In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.

Objective To compare sensitivity and specificity of the acute physiology,age,and chronic health evaluation system Ⅱ (APACHE Ⅱ),the acute physiology,age,and chronic health evaluation system Ⅲ (APACHE Ⅲ) system in predicting prognosis after cardiac operation.Methods A prospective study of 1 180 consecutive patients entering in a single cardiac postoperative intensive care unit of Anzhen hospital was assigned between November 2013 to January 2014.APACHE Ⅱ and APACHE Ⅲscore was calculated daily at least three days or until death,then compared the calibration and discrimination of the two different system using Hosmer-Lemeshow goodness-of-fit and receiver operating characteristic(ROC) curve.Results In discrimination analysis,ROC value of the first day after operation was(APACHE Ⅱ 0.699 、APACHE Ⅲ 0.734),ROC of the maximum(APACHE Ⅱ 0.836,APACHE Ⅲ 0.862),ROC of the maximum during the first 3 days(APACHE Ⅱ 0.814、APACHE Ⅲ 0.855),ROC of the change between the third day and the first day(APACHE Ⅱ 0.524 、APACHE Ⅲ 0.549).In calibration analysis,we compared the x2 value and overall corrected percentage of the first day value,the maximum value,the maximum value during the first 3 days,the change value between the third day and the first day of the three different system.x2 value of APACHE Ⅱ was(15.688,10.132,8.061,42.253),x2 value ofAPACHE Ⅲ was(13.608,11.196,19.310,47.576).Conclusion APACHE Ⅲ was better than APACHE Ⅱ in prediction of death risk after cardiac surgery.

Objective To investigate the effectiveness, dose-effect and time-effect relationships for inhibiting neointimal proliferation by 103 Pd radioactive stent, and the safety of the radioactive stent. Methods By angiogaphic, morphometric and histopathologic analysis, we compared 1?000 ?Ci, 500 ?Ci and 100 ?Ci 103 Pd stents with non-radioactive stents on 5 weeks and 12 weeks after stenting in a micro-porcine coronary model of restenosis. Results The neointimal areas of 500 ?Ci and 100 ?Ci 103 Pd stents were significantly smaller than control stents. 1?000 ?Ci stents and control stents had similar neointimal areas. The neointimal areas of 500 ?Ci stents were significantly smaller than 100 ?Ci stents. Compared with control stents, 500 ?Ci stents reduced the neointimal areas by 49% and 50% respectively on 5 weeks and 12 weeks after stenting. Compared with 5 weeks after stenting, the effect of inhibiting neointimal proliferation by 100 ?Ci stents was reduced by 56% (32% vs 14%) on 12 weeks. The neointimal areas on both edge of 100 ?Ci stents were significantly larger than control stents. The neointimal areas on both edge of 1?000 ?Ci stents and 500 ?Ci stents were similar with control stents. No evident radiation damage had been found in the experimental animals who had 103 Pd stent. Conclusion There may be an effective dose window for 103 Pd radioactive stent in inhibiting neointimal proliferation. The effect of inhibiting neointimal proliferation was dose dependent. 103 Pd radioactive stent with appropriate activities may effectively, persistently inhibit neointimal proliferation with no adverse radiation sequelae. These results suggest that 103 Pd radioactive stent prevent restenosis. These data may be useful in predicting safe and effective activity for 103 Pd radioactive stent.

Carcinoma, Non-Small-Cell Lung ; diagnostic imaging ; radiotherapy ; Fluorodeoxyglucose F18 ; Humans ; Lung Neoplasms ; diagnostic imaging ; radiotherapy ; Neoplasms ; diagnostic imaging ; radiotherapy ; Positron-Emission Tomography ; methods ; Radiotherapy, Intensity-Modulated ; methods ; Tomography, X-Ray Computed ; methods ; Tumor Burden ; radiation effects

Adult ; Analgesia ; methods ; Female ; Humans ; Male ; Middle Aged ; Pain, Postoperative ; metabolism ; prevention & control ; Stress Disorders, Post-Traumatic ; prevention & control

