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.

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 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 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 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.

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

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

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

The objective of this study was to investigate the effect of Tanshinone IIa on IL-1beta, IL-6 and TNF-alpha cytokines in immune vasculitis and platelets, as well as their relationship. The model of immune vasculitis of rabbits were established by intravenous injection of bovine serum albumin twice. Experiment was divided into 4 groups: control group, model group, tanshinone IIa-treated group and aspirin-treated group. The platelet count, platelet aggregation of peripheral blood were determined. The levels of serum IL-1beta, IL-6, TNF-alpha were detected by ELISA. The pathological changes of immune vasculitis were analyzed by hematoxylin & eosin staining, elastic fibers staining and electron microscopy. The results showed that the levels of IL-1beta and TNF-alpha in model group were significantly higher than those in normal group (p < 0.05), while the level of IL-6 was not significantly different between various groups. The serum level of IL-1beta was correlated with platelet number, while serum levels IL-1beta and TNF-alpha were both correlated with the platelet aggregation. The treatment with tanshinone IIa could significantly decrease the serum levels of IL-1beta, TNF-alpha and platelet number, and the efficacy of tanshinone IIa was same as aspirin. The tanshinone IIa and aspirin both could alleviate the vessels damage in patients with immune vasculitis. It is concluded that the tanshinone IIa may diminish the inflammation damage of vessels in patients with immune vasculitis through the inhibition of cytokines and platelets.
Animals ; Blood Platelets ; drug effects ; Diterpenes, Abietane ; pharmacology ; Drugs, Chinese Herbal ; pharmacology ; Interleukin-1beta ; blood ; Interleukin-6 ; blood ; Platelet Count ; Rabbits ; Tumor Necrosis Factor-alpha ; blood ; Vasculitis ; blood ; pathology

OBJECTIVETo explore the effect of Scalp acupuncture on serum neuron specific enolase (NSE) and S-100β concentrations, and incidence rates of postoperative delirium (POD) and postoperative cognitive function (POCD) of elderly patients undergoing hip replacement.

METHODSEighty-four patients undergoing scheduled hip replacement under combined spinal-epidural anesthesia (CSEA) were assigned to the control group (group C) and the scalp acupuncture group (group S) according to random digit table, 42 cases in each group. In group S, scalp acupuncture was additionally performed according to International Standardized Scheme for Scalp Acupuncture. Scalp acupuncture was performed during the operation from the MS1 middle line of forehead [1 cun before Shenting (GV24), including Shenting (GV24)] and MS5 middle line of vertex [from Baihui (DU20) to Qianding (DU21), including Baihui (DU20) and Qianding (DU21)]. The operation time and post-operative length of stay were observed. The midazolam dosage, hemorrhage amount, fluid transfusion amount, urine amount, use rates of ephedrine and atropine during the operation were also observed and compared between the two groups. The occurrence rate of POD and POCD at post-operative day 3 (T₁), week 1 (T₂), month 3 (T₃), and month 6 (T₄) were measured. Eighteen patients were randomly selected to collect blood from internal jugular vein before anesthesia t₀), immediately after ending the surgery (t₁), 6 h after operation (t₂), 24 h after operation (t₃), and 48 h after operation (t₄), respectively. Serum levels of NSE and S-100β were correspondingly measured.

RESULTSThere was no statistical difference in the operation time, midazolam dosage used during the operation, hemorrhage amount, fluid transfusion amount, urine amount, use rates of ephedrine and atropine (P > 0.05). Compared with group C, the post-operative length of stay was shortened in group S (P < 0.05). The incidence rate of POD and that of POCD at each time point were lower in group S (P < 0.05). The expression level of NSE decreased at t₂, t3, and t₄, and the expression level of S100β also decreased at t₁, t₂, t₃, and t₄(P < 0.05). There was no statistical difference in expression levels of NSE or S100β between the two groups at other time points (P > 0.05).

CONCLUSIONScalp acupuncture could attenuate central nervous system lesion and improve POCD of elderly patients undergoing hip replacement.

Acupuncture Points ; Acupuncture Therapy ; Aged ; Arthroplasty, Replacement, Hip ; Cognition ; Humans ; Length of Stay ; Phosphopyruvate Hydratase ; blood ; Postoperative Complications ; Postoperative Period ; S100 Calcium Binding Protein beta Subunit ; blood ; Scalp