This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.

Objective To learn the exposure levels and health hazards of long-term exposure to hexavalent chromium (Cr6+) through drinking water in a west county,and to provide a scientific basis for making preventive measures.Methods Five water points were selected to test the Cr6+ concentration of drinking water in the county in 2015,data of 3 water points with water Cr6+ concentrations exceeded the standard (Cr6+ ＞ 0.05 mg/L) were selected from 12 drinking water points in some west counties in the recent six years (2009-2014) as the exposed group,2water points that drinking water Cr6+ concentrations not exceeded the standard (Cr6+ ≤0.05 mg/L) in the county and adjacent to the exposed group were selected as the control group.Sixty villagers were selected as the investigation objects in each water point to conduct internal medicine,ears,nose,throat (ENT),dermatology and health examination,urinary chromium content,routine blood and urine test were done.Determination of hexavalent chromium concentration in drinking water was done according to The Drinking Water Standard Examination Method 1,5-diphenylcarbazide Spectrophotometry (GB/T 5750-2006);routine urine was tested using the 10 urine analyzer test;urinary chromium was tested using graphite furnace atomic absorption spectrometer;routine blood five classification was tested using automatic blood analyzer;determination of drinking water hexavalent chromium concentration was done according to The Hygienic Standard for Drinking Water (GB 5749-2006).Higher than 0.05 mg/L was judged as exceeded the standard;physical examination was done according to The Diagnostic Criteria of Occupational Chromium Nasal Disease (GB Z12-2002) and The Diagnostic Standard of Occupational Contact Dermatitis (GB Z20-2002).Results There were 184 and 109 people in the exposed group and the control group,respectively.The average concentration of Cr6+ exceeding the standard ratio was 2.82-3.22 in drinking water,the nasal septum nucosa perforation,skin erythema edema,skin ulcers were 4.9％ (9/184),4.3％ (8/184) and 4.3％ (8/184) in the exposed group,and the urinary chromium level (0.31 μg/L) in the exposed group was significantly higher than that of the control group (0.27 μg/L,Z =-4.078,P ＜ 0.05).Routine blood test result of mean corpuscular haemaglobin (MCH) was (29.56 ± 2.07) pg,platelet counts (PLT) was (222.38 ± 47.53) × 109/L and plateletcrit (PCT) was (0.25 ± 0.05)％ in the exposed group,it was all higher than those of the control group [(29.03 ±2.95) pg,(211.74 ±75.27)× 109/L,(0.24 ± 0.08)％,t =1,940,2.318,2.079,all P ＜ 0.05];standard difference coefficient of variation of red blood cell distribution width (RDW-CV) was (13.14 ± 1.05)％,lymphocyte number (LYMPH) was (2.01 ± 0.64) × 109/L in the exposed group,it was all lower than those of the control group [(13.38 ±1.54)％,(2.21 ± 1.02) × 109/L,t =-1.989,-1.956,all P ＜ 0.05].The positive rate of glycosuria,uric bravery red,and urine nitrite in routine urine test of exposed group was 17.39％ (32/184),23.36％ (43/184),7.61％ (14/184);it was all higher than those of the control group [(8.25％ (9/109),11.93％ (13/109),0.91％ (1/109),x2 =4.746,5.798,6.309,all P ＜ 0.05].Conclusions Urine chromium accumulation has been found in populations long-term exposed to 2.82-3.22 times excessive Cr6+ through drinking water,which has affected the population's health to some extent.Therefore,it is necessary to speed up the local drinking water improvement project.

