A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
Biostatistics ; Clinical Trials as Topic ; statistics & numerical data ; Data Collection ; standards ; Quality Control ; Research Design ; standards

Objective: To access the risk for smoking on morbidity of acute ST-segment elevation myocardial infarction (STEMI) at different gender and age population. Methods: A case-control study was conducted in 2026 STEMI patients and 2026 control subjects with matched gender and age (±2 years) in our hospital from 2010-01-14 to 2016-02-27. The relationship between smoking and STEMI morbidity was analyzed. Results: Smoking was an important risk factor for STEMI morbidity in male gender and it was negatively related to age, as STEMI in young male smokers (≤45 years): adjusted OR=7.000, 95% CI 4.235-11.570; in middle age male smokers (46-59 years):adjusted OR=5.296, 95% CI 3.904-7.185 and in elder male smokers (≥60 years): adjusted OR=4.686, 95% CI 2.860-4.751. Conclusion: Smoking is a major risk factor for STEMI morbidity, while it is different from age and gender; the young male smokers have the highest risk to suffer from STEMI.

Actins ; metabolism ; Adenoma, Pleomorphic ; congenital ; metabolism ; pathology ; surgery ; Diagnosis, Differential ; Fibrosarcoma ; metabolism ; pathology ; Humans ; Infant ; Male ; Nasopharyngeal Neoplasms ; congenital ; metabolism ; pathology ; surgery ; Rhabdomyosarcoma ; metabolism ; pathology ; Salivary Gland Neoplasms ; congenital ; metabolism ; pathology ; surgery ; Vimentin ; metabolism

Objective:To explore the urgent management strategy for quadriplegia following China Wenchuan earthquake under filed condition.Methods:The 57-year-old male patient was sent to the earthquake relief team of Changzheng Hospital,Second Military Medical University.He was hit by heavy object during the Sichuan earthquake 6 days ago.Physical examination revealed cervical spinal cord injury accompanied by incomplete paralysis.The patient underwent cervical 3-7 laminectomy under general anesthesia.Results: After surgery,the muscle strength of lower limbs recovered to grade four from grade one;the muscle strength of upper limbs recovered to grade five from grade three.Sensory loss was found below the nipple level and totally recovered after operation.Conclusion:Early surgery for quadriplegia following earthquake trauma can timely relieve compression to the spinal cord and therefore improve prognosis of patients.Under field condition where facilities are not readily available,decompression of spinal cord can be achieved by lamineetomy via posterior approach.The key to successful operation is correct diagnosis and skillful manipulation.

Objective To evaluate the technique of finger palpation in thoracoscopic localization in patients with pulmonary nodules,and to summarize its technical details,especially with exploit of chest computed tomography (CT) facilitating it.Methods 95 patients with total amount of 109 pulmonary nodes 20 mm or smaller in size shown with lung window of CT,were reviewed.They were located subpleurally,with a median depth of 8.2 mm and a median size of 10.0 mm.The value of their depth over their size (D/d value) could be used as the extent of localizing difficulty.Each node had its own radiographic fealures for being localized,which was built preoperatively.Under thoracoscopic vision,nodules were finger-palpated by index finger via the 4th or 5th intercostal space on anterior axillary line,followed by wedgectomy or lobectomy for instant histopathological diagnosis to further decide the final surgical type.The distance between the nodule and the origin of segmental bronchus (L value) were also calculated out,as it might be relevant to the way the nodule could be biopsied.Results All nodules were successfully localized and resected for biopsy goal,105 by wedgectomy,4 by lobectomy.After intraoperative diagnosis was made by the pathologist,VATS lobectomy and lymph node dissection were further performed in 55 patients.L value of 4 cases being biopsied by lobectomy ranged from 18.3 to 30.3 mm,averaging 26.1 mm.Conclusion Finger palpation is viable in any cases of pulmonary nodules.Detailed reference of CT digital information,and enough detachment of mediastinal pleura,can greatly facilitate thoracoscopic localization by finger palpation.Lobectomy or segementectomy is preferable when L value is less than 30 mm.

Objective To analyze the investigation results of an acute respiratory infection outbreak caused by adenovirus and provide scientific information for the prevention and control of congener public health emergencies .Methods A case‐control study was performed with grades and gender as matching factor ,all cases and selected controls were investigated with the same question‐naire .Results A totul of 47 cases were diagnosed in the outbreak ,no death ,the attack rate was 8 .88% ;the main clinical symptom was fever and 27 .7% of the cases became pneumonia .The case‐control study analysis demonstrated that with close contact to cases or not(χ2 =7 .96 ,P<0 .05) ,contact time (χ2 =7 .95 ,P<0 .05) ,hand washing habits (χ2 =25 .92 ,P<0 .05) and with or without the habit of cleaning snivel by hand directly (χ2 =22 .78 ,P<0 .05) were statistically different between cases and controls .Conclu‐sion long‐time contact to cases maybe the main risk factor for the adenovirus infection ,especially the contact manner were sharing the same desk or playing together .A good health habit of washing hands often and no cleaning snivel by hand directly were impor‐tant protective factors .Thus ,strengthening the training of health habit and awareness is the important preventive measure for re‐spiratory infectious diseases .

