The EU is an international bridge of traditional Chinese medicine (TCM), and TCM in EU is of strategic importance. In this paper the progress on policies and regulations and approved products of herbal medical products in EU in 10 years were briefly reviewed, registration regulations were systematically, studied and some typical cases were analyzed. To provide reference for successful registration of TCM in EU and implementation of international strategy of TCM, five key elements (i. e. registration classification, approval procedure, approval authority, application product and application enterprise) to break through the registration barriers on TCM in EU were putted forwards correspondingly.
Drug Approval ; European Union ; Medicine, Chinese Traditional ; Policy ; Publications ; Social Control, Formal

Objective To explore the feasibility of detecting the mutations of rpoB gene in rifampin-resistant Mycobacterium tuberculosis strains by gene chip. Methods The DNA chip was designed according to the sequence of Mycobacterium tuberculosis rpoB gene. The DNA fragments which contained hot mutation sites of rpoB gene were labelled with cy3 fluorescence, amplified by PCR technique and hybridized with gene chip. The DNA sequencing was used as the control. Results Eighteen of the Mycobacterium tuberculosis strains were detected for the mutations of rpoB gene by gene chip. Among them, one sensitive strain was identical with the type strain, and all of 17 strains with rifampin-resistant, rpoB mutations were detected. Of the 17 strains with rpoB mutations, 14 were detected as single point mutation, one was detected as double sites point mutations with the sites of 511 and 516, and two were detected as single point mutation with the sites of 518 and 526, respectively. Because the probe of 517 rifampin-resistant did not be dotted on the gene chip, only sites of 518 and 526 mutations were detected, which were consistent with the results of DNA sequencing. Conclusion Using the gene chip could detect mass rpoB gene mutation of rifampin-resistant with higher specialty and sensitivity, which could be used for clinical detection of rifampin-resistant strains and clinical medicine.

This paper summarizes the perioperative nursing of 65 patients undergoing eyelid malignant tumor resection combined with primary eyelid reconstruction. The nursing care focused on routine preoperative preparations as well as postoperative care of incision dressing, dressing change, medication administration and monitoring, prevention of infections and health education. All the patients had Ⅰ-phase wound healing and good shape of eyelid repair without postoperative complications.

The ultrasound part of “2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer” is comprehensive and informative. The content includes the indications for thyroid ultrasound and aspects needed to be evaluated, malignancy risk prediction based on sonographic pattern, decision-making based on ultrasound appearances, follow-up of benign thyroid nodules and surveillance of persistent and recurrent thyroid cancer with ultrasound. Compared with 2009 version of American Thyroid Association (ATA) guidelines, there is a great deal of development. The most important revision was that it analyzed ultrasound pattern of risk stratiifcation of malignancy in thyroid nodules and gave a detailed description of relevant concepts and definitions. Altogether, the new guidelines provided an algorithm for evaluation and management of patients with thyroid nodules based on sonographic pattern and ifne needle aspiration (FNA) cytology. Comprehensive review of the guidelines and appropriate adjustment in practices will make ultrasound examination more reasonable and may enhance the level of medical practices basically..

Objeetive To explore the value of antisense imaging of 99Tcm-labeled ASON targeting mouse double minute 2(MDM2) mRNA for the diagnosis of human prostate cancer.Methods The ASON targeting MDM2 mRNA and the mismatched oligonucleotide (ASONM) were synthesized and radiolabeled with 99Tcm using the bifunctional chelator HYNIC.The labeling efficiency and radiochemical purity were investigated.Animal models of nude mice bearing human prostate cancer LNCaP were established and divided into 3 groups with 10 mice in each group.99Tcm-HYNIC-ASON,99Tcm-HYNIC-ASONM (study groups) and 99TcmO4-(control group) were injected at the dose of 7.4 MBq through the tail vein,respectively.Tumor imaging was acquired with SPECT and the tumor-to-muscle (T/M) ratio was measured.The data was compared by one-way analysis of variance.Results The labeling efficiencies of ASON and ASONM were (65.15± 2.05) ％ and (64.93±2.18) ％,respectively.Their radiochemical purity was greater than 90％.At 1,4 and 10 h post injection,the T/M ratios of 99Tcm-HYNIC-ASON group were 3.217±0.125,3.749± 0.201 and 4.028±0.186,and those of 99Tcm-HYNIC-ASONM group were 1.579t0.128,1.715±1.140 and 1.683±0.139,and control group 2.146±0.132,1.847±0.124,1.528±0.152,respectively.The T/M ratios in control group and 99Tcm-HYNIC-ASONM group were significantly lower than those in 99Tcm-HYNICASON group at 1,4 and 10 h,respectively (F=213.37-235.41,t=3.527-4.738; all P＜0.01).The T/M ratios of 99Tcm-HYNIC-ASONM group and control group were not significantly different at 1,4 and 10 h (t=2.154,2.287 and 2.236,all P＞0.05).Conclusion The antisense probe of MDM2 can accumulate specifically in prostate cancer tissue in animal models,which might be useful as a non-invasive genetic tool for the early diagnosis of prostate cancer.

