With the in-depth study of related substances and the development of consistency evaluation of generic drugs, relative correction factors are gaining increasing attention. By analyzing the domestic and foreign literature on correction factors in recent years, this paper describes the correction factor component, the current measurement method and its application. The rules and key points of use of an impurity correction factor and its determination and application are described, and some problems in its determination and application are discussed, providing a reference and basis for the standardization of research on impurity correction factors in the future.

The change of kirenol, darutigenol and darutoside in Siegesbeckia and its first to ninth processed products were studied, and the ten fingerprints were compared, which provided the experimental basis for the study of Siegesbeckia processing tech- nology. The samples were analysed by HPLC on a SunFire-C18 column (4.6 mm x 150 mm, 5 μm) with gradient elution of acetonitrile (0.1% formic acid)-water (0.1% formic acid) at a flow rate of 1.0 mL x min(-1). Column temperaturewas 30 °C and the detected wavelength was 215, 320 nm. The calibration curves of kirenol, darutigenol and darutoside were linear in the range of 2.180-26.16, 2.900-34.80, and 1.012-6.072 mg x L(-1), respectively, and the average recoveries were 96.4%, 97.2% and 96.3% wit RSD 2.2%, 1.7% and 2.4%. This method was simple, the result was stable and had good repeatability, recovery and precision. The re- sult was the basis of the chemical contents variation in the processing of Siegesbeckia Herbs and further clarifying the effect of the changing.
Asteraceae ; chemistry ; Chemistry, Pharmaceutical ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; chemistry ; Temperature

Objective To study the ratio of anti-drug antibody(ADA) produced by tumor necrosis factor alpha (TNF-α) monoclonal antibody in Chinese healthy adult volunteers,and to analyze its influencing factors.Methods This is a parallel,randomized,double-blind,controlled study.Three sets of test totally included 164 cases of Chinese healthy adult volunteers.Trial one:56 cases of Chinese healthy adult volunteers were randomized into six groups,given 10,20,35,50,65,75 mg of L00653 test drugs in abdominal subcutaneous injection way.Trial two:64 cases of Chinese healthy adult volunteers were divided into six groups,given 5,15,30,50,75,100 mg of the test drug L02151 by abdominal subcutaneous injection.Trial three:48 cases of Chinese healthy adult volunteers were randomized into four groups,The volunteers in each group were given L00)048 and primary research drugs by intravenous infusion according to 1∶1 proportion as controlled trials.The levels of ADA were measured by ligand binding assay (LBA).Results A total of 164 healthy volunteers were performed in the study.Trail one:The positive rates of A,B,C,D,E,F groups were 17.00％,20.00％,40.00％,30.00％,0,30.00％,respectively.There was no significant difference between ADA positive rate and administration dose (P ＞ 0.05);Trail two:The positive rates of 5,15,30,50,75 and 100 mg groups were 100.00％,1000.00％,100.00％,100.00％,100.00％,70.00％,respectively.There was no significant difference in ADA positive rate between the groups and the dose of Administration (P ＞ 0.05);Trail three:Only two cases of ADA appeared.Conclusion The ADA produced in the body by TNF-o monoclonal antibody drug was associated with its source and structure,but without close relationship with drug doses.The research could be used to TNF-o monoclonal antibody drug research,providing experimental basis for clinical safe use.

BACKGROUNDIntertrochanteric femur fracture is common in elderly population. Though multiple treatment options are available, the choice of implant remains controversial. The reverse less invasive stabilization system (LISS) plating was introduced for treatment of a patient with ipsilateral intertrochanteric and midshaft femoral fractures. The aim of this research was to compare such technique to intramedullary nailing (proximal femoral nail, PFN) for intertrochanteric fractures.

METHODSFifty-six patients with an age of at least sixty-five years and an AO/OTA type-A1 or A2 fractures were included and divided into LISS and PFN treatment group.

BACKGROUNDparameters, fracture and surgery details were documented. Follow-up time was at least 12 months. Radiology, complication, Harris Hip Score and Rapid Disability Rating Score (RDRS) were recorded to evaluate fixation status and hip function for each patient during follow-up.

RESULTSThere was no significant difference between the two groups in surgical time ((48.0 ± 8.6) minutes, vs. (51.8 ± 10.8) minutes, P = 0.3836) and intraoperative blood loss ((149.1 ± 45.1) ml vs. (176.4 ± 25.4) ml, P = 0.0712). The LISS group had less postoperative haemoglobin (Hb) reduction ((10.2 ± 4.5) g/L Hb, vs. (15.1 ± 5.9) g/L Hb, P = 0.0475). There was no complication observed in PFN group. All 31A1 type fracture in LISS group showed 100% maintenance of reduction. One nonunion with locking screw breakage and 2 varus union were found in the LISS group. Postoperative hip function was similar between the two groups.

CONCLUSIONSThough reverse LISS plating may not be recommended as a routine fixation method for elderly unstable intertrochanteric fractures compared to PFN, it may possibly be reserved for rapid fixation and damage control in polytrauma patients and ORIF of subtrochanteric and reverse oblique intertrochanteric fractures.

