In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.
Biomedical Research ; China ; Clinical Trials as Topic ; Databases, Factual ; Humans ; Medicine, Chinese Traditional ; United States

International clinical trials register is one of the global measures to realize transparency in clinical trials and also one of a powerful measure to improve the quality of clinical trials. Many scholars studying the quality of TCM clinical trials find that they are poor in quality and lack transparency. Furthermore, they find that TCM clinical trial registry has many problems. We must base on the successful experiences of WHO and international clinical trial registry to establish technical specifications for registry of traditional Chinese medicine clinical study of their own. Then, it can effectively improve the overall level of TCM clinical studies. We have suggested some concrete and feasible measures to establish technical specifications for registry of traditional Chinese medicine clinical study of their own based on the problems of TCM clinical trial registry.
Biomedical Research ; Humans ; Medicine, Chinese Traditional ; standards ; Registries

BackgroundRetinal pigment epithelial(RPE) cells can secrete platelet-derived growth factor (PDGF) and PDGF receptor(PDGFR).Studies have shown that PDGF plays a key role in the formation of proliferative vitreous retinopathy(PVR). ObjectiveThis study was to investigate the proliferation and apoptosis changes of RPE after blockage of the PDGFR-α expression by antisense oligonucleotide ( ASODN ) in vitro. Methods Human RPE cells strain was cultured in low glucose DMEM with 10％ fetal bovine serum.Logarithmic phase cells were collected and incubated in 96-well plate at the density of 5 × 105 cells/hole.PDGFR-α ASODN was transfected into RPE cells at different concentrations for 48 hours.The cells of the blank control group were regularly cultured without any transfection.The changes of PDGFR-α expression were detected by reverse transcription-polymerase chain reaction(RT-PCR),and the proliferation of RPE was detected by MTT as the A490 value.Hoechst 33258 fluorescence staining was used to determine the apoptosis of RPE.Flow cytometry method (FCM) was applied to detect the change of cell cycle and apoptosis rate of RPE cells. ResultsThe A490 values of RPE cells were 1.45±0.12,1.07±0.06,0.65±0.05 in blank control group,1.0 μmol/L Lipo-ASODN group and 2.0 μmol/L Lipo-ASODN group with the significant difference(P=0.00 ),and that of 1.0 μmol/L Lipo-ASODN group and 2.0 μ mol/L Lipo-ASODN group were significantly lower than the blank control group ( P =0.00,0.00).Hoechst 33258 staining showed that the apoptosis cells were obviously more in Lipo-ASODN group compared with blank control group.PDGFR-α ASODN transfection induced an increase of percentage of RPE cells in G0/G1 phase( F =206.70,P =0.00),and the apoptosis rates in 1.0 μmol/L Lipo-ASODN group and 2.0 μmol/L Lipo-ASODN group were significantly enhanced in comparison with blank control group ( 37.8 ± 1.3 vs 10.5 ± 0.1,61.2 ± 1.9 vs 10.5 ± 0.1 ) ( F =1808.90,P =0.00 ).Expression intensity of PDGFR-α mRNA in RPE cells in Lipo-ASODN groups was lower. ConclusionsBlocking the PDGFR-α expression with ASODN technology can suppress proliferation and induce apoptosis of RPE cells.Intensity of PDGFR-α mRNA expression in RPE cells is ASODN dose-dependent.ASODN targeted to PDGFR-α offers an experimental basis of the gene therapy for PVR.

