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 We analyzed the curative effect of ERCC1 and RRM1 expression on the Neo-adjuvant Chemotherapy of stage Ⅲ NSCLC to investigate the guiding function of ERCC1 and RRM1 expression in chemotherapy regimen containing platinum.Methods Branch DNA-liquid phase chip methods were used to detect ERCC1 and RRM1 expressions before chemotherapy in 80 cases of stage Ⅲ NSCLC confirmed by pathology.All patients received 2 periods Neo-adjuvant Chemotherapy with GP regimen.According to WHO efficacy appraisal standard,the Enhanced Scan of CT showing reaching complete remission or partial remission was effective or stable,otherwise the progression was considered ineffective.Results For the 80 cases of stage Ⅲ NSCLC,the treatment for 20 of the 25 patients with low expressions of both ERCC1 and RRM1 were effective with an effective rate of 80.0％;The treatment for 14 of the 23 patients with low expressed ERCC1 and high expressed RRM1 were effective with an effective rate of 60.9％;The treatment for 10 of the 20 patients with high expressed ERCC1 and low expressed RRM1 were effective with an effective rate of 50.0％;and the treatment for 4 of the 12 patients with both high expression were effective with an effective rate of 33.3％.The difference of effective rates among the four groups had statistical significance ( x2=7.81,P＜0.05 ) with group A having significantly higher rate than the other three groups and group B and group C having significantly higher rate than group D ( P＜0.05 ).Conclusion ERCC1 detection has guiding significance on the regimen selection of NSCLC Neo-adjuvant Chemotherapy.It was worthwhile to use ERCC1 detection widely in the individualized treatment of the stage Ⅲ NSCLC before surgery.

Objective To observe the onset of vascular smooth muscle cell (VSMC) senescence induced by tert-butyl hydroperoxide (t-BHP) and the intervention effect of dehydroepiandrosterone (DHEA). Methods The VSMCs were divided into four groups: blank control group, t-BHP group (incubated with 80 μmol/L t-BHP for 72 h), 10 nmol/L DHEA intervention group (pretreated with 10 nmol/L DHEA 30 min before t-BHP) and 100 nmol/L DHEA intervention group (pretreated with 100nmol/L DHEA 30 min before t-BHP). Two ageing markers of ageing associated β-galactosidase activity and cell proliferation activity were adopted as main indexes. β-galactosidase activity was measured with immunocytochemical method and cell proliferation activity was measured with flowcytometry. Results After continuous treatment with 80 mmol/L t-BHP for 72 h, the ratios of G0/G1 phase cells and SA-β-galactosidase staining positive cells increased as compared with blank controlgroup [(89.4±3.4)% vs. (49.5±5.5)%, (3.5±1.2)% vs. (75.3±4.3)%], which indicated that VSMCs senescence were successfully induced by t-BHP. While the above changes were smaller in 100 nmol/L DHEA intervention group than in t-BHP group. Conclusions With ageing,accumulation of damage produced by reactive oxygen species may be an important mechanism causing the onset of VSMCs senescence. DHEA may be able to retard the progression of VSMCs senescence through antioxidant effect.

To establish a high-performance liquid chromatography (HPLC) method for the determination of baicalin in Xiaoyanling Decoction.

Objective To report a retroperitoneal laparoscopic surgery for ureteropelvic junction obstruction (UPJO) by double renal veins.Methods A 28-year-old male patient with left low back pain for 6 months was diagnosed as left hydronephrosis and UPJO.A ureteral stent had been placed 3 months before and failed to improve hydronephrosis,so the ureteral stent was pulled out.CT scan showed that left UPJ went through the two renal veins,suggesting UPJO.Nephrogram showed that left GFR and right GFR were 35 ml/min and 34 ml/min,respectively.These results indicated mechanical obstruction of left upper urinary tract.The patient underwent retroperitoneal laparoscopic Anderson-Hynes dismembered pyeloplasty.Results The surgical procedure was successful.Two left renal veins were found,and the ventral one was in front of ureter,compressing the ureter.An aberrant renal artery went into left kidney with the ureter.0.5 cm stenosis of ureteropelvic junction was excised,and pyeloplasty was performed.A ureteral stent was placed into the ureter,then the pelvis and the ureter were sew up in front of the ventral renal vein.The surgical time was 240 min,and blood loss was 50 ml.Postoperative hospital stay time was 4 d.During 4 months' follow up,hydronephrosis was attenuated significantly.Conclusion Retroperitoneal laparoscopic surgery for UPJO with aberrant two renal vein might be a minimally-invasive and effective procedure.

