OBJECTIVE: To put forward several suggestions on designing procedure of authorization transfer in marketing authorization system. METHODS: Domestic and foreign regulations and articles were searched. The elements and procedures of marketing authorization transfer in America, Europe and Japan were analyzed. RESULTS: Marketing authorization transfer should be reviewed in Europe. In America and Japan, the transfer will not be reviewed, America requires the two sides of transfer to submit some information while Japan requires the transferee submit transfer notifications. These three managements all focus the transfer time of marketing authorization holder' responsibility, transferee's commitment of undertaking responsibility and the transfer of related documents. CONCLUSION: When design the procedure of marketing authorization transfer, the transfer essence should be catched, and a brief review should be conducted. Moreover, before and during the procedure, there should be some in-time communications between CFDA and two sides of transfer.

Objective To study the expression of intermediate-conductance-Ca~(2+)-activated K~+ (IKCa1)channels in endometrial cancer and its role in regulating proliferation of endometrial cancer cells. Methods Western blot and RT-PCR were used to examine the expression of IKCa1 channels in 13 normal endometrial specimens and 25 endometrial cancer specimens;and RNA interference(RNAi),[ ~3H ] thymidine incorporation,and inhibitor of IKCa1 channel were used to explore the role of IKCa1 channels in regulation of proliferation of endometrial cancer cells HEC-1A.Results The expression rate and level of IKCa1 mRNA in endometrial carcinoma(84%,0.89?0.52)were higher than in normal endometria(8%, 0.14?0.12;P

Objective To identify novel proteins of human adipocytes by proteomic study,and analyze their strueture and function.Methods The expressed proteins of human adipocytes were identified by 2-D electrophoresis and mass spectrometry,and the structure and function of the novel proteins were predicated via bioinforrnatics.Results My027 is a novel protein of human adipocytes identified by 2-D electrophoresis and mass spectrometry.This protein was confirmed by RT-PCR,sequencing,and prokaryotic expression.My027 protein is located in the cytoplasm and has highly conserved structure,indicating that it is an important functional protein. This protein is highly homologous to glyoxalase superfamily with a whole domain of glyoxalase.It shares 96.7% homologous to glycoxalase between 141-253 amino acids and 95.7% homologous to glycoxalaseⅠbetween 144-244 amino acids.Conclusion The results show that protein My027 appears to have the same function as glyoxalaseⅠ.

Due to the low effectiveness of traditional assisted reproductive technology (ART), new technological possibilities are constantly explored. Lots of studies have demonstrated the potential of microfluidics to revolutionize the fundamental processes of in vitro fertilization (IVF). With the advantages of high efficiency, short time, harmless collection, real-time observation of separation, similar microenvironment, and automation, the application of microfluidics in sperm isolation and IVF has shown an evident superiority over the conventional approaches and provided a new platform for ART. This review highlights the application of various microfluidic techniques in sperm motility assessment and isolation, sperm chemotaxis assay, IVF, sperm concentration, and sperm separation and enrichment in recent years. It also briefly introduces the basic principles, structural design, and operation processes of the microfluidic platform, focusing on the advantages and disadvantages of each method and the potential of their clinical application. Obviously, there are still some challenges to the application of microfluidics in ART. However, it is believed that the development of this new technology would be toward a highly integrated application of several steps in one single device, known as IVF-lab-on-a-chip.
Fertilization in Vitro ; methods ; Humans ; In Vitro Techniques ; Male ; Microfluidics ; methods ; Reproductive Techniques, Assisted ; Sperm Motility ; Spermatozoa

OBJECTIVE To enhance the rational usage of antibiotics by comprehensive interventional measures in clinics.METHODS Several interventional measures have been adopted in our hospital since January 2001: to(establish) expert team on antibiotics usage and administration consultation;constitute antibiotics use criteria(suitable) for each clinical specialty;train and examine the usage of antibiotics;censor the distribution of pathogen and drug-resistance variance.Then 10% of the discharged medical records in 2000,2002 and 2004 were drawn out respectively to analyze the usage of antibiotics and the isolation of pathogen from nosocomial infection cases.(RESULTS) The proportion of the patients with prophylactic and remedial indications was increased remarkably((P

Objective To explore the relationship of the whole blood concentrations of FK506 with the occurrence of acute rejection after renal transplantation and further, with the toxicity of this medication. Methods Ten patients with renal transplantation were given FK506-based immunosuppressive regimen 24 h after the operation. Heparinized blood samples were obtained after the initial oral administration of the drug for the pharmacokinetic evaluation. The FK506 dosage, the episodes of acute rejection and the toxicity of the medication were recorded in detail. Results t(peak) was (1.4797±1.2174) h，t1/2 beta was (10.8065±12.0799) h, and the mean residence time (MRT) was (8.0535±4.4750) h. Within the first postoperative month, 2 patients experienced acute rejection and 2 others developed diabetes which necessirare insulin therapy. The blood concentrations of the drug were not significantly different between patients with acute rejection and those without, but were significantly different between diabetic and non-diabetic patients. Conclusions FK506 is an effective prophylactic immunosuppressant for renal transplantation. The whole blood concentrations, in a certain range, are not corresponding to the episode of acute rejection. There was a significant tendency for side effects with increase of the dose concentrations, and small dose low concentrations of Fk506 can achieve good effect and reduce its toxicity.