AIM:To detect and compare the longitudinal mitral annulus diastolic velocity and time interval changes by pulsed Doppler tissue imaging(DTI)in patients with angina pectoris(AP)and myocardial infarction(MI),and to explore the value of mitral annulus diastolic velocities and time intervals for evaluation of global left ventricular diastolic dysfunction.METHODS:Fifty patients with established coronary artery disease were divided into AP group(16 cases)and MI group(34 cases).Sixteen age-matched healthy individuals served as the control group.The septum,lateral,anterior and inferior walls of the mitral annulus were displayed,and selected for DTI spectrum sampling.Peak early and late diastolic velocities and their ratio,time to the onset and peak of the early diastolic wave,and regional isovolumic relaxation time were measured,and the average values of the four mitral annular sites were calculated and presented as Em,Am,Em/Am,QEm,TEm and IVRTm,respectively.RESULTS:Compared with the control group,Em and Em/Am were significantly lower in both the AP and the MI groups(P＜0.01).Em was even lower in the MI group than that in the AP group(P＜0.01).QEm,TEm and IVRTm were significantly longer in the AP and the MI groups than those in control group(P＜0.01 or P＜0.05).IVRTm was even longer in the MI group than that in AP group(P＜0.01).IVRTm had significantly negative correlation with Em(r=-0.64,P＜0.01).CONCLUSION:Em,Em/Am,QEm,TEm and IVRTm as measured by pulsed DTI may be promising indexes for quantitative assessment of global left ventricular diastolic dysfunction in patients with coronary artery disease.Em and IVRTm may indicate the severity of ischemic myocardial damage.

Objective To investigate the functional characteristic of adolescents with conduct disorder (CD) in the resting state.Methods Resting-sate fMRI (rs-fMRI) scans were administered to 28 male adolescents with CD and 28 age-,gender-and IQ-matched healthy controls (HCs).The rs-fMRI data were subjected to amplitude of low-frequency fluctuation (ALFF) analysis and ALFF values were compared between the two groups.Additionally,the region ROIs showed significant difference and correlation analysis was conducted between ALFF in each ROI and Barratt's scores.Results ① Compared to HCs,the CD group showed decreased ALFF (P＜0.005) bilaterally in the superior frontal gyrus,right middle frontal gyrus,right posterior cingulate gyrus,right inferior parietal lobule (MNI coordinates:-21,48,27;21,24,48;36,24,33 6,-36,39;48,-45,57 respectively) as well as increased ALFF (P＜O.005) in the left thalamus and left lingual gyrus (MNI coordinates:-15,-27,-3;-18,-87,-12 respectively).② There was no significant correlation between ALFF and Barratt's scores in ROIs.Conclusion The results suggest that CD is associated with abnormal intrinsic brain activity,mainly in frontal-parietal-occipital-limbic cortices,which is related to emotional and cognitive processing and behavioral functions.

