Through the analysis of the current status and problems of innovative medical devices evaluation, tnis paper discussed the strategies of evaluation, and ultimately raises the frame of evaluation, so as to provide reference for scientific evaluation of medical devices in China.
China ; Equipment and Supplies ; standards ; Evaluation Studies as Topic

Background The excessive growth of human Tenon fibroblasts (HTFs) is a primary cause of failure of anti-glaucomatous filtering surgery.To seek a drug of anti-fibrosis is of an important significance for improving the successful rate of anti-glaucomatous filtration surgery.Objective The goal of this study was to investigate the effect of paclitaxel on proliferation of HTFs in vitro.Methods Human Tenon tissue was obtained during the anti-glaucomatous filtering surgery.HTFs were cultivated using explant method and 3-6 generations of cells were used in the experiment.The cells were identified by immunochemistry using keratin,vimentin,fibronectin and S-100.Different concentrations (0,1 ×10-s,1 × 10-7,1 × 10-6 mol/L) of paclitaxel were added into the medium,and then the cell indexes (CI) in the various groups were detected by real-time cell electronic sensing (RT-CES) 24 hours after affection of paclitaxel.Apoptosis of the cells was examined using DAPI staining,and the proportion of the cells in different cycles were assayed by flow cytorneter 12 hours after addition of paclitaxel.The expressions of matrix metalloproteinase-1 (MMP-1) protein and mRNA were detected by ELISA and real-time PCR,respectively.Results The cells migrated from the cultivated tissue within 7 days with the fibrocyte-like shape.The cells showed the positive response for vimentin and absent response for keratin,fibronectin and S-100.The CI values were 1.093 ±0.191,0.665 ± 0.093 and 0.473 ± 0.117 in the 1 × 10-8,1 × 10-7 and 1 × 10-6 mol/L paclitaxel groups,showing significant rise in comparison with the 1.514 ±0.283 of the 0 mol/L paclitaxel group (all at P =0.000).The cell nuclei were normal in the 0 mol/L paclitaxel group,however,blue-fluorescent particles and apoptotic bodied were found in the cell nuclei after affection of paclitaxel.The proportion of G2/M phase of cells were (9.20±0.80) ％,(12.37±0.45)％ and (13.80±0.35)％ in the 1×10-8 mol/L,1×10-7 mol/L and 1×10-6 mol/L paclitaxel groups,which were higher than the (7.17±0.50) ％ in the 0 mol/L paclitaxel group (P=0.005,0.000,0.000).In addition,the relative expressing level of M MP-1 mRNA (MMP-1 mRNA/GAPDH mRNA) and the expression level of MMP-1 protein in the HTFs were significantly lower in the 1 ×10-8 mol/L,1 × 10-7 mol/L and 1 × 10-6 mol/L paclitaxel groups than those in the 0 mol/L group (all at P＜0.05).Conclusions Paclitaxel at the concentrations of 1 × 10-8 mol/L-1 × 10-6 mol/L inhibits the proliferation of HTFs in vitro by arresting the cellular mitosis and inducing cell apoptosis.These effects probably associated with down-regulation of MMP-1 expression in the HTFs.

Objective Establish an objective and fair evaluation index system for the implementation effectiveness of the National Major New Drug Development Program of China.Methods Based on literature review and Delphi method,the framework of the evaluation index system was built and analytic hierarchy process was applied to determine the priority of each indicator of the system.The objectiveness and validness of the results were assured by determining expert activeness coefficient,authority coefficient,indicator rationality,and by applying consistency check.Results A targeted and systematic evaluation index system was constructed for the National Major New Drug Development Program,and through expert consultation and analytic hierarchy process,the factor of product result was considered of the highest weight of 39.03％,followed by technical result,theoretical result and organization and management result.The evaluation index system suggested that product result and technical result are two relatively more significant factors to be considered during evaluation.Conclu sion After consultation on expert opinions,the evaluation index system for the National Major New Drug Development Program was constructed with each factor been assigned with a scientific and rational weight,and this will provide a guideline for the decision making of program administrators and evaluation practice.

Objective Pleural effusion of patients with tuberculous pleurisy was analyzed by ultra high performance liquid chromatography-mass spectrometry (UPLC-MS).Orthogonal partial least squares discriminant analysis (OPLS-DA) model was established for searching and analyzing the potential metabolic biomarkers to provide new ideas for the early diagnosis of tuberculosis pleurisy.Methods Totally 166 cases of pleural samples were collected from November 2012 to September 2013 in Tianjin Haihe Hospital (tuberculosis pleurisy 83 cases,bacterial pleurisy 31 cases,lung cancer 30 cases and heart failure 22 cases)and metabonomics quantitative analysis was conducted.Quantitative analysis of metabolic methods was enrolled.Orthogonal partial least squares discriminant analysis (OPLS-DA) model was constructed by the pattern recognition method.Based on the OPLS-DA model,potential biomarkers was filtered preliminary by variable importance in the projection (VIP) and VIP confidence interval value.The specific metabolites were determined by applying non-parametric test(Kruskal-Wallis H test)by using SPSS 17.0,and potential metabolic biomarkers were screened.Results The prediction accuracy of OPLS-DA model was 100％ (38/38),which illustrated that the model could verify the tuberculous pleurisy group and the control group accurately.Based on the data of metabolites,46 potential metabolites were finally screened and 5 metabolites were identified with statistically significant differences (P ＜ 0.05).The data of tuberculosis pleurisy group showed a significant increase in 17a,20a-Dihydroxy cholesteryl,phospholipid [20∶4 (8Z,11Z,14z,17Z)] (1 188 670.00),tocotrienols (1 051 760.00) and phospholipid(O-18:0) (434 394.00) compared with the lung cancer group(735 615.00,336 815.00,324 563.00,193 055.00),bacterial pleurisy group (1 678 805.00,598 256.50,699 384.00,343 866.00),and heart failure group(535 842.00,253 503.00,234 503.00,130 185.00) (H =26.787,18.680,26.193,21.024,P ＜0.01),and a significant decrease in L-phenylalanine(245 976.00)compared with the lung cancer group(753 033.50),bacterial pleurisy group (357 278.00),and heart failure group(586 678.00) (H =13.635,P ＜ 0.01).Conclusions The OPLSDA model constructed on the basic of UPLC-MS technology platform can verify the tuberculous pleurisy group and the control group accurately,and the study provides new ideas and methods for identifying features of tuberculous pleurisy markers and early diagnosis.

