OBJECTIVETo assess the current status on re-evaluation of marketed drug in China since the promulgation of drug law in 1985.

METHODSReview of literature on Chinese pharmaceutical abstract and CBMdisc from 1985 to 2001 year was done.

RESULTS4029 papers and 855 marketed drugs from 1985 to 2001 were included. Drugs on anti-infection agent, cardiovascular system and digestive system were the main drugs being re-evaluated, with the proportions of 27.1%, 20.1% and 11.1% respectively. The amounts of both marketed drugs and literature were increasing year by year. The method used for re-evaluation were random and non-random clinical trial. 41.4% of all the samples had a sample size of 50 - 100 research subjects. There were 13 papers with more than 5000 samples. The level on evidence based literature was assessed. 44 papers were graded as first class, and 182 papers the second, 2466 papers the third and 1337 papers the fourth. The quality of literature was improved year by year.

CONCLUSIONThe amount, quality as well as the sample size of literature being re-evaluated on marketed drug were increased from 1985 to 2001. However, the design and evaluation of those trials were not standardized.

Anti-Infective Agents ; therapeutic use ; Biological Products ; therapeutic use ; Cardiovascular Agents ; therapeutic use ; China ; Clinical Trials as Topic ; Cost-Benefit Analysis ; Evidence-Based Medicine ; Humans ; Product Surveillance, Postmarketing

UNLABELLEDTo study the androgen dependence of the neurotransmitter, calcitonin gene-related peptide (CGRP) in rat penis.

METHODSForty-four Sprague-Dawley rats were randomly divided into Group A (intact controls), Group B (castrated) and Group C (gavaged with finasteride 4.5 mg.kg(-1).day(-1)). Four and ten weeks later respectively, half of rats in each group were anaesthetized. Blood samples were taken for the measurement of serum testosterone and dihydrotestosterone (DHT) by means of radioimmunoassay. Penile samples were harvested for the investigation of calcitonin gene related peptide (CGRP)-immunoreactive nerve fibers with immunohistochemistry. The computer-assisted imaging analysis system was applied to calculate the area proportion of the CGRP-positive nerve fibers (CGRP-PNF) in each group.

RESULTS1) Both 4 and 10 weeks later, testosterone and DHT levels in Group B decreased significantly compared with those in Group A, (P <0.05, P <0.01, respectively); DHT level in Group C was also significantly decreased in comparison with that in Group A for both 4- and 10- week animals (P <0.05); 2) There was no significant differences in area proportion of CGRP-PNF among Groups A, B and C 4 weeks after treatments (P >0.05); However, 10 weeks later, the proportion of CGRP-PNF in Groups B and C was significantly less than that in Group A (P <0.01); 3) The proportion of CGRP-PNF of 4-week animals in Groups B and C was significantly higher than that of 10-week animals (P <0.05).

CONCLUSIONThe expression of neurotransmitter, CGRP may depend on androgens, including testosterone and DHT in rat penis.

Androgens ; metabolism ; Animals ; Calcitonin Gene-Related Peptide ; metabolism ; Dihydrotestosterone ; blood ; Gene Expression Regulation ; Immunohistochemistry ; Male ; Penis ; metabolism ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Testosterone ; blood

OBJECTIVETo observe the specific clinical efficacy of electroacupuncture at Lingtai (GV 10) and Shendao (GV 11) on premature heartbeat.

METHODSSeventy-two cases of premature heartbeat were randomized into an observation group and a control group. In the observation group, electroacupuncture was applied at Lingtai (GV 10) and Shendao (GV 11). In the control group, electroacupuncture was applied at bilateral Xuanzhong (GB 39). The treatment was given once a day and 10 times made one session in both groups. Respectively, the dynamic electrocardiogram detection was done before treatment and after one session of treatment in each group.

RESULTSThe total effective rate was 47.1% (16/34) in the observation group and 6.5% (2/31) in the control group. The efficacy in the observation group was superior to that in the control group, presenting the statistical significant difference in comparison (P < 0.05).

CONCLUSIONElectroacupuncture at Lingtai (GV 10) and Shendao (GV 11) has specific clinical efficacy on premature heartbeat.

Acupuncture Points ; Aged ; Arrhythmias, Cardiac ; therapy ; Electroacupuncture ; Female ; Humans ; Male ; Middle Aged ; Treatment Outcome

OBJECTIVETo investigate the lineage of the malignant cells in malignant histiocytosis.

METHODSPolymerase chain reaction with two groups of common primers for TCR-gamma gene was used to analyze the malignant cells of 28 autopsied cases of malignant histiocytosis.

RESULTSMonoclonal TCR-gamma gene rearrangements were detected in 12 out of the 28 samples (43%).

CONCLUSIONMost cases diagnosed as malignant histiocytosis in Southwest China seems to be peripheral T-cell lymphomas.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; CD56 Antigen ; analysis ; Child ; Child, Preschool ; Female ; Gene Rearrangement, gamma-Chain T-Cell Antigen Receptor ; Histiocytosis ; genetics ; immunology ; Humans ; Infant ; Male ; Middle Aged ; Polymerase Chain Reaction

OBJECTIVETo study the value of high-frequency ultrasound in the diagnosis of duchenne muscular dystrophy diseases (DMD) in children.