Objective - （ ） To analyze the occurrence pattern of work related musculoskeletal disorders WMSDs among workers Methods in a shipyard based on latent category model. A total of 446 workers from a shipyard in Guangdong Province were selected as the research subjects using convenience sampling method. The prevalence of WMSDs in the past year was ， investigated using China Musculoskeletal Questionnaire and the occurrence patterns of WMSDs were analyzed by latent class. Results （ ） The prevalence of WMSDs in the past year was 71.1% 317/446 . The prevalence of WMSDs in single site was 24.4% （ ）， （ ） - 109/446 and was 46.6% 208/446 in multiple sites. The prevalence of WMSDs in multiple sites was 3.9 17.3 times higher than that in single site. The fitting results of latent class model showed that the model with three latent classes was the best - （ ）， model. The three potential categories of WMSDs occurrence patterns in the study subjects were the all site group 28 patients （ ）， （ ）， ， the neck and lower back/waistgroup 153 patients and the few or no site group 265 patients accounting for 6.3% 34.3% ， Conclusion and 59.4% respectively. WMSDs of shipyard workers have obvious category characteristics. Latent class analysis can be used to explore the occurrence pattern of WMSDs in shipyard workers.

Objective To investigate the clinical value of pharyngeal protection tube in endoscopic therapy for patients with liver cirrhosis and esophagogastric varices. Methods The clinical data of 120 patients from January 2013 to October 2016, suffered from liver cirrhosis and esophagogastric varices, and accepted the endoscopic therapy were analyzed retrospectively. 60 patients underwent endoscopic therapy and were meanwhile applied pharyngeal protection tube; 60 cases were treated with the assistance of routine endoscopy. The completion rate of treatment and the incidence of complications were observed and compared between the two groups. Results Pharyngeal protection tube group: The completion rate of endoscopic treatment in the pharynx protective tube group was 98.3%, without complications. In the control group, the completion rate of the treatment under endoscopy was 88.3%, and there were 7 cases of aspiration, asphyxia and inhalation pneumonia. Conclusions Using pharyngeal protection tube to protect airway can improve the safety and completion rate of endoscopic treatment of esophageal and gastric varices, reduce the incidence of complications, and the pharyngeal protection tube is simple and cost-effective, which is worthy of clinical application.

Abstract: Objective　To explore the spatial epidemiological characteristics of severe cases hand, foot and mouth disease (HFMD) in Guangxi, China, from 2014 to 2018, and to provide a basis for identifying the high-risk regions as well as the prevention and control of severe cases of HFMD in Guangxi. Methods　Spatial-temporal scanning analysis, global and local spatial autocorrelation analysis were used to analyze the spatial clustering of HFMD. The trend surface analysis was used to evaluate the spatial distribution trend of HFMD. Results　From 2014 to 2018, the incidence and severe case fatality rates of HFMD were 3.89/100 000 and 4.23%, respectively. Monte Carlo scanning analysis showed that the first cluster region was Cenxi City, the second cluster was mainly concentrated in northwest of Guangxi, and the aggregation time was mainly concentrated in April to May and August to October. The global spatial autocorrelation analysis showed that the severe HFMD was significant clustering distribution, and the Moran's I coefficients of the sever cases, severe morbidity and severe case fatality rate were 0.088, 0.118, 0.197, respectively (P<0.05). Local spatial autocorrelation analysis showed that hotspots of severe HFMD cases were concentrated in the southern Guangxi, mainly in Lingshan County. Anselin local Moran's I clustering and outlier analysis indicated that 5 high-high (H-H) clustering regions for fatality were Lingshan, Pubei, Zhongshan, Zhaoping and Pinggui County. There were 6 high-high (H-H) clustering regions for severe incidence rate, namely Lingshan, Qinnan, Lingyun, Youjiang, Bama Yao Autonomous and Pinggui County, and 1 high-low (H-L) clustering region, Cenxi County. The trend surface analysis showed that the overall number of severe cases of death decreased from east or west to the middle, and increased from north to middle, and then decreased to south. Conclusions　Severe HFMD cases in Guangxi have obvious spatial-temporal clustering, and the hop spots are mainly concentrated in southern Guangxi. The prevention and control of HFMD in areas with high incidence of severe cases should be strengthened to reduce the burden of HFMD cases.

OBJECTIVETo study the clinical features, diagnosis and therapy of thyroid neoplasm in children.