Objective To evaluate the changes of the activation and proliferation of rat cardiac fibroblasts in infarcted and non-infarcted regions.Methods The model of myocardial infarction (AMI)was developed through the ligation of anterior descending branch of left coronary artery.After 24 hours,the survived 114 rats were randomly assigned to the following 2 groups:(1)AMI group (n=57);(2)telmisartan treatment group(n=57).And a sham-operated group(n=32)was used asa control.All groups were terminated at day 4,7,14,28,respectively(n=10,12,15,20).At the end of the study,heart rate(HR),blood pressure (BP),ventricle relative weight (ventricle weight/body weight,VW/BW) and survival rate were measured,and the activation and proliferation of fibroblast and collagen volume fraction (CVF) were assessed.Results (1)The 28 day accumulated survival rate for treatment group was lower than that for AMI group (P

Objective To analyze the ultrasonic features of thyroid microcarcinoma (TMC) and the causes of misdiagnosis. Methods The ultrasonic features including shape, margin, echogenecity, microcalcification, vascularity and lymphadenopathy were analyzed retrospectively in 26 pathologically-proven TMC patients. Results In 26 cases, 11 cases were diagnosed correctly before operation (11/26, 42.31%), 12 cases were misdiagnosed (12/26, 46.15%) as adenoma or benign nodule, and 3 cases were missed diagnosed (3/26, 11.54%). Among the 23 cases detected on ultrasound, 21 cases were solid and hypoechoic (21/23, 91.30%);19 cases were ill-defined (19/23, 82.61%);12 cases were taller than wide in shape (12/23, 52.17%); 14 cases had microcalcification (14/23, 60.87%); 7 cases showed central or peripheral blood flow signals (7/23,30.43%) with arterial resistance index>0.70 in 3 lesions and<0.70 in 4 lesions. Conclusions Several ultrasonographic features are helpful in identiifcation of TMC, including hypo/iso-echogenecity, ill-deifned margin, taller-than-wide shape, microcalciifcation, arterial signals with high resistance index, and abnormal lymphadenopathy. Moreover, for cases with multiple lesions, to the potential co-existence of benign and malignant lesions should be considered.

OBJECTIVETo evaluate pathologically the effect of the single or combined application of UDP-glucose, GDNF and memantine on the improvement of white matter injury in neonatal rats with periventricular leukomalacia (PVL) under light and electron microscopy.

METHODSA five-day-old neonatal rat model for PVL was established by ligation of the lateral common carotid artery following 120-minute hypoxia. Rats were randomly divided into six groups (30 rats in each group): sham-operated, PVL, UDP-glucose (UDP-glucose 2000 mg/kg intraperitoneally after PVL), GDNF (GDNF 100 μg/kg intracerebrally after PVL), tmemantine (memantine 20 mg/kg intraperitoneally after PVL), and a combination administration of three drugs (UDP-glucose, GDNF and memantine). The rats were sacrificed 7 or 21 days after PVL for assessment of pathological changes in the white matter under both light and electron microscopy. The number and thickness of the myelin sheath in the white matter were measured under electron microscopy, and both of pathological grading and scoring were undertaken under light microscopy.

RESULTSThere was rare and sparse myelinogenesis with a loose arrangement of nerve fibers in the white matter under electron microscopy in the PVL group at 7 and 21 days after PVL. The number and thickness of the myelin sheath in the PVL group were significantly less than in the sham-operated, UDP-glucose, GDNF, memantine and combination administration groups (P<0.01). The results of pathological grading of white matter under light microscopy showed that all rats in the PVL group manifested either mild injury (38%-50%) or severe injury (50%-62%) at 7 and 21 days after PVL. The majority of rats (50%-88%) in the four drug administration groups had normal white matter at 7 and 21 days after PVL. The pathological scores at 7 and 21 days after PVL in the PVL group were the highest, and they were significantly higher than in the other five groups (P<0.05).

CONCLUSIONSThe single or combined application of UDP-glucose, GDNF and memantine may significantly improve pathological changes in the white matter of rats with PVL. The favorable effect is inferred to be closely correlated with the improvement of brain microenvironment and the enhancement of nerve regeneration promoted by the three drugs.

Animals ; Brain Ischemia ; drug therapy ; pathology ; Cerebral Ventricles ; pathology ; ultrastructure ; Female ; Glial Cell Line-Derived Neurotrophic Factor ; administration & dosage ; therapeutic use ; Humans ; Infant, Newborn ; Leukomalacia, Periventricular ; drug therapy ; Male ; Memantine ; administration & dosage ; therapeutic use ; Microscopy, Electron ; Rats ; Rats, Sprague-Dawley ; Uridine Diphosphate Glucose ; administration & dosage ; therapeutic use

OBJECTIVETo improve the X-ray diagnosis of cervical spondylosis of vertebral artery type (VCS).

METHODSA blinded design research. The X-ray signs both 60 patients with VCS and 60 patients with cervical spondylotic radiculopathy were collected from January 2011 to November 2012. There were 36 males and 84 females, aged from 25 to 65 years old with an average of (48.4 ± 12.3) years old. Cervical curvature, atlanto-occipital joint angle, atlanto-axial joint angle, C2/C3 joint angle and lower cervical instability condition and segmental distribution were measured and recorded by X-rays. These data were analyzed and compared between the two groups after unblended. Combined with clinical manifestations,the X-ray imaging features of VCS were further analyzed.

RESULTSThere was significant difference in cervical curvature between two groups in anteflexion X-ray films (P < 0.05). There was significant difference in extension degree of atlanto-occipital joint angle between two groups (P < 0.01). There was significant difference in atlanto-axial joint angle between two groups in lateral X-ray films (P< 0.05). There was significant.difference in anteflexion degree of atlanto-axial joint angle between two groups (P < 0.05). There was no significant difference in C2/C3 joint angle between two groups. There was no significant difference in the lower cervical instability condition and segmental distribution between two groups. In VCS group, the mild and moderate dizziness was main symptom, flexion and extension activities of neck was most common cause in the dizziness; and always accompanied with headache; tenderness mostly concentrated in the upper cervical area.

CONCLUSIONBoth X-ray signs and clinical manifestations can prompt the abnormalities of the upper cervical structure or function in patