As an important resource for a country to participate in international high-tech competition in the bio-pharma-ceutical field, clinical research resources play a key role in the multi-center clinical research and the translation from basic research to clinical practice.China has a large population and diverse diseases, but chinical disease research relevant policies and regulations are imperfect.In contrast, the United States has perfect laws and regulations related to clinical research.By comparatively analyzing the disease resource, platform support and regulatory environment between China and the U.S., this article offers suggestions on the development of clinical research resources so as to facilitate the clinical research in China.

In October 2015 ,the White House issued a New Strategy for American Innovation which was also concerned with precision medicine initiative , BRAIN initiative and health care .This paper introduces the background , main content and developments of this new strategy ,hoping to facilitate the development of healthcare in China .

HPLC analysis was performed to study the changes in chemical composition of ginseng extracts prepared from high quality ginseng with 0, 2, 4, 8 h of steamed times. An UFLC-MS/MS multiple-reaction monitoring (MRM) quantitative analysis was made to investigate the pharmacokinetic behavior differences of ginsenosides in mice ig administered of ginseng extracts with different steamed times in the negative ion mode, with Digoxin as the internal standard substance. The mice were injected with LPS to establish inflammation model after ig administration of ginseng for a week and the contents of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in mice plasma were detected by ELISA, in order to study on anti-inflammatory effects of ginseng with different steamed times. It was determined that levels of TNF-α and IL-1β were significantly decreased in inflammation model group ig administered of ginseng extracts with 8h of steamed time. The results showed that the chemical components in ginseng changed after steaming and the components into the blood changed, correspondingly. Ginseng with steamed 8 h contributes to anti-inflammatory effects. These results provided an experimental basis for revealing the active substance basis and dose-effect relationship of ginseng on anti-inflammatory effect.
Animals ; Anti-Inflammatory Agents ; chemistry ; pharmacokinetics ; Chemistry, Pharmaceutical ; methods ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Ginsenosides ; chemistry ; pharmacokinetics ; Hot Temperature ; Humans ; Inflammation ; drug therapy ; Male ; Mice ; Mice, Inbred ICR ; Panax ; chemistry ; Time Factors

Objective To investigate the relationship between hepatitis B virus (HBV) genotype and liver function. Methods The method of microboard nucleate molecular hybridization was employed to detect the genotype in 93 HBV patients of different clinical types and the function of liver. Results Among the 93 HBV patients of different clinical types, there were 24 cases of genotype B (25.81%), 59 cases of genotype C (63.44%), 5 cases of genotype D (5.38%), and 5 cases of mixed type (3 cases of B/D, 2 cases of C/D, 5.38%). Therefore, genotype C took up the largest proportion, followed by genotype B, and then D and mixed genotypes, but there was no genotype A, E or F. The detection rate of genotype C increased according to the sequence of chronic hepatitis B, subacute severe hepatitis and hepatocirrhosis while the detection rate of genotype B decreased gradually. However, the detection rate of genotype C in hepatocellar carcinoma did not rise correspondingly. The levels of ALT, AST and TBIL of genotype C were higher than those of genotype B, but the level of ALB in genotype C was lower than that of genotype B. None of the differences had significance. Conclusion Most of HBV genotypes in Xi'an were C, some of them were B, D and mixed genotypes, but no genotype A, E or F was detected. Except hepatocellar carcinoma, the detection rate of genotype C rose according to the severity of clinical type.

Objective To observe the roles of nuclear factor-κB (NF-κB) and hypoxia-inducible factor-1 o (HIF-1 α) in hippocampal neurodegeneration of status epilepticus (SE) rats, and explore whether HIF-1α activation is regulated by NF-κB.Methods A total of 110 male Sprague-Dawley rats were randomly divided into seven groups : (1) Control group treated with saline (control, n =15), (2) sham group implanted cannula into lateral ventricle and treated with saline (sham, n =15), (3) SE group treated with pilocarpine (SE, n =20), (4) NF-κB activity inhibitor pyrrolidine dithiocarbamate (PDTC) group treated only with PDTC (PDTC, n =15), (5) SE + PDTC group treated with pilocarpine plus PDTC (SE + PDTC, n =15), (6) SE + HIF-1o siRNA group implanted cannula into lateral ventricle and treated with pilocarpine plus HIF-1 α siRNA (SE + HIF-1α siRNA, n =15), (7) SE + control siRNA group implanted cannula into lateral ventricle and treated pilocarpine plus control siRNA (n =15).SE was induced by injecting lithium chloride and pilocarpine.The seizure of rats was observed.The protein expressions of NF-κB and HIF-1 α in hippocampus of rats were examined by Western blotting.The degenerating neurons in hippocampus were detected by Fluoro-Jade C (FJC) staining.Results Twenty-four hours after termination of SE, the nuclear protein expressions of NF-κB and HIF-1α in hippocampus of rats were increased in SE group (0.57 × 0.06, 0.47 ± 0.07) compared with those in control group (0.23 ± 0.03, 0.20 ± 0.03;P ＜0.05);and compared with SE group PDTC significantly decreased the nuclear protein expressions of NF-κB and HIF-1 α in SE + PDTC group (0.23 ± 0.03, 0.14 ± 0.03;P ＜ 0.05);in SE + PDTC group the numbers of FJC positive cells in CA1 area (28.33 ±5.03) were decreased compared with that in SE group (76.67 ± 13.32);HIF-1 o siRNA injected into lateral ventricle of rats significantly decreased the expression of HIF-1α in hippocampus (0.22 ±0.03) and the number of FJC positive cell in CA1 area (27.34 ±7.02) in SE + HIF-1α siRNA group compared with those in SE group (0.39 ±0.06, 76.67 ± 13.32;P ＜0.05).Conclusions These data suggest that SE can result in activation of NF-κB/HIF-1o pathway in brain.Inhibition of the pathway can attenuate hippocampal neurodegeneration caused by SE, which has the brain protective effect.

