Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

? amyloid protein(A?) including A?40 and A?42 are the important bioactive substances in vivo.Their toxic and beneficial attributes in the body depend on its concentration.The brain A? level is maintained by two balances under the physiological condition.The first balance is the generation involved in ?-secretase and ?-secretase and the degradation involved in neprilysin(NEP) and insulin-degrading enzyme(IDE) of A?. The second one is the balance between the receptor for advanced end glycation products(RAGE)-mediated influx and low-density lipoprotein receptor related protein 1(LRP1)-mediated efflux of A? across the blood-brain barrier(BBB).Breakdowning any one of the two balances would result in the aggregation and precipitation of A? in the brain,which is a crucial event in the pathogenesis of Alzheimer's disease(AD).This paper reviews the regulation of brain A? level under the physiological condition and the reducing strategies on the level of brain A? under the pathological condition for developing new drugs in the treatment of AD.

OBJECTIVETo investigate the effect of baicalein on the gap junction intercellular communication (GJIC) in the TM4 Sertoli cells of the mouse testis and its related mechanism.

METHODSWe measured the cytotoxicity of different concentrations of baicalein on the TM4 Sertoli cells in the mouse testis by MTT, detected the fluorescence transfer of the TM4 Sertoli cells by parachute assay, and determined the expression of the protein connexin 43 ( Cx43) in the baicalein-treated cells by Western blot and immunofluorescence assay.

RESULTSBaicalein produced no obvious cytotoxicity on the TM4 Sertoli cells at the concentration below 60 µmol/L but significantly increased their GJIC at 0-20 µmol/L (P < 0.01). Western blot and immunofluorescence assay showed that 0-20 µmol/L baicalein remarkably elevated the expression of Cx43 in the TM4 cells (P < 0.01) and on the membrane of the TM4 cells.

CONCLUSIONBaicalein at the concentration of 0-20 µmol/L can significantly enhance GJIC in mouse TM4 Sertoli cells by increasing the expression of the Cx43 protein.

Animals ; Cell Communication ; drug effects ; Connexin 43 ; metabolism ; Flavanones ; administration & dosage ; pharmacology ; Gap Junctions ; drug effects ; Male ; Mice ; Sertoli Cells ; drug effects ; metabolism ; ultrastructure

OBJECTIVETo observe the effect of salidroside on tic behavior and in vivo dopamine DA) and serotonin (5-HT) levels in Tourette syndrome (TS) model rats.

METHODSForty rats were randomly divided into the blank control group, the TS model group, the haloperidol-treated group (0.5 mg/kg x d(-1)), and the salidroside-treated group (50 mg/kg x d(-1)), 10 in each group. TS rat model was induced by imino-dipropio-nitrile (IDPN). Peritoneal injection of haloperidol and salidroside was started from the 4th day of modeling in the haloperidol-treated group and the salidroside-treated group respectively. Normal saline was peritoneally injected to rats in the blank control group and the TS model group respectively. Stereotyped behavior was scored, and changes of DA and 5-HT levels in blood and striatum were measured before modeling, after modeling, and after intervention.

RESULTSCompared with the blank control group, the score of the tic behavior was elevated (P < 0.01) , levels of DA and 5-HT in plasma and striatum were reduced in the model group (P < 0.01, P < 0.05). Compared with the same group after modeling, the tic behavior score decreased and plasma DA levels increased in the two treated groups after intervention (P < 0.01). 5-HT content increased in the salidroside-treated group (P < 0.01). Compared with the model group after intervention, the tic behavior score was significantly reduced (P < 0.01), and DA levels in plasma and striatum were elevated (P < 0.01, P < 0.05) in the salidroside-treated group and the haloperidol-treated group. Compared with the haloperidol-treated group, the tic behavior score increased (P < 0.01), DA levels in plasma and striatum were lowered (P < 0.01, P < 0.05), the 5-HT level increased in plasma and striatum (P < 0.01, P < 0.05) in the salidroside-treated group.

CONCLUSIONSIn the salidroside-treated group, the tic behavior was significantly reduced, and DA levels in plasma and striatum were elevated. Its mechanism might be related to regulating activities of dopamine neurons in striatum.