Objective To explore the correlation of rhinovirus infection and the morbidity of asthma in children.Methods The RV gene in nasopharyngeal secretion of 30 children with asthma acute exacerbation(asthma group),30 children in asthma clinical remission(remission group) and 30 healthy children (control group) were detected by reverse transcription-polymerase chain reaction(RT-PCR).The total serum IgE(T-IgE) was determined by chemiluminescence.The eosinophil(EOS) count (EOS%) of peripheral blood and lung function were also measured.Results The rhinovirus infection rate was 36.67% in asthma group and 3.33% in remission group.No rhinovirus was detected in control group.The rate of rhinovirus infections in asthma group was significantly highter than that in remission group and control group(?2=7.50,13.47 Pa0.05). FEV1% was (62.73?13.54)% in asthma rhinovirus infection and (86.42?17.78)% masthma with no rhinovirus infection.There was remarkable difference between 2 groups(F=14.553 P﹤0.05). The T-IgE was (836.32?44.801) kU/L and EOS% was 10.63?4.09 in asthma group with rhinovirus infection.The total IgE was (439.10?231.28) kU/L and EOS% was 5.04?2.64 in asthma group with no rhinovirus infection.There was significant difference between 2 groups(U=2.475,F=20.806 Pa0.05).Conclusions There is a close correlation between rhinovirus infection and acute attack of asthma(or worsening asthma) in children. Asthma exacerbations would be likely to happened easier because of rhinovirus infection in asthmatic children with high T-IgE.

Objective To explore the effect of electrical acupuncture on the cytokines in adjuvant arthritis rats. Methods 60 rats were divided into 5 groups randomly, each with 12 rats. The blank control group and the model group were only bundled; while the Zusanli group, the Guanyuan group, and the Weizhong group were electroacupunctured each single point after bundled, once per 2 d. 32 d later, the swelling of voix pedis was measured and the level of interleukin (IL)-1, IL-2, IL-10, tumor necrosis factor (TNF)-α in plasma was determined in each group. Results After being modeled, the voix pedis of rats were swelling (P<0.05), while the swelling of voix pedis in the Zusanli, Guanyuan and Weizhong groups significantly reduced (P<0.05). The plasma IL-1, IL-2 and TNF-α was significantly higher in the model group than in the blank group (P<0.01), and reduced in Zusanli, Guanyuan and Weizhong groups (P<0.05). Compared with Zusanli and Guanyuan groups, there was a significant difference in the Weizhong group (P<0.01). The plasma IL-10 was significantly lower in the model group than in the blank control group (P<0.05), and increased in the Zusanli, Guanyuan and Weizhong groups (P<0.05). Compared with Zusanli and Guanyuan groups, there was a significant difference in the Weizhong group (P<0.01). The swelling of voix pedis was positively correlated with the level of IL-1, IL-2, and TNF-α (r=0.881~0.912, P<0.01). There was positive correlation among the IL-1, IL-2, and TNF-α (P<0.01). IL-10 was negatively correlated with the swelling, IL-1, IL-2, and TNF-α (r=-0.293~-0.519, P<0.05). Conclusion Electroacupuncture can significantly reduce the swelling of voix pedis in adjuvant arthritis rats, and it may be related with improving immune function by increasing the level of IL-10 and decreasing the level of IL-1, IL-2 and TNF-α in plasma.

Objective To explore the effective method of treating childhood acute aplastic anemia(AAA) by overviewing the curative effect of therapeutic alliance to the children diagnosed as AAA with immunodepressants.Methods Retrospective analysis was performed on 13 patients diagnosed as AAA,who were treated by high dose of methyllprednisolone,antilymphocyte globulin,ciclosporin A,large dose of gamma globulin,granulocyte colony-stimulating factor and blood transfusion in 4 years.Results Among 13 cases,9 cases were healing well on the whole,one was relieved,one was improving,two were ineffective(one of them was dead).In 9 cases who were healing,WBC took(24.60?8.86) days to reach 4?10~9/L,hematoglobin took(152.22?68.88) days to reach normal and platelet took(125.55?55.86) days to reach 80?10~9/L.During the procedure of treating,infection appeared in 7 cases,the ALT and AST was high in 2 cases,hypoproteinemia and edema in 1 case,gross hematuria in 2 cases,gingival hyperplasia obviously and dedentition in 1 case.Conclusion Therapeutic alliance with immunodepressants to childhood AAA is a safe and effective method.

