OBJECTIVE:To strengthen the inspection for qualification of new drugs when introduced in order to guarantee the quality of new drugs and the safety of drug use.METHODS:The problems existing in the inspection for qualification of new drugs were exemplified and classified.RESULTS&CONCLUSION:There existed the problems in the respect of validity,authenticity,effectiveness,and integrality.The good maintainance of the database of SFDA plays a important role in in-specting the new drugs when introduced,while on the other hand such issues as establishment and use of credibility file in medical agencies are worth discussing.

OBJECTIVE:To facilitate the in-depth implementation of Prescription Administrative Policy("New Method" in short).METHODS:The change of the Prescription Administrative Policy and its problems were analyzed through comparison between the "New Method" and the trial edition.RESULTS & CONCLUSIONS:Improvements of Prescription Administrative Policy such as the introduction of prescription comment system,clarifying supervising subjects and strengthening requirement on prescription dispensing rights etc play a role in tightening comprehensive management on prescriptions and promoting rational drug use.However,the defects of Prescription Administrative Policy such as the absence of the regulations unsuitable for medical orders in retail pharmacy and endemic areas and the unidentified prescription forms need to be improved step by step in the practice.

Background Posterior capsule opacification (PCO) is a main cause for visual acuity decline after modern extracapsular cataract surgery.Objective The aim of this study was to investigate the effect of rapamycin on PCO formation following phacoemulsification combined with intraocular lens (IOL) implantation in rabbit eyes.Methods Thirty New Zealand albino rabbits were randomized into three groups according to the difference in the implanted IOLs:conventional IOL without modification,IOL coated by a polymer material and IOL with sustained released rapamycin.Phacoemulsification combined with intraocular lens implantation surgery was performed in the left eye.The anterior ocular segment and PCO formation in the rabbit eyes were examined by slit lamp biomicroscope 1-7 days after operation,and the flare and inflammatory response of the anterior chamber as well as the degree of PCO severity were graded based on the criteria of Yang.The differences in examination outcomes were compared by the Kruskal-Wallis H test.The animals were sacrificed 12 days after surgery and eye specimens were prepared for histopathological examination to evaluate the biological behavior of lens epithelial cells (LECs) on the posterior capsule.Results The coated area of the implanted lens was semi-transparent with a smooth surface.The number of eyes with aqueous flare at grades 3 and 4 insignificantly increased but those with an inflammatory response at grades 3 and 4 significantly increased in the conventional IOL group and the polymer modified IOL group,compared with the rapamycin modified IOL group on the first day after operation (H =4.038,P =0.133 ; H =8.604,P =0.014).On the seventh day,the number of eyes with aqueous flare at grades 3 and 4 and inflammatory response at grades 3 and 4 significantly increased in the conventional IOL group and the polymer modified IOL group,compared with the rapamycin modified IOL group (H =8.891,P =0.012 ; H =7.664,P =0.0220).The histopathological examination showed that marked proliferation of LECs appeared between the anterior and posterior capsule in the conventional IOL group and the polymer modified IOL group;however,less LECs and regenerative cortex were seen in the rapamycin modified IOL group.Conclusions IOL loaded with rapamycin can inhibit the inflammatory response and alleviate the severity of PCO after phacoemulsification combined with IOL implantation.The implantation of IOL loaded with rapamycin may be a new approach to the prevention and treatment of PCO.

0.05).Seven cases in LDH group and 9 cases in HID group were found in FT picture.The mean DCavg value in annulus fibrosus disruption was significantly larger (1.01?0.10)?10~(-9)mm~2/s and the mean FA value(0.15?0.03)was significantly smaller than those in normal place(P

OBJECTIVETo investigate the histological features of oral leukoplakia which underwent malignant transformation and its correlation with the clinical manifestation.

METHODSA total of 1832 cases of oral leukoplakia were reviewed and the clinicopathological characteristics of malignant transformation were analyzed.

RESULTSMalignant transformation occurred in 85 cases (4.6%) of the 1832 cases. Thirty cases (2.1%) of 1404 cases with simple epithelial hyperplasia had malignant transformation. Fifty-five cases (12.9%) in 428 cases with epithelial dysplasia were transformed to malignancy, especially in the cases with moderate or severe dysplasia, in which the ratio of malignant transformation was higher than in the cases with simple epithelial hyperplasia (P < 0.005). Clinical parameters associated with an increased risk of malignant transformation were female gender and epithelial dysplasia was more often seen in non-homogenous leukoplakias than in homogenous (P < 0.005).

