To establish a detection method of oncolytic adenovirus/p53 and standard of quality control, human telomerase reverse transcriptase (hTERT) promoter, CMV fusion promoter containing hypoxia reaction element (HRE) and p53 gene were identified by vector DNA restriction enzyme digestion and PCR analysis. The result conformed that all modified regions were in consistent with theoretical ones. Particle number was 2.0 x 10(11) mL(-1) determined by UV (A260). Infectious titer was 5.0 x 10(10) IU mL(-1) analyzed by TCID50. In vitro p53 gene expression in human lung cancer cell H1299 was determined by ELISA, and A450 ratio of nucleoprotein in virus infection group to control group was 5.2. Antitumor potency was evaluated by cytotoxicity assay using human lung cancer cell A549, and the MOI(IC50) of this gene therapy preparation was 1.0. The tumor cells targeted replication ability of recombinant virus was determined by TCID50 titer ratio of filial generation virus between human lung cancer cell A549 and human diploid epidermal fibrolast BJ cells after infected by virus with same MOI. TCID50 titer ratio of tumor cell infection group to normal cell infection control group was 398. The IE-HPLC purity of virus was 99.5%. There was less than 1 copy of wild type adenovirus within 1 x 10(7) VP recombinant virus. Other quality control items were complied with corresponding requirements in the guidance for human somatic cell therapy and gene therapy and Chinese pharmacopeia volume III. The detection method of oncolytic adenovirus/p53 was successfully established for quality control standard. The study also provided reference for quality control of other oncolytic viral vector products.

OBJECTIVETo observe the curative effect of Shenyanning (SYN) on non-nephrotic syndrome IgA nephropathy (IgAN).

METHODSSeventy primary IgAN patients were equally randomized into two groups, the treatment group and the control group, they were orally treated with SYN Decoction (one dose per day) and Losartan (50 mg per day) respectively for 1 year. Efficacy of treatment, Chinese medicine syndrome scores, end-point events occurrence as well as changes of related laboratory indices were observed.

RESULTSThe total effective rate in the treatment group was obviously higher than that in the control group (77.1% vs. 54.3%, P < 0.05). After treatment, the Chinese medicine syndrome scores, urinary protein and urinary red-cell count reduced significantly in the treatment group (P < 0.05 or P < 0.01) and showed significant difference as compared with those in the control group (P < 0.05 or P < 0.01); while the endogenous creatinine clearance was changed insignificantly in both groups. Beside, the occurrence of end-point events in the treatment group was slightly lower than that in the control group, though showed no statistical difference between them.

CONCLUSIONThe curative effect of SYN in treating IgAN was obviously better than that of simple Western medicine.

Adolescent ; Adult ; Diagnosis, Differential ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Glomerulonephritis, IGA ; drug therapy ; Hematuria ; urine ; Humans ; Losartan ; therapeutic use ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; Proteinuria ; urine ; Young Adult

0.05).There was significant difference in lymph node metastatic rate between poorly-differentiated and undifferentiated adenocarcinoma(17.83%) compared with well-differentiated and middle-differentiated adenocarcinoma(1.58%)(P

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.

Objective To evaluate the CT and MRI characteristics of Primary Central Nervous System Lymphoma(PCNSL)in immunocompetent patients,and enhance its diagnosis level.Methods CT and MRI data of 20 patients with PCNSL confirmed by histo-pathology were analyzed retrospectively.MRI scans were performed with and without Gadolinium contrast.Two of them had contrast-enhanced CT scan;six had CT scan without contrast administration;1 had CT scan with both non-contrast and contrast enhancement.Re- suits Totally,38 lesions were found in all patients:14 lesions of them were single and 24 lesions were found in 6 patients.Generally,the lesions were located in the surface and/or midline of the brain.The signal features and density were similar to meningioma,and strongly enhancing after contrast administration.Thirty-six of the 38 lesions had spicular sign peripheral to the lesion.Conclusion Although the manifestations of the PCNSL are variety,there are still many characteristics in the medical imaging,especially in the locations,the signal features,and spicular sign in the edge of the lesions after contrast material injection.

