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

Objective: To evaluate the eruption of mandible third molar in orthodontic patients with non-extraction or extraction of the lower premolars. Methods: We selected 3 group of the orthodontic patients. One group consisted of 23 subjects (12 males, 11 females, average age 13.5 years) with non-extraction. One group consisted of 23 subjects (12 males, 11 females, average age 13 years) with lower first premolar extraction. One group consisted of 21 subjects (11 males, 10 females, average age 14.07 years) with lower second premolar extraction. The panoramic radiography was taken. The lower third molar angulation and eruption space were measured before and after the orthodontic treatment. The comparison of treatment changes in 3 groups were performed by means of a paired-sample t test using SPSS 17.0 software package. Results: The RS, LS, Rratio and Lratio increased significantly after treatment in patients with lower first premolar extraction(P<0.01). The RM3 and LM3 increased(P<0.05) and RS, LS, Rratio and Lratio increased significantly(P<0.01) after treatment in patients with lower second premolar extraction(P<0.05). Conclusion: The mandibular third molars show improvement in eruption space and inclination in the orthodontic patients with lower premolar extraction.

Adult ; Bronchoalveolar Lavage ; methods ; Female ; Humans ; Male ; Middle Aged ; Pneumoconiosis ; therapy ; Respiration, Artificial ; Young Adult

Objective To investigate the impact of hyper-homocystinemia (Hcy)on cardiac remolding in spontaneously hypertensive rat(SHR)and the protective effects of folic and vitamin B12 on the remolding.Methods The seven-week-old SHR were divided into four groups according to different diet for 20 weeks.The control group was fed a perfect compound diet without methionine,the methionine group was fed a perfect compound diet added with 2 ％ methionine,the treatment group was fed as that of methionine group,but added with vitamin B12 0.09 mg/(kg.d)and folate 4 mg/(kg.d)in the last 12 weeks,the mixture group was fed as that of methionine group in the first 8 weeks,and as that of control group.At the end of the intervention period,plasma levels of Hcy and matrix metalloprotease(MMP)-9 were measured.The blood pressure was detected by the non-invasive blood pressure sensing device.The cardiac structure and function were detected using echocardiography and invasive hemodynamic method.Picro-sirius red(PSR)staining was used to check the fibrosis in paraffin embedding ventricle section.Results Plasma levels of Hcy and MMP-9 were increased in the methionine group,while there was no significant difference in plasma levels of Hcy and MMP-9 among the treatment group,the mixture diet group and control group.Rats in methionine group had the largest heart weight among four groups,and systolic blood pressure was lower in methionine group than in the control group(P＜0.05).Compared with the other three groups,the methionine group showed that the left ventricular end-diastolic pressure(LVEDP)was increased and-dp/dt maxwas decreased.Meanwhile,LVEDP and-dp/dt m,x had no significant difference between the control group,treatment group and mixture group.The methionine group showed the most severe decrease in the left ventricular fractional shortening(LVFS)and +dp/dt While LVFS and + dp/dt max had no statistical significance between the treatment group and control groups,but the mixture group had lower LVFS and +dp/dt max values as compared with the control group(both P＜0.05).Perivascular fibrosis was increased significantly in methionine group as compared with the other three groups,while the treatment and control groups had similar perivascular fibrosis,but the mixture group had higher perivascular fibrosis than did the control group,and had similar perivascular fibrosis to the treatment group.Fibrosis deposition in myocardium mesenchymal was similar to those observed in perivascular fibrosis,but the treatment group showed a more improvement of collagen deposition as compared with the mixture group.Conclusions Hyper-homocystinemia can accelerate systolic and diastolic dysfunction through accumulating fibrosis in myocardium and perivascular wall which lead to adverse cardiac remolding.Folate and vitamin B12 have protective effects on heart function by reversing the adverse changes through decreasing Hcy level.

OBJECTIVETo investigate the regulation of Cha Gan Beng Ga on the activity of biomarker PGC-1α in vivo and in vitro, and lay the foundation for studying the efficacy result of Cha Gan Beng Ga on xenograft tumor model and extracting active constituents.

METHOD(1) The coarse powder of Cha Gan Beng Ga was extracted with 70% ethanol solution through heating and refluxing, and finally was used to freeze dry powder. (2) 50 mg x kg(-1) of freeze-dried power was orally administrated to KM and C57BL/6J mice once daily, lasting for 5 consecutive days; different concentrations of extracted materials was given to non-small cell lung cells A549. (3) The expression level of PGC-1α mRNA was quantitatively determined in lung tissue of mice and non-small cell lung cells A549.

