OBJECTIVETo explore the theory of "Fei and Dachang being interior-exteriorly related" and the pathogenesis of lung injury by observing changes of inflammatory cytokines and oxygen free radicals in ulcerative colitis (UC) rats.

METHODSTotally 50 healthy male Wistar rats were randomly divided into two groups, the normal control group and the model group, 25 rats in each group. The UC model was established by allergizing colon mucosa combined with TNBS-alcohol (50%) enema. Another 25 rats were recruited as the normal control group. At week 2 and 4 after modeling, the pathomorphological changes of the lung were observed. Furthermore, the contents of tumor necrosis factor alpha (TNF-alpha) and IL-1beta were determined by ELISA. The activities of superoxide dismutase (SOD) and malondialdehyde (MDA) were evaluated with colorimetry.

RESULTSCompared with the normal control group, the pathomorphology of the lung tissue in the model group appeared abnormal at week 2 and 4. Compared with the normal control group, levels of TNF-alpha, IL-1beta, and MDA in the lung tissue significantly increased in the model group (P < 0. 01) and the activities of SOD significantly decreased (P < 0.05, P < 0.01).

CONCLUSIONTNF-alpha, IL-1beta, SOD, and MDA might be common material bases for the large intestine involved in lung disease of UC patients, thus providing a modern scientific basis for the theory of Fei and Dachang being interior-exteriorly related.

Animals ; Colitis, Ulcerative ; diagnosis ; metabolism ; pathology ; Cytokines ; metabolism ; Interleukin-1beta ; metabolism ; Lung ; metabolism ; Male ; Malondialdehyde ; metabolism ; Medicine, Chinese Traditional ; Rats ; Rats, Wistar ; Reactive Oxygen Species ; metabolism ; Superoxide Dismutase ; metabolism ; Tumor Necrosis Factor-alpha ; metabolism

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control

OBJECTIVETo explore the pathophysiological and biomechanical features of skeletal muscular injury for providing a rational basis for its treatment, prevention and rehabilitation.

METHODSIn 70 adult rabbits, the left tibialis anterior (TA) muscle was stretched to injury, while the right TA muscle served as control. Histological, enzymohistochemical and biomechanical changes were observed on days 0, 1, 2, 3, and 7 after injury. Cytochrome oxidase (CCO), acid phosphatase (ACP), ATPase, succinate dehydrogenase (SDH), malate dehydrogenase (MDH), NADH-diaphorase (NADHD), glutamatedehydrogenase (GDH), alpha-glycerophosphate dehydrogenase (alpha-GPD) and lactate dehydrogenase (LDH) were measured. The examined biomechanical parameters included maximal contractile force, ultimate load, length, energy absorption, tangent stiffness, and rupture site.

RESULTSPartial or complete rupture of TA muscle occurred near the muscle-tendon junction. There was an intense inflammatory reaction on day 1 and 2 after injury. Endomysium fibrosis and myotube formation were observed on day 3, and developed further on day 7. The activity of cell oxidases (CCO, ATPase, MDH, alpha-GPD, SDH, NADHD and GDH) showed a significant drop from day 0 to 2, and resumed with different levels on day 3. The increment of enzymatic activities continued on day 7 and the levels of NADHD and alpha-GPD reached to the levels of control muscle. Maximal contractile force was 70.17%+/-3.82% of controls immediately after injury, 54.82%+/-3.09% at 1 day, 66.41%+/-4.36% at 2 days, 78.39%+/-4.90% at 3 days and 93.64%+/-5.02% at 7 days. Ultimate load was 85.78%+/-7.54% of controls at the moment of injury, 61.44%+/-5.91% at 1 day, 49.17%+/-4.26% at 2 days, 64.43%+/-5.02% at 3 days, and 76.71%+/-6.46% at 7 days.

CONCLUSIONSEndomysium fibrosis and scar formation at the injured site are responsible for frequent recurrence of skeletal muscle injury. Recovery of tensile load slower than that of maximal contractile force may be another cause. Whether the injured muscle returns to normal exercise is mainly determined by the tensility on which the muscle-tendon can bear rather than the maximal contractile force.

