OBJECTIVE:To provide reference for definition and research & development of new drugs in China.METHODS:The history of the definition for new drugs was reviewed,and the effects of the definition of new drugs on the research and development of drugs were discussed by using the game theory "Tragedy of the Commons" and "Anti-Tragedy of the Commons".RESULTS & CONCLUSIONS:The definition of new drugs should be more and more scientific and reasonable and in line with the aim of building new creative country,meanwhile,efforts should be paid to avoid the above mentioned two kinds of tragedies.

Antigens, CD ; metabolism ; Diagnosis, Differential ; Female ; Humans ; Killer Cells, Natural ; pathology ; Leg ; Lymphoma, T-Cell, Cutaneous ; immunology ; pathology ; Middle Aged ; Skin Neoplasms ; immunology ; pathology

50Gy gave better survivals.Conclusion Age,tumor histology,ex- tent of resection,interval time of postoperative radiotherapy and the dosage of target were related to survival.

Objective To study the relationship between tyrosine phosphorylation(TP)and protein expression of insulin receptor substrate-1(IRS-1)and insulin resistance in patients with gestational diabetes mellitus(GDM).Methods IRS-1 expression and TP in skeleton muscle tissue were determined by Western blot and immunoprecipitation in women with GDM(GDM group,n=22),normal pregnant women(normal pregnancy group,n=22)and normal nonpregnant women(normal nonpregnant group,n=13).Fasting plasma glucose(FPG)and fasting insulin(FINS)were measured by oxidase assay and immunoradioassay. Results(1)The levels of FPG,FINS,and insulin resistance index were calculated according to homeostasis model assessment [ HOMA-IR;(5.6?0.8)mmol/L,(15.4?5.1)mU/L,and 1.2?0.5 ] in GDM group were significantly higher than those in normal pregnancy group [(4.4+0.5)mmol/L,(10.6 ?3.1)mU/L,and 0.8?0.3;P

Adenosine Triphosphate ; metabolism ; Colorectal Neoplasms ; diagnosis ; genetics ; DNA Methylation ; Diphosphates ; metabolism ; Glioma ; diagnosis ; genetics ; Humans ; Isocitrate Dehydrogenase ; genetics ; Janus Kinase 2 ; genetics ; Mutation ; Myeloproliferative Disorders ; diagnosis ; genetics ; Polymorphism, Single Nucleotide ; Proto-Oncogene Proteins ; genetics ; Proto-Oncogene Proteins p21(ras) ; Sequence Analysis, DNA ; methods ; Templates, Genetic ; ras Proteins ; genetics

Acupuncture Therapy ; Adult ; Catgut ; utilization ; Female ; Humans ; Lactation ; Lactation Disorders ; physiopathology ; therapy ; Postpartum Period ; physiology ; Qi ; Young Adult

Objective To develop a convenient method efficiently expands the frequency of specific CTLS.Methods We used different concentrations of CMV-speeific epitope peptides pp65 to stimulate PBMCs for expansion of CMV-specific CTLs.CMV-specifie CTLs were doubly labeled by tetramers-PE and CD_8-FITC for FACS analysis.Results The method expands CMV-speeific CTLs efficiently.CMV-specific CTLs were expanded from 1% to 20% of PBMCs quickly(namely 40% of CD_8~+ T cells).The method provided a large number of cells with tetramer staining of CD_8~+ T cells for FACS analysis from a single blood sampling.Conclusions Peptides stimulation methods are convenient,easy to operate and expanded CMV- specific CTLs efficiently.The increased frequencies of CMV-specific CTLs allowed the data of different individuals to be easily compared and sequentially evaluated.The methods lay the base for adoptive immunotherapy to prevent CMV disease.

