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

Child, Preschool ; Hemophilia A ; classification ; diagnosis ; therapy ; Hemorrhage ; diagnosis ; therapy ; Humans ; Infant

Objective To explore the effect of sodium cantharidinate and vitamin B6 injection on plasma D-dimer level in patients of advanced esophageal cancer after chemotherapy and the relationship between plasma D-dimer level and clinical pathological parameters thereof. Methods Fifty-eight patients with advanced esophageal cancer confirmed by path-ological examination were randomly divided into two groups. Twenty-nine patients (experimental group) received chemother-apy (PF chemotherapy) combined with sodium cantharidinate and vitamin B6 (0.5 mg once daily). Twenty-nine patients (con-trol group) received same volume of saline. And there were 20 healthy volunteers as the normal control. The plasma D-dimer level was determined one day before the first cycle of chemotherapy and the third cycle of treatment. Results The plasma D-dimer level was significantly higher before chemotherapy in patients with advanced esophageal cancer than that in normal control group (P<0.05). There were no significant differences in plasma D-dimer level between patient gender, age, clinical stage and pathological levels. The D-dimer level was significantly down-regulated after chemotherapy. The D-dimer level was significantly lower in experimental group than that in control group (P<0.05). The incidences of digestive and hemato-logical adverse reactions were much lower in experimental group than those in control group. Conclusion The elevated plasma D-dimer level was found in patients with advanced esophageal cancer, and which was down-regulated by chemother-apy. The chemotherapy of sodium cantharidinate and vitamin B6 can further reduce the D-dimer level, and relieve the ad-verse reactions of chemotherapy.

Objective To investigate the change pattern of perioperative plasma D-dimer levels in patients with lung cancer, and the relationship between plasma D-dimer level and clinical pathological features thereof. Methods A to-tal of 64 patients with lung cancer were taken as cancer group, and 15 cases of benign lung disease were used as control group. The plasma levels of D-dimer were determined 2 days before operation, 1 day, 5 days and 9 days after operation in two groups. The clinical pathological parameters and type of surgery were evaluated at the same time. Results Plasma D-dimer levels were significantly higher in patients with lung cancer than those in control group (t=3.087, P<0.05). D-dimer levels were significantly lower in patients of TNM stageⅠthan those in patients of stageⅡorⅢ(P<0.05, respectively). Plas-ma D-dimer levels were significantly higher in patients with small cell cancer than those of patients with non-small cell can-cer (P<0.05). The perioperative plasma levels of D-dimer changed with time trends (P<0.001). In cancer group, D-dimer levels increased on the first day after operation, and then significantly decreased on the fifth and ninth day after operation (P<0.05). In control group, D-dimer levels increased on the first day after operation. The level of D-dimer was the same lev-el on the fifth day and the first day after operation (P=0.174). The level of 9 days after operation decreased to the level before operation (P=0.631). There was significant difference in overall data between cancer group and control group (P=0.005). D-dimer levels were significantly higher in cancer group than those of control group except for the fifth day after operation. Con-clusion Plasma D-dimer levels were much higher before operation in patients with lung cancer than those of controls. Plas-ma D-dimer levels were associated with TNM stage and cell type. D-dimer levels were significantly increased from the first day after operation, and then decreased significantly until the 9-day after operation, which were lower than that before opera-tionin lung cancer patients. But the level was still higher than that in patients with benign lung diseases.

Objective:To study the effect of ischemic postconditioning(I-postC)on the lung injury following ischemia-reperfusion(I/R)of skeletal muscle in the hind limbs of rats.Methods:The rat model of hind limbs I/R injury was established by subrenal abdominal aorta cross-clamping for 4 hours.Forty-eight rats were divided into 3 groups:I/R group,IPC and I-postC group.Each group received 4 hours of ischemia and then 12 or 24 hours of reperfusion respectively.The tissue morphology,wet-to-dry weight(W/D)ratio,malondialdehyde(MDA)and myeloperoxidase(MPO) of lung tissue were compared.The expression of ICAM-1 mRNA in lung was also studied by RT-PCR or in situ hybridization.The protein product was detected by Western blot.Results:In IPC and I-postC groups,all parameters decreased significantly compared with I/R ischemia group(P

Air Pollutants ; toxicity ; Air Pollution, Indoor ; adverse effects ; Animals ; DNA Damage ; drug effects ; Female ; Interior Design and Furnishings ; Male ; Mice ; Mutagenicity Tests

