ORFs: ORF1a and 1b encode the non-structural protein (from 83 nt to 4372 nt), ORF2 encodes the structural protein (from 4364 nt to 6727 nt). Compared with the ORF2 gene of those eight astrovirus sero-types in GenBank, revealed that the highest homology is with genotype 1 (97%). Homology with other gen-otypes ranged between 63% and 70%. Conclusion HAstV-SH belonged to genotype 1 and closely clus-tered with a strain of Japan (AB009985).
10.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.