OBJECTIVE:To discuss how can the pharmacoeconomics be applied in "me-too" drug research and development.METHODS:The current situation of "me-too" drugs,i.e.the advantageous and disadvantageous of "me-too" drug research and development was discussed.Then,the necessity and the application stage of pharmacoeconomics in "me-too" drug research and development,and issues regarding the option of pharmacoeconomic evaluation methods as well as the possible problems and the countermeasures in the application were addressed.RESULTS & CONCLUSION:Pharmacoeconomics can help promote the rationality of "me-too" drug research and development.

Objective To investigate the clinical efficacy and prognosis of early protective pulmonary ventilation and intra-aortic balloon pump(IABP)combined with percutaneous coronary intervention(PCI)in treating patients with acute myocardial infarction(AMI)complicated with cardiogenic shock(CS)and hypoxemia.Methods The 49 patients diagnosed as AMI complicated with CS and hypoxemia and treated with early protective pulmonary ventilation and IABP combined with PCI in Tianjin Chest Hospital from January 2015 to December 2015 were retrospectively analyzed.Major adverse cardiovascular events(MACE)including sudden cardiac death,recurrent myocardial infarction,heart failure and development of target vessel revascularization were recorded during one year of follow-up visits.Survival rate was analyzed and Cox regression analysis was used to explore risk factors for occurrence of MACE after the treatment.Results The revascularization of target vessel was successfully operated on all of the 49 patients.The mean time from attack to hospitalization was(6.2±1.5)hours,while the mean time from emergency room to balloon dilatation was(118.55±28.28)minutes.In these patients,30(61.2%)cases were diagnosed as STEMI,among which 23(76.6%)cases as anterior wall myocardial infarction and 5(16.7%)cases as inferior wall myocardial infarction.While the other 19(38.8%)cases were diagnosed as non-STEMI.Using coronary arteriography,46(93.9%)cases had multi-vessel coronary artery disease,among which 13(26.5%)cases were complicated with severe left main coronary artery disease and 27(55.1%)cases had severe vascular calcification.44(89.8%)cases had TIMI perfusion grade 3 blood flow after PCI,while 5(10.2%)cases did not achieve TIMI grade 3 blood flow.One(2.0%)case had serious complications and 12(24.5%)patients died in hospital.31(63.3%)patients survived 1 year during follow-up visits.Total number of MACE was 32(65.3%).Among these events,18(36.7%)died,4 cases(8.2%)had recurrent myocardial infarction,13 cases(26.5%)had heart failure(HF)and 5 cases(10.2%)had target vessel revascularization(TVR).The total event-free survival rate was 34.7%.Multivariable Cox regression analysis showed that severe vascular calcification〔HR(95%CI):2.677(1.184-6.054),P=0.018〕,TIMI grade blood flow less than level 3 after PCI〔HR(95%CI):26.289(6.314-109.470),P=0.000〕and more than 120 minutes from emergency room to balloon dilatation〔HR(95%CI):2.923(1.325-6.446),P=0.008〕were risk factors for MACE.Conclusions Early protective pulmonary ventilation and IABP combined with emergency PCI are safe and effective for treatment of patients with AMI complicated with CS and hypoxemia.The pattern of treatment can significantly decrease death rate and increase 1-year survival rate.

Objective A new method is researched based on ECG for human identification.Methods Three features of wave feature,wavelet feature,fusion feature were selected as the feature vectors for 35 normal subject ECGs,and correlation coefficient discriminate analysis was used for human identification. Results The other 40 sessions from 35 subjects were used for verifying the accuracy of each feature.They were 82.5%、87.5% and 95% respectively for wave feature,wavelet feature and fusion feature. ECG wavelet feature outperformed ECG wave feature. While ECG fusion feature performed better than either feature. Conclusion The verification experiment demonstrates that the technology of human identification based on ECG is feasible. ECG can be combined with other biometric features such as fingerprint for developing the multi-biometric identification system. The method proposed in this paper is simple,real-time and exact for human identification.

