Chondrodysplasia Punctata ; congenital ; Humans ; Infant, Newborn ; Male

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

OBJECTIVETo investigate the tongue manifestation features of sexually transmitted and intravenous drug use spread HIV infected population in Xinjiang.

METHODSRecruited were 990 HIV infected subjects in Xinjiang from May 2011 to March 2012, who were assigned to the intravenous drug use spread HIV infected (498 cases) and the sexually transmitted (492 cases). By using tongue figure shoot combined with analyses of experts, tongue manifestations were analyzed and compared between the sexually transmitted and the intravenous drug use spread from four aspects, i.e., the tongue color, the tongue shape, the fur color, and the fur property.

RESULTSCompared with the sexually transmitted population, red tongue, fissured tongue, yellow fur, thick fur, eroded fur, deficiency of fur fluid were more often seen, showing statistical difference (P < 0.05). Compared with the intravenous drug use spread population, pale tongue, white fur, and thin fur were more often seen, showing statistical difference (P < 0.05).

CONCLUSIONSThe tongue manifestations of the intravenous drug use spread HIV population reflected inner exuberance of evil toxin and heat impairing qi and yin. Compared with the intravenous drug use spread population, the attack of HIV infection was more hiding in the sexually transmitted population, with milder internal injury. Their Wei-qi was not damaged and no obvious change occurred in the tongue figure.

Adolescent ; Adult ; Aged ; Female ; HIV Infections ; diagnosis ; etiology ; pathology ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Sexually Transmitted Diseases, Viral ; diagnosis ; pathology ; Substance-Related Disorders ; complications ; diagnosis ; Tongue ; pathology ; Young Adult

The diethyl sulfate (DES) mutagenesis was chosen for the mutagenic treatment to Phellinus igniarius, and the relationship of mutagenesis time and death rate was investigated with 0.5% DES. The differences of mycelial growth speed, liquid fermentation mycelia biomass, morphology and pigment classes of secondary metabolites production speed and antioxidant activities of metabolite products were discussed. The study displayed that DES mutagenesis could change mycelial morphology without obvious effect on mycelium growth, and the DES mutagenesis improved antioxidant activities of the active ingredients of P. igniarius and had more antioxidant activity of hypoxia/sugar PC12 nerve cells than that of P. igniarius.
Basidiomycota ; drug effects ; genetics ; growth & development ; metabolism ; Mutagenesis ; Mutagens ; pharmacology ; Mycelium ; drug effects ; genetics ; growth & development ; metabolism ; Pigments, Biological ; analysis ; metabolism ; Secondary Metabolism ; drug effects ; Sulfuric Acid Esters ; pharmacology

BackgroundChoriodal neovascularization is an important ocular manifestation of angiogenesis in eyes,which derives from the choroid capillaries.Recent studies have found that complement activation is playing a key role in the laser-induced CNV.Because of the key position of CFB in the alternative pathway,bytargeting CFB and blocking the alternative pathway may provide an approach to observe the role of this alternative pathway in the generation of CNV.Objective This study was to investigate the inhibitory effect of reconstructed complement factor B (CFB)-small interfering ribonucleicacid(siRNA)on choroidal neovascularization (CNV)and its mechanism. Methods Experimental CNV was induced by laser photocoagulation in 96 eyes of 48 clean Brown Norway rats.The rats were randomly divided into 4 groups.25,50 and 75 μg B factor siRNA were injected via caudal vein on 1 day,3,5 days after photocoagulation in different dose groups,and normal saline solution was injected at the same way in experimental control group.Other 12 normal rats were used as blank control group.Fundus fluorescein angiography(FFA) was performed on 3,7,14,21,28 days after injection of CFB-siRNA and CNV was scored.The expressions of vascular endothelial growth factor(VEGF) and factor Ⅷ in choroid were detected by immunochemistry.The expressions of CFB-siRNA,VEGF,transforming growth factor β2( TGF-β2 )proteins in choroid were determined using immunochemistry in 7,14,21,28 days,and the expressions of mRNA of CFB-siRNA,VEGF,TGF-β2 were examined by reverse transcription polymerase chain reaction(RT-PCR). ResultsFFA revealed that the CNV rates in various doses of CFB-siRNA groups were significant lower than those of experimental control group in various time points(P＜0.05),and those in 75 μg B factor siRNA were decreased in comparison with 25 μg B factor siRNA (P＜0.05).Immunochemistry showed that the intensities of the VEGF and factor Ⅶ expression in various doses of CFB-siRNA groups were weaker than the blank control group ( P ＜ 0.05 ).Compared with the control group,the expression of CFB reduced in 7 days,and then approached to the level near the control group.Fourteen to twenty-one days after injection of CFB-siRNA,VEGF and TGF-β2 depressions in different doses of CFB-siRNA groups were lower than blank control group( P＜0.05 ).CFB expression in choroid showed the lower levels in CFB-siRNA injection group compared with blank control group in from 7 through 21 days (P＜0.05).RT-PCR displayed the gradual increase of CFB mRNA and curve-like changes of VEGF and TGF-β2 with time prolong. Conclusions Recombinated CFB-siRNA can effectively inhibit laser-induced CNV by down-regulating the expression of VEGF and factor Ⅷ.Alternative pathway of complement plays an important role in the production of CNV.

