Objective:This paper intends to provide reference for consummation of biosimilar registration poli-cies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimi-lars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the bio-medicine industry has achieved great development. On the other hand, it's recommended that the guideline for the de-velopment and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the regis-tration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration.

Objective To explore the application value of INTERGROWTH-21st standard evaluate intrauterine growth restriction (IUGR).We aimed at predicting IUGR with ultrasonic fetal growth measurements.Methods A prospective cohort of singleton pregnancy scanned after 28 gestational weeks was constructed.The Z-score values of growth measurements were calculated using the INTERGROWTH-21st standard.Logistic regression equation was used to establish the prediction formula.Finally,the new formula was compared with the traditional Hadlock method to predict the accuracy of IUGR.We assessed outcomes for consenting participants who attended research scans and delivered at the Obstetrics and Gynecology Hospital of Fudan University.Results A total of 834 patients fulfilling the inclusion criteria were included.After the exclusion of 143 lost cases,565 of control cases and 126 of IUGR cases were obtained.The sensitivity,specificity,positive predictivevalue,negative predictive value,false positive rate and false negative rate of prediction model wererespectively:88.9 ％,85.4 ％,57.7 ％,97.2 ％,14.6 ％,11.1 ％.In contrast,the values of Hadlock wererespectively:81.7％,82.7％,51.2％,95.3％,17.3％,18.3％.Conclusions This study shows aprediction model of IUGR.INTERGROWTH-21st standard improved the diagnostic accuracy of IUGR,especially enhanced the positive predictive value.

Action Potentials ; Humans ; Models, Neurological

Objective To study the influence of precision medicine-based health education on cognitive level of disease knowledge,anxiety and depression in patients with gestational diabetes.Methods Toally 84 cases of gestational diabetes patients in our hospital from September 2014 to December 2015 were divided into a study group and a control group according to the random number table,42 cases in each group.While the routine nursing intervention was done in the control group,the precision medicinebased health education program was carried out in the study group.The two groups were assessed using the cognitive questionnaire designed by our hospital.The self rating anxiety scale (SAS) and self rating depression scale (SDS) prepared by Zung were used to assess the levels of anxiety and depression in the two groups before the intervention and two weeks after the intervention.Results The cognitive level of disease knowledge in the study group after the intervention was statistically significantly higher than that of the control group (P＜0.05).Before the intervention,there were statistically insignificant differences in anxiety and depression between the two groups (P＞0.05),but after the intervention,the levels of anxiety and depression in the study group were significantly lower than those of the control group (P＜0.05).Conclusion The precision medicine-based health education is helpful for the patients with gestational diabetes to improve their diabetes-related knowledge and meanwhile it can relieve their anxiety and depression.

Objective To guarantee the quality of measurenents with the radon-thoron discriminative detectors of our laboratory.Methods LD-P radon-thoron discriminative detector participated in the international intercomparison for integrating radon/thoron detectors organized by National Institute of Radiological Science (NIRS,Japan).Detectors were sent to NIRS for exposure.Radon intercomparison was conducted with radon chamber providing three levels of exposure:low,medium and high levels.Thoron intercomparison was carried out at thoron chamber,which also provided three levels of exposure:low,medium and high levels.Detectors were posted back to our laboratory for etching and analysis after exposure.Then the measured values were submitted to NIRS.Finally the reference values were informed of us.Results The relative percent difference (RPD) between the measured value and the reference value for radon was-13.8％,-14.4％ and-17.1％ at low,medium and high levels respectively,and that of thoron were-14.4％,8.9％ and-3.2％ at three levels respectively.Conclusions Both radon and thoron measurement of our detectors rank asCategory Ⅰ in the 4th international intercomparisons for integrating radon/thoron detectors with the NIRS radon/thoron chambers.