Objective To investigate the diagnostic value of intraductal ultrasonography for the quality of biliary stricture.Methods Data of the patients who had received operation because of biliary stricture after IDUS examination from 2006 to 2010 were collected.IDUS results were compared with those of operation.Results There were 43 cases of malignant strictures and 6 benign strictures in total.The sensitivity,specificity,positive predictive value,negative predictive value and diagnostic accuracy of intraductal uhrasonography for the quality of biliary stricture were 97.7％ ( 42/43 ),83.3％ ( 5/6 ),97.7％ ( 42/43 ),83.3％ (5/6) and 95.9％ (47/49),respectively,which were significantly higher than conventional imaging like ultrasound B,CT and MRCP.Twenty one cases in 32 were diagnosed as malignant biliary stricture with cytological brushing,with the diagnostic accuracy of 65.6％.All cases had been diagnosed by IDUS.Conclusion Intraductal ultrasonography is of high diagnostic value for biliary stricture.However,cytological brushing based on IDUS is of limited diagnostic value for malignant biliary stricture.

Objective To validate a new standardized training program for urological surgeons to improve their laparoscopic surgical skills. Methods The laparoscopic surgical training program was carried out by using the traditional mechanical simulators and animal models. Thirty-three trainees participated the urological laparoscopic surgical training program. Initially, the novices were assigned to practise basic laparoscopic skills step by step on the simulator with fixed trocar positions. After a period of basic training, they were allowed to practise on animal models for some particular proce-dures. Results All trainees (33/33, 100.0%) participated were able to perform all basic techniques skillfully and completed laparoscopic anastomosis accurately after the training. The time required for performing the partial nephrectomy, dismembered pyeloplasty and ureteral reimplantation on animal models declined from 64.0±18.4, 127.54±17.5 and 75.84±11.6 min at the beginning to 30.94±3.8, 65.2±7. 5 and 37.7±7.2 min after practicing these procedures 8 times (P<0.01). They could un-derstand the crucial procedures of the laparoseopic surgeries after 6 to 8 special trainings on animal models. Fifteen trainees (15/33, 45.5%) had started to carry out laparoscopic surgeries after-finish- ing the training program. Conclusions Our program enables the participants to improve their techniques in complicated laparoscopic surgeries. The challenging parts of reconstructive laparoscopic surgeries such as laparoscopic dismembered pyeloplasty can be taught by using animal models. This program could be incorpo-rated easily by all urological departments developing a laparoscopie surgical training program.

Adult ; Female ; Humans ; Meningeal Neoplasms ; complications ; pathology ; Meningioma ; complications ; pathology ; Metaplasia ; complications

Objective To investigate the relationship between hypoxia inducible factor-1?、angiopoietin2 and vascular endothelial growth factor and angiogenesis in hepatocellular carcinoma(HCC).Methods The(expression) of hypoxia inducible factor-1?、angiopoietin2 and vascular endothelial growth factor mRNA was(detected) in 52 HCC surgical specimens.And microvessel density(MVD) in tissue specimens of patients with coexpression of the parameters was examined.Results Of the 52 surgical specimens,36 cases had over(expression) of HIF-?、angiopoietin and VEGF protein,and coexpression of HIF-? and angiopoietin and VEGF mRNA in 38 of 52 cases.The expression of HIF-?、angiopoietin was related with the expression of VEGF(r_1= 0.783,P

Objective To probe the effects of nuclear factor kappa B (NF-?B) on cell apoptosis and left ventricular segmental function in acute ischemia repeffusion in dogs.Method Twenty-four dogs were randomly divided into three groups:without left anterior artery (lAD) ligation group (C group),LAD was occluded 30 min following reperfusion 120 minutes in isehemical reperfusion group (IR group),and dogs were administered with PDTC before LAD ligation in ischemical reperfusion plus pyorrole dithitocarbamate group (PDTC group).The left ventricular segmental function was detected by echo cardiography using strain rate anlysis software.EF measured by Simpson's method.Cardiac myocyte apoptosis numbers were determined by terminal deoxynudeotidy transferease-mediated biotinylated deoxyuridine triphosphate nick end labeling (TUNEL).lmmunohistochemistry and western-blot anylysis of NF-?B protein expression.Results NF-?B was obviously expression on injury myocardium of IR group,and increased significantly in contrast to control group (P0.05)Conclusions NF-?B might play an important role in acute myocardial ischemia reperfusion.PDTC reduces myocardial iscbemia/repeffasion injury by preventing expression of factor NF-?B.