Objective To value the clinical application of diffusion tensor imaging (DTI) in cerebral diseases. Methods Six volunteers and 6 patients (including 3 patients with ischemic stroke and 3 patients with glioma) were examined by DTI and T1weighted, T2weighted MR scan. All data were processed with DtiStudio software to show the white matter fiber tracts. The fractional anisotropy (FA) of the diffusion tensor were measured between the affected and the unaffected side. Results The white matter fiber tract could be observed clearly on the FA map. The pyramidal tract with different degree disruption could be showed in 3 patients with ischemic stroke. Compression, displacement, infiltration or destruction of pyramidal tract, corpus callosum or internal capsule and external capsule could be seen in 3 patients with glioma, and FA was significantly reduced on the affected side as compared to the unaffected side. Conclusion Diffusion tensor imaging is useful in observing the damage and displacement of the white matter fiber tracts in vivo, beneficial to the surgical plan for patients and prognosing recovery of function.

Objective To investigate the effects of preventive chemotherapy for hepatocellular carcinoma (HCC) exceeding Milan criteria after liver transplantation. Methods The clinical data of 243 patients who had undergone orthotopic liver transplantation for HCC exceeding Milan criteria from April 2001 to July 2007 were retrospectively analyzed. Of all patients, 162 received preventive chemotherapy after transplantation. Results The 1- and 3-year survival rates and disease-free survival rates were not statistically different between patients who had received chemotherapy (78.5%, 63.7% ; 76.8%, 52.5% ) and those without chemotherapy (56.6%, 39.1%; 69.3%, 64.7% ) (X2 = 3.084, 0.444, P > 0.05). Cox regression analysis demonstrated that postoperative chemotherapy was not an independent factor affecting the survival rates of HCC patients without vascular invasion, but an independent factor affecting the survival rates of HCC patients with vascular invasion. Conclusions Early preventive chemotherapy could obviously increase the survival rate and delay the tumor recurrence of patients with HCC exceeding Milan criteria, especially for HCC patients with vascular invasion.

Objective To assess the clinical threatment results of pilon fractures managed with arthroscopyassisted minimally invasive percutaneous plate osteosynthesis (MIPPO).Methods 33 patients with pilon fractures were classified into 3 groups according to the Ruedi-Allgower classification:type Ⅰ in 26 cases,type Ⅱ in 5 cases,type Ⅲ in 2 cases,including 29 males and 4 females,aged 22 to 51 years,mean 31.5 years of age.All patients were treated with arthroscopy-assisted MIPPO with the postoperative follow-up time of 12 to 84 months.Results The clinical surgery efficacy according to Mazur's criterion was evaluated as excellent in 22 cases,good in 8 cases,fair in 3 cases.The excellent and good rate was 90.9％.Conclusion Arthroscopy-assisted MIPPO surgical treatment is an effective method for Pilon fractures with the advantages of good healing,minimal trauma and less complications,it is worthy of clinical application.

To have a better understanding on the evolution of Metallosphaera sedula-mediated precipitation and the properties of the precipitate synthesized by this species，a newly identified extremely thermophilic strain (YN23) of Metallosphaera sedula was cultured in the medium containing Fe2+ as energy resouTce under optimal condidons (pH1.5，65℃,0.2g·1-1 yeast extract,30g·1-1 Fe2SO4·7H2O and 170rpm)．XRD，EDS，ETIR and SEM reveal the precipitate obtained from YN23-inoculated flasks to be a mixture of potassium jarosite and ammoniojarosite，with morphological features similar to the latter．Precipitation Was first detected once over 90％ of Fe2+ was oxidized at hour 25 with a peak pH value of 1.92，and was ended when precipitate reached the highest point of 7.9g·1-1 at hour 95 with the lowest pH value of 1.32 in solution．Microbial density underwent a rapid increase along with Fe2+ oxidation and a gradual decrease with precipitate piling up.

Naturally occurring mutations in surface proteins of Hepatitis B virus(HBV)usually result in altered hepatitis B surface antigen(HBsAg)secretion efficiency.In the present study,we reported two conserved residues,M75 and M103 with respect to HBsAg,mutations of which not only attenuated HBsAg secretion(M75 only),but also suppressed HBV genome replication without compromising the overlapping p-gene product.We also found M75 and M103 can initiate truncated surface protein(TSPs)synthesis upon over-expression of full-length surface proteins,which may possibly contribute to HBV genome replication.However,attempts to rescue replicationdefective HBV mutant by co-expression of TSPs initiated from M75 or M103 were unsuccessful,which indicated surface proteins rather than the putative TSPs were involved in regulation of HBV genome replication.