Implementation of information technology in clinical research has resulted in revolutionary changes in drug development. Based on the good clinical practice (GCP) requirements on data, processes and documentations, and the era of fast growth in clinical studies using up-to-date information technology, we explore an integrated e-clinical solution in clinical studies in China.
China ; Clinical Trials as Topic ; Data Collection ; methods ; Medical Informatics ; methods

Objective To evaluate the effect of dexamethasone to the cultured rat thoracic aortic smooth muscle cells(SMC)in vitro,and explore the role on it's prevention and cure for the in-stent restenosis after vascular intervention.Methods The rat thoracic aortic SMC were harvested and cultured for six to ten passages.The cultured SMC were synchronized and then restimulated to enter the cell cycle,and treated with incremental concentrations of dexamethasone or without dexamethasone as control.The proliferative assay was performed with MTT method in the different time points after treatment.RT-PCR was performed to assay the level of proliferating cell nuclear antigen(PCNA)mRNA.Results 1.Dexamethasone progressively inhibited rat aortic SMC proliferation in a concentration-dependent fashion.The A value was statistically significant for different concentrations(F=36.02,P＜0.001).The effect was not significant for dexamethasone concentrations either between 10~(-6)and 10~(-5)mol/L(P=0.065)or between 10~(-11)mol/L and control group(P= 0.567).2.RT-PCR suggested dexamethasone significantly decreased rat aortic SMC PCNA mRNA transcription in a concentration-dependent fashion.Statistical analysis indicated F=15.407 and P＜0.001 by ANOVA. Comparing to the control,the corrected A value was not statistically significant at 10~(-9)or 10~(-11)mol/L groups by post hoc analysis.Conclusions Dexamethasone inhibits rat aortic SMC proliferation in a concentration- dependent fashion.The data suggest that effective action concentration is 10~(-7)mol/L with persistent time up to 96 hours or more.Dexamethasone may play the inhibit role to SMC at lower concentration with prolonging action time.

OBJECTIVETo compare the effect of Sodium Morrhuate on ECV-304 between its lipo- and normal preparation.

METHODSThe ECV-304 cell line was supplemented with Sodium Morrhuate and lipo-Sodium Morrhuate in order, and the result on morphology (microscope, Giemsa Staining and electron microscope), cell activity (MTT), and flow cytometer between the two preparation were compared.

RESULTSIn normal preparation group, cell's edema occurred. Chromatin was like catkins. Tumefaction and degeneration of mitochondrion and endoplasmic reticulum appeared. In lipo-Sodium Morrhuate group, the membrane was creased and processus appeared. Chromatin aggregates to the membrane of nucleus was like crescent, and then broken. The apoptotic body was formed. MTT changes showed that the curve of the normal preparation group was steep and the change time was short relatively, which cues the vital cells decreased sharply. The curve of lipo-Sodium Morrhuate group was gentle and the change time was long relatively, which cues the vital cells decreased slowly. The flow cytometer showed that typical apoptosis peak appeared.

CONCLUSIONThe normal preparation group shows an acute toxic effect on ECV-304 cell line, which result in a necrosis course, while lipo-Sodium Morrhuate shows a gradual releasing process, which may indicate a apoptosis course.

Animals ; Apoptosis ; Cell Line ; Humans ; Necrosis ; Sclerosing Solutions ; Sodium Morrhuate

OBJECTIVEOccult hepatitis B infection of voluntary blood donors has been plagued in the serum screening. Determined the OBI through the highly sensitive detection methods Nest-PCR among the blood donors, and then learned occult HBV infection and analysed the genotypes of this area.

METHODS10 080 serums of donors were determined respectively by the imported Abbott HBsAg kit and Beijing Wantai anti-HBc and anti-HBs reagents, obtained the gene and detected DNA sequences by the high sensitive Nest-PCR method.

RESULTSAmong 10 080 cases of unpaid blood donors, 108 cases were detected HBsAg positively by Abbott sensitivity kit (positive rate of 1.07%), 767 cases were anti-HBc single - positive (positive rate of 7.67%). 25 patients screened blood donors who tested negative for serum HBsAg and positive for HBV DNA in the 10 080 cases. Occult HBV infection incidence rate was 0.25%. 12 cases were HBV genotype C (48%), 13 cases were genotype B (52%), and no other genotypes. Genotype B has no statistically significant difference to genotype C (P > 0.05). Sequence analysis showed that 5 patients in the HBsAg epitope "a" (aa124 - aa147) have mutation (20%).