METHODSA retrospective study was performed on 32 children with thyroid nodular who were underwent operation in Xiangya Hospital between January 2002 and December 2010.

RESULTSOf the 32 cases, there were 23 girls and 9 boys. Six cases were diagnosed as nodular Goiter adenoma and 26 cases were diagnosed as thyroid papillary carcinoma. B-ultrasonic examination showed a 100% accurate rate for the diagnosis of thyroid carcinoma. Fourteen children (44%) were proven to have concurrent Hashimoto's thyroiditis. Twenty-two (69%) children with thyroid carcinoma were found to have lymph metastasis in the lateral neck. The children younger than 10 years showed a high rate of metastasis than those older one (94% vs 56%, P<0.05). All 32 children received a surgical therapy. Subtotal thyroidectomy was performed on the 6 children with nodular Goiter adenoma. Total thyroidectomy (17 cases) or ipsilateral thyroidectomy (9 cases) was performed according to the stage of thyroid carcinoma. The surgical outcomes were followed up for 3 months to 9 years and no recurrence or death occurred. The development and growth were normal in the children.

CONCLUSIONSChildhood thyroid nodular attacks girls more than boys, and the frequency of malignancy is high. Hashimoto's thyroiditis is a common concurrent disease. The incidence of local lymph metastasis is high in those younger than 10 years. The surgical therapy for thyroid neoplasm may lead satisfactory outcomes in children.

Adolescent ; Child ; Female ; Follow-Up Studies ; Humans ; Male ; Retrospective Studies ; Thyroid Neoplasms ; diagnosis ; pathology ; surgery

Objective To evaluate the effect of PTH gene polymorphisms on bone mineral density (BMD) at multiple skeletal sites in normal females.Methods PTH gene phenotype was determined by PCR-RFLP of restriction enzyme Bst BⅠin 596 females aged (46.3?13.7) years (20-80 years),and PCR products with or without enzymolytic site were considered as genotype B or genotype b respectively.BMDs of the anteropesterior spine (AP) and supine lateral spine (Lat) of lumbar vertebrae (L_1-L_4),femoral neck (FN),total hip (T-hip), Ward's triangle (Ward),Trochanter (Troch),forearm [radius+ulna ultradistal (RUUD) and total area of radius + ulna (RUT) ] were measured by DEXA (QDR4500A).Results (1) Hardy-Weinberg equilibrium was evident for PTH polymorphisms.The frequencies of genotype were BB 0.784,Bb 0.208,bb 0.008 and frequencies of alleles B,b were 0.888 and 0.112 respectively in 596 normal females.Frequencies of BB,Bb,bb genotypes were 0.781,0.210,and 0.009 respectively in 347 postmenopausal women and their frequencies of alleles B,b were 0.886,0.114.No significant difference was found between post- and premenopausal women in genotype frequen- cy.(2) Comparing their BMDs of AP,Lat,FN,T-hip,Ward,Troch,RUUD and RUT,there was no significant difference between BB and Bb genotypes of pre- and postmenopansal women groups.(3) Logistic regression analysis failed to show any statistical difference between normal and osteoporosis women with regard to PTH phenotype.Conclusion PTH gene polymorphism has little effect on BMD in normal females.

OBJECTIVEAge, body weight and dose have been shown as important influencing factors for sodium valproate plasma concentrations. However it is unclear whether there is interaction among them and whether the interaction could influence sodium valproate plasma concentrations. This study aimed to evaluate the influence of age, body weight and dose on plasma concentrations of sodium valproate and the interaction among them.

METHODSOne hundred and thirty-two children with epilepsy (age: 4 months-6 years, weight: 5-25 kg) were enrolled. Sodium valproate was administered at the dosage of 10-30 mg/kg/d. Plasma concentrations of sodium valproate were measured by high-performance liquid chromatography 3-5 days after administration. The relationship of sodium valproate plasma concentrations with age, body weight, and dose of sodium valproate was examined using variance analysis, pearson correlation analysis and stepwise regression analysis.