BACKGROUND: Causes of Parkinson disease have not been mentioned clearly up to now yet. Theory of hereditary susceptibility is the main theory to explain Parkinson disease now. But there is no definite conclusion on which hereditary factors have relationship with it.OBJECTIVE: To study the relationship between gene polymorphism caused by point mutation C to T on cDNA609 basic group of reduced NAD(P) H:quinone oxidoreductase(NQO1) gene and hereditary susceptibility of Parkinson disease.DESIGN: A non-randomized synchronized control research based on patient and healthy people.SETTING: Neurology departments in two university hospitals and a senile disease research institute in a university hospital.PARTICIPANTS: Totally 126 patients(Parkinson disease group) diagnosed as Parkinson disease in Neurology Clinic of First Hospital Affiliated to Sun Yat-sen University from September 1994 to September 1997, aged 46 to 73 years, in which 74 were males and 52 were females. Totally 136 healthy adults (control group), in which 66 were males and 70 were females, who came to the clinic to do health examination at the same time, aged 40 to 72 years.METHODS: Polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP) was used to analyze NQO1 gene polymorphism in Parkinson disease group and healthy adult control group.MAIN OUTCOME MEASURES: Mutation frequency and genotype of point mutation of basic group C to T on NQO1 gene cDNA609.RESULTS: T allele frequency in Parkinson disease group was 52% and that in control group was 43%. There was significant difference between two groups (P ＜ 0. 005) . There was significant difference on distribution of genotype in Parkinson disease group and control group( P ＜ 0.05). The risk incidence increased 3.8 times in individual with T allele.CONCLUSION: NQO1 gene cDNA609 mutation T allele may be a risk factor to Parkinson disease, which could be associated with the hereditary susceptibility of Parkinson disease.

Objective To investigate the intervention ways of endoscopes in the treatment of esophagus stenosis due to carcinoma of esophagus and improvement of quality. Method 11 cases of advanced carcinoma of esophagus were included in this study. Operation and chemical therapy were unavailable for these patients. Memory trestle with membrane and made of alloy of Nickel－ titanium was inserted under intervention of endoscope. Trestle was posed in stenosis part of esophagus under direction of X－ ray. Trestle could be dilated 3－ 7 days after operation due to its reaction characteristics to temperature. So, redilated therapy was unnecessary. Trestle could reconstruct swallowing tract and made feeding through mouth become available during limited survival time.Results All trestles were successfully inserted.Half－ fluid feeding was available after operation. Obstruction was removed in all patients(100％ ).Conclusion Method described in this study was safe and effective .Effective swallowing tracts were reconstructed in all patients after trestle was planted and quality of life and survival time were both improved.

0.05).The degreeⅢ～Ⅳthrombocytopenia was more common in group A than in group B,but the degreeⅢ～Ⅳhypolekocytosis and phlebitis was more serious in group B.Conclusion NC and GC for treating refractory metastatic breast cancer have a high response rate and tolerable side effects.

Objective To explore the effects of low load exercise on the gait and balance in patients with Parkinson's disease. Methods 12 inpatients with Parkinson's disease from May to August, 2015 accepted low load exercise on Power Rehabilitation System 14 times in 2 weeks, with the medication as before. They were assessed with 3D gait analysis and Berg Balance Scale before and after treatment. Results The step length, stride length and walking speed improved after treatment (P<0.05), and improved more in the seriously affected limbs. There was no difference in cadence, stride time, step time, single support, double support, opposite foot off and opposite foot contact after treatment (P>0.05). The scores of Berg Balance Scale improved after treatment (P<0.05). Conclusion The low load exercise can improve the gait and balance in patients with Parkinson's disease.

Objective To evaluate therapeutic effects and toxicity of advanced non-small cell lung cancer (NSCLC)treated by combining chemotherapy on ifosfamide(IFO)and vinorelbine(NVB).Methods 107 cases pa- tients with advanced NSCLC were enrolled.IFO was given in a dosage of 1.5g/m~2 on day 1 to 4.and NVB in a dosage of 25mg/m~2 on day 1 and 8.It was repeated every three or four weeks,up to two to four cycles.Results Two patients had complete response and 40 patients had partial response.The overall response rate was 47.7% ,the median survival time 10.3 months,1-year and 2-year survival rate was 42% and 12.3%,respectively.The main toxicity was bone marrow suppression.Conclusion The regimen is effective,sale and tolerable in advanced non- small cell lung cancer therapy.