METHODSEight children with DMD were enrolled as DMD group and 10 healthy children as the control group. The echogenicity of the rectus femoris muscle and the gap between the gastrocnemius and soleus muscles in the two groups were detected by high-frequency ultrasound.

RESULTSCompared with the control group, rectus femoris and gastrocnemius muscles in the DMD group showed increased echogenicity and their muscle fibers were arranged irregularly, and the gap between the gastrocnemius and soleus muscles became wilder (P<0.01).

CONCLUSIONSHigh-frequency ultrasound is valuable in the diagnosis of DMD.

Child ; Child, Preschool ; Female ; Humans ; Male ; Muscular Dystrophy, Duchenne ; diagnostic imaging ; Ultrasonography

OBJECTIVESTo study the clinicopathologic features of Rosai-Dorfman disease (RDD), expression of various antigens, human herpes virus type 8 (HHV8), human papillomavirus (HPV)-DNA and Epstein-Barr virus (EBV)-mRNA, and compare the findings with those in the literature.

METHODSThe clinicopathologic findings of 16 Rosai-Dorfman disease cases were retrospectively reviewed. Immunohistochemical study for S-100 protein, CD68 (PG-M1), CD163, CD21, CD1a, CD20, CD45RO, CD4, CD8, M-CSF and HHV8 was carried out in 9 of the 16 cases. In-situ hybridization for EBV-mRNA and HPV-DNA was also performed.

RESULTSThe male-to-female ratio of the patients was 4.33:1. Amongst the 16 cases studied, 62.5% (10/16) presented nodal RDD, with cervical lymph node predominantly involved. Half of these cases had affected lymph nodes in more than one anatomic site. Extranodal RDD represented 37.5% (6/16) of the cases. The relapse rate of extranodal RDD was higher than that of nodal RDD. Histologically, nodal RDD was characterized by dilated sinuses filled with large polygonal histiocytes which contained lymphocytes and plasma cells. For extranodal lesions, various degrees of stromal fibrosis were seen in association with mixed inflammatory cells (especially plasma cells). The large polygonal histiocytes varied in number and were distributed in clusters or patches. Immunohistochemical study showed that the abnormal histiocytes were strongly positive for S-100 protein. They also expressed CD68, CD163 and M-CSF, but were negative for CD1a, CD21 and HHV8. The lymphocytes in cytoplasm of these histiocytes were positive for both T and B cell markers (with T cell predominance, including a mixture of CD4- and CD8-positive cells). HPV-DNA and EBV-mRNA were not detected by in-situ hybridization. To date, 62 cases of RDD have been reported in mainland China, including 34 cases of nodal RDD and 18 cases of extranodal RDD. The remaining 10 cases involved both lymph nodes and extranodal sites. Compared with overseas reports, RDD occurring in China tended to affect older patients and with slight male predilection.

CONCLUSIONSRosai-Dorfman disease is relatively rare in China. Pathologic diagnosis of extranodal RDD may be difficult. The demographic data of RDD in China, including age and sex of patients, are different from those in the literature.

Adolescent ; Adult ; Aged ; Antigens, CD ; metabolism ; Antigens, Differentiation, Myelomonocytic ; metabolism ; Bone Diseases ; metabolism ; pathology ; virology ; Child ; DNA, Viral ; analysis ; Female ; Follow-Up Studies ; Herpesvirus 8, Human ; genetics ; isolation & purification ; Histiocytosis, Sinus ; metabolism ; pathology ; virology ; Humans ; Immunohistochemistry ; Lymph Nodes ; pathology ; Macrophage Colony-Stimulating Factor ; metabolism ; Male ; Middle Aged ; Nose Diseases ; metabolism ; pathology ; virology ; RNA, Viral ; analysis ; Receptors, Cell Surface ; metabolism ; Retrospective Studies ; S100 Proteins ; metabolism ; Skin Diseases ; metabolism ; pathology ; virology ; Young Adult

Adolescent ; Adult ; Aged ; Child ; Endoscopy, Gastrointestinal ; methods ; Female ; Gastrointestinal Hemorrhage ; diagnosis ; pathology ; Humans ; Male ; Middle Aged

BACKGROUNDChronic obstructive pulmonary disease (COPD) has a variable natural history and not all individuals follow the same course. This study aimed to identify the prevalence and characteristics of asymptomatic COPD patients from a population-based survey in China.

METHODSA multistage cluster sampling strategy was used in a population from seven different provinces/cities. All residents (over 40 years old) were interviewed with a standardized questionnaire and spirometry. Post-bronchodilator forced expiratory volume in 1 second (FEV(1))/forced vital capacity (FVC) of less than 70% was defined as the diagnostic criterion of COPD. All COPD patients screened were divided into symptomatic group and asymptomatic group according to the presence or absence of chronic respiratory symptoms. Socio-demographic, personal and exposure variables were collected and analyzed.