Objective To study the effects of dendritic cells (DC) modified with transforming growth factor ?1 (TGF-?1) gene on experimental autoimmune myasthenia gravis (EAMG) in Lewis rats. Methods 30 female Lewis rats were divided randomly into 6 groups: normal group, EAMG group, DCs treatment group, pcDNA_3-TGF-?1-DCs treatment group, pcDNA_3-DCs treatment group and normal saline group. The rats were immunized with the acetylcholine receptor (AChR) protein extracted from electric organ of Narcine timilei and completed Freund’s adjuvant (CFA) in the experiment groups except normal group. 2?106 pcDNA_3-TGF-?1-DCs/rat were injected subcutaneously into the backs of the rats that had been immunized 5 days earlier with AChR+CFA. The rats in DCs treatment group, pcDNA_3-DCs treatment group and normal saline group were injected in parallel with untreated DCs, pcDNA_3-DCs and normal saline respectively. Then the clinical manifestations were observed everyday. And 7 weeks after the first immunization, repetitive nerve stimulation, detection of acetylcholine receptor antibody (AChRab) and ultrastructural study of neuromuscular junction (NMJ) were performed. Results (1) The mild symptoms were observed on 1 or 2 rats in the experiment groups except normal group after a week, which lasted for 2 to 5 days. After about 5 weeks, the rats in EAMG group, DCs treatment group, pcDNA_3-DCs treatment group and normal saline group presented some symptoms at different degree like myasthenia gravis, and only one of the rats in pcDNA_3-TGF-?1-DCs treatment group presented mildly decreased activity. (2) The significant decrement of repetitive nerve stimulation were found in EAMG group, DCs treatment group, pcDNA_3-DCs treatment group and normal saline group(16.75?6.13, 17.75?7.81, 18.25?8.22 and 16.50?7.14, respectively), but there was no attenuation in pcDNA_3-TGF-?1-DCs treatment group and normal group(3.20?3.70 and 5.60?2.70, respectively). The percentage of decrement in pcDNA_3-TGF-?1-DCs treatment group was lower than that in EAMG group(5.60?2.70 and 16.75?6.13, respectively,P0.05). (4) The combined AChRs in NMJ of the rats in pcDNA_3-TGF-?1-DCs group were higher than that in EAMG group, and the structure changes of the synapse were relieved.Conclusion It suggests that DCs, transfected with pcDNA_3-TGF-?1, when injected subcutaneously into Lewis rats with incipient EAMG, could inhibit the production of AChR-Ab, relieve the pathologic changes in NMJ and ameliorate the development of EAMG.

Objective To evaluate the effect of proper nutritional therapy guided by indirect caloimetry . Methods According to the digitaltable ,70 critically ill patients whose APACHE II >5 were randomly divided into oberserving ( nutritional therapy guided by indirect caloimetry ) and control groups ( nutritional therapy guided by harris-benedict formula),each group 35 cases.The results of nutrition support were analysed .Results TP,MAMC,ALB were higher than that before treatment in oberserving group (all P<0.05),the MAMC was also higher than that in control groups(P<0.05).There was no significant difference in Hb and TSF after treatment IN oberserving group (all P>0.05).Conclusion The nutritional therapy guided by indirect caloimetry by harris-benedict formula have the some nutritional effect in critically ill patients .

OBJECTIVE: To set up a natural degeneration model of chondrocytes derived from endplate of intervertebral discs of rats in order to offer an appropriate carrier for the study on mechanism of intervertebral disc degeneration. METHODS: The method of enzyme digestion combined with natural subculture was used to set up the in vitro natural degeneration model of chondrocytes derived from the endplate of intervertebral disc of rats. The morphological appearances and microstructures of the chondrocytes of different generations were observed. The expression of collagen II in chondrocytes was detected by immunocytochemical method. RESULTS: The chondrocytes derived from the endplate of intervertebral disc expressed collagen II. After 13 days of culture, the chondrocytes of generation III showed that the ability of cell division descended, the nucleoli became unclear, the cells deformed obviously, fusiform shape with weak optical activity appeared, and the intercellular space was enlarged. There were vacuoles and lipid droplets in cytoplasm. The synthesis of collagen II, as well as the cell proliferation rate, descended notably. All results showed the natural degeneration process of the chondrocytes. CONCLUSION: The in vitro natural degeneration model of chondrocytes derived from endplate of intervertebral discs of rats was successfully established. This can offer the cytological basis for study on the mechanism of intervertebral disc degeneration.

Under the background of severe shortage of donor organs and organ donation after citizen's death becoming the main source of donor organs in China, expanded criteria donor (ECD) has been widely applied in clinical practice. However, ECD has the disadvantages of basic diseases, old age, trauma, shock or infection, which will affect the quality of donor organs to varying degrees and become one of critical factors affecting clinical efficacy of organ transplantation. The recipients of ECD organ transplantation will also bear the additional risk and uncertainty of efficacy brought by ECD organs. Hence, it is necessary to pay attention to the protection of the recipients’ rights and interests. In this article, ethical issues faced by ECD organ transplantation in recipient protection and the shortcomings in the ethical review of organ ethics committee were reviewed, and suggestions on the ethical review institution and system construction of the rights and interests of organ transplantation recipients were elucidated, aiming to provide reference for promoting the advancement of ECD organ transplantation.

