The quality control of new drug cilnical trial is the effective guaranty for the pharmaceutical safety and effective after available on market. Enhancing the inspection and quality control of new drug clinical trials provide the crucial importance to achieve a persistent profitable standard. This paper mainly discussed the problems of current clinical trials based on annual check of drug clinical trial institution.
Clinical Trials as Topic ; Drug Evaluation ; Health Facilities ; Humans ; Quality Assurance, Health Care ; Quality Control

Objective To investigate the inhibitory effect and the effect on cell proliferation and apoptosis of artemether(ART) on human gastric adenocarcinoma cell lines and pancreatic cancer cell lines in vitro. Methods The inhibitory effect of ART on human gastric cancer cell lines(SGC-7901 and MKN-45) and human pancreatic cancer cell lines(SW-1990 and BXPC-3) were detected by MTT assay,and the effect on cell cycle and apoptosis were evaluated by flow cytometry. Results It was indicated by MTT assay that the killing effect of ART on the cancer cell lines were positively correlated to time and dosage(P

Objective To identify the effects of the subthalamic nuclei(STN)high frequency stimulation(HFS)on striatal and nigral dopaminergic metabolism in rats.Methods The effects of subthalamie nuclei high frequency stimulation(STN-HFS)on striatal dopaminergie metabolism was investigated in free moving rats.Reverse transcriptase polymerase chain reaction(RT-PCR)and Western blot of striatal and nigral tyrosine hydroxyiase(TH)were performed.Results Our data suggest that STN- HFS elevated TH protein(0.99?0.14 vs 0.33?0.08,P

OBJECTIVETo explore the operative methods and curative effects of the deltoid ligament injuries.

METHODSFrom 2002 to 2008, all 61 patients with ankle fractures complicated with deltoid ligament injuries were treated with open reduction and firm internal fixation. Among the patients, 39 patients were male and 22 patients were female, ranging in age from 14 to 71 years, with an average of 41 years. During the operation, the deltoid ligament was reconstructed to restore the medial and lateral stability of ankle joint.

RESULTSAll the patients were followed up ranged from 5 to 30 months, with an average of 17 months. Fifty-nine patients had incision healed at the first stage; 2 patients had superficial infections at lateral malleolus, and healed at the 3rd week after changing dressings. The incisions at the internal medial malleolus were all healed at the first stage. According to Qi evaluation criteria, 35 patients got an excellent result, 13 good and 13 fair.

CONCLUSIONThe deltoid ligament should be treated properly in the treatment of ankle joint fractures when open reduction and firm internal fixation were emphasized.

Adolescent ; Adult ; Aged ; Ankle Injuries ; surgery ; Ankle Joint ; surgery ; Female ; Fracture Fixation, Internal ; Fractures, Bone ; complications ; surgery ; Humans ; Ligaments, Articular ; injuries ; surgery ; Male ; Middle Aged ; Range of Motion, Articular ; Young Adult

Objective To described the prevalence of school physical violence behaviors and to explore its associated factors among middle school students in Beijing. Methods In 2009, a randomly selected cross- sectional survey was conducted among 5718 students in grades 7 to 12 in Beijing. A self-report anonymous questionnaire involving physical violence at school and sociodemographic variables, such as sex, grades, family economic status and family structure, peer relationships, and communication with their parents etc. were completed by students themselves.Logistic regression was used to estimate the association between physical violence and sociodemographic variables. Results Among the students, 14.3% reported that they had had physical violence behavior in school during the past 12 months. Male students had been more likely to have physical violence behaviors than female students (Male 25.2%, Female 5.1% ). For both male and female students, poor school cohesion were the risk factors of physical violence behaviors (Male OR=1.060, Female OR=1.065). For male students, factors as father' s lower education level (OR=1.653 ), remarried/single-parent families ( OR = 1.834 ), low-grade ( grade 7 OR = 5.291; grade 11 OR =1.526) , poor school performance (OR=1.470) etc were the risk factors of physical violence behaviors; while better-off family economic status (OR=0.546), good peer relationships (OR=0.618) , and easy to communicate with the father (OR=0.756) were the protective factors of physical violence behaviors. For female students, easy to communicate with her mother (OR = 0.358)were the protective factors of physical violence behaviors. Conclusion For male and female students, the prevalence of school physical violence and its related factors were different. Actions on prevention against physical violence behaviors should be fully considered, including factors as gender, personal characteristics, family, school and peers etc.