CONCLUSIONThe high proportion of occult hepatitis B infected among voluntary blood donors in our country. Also genotype and mutation was differences in different regions.

Adolescent ; Adult ; Blood Donors ; DNA, Viral ; blood ; Female ; Genotype ; Hepatitis B ; epidemiology ; Hepatitis B virus ; classification ; genetics ; Humans ; Male ; Middle Aged ; Mutation ; Sequence Analysis, DNA

OBJECTIVETo determine ITI implants stability in different bone types using RFA and to provide evidence for feasibility of early loading.

METHODSA total of 104 ITI sand-blasted large-grit acid-etched (SLA) implants in 50 patients were classified into 3 groups according to bone type. Resonance frequency analysis was conducted at 0, 1, 4, 6, 8 and 12 weeks after installation.

RESULTSThe survival rate was 100%. Primary stability was affected by bone type (P < 0.001). The implant stability quotient (ISQ) was significantly higher in type I bone than in type IV bone. At 12 weeks, there was no significant difference among the 3 groups. Comparison of ISQ was made between 6 th week and 12 th week for all bone types, there was no significant difference for type I and III (P > 0.05) while there was for type IV (P < 0.001).

CONCLUSIONSEarly loading with ITI SLA implants placed in type I, III bone were highly predictable.

Bone Density ; Dental Implantation, Endosseous ; Dental Implants ; Dental Prosthesis Retention ; Humans

This study was aimed to analyze the polymorphism of HLA-A, B, DRB1 alleles at high-resolution level in Han population from southern area of Shandong province in China. 688 randomly selected, unrelated and healthy individual from southern area of Shandong province were genotyped for HLA-A, -B and HLA-DRB1 loci by PCR-SBT. Then, allelic and haplotypic distributions of HLA-A, B and DRB1 were estimated by maximum likelihood estimation method using Arlequin 3.0. The results indicated that a total of 31 HLA-A, 63 HLA-B and 39 HLA-DRB1 alleles were identified in Han Population from southern area of Shandong province. Six HLA-A alleles were found with a frequency greater than 0.05 (A*24:02, *30:01, *11:01, *02:01, *33:03 and *02:06), with a cumulative frequency of 0.7223. For HLA-B locus, there were also six alleles which had a frequency higher than 5% (B*1302, *4403, *5101, B*4601, *1501 and *5801), representing 0.4432 of the all alleles in the population. And four HLA-DRB1 alleles were defined as predominant (DRB1*0701, *1501, *0901and *0803), accounting for 0.5453 of the defined alleles. The most common three-loci haplotype was A*30:01-B*13:02-DRB1*07:01 (0.1151) and the most frequent two-loci haplotype were A*30:01-B*13:02 (0.1303), A*30:01-DRB1*07:01 (0.1157) and B*13:02-DRB1*07:01 (0.1307). It is concluded that the allelic and haplotypic diversities of HLA-A, -B and HLA-DRB1 at high-resolution in Han population from southern area of Shandong province in China provide useful information for HLA matching in transplantation and diseases-associated study in this population.
Alleles ; Asian Continental Ancestry Group ; genetics ; China ; Female ; Gene Frequency ; Genetics, Population ; HLA-A Antigens ; genetics ; HLA-B Antigens ; genetics ; HLA-DRB1 Chains ; genetics ; Haplotypes ; Humans ; Male ; Polymorphism, Genetic

OBJECTIVETo identify a novel human leukocyte antigen (HLA) allele in Chinese and investigate its inheritance in the family.

METHODSExceptional reaction pattern was detected in HLA-B locus in HLA typing using Luminex DNA polymerase chain reaction with sequence specific oligonucleotide probe hybridization (PCR-SSOP) assay. A confirmatory test for the novel HLA allele was performed by DNA sequencing based typing of the proband's family.