Acid Phosphatase ; analysis ; Adenosine Triphosphatases ; analysis ; Animals ; Biomechanical Phenomena ; Dihydrolipoamide Dehydrogenase ; analysis ; Electron Transport Complex IV ; analysis ; Glutamate Dehydrogenase ; analysis ; Glycerolphosphate Dehydrogenase ; analysis ; L-Lactate Dehydrogenase ; analysis ; Malate Dehydrogenase ; analysis ; Muscle, Skeletal ; injuries ; pathology ; physiology ; Rabbits ; Succinate Dehydrogenase ; analysis

Coal Mining ; Humans ; Microbial Sensitivity Tests ; Pneumoconiosis ; microbiology ; Pseudomonas Infections ; microbiology ; Pseudomonas aeruginosa ; drug effects ; enzymology ; Respiratory Tract Infections ; microbiology ; Sputum ; microbiology ; beta-Lactam Resistance

Objective To study the anatomical classification and surgical management of communicating tumors invading the anterior or middle skull base. Methods According to the location and growth direction of the tumors, the communicating tumors invading the anterior or middle skull base in 29 patients were classified into 4 types, namely fronto-naso-orbital tumors in 16 cases, middle-lateral cranial base tumors in 8 cases, central-medial skull base tumors in 4 cases and petrous bone-jugular foramen tumor in 1 case. Based on this classification, extended transbasal approach (13 cases), supraorbital-pterional approach (9 cases), fronto-temporal approach (3 cases), ffontotemporal-orbitozygomatic approach (3 cases) and transpetrol approach (1 case) were adopted for tumor resection and skull base defect reconstruction. In the transbasal approach group, the surgery was performed also through transnasal endoscopic approaches. Results Twenty-four patients underwent total tumor resection and 5 had subtotal tumor resection. No operative death or serious complications (e.g. intracranial infection, cerebrospinal fluid leakage or meningoencephalocele) occurred after the operations. Conclusion Classification of the communicating tumors invading the anterior or middle skull base according to their location and growth direction facilitates planning of the surgical approaches for tumor resection and skull base defect reconstruction.

OBJECTIVETo investigate the changes of pulmonary function and fractional exhaled nitric oxide (FeNO) in the standardized treatment of bronchial asthma in children.

METHODSA total of 254 children who were newly diagnosed with acute exacerbation of bronchial asthma were selected as asthma group, and they were divided into two subgroups: asthma with concurrent rhinitis and asthma without concurrent rhinitis. All patients received the standardized management and treatment for one year. The pulmonary function parameters included forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), maximal mid-expiratory flow (MMEF), and mid-expiratory flow at 25%, 50%, and 75% of vital capacity (MEF25, MEF50, and MEF75). The FeNO levels were measured before treatment and at 3, 6, 9, and 12 months after treatment. Another 62 healthy children were selected as the control group, and the pulmonary function and FeNO levels were measured only once.

RESULTSDuring one year of standardized treatment, FEV1, PEF, MMEF, MEF25, MEF50, and MEF75 gradually increased, and FeNO levels gradually decreased (P<0.05). Indicators of large airway function, such as FEV1 and PEF, almost returned to normal after 6 months of treatment; indicators of small airway function, such as MMEF, MEF25, MEF50, and MEF75 almost returned to normal after 9 months of treatment; there were no significant differences in the above indices between the asthma group and the control group after one year of treatment (P>0.05). However, the asthma group had a significantly higher FeNO levels than the control group after one year of treatment (P<0.05). The asthmatic patients with concurrent rhinitis had significantly higher FeNO levels than those without concurrent rhinitis before treatment and 3 months after treatment (P<0.05). Before treatment, there was a significant negative correlation between FeNO levels and pulmonary function parameters (P<0.05).

CONCLUSIONSWith the standardized treatment of bronchial asthma in children, pulmonary function parameters gradually increase and FeNO levels gradually decrease. The recovery of large airway function occurs earlier than the recovery of small airway function. Furthermore, the effect of rhinitis on airway responsiveness should be noted.

Asthma ; physiopathology ; therapy ; Breath Tests ; Child ; Female ; Forced Expiratory Volume ; Humans ; Lung ; physiopathology ; Male ; Maximal Midexpiratory Flow Rate ; Nitric Oxide ; analysis ; Rhinitis ; physiopathology

OBJECTIVETo summarize the electroclinical characteristics of myoclonic atonic epilepsy (MAE) in children.

