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

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

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.

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

OBJECTIVETo explore the pattern of lymph node metastasis (LNM) in advanced Siewert type II adenocarcinoma of the gastroesophageal junction (AGEJ) in order to properly guide lymphadenectomy.

METHODSFrom January 2009 to Jun 2011, a total of 86 patients with advanced Siewert type II AGEJ underwent radical esophagogastrectomy by thoracic-abdominal incision and two-field lymphadenectomy. The clinical characteristics, pathologic features, LNM, and influence factor of thoracic metastasis were retrospectively analyzed.

RESULTSLNM was observed in 65 of the 86 cases (75.6%). Simple abdominal lymph node metastasis was observed in 49 of the 86 cases (57.0%), simple thoracic lymph node metastasis was 2.3%, and thoracic-abdominal metastasis was 16.3%, with a significant difference between the abdominal and thoracic metastatic patterns. LNM frequency was found in the lymph node groups No. 3, No. 1, No. 7, No. 110, No. 2 and No. 9 (from the highest to the lowest). The incidences of those lymph node metastases were 46.5%, 41.9%, 17.4%, 14.0%, 10.5%, and 5.8%, respectively. Vascular tumor embolus was the only independent factor for thoracic lymph node metastasis.

CONCLUSIONSAbdominal lymph node metastases of advanced Siewert type II AGEJ mainly occur around the proximal stomach and the coeliac trunk. The metastatic rate of distal stomach and splenic perihilar lymph nodes is low, but metastatic rate of the group No.110 lymph nodes is high. The thoracic lymph node metastasis is only correlated with vascular tumor embolus.

Abdominal Cavity ; Adenocarcinoma ; pathology ; surgery ; Adult ; Aged ; Aged, 80 and over ; Esophageal Neoplasms ; pathology ; surgery ; Esophagogastric Junction ; Female ; Gastrectomy ; Humans ; Lymph Node Excision ; Lymph Nodes ; pathology ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Neoplastic Cells, Circulating ; Stomach Neoplasms ; pathology ; surgery ; Thorax

Hepatitis, Viral, Human ; drug therapy ; Humans ; Prostaglandins E ; therapeutic use ; Randomized Controlled Trials as Topic ; Research Design

OBJECTIVETo observe the inhibitory effect of gefitineb on the proliferation and its inducing effect on the apoptosis of mouse I-10 Leydig testicular cancer cells in vitro.

METHODSWe treated I-10 Leydig testicular cancer cells of mice with gefitineb at 0, 1.25, 2.5, 5, 10, 20, and 40 µmol/L. Then we determined the inhibitory effect of gefitineb on the growth of the cells by MTT, detected their early and late apoptosis by Annexin V-FITC/propidium iodide double staining and Hoechst 33258 nuclear staining, respectively, and observed the expressions of apoptosis-related proteins Bcl-2, Bax and caspase 3/9 by Western blot.

RESULTSCompared with the blank control group, gefitineb significantly inhibited the proliferation of the I-10 cells at 10 and 20 µmol/L (P < 0.05). The survival rate of the cells was (32.4 ± 2.8)% (P < 0.01) and their early and late apoptosis rates were (26.7 ± 4.2)% and (59.33 ± 10.2)% in the 40 µmol/L group, significantly different from those in the control (P < 0.05 and P <0.01). In comparison with the blank control group, gefitineb at 10, 20, and 40 µmol/L increased the expression of pro-apoptotic protein Bax by (41.9 ± 7.1), (60.1 ± 9.8), and (69.0 ± 11.3)% (all P < 0.05), decreased that of apoptosis-inhibitory protein Bcl-2 by (50.3 ± 8.9), (63.9 ± 6.9), and (88.7 ± 13.9)% (all P < 0.05), and elevated that of the cleft proteins caspase-3 by (69.0 ± 6.9)% (P < 0.05), (71.5 ± 8.1)% (P < 0.05), and (110.9 ± 14.2)% (P < 0.01) and caspase-9 by (51.8 ± 4.9), (54.7 ± 6.7), and (43.8 ± 11.8)% (all P < 0.05).

CONCLUSIONGefitineb can increase the cytotoxicity of I-10 Leydig testicular cancer cells of mice and induce their apoptosis via the mitochondria-mediated apoptosis signaling pathway.

Animals ; Antineoplastic Agents ; pharmacology ; Apoptosis ; drug effects ; Apoptosis Regulatory Proteins ; metabolism ; Caspase 3 ; metabolism ; Caspase 9 ; metabolism ; Cell Proliferation ; drug effects ; Cell Survival ; Leydig Cell Tumor ; drug therapy ; metabolism ; pathology ; Male ; Mice ; Neoplasm Proteins ; metabolism ; Neoplasms, Germ Cell and Embryonal ; drug therapy ; metabolism ; pathology ; Quinazolines ; pharmacology ; Testicular Neoplasms ; drug therapy ; metabolism ; pathology ; bcl-2-Associated X Protein ; metabolism

Brown-Sequard Syndrome ; etiology ; Cervical Vertebrae ; Humans ; Intervertebral Disc Displacement ; complications ; surgery ; Male ; Middle Aged

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.