Abstract:This study aims to investigate the genetic characteristics of group A rotavirus (GARV) G9P[8] strains from infantile diarrhea samples in Hebei Lulong region from 2009 to 2011. We randomly selected five GARV G9P[8] strains in Hebei Lulong region from 2009 to 2011, amplified the 11 gene fragments of GARVs by RT-PCR, and analyz their full-genome sequences by homology and phylogenetic analysis with DNAStar and MEGA. The nucleotide homology between strains LL11131077 and LL11131083 in 2011 was significantly higher than hat etween them and the other three strains in 2009 and 2010. The G9P[8] GARVs circulating in Hebei Lulong region from 2009 to 2011 elenged to the same genotype as the prevalent G9P[8] GARVs in other parts of the world. However,the two strains in 2011, compared with those in 2009 and 2010, were located in a different sub-branch of the phylogenetic tree and had amino acid mutations at many sites.
China ; Feces ; virology ; Genome, Viral ; Genotype ; Humans ; Molecular Sequence Data ; Phylogeny ; Rotavirus ; classification ; genetics ; isolation & purification ; Rotavirus Infections ; virology ; Viral Proteins ; genetics

Objective To explore the activation and function of Janus protein-tyrosine kinase (JAK)/ signal transducer and activator of transcription (STAT1) signal transduction pathway in kidney,lung and brain of MRL/lpr mice.Methods MRL/lpr mice with systemic lupus erythematosus (SLE) were studied at the age of 12 weeks up.Non-SLE MRL/lpr mice were used as controls.We used phosphospecific antibodies to detect STAT1 activation in kidney,lung and brain by immunohistochemistry and Western blots.Gene expression of the STAT induced feedback inhibitors of cytokine signaling 1 (SOCS-1) was investigated by SYBR green I real-time reverse transcriptase polymerase chain reaction (PCR).Results Phosphorylation of STAT1 protein was markedly activated in these three organs,although renal and pulmonary STAT1 activation were much more evidently activated.SOCS-1 gene expression increased in all three organs,while renal SOCS-1 gene expres- sion increased less than lung and brain.Conclusion The activation of JAK/STATI signal transduction path- way may be pathogenic in the organ involvement and progression of SLE.The pathogenesis of lupus nephritis may also be associated with the down-regulation of SOCS-1 feedback inhibition.

OBJECTIVETo evaluate how the oral language development enhances articulators to function well in cleft palate movement and velopharyngeal closure in the young Chinese children with repaired cleft palate.

METHODSThe recordings of 78 cases of Chinese toddlers with repaired cleft palate were reviewed. This group of children aged from 27 months to 33 months (average: 30 months). Transcription using Pinyin system was made. Mean utterance count (MUC) and mean special consonant correct count (MSCC) were calculated. Correlation between MUC and MSCC was statistically analyzed.

RESULTSThe correlation coefficient of MUC and MSCC is 0.360 (P < 0.01).

CONCLUSIONSThere is positive correlation between the oral language development and restoration of velopharyngeal closure function. Children with repaired cleft palate should be encouraged to start oral language as early as possible and as much as possible in order to get the restoration of velopharyngeal closure function.