Objective To explore the relationship of the whole blood concentrations of FK506 with the occurrence of acute rejection after renal transplantation and further, with the toxicity of this medication. Methods Ten patients with renal transplantation were given FK506-based immunosuppressive regimen 24 h after the operation. Heparinized blood samples were obtained after the initial oral administration of the drug for the pharmacokinetic evaluation. The FK506 dosage, the episodes of acute rejection and the toxicity of the medication were recorded in detail. Results t(peak) was (1.4797±1.2174) h，t1/2 beta was (10.8065±12.0799) h, and the mean residence time (MRT) was (8.0535±4.4750) h. Within the first postoperative month, 2 patients experienced acute rejection and 2 others developed diabetes which necessirare insulin therapy. The blood concentrations of the drug were not significantly different between patients with acute rejection and those without, but were significantly different between diabetic and non-diabetic patients. Conclusions FK506 is an effective prophylactic immunosuppressant for renal transplantation. The whole blood concentrations, in a certain range, are not corresponding to the episode of acute rejection. There was a significant tendency for side effects with increase of the dose concentrations, and small dose low concentrations of Fk506 can achieve good effect and reduce its toxicity.

OBJECTIVETo establish a HPLC-based method for simultaneous determination of 2 classes of compounds (flavonoids and chromones) and 6 their effective components,(including prin-O-glucosylcimifugin, cimifugin, 4'-O-beta-D-glucosyl- 5-O-methylvisamminol, quercetin, sec-o-glucosylhamaudol and formononetin), in Yupingfeng Decoction.

METHODSHPLC-based separation of the agents was performed on Agilent Extend-C(18) column (4.6 mm x 250 mm, 5 microm) at 25 degrees with the mobile phase of MeOH-1% acetic acid water solution (gradient elution), flow rate of 0.8 ml/min and detection wavelength of 254 nm.

RESULTS AND CONCLUSIONHPLC allowed simultaneous quantitative determination of the 6 components in Yupingfeng Decoction, and they showed good linear relationships when their sample amount ranged 90-1810 ng, 97-1940 ng, 190-1906 ng, 105-3144 ng, 88-2625 ng and 109-3279 ng, respectively, with correlation coefficients all beyond 0.9999 and average recovery rates of 98.2%, 99.1%, 97.3%, 97.8%, 98.8% and 99.2%, respectively. This simple and convenient method accommodated a broad linear range with high sensitivity and precise and reproducible results.

Chromatography, High Pressure Liquid ; methods ; Chromones ; analysis ; Drugs, Chinese Herbal ; chemistry ; Flavonoids ; analysis ; Isoflavones ; analysis ; Quercetin ; analysis ; Reproducibility of Results

OBJECTIVETo investigate the presenting symptoms and signs, endoscopic findings, imaging changes and the clinical outcomes of endoscopic surgery in 23 patients with sphenoid mycetoma.

METHODSThe clinical data and the follow-up results of endoscopic surgery in 23 patients with sphenoid mycetoma, between April 2001 and January 2006, were retrospectively analysed.

RESULTSThe study population included 15 women and 8 men with a median age of 52.7 years. Presenting symptoms included headache (13 cases, 57%) and bloody discharge (9 cases, 48%). The computed tomography scans showed high density shadow in all 23 cases, with 17 cases (74%) had plaque or cord shaped calcification. All patients were treated by endoscopic transnasal approach. No surgical complications were found. Follow-up ranged 3-18 months, all symptoms disappeared, except strabismus in one case after 7 months of operation. The mucosa in surgical cavity is good.

CONCLUSIONSThe most common clinical symptoms of sphenoid mycetoma are headache and bloody discharge. Computed tomography scan has great value for the diagnosis of sphenoid mycetoma. The minimal invasion and the good outcome are the main advantages of the endoscopic surgery.

Adult ; Aged ; Endoscopy ; Female ; Headache ; Humans ; Male ; Middle Aged ; Mycetoma ; surgery ; Retrospective Studies ; Sphenoid Sinus ; pathology ; Sphenoid Sinusitis ; diagnosis ; surgery

OBJECTIVE: To explore alcohol pharmacokinetics as well as acetaldehyde level in peripheral blood in human subjects with different ALDH2 genotypes after drinking. METHODS: Venous blood samples of 14 unrelated volunteers were collected. Polymerase chain reaction-restriction fragment length polymorphism technology was adopted for DNA extraction and ALDH2 genotyping. The volunteers were asked to drink beer at certain doses. The concentration of alcohol and acetaldehyde were assayed by headspace gas chromatography method at different time. The pharmacokinetic parameters were calculated. RESULTS: According to the results of electrophoresis, 5 people carried ALDH2*1/*1 as wild group and 9 people carried ALDH2*1/*2 as mutation group. The good linear range of alcohol and acetaldehyde were 0-1 570.7 microg/mL and 0-5.1772 microg/mL, respectively. The AUC values of alcohol and acetaldehyde and the t1/2Z value of alcohol were higher in the mutation group than that in the wild group. But the CL/F value of alcohol was lower in the mutation group than that in the wild group (P<0.05). CONCLUSION After the consumption of alcohol, alcohol and acetaldehyde metabolism in blood slow down in ALDH2*1/*2 mutation group influenced by the inhibition of enzyme activity, leading to the accumulation of acetaldehyde in peripheral blood, thus reinforcing their effects in the body.
Alcohol Drinking ; Aldehyde Dehydrogenase/genetics* ; Aldehyde Dehydrogenase, Mitochondrial ; Ethanol/metabolism* ; Genotype ; Humans ; Polymerase Chain Reaction ; Polymorphism, Genetic