RESULTSAge (F=8.630, P<0.01), body weight (F=3.650, P<0.05) and dose of sodium valproate (F=11.720, P<0.01) were influencing factors for sodium valproate plasma concentrations. The interaction between age and oral dose (F=2.484, P<0.05) and the interaction of age and body weight with oral dose (F=4.923, P<0.01) had significant effects on sodium valproate plasma concentrations. Stepwise regression analysis showed that dose of sodium valproate and body weight were entered to the regression equation.

CONCLUSIONSAge, body weight and dose of sodium valproate as well as the interactions between age and dose and between age, body weight and dose were influencing factors for valproate plasma concentrations.

Age Factors ; Anticonvulsants ; blood ; Body Weight ; Child ; Child, Preschool ; Epilepsy ; drug therapy ; Female ; Humans ; Infant ; Male ; Regression Analysis ; Valproic Acid ; administration & dosage ; adverse effects ; blood

OBJECTIVETo explore CT and MRI manifestations of the axial area peripheral primitive neuroectodermal tumors (pPNETs) in order to improve the knowledge of this disease.

METHODSThe clinical data of 10 patients with pPNETs underwent pathologically confirmed were retrospectively analyzed from October 2008 to May 2014. There were 7 males and 3 females, aged from 8 to 49 years old with median of 23.6 years. The preoperative multi-slice spiral CT scan was completed in 3 cases, plain CT scan and enhancement in 4 cases; MRI and enhancement scanning in 5 cases; and among them, 2 cases underwent both MRI and CT scan.

RESULTSIn-bone type was found 6 cases and out-bone type was found 4 cases. Three cases occurred in sacral vertebrae, 2 cases in lumbar vertebrae, 1 case in cervical vertebrae, 1 case in cervical spinal canal, 1 case in coccyx, 1 case in the right iliac bone, 1 case in presacral space. Cross sectional the smallest tumor maximum level was 1.1 cmx 1.2 cm in size, the biggest tumor was 8.0 cm x 9.2 cm, the median size was 4.4 cm x 5.7 cm, of them, the tumor of maximal diameter larger than 5 cm had 6 cases. Except 2 cases-without destruction of bone, the other 5 cases with osteolytic destruction, 2 cases with calcification, 1 case with mixed. Equidensite was main in CT scan, 1 case with uniform density, other 6 cases with uneven density,in which 3 cases with "floating ice" change; 1 case with moderate strengthening, other 3 cases with obviously strengthening, 2 cases with multiple small blood vessels in enhancement scanning. MRI of 5 cases showed the signal of isointensity on T1WI, the slightly high signal on T2WI and the signal was not uniform; after enhancement scan, the signal of 5 cases obviously enhanced. Two patients complicated with vertebral compression fractures, no periosteal reaction was found in all patients, and no the destruction of intervertebral disk was found in 5 patients of MRI scan.

CONCLUSIONThe axial area pPNETs is common among children and the youth, and the mass often is huge. The mass of in-bone type often envelopes the vertebral body, and main located on prevertebral space, all associated with bone destruction, osteolytic destruction is common, and primary vertebral bodies also is common, attachment primary or involvement is few found, it can involve the spinal canal and anterior wall of spinal canal is common, some cases complicate with multiple newly born small vessels. The mass of out-hone type in deep soft tissue is common, minority primary spinal canal, many complicated with vertebral bone destruction, osteolytic destruction was main. The intervertebral disk was not invaded and intervertebral space has not stenosis. CT scan offer complicate with "floating ice" sign, and in-bone type is common. Isointensity is main on MRI TlWI and slightly longer signal is main on MRI T2WI, strengthening signal is obvious.

Adolescent ; Adult ; Child ; Cross-Sectional Studies ; Diagnosis, Differential ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Neuroectodermal Tumors, Primitive, Peripheral ; diagnosis ; diagnostic imaging ; Radionuclide Imaging ; Tomography, X-Ray Computed ; Young Adult