OBJECTIVETo explore the feasibility of using single cell fluorescent polymerase chain reaction (PCR) in the preimplantation genetic diagnosis (PGD).

METHODSingle buccal cell genetic analysis was performed with fluorescent PCR of linked microsatellite D16S423, followed by electrophoresis on ABI 3730.

RESULTThe amplification success rate, allele dropout rate, and diagnostic accuracy rate of the single cell fluorescent PCR were 93.3%, 10.7%, and 89.3%, respectively.

CONCLUSIONSingle cell fluorescent PCR is a stable and reliable approach for the PGD.

Female ; Fluorescent Dyes ; Humans ; Molecular Diagnostic Techniques ; methods ; Pedigree ; Polycystic Kidney Diseases ; diagnosis ; genetics ; Polymerase Chain Reaction ; methods ; Pregnancy ; Preimplantation Diagnosis ; methods

In vivo extracellular recordings were made in the subthalamic nucleus (STN) of intact control rats and rats with 5,7-dihydroxytryptamine (5,7-DHT) -produced lesion of dorsal raphe nucleus (DRN). The results showed that the firing rate of STN neurons in control rats and DRN-lesioned rats were (6.93+/-6.55) Hz and (11.27+/-9.31) Hz, respectively, and the firing rate of DRN-lesioned rats significantly increased when compared to the control rats (P<0.01). In control rats, 13% of STN neurons discharged regularly, 46% irregularly and 41% in bursts. In DRN-lesioned rats, 9% of STN neurons discharged regularly, 14% irregularly and 77% in bursts, the percentage of STN neurons firing in bursts was obviously higher than that of the control rats (P<0.01). In addition, the mean interspike interval coefficient of variation of STN neurons in control rats and DRN-lesioned rats were (0.05+/-0.04) and (0.11+/-0.09), respectively. The mean interspike interval coefficient of variation of DRN-lesioned rats was significantly higher than that of the control rats (P<0.001). These results show that the firing rate and the bursting pattern rate of neurons in STN of DRN-lesioned rats increase significantly, suggesting that DRN inhibits the neuronal activity of the subthalamic neurons in the intact rat.
5,7-Dihydroxytryptamine ; pharmacology ; Adrenergic Agents ; pharmacology ; Animals ; Electrophysiological Phenomena ; Male ; Neurons ; physiology ; Random Allocation ; Raphe Nuclei ; drug effects ; pathology ; Rats ; Rats, Sprague-Dawley ; Subthalamic Nucleus ; physiopathology

OBJECTIVETo observe different effects of moxibustion on extracellular potassium ion in acupoint under physiological and pathological status and provide experimental evidence for exploring action mechanism of moxibustion on acupoint local.

METHODSForty female SD rats were randomly divided into a blank group, a blank-moxibustion group, a model group and a model-moxibustion group, 10 cases in each one. The complete Freund's adjuvant(CFA) was adopted to establish model of adjuvant arthritis (AA) in the model group and model-moxibustion group. No treatment was given in the blank group and model group while moxibustion was applied at "Zusan-li" (ST 36) for 30 min in the blank-moxibustion group and model-moxibustion group. The tissue fluid in "Zusanli" (ST 36) was collected with microdialysis and real-time analyzed by electrolytic analyzer. The change of concentration of potassium ion in "Zusanli" (ST 36) was observed.