Aged ; Aged, 80 and over ; Female ; Femoral Fractures ; surgery ; Femur ; surgery ; Fracture Fixation, Intramedullary ; methods ; Hip Fractures ; surgery ; Humans ; Male ; Prospective Studies ; Treatment Outcome

A fetal/maternal multi-parameter monitor is introduced here in the paper. It can monitor the vital signs of a fetus and his/her mother in a same screen synchronously. It is more useful in obstetric clinics. Its other functions include management of patient file, computer-assistant analyses.
Adult ; Automatic Data Processing ; instrumentation ; Electrocardiography, Ambulatory ; instrumentation ; Equipment Design ; Female ; Fetal Monitoring ; instrumentation ; Heart Rate, Fetal ; Humans ; Microcomputers ; Monitoring, Ambulatory ; instrumentation ; Pregnancy ; Signal Processing, Computer-Assisted ; Software

OBJECTIVETo investigate the influence of pyrrolidine dithiocarbamate (PDTC) on the expression of transforming growth factor beta(1) (TGF-beta(1)), matrix metalloproteinase-2 (MMP-2) and tissue inhibitor-1 of metalloproteinase (TIMP-1) in rats with pulmonary damage induced by paraquat (PQ).

METHODSFifty-four healthy male SD rats were randomly assigned into the control group (normal saline), the PQ-treatment groups (4 groups) and the PDTC treatment groups (4 groups). Except the rats in the control group, the rats in the PQ group were gavaged only with 40 mg/kg PQ, and PDTC group with 40 mg/kg PQ plus immediate injection 120 mg/kg PDTC (i.p). On the 3rd, the 7th, the 14th and 28th day after treatments, one group rats of each treatments were sacrificed and lung and blood samples were collected. The level of TGF-beta(1) protein in the plasma, the mRNA expression of TGF-beta(1), MMP-2 and TIMP-1 were evaluated using RT-PCR and real-time quantitative PCR, while pathological changes of lung were examined under optical microscope and electrical microscope.

RESULTSThe TGF-beta(1) protein, TGF-beta(1) and MMP-2 mRNA expression were increased significantly in the earlier stage and then decreased after PQ administration (P < 0.05 or P < 0.01), while the mRNA level of TIMP-1 was augmented continuously (P < 0.01) throughout the study compared to the control group. In comparison with the PQ group, in the PDTC treatment group, the TGF-beta(1) mRNA expression on the 3rd and the 14th day, 0.54 +/- 0.08 and 0.72 +/- 0.04 respectively, the MMP-2 mRNA expression on the 7th and 14th day, 1.62 +/- 0.50 and 1.97 +/- 0.34 respective-ly, and the TIMP-1 mRNA on the 7th and 21st day, 1.79 +/- 0.21 and 2.00 +/- 0.34 respectively, were significantly decreased (P < 0.05 or P < 0.01).

CONCLUSIONPDTC could attenuate paraquat-induced up-regulation of TGF-beta(1) and its mRNA expression, MMP-2 and TIMP-1 mRNA levels, which indicates that PDTC may exert its protective effects on paraquat-induced pulmonary damage by alleviating the earlier inflammation damage and adjust-ing the balance between MMPs and TIMPs. However, further studies are still warranted to investigate and clarify the underlying mechanisms involved in this complicated process.

Acute Lung Injury ; chemically induced ; metabolism ; pathology ; Animals ; Disease Models, Animal ; Lung ; metabolism ; pathology ; Male ; Matrix Metalloproteinase 2 ; genetics ; metabolism ; Paraquat ; poisoning ; Pyrrolidines ; pharmacology ; RNA, Messenger ; genetics ; Rats ; Rats, Sprague-Dawley ; Thiocarbamates ; pharmacology ; Tissue Inhibitor of Metalloproteinase-1 ; genetics ; metabolism ; Transforming Growth Factor beta1 ; genetics ; metabolism

Since late 2010, porcine epidemic diarrhea virus (PEDV) has been re-emerging in central China. To explore the possible reason of the PEDV outbreaks, twelve PEDV field strains were isolated from different swine breeding farms in central China during 2010-2012, and molecular diversity, phylogenetic relationships of these strains with other PEDV reference strains were investigated. Sequence analysis of S, M and ORE3 genes revealed that the central China PEDV isolates had several specific nucleotides and amino acids which were different from PEDV reference strains. In addition, the entire S genes of eleven central China PEDV isolates were found to be nine nucleotides longer in length than CV777 and large number of amino acid variations was accumulated in the N-terminal region of S gene. Phylogenetic analysis showed that the central China PEDV isolates had close relationship with Korea strains (2007-2009), Thailand strains (2007-2008), Vietnam strains (2009-2010), Japan strains (2010), and other prevailing strains from other parts of China (2010-2012). However, they differed genetically from European strains (CV777, Brl/87), China strains (2003-2007) and the vaccine strains (CV777) used in China. These results imply that a rapid variation and evolution of central China PEDV strains has occurred in recent years, and a more efficient vaccine strain should be selected to prevent and control outbreaks of PEDV in China.
Animals ; China ; epidemiology ; Disease Outbreaks ; Feces ; virology ; Molecular Sequence Data ; Open Reading Frames ; Phylogeny ; Porcine epidemic diarrhea virus ; classification ; genetics ; isolation & purification ; Swine ; Swine Diseases ; epidemiology ; virology ; Viral Proteins ; genetics

OBJECTIVETo investigate the risk of Alzheimer's disease (AD) associated with life style, early exposure to magnetic fields, family history of dementia and other risk factors.