Animals ; Corpus Striatum ; Dopamine ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Glucosides ; pharmacology ; therapeutic use ; Haloperidol ; Phenols ; pharmacology ; therapeutic use ; Rats ; Serotonin ; Stereotyped Behavior ; Tics ; drug therapy ; Tourette Syndrome ; drug therapy

Objective To investigate the expression and significance of Smad4 in peripheral hepatocytes of lesions in mice with hepatic alveolar echinococcosis.Methods Eight mice in the test group were inoculated with alveolar echinococcosis and 8 mice in the control group were injected with normal saline.The expression of Smad4 protein in the hepatic tissue of the mice was detected by immunohistochemistry method,and the data were analyzed by chi-square test.The effect of alveolar echinocoeeosis on the expression of Smad4 protein was investigated.Results Smad4 was detected in cell nuclei and partly in the cytoplasm.Six months after the establishment of the mice model for alveolar echinococeosis,the expression of Smad4 in the hepatic tissue in the test group was significantly higher than in the control group(x2=19.869,P＜0.05).The number of Smad4 with positive expression in the hepatocytes in the test group was slightly higher than in the control group,and the expression intensity of Smad4 in the test group was greater than in the control group(x2=58.3 10,P＜0.05).Conclusions The increase of the expression of Smad4 protein in the periphery hepatocytes and tissues of hepatic alveolar echinococcosis lesions may play a role in hepatic cirrhosis and immune evasion.

AIM: To detect the effect of sepsis on hepatic,renal functions and corresponding enzymes in intestine of mice,and to explore the role of leptin in acute inflammation.METHODS: A mice model of sepsis was made by cecum ligation and perforation,and 96-well spectrophotometry was used to detecte the levels of alanine aminotransferase(ALT),uric acid(UA) and activities of myeloperoxidase(MPO),glutathin-S-transferase(GST),xanthine oxidase(XOD),superoxide dismutase(SOD) in serum and intestinal homogenized fluids,respectively.Hematoxylin-eosin staining was used simultaneously to check the histopathologic changes of intestine.RESULTS: Compared with sham group(330.12 ?mol/L?94.15 ?mol/L),serum UA level(521.92 ?mol/L?91.86 ?mol/L) at 6 h after sepsis was significantly higher.12 h after sepsis,both serum ALT(83.55 U/L?40.44 U/L) and UA(474.03 ?mol/L?75.22 ?mol/L) were significantly higher than those in sham group(66.23 U/L?16.80 U/L and 320.95 ?mol/L?99.14 ?mol/L,respectively).12 h after leptin injection(0.1 mg/kg,ip) or indomethacin injection(2 mg/kg,ip),the serum ALT and UA levels significantly decreased(vs sepsis group,P

Objective To establish a suitable evaluation index system to track implementation effect of clinical research program.Methods Delphi method was used to creat the evaluation index system.The weighted average method was adopted to determine the weight of each index.Results After two rounds of expert consultation,twenty seven evaluation indices were selected,including three first-class indices,eight second-class indices and sixteen third-class indices,and the weight of each index was determined.Conclusions The evaluation index system reflects the purpose of tracking clinical research to a certain extent.This index system is simple and easy to be used.

OBJECTIVE To investigate the effect of sodium ferulate (SF) on lipopolysaccharide (LPS)-induced preterm delivery and intra-uterine fetal death (IUFD). METHODS Pregnant Kunming mice were subcutaneously pretreated with SF (25 or 50 mg · kg-1) from gestational day (GD) 10 to GD 15 and with the single injection of LPS (150μg·kg-1, ip) on GD15.5. The incidence of preterm delivery and IUFD was observed. HE staining was used for uterine and placental histological evaluation. The levels of thiobarbituric acid reactive substances (TBARS) and reduced glutathione (GSH) as well as the activities of glutathione S-transferase (GST) and glutathione peroxidase (GSH-Px) were detected in the maternal liver, placenta, and fetal liver using commercial kits. Interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) levels in amniotic fluid were evaluated by enzyme linked immunosorbent assay. RESULTS For LPS group, the incidence of preterm was 47.8%, delivery time was (17.5 ± 1.3) d, and the pups′survival rate was only 42.6%. Compared with LPS-treated group, SF 50 mg · kg-1 group showed a lower incidence of preterm (14.3%, P<0.01), longer gestational days (18.4 ± 0.5, P<0.05), and a higher pups′survival rate (75.6%, P<0.01). SF 50 mg · kg-1 restored the LPS-induced GSH both in the maternal and fatal liver (a tendency without statistical significance), GST activity〔(163±82) kU·g-1 protein vs (95±90) kU·g-1 protein, P<0.01)〕in the placenta, TBARS content〔(2.5±0.4)μmol·g-1 protein vs (3.1±0.6)μmol·g-1 protein, P<0.01〕in the fetal liver, and TNF-αlevel〔(11±8) ng·L-1 vs (20±8) ng·L-1, P<0.01〕in the amniotic fluid. SF also attenuated LPS-induced placental congestion and neutrophil infiltra?tion in the uterus. CONCLUSION SF may protect against LPS-induced preterm delivery and IUFD, and anti-oxidation as well as anti-inflammation may contribute to these effects.

