Chromosomes, Human, Pair 22 ; Chromosomes, Human, Pair 8 ; Humans ; Male ; Middle Aged ; Multiple Myeloma ; genetics ; Translocation, Genetic

Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems.Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010),and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results.Results All 42 batches of samples were qualified.The production process of each enterprise was steady.Conclusion At present the quality of recombinant human interferon αlb injection is generally good.The current standards are feasible,but the specified standard of osmolality needs to be improved.

Chinese medicine pairs (CMP) are specific compatibility with traditional Chinese medicine (TCM) theory as principle, which was formed on basis of effect and treatment theory of TCM. The compatibility of CMP can enhance the effect, or reduce the toxicity. So, compatibility effects of CMP were studied from different pharmacology levels including animals, tissues and organs, cell and molecular levels, their synergy and compatibility attenuation were also evaluated with monomer component-component (group) compatibility-single herb-CMP-formulae as the main line, and the action mechanisms were investigated, all of which can provide scientific basis for the clinical applications of CMP and creation of TCM new drugs.
Animals ; Drug Interactions ; Drug Synergism ; Drug-Related Side Effects and Adverse Reactions ; prevention & control ; Humans ; Medicine, Chinese Traditional ; adverse effects ; methods

Objective To determine the expression of membrane-bound B lymphocyte stimulator (BLyS) protein and its mRNA in vitro of peripheral blood mononuclear cells (PBMCs) from individuals with systemic lupus erythematosus (SLE),and to investigate the role of interferon-?(IFN-?) on the expression of BLyS.Methods PBMCs were obtained from 25 SLE patients (mean age of 31+14) and 20 healthy volunteers (mean age of 28?10).They were randomized into IFN-?(5 ng/ml) group and control group.PBMCs were col- lected at 0,6,12 and 24 h for BLyS mRNA assessment using semi-quantitative reverse transcription-PCR (RT-PCR).PBMCs were also collected at 72 h for membrane-bound BLyS protein detection using flow cy- tometry (FACS) and direct immunofluorescence.Results①The expression of BLyS mRNA and membrane- bound protein in PBMCs was significantly higher in individuals with SLE compared with healthy controls (P＜0.05);②IFN-?enhanced BLyS mRNA expression in PBMCs in both healthy controls and SLE patients,with the greatest effect at 6 h (stimulated vs unstimulated,0.42?0.19 vs 0.25?0.14,P＜0.01;0.59?0.28 vs 0.44?0.21,P＜0.01 );③IFN-?also increased the expression of membrane-bound BLyS protein in both healthy con- trols and individuals with SLE (FACs,mean fluorescence intensity,4.5+3.0 vs 3.7~2.6,P

The FTIR method was used to investigate the correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test. The similarity of bacteria in the contaminated drug and environmental microbes was compared by critical hit value method and cluster analysis method. This constructed the FTIR spectra library of clean room environmental microbe, and determined the criterion to promptly judge if the bacteria isolated from pharmaceuticals were contaminated by environment or not, hence the exactness of "one-off report" of sterile test result can be guaranteed, and can be used for the dynamic monitoring of environmental bacteria of clean room. The method is proven to be simple, accurate and rapid, and can be easily spread to the pharmaceutical microbial control.
Bacteria ; isolation & purification ; Cluster Analysis ; Drug Contamination ; Drug and Narcotic Control ; Environment, Controlled ; Environmental Microbiology ; Spectroscopy, Fourier Transform Infrared ; methods

OBJECTIVETo investigate the significance of serum cholesterol and fibrinogen (Fib) in evaluating the risk of glomerulosclerosis in children with nephrotic syndrome.

METHODSSixty-three children with primary nephrotic syndrome were divided into two groups according to their pathological types: minimal change glomerulopathy (MCG) (n=39) and focal segmental glomerulosclerosis (FSGS) groups (n=24). Serum levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C and Fib and 24-hour urinary protein excretion were retrospectively analyzed.

RESULTSSerum levels of TC, non-HDL-C, and LDL-C were significantly higher in the FSGS group than in the MCG group (P<0.05), but there were no significant differences in HDL-C, Fib and 24-hour urinary protein excretion between the two groups (P>0.05). According to the results of logistic regression analysis, high levels of LDL-C, non-HDL-C and TC were risk factors for FSGS (P<0.05). In patients whose proteinuria did not disappear after taking enough glucocorticoid for 4 weeks, the level of non-HDL-C was significantly higher in the FSGS group than in the MCG group (P<0.05); there were no significant differences in TC, LDL-C, HDL-C, and Fib between the MCG and FSGS groups (P>0.05).

CONCLUSIONSSerum cholesterol, especially non-LDL-C, is of great significance in evaluating the risk of glomerulosclerosis in children with nephrotic syndrome. There is no sufficient evidence to support serum Fib as a marker for predicting glomerulosclerosis in these children.

Child ; Child, Preschool ; Cholesterol ; blood ; Female ; Fibrinogen ; analysis ; Glomerulosclerosis, Focal Segmental ; etiology ; Humans ; Logistic Models ; Male ; Nephrosis, Lipoid ; etiology ; Nephrotic Syndrome ; blood ; complications ; Retrospective Studies ; Risk

OBJECTIVETo study the difference in clinico-pathological features between IgA nephropathy (IgAN) and Henoch-Schonlein purpura nephritis (HSPN) in children.

METHODSThe medical data of 103 children with HSPN and 61 children with IgAN were retrospectively studied.