RESULTSAmong the 1668 patients who were diagnosed with COPD from the 25 627 sampling subjects, 589 (35.3%) were asymptomatic. The age, sex, body mass index (BMI), rural and urban distributions, smoking habit and education levels were similar in the two groups. A total of 64.7% of the asymptomatic patients had no comorbidities. Cardiovascular diseases and lung cancer were more common among symptomatic COPD patients than asymptomatic group. Asymptomatic COPD group were less likely to present with poor ventilation in the kitchen, a family history of respiratory disease and recurrent childhood cough. Asymptomatic COPD patients had significantly higher FEV(1) (73.1% vs. 61.0%), FVC (91.9% vs. 82.0%), and a higher ratio of FEV(1)/FVC (62.9% vs. 58.7%) (all P < 0.001) than symptomatic group. More asymptomatic patients were underdiagnosed (91.9% vs. 54.3%, P < 0.001) than symptomatic patients.

CONCLUSIONSThis large population-based survey confirmed a high prevalence of asymptomatic COPD patients in China. More use of spirometry screening test may be important to the early detection of COPD.

Adult ; Aged ; Aged, 80 and over ; China ; epidemiology ; Educational Status ; Female ; Humans ; Male ; Middle Aged ; Pulmonary Disease, Chronic Obstructive ; diagnosis ; epidemiology ; Risk Factors ; Smoking ; Spirometry ; Surveys and Questionnaires

OBJECTIVES: To evaluate the effect of echinacoside (ECH) on cognitive dysfunction in post cerebral stroke model rats. METHODS: The post stroke cognitive impairment rat model was created by occlusion of the transient middle cerebral artery (MCAO). The rats were randomly divided into 3 groups by a random number table: the sham group (sham operation), the MCAO group (received operation for focal cerebral ischemia), and the ECH group (received operation for focal cerebral ischemia and ECH 50 mg/kg per day), with 6 rats in each group. The infarct volume and spatial learning were evaluated by triphenyl tetrazolium chloride staining and Morris water maze. The expression of α7nAChR in the hippocampus was detected by immunohistochemistry. The contents of acetylcholine (ACh), malondialdehyde (MDA), glutathione (GSH), superoxide dismutase (SOD), activities of choline acetyltransferase (ChAT), acetylcholinesterase (AChE), and catalase (CAT) were evaluated by enzyme linked immunosorbent assay. The neural apoptosis and autophagy were determined by TUNEL staining and LC3 staining, respectively. RESULTS: ECH significantly lessened the brain infarct volume and ameliorated neurological deficit in infarct volume and water content (both P<0.01). Compared with MCAO rats, administration of ECH revealed shorter escape latency and long retention time at 7, 14 and 28 days (all P<0.01), increased the α7nAChR protein expression, ACh content, and ChAT activity, and decreased AChE activity in MCAO rats (all P<0.01). ECH significantly decreased MDA content and increased the GSH content, SOD, and CAT activities compared with MCAO rats (all P<0.05). ECH suppressed neuronal apoptosis by reducing TUNEL-positive cells and also enhanced autophagy in MCAO rats (all P<0.01). CONCLUSION ECH treatment helped improve cognitive impairment by attenuating neurological damage and enhancing autophagy in MCAO rats.
Acetylcholinesterase ; Animals ; Autophagy ; Brain Ischemia/metabolism* ; Cerebral Infarction ; Cognitive Dysfunction/drug therapy* ; Glutathione/metabolism* ; Glycosides ; Infarction, Middle Cerebral Artery/drug therapy* ; Neuroprotective Agents/therapeutic use* ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury/drug therapy* ; Stroke/drug therapy* ; Superoxide Dismutase/metabolism* ; alpha7 Nicotinic Acetylcholine Receptor

MCT is an important key enzyme in the terpenoid biosynthesis in MEP pathway. In this study, Gateway technology was used to construct RNAi vector of TwMCT, and a vector fragment with a size of 484 bp was obtained. The TwMCT RNAi vector was transferred into the suspension cells of Tripterygium wilfordii by gene gun. Accumulation of terpenoids was assayed by UPLC, and the result showed that the content of triptolide and celastrol in cells decreased by 23.4% and 42.8%, respectively, compared with the control group pK7GWIWG2D. Moreover, the gene expression of TwMCT and major genes in terpenoid biosynthesis pathway was detected by qRT-PCR, which demonstrated that the expression of TwMCT reduced by 29.2% relative to that of the control group pK7GWIWG2D, and the relative expression of TwDXR, TwGGPS, TwHMGR and TwHMGS diminished by 36.3%, 31.3%, 62.2%, and 29.1%, respectively, but the expression of TwDXS was up-regulated by 114.2%, and there was no significant change in TwFPS. Thus, it was verified in vivo that interference with TwMCT expression significantly inhibited the accumulation of triptolide and celastrol in Tripterygium wilfordii, laying a foundation for further exploring the regulation mechanism of MCT gene on the terpenoid biosynthesis in Tripterygium wilfordii.