Objective·To analyze the choice of smoking cessation methods and its influencing factors in moderate-to-severe nicotine-dependent population.Methods·A retrospective clinical analysis was conducted for170 moderate-to-severe nicotine-dependent smoking-quitters (Fagerstr(o)m scale ≥ 4).Different smoking cessation methods (pharmacotherapy and non-pharmacotherapy) and abstinence rates of the selected population (7 d point prevalence abstinence rates and sustained abstinence rates 1,3,and 6 months after treatment) were compared and possible influencing factors were analyzed.Results·The differences in choosing the smoking cessation method in moderate-to-severe nicotine-dependent population with different ages,levels of education,and employment status were statistically significant (P=0.000).The Logistics regression analysis showed that the level of education was the major factor for choosing the smoking cessation method (P=0.006).The 7 d prevalence abstinence rate was much lower for pharmacotherapy than for non-pharmacotherapy 1 month after treatment (P=0.000) and was much higher for pharmacotherapy than for non-pharmacotherapy 3 and 6 months after treatment (P=0.000).The sustained abstinence rate was much higher for pharmacotherapy than for non-pharmacotherapy 3 and 6 months after treatment (P=0.002,P=0.000).Conclusion·For moderate-to-severe nicotine-dependent smoking-quitters,attention should be paid to the formulation and implementation of personalized strategies.The choice of smoking cessation methods depends on the age,level of education,and employment status.Reasonable pharmacotherapies can significantly increase the abstinence rate.

Objective To analyze the hot spots and frontiers in domestic and foreign precision medicine with CiteSpace. Methods The CNKI and WOS-covered papers on precision medicine were analyzed by bibliometrics combined with CiteSpace. Results Domestic precision medicine got off in 1992 and scholars became interested in it from 2010 . Foreign precision medicine started in 1985 and studies on it increased rapidly from 2006 . The node of precision medicine was the largest in China with a rather high value of gene mutation, US president Barack Obama ( precision medicine program) , personalized medicine, gene chip, genomics and pharmacogenomics whereas the node of personalized medicine, cancer and breast cancer was the largest with a rather high value of precision medi-cine, pharmacogenomics and pharmacogenetics. Conclusion The number of domestic and foreign papers on US president Barack Obama ( precision medicine program) is rapidly increased and pharmacogenomics is their common frontier. However, cancer is highly concerned in foreign countries.

Objective To analyze the management experience of Swedish medical research funding,and provide reference for further rationalization of medical research investment management in China.Methods Literature research method,descriptive statistics and other methods were used to systematically sort out the source of Swedish medical research funding,and specifically analyze the capital investment and distribution in medical fields in the past ten years.Results The Swedish government 's budget in the UO9 (health,medical and social care) field is steadily increasing.The annual average budget accounts for 7.14％ of the total government budget.There are scientific management methods for fund allocation.The appropriation projects are mainly divided into three main directions including public health categories,health care and social care.Conclusions Taking into account of the problems existing in the investment and distribution of medical research funds in China,this paper proposes to explore the capital investment mode suitable for China's national conditions,enhance the targeted investment of funds in medicine,and establish a scientific and efficient fund investment management mechanism.

0bjective The cognitive intervention effects of different forms of virtual reality technology in mild cognitive impairment (MCI) patients were systematically evaluated to find the best form of virtual reality intervention in MCI patients. Methods The computer searched of CNKI, Wanfang, VIP, CBM, PubMed, Embase and Cochrane Library included literatures on virtual reality technology intervention for MCI patients for evaluation. Results 5 randomized controlled trials were included, a total of 232 participants were in, the intervention group was 115 participants,control group was 117 participants, the results showed that virtual reality memory training had greatly improved cognitive function (P<0.01), Virtual reality program training, double interactive virtual reality technology therapy and virtual reality rehabilitation training system combined with primary meridian acupuncture therapy can improve the cognitive ability of MCI patients (P<0.05). The virtual reality dual task training has no statistical significance for the improvement of cognitive function (P>0.05). Conclusions Virtual reality technology intervention for MCI patients is an effective way to improve the cognitive ability of patients.

The paper reviewed the development history, current application and technical features of 3D ultrasound and 3D breast ultrasound. 3D ultrasound is used in breast screening methods. Special 3D breast ultrasound equipment can enhance breast characteristics, corresponding the breast characteristics to carry out technological innovation and improvement, provide more accurate and convenient way to inspect breast.
Breast Neoplasms ; diagnostic imaging ; Female ; Humans ; Imaging, Three-Dimensional ; Ultrasonography, Mammary ; methods

The key factor responsible for the slowness of registration of medical devices in China is clinical trial. The clinical trial in European and U.S. is taken as an example to analyze the problems in clinical trials in China. Some suggestions are proposed to solve the problem.
China ; Clinical Trials as Topic ; Device Approval ; Research Design