RESULTSThere were no significant differences in age, sex and disease course between the HSPN and IgAN groups (P>0.05). Clinical classification demonstrated that more severe conditions were found in the IgAN group than in the HSPN group and gross hematuria was more common in the IgAN group (P<0.05). Serum creatinine and cholesterol levels were higher in the IgAN group than in the HSPN group (P<0.05). Fibrinogen-related antigen deposition was more common in the HSPN group, while complement 3(C3) deposition was more common in the IgAN group. Interstitial fibrosis, tubular casts and tubular inflammatory infiltration were also more common in the IgAN group (P<0.05).

CONCLUSIONSSignificant clinico-pathological differences can be found between HSPN and IgAN in children, and these differences do not support a one disease entity hypothesis.

Child ; Child, Preschool ; Female ; Glomerulonephritis, IGA ; immunology ; pathology ; Humans ; Kidney ; pathology ; Male ; Nephritis ; immunology ; pathology ; Purpura, Schoenlein-Henoch ; immunology ; pathology ; Retrospective Studies

Asthma ; complications ; therapy ; Humans ; Invasive Pulmonary Aspergillosis ; complications ; drug therapy ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; complications ; therapy

OBJECTIVETo establish a method for inducing apoptosis of rhesus peripheral blood lymphocytes (PBLs).

METHODSRhesus PBLs were irradiated with X-ray, (60)Co gamma-rays and ultraviolet (UVC254 nm), respectively, and the cell apoptosis was evaluated with flow cytometry using annexin-V staining and propidium iodide staining.

RESULTSX-ray and (60)Co gamma-ray irradiation induced only low apoptotic rates of the PBLs, and UVC resulted in the highest apoptotic rate of about 60%. UVC irradiation of the PBLs in RPMI supplemented with 10% heat-inactivated fetal calf serum for 60 min at a distance of 20 cm led to an early apoptotic rate of 58.85% and necrotic rate of 11.5%. The apoptotic rate of PBLs increased in a dose- and time-dependent fashion.

CONCLUSIONFor inducing apoptosis of the rhesus PBLs, UVC can be more effective than X-ray and (60)Co gamma-ray. The highest apoptotic rate can be achieved when the rhesus PBLs in RPMI supplemented with 10% heat-inactivated fetal calf serum are exposed to UVC for 60 min at the distance of 20 cm.

Animals ; Apoptosis ; radiation effects ; Cells, Cultured ; Dose-Response Relationship, Radiation ; Flow Cytometry ; Gamma Rays ; Leukocytes, Mononuclear ; cytology ; radiation effects ; Lymphocytes ; cytology ; radiation effects ; Macaca mulatta ; Male ; Time Factors ; Ultraviolet Rays ; X-Rays

OBJECTIVETo evaluate the effectiveness of intravenous immunoglobulin IVIG, 1 g/kg single intravenous injection in treating and preventing cardiac consequences of Kawasaki disease (KD) in children.

METHODSA total of 242 children with KD disease were enrolled in the study. In the randomized controlled trial, they were randomly divided into two groups: IVIG 1 g/kg group and IVIG 2 g/kg group, with aspirin administered within the first 7 to 10 days of illness. The occurrence and restoration of coronary artery lesion (CAL) in these two groups as well as the clinical and laboratory indexes including total fever duration, restoration of cervical lymphadenopathy, white blood cells count, platelet count, serum immunoglobulin, C reactive protein, erythrocyte sedimentation rate and EKG were observed. The clinical effectiveness of the groups before and after the treatment was analyzed.

RESULTSThe age of the 242 children with KD disease ranged from 3 months to 14 years (mean 4.0 +/- 2.8 years old). Male to female ratio was 1.66:1, 83.1% of KD patients were blow 5 years old, 93.4% patients were followed up with echocardiography at the end of the first year and the follow-up period was (38 +/- 18) months, ranging from 4 months to 5.4 years; 86.9% of the cases in 1 g/kg group and 91.7% of the cases in 2 g/kg group had their fever controlled within 48 hours. The difference was not significant (P > 0.05). Serum immunoglobulin level was markedly enhanced after IVIG. Serum immunoglobulin levels in the patients of 2 g/kg group and 1 g/kg group were (26.9 +/- 7.4) g/L and (18.3 +/- 6.9) g/L, respectively (P < 0.01). The average duration of fever in IVIG 1 g/kg group was 10.6 days. After the treatment with 1 g/kg of IVIG, the abnormal white blood cells count, platelet count, C reactive protein, erythrocyte sedimentation rate and abnormal EKG findings were greatly improved (P < 0.001). However, there was no significant difference in the above-mentioned improvement between IVIG 1 g/kg group and IVIG 2 g/kg group (P > 0.05). In IVIG 1 g/kg group the occurrence of CAL was 29.5%. After the one-year follow-up, 87.5% CAL restored, but 12.5% did not, among which 9.4% were those of IVIG non-responders. In IVIG 2 g/kg group the incidence of CAL was 24.2%. After the one-year follow-up, 89.3% CAL restored, but 10.7% did not, all of which were those of IVIG non-responders. There was no significant difference in the incidence of CAL between the two groups (P > 0.05).

CONCLUSIONSingle intravenous injection of IVIG at 1 g/kg could effectively alleviate the clinical symptoms, decrease the incidence of CAL and reduce the complication of cardiovascular system. In the treatment of KD, the therapeutic effectiveness of IVIG at 1 g/kg was not significantly different from that of single intravenous injection of IVIG at 2 g/kg.

Adolescent ; Blood Sedimentation ; C-Reactive Protein ; analysis ; Child ; Child, Preschool ; Coronary Artery Disease ; prevention & control ; Electrocardiography ; Female ; Follow-Up Studies ; Humans ; Immunoglobulins ; blood ; Immunoglobulins, Intravenous ; administration & dosage ; therapeutic use ; Infant ; Male ; Mucocutaneous Lymph Node Syndrome ; therapy ; Platelet Count ; Treatment Outcome