AIM: To determine the relationship between the mutation of the RII gene and RER status in the tumorigenesis of sporadic colorectal cancer. METHODS: We screened RER status and mutation of the RII gene from 50 sporadic colorectal cancers (19 in the proximal colon, 31 in the distal colorectum). RESULTS: RER was found in 13 cases (8 in the proximal colon, 5 in the distal colorectum), and 5 of them showed mutations of the RII gene. All 5 cancers carrying a TGF-? RII gene mutation showed RER+, but there wasn't any mutation of RII gene in RER(-) cases. Four of 5 RII mutation were located at the cecum. CONCLUSION: These data indicate that the TGF-? RII gene is a major target of microsatellite instability and mutation of the RII gene play an important role in carcinogenesis of sporadic colorectal cancer with microsatellite instability, especially at the cecum. [

Objective To investigate the effect of mouse double minute 2 (MDM2) mRNA ASON and mismatched oligonucleotide (ASONM) radiolabeled with 99Tcm on target gene expression in LNCaP cells.Methods The ASON and ASONM targeted to MDM2 mRNA were synthesized and radiolabeled by 99Tcm with the bifunctional chelator of HYNIC.The labeling efficiency,radiochemical purity,stability and molecular hybridization activity were investigated.The different concentrations of 99Tcm-HYNIC-ASON (0,100,500 nmol/L) and 99Tcm-HYNIC-ASONM (500 nmol/L) coated with lipofectamin 2000 were incubated with prostate cancer cells for 24 h,then RT-PCR and Western blot were carried out to assay the MDM2,p53 mRNA and the corresponding protein level.The variables of RT-PCR and Western blot were analyzed using one-way analysis of variance and q test.Results The labeling efficiency of ASON and ASONM were (65.15± 2.05)％ (n=5) and (64.93±2.18)％ (n=5),respectively.The radiochemical purity were both more than 90％.99Tcm-HYNIC-ASON had a good stability and could hybridize to the sense oligonucleotide (SON).The contents of MDM2 mRNA in 0,100,500 nmol/L 99Tcm-HYNIC-ASON and 500 nmol/L 99Tcm-HYNIC-ASONM groups were 0.458±0.035,0.250±0.026,0.174±0.032,0.463±0.033,respectively,and there were significant differences between each 2 groups except between 0 nmol/L 99Tcm-HYNIC-ASON and 500 nmol/L 99Tcm-HYNIC-ASONM groups (F=33.69,q =24.32-91.45,all P＜0.01).The average density of MDM2 protein in the 4 groups were 90.712±3.042,71.218±2.915,32.775±3.062,88.121±2.710,respectively (F=235.93,q=6.43-19.14,all P＜0.01; except 0 nmol/L99Tcm-HYNIC-ASON and 500 nmol/L 99Tcm-HYNIC-ASONM).The contents of p53 mRNA in the 4 groups were 0.185±0.046,0.203±0.040,0.213±0.027,0.163±0.049,respectively(F =2.18,P＞ 0.05).The average density of p53 protein was 33.865 ± 2.213,70.445±2.180,99.025±3.012,38.351±3.271,respectively (F=53.98,q =3.32-6.74,all P＜0.01 ; except 0 nmol/L 99Tcm-HYNIC-ASON and 500 nmol/L 99Tcm-HYNIC-ASONM).Conclusions The MDM2 antisense probe can accumulate in the prostate cancer cells,and specially hybridize to the MDM2 mRNA and inhibit target gene expression.This novel molecular probe has a promising potential for the diagnosis of prostate cancer at gene level.

Objective To study the expression of vesicular GABA transporter and vesicular glutamate transporter 1 in de‐pression .Methods Mice was divided into control group and defeat group stochastically .By social defeat model and social avoidance , the defeat group was divided into two groups:susceptible group and unsusceptible group .Synaptic proteins were extracted respec‐tively from the 3 groups .We detected the expression abundance of VGAT and VGLUT1 by Western blot .Results Compared with the control group ,in susceptible group ,the residence time in the contact area was significantly reduced ,and the residence time in the corner area was significantly increased ,with statistical difference(P<0 .05) .In the prefrontal cortex and hippocampus ,Com‐pared with the control group and the unsusceptible group ,the expression levels of VGLUT1 and VGAT were increased in the sus‐ceptible group(P<0 .05) .there were no statistically significant in VGLUT1 and VGAT leveles between control group and the un‐susceptible group(P>0 .05) .In the striatum ,although the expression levels of VGAT and VGLUT1 were increased in susceptible group ,but in unsusceptible group ,the expression of these proteins also increased significantly .Conclusion The prefrontal cortex and hippo‐campus excitability and inhibitory vesicle transport were changed in depression ,which may relate to the transcription disorder .