Child, Preschool ; Cleft Palate ; physiopathology ; surgery ; Humans ; Language Development ; Pharynx ; Velopharyngeal Insufficiency ; physiopathology ; surgery

OBJECTIVETo investigate the association between a new polymorphism (IVS3-20 T>C GenBank accession number: AY463003) in intro 3 of the parkin gene and the risk for Parkinson's disease (PD) in Chinese, particularly the relation between this polymorphism and the age of onset of PD patients.

METHODSPD was diagnosed according to the criteria of Core Assessment Program for Intracerebral Transplantations(CAPIT). All patients and controls were examined by two neurologists and were of the Han ethnic background. Polymerase chain reaction (PCR), denaturing high performance liquid chromatography (DHPLC) and sequencing were used to determine the genotype of each subject.

RESULTSA total of 312 PD patients (including 99 early-onset PD patients and 213 late-onset PD patients) and 236 controls were studied. The C/C homozygote was not found in this study. Chi-square analysis revealed that the frequencies of the C allele and T/C genotype were higher in total PD group but were not statistically different from those of the control group (P=0.6350 and 0.6331, respectively). After being stratified by age of onset, the frequency of T/C genotype was significantly higher (OR=3.52, 95%CI 0.97-13.13) in PD group with an onset age at or below 45 years old (7.07%), compared with that in the control group (2.12%). Similarly, C allele was much higher (OR=3.42, 95%CI 0.96-12.57, P=0.0276) in the early-onset PD group (3.90%) than that in the control group (1.06%). The linear trend analysis showed that both the T/C genotype and C allele increased significantly in the PD group with the increase of the onset age [chi-square(trend of Genotypes)=4.414, P=0.036; chi-square(trend of Alleles)=4.344, P=0.037]. On the other hand, there was no difference in the frequencies of allele and genotype between the late-onset PD patients and controls.

CONCLUSIONThe above results suggest that the parkin IVS3-20 T>C polymorphism might be a genetic risk factor for early-onset PD in Chinese.

Adult ; Age Distribution ; Aged ; Aged, 80 and over ; Base Sequence ; Female ; Humans ; Male ; Middle Aged ; Molecular Sequence Data ; Parkinson Disease ; genetics ; Polymorphism, Genetic ; Sex Distribution ; Ubiquitin-Protein Ligases ; genetics

OBJECTIVETo investigate the possible association of IVS5-5G>A polymorphism, positioned in the upstream region of exon 5 of PINK1 gene with the risk for sporadic late onset Parkinson disease (LOPD) in Chinese.

METHODSIntronic regulatory sequence analysis was performed using the web-based in-silico analysis. The authors performed an association study using a case-control series (comprising 382 LOPD patients and 336 controls, Chinese of Han ancestry). Genotyping was performed by PCR-based denaturing high performance liquid chromatography (DHPLC) combined with sequencing analyses. Allele and genotype frequencies were compared by the Chi-square test.

RESULTSIn-silico analysis showed that the intronic IVS5-5G>A polymorphism was located within acceptor site of exon 5 and may be the functional single polymorphism (SNP) in the regulatory region with impact on the splicing of PINK1 gene. Those result yielded statistical significant evidence for the association of PINK1 IVS5-5G>A polymorphism with risk for typical PD in Chinese Han population (OR=1.95, 95%CI: 1.29-2.94, P=0.0012). Homozygote of A allele may have increased risk for LOPD (OR=2.45, 95%CI: 1.27-4.72, P=0.009).

CONCLUSIONThe authors provide the first evidence that the common genetic variation PINK1 IVS5-5G>A may contribute to the risk of LOPD in Chinese population.

Age Distribution ; Age of Onset ; Aged ; Aged, 80 and over ; Alleles ; Asian Continental Ancestry Group ; genetics ; Base Sequence ; Exons ; genetics ; Female ; Genetic Predisposition to Disease ; genetics ; Genotype ; Humans ; Male ; Middle Aged ; Molecular Sequence Data ; Parkinson Disease ; genetics ; Polymorphism, Genetic ; Protein Kinases ; genetics ; Sex Distribution