Antirheumatic Agents ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Methotrexate ; therapeutic use ; Phytotherapy ; Prednisone ; therapeutic use

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.

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

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.

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 ; drug effects ; Hemoglobins ; analysis ; Humans ; Tripterygium ; adverse effects

Bridged-Ring Compounds ; poisoning ; Humans ; Male ; Middle Aged ; Poisoning ; therapy ; Treatment Outcome

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.

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.

Objective To investigate the proliferation and differentiation characteristics of fibroblast like synovial cells(FLS)in rheumatoid arthritis(RA)in vitro and the mechanism of the immunosuppressive effect of differentiation inducers, such as all trans retinoid acid(ATRA), ealcitriol [1,25(OH)_2D_3] and dexamethasone(DEX). Methods FLS of knee synovial tissues from RA patients were cultured and identified in vitro in the presence or absence of ATRA, 1,25(OH)_2D_3 and DEX respectively. Synoviocyte proliferation in RA were measured by MTT colorimetrie assay and the survival fraction(SF)of FLS was evaluated. Cell cycle of FLS was observed using fluorescence-activated cell sorting(FCS)method in RA patients. Results The identified synovial cells in patients with RA were FLS(Vimentin and Fibronectin expression was positive), and hadn't been transformed or differentiated to adipocytes and osteoblasts with the three inducers. The SF of all RA-FLS interfered by ATRA, 1,25(OH)_2D_3 and DEX was much lower than that without drugs vehicle group in RA-FLS(P

Objective To identify serum biomarkers for rheumatoid arthritis(RA)by protein finger- print pattern. Methods One hundred and forty-one serum samples of 90 RA patients, 20 systemic lupus ery- thematosus(SLE)patients, and 31 healthy individuals were randomly divided into training set(n=93, 60 RA patients, 13 SLE patients and 20 healthy individuals)and test set(n=48, 30 RA patients, 7 SLE patients and 11 healthy individuals). They were detected by surface enhanced laser desorption/ionization-time of flight- mass spectrometry(SELDI-TOF-MS). The protein fingerprint pattern obtained from SELDI-TOF was trained by a multi-layer artificial neural network(ANN)to establish a diagnostic model. Results The detective mod- el obtained by ANN was used to detect the 48 unknown serum samples. The sensitivity and specificity for RA detection was 90% and 90.9% respectively. Conclusion In comparison with traditional methods, SELDI- TOF-MS could identify new serum biomarkers in RA. Combined with ANN, it provides high sensitivity and specificity for RA diagnosis.