RESULTS(1) Under physiological status, the concentration of extracellular potassium ion in the blank group was not changed within 150 min (P > 0.05); before the moxibustion, the concentration of extracellular potassium ion in the blank-moxibustion group was (1.21 +/- 0.31) mmol/L, and after treatment it was gradually increased and reached its peak at (2.38 +/- 0.42) mmol/L after 60 min (P < 0.05), then it was reduced. 150 min after the treatment, concentration of potassium ion was slightly higher than that before moxibustion as well as that in the blank group. The concentration in the blank-moxibustion group at 60 min was statistically significant compared with that in the blank group (P < 0.05). (2) Under pathological status, the concentration of extracellular potassium ion in the model group was not changed within 150 min, differences of which at each time point was not statistically significant (all P > 0.05). Before the moxibustion, the concentration of extracellular potassium ion was (1.09 +/- 0.12) mmol/L in the model-moxibustion group, and it was immediately increased to (1.96 +/- 0.18) mmol/L after moxibustion. 60 min and 90 min after the moxibustion, it still maintained a higher level, which was (1.87 +/- 0.29) mmol/L and (1.59 +/- 0.16) mmol/L respectively (both P < 0.05). The differences of each time point after moxibustion in the model-moxibustion group were statistically significant compared with those in the model group (all P < 0.05).

CONCLUSIONThe moxibustion could increase the concentration of potassium ion in rat's acupoint local under physiological status but time of effect is short; with moxibustion at "Zusanli" (ST 36) under pathological status, the concentration of local potassium ion is obviously increased and maintains for a long time.

Acupuncture Points ; Animals ; Arthritis, Experimental ; metabolism ; therapy ; Disease Models, Animal ; Female ; Humans ; Moxibustion ; Potassium ; metabolism ; Rats ; Rats, Sprague-Dawley

BACKGROUNDLung cancer has become the leading cause of the cancer death in China. Population-based lung cancer screening is still in controversy. The objective of this study is to analyze the effect of annual chest radiography and sputum cytological screening conducted in high lung cancer risk population who were exposed to work related carcinogens.

METHODSA retrospective analysis was conducted to evaluate the screening results of the lung cancer cases diagnosed from 1992 to 2001 in the miners of Yunnan tin mine.

RESULTSA total of 9317 miners had been screened annually from 1992 to 1999. A total of 46 779 chest radiography and 45 672 sputum cytological examinations had been conducted, and 793 cohort subjects had at least one positive result. The annual positive detection rate ranged from 1214.1/100 000 to 3482.7/100 000. By December 31, 2001, 433 lung cancer cases had been confirmed, 371 cases out of them had cytological/pathological evidence, and 55.0% were squamous cell carcinoma followed by adenocarcinoma and small cell carcinoma. Stage I or II accounted for 24%. 62.1% of the cases had at least one positive screening result, while 165 cases were detected by chest radiography alone, 56 were detected by sputum cytology, and 48 were detected by both screening modalities. 64.2% of X-ray detected cases were squamous/adenous carcinomas and 75.0% of cytological detected cases were squamous carcinoma. 80.8% of early stage cases had at least one previous positive finding from screening.

CONCLUSIONSAnnual lung cancer screening with combination of chest radiography and sputum cytology play some extent role in early detection of lung cancer in high risk population. The results may provide some primary data for lung cancer screening in special population who are at high risk of lung cancer in China.

BACKGROUNDTo establish a cohort for the study of risk factors of lung cancer, and to support the study of early biomarkers and prevention of lung cancer.

METHODSDesigned a special population-based prospectively dynamic cohort among radon- and arsenic-exposed tin miners aged 40 or more years old with at least 10 years of occupational exposure in Yunnan Province, P.R.China. The mass screenings with sputum cytology and chest X-ray were conducted annually. The baseline information was collected for assessing demographic characteristics and risk factors. The multiple sputum specimens, chest radiographs and numerous biologic specimens have been collected and stored.

RESULTSFrom 1992-1999, 9143 miners have been enrolled and 460 new cases of lung cancer have been found. There had 47655 person-time chest radiographs and 46625 person-time sputum cytology among the cohort in 8 years. The relative risks of age-adjusted exposure to chronic bronchitis, silicosis, and tobacco were 1.73, 1.46, and 1.32 respectively.

CONCLUSIONSA cohort of unique occupationally-exposed tin miners with an extensive biologic specimen repository and data bank has been successfully established. Although occupational exposures are the predominant risk factors among the high risk miners, lung cancer risk is also associated with chronic obstructive lung disease (chronic bronchitis and silicosis) and a number of measures of exposure to tobacco smoke, including early age of first use, duration, and cumulative exposure.