CONCLUSIONSNon-dysplastic leukoplakia may become malignant. Epithelial dysplasia was associated with an increased risk of malignant transformation. Leukoplakia in female may be at a higher risk for malignant transformation.

Adult ; Aged ; Cell Transformation, Neoplastic ; Female ; Humans ; Hyperplasia ; Leukoplakia, Oral ; pathology ; Male ; Middle Aged ; Mouth Mucosa ; pathology ; Mouth Neoplasms ; pathology ; Precancerous Conditions ; pathology ; Retrospective Studies ; Risk Factors ; Sex Factors

OBJECTIVETo reconstruct 3D shape of edentulous jaw by using improved measurement system and to analyze the precision of this method.

METHODSStandard edentulous jaw models were measured with a improved measurement system by cutting and scanning layer-by-layer, and the 3D shape of the models was reconstructed by image processing with specialty software. Ten cubic plaster modes were reconstructed by the same way, data of every border before and after reconstruction were measured and analyzed.

RESULTSData of edentulous jaw models were obtained. The errors in ten cubic before and after reconstruction were not significantly different (P > 0.05), data measured in horizontal plane were not significantly different (P > 0.05), and data measured in altitude direction were significantly different (P < 0.01), data measured after reconstruction were less than before, the error was (0.09 +/- 0.08) mm.

CONCLUSIONThe improved cutting and scanning measurement system can be fit for the 3D reconstruction of stomatognathic system with high precision.

Humans ; Image Processing, Computer-Assisted ; Imaging, Three-Dimensional ; Jaw, Edentulous ; Reproducibility of Results ; Software ; Stomatognathic System ; Tomography, X-Ray Computed

OBJECTIVETo study the effect and potential mechanism of expression of c-jun N-terminal kinase (JNK) signal pathway on neuron autophagy after diffuse brain injury (DBI).

METHODSMale Sprague Dawley rats (n = 216) were randomly divided into four groups: DBI group (n = 54), SP600125 intervene group (n = 54), DMSO group (n = 54) and sham operation group (n = 54). DBI rat model was established according to the description of Marmarou DBI. At different time points (1, 6, 12, 24, 48 and 72 h) after operation, the histopathologic changes of neurons in cortex were observed by HE staining method; The expression of p-JNK, p-P53, DRAM and Beclin-1 were detected by Western blot and immunohistochemistry.

RESULTSThe results showed that under light microscope degenerated and necrotic neurons were observed to be scattered in cortex at 6 h after operation in DBI group, but these changes were low in SP600125 intervene group. Compared with SP600125 intervene group, the expression of p-JNK in DBI group were enhanced obviously at 6, 12 and 24 h (F = 17.902, P < 0.05); the expression of p-P53 in DBI group were enhanced obviously at 12, 24, 48 and 72 h (F = 7.107, P < 0.05); the expression of DRAM in DBI group were enhanced obviously at 6, 12, 24, 48 and 72 h (F = 15.455, P < 0.05); the expression of Beclin-1 in DBI group were enhanced obviously at 6, 12, 24, 48 and 72 h (F = 11.517, P < 0.05). Compared with DBI group, the expression of p-JNK, p-P53, DRAM and Beclin-1 in DMSO group were similar at 1, 6, 12, 24, 48 and 72 h (F = 1.509, P > 0.05).

CONCLUSIONSThe present results indicate that SP600125 can dramatically improve trauma brain injury from autophagy after DBI and the molecular mechanism is related to the modulation of JNK signal pathway following DBI, while it measures the neuron autophagy by means of intervening JNK signal pathway.

Animals ; Anthracenes ; pharmacology ; Autophagy ; Brain Injuries ; metabolism ; pathology ; Disease Models, Animal ; JNK Mitogen-Activated Protein Kinases ; metabolism ; Male ; Neurons ; pathology ; Rats ; Rats, Sprague-Dawley

BACKGROUNDBecause of the pivotal role of the human leukocyte antigen (HLA) class II molecules in regulating the immune response and their extensive polymorphism, it is not surprising that particular HLA class II alleles have been implicated in susceptibility to allergic diseases and in restriction of the IgE responses to a variety of allergens. We investigated the relationship between HLA-DRB genotype and allergies to various penicillins and explored HLA-DRB restriction of IgE responses to these derivatives of penicillin.

METHODSRadioallergosorbent test was used to examine 8 kinds of specific IgE antibodies (4 major and 4 minor antigenic determinants) in the sera of 248 patients with an allergy to penicillins and 101 healthy subjects without any allergic reaction. Some (113 patients and 87 healthy control subjects) were chosen from all subjects to type for HLA-DRB alleles by sequence specific primer-polymerase chain reaction.

RESULTSCompared with control subjects, a significantly increased frequency of DR9 was present in 77 patients with allergic reactions, with immediate hypersensitive reaction and with urticaria (P = 0.011; P = 0.019; P = 0.005 respectively). Conversely, a significantly decreased frequency of DR14.1 was found in 80 patients with positive IgE antibodies, with immediate reaction and with urticaria compared with control group (P = 0.024; P = 0.038; P = 0.038). A possible excess of HLA-DR17 was found in subjects who were responsive to benzylpenicilloyl compared with those were not (chi(2) = 5.134, P = 0.023), and of HLA-DR4 was found in subjects responsive to phenoxomethylpenicillanyl (PVA, chi(2) = 4.057, P = 0.044).

CONCLUSIONHLA-DRB gene may be involved in allergy to penicillins through modulating specific serum IgE to penicillins.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Alleles ; Child ; Child, Preschool ; Drug Hypersensitivity ; genetics ; immunology ; Female ; Genotype ; HLA-DR Antigens ; genetics ; Humans ; Immunoglobulin E ; blood ; Male ; Middle Aged ; Penicillins ; adverse effects ; immunology

OBJECTIVETo establish a method for culturing dental follicle cells of rat and observe the growth characteristics of the cultured cells in vitro.

METHODSDental follicle and associated enamel organs were dissected from the first and second mandibular molars of 6-7-day-old rats, and then cultured in vitro. Purified dental follicle cells derived from the third or the fourth passage cells were utilized in the following experiments. The shape and ultrastructure of dental follicle cells were observed by light-microscopy and transmission electron microscopy. Immunocytochemistry was used to detect the expression of vimentin, type I collagen and fibronectin.

RESULTSThe cultured cells were fibroblastic in shape, elongate with processes, and transmission electron microscopy revealed that they contained electron-dense granules, an abundant rough endoplasmic reticulum, but did not form desmosomes. Vimentin, type I collagen and fibronectin were present in dental follicle cell.

CONCLUSIONThe dental follicle cells of rat could be successfully cultured in vitro and the cultured cells had the same characteristics of dental follicle cells of normal rat.

Animals ; Animals, Newborn ; Cells, Cultured ; Collagen Type I ; analysis ; Dental Sac ; chemistry ; cytology ; ultrastructure ; Fibroblasts ; cytology ; ultrastructure ; Fibronectins ; analysis ; Immunohistochemistry ; Molar ; chemistry ; cytology ; Rats ; Rats, Sprague-Dawley ; Tooth Eruption ; Vimentin ; analysis

OBJECTIVETo evaluate the value of coronary CT angiography in assessment of bifurcation lesions.

METHODSThe original image of 79 established and suspected coronary artery disease patients who underwent both coronary CT angiography and conventional artery angiography (CAG) sequentially were included in this analysis. Bifurcation lesions were assessed on primary and secondary vessels with diameter ≥ 2.0 mm, bifurcation lesions were graded according to Chen's classification. CAG was used as golden standard. The sensitivity, specificity, positive predictive value and negative predictive value were calculated. Spearman's test and Kappa test were used to evaluate the correlation and classification identity of the two methods.

RESULTSCAG evidenced 177 bifurcation lesions out of 445 bifurcation vessels and coronary CT detected 168 bifurcation lesions out of 404 bifurcation vessels with satisfactory imaging quality and 390 bifurcation vessels could be analyzed by both CAG and coronary CT. Sensitivity, specificity, positive predictive value and negative predictive value of coronary CT angiography were 94.2%, 94.6%, 90.7%, 96.1%, respectively. The results for the lesions at LM-LAD/LCX + LAD/Mid, LAD/Diag, RCA/PDA were more satisfactory and the sensitivity and specificity were as high as: 97.1% and 94.2%, 95.7% and 89.5%, 92.3% and 98.7%, respectively. There were significant correlations for evaluating the narrow degree of the opening of the bifurcation branch with these two methods (r = 0.799 58, P < 0.01) and for identifying I, II, III type bifurcation lesions (Kappa coefficient = 0.7959, P < 0.01) as well as for identifying the subtype bifurcation lesions (Kappa coefficient = 0.6328, P < 0.01) using the two methods.

CONCLUSIONCoronary CT angiography is efficient in identifying the bifurcation lesions and offers a reasonable indication for bifurcation lesion classification.

Adult ; Aged ; Aged, 80 and over ; Coronary Angiography ; methods ; Coronary Artery Disease ; diagnostic imaging ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Tomography, X-Ray Computed