Objective To investigate the effect of behavior change mission mode in traditional Chinese medicine treatment of patients with bone marrow suppression after chemotherapy.Methods Totals of 60 patients after gynecological malignancies who undergone chemotherapy were randomly divided into control and observation groups,both groups used the same kinds of Chinese medicine.Patients in the observation group received health education by behavior change mode,while patients in control group received the general health education.The routine blood test in the two groups were observed and patients were followed up regularly.Results The decrease incidence of WBC in observation group was significantly lower than that in control group (30％ vs 60％),the different were statistical significant (x2 =5.46,P ＜ 0.05).The observation group's bone marrow suppression showed lower incidence than control group with no Ⅳ bone marrow suppression happened.Significant differences were found in the extent of WBC damaged and time required to recover WBC between two groups (P ＜ 0.05).The utilization of leucocyte-stimulating agents,and the use rate of rising WBC medicine in observation group were lower than that in control group [232.5 μg vs 450.0 μg,3.33％ vs 26.67％ ; P ＜0.05)].The time in leukocyte to recovery normal level was more quicker in observation group than control group,the difference was statistical significant (t =5.547,6.364 ; P ＜ 0.05).Conclusions The health education model of behavior change shows the clinical significance in improving the efficacy of traditional Chinese medicine treatment of bone marrow suppression after chemotherapy.

OBJECTIVESTo investigate the histological changes in liver biopsy tissues taken from chronic hepatitis B patients with HBsAg and HBeAg positive and ALT abnormal after lamivudine therapy for one year.

METHODSLamivudine was given orally at the dose of 100 mg once a day for one year. 101 patients were enrolled into this open-label study. Paired liver biopsies from patients with hepatitis B before and after therapy with lamivudine were studied. Blinded biopsies were evaluated by a histopathologist and scored according to Knodell's histology activity index(HAI).

RESULTS53.5% (54/101), 51.5% (52/101) and 31.7% (32/101) patients had a reduction of their total hepatic HAI score, necroinflammation and fibrosis scores by >or=2 points or 1 points at the end of one year of lamivudine therapy, compared with their pretreatment values, respectively. There were significant reduction of HAI score, necroinflammation and fibrosis scores from 8.0+/-4.7 to 5.2+/-3.3 (t=7.358, P<0.01), from 5.9+/-3.8 to 3.6+/-2.5 (t=7.298, P<0.01), and from 2.1+/-1.2 to 1.6+/-1.2 (t=3.827, P<0.01), respectively. The histological improvement was independent on the HBeAg seroconvertion during the therapy.

CONCLUSIONSignificant improvement in liver histology, both necroinflammation and fibrosis, can be obtained in the majority of patients treated with lamivudine for one year.

Adolescent ; Adult ; Antiviral Agents ; therapeutic use ; Child ; Female ; Hepatitis B e Antigens ; analysis ; Hepatitis B, Chronic ; drug therapy ; pathology ; Humans ; Lamivudine ; therapeutic use ; Liver ; pathology ; Liver Cirrhosis ; pathology ; Male

Objective To explore the effect of recovery sleep on the executive function after 36 h of total sleep deprivation by event related potential technology.Methods Thirteen healthy male college students participated in two trials. At the first trial normal sleep as control was investigated. At the second trial participants experienced 36 h of sleep deprivation and then accepted 8 h recovery sleep. In each trial six Go/Nogo tests were employed to test the executive control function and the ERP data were recorded. Results There was no statistical difference in behavior and ERP results at each time point as the subjects had normal sleep. After 36 h of sleep deprivation, the behavior results were statistically significant when compared to the baseline. The amplitude and latency of Nogo-N2, Nogo-P3 on Fz electrode, the amplitude and latency of Nogo-P3 on Cz electrode showed statistical significance when compared to the baseline. After 8 h recovery sleep, the average correct reaction time and the Go correct reaction rate had statistical significance compared to 36 h value. The amplitude of Nogo-N2 and Nogo-P3 had no statistical significance compared to the baseline.However,it was of statistical significance[(-6.80 3.95)vs(-3.37 2.63)μV,(10.63±6.62)vs(5.63±5.45)μV,(9.49±7.37)vs(6.08±6.56)μV] compared to 36 h value. The latency of the recovery value of Nogo-N2 and Nogo-P3 was statistically significant[(254.14±15.55)vs(243.08±13.97)ms(382.14±41.07)vs(349.17±30.36)ms,(369.86±26.48)vs(347.48±29.24)ms]compared to the baseline.Conclusion As the time of sleep deprivation is prolonged, the executive function is impaired and the executive function is not completely recovered after 8 h recovery sleep.

OBJECTIVETo analyze clinical information and efficacy of 602 cases of nevus of Ota, and investigate the histopathology and ultrastructure on the melanocytes before and after Q-switched Alexandrite laser irradiation.