[Abstract ] Objective High-mobility group box-1 (HMGB1) is abundantly released in the epileptogenic brain tissue , but few reports are seen about the effect of HMGB 1 on the expression of P-glycoprotein ( P-gp) in the vascular endothelial cells of the epi-leptogenic tissue .This study is to explore whether HMGB 1 can regulate P-gp expression in the brain microvascular endothelial cells of the mouse in vitro . Methods Immortalized brain microvascular endothelial bEnd .3 cells of the mouse were cultured in vitro and al-located to different concentration groups ( treated with culture medium containing 10 , 100 , 500 , and 1000 ng/mL HMGB1 for 8 hours), treatment duration groups (treated with culture medium containing 100 ng/mL HMGB1 for 4, 8, 16, 24, and 32 hours), and a control group ( treated with culture medium without HMGB 1 ) .The mRNA expression of P-gp-encoding gene-multidrug resistance gene 1a (mdr1a) was detected by real-time qPCR, and its protein expression determined by Western blot and immunocytochemistry . Results The results of qPCR manifested that the expressions of mdr 1a mRNA were 1.646 ±0.176, 1.777 ±0.135, 1.617 ±0.043, and 1.398 ±0.182 in the 10, 100, 500, and 1000 ng/mL HMGB1 groups, respectively, significantly higher than 1.030 ±0.284 in the control group (P<0.05), and so were those in the 4, 8, 16, 24 h, and 32 h groups (2.655 ±0.112, 2.168 ±0.212, 1.823 ± 0.232, 1.418 ±0.376, and 1.445 ±0.123) than in the control (1.010 ±0.164) (P <0.05).Western blot showed a significant increase in the P-gp protein expression in all the concentration groups (P<0.05) as well as in the 8 h and 16 h treatment duration groups as compared with the control group (P<0.05).Immunocytochemis-try also revealed a higher P-gp expression in the HMGB1-treated than in the control cells (P<0.01). Conclusion HMGB1 can upregu-late the expressions of mdr1a mRNA and P-gp protein in the brain microvascular endothelial cells of the mouse , which may associated with drug resistance of central nervous system diseases , especially that of epilepsy .

An absorbable hemostatic material based on polysaccharide was prepared. The concentration of blood cells and coagulation factors was increased by reducing the water content in the blood, so as to reduce the coagulation time and achieve the purpose of rapid hemostasis. The specific surface area of starch was increased by using hydrochloric acid to hydrolyze potato starch, which made it easier to combine with α-amylase and increased the degradation rate. Starch was crosslinked into microspheres by crosslinking agent, which made the particle size uniform and greatly improved the water absorption. The surface modification of crosslinked starch microspheres with carboxymethyl group can further improve the water absorption of hemostatic materials. The results showed that the water absorption rate of our hemostatic material was more than 800%, and the average hemostatic time in the animal model was 138.7s. Compared with the imported products on the market, our hemostatic material have better hemostatic performance.
Animals ; Hemostasis ; Hemostatics/pharmacology* ; Polysaccharides/pharmacology* ; Starch/pharmacology* ; Water/pharmacology*