Objective To investigate the levels and distribution of radon concentrations in groundwater in some representative cities in China,and estimate the effective dose from inhaled radon released from domestic groundwater.Methods A total of 12 cities in 7 provinces (municipalities) were selected,including Beijing,Inner Mongolia,Ningxia,Shaanxi,Henan,Liaoning and Heilongjiang.In total,73 water samples from groundwater supply were taken.Radon concentrations in water samples were determined by using a continuous radon monitor with air-water exchanger.Results The average radon content in groundwater for drinking was 11.8 Bq/L in 12 cities in 7 provinces,ranging from 1.0 to 63.8 Bq/L.The radon concentrations in 37％ water samples exceeded 1 1.1 Bq/L,the safe limit recommended for drinking water by the United States Environmental Protection Agency (EPA).The radon contents in all of the water samples was lower than the reference level 100 Bq/L recommended by World Health Organization (WHO).The average annual effective dose arising from inhaled radon released from groundwater was 29 μSv (2.4 to 160 μSv).Conclusions Generally,the effective dose from inhaled radon released from groundwater is negligibly low.However,in some areas dominated by granite bedrock,the dose contribution from radon released from groundwater to residents should be routinely monitored.

Objective To develop a comprehensive integrated POCT system.Methods To meet the requirement of medical relief operation under the circumstances of field operations and Military Operations Other Than War,several dry chemical inspection instruments were selected,integrated and informatized.Then,a portable platform,being easy to deploy,undeploy,store and transport,came into being,which was gifted with the functions for regular rapid laboratory test in filed operation.Results The POCT system's net weight was about 80Kg,and the deployment/un-deployment time was 3 minutes.The tests could be finished in 5minutes.Conclusion The system has reached the goal of rapid response and on -site application,which will greatly enhance the work efficiency of clinical laboratory under the circumstances of field operations.

Objective To investigate the micro vibration with the hand nursing methods for disuse syndrome patients constipation curative effect. Methods During the time of March 2016 to September, 76 patients who had long term disuse syndrome with the constipation in two Elderly Care Homes in Urumqi were randomly divided into intervention group (n=37) and control group (n=39), in the experimental group, was treated by manual micro vibration nursing method which included hand micro vibration therapy, exercise therapy, health education guidance once a day, 50 minutes each time, a total of 4 weeks of intervention, while the control group received routine rehabilitation nursing. Before the intervention, intervention after 4 weeks, follow-up period after the end of 8 weeks according to the symptoms of constipation and evaluate the stool frequency. Results Preliminary experimental group and control group patients have different degrees of constipation symptoms, with the hand micro vibration method of nursing intervention, the experimental group had not constipation of symptoms, 17(43.6%) had constipation symptoms in the control group. Compared with the incidence of two groups of constipation patients. Before the intervention, intervention after 4 weeks, follow-up period after the end of 8 weeks, the experimental group patients defecation frequency was (5.33 ± 1.47), (29.70 ± 6.49) , (43.41 ± 6.15)times, The control group patients was(5.77 ± 1.39), (13.10 ± 1.27), (21.15 ± 4.23) time, comparison of the two groups, t=-1.357, 15.275, 18.458, P=0.179, 0.000, 0.000. Conclusions Hand micro vibration nursing method has remarkable effect on relieving constipation, and the treatment effect can be maintained for a long time, no recurrence occurred and adverse reactions, however, this method also economic, convenient, less time consuming and efficient.

Objective To investigate the experience of family caregivers in nursing perioperative patients undergoing permanent cardiac pacemaker. Methods Twenty-five family caregivers taking care of the patients undergoing permanent cardiac pacemaker participated in the non-structural study. Data were analyzed by phenomenological procedure. Result The factors by category analysis includes fear, anxiety and uneasiness due to preoperative lack of relevant knowledge and postoperative lack of caring experience, lowered health level of the caregivers, strong demand for health education and lack of confidence in home care. Conclusions The family caregivers′ experience varies with different phases in perioperative period. Nurses should provide personalized services to enhance the continuity of home care so as to enhance the care quality.

The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device.
Decision Support Techniques ; Durable Medical Equipment ; standards ; Equipment Design ; Quality Control