BACKGROUND:Delayed graft function (DGF) occurs frequently in kidney transplants from donation after cardiac death if creatinine level is high in kidney recipients. OBJECTIVE:To analyze the clinical effects of renal transplantation with kidneys from donors dying of cardiac death in organophosphate poisoning. METHODS:Data were col ected from kidney transplants from two donors dying of cardiac death in organophosphate poisoning. After some donor maintenance, donor organ were obtained and perfused with impulse type machine. Recipients were treated with intervention of immunity induction, anti-rejection drugs and infection prevention drugs during and after renal transplantation. Pathological data of donor kidney zero needle biopsy, DGF after kidney transplantation, complication rate (such as acute rejection), renal al ograft recovery situation, the survival rate of recipients and kidney transplants were col ected and analyzed. RESULTS AND CONCLUSION:Needle biopsy results from four donor kidneys showed that glomerular morphology was normal, but there were edema and degeneration in kidney tubules in some degree. Donor DGF rate was 75%(3/4), acute rejection rate was 0%(0/4), perioperative period donor kidney and recipient survival rate were 100%(4/4). Al recipients showed a good result of transplanted kidney, their creatinine and urea nitrogen were at low level, and had no proteinuria. One recipient died of severe pulmonary infection 4 months after surgery. For some organophosphate poisoning donors dying of cardiac death, donor kidney quality can be improved by suitable donor maintenance and high-quality donor kidney preservation using machine perfusion. Kidney transplants from donors dying of cardiac death in organophosphate poisoning who receive the maintenance of organ function may be a promising candidate for renal transplantation due to a severe lack of kidney donor sources.

Organ shortage is one of the important factors restricting the development of human organ transplantation. The identification and referral of potential donors determine the total scale of organ donation. Whether potential donors can be identified and referred is the most important reason for the difference of organ donation rates in different regions. This paper interprets the chapter of the identification and referral of potential donors in the Guide to the Quality and Safety of Organs for Transplantation (6th edition) issued by European Union in order to provide reference for the staff of organ procurement organization and related medical personnel in China and improve the organ donation rate in China.

Objective To observe the clinical effect of the maintenance for the liver and kidney function by extra corporeal membrane oxygenation (ECMO) in brain death donor with severe hemodynamic instability.Methods Ninety-nine brain death donors maintained by ECMO were followed up.The criteria for using the ECMO to protect the organ function were as follow:cardiopulmonary resuscitation history (cardiac compression ＞ 20 min);mean arterial pressure (MAP),for Adult ＜60-70 mmHg,for child ＜50-60 mmHg,and for infant ＜40-50 mmHg;cardiac index ＜2 L/(m2 ·min) (3 h);Large doses of vasoactive drugs,for doparnine 20μg/(kg·min),for (norepinephrine) epinephrine 1.0 μg/(kg· min) (3 h),and for oliguria ＜0.5 mL/(kg · h);blood biochemical indexes,moderate,severe impairment on acute hepatic and renal function;others,ST-T significant changes in electrocardiogram,and difficult to correct the metabolic acidosis (3 h).The organs were evaluated during their retrieval and as well their evolution after transplantation was evaluated.Results ECMO allowed for the maintenance of hemodynamic stability before organ procurement.A total of 99 cases receiving ECMO maintenance were collected,equal to100 ％ of the total donation cases (100％).198 kidneys,and 99 livers were procured from these donors meanwhile 15 kidneys and 42 livers respectively were discarded as theywere shown in a macroscopic evaluation.177 of the procured kidneys were transplanted.DGF of kidney transplantation was observed in 20.9％of the cases.Acute rejection incidence was 12.99％.Transplanted kidneys and recipient survival rate was 96.1％/99.3％ for one year,94.7％/97.8％ for 3 years,and 93.6/97.8％ for 4 years,respectively.There was no significant difference in patient or graft survival between the group with ECMO and the group without ECMO.Conclusion ECMO in the brain dead donors with severe circulatory dysfunction allows to avoid organ donors loss and obtain good quality kidneys and livers with excellent graft survival after transplantation.