Aim To make a research of rats with focal cerebral ischemia/reperfusion injury on pathological changes in brain and the changes of AQP4 and related proteins, in order to explore the relationship between AQP4 and brain edema. Methods Adult male SD rats, weighting 250~300 g, were randomly divided in-to Sham group and cerebral ischemia/reperfusion ( I/R) injury model group. The I/R model group was di-vided into the I/R-6 h, 12 h, 24 h, 48 h-four time point groups. The animal model of the right MCA is-chemia/reperfusion was established by suture method in mature SD rats. The nerve symptom score was con-ducted in the corresponding time points. Then, the permeability of brain tissue was detected by EB stai-ning;TTC staining was conducted to observe the cere-bral infarction volume;the dry wet weight method was used to detect the changes of brain water content; im-munohistochemical( IHC) , WB and RT-PCR were ap-plied to detect the expression of AQP4 , and the related factors at different time points of the model rats after is-chemia-reperfusion around infarcts. Results Com-pared with the Sham group, then ever function score of the rats in I/R model groups were much higher. With the increase of the reperfusion time, the cerebral in-farction volume, brain tissue permeability and the brain water content were also increased. IHC results showed that AQP4 expression gradually rose with widen distribution. WB and RT-PCR results verified the in-creasing level of AQP4 expression. The detection of the related proteins expression showed apparent changes. The expression of MMP-9 was increased, while the Oc-cludin and JAM-1 expression showed a decreasing trend. The I/R-48 h model group showed the most ob-vious differences in the expression of the related pro-teins and mRNA ( P <0. 01 vs Sham, respectively ) . Conclusion Accompanied with the aggravating cere-bral injury after cerebral ischemia/reperfusion, the ex-pression of AQP4 and MMP-9 level were activated, while the degradation of TJPs, Occludin and JAM-1, was increased. These factors are combined to make the formation of brain edema. This study makes a further research on the formation mechanism of the early stage for cerebral edema on I/R model and offers a potential for intervention in the filed of looking for a reliable drug therapy on cerebral edema.

Objective To discuss the correlation between SIRT3 protein and clinicopathological parameters of gastric carcinoma.Methods Immunohistochemistry and Western blot were used to detect the expression of SIRT3 in the gastric carcinoma and normal gastric tissue.The correlation between the expression of SIRT3 and clinicopathological parameters was analyzed.Results The immunohistochemistry showed that the positive expression rate of SIRT3 protein in gastric carcinoma tissue (53.8 ％,43/80) was obviously lower than that in normal gastric tissue (86.0 ％,43/50),and the expression of SIRT3 protein showed close relationship with invasion depth,lymph node metastasis and TNM stage (P ＜ 0.05),rather than the age,gender,tumor size,or differentiation status (P ＞ 0.05).The Western blot showed that the expression rate of SIRT3 protein (SIRT3/β-actin) in gastric carcinoma tissue (0.655±0.317) was lower than that in normal gastric tissue (0.803±0.329) (P ＜ 0.05).Conclusion The expression of SIRT3 protein is lower in gastric cancer than that in normal gastric tissue,and relates to invasion depth,lymph node metastasis and TNM stage.SIRT3 may inhibit the occurrence and development of gastric cancer.

Objective To evaluate the effect of home-made immobilization device with KV-CBCT in lung-SBRT and investigate its clinical use value.Methods Choosing 10 lung tumor patients (half centre type tumor;half peripheral type) random analysis the interfractional and intrafractional setup errors in the SBRT process by this fixed device with KV-CBCT.The concrete method is using Varian's KV-CBCT scans the patients before and after the SBRT each time,then make the registration between the reconstructed 3 d image and the planned CT image (both based on bone landmark),we then obtain the average setup errors in LR,AP and SI directions.Simultaneously,this research make contrastive analysis of setup errors among this fixed device and other fixed devices such as vacuum pad,phantom in body IMRT.All data make one-factor analysis of variance by SSPS 17.0.Results All the setup errors data was gaussian distribution,the centre type interfraction was at (0.01 ±0.32) cm (LR),(-0.08 ±0.38) cm (AP),(0.14 ±0.36) cm (SI) of the cross section,peripheral type interfraction was at (0.01 ± 0.32) cm (LR),(-0.08 ± 0.38) cm (AP),(0.14 ± 0.36) cm (SI) of the cross section (P =0.001).We found out that the average of lung tumor's setup error at all three directions have no significant difference-the largest was the AP directions (P =0.003),the second was the SI direction (P =0.003) and the smallest was the LR direction (P =0.001).The central type has no significant difference at three directions.Compare to the other fixed device,the average setup errors of our device are (0.09 ± 0.33) cm (LR),(-0.10 ± 0.44) cm (SI),(0.17 ±0.35) cm (AP) better than the report at present paper.As the interfraction setup error was small enough by using this fixed device while it has beyond the system algorithm,the registration software of system shows (0.0 ± 0.0 cm).Conclusions The range of lung tumor motion can be cut down obviously and enhance each placement accuracy,repeatability,on SBRT with home-made immobilization device.