METHODThe clinical data, video electroencephalogram (EEG) and simultaneous electromyography (EMG) of MAE patients were analyzed. The treatment and its effects were followed up.

RESULTIn 47 MAE patients, 25 had a history of febrile seizures (FS), 20 had a family history of FS or epilepsy. All patients had a normal development before the illness. The age of afebrile seizure onset was between 1.4 years to 5.8 years. The first seizure was generalized tonic-clonic seizure (GTCS) in 41 patients (87.2%). All patients had multiple seizure types, including 47 GTCS (97.9%), 34 myoclonic atonic seizures (72.3%), 47 myoclonic seizures (100%), 32 atonic seizures (68.1%), 36 atypical absences (76.6%) and 3 tonic seizures (6.4%). EEG backgrounds were slow or parietal θ rhythm, interictal EEG showed 1-4 Hz (predominant 2-3 Hz) generalized spike and wave or poly spike and wave discharges in all cases. Seizures were controlled by antiepileptic drugs (AEDs) in 41 patients (87.2%). Valproate was used in 37. Lamotrigine was used in 26. Mild mental retardation was observed in 10 children after the onset of the illness.

CONCLUSIONThe clinical features of MAE included the following: the development was normal before the onset of the illness; the onset of seizure type was often GTCS. All patients had multiple generalized seizure types. Myoclonic atonic seizure was its characteristic seizure type. EEG showed generalized discharges. Early diagnosis and rational choice of AEDs are important for getting a better prognosis.

Child ; Child, Preschool ; Electroencephalography ; Epilepsies, Myoclonic ; diagnosis ; physiopathology ; therapy ; Epilepsy, Generalized ; diagnosis ; physiopathology ; therapy ; Female ; Humans ; Infant ; Male

OBJECTIVETo explore characteristics of the myelin-like bodies in the hepatocytes of patients with Dubin-Johnson syndrome (DJS) complicated with chronic hepatitis B (CHB).

METHODS11 cases of DJS complicated with CHB and 5 cases DJS without CHB were studied clinicopathologically. The hepatocyte ultrastructure was observed with transmission electron microscope and taken photos. The data were compared and analyzed using Fisher's Exact Test.

RESULTSDeposition of myelin-like bodies can be observed in the hepatocytes of DJS patients with CHB but can not in DJS patients without CHB. The morphology of pigment varys. The electron density and volume of pigment in DJS patients with CHB can be classified into five types: brights (2/11,18.2%), reticulation (1/11, 9.1%), punctiform (6/11, 54.5%), abnormity (1/11, 9.1%) and primary type (1/11, 9.1%). The myelin-like bodies in the hepatocytes of patients with DJS are high density and round with membrance (we named it as primary type) (5/5, 100%).

CONCLUSIONSThe myelin-like bodies in the hepatocytes of DJS patients with CHB possess special pleomorphism and may have important diagnostic value.

Adolescent ; Adult ; Female ; Hepatitis B, Chronic ; complications ; pathology ; Hepatocytes ; chemistry ; pathology ; ultrastructure ; Humans ; Jaundice, Chronic Idiopathic ; complications ; pathology ; Male ; Myelin Sheath ; ultrastructure ; Young Adult

Objective To explore the changes and influencing factors of cerebral vasoreactivity (CVR) in patients after carotid angioplasty and stenting (CAS). Methods Thirty-seven patients performed CAS, admitted to our hospital from July 2008 to September 2009, were finished the follow-up and chosen in our study; the breath-holding index (BHI) of the bilateral middle cerebral artery was measured using transcranial Doppler combined with breath holding test before thc operation, and 1 d and 3-10 months after the operation. Repeated measures design analysis of variance was employed to detect the BHI changes before and after the stenting; multiple regression was employed to analyze the influencing factors of BHI. Results BHI values after stenting were significantly higher than those before stenting on the stenotic side (P＜0.05). The follow-up BHI values were negatively correlated with those of tandem stenoses (β=-0.016, P=0.002) and positively correlated with the postoperative BHI values (β=1.030, P=0.000). Conclusion CAS can immediately improve CVR on the ipsilateral side and make it close to normalization gradually. Tandem stenoses are the independent risk factors of CVR.