Objective To analyze the ophthalmologic characteristics and examinations which caused by vertebral-basilar insuffi- ciency.Design Retrospective case series.Participants 469 eases of vertebral-basilar insufficiency.Methods Retrospective analysis of 469 cases of vertebral-basilar insufficiency patients with ophthalmologic signs' features,incidence,the main cause,color Doppler flow imaging and(or)digital subtraction angiography clearly stenosis location,the degree of stenosis from July 1st 2005 to July ist 2007 in PLA General Hospital.Main Outcome Measures Ophthalmologic signs' related reasons and supplementary examination.Results 96 cases were with the corresponding eye symptoms(20.4%).Vision decreased in 83 cases,diplopia was in 56 cases,ipsilateral hemiopia quadrant blind in 12 cases and depending on deformation in 10 cases,fundus arteriosclerosis in 72 cases,nystagmus in 39 cases,the eye movement disorder in 16 cases.Among 96 patients with associated ocular symptoms,75 patients with color Doppler flow imaging (CDFI)showed unilateral vertebral artery abnormal in 66 cases(88%),among those blood flow velocity decreased in 26 cases,17 cases with vascular plaque stenosis,thinning in 20 cases,3 cases with complete occlusion;different bilateral vertebral artery abnormal in 9 cases(12%),among those velocity dropped in 4 cases,two cases with vascular plaque stenosis and thinning in 3 cases.Forty-five cases with the digital subtraction angiography(DSA),left vertebral artery was abnormal in 24 cases,18 cases with stenosis,occlusion in 5 cas- es,abnormal bending in 1 case.Right vertebral artery was abnormal in 16 cases,13 cases with stenosis,occlusion in 3 cases.Bilateral vertebral artery stenosis was found in 2 cases;vertebral artery stenosis was in 3 patients.Conclusion Vertebral-basilar insufficiency may cause eye-related symptoms,therefore,vision acuity decrease,fundus 'arteriosclerosis,diplopia and nystagmus symptoms are more likely for patients with vertebral-patients with basilar artery insufficiency performance of the eye.(Ophthalmol CHN,2002,16:406-410)

Objective:To evaluate the diagnostic values of serum fibrinogen and D-dimer for periprosthetic joint infection (PJI).Methods:The medical records were retrospectively analyzed of the 175 patients who had undergone hip or knee revisions at Department of Joint Surgery, Affiliated Hospital to Qingdao University from August 2013 to June 2019. Of them, 59 were diagnosed as PJI (31 knees and 28 hips), including 33 males and 26 females with an age of (67.4±11.7) years and a body mass index (BMI) of (26.1±3.6) kg/m 2 while 116 as aseptic loosening (AL) (19 knees and 97 hips), including 67 males and 49 females with an age of (70.3±8.9) years and a BMI of (25.0±3.6) kg/m 2. The plasma levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen and D-dimer in the 2 groups were recorded and analyzed. The receiver operating characteristic curve (ROC) was used to calculate the sensitivity and specificity of each indicator; the diagnostic value for each indicator was calculated according to the area under the curve (AUC). Results:There was no significant difference between the PJI and AL groups in gender, age or BMI ( P>0.05), but there was a significant difference in the joint type ( P<0.05). Compared with the AL group, the PJI group had significantly higher levels of CRP, ESR, fibrinogen and D-dimer ( P<0.05). The AUCs for CRP, ESR, fibrinogen and D-dimer were 0.830, 0.850, 0.848 and 0.664, respectively. By the Youden index, the optimal predictive cutoffs for CRP, ESR, fibrinogen and D-dimer were 8.06 mg/L, 17.60 mm/h, 3.73 g/L and 685.00 ng/mL, giving sensitivities of 79.2%, 85.4%, 81.3% and 64.6% and specificities of 85.7%, 76.2%, 79.8% and 61.9%. Conclusions:The diagnostic value of serum fibrinogen may be high for PJI, similar to that of CRP or ESR. However, D-dimer may be of limited value for diagnosis of PJI.