2.Performance of registration regulation policies on biosimilars in Japan and its enlightenment
Yongfa CHEN ; Yunyun BIAN ; Lin WU
Chinese Journal of Health Policy 2016;9(12):50-55
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.
3.The clinical value of INTERGROWTH-21st standard in evaluating intrauterine growth restriction
Chen ZHU ; Yunyun REN ; Jiangnan WU
Fudan University Journal of Medical Sciences 2017;44(3):307-311,325
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.
4.Influence of precision medicine-based health education on cognitive level of disease knowledge, anxiety and depression in patients with gestational diabetes
Zhaona SUN ; Yunyun LI ; Lanjun WU ; Qingxian ZHU ; Xiaoyan WU
Modern Clinical Nursing 2017;16(1):38-42
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.
5.Analysis of international intercomparisons results organized by Japan for integrating 222Rn-220Rn detectors
Yunyun WU ; Hongxing CUI ; Qingzhao ZHANG ; Bing SHANG ; Xu SU
Chinese Journal of Radiological Medicine and Protection 2012;32(5):514-517
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.
6.Investigation and analysis on seasonal variations of indoor 222Rn and 220Rn concentrations in Longdong district,Gansu Province
Hongxing CUI ; Yunyun WU ; Qingzhao ZHANG ; Bing SHANG
Chinese Journal of Radiological Medicine and Protection 2011;31(3):336-339
Objective To study the seasonal variation of indoor 222Rn and 220Rn concentrations in Longdong district,Gansu Province.Methods A total of 44 houses from 5 different types of raw soil architectures and 5 ordinary brick houses from a typical area were selected in Longdong district,Gansu Province in China.The LD-P discriminative 222Rn and 220Rn detectors were used to measure the indoor concentrations of 222Rn and 220Rn during four seasons in one year.Results The indoor concentrations of 222Rn showed a significant seasonal variation,which varied with different types of houses.222Rn concentrations of ordinary brick houses,soil brick houses and the cave dwellings were higher in winter and autumn and lower in summer.The average concentrations of 222Rn were 55.3-90.3 Bq/m3 in winter,36.4-65.7 Bq/m3 in spring,35.6-63.9 Bq/m3 in summer,and 60.7-87.2 Bq/m3 in autumn.For cave dwellings,open-cut cave dwellings and the underground cave dwellings,222Rn concentrations were higher in summer and autumn,and lower in winter and spring.The average concentrations of 222Rn ranged from 139-184 Bq/m3 in winter,135-199 Bq/m3 in spring,179-252 Bq/m3 in summer,172-242 Bq/m3 in autumn.The seasonal variation of indoor 220Rn was basically consistent in six types of houses,and lower in winter and spring and highest in autumn.The average concentrations of 220Rn ranged from 43.4-64.3 Bq/m3 in winter,60.6-537 Bq/m3 in spring,77.7-792 Bq/m3 in summer,63.2-1077 Bq/m3 in autumn.The indoor concentrations of 222Rn and 220Rn were different among different types of houses,and they were generally higher in type of raw soft architectures than in that of ordinary brick houses.Conclusions 222Rn concentrations indoors showed a significant seasonal variation and varied with different types of houses.
7.Discussion on Quality Evaluation Method of Medical Device During Life-Cycle in Operation Based on the Analytic Hierarchy Process.
Caixian ZHENG ; Kun ZHENG ; Yunming SHEN ; Yunyun WU
Chinese Journal of Medical Instrumentation 2016;40(1):13-16
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
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Durable Medical Equipment
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standards
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Equipment Design
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Quality Control
8.Levels and distribution of indoor radon concentrations in Shenzhen, China
Yunyun WU ; Hao SUN ; Dan LIU ; Bing SHANG ; Hongxing CUI
Chinese Journal of Radiological Medicine and Protection 2016;36(7):513-516
Objective To investigate the levels and distribution of radon in dwellings in Shenzhen cities of China.Methods A total of 108 low-,multi-,middle-and high-rise buildings were selected.Indoor radon concentrations were measured by using solid track detector.Results The arithmetic mean of indoor radon concentrations in Shenzhen was 64 Bq/m3,and geometric mean was 58 Bq/m3,in range of 15 to 155 Bq/m3.The average indoor radon concentration in Bao'an district was 50 Bq/m3 with the lowest value,and that in Pingshan new district was 87 Bq/m3 with the highest value.There were 12 measuring points where indoor radon concentrations were higher than 100 Bq/m3 in Shenzhen,accounting for 11.1% of the total number.Shapiro-Wilk test showed that the frequency distribution of indoor radon concentration in Shenzhen follows lognormal distribution (P > 0.05).The indoor radon concentrations showed a downward trend from 1990 to 2015.The indoor radon concentration decreases with the elevated floors except 10th and above floors.Conclusions The indoor radon concentrations in Shenzhen increased by 35%,compared to the previous investigations.It is recommended that efforts continue to improve radioactive materials standards about building material and to enhance the natural ventilation in high-rise buildings in order to lower the radiation hazards from radon.
9.Experience of family caregivers in nursing perioperative patients undergoing permanent cardiac pacemaker:a qualitative study
Cuihuan WU ; Yulan XU ; Yanmei ZHANG ; Yunyun LI
Modern Clinical Nursing 2015;(8):54-57
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.
10.Micro vibration with the hand nursing methods on the disuse syndrome patients with constipation nursing effect assessment
Maimaiti RUKEYAGULI ; Muhammat PARIDA ; Caiyun GAO ; Yunyun WU ; Aerken MIHERIAIYI
Chinese Journal of Practical Nursing 2017;33(17):1293-1296
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.