RESULTSThe DNA sequence was confirmed to be a novel HLA B allele. There were 7 nucleotides which differed from the closest matching HLA B*40:06:01 at positions 302(G to A), 309(G to C), 311(A to C), 313(C to G), 314(T to C), 317(G to T), and 319(G to C) in exon 2, which resulted in 5 amino acid changes at codon 101 (Ser to Asn), 104 (Asn to Thr), 105 (Leu to Ala), 106 (Arg to Leu), and 107 (Gly to Arg), respectively. Family investigation indicated that the novel allele was transmitted from the proband's father.

CONCLUSIONA novel HLA B allele was identified and officially named as HLA-B*40:96 (GenBank accession No. FJ374890) by the WHO Nomenclature Committee for Factors of the HLA System.

Alleles ; Base Sequence ; Female ; HLA-B Antigens ; genetics ; Haplotypes ; Histocompatibility Testing ; Humans ; Molecular Sequence Data ; Pedigree ; Sequence Alignment

OBJECTIVETo investigate the application of penile cavernous bodies elongation combined with fat flap for the treatment of micro-penis.

METHODSAnatomic study was performed to study the thickness of penile suspension ligaments and the relationship between the penile erection stability and the mobilization of cavernous bodies crus. The suspension ligaments were divided and cavernous bodies crus were partially mobilized, so as to release part of the cavernous bodies from inferior ramus of pubis. Then the penis was elongated sufficiently. Local fat flap was transposed to fill the front space of pubis to make sure the effective elongation of penis.

RESULTS205 cases of micro-penis were treated. The average length of the penis was 4.26 cm in the static state, 8.13 cm in erectile state before operation. After operation, it increased to 8.63 cm in the static state, 12.11 cm in erectile state.

CONCLUSIONSThe cavernous bodies can be elongated 1-2 cm more with the modified method, while the stability of penile erection is not affected.

Adolescent ; Adult ; Aged ; Humans ; Male ; Middle Aged ; Penis ; anatomy & histology ; surgery ; Surgical Flaps ; Treatment Outcome ; Young Adult

Objective To explore the clinical characteristics and treatment scheme of periprosthetic joint infection(PJI)caused by Cutibacterium avidum(C.avidum).Methods The diagnosis and treatment process of a patient with PJI caused by C.avidum was summarized,and relevant literatures in the database were retrieved for review.Results A 65-year-old female patient with body mass index(BMI)of 31.1 kg/m2 underwent left humeral head prosthesis replacement surgery following a left proximal humerus fracture.Ten months after the surgery,the pa-tient exhibited poor wound healing and oozing,along with limited movement of the left shoulder joint,and was diag-nosed infection following shoulder arthroplasty.Patient underwent debridement of the infected lesion and removal of the prosthesis.The tissue,bone cement and prosthesis were cultured for C.avidum.Four literatures were re-trieved and screened,a total of 30 patients with PJI(28 cases hip joint infection and 2 cases shoulder joint infection)caused by C.avidum were reported through literature retrieval,and 78.6％(n=22)total hip arthroplasty(THA)surgeries were performed using direct anterior approach(DAA).The positive rate of preoperative joint fluid culture was 71.4％,29 cases underwent surgical combined with sensitive antimicrobials treatment.Except for one patient who had repeated infection and underwent three surgeries,other patients had a good prognosis.Conclusion PJI caused by C.avidum is mostly seen in THA patients who are obese and undergo DAA,with a few cases reported after shoulder arthroplasty.The high sensitivity of preoperative joint fluid culture provides an important basis for the development of surgical strategies and anti-infection protocols.

This study was purposed to analyze and identify a novel HLA allele in Chinese population. A new HLA-B allele which is closely related to HLA-B*35:03:01 was initially detected by PCR-SSOP, then DNA sequencing was performed to identify the difference between the novel allele and HLA-B*35:03:01 allele. The result showed that the sequence of the new allele was different from all other known sequence. It differs from the closest matching HLA-B*35:03:01 by a single substitution at position 387 C→G in exon 3, no resulting in amino acid change. It is concluded that this allele is a novel one and has been officially named B*35:03:07 by the WHO Nomenclature Committee.
Alleles ; Asian Continental Ancestry Group ; genetics ; HLA-B Antigens ; genetics ; Humans ; Male ; Sequence Analysis, DNA