RESULTThe expression levels of PGC-1α in lung tissue of different mice strains had an increasing tendency. Furthermore, the expression levels of PGC-1α in non-small cell lung cells A549 also had an increasing tendency, showing dose and time-dependent relationships.

CONCLUSIONMongolian Medicine Cha Gan Beng Ga could induce the over-expression of PGC-1α mRNA in lung tissue of mice and in non-small cell lung cells A549. The present results will lay foundation for studying the efficacy result of antitumor and active constitutes in future.

Aconitum ; chemistry ; Animals ; Biomarkers, Tumor ; genetics ; Carcinoma, Non-Small-Cell Lung ; genetics ; pathology ; Cell Line, Tumor ; Dose-Response Relationship, Drug ; Gene Expression Regulation, Neoplastic ; drug effects ; Humans ; Lung ; drug effects ; metabolism ; Lung Neoplasms ; genetics ; pathology ; Male ; Medicine, Mongolian Traditional ; Mice, Inbred C57BL ; Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-alpha ; Plant Extracts ; pharmacology ; Reverse Transcriptase Polymerase Chain Reaction ; Time Factors ; Transcription Factors ; genetics

The protoplasts of Micromonospora purpurea,the high yield strains of gentammicin producer were mutagenized by diethyl sulfate(DES)and ultraviolet radiation(UV)respectively,then fused,screened by gentamicin resistance and regenerated.The average fermentation unit 2200?U/ml could be achieved by shake flask for 10 batches.The average fermentation unit 1900?U/ml could be obtained by 5L fermentor for 7 batches.The quality of the end product conformed to CP2000,BP2000 and USP26 pharmacopoeia.

Objective To analyze the causes for diffuse bone marrow uptake of 18F-FDG on PET/CT scans. Methods Sixty-six patients with diffuse bone marrow uptake on whole-body FDG-PET/CT imaging were enrolled for this study. Seventy-nine healthy subjects ( with no history of tumor or recent fever) were selected as normal control. The SUVmax and SUVmean were measured in bone marrow and mediastinum in both groups. The maximum (bone marrow SUVmax/ mediastinum SUVmax) and mean value ratios (bone marrow SUVmean/ mediastinum SUVmean) were calculated. Statistical analysis was performed by one-factor variance analysis. Results With diffuse bone marrow uptake pattern of 18F-FDG, 27 were caused by injection of hematopoietic growth factor, 21 by hematopathy and 18 due to fever. SUVmeanof those three causes were 3.076±1.955, 3.633±2.405 and 2.546±0.791 respectively, each was significantly different from that of the control group (1.026±0.190; F =34.465, P<0.001). Conclusion Diffuse bone marrow uptake on FDG-PET/CT are caused by both benign and malignant reasons.

ObjectiveTo investigate the effects of different amounts of iodine intake on the cellular and humoral immune in Grave's disease (GD) patients.MethodsThe clinical GD cases were diagnosed by thyroid fine needle Cytology examination.Patients in GD group are divided into GD group Ⅰ and GD group Ⅱ based on the median of urine iodine.The blood levels of FT4,FT3,TSH,TPOAb,TGAb,TRAb and TNF-t were detected.The difference and association of these parameters between these groups were analyzed.ResultsThe TNF-αt level in GD Ⅰ group was higher than that of GD Ⅱ group( P ＞ 0.05 ) ;The average level of TRAb of GD Ⅰgroup ( [ 1.4 ±0.2 ] U/L) were higher than that of GD Ⅱ group ( [ 1.2 ± 0.1 ] U/L) ( P ＜ 0.05 ) ;The positive rates of TGAb and TPOAb of GD Ⅰ group were higher than that of GD Ⅱ group ( P ＜ 0.05 ).The percentages of patients with high level of TGAb and TPOAb in GD Ⅰ group ( 78.9％ 、84.2％ ) were higher than that in GD Ⅱ group (50.0％,62.5％ ) ( x2 =6.79,10.70,P ＜0.05 ) ; Analysis showed a linear positive correlation of TNF-αwith TRAb and TPOAb ( r is 0.489 and 0.563,P ＜ 0.01 ).ConclusionIodine is an important factor to the development of Graves disease.Excessive iodine intake will exaggerate the GD condition and patients with GD should be controlled for iodine intake.

Objective To study the relationship between cellular immunity in vivo,humoral immunity and different iodine intakes in patients with hashimoto thyroiditis(HT).Methods Seventy-six HT patients were divided into two groups acconding to the median of urine iodine (MUI =491.20 μ g/L):HT I group (urine iodine≥MUI) with 37 cases and HT Ⅱ group (urine iodine ＜ MUI) with 39 cases.And 49healthy persons were selected as control group.The level of free three triiodothyronine (FT3),free thyroxine (FT4),thyroid stimulating hormone (TSH),thyroglobulin antibody (TGAb),thyroid peroxidase antibody (TPOAb),thyroid hormone receptor antibody ( TRAb ),tumor necrosis factor-alpha ( TNF- α )of all groups were detected.Results The levels of FT3 and FT4 in HT I group [ (2.67 ± 1.93 ),( 4.22 ± 3.77) pmol/L ]and HT Ⅱ group [ ( 3.19 ± 1.63 ),( 5.99 ± 3.97 ) pmol/L ] were significantly lower than those in control group [(5.30± 1.10),(16.50 ±2.70) pmol/L] (P ＜ 0.01).The levels of TNF-α in HT I group [(6.14 ± 1.83)ng/L] and HT Ⅱ group [ (6.09 ± 1.50) ng/L] were both obviously higher than that in control group [ ( 1.90 ±0.60) ng/L] (P ＜ 0.01 ).The levels of FT3 and FT4 were lower and TNF α was higher in HT I group than those in HT Ⅱ group,but there was no statistically significance (P ＞ 0.05 ).The positive rate of TPOAb,TGAb in HT I group [97.3％(36/37),81.1％(30/37)] and HT Ⅱ group [89.7％(35/39),74.4％(29/39)]were significantly higher than those in contnol group [ 18.4％(9/49),12.2％(6/49 ) ] (P ＜ 0.01 ).There was no statistically difference of the positive rate of TPOAb,TGAb and TRAb between HT I group and HT Ⅱ group (P ＞ 0.05).While the percentage of patients with high titer of TPOAb and TGAb in HT I group was higher than that in HT [Ⅱ group,and there was statistical difference(P ＜ 0.05 ).The level of TRAb in HT I group was higher than that in HT Ⅱ group [ ( 1.25 ± 0.14) mU/L vs.( 1.16 ± 0.21 ) mU/L ],but there was no significant difference (P ＞ 0.05).Correlated anlysis showed that FT3 was negatively correlated with TGAb and TPOAb (r =0.342,-0.397,P ＜0.05),and TNF-αwas positively correhted with TGAb and TPOAb (r =0.405,0.561,P ＜ 0.05).Conclusions High iodine intake influences the autoimmune mechanism of HT patients.The iodine intake should be limited in HT patients.

Objective To evaluate the protective value of cardioplegia solution plus metformin in different cardiac arrest time and concentration of metformin in isolated rat hearts .Methods There were 36 male Sprague–Dawley rats divided into six groups randomly, according to the duration of cardioplegic arrest(30 min or 60min) and the concentrations of metformin(50μmol/L or 100 μmol/L) .Langendorff-perfused Sprague-Dawley rat hearts were perfused for 20 minutes with Krebs-Henseleit buffer followed by 30 or 60 minutes of crystalloid cardioplegia or plus metformin (50 or 100 μmol/L) and 60 minutes of reperfu-sion.The left ventricular performance was recorded at 5 time points.The expressions of AMPKαand phosphorylation of AMPKαwere detected by western Blot.The changes of myocardial mitochondria were observed under transmission electron mi-croscope.Results There were no significant differences in Con(A), 50(A) and 100(A) groups in LVDP, ±dp/dtmax and HR.Compared with Con(B) group subjected to 60 minutes of ischemia followed by 60 minutes of reperfusion, the 100(B) group significantly improved myocardial performance , and the ratio of p-AMPKα/AMPKαwas the highest in all 6 groups.The structure of myocardial mitochondria in 100(B) group was better protected than that of Con(B) group.Conclusion These findings suggested that the left ventricular performance was protected in rat heart perfused by cardioplegia plus 100 μmol/L after 60 minutes cardioplegic arrest .The mechanism may be the activation of AMPK and the protection of structures of myocardial mitochondria.