METHODSWe conducted a case-control study among the inpatients of Chinese PLA General Hospital in 2000 - 2003. Sixty-two AD cases and 124 controls were selected and matched for age. Univariate and multivariate analyses were conducted using logistic regression model.

RESULTSAll subjects were males aged 66 to 102. In univariate analysis, lack of social activities, more physical exercises, early exposure to magnetic fields, suffering from negative life events and family history of dementia were statistically different between two groups (P < 0.05). Multivariate analysis showed that after adjusting for potential confounders, suffering from negative life events, family histories of dementia increased the risk of AD with odds ratio (OR) and 95% confidence interval (CI) 3.27 (1.53 - 6.97) and 5.78 (1.39 - 24.10). Early exposure to magnetic fields seemed a possible risk factor for AD, with OR (95% CI) 2.49 (0.96 - 6.45). The amount of social activities, cigarette smoking and history of cancers were negatively correlated with AD and their ORs (95% CI) were 0.81 (0.72 - 0.92), 0.46 (0.21 - 1.00) and 0.31 (0.12 - 0.82) respectively.

CONCLUSIONThe study demonstrated that suffering from negative life events and family history of dementia were risk factors for AD, and the early exposure to magnetic fields might also play a role.

Aged ; Aged, 80 and over ; Alzheimer Disease ; epidemiology ; etiology ; Case-Control Studies ; China ; epidemiology ; Electromagnetic Fields ; adverse effects ; Humans ; Logistic Models ; Male ; Middle Aged ; Military Personnel ; Occupational Exposure ; Risk Factors ; Smoking ; adverse effects

OBJECTIVETo observe the biocompatibility of new biomaterials porous calcium phosphate (CPC) and ectopic bone formation of CPC with bone marrow stromal cells (BMSCs).

METHODSThe BMSCs were cultured from Beagle dog and combined with the porous CPC with the best concentration after transfect green fluorescent protein (GFP). The adhesion and growth of BMSCs on CPC were observed under inversion, fluorescence and scanning electron microscopy. The ectopic bone formation were observed at the 8th week after CPC and BMSCs were implanted subcutaneously into nude mice.

RESULTSWhen BMSCs with CPC were cultured at the 1st day, cells were climbing out from CPC with normal morphology. At the 7th day cells can be seen protruding pseudopods, secretion of matrix. Bone formation could be seen histomorphologically at the 8th week.

CONCLUSIONPorous CPC has good biocompatibility and is an ideal scaffold material for bone tissue engineering.

Animals ; Biocompatible Materials ; Bone Cements ; Bone and Bones ; Calcium Phosphates ; Dental Cementum ; Dogs ; Mesenchymal Stromal Cells ; Mice ; Mice, Nude ; Tissue Engineering

This study was aimed to investigate the effects of peripheral blood Th17 cells, IL-17 and IL-21 in the occurrence and development of acute leukemia. 60 patients with acute leukemia (19 patients with ALL, 41 patients with AML) were divided into non-remission group (group A, n=24), remission group (group B, n=36); 25 healthy volunteers were used as control group (group C). In addition to this, these 60 patients were divided into infection group (n=32) and non-infection group (n=28) on the basis of infection status. The concentration of IL-17 and IL-21 in the peripheral blood mononuclear cell culture supernatant after stimulation with anti-CD3 and anti-CD28 mAb were determined with ELISA. The expression of CD4+ IL-17+ cells was determined by flow cytometry. The results showed that (1) the concentrations of IL-17 and IL-21, and proportion of Th17 cells in group A and group B were much lower than those in group C (p<0.05); (2) the expression levels of IL-17 and IL-21, and the proportion of Th17 cells in group A were lower than those in group B (p<0.05); (3) the expression levels of Th17 and IL-17 in infection group were lower than those in non-infection group (p<0.05). It is concluded that Th17 cells may play important roles in the occurrence and development of acute leukemia through secreting IL-17 and IL-21, and their functional level can partially reflect the status of leukemia and can be used to evaluate the risks of infection in patients with leukemia.
Adolescent ; Adult ; CD4-Positive T-Lymphocytes ; Case-Control Studies ; Female ; Humans ; Interleukin-17 ; metabolism ; Interleukins ; metabolism ; Leukemia, Myeloid, Acute ; metabolism ; Male ; Middle Aged ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; metabolism ; Th17 Cells ; secretion ; Young Adult