Objective To evaluate the predictability of MSCT perfusion in the restorability of renal function of hydronephrotie kidneys with unilateral partial ureteric obstructed rabbit model as to explore a method to predict the restorability of renal function of hydronephrotic kidneys and to investigate the changes of MSCT perfusion parameters during the course of the restore of renal function.Methods Establish a unilateral partial ureteric obstructed rabbits hydronephrotie model.Hydronephrotie rabbits were grouped as control,2,4 and 8 week(G_2w,G_4w and G_8w)after obstruction and the later 3 groups of rabbits were reared for further 4 weeks after the obstruction was released.MSCT perfusion scanning was performed and the specimen was made into histological slices with HE staining.Results BF and BV value of renal cortex and medulla of G_2w after obstruction [(864?32)ml?100 g~(-1)?min~(-1),(19.5?0.9)ml/100 g (cortex ); (182.1?7.5)ml?100g~(-1)?min~(-1),(8.37?0.51)ml/100g(medulla)]was released restored in substance and approached that of control[(899?63)ml?100g~(-1)?min~(-1),(21.6 + 1.4)ml/100 g (cortex);(193.5?16.5 )ml?100g~(-1)?min~(-1),(8.50?0.54 )ml/100 g (medulla)]while there was no significant restore in that of G_4w and G_8w after obstruction[(525?15)ml?100g~(-1)?min~(-1),(12.8? 0.6)ml/100g (G_4 w);(512?10)ml?100g~(-1)?min~(-1),(9.4?1.0)ml/100 g (G_8w)] was released. Histologically,there was a positive correlation between the duration of obstruction and the seriousness of pathologic changes.Conclusion MSCT perfusion can provide information not only morphologically but also about renal perfusion of hydronephrotic kidneys.

Objective:To observe the clinical efficacy of Gao's nape acupuncture plus swallowing training in treating pharyngeal deglutition disorder after stroke.Methods:One hundred patients with post-stroke pharyngeal deglutition disorder were randomized into a treatment group and a control group,with 50 cases in each group.The two groups both received routine neurological intervention.In addition,the treatment group was given Gao's nape acupuncture plus swallowing training,while the control group was intervened by swallowing training alone.After eight-week treatment,the two groups were observed in terms of the changes in repetitive saliva swallowing test (RSST),modified water swallowing test (MWST),standardized swallowing assessment (SSA) and swallowing-related quality of life (SWAL-QOL).The clinical efficacies of the two groups were also compared.Results:After treatment,the RSST grading,and scores of MWST,SSA and SWAL-QOL changed significantly in both groups (P＜0.05 or P＜0.01).The RSST grading,and scores of MWST,SSA and SWAL-QOL in the treatment group were significantly different from those in the control group after treatment (P＜0.05 or P＜0.01).The total effective rate and markedly effective rate were respectively 100.0％ and 72.3％ in the treatment group,versus 97.9％ and 34.0％ in the control group.There was a significant difference in the markedly effective rate between the two groups (P＜0.01).The difference in the clinical efficacy between the two groups was statistically significant (P＜0.01).Conclusion:Gao's nape acupuncture plus swallowing training is an effective approach for post-stroke pharyngeal deglutition disorder.Its therapeutic efficacy is more significant than that of swallowing training alone.

BACKGROUND:Polyhydroxybutyrate-co-volerate (PHBV) is a noticeable tissue engineering material of polyhydroxyalkanoates family. It has the properties of low immune rejection response and good biocompatibility, and its degradation products are non-toxic.
OBJECTIVE:To investigate the biocompatibility of PHBV membrane material and human bone marrow mesenchymal stem cel s in vitro.
METHODS:Human bone marrow mesenchymal stem cel s at passage 3 were seeded upon PHBV membrane as experimental group and upon conventional culture plates as control group. Then we calculated the adherent cel number of two groups at 1, 2 and 4 hours and got the cel adherent rate. 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide assay was used at days 2, 4, 6, 8 to observe the cel proliferation of two groups. Fluorimetric method with the fluorescent dye Hoechst 33258 was used to detect the DNA content of cel s at days 3, 6, 9 and 12 in both groups. After cel s were seeded upon PHBV membrane for 5 days, the cel growth upon the material was examined under a scanning electron microscope.
RESULTS AND CONCLUSION:When the cel s were cultured for 1 hour, the adherent rate in the experimental group was lower than that in the control group;but there were no significant differences between two groups at the other two periods. No difference was found in the cel proliferation and the DNA content between the two groups. Human bone marrow mesenchymal stem cel s seeded upon PHBV membrane for 5 days grew wel with spindle morphology and the intercel ular connections were tight and more extracel ular matrices were observed by scanning electron microscopy. Taken together, PHBV membrane material shows a good biocompatibility with human bone marrow mesenchymal stem cel s.