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 .

Objective To develop an in vitro model for cranial suture of neonatal SD rat. Methods The parietal hones with the sagittal suture were removed from SD rats (19-days old) for organ culture. In the experimental group, tensile force 3.92×10~(-3) N (0.4 g) was applied by helical springs, whereas no tension (0 N) was set in control group. These explants were observed under inverted microscope. At the end of the incubation period for 24 hours, general conditions were observed under inverted microscope and histological conditions were observed after hematoxylin and eosin stain. Results Under inverted micro-scope, sutures had no obvious changes in control group, whereas sutures were enlarged gradually in the experimental group. With histological observation, sutures developed normally in control group, but in experimental group, osteohlasts and capillary vessels proliferated actively in the suture. Conclusions In vitro model of cranial suture can be cultured and grown successively.

In the present study, the effect of serum (fetal bovine serum, FBS) on cellular uptake behaviors of DNA tetrahedron (TDNs) was investigated.Fluorescence-labeled TDNs were synthesized by self-assembly and purified with HPLC to achieve TDNs product with purity of 95%.By means of flow cytometry and confocal microscopy, the kinetics of TDNs endocytosis in HeLa cells in the presence or absence of FBS was compared.The results showed that TDNs remained intact in complete medium and cell lysate for more than 12 hours.FBS increased the amount of internalized TDNs in HeLa cells, whereas it did not change the route of caveolin-dependent endocytosis.Herein, our study provided a new insight into the effects of biomolecules on the interaction between cells and DNA nanostructures, which helped the future development of DNA-based intracellular nanocarriers.

Objective According to the fine artery anatomy of the lower lip, we developed an innovative partial-thickness myocutaneous flap based on the vascular network of the submucosal and subcutaneous layers of the lower lip.We attempted to treat the secondary bilateral cleft lip deformities using this innovative cross-lip flap.Methods From July 2009 to June 2015, this new technique was used in 98 patients with secondary bilateral cleft lip deformities.The central defects usually occurred in these patients.The defects were reconstructed partially or completely according to the severities of the defects.The operative procedures were as follows: The split flap was elevated from the posterior portion of the oris orbicularis muscle after the inferior labial arteries were divided.Then the partial-thickness flap was rotated 180 degrees horizontally and inverted 180 degrees upward to the upper lip defect.Results All 98 musculomucosal pedicle flaps were viable.The upper lips were reconstructed according to the severities.Conclusions This myocutaneous cross-lip flap with musculomucosal-pedicle has a more reliable blood supply, better flexibility and plasticity.It is an effective method for aesthetic reconstruction for the secondary bilateral cleft lip deformities.

In this study, we investigated the effect of Cigu Xiaozhi formula on HSC-T6 activity in hypoxic microenvironment based on network pharmacology and computer-aided drug design, and predicted and verified its possible targets and related signaling pathways. The potential active components and targets of Cigu Xiaozhi formula were screened by searching Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP), Encyclopaedia of Traditional Chinese Medicine (ETCM) and Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine (BATMAN-TCM) databases, and the liver fibrosis related targets retrieved from Gene Cards and Pharm GK database were integrated to obtain the potential targets of Cigu Xiaozhi formula in the treatment of liver fibrosis. GO enrichment analysis and KEGG signaling pathway enrichment analysis were performed on Omic Share platform, and Cytoscape software was used to construct the "potential active ingredient-key target-pathway" network. The active components and target proteins were subjected to molecular docking analysis by Auto Dock software. According to the results of molecular dynamics simulation and binding free energy calculation, the top 5 active components with degree were scored. The active components stigmasterol and β-sitosterol were subjected to molecular docking. CoCl₂ was used to induce HSC-T6 cells to construct hypoxia model in vitro. The cell viability was detected by CCK-8 assay, and the optimal time and concentration of hypoxia model of HSC-T6 cells was determined to be 100 µmol·L^-1 CoCl₂ for 24 h. Under hypoxia condition, HSC-T6 cells were activated, the wound healing rate was significantly increased, and the fluorescence signal of activation marker protein α-smooth muscle actin (α-SMA) was significantly enhanced. However, 6% drug-containing serum could inhibit the activation of HSC-T6 cells, and the wound healing rate was significantly decreased, and the fluorescence signal of α-SMA was significantly weakened. Further studies showed that the expressions of hypoxia-inducible factor-1α (HIF-1α), α-SMA and key proteins of Hedgehog (Hh) signaling pathway in HSC-T6 cells were up-regulated under hypoxia, while the expressions of HIF-1α, α-SMA, Patched-1 (Ptch-1) and glioma related oncogene homology-1 (Gli-1) were down-regulated in 6% drug-containing serum group, the YC-1 group and the cyclopamine group. These results indicated that HIF-1α and Hh signaling pathways were involved in the activation of HSC-T6 cells, and the traditional Chinese medicine Cigu Xiaozhi formula could inhibit the activation of HSC-T6 cells, and the mechanism may be related to the inhibition of HIF-1α expression and the blocking of Hh signaling pathway. In conclusion, Cigu Xiaozhi formula can inhibit the activation of HSC-T6 cells by directly acting on HIF-1α and Hh signaling pathway, and exert an anti-hepatic fibrosis effect. The animal experimental protocol has been reviewed and approved by Laboratory Animal Ethics Committee of Gansu University of Chinese Medicine, in compliance with the Institutional Animal Care Guidelines.