METHODSClinical information of 602 cases of nevus of Ota were collected by applying clinical records, checking photos, and inquiry to patients by letters and telephones. Ten cases of biopsies were observed by light microscopy and 6 cases by electron microscopy before and after laser irradiation.

RESULTSNevus of Ota included congenital and acquired cases. Skin lesions mainly occurred in adolescence for the acquired cases. The main colours of lesions were brown and blue. The most local lesions were zygomata, temporal regions, and lower eyelids. According to multiple regression, the more treatment times, the better results. The effective rate was 85.20% and 100% after 6 and 9 treatment times, respectively, while the cure rate was 55.72% and 98.46%, respectively. The eyelids involved and Tanino types influenced the treatment times by COX models analysis. Electron microscopy showed many melanosomes in the dermal melanocytes. After laser irradiation, the outlines of the dermal melanocytes were observed, the melanosomes were broken to dense and tiny granules.

CONCLUSIONSQ-switched Alexandrite laser is safe and effective for the treatment of nevus of Ota. The results of treatment are correlated with the area and size of the lesion. The dermal melanocytes in nevus of Ota can be selectively destroyed by Q-switched Alexandrite laser with less injury around tissues.

Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Laser Therapy ; Male ; Melanocytes ; ultrastructure ; Melanosomes ; radiation effects ; ultrastructure ; Nevus of Ota ; radiotherapy ; ultrastructure ; Skin ; ultrastructure ; Skin Neoplasms ; radiotherapy ; ultrastructure

AIMTo prepare heart-protecting musk pH-dependent gradient-release pellets and investigate the drug release in vitro and in vivo.

METHODSThe pH-dependent gradient-release pellet system was prepared by using HPMC, Eudragit L-30D-55 and Eudragit L100-Eudragit S100 (1:5) combinations as coater. The release of borneol and total ginsenoside from pH-dependent gradient-release pellets were determined according to the method of Pharmacopoeia of the People's Republic of China (2000) in the simulated gastrointestinal pH conditions. The gastrointestinal transit and disintegration of pellets was investigated by using gamma-scintigraphic trace in volunteers. The pharmacokinetics of borneol of heart-protecting musk pH-dependent gradient-release pellets was studied in 6 healthy volunteers by GC methods.

RESULTSThe f2 value of release data of borneol and total ginsenoside of the heart-protecting musk pH-dependent gradient-release pellets was 79.6 in the simulated gastrointestinal pH conditions. The gamma-scintigraphic trace evaluation demonstrated that the pellets coated with HPMC, Eudragit L-30D-55 or Eudragit L100-Eudragit S100 (1:5) combinations can disintegrate in stomach, duodenum and jejunum or ileum. The gastrointestinal transit time of pellets was about 5 hours in fasted state and about 6 hours in fed state. The concentration-time curves of borneol of heart-protecting musk pills fit in two-compartment model. The pharmacokinetics data showed that borneol had a short time of absorption and elimination. The mean residence time (MRT) of borneol of heart-protecting musk pills was 2.61 hours. The plasma concentration of borneol of heart-protecting musk sustained-release capsule which consisted of three kinds of pellets coated with HPMC, Eudragit L-30D-55 or Eudragit L100-Eudragit S100 (1:5) combinations was steadier than those of heart-protecting musk pills, its Cmax was lower than and Tmax was near to those of heart-protecting musk pills, its MRT was 4.0 hours, and its relative bioavailability was 96%.

CONCLUSIONThe lipidsoluble borneol and watersoluble total ginsenoside of heart-protecting musk pH-dependent gradient-release pellets can release simultaneously while sustained-releasing in vitro. The heart-protecting musk pH-dependent gradient-release pellets had the characteristics of pH-dependent gradient-releasing and disintegration while transiting in gastrointestinal tract. A characteristic of gradient sustained-release was shown in the concentration-time curves of borneol of heart-protecting musk sustained-release capsule in volunteers.

Adult ; Bornanes ; pharmacokinetics ; Delayed-Action Preparations ; Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; pharmacokinetics ; Fatty Acids, Monounsaturated ; administration & dosage ; Gastrointestinal Transit ; Ginsenosides ; pharmacokinetics ; Humans ; Hydrogen-Ion Concentration ; Lactose ; analogs & derivatives ; Male ; Materia Medica ; administration & dosage ; pharmacokinetics ; Methylcellulose ; analogs & derivatives ; Oxazines ; Polymethacrylic Acids ; Random Allocation