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 study the effect of anti anxiety treatment in residual dizziness after successful canalith repositioning procedure in benign paroxysmal positional vertigo.Methods 68 cases of benign paroxysmal position vertigo patients with residual dizziness after successful canalith repositioning procedure were collected,who visit department of Neurology..They were randomly assigned to anti anxiety group and the control group according to randomized controlled method.Deanxit (0.5mg/10mg,1times/day)combined with betahistine mesilate tablets (6mg, 3 times/day)were taken by patients in the anti anxiety group;take betahistine mesilate tablets (6mg,3 times/day) were taken in the control group.Follow up 3 months,the duration of residual dizziness and the changes of symptoms between the two groups were compared.The symptoms of all patients were evaluated before and after treatment by dizziness handicap inventory.Results The duration of residual dizziness in the control group was (16.38 ±8.83)days, and that in the anti anxiety group was (10.13 ±5.10)days.The duration of residual dizziness in the anti anxiety group was significantly shorter than that in the control group (t =3.440,P <0.05).In the control group,the scores of first week,s econd week and third week were (26.60 ±13.54)points,(20.80 ±10.97)points and (6.27 ±5.88)points.In the anti anxiety group,the scores of first week,second week and third week were (23.10 ±11.02)points,(13.33 ± 5.83)points and (0.67 ±2.50)points.There was not significant difference between the two groups (t =1.122,P >0.05)in the treatment of first week.In second week and third week,the scores of the anti anxiety group were lower than those of the control group,the differences were statistically significant (t =3.378,4.935,all P <0.05).After 3 weeks of treatment,the scores of the anti anxiety group were significantly decreased in the functional,emotional and physical scores (t =5.297,4.537,4.451,all P <0.01 ).Conclusion Deanxit can shorten residual dizziness duration of benign paroxysmal position vertigo patients after successful canalith repositioning procedure,and can reduce the degree of residual dizziness.

Objective:To investigate if a plant-derived polysaccharide sulfate(M33A) binding to HIV1 gp120 may induce the exposure of neutralization epitopes of gp120,and if M33A-bound HIV-1ⅢB antigens may be used as a AIDS vaccine for inducing neutralizing antibodies against HIV-1.Methods:Whole-inactivated M33A-bound HIV-1ⅢB antigens were prepared and used to immunize mice after mixing with FCA or FIA.The titers of anti-HIV-1 IgG antibodies in immunized mouse plasma were detected by ELISA,and the HIV-1 neutralization by those plasma was detected by the improved microtiter neutralization assay.Results:M33A-bound HIV-1 antigens induced higher titers of anti-HIV-1 IgG antibodies(group C:1.5?10~6;group D:1.5?10~6) than HIV-1 antigens alone(4.9?10~5),and female mice produced 3 times higher titers of anti-HIV-1 IgG antibodies than male mice after immunized with various HIV-1 antigens.All three immunization schemes did not induce the production of anti-HIV-1 neutralizing antibodies.Conclusion:M33A binding does not induce gp120 to expose neutralization epitopes.However,M33A may improve the level of mice immune responses to HIV-1 antigens,suggesting M33A may enhance immune response to HIV-1 antigens.

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.

Objective To follow up the changes of postnatal cardiac sizes and function in infants of mothers with gestational diabetes mellitus (GDM). Methods Eighteen GDM mothers with euglycemia (GDM group) and 24 gestational age-matched normal pregnant women (control group),having prenatal examination and delivered in Women's Hospital of Fudan University from January to August in 2007, received fetal echocardiographic examination in late pregnancy. Infants of these GDM mothers and 24 age-matched healthy infants of normal pregnancy (control group) received sonographic follow up. Cardiac sizes and function were evaluated and compared. Results At birth, there were six (33.3%) infants of large for gestational age (LGA) and 12(66.7%) appropriate for gestational age(AGA) in GDM group, while in the control group, there were two LGA (8. 3%) and 22(91.7%)AGA infants (x2 =3. 840, P= 0. 05). Both the interventricular septum and left ventricular walls in GDM fetuses were thicker than in control fetuses (P ＜ 0.05). No increase in the thickness of ventricular walls was observed till infantile period. However, the end-systolic thickness of left ventricular walls in LGA infants was still larger than in control infants [(4.55 ± 0.37) mm vs (4. 13±0.39)mm, P＜0. 05], and end-diastolic left ventricular long-diameters were also larger [(37. 3±2.3) mm vs (34.6±2.6) mm] (P＜0. 05). In GDM fetuses, the peak velocities of aorta and pulmonary artery and left cardiac output were higher than in the controls (P＜ 0. 01 ), and right/left cardiac outputs ratios were lower (1.198±0.206 vs 1. 430±0. 321, t= -2.668,P=0. 011). Till infantile period, only right/left cardiac outputs ratios in AGA infants of GDM group were larger than in controls (P＜0. 05). GDM fetuses' left atrial shortening fraction and tricuspid E/A ratios were smaller (P＜0. 05). In infantile period, only left atrial shortening fraction in GDM infants was still smaller than in controls (0. 356 ± 0. 040 vs 0. 386 ± 0. 041, t = - 2. 332, P = 0. 025). Left and right ventricular Tei index in GDM fetuses were 0. 482±0. 129 and 0. 414±0. 094, both larger than those of control fetuses (0. 309 ± 0. 074 and 0. 283 ± 0. 072) (t = 5. 075 and 5. 129, P = 0. 000 ). Till infantile period they both became significantly lower and no differences were found among LGA, AGA and control infants. Conclusions The cardiac sizes and function at 2-3 months of age, in infants of GDM mothers with good glucose control, became better than that in uterus.