Polymyxin E shows effective treatment of the infection induced by resistant gramnegative bacteria, but its nephrotoxicity severely limits the clinical application of this drug. In this work, methoxypolyethylene glycols 2000 (mPEG2K)-polymyxin E (PME) was synthesized via chemical grafting reaction and had been characterized. The antimicrobial activity and cytotoxicity of mPEG2K-PME in vitro were investigated on Escherichia coli and HK-2 cells, separately. Intra-abdominal infection model was further established in order to study the therapeutic effect and the toxic effect on kidney of mice. The results showed that mPEG2K-PME exhibited significant inhibitory effect on Escherichia coli and had a lower toxicity on HK-2 cells in vitro. At the same time, mPEG2K-PME had a good efficacy in the treatment of Escherichia coli infected mice in vivo. Moreover, nephrotoxicity caused by mPEG2K-PME was significantly reduced compared to free PME. mPEG2K-PME is promising in development of new preparations with high efficiency and low toxicity.
Animals ; Cell Line ; Colistin ; pharmacology ; toxicity ; Escherichia coli ; drug effects ; Escherichia coli Infections ; drug therapy ; Humans ; Kidney ; cytology ; drug effects ; Mice ; Polyethylene Glycols ; chemistry

OBJECTIVETo study the effect of Jinlida on changes in expression of skeletal muscle lipid transport enzymes in fat-induced insulin resistance ApoE -/- mice.

METHODEight male C57BL/6J mice were selected in the normal group (NF), 40 male ApoE -/- mice were fed for 16 weeks, divided into the model group (HF), the rosiglitazone group ( LGLT), the Jinlida low-dose group (JLDL), the Jinlida medium-dose group (JLDM), the Jinlida high-dose group (JLDH) and then orally given drugs for 8 weeks. The organization free fatty acids, BCA protein concentration determination methods were used to determine the skeletal muscle FFA content. The Real-time fluorescent quantitative reverse transcription PCR ( RT-PCR) and Western blot method were adopted to determine mRNA and protein expressions of mice fatty acids transposition enzyme (FAT/CD36), carnitine palm acyltransferase 1 (CPT1), peroxide proliferators-activated receptor α( PPAR α).

RESULTJinlida could decrease fasting blood glucose (FBG), cholesterol (TC), triglyceride (TG), free fatty acid (FFA) and fasting insulin (FIns) and raise insulin sensitive index (ISI) in mice to varying degrees. It could also up-regulate mRNA and protein expressions of CPT1 and PPARα, and down-regulate mRNA and protein levels of FAT/CD36.

CONCLUSIONJinlida can improve fat-induced insulin resistance ApoE -/- in mice by adjusting the changes in expression of skeletal muscle lipid transport enzymes.

Animals ; Apolipoproteins E ; deficiency ; genetics ; Blood Glucose ; metabolism ; CD36 Antigens ; genetics ; metabolism ; Carnitine O-Palmitoyltransferase ; genetics ; metabolism ; Dietary Fats ; adverse effects ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; Humans ; Hypoglycemic Agents ; administration & dosage ; Insulin ; metabolism ; Insulin Resistance ; Lipid Metabolism ; drug effects ; Male ; Metabolic Diseases ; drug therapy ; enzymology ; genetics ; metabolism ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Muscle, Skeletal ; drug effects ; metabolism

The stability of microbial flocculant (MBF) produced by Aspergillus sojae and its application to municipal thickened sludge dewatering were studied. The results showed that the MBF had high heat and acid-base endurance with high flocculating activity in a wide range of pH from 1.5 to 12. The MBF retained 96% of flocculating activity after 35 days preservation at 4℃, but in different pH the flocculating activity difference was very apparent after 35 days store at room temperature. The experimental results also demon- strated that the MBF was better than PAM and PAC in reducing specific resistance filtration. The optimal dose of MBF used for intensifying thickened sludge dewatering is 7%(volume fraction). And the more the volume of sludge is treated, the less the cost of MBF for unit volume sludge treatment.

Objective To investigate the association between single nucleotide polymorphism (SNPs) (rs1053005 and rs744166) and expression level of STAT3 gene and the susceptibility to acute lymphoblastic leukemia (ALL) in Chinese children.Methods A case-control study was performed,and 184 children with ALL and 377 healthy children as controls were recruited.The genotypes of 2 SNPs were detected by using polymerase chain reaction-restriction fragment length polymorphism method.And the expression level of STAT3 gene was detected by using real-time PCR;All the data were analyzed by using SPSS 16.0 software.Results (1) In this study,the genotypes (GG,AG,AA) of rs1053005 had a significant difference between the ALL group and control group (x2 =6.737,P =0.034).Compared with control group,the A allele had a higher frequency in ALL group and A allele was a risk factor(x2 =5.853,P =0.016).But,there was no difference in frequency of genotype rs744166 between the 2 groups (x2 =1.866,P =0.393).(2) There was no significant association between genotypes and risk degree among 3 groups (high risk group,medial risk group and standard risk group) (x2 =0.335,P =0.987).(3) The expression level of STAT3 gene in patients with AA genotype was lower than that of the patients with GG genotype (t =4.758,P =0.009);and compared with patients of the standard risk group,high risk patients had a lower expression level of STAT3 gene (t =5.284,P =0.007).Conclusions The polymorphism of SNP rs1053005 was associated with ALL,with A allele being a risk factor;and the expression level of STAT3 gene maybe associated with the risk degree in ALL patients.