OBJECTIVETo observe clinical therapeutic effect of pricking blood therapy with three-edged-needle plus cupping on Bi-syndrome of wind-dampness type in Yemenia and compare with "Heigama", a traditional Arabic therapy. Methods Forty cases of Bi-syndrome of wind-dampness type were treated with pricking blood therapy with three edged needle plus cupping and 40 cases with "Heigama" for 3 weeks, once each week.

RESULTSThe total effective rate in the two groups was 82.5% and 80.0% respectively, with no significant difference between the two groups (P > 0.05).

CONCLUSIONPricking blood therapy with three-edged-needle plus cupping of TCM has obvious therapeutic effect on Bi-syndrome of wind-dampness type in Yemenia, with more convenience than Arabic "Heigama".

[ ABSTRACT ] AIM: To investigate the expression and clinical significance of bone morphogenetic protein 3 (BMP3) in hilar cholangiocarcinoma tissues.METHODS: Thirty cases of hilar cholangiocarcinoma specimens were col-lected.The expression of BMP3 at mRNA and protein levels in the tumor tissues and paracancerous tissues was detected by real-time PCR and Western blot.The hilar cholangiocarcinoma paraffin-embedded specimens (n=103) were collected. The protein expression of BMP3 was determined by immunohistochemical method, and the relationship of BMP3 protein ex-pression with clinical pathological characteristics was evaluated.RESULTS:In the 30 patients with hilar cholangiocarcino-ma, the expressions of BMP3 protein and mRNA in 22 cases of tumor tissues were significantly decreased compared with the adjacent normal tissues.The results of immunohistochemistry showed that 87 cases were negative and 16 cases were weakly positive in all 103 cases of hilar cholangiocarcinoma.The expression of BMP3 protein was associated with the tumor TNM staging, lymph node metastasis and tumor differentiation (P<0.05).CONCLUSION:BMP3 gene might be inhibited in human hilar cholangiocarcinoma.The down-regulation of BMP3 gene might be associated with the carcinogenesis and devel-opment of hilar cholangiocarcinoma.

Objective Methylation of anti-oncogene can be demethylated by related drugs which can help the inactivated gene to express again .This study aims to study the effects of the demethylating agent 5-Aza-2′-deoxycytidine on the growth of human thyroid papillary cancer cell line TPC-1 and mRNA and protein expres-sion of KLF4.Methods TPC-1 cells were treated with different concentration of 5-Aza-CdR.MTT was used to detect the influence of 5-Aza-CdR on cell proliferation .RT-PCR was used to detect mRNA and protein expression levels of KLF4.Results After being treated with 5-Aza-CdR for 24 hours, 48 hours, and 72 hours, the growth of TPC-1 cells was inhibited and the inhibition was in time and concentration depended manner .After treatment with 5-Aza-CdR, mRNA and protein expression levels of KLF 4 were increased, and the difference had statistical significance(P<0.05).Conclusion 5-Aza-CdR can inhibit the cell viability of TPC-1 cells through upregulat-ing KLF4 expression , which may provide experimental basis for 5-Aza-CdR in treating thyroid cancer .

OBJECTIVE:To observe the occurrence of paclitaxel(PTX)-induced muscle soreness and therapeutic efficacy and safety of diclofenac sodium. METHODS:Among 84 patients with malignant tumor receiving PTX chemotherapy,56 patients suf-fered from PTX-induced muscle soreness,among which 22 female patients suffered from medium and severe muscle soreness and then were randomly divided into group A and B,with 11 cases in each group. Group A was given Diclofenac sodium sustained-re-lease tablet 75 mg orally,once a day;group B was given Paracetamol and tramadol hydrochloride tablets one tablet orally,once a day,and then given Promethazine hydrochloride injection 100 mg subcutaneously,2-3 times a day when muscle soreness could not be born. Treatment course of both groups lasted for 5 d. The distribution of muscle soreness were observed. The onset time and dura-tion of muscle soreness were also observed as well as pain relief and the occurrence of ADR in group A and B. RESULTS:Among 84 cases,the incidence of muscle soreness was 66.67%,among which mild pain accounted for 23.81%,moderate pain accounted for 13.10%,and severe pain accounted for 29.76%. Among 56 patients with muscle soreness,earliest muscle soreness occurred on the day of medication,and most of muscle soreness occurred on 1-3 days after medication,mainly manifesting as sore,activity limitation when severe,associated with fatigue. The pain relief rate of group A and B were 100%,but the incidence of adverse re-actions in group A was significantly lower than group B,with statistical significances(P<0.05).CONCLUSIONS:Diclofenac sodi-um is similar to paracetamol and tramadol hydrochloride in the treatment of PTX-induced muscle soreness,but it is better than paracetamol and tramadol hydrochloride in safety.