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 changes in serum level of vascular endothelial growth factor (VEGF), nitric oxide (NO), erythropoietin (EPO) and plasma level of carbon monoxide (CO) in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) and their clinical significance. Methods Sixty-four patients diagnosed as OSAHS by polysomnography (PSG), were divided into two groups according to apnea-hypopnea index (AHI), 20 in mild group [5/h≤AHI≤20/h, with a mean of (12± 5)/hi and 44 in moderate-severe group[AHI > 20/h, with a mean of (63±23)/h]. Blood samples were obtained from all the patients after PSG for measurement of levels of serum VEGF, NO and EPO and plasma CO. Results Levels of serum VEGF [(101±91) ng/L], NO [(10.3±3.3) μmol/L]and plasma CO [(0.56±0. 35) mg/L]in moderate-severe OSAHS group were significantly higher than those in mild group (all P <0.05). There was no significantly difference in serum level of EPO between the two groups (P> 0.05). Levels of serum VEGF, NO and plasma CO in OSAHS patients positively correlated with AHI and percentage of time with percutaneous arterial blood oxygen saturation lower than 0. 9 (SLT90) of all sleep time (all P < 0. 05), but reversely correlated with the lowest arterial blood oxygen saturation (LSaO2) at night (P>0.05). No correlation between EPO and all the indicators was found (P>0.05). Multiple linear regression analysis showed that LSaO2 was an independent risk factor to affect levels of serum VEGF and plasma CO (R2=0.198, P=0.001, and R2=0.210, P=0.000, respectively) and SLT90 was an independent risk factor to affect serum level of NO (R2= 0. 148, P=0.004) in OSAHS patients. Conclusion Hypoxia at night is a main cause leading to increased level of serum VEGF, NO and plasma CO in OSAHS patients.

Traditional Chinese medicine considers that the final purpose of acupuncture treatment for disease is to harmonize yin and yang. Acupuncture redresses a balance between yin and yang by transmitting information to acupoints and then to corresponding visceral tissues and organs and the brain through the meridian system or the nervous system. In recent years, scholars at home thoroughly studied heart rate variability (HRV) analysis for acupuncture treatment of diseases and found that the regulating effect of acupuncture on visceral organs was closely related to autonomic nerves and acupuncture could restore a balance between sympathetic and parasympathetic nerves. Many scholars explored the effect of acupuncture on diseases related to autonomic nervous dysfunction by HRV frequency domain or time domain analysis and gained a certain achievements. This article summarizes recent years’ domestic studies on HRV-based analysis of acupuncture for diseases with autonomic nervous dysfunction and reviews the close relationship between autonomic nerves and diseases and the related mechanism of acupuncture action.

Objective To systematically analyze the current situation of case‐control studies published on Chinese nursing ac‐ademic journals and provide references for future researches .Methods All literatures related to case‐control studies published on Chinese nursing academic journals were retrieved from CNKI ,CBM ,Wangfang databases ,and VIP by computer .The literatures were analyzed by bibliometrics method .Results Totally 77 literatures published in 17 journals were retrieved .The number of liter‐atures revealed an increasing tendency .T he content of these literatures involved 11 nursing fields ,such as medicine nursing ,surgery nursing ,and fundamental nursing .29 .9% of studies were supported by research grants .On the other side ,authors were located in 18 provinces ,autonomous regions and municipalities .Meanwhile ,most of them were from developed regions and worked in medical institutions .Conclusion The method of case‐control studies have gradually gained recognition of Chinese nursing researchers . However ,the number of case‐control studies were still small .Nursing researchers should be encouraged to conduct case‐control studies actively and apply this kind of method in more extensive fields of nursing .

Objective:To understand the state of Chlamydia pneumoniae (Cpn) infection in patients with coronary hear disease (CHD), and explore the relationship between Cpn infection and the gonesis and progressin of CHD.Methods:By means of PCR and ELISA, Cpn IgG antibody and nucleic acid were detected in 159 patients with CHD and 41 control subjects.Results:The positivity rate of Cpn DNA was 43 40%(69/159) in the patient group and 7 32%(3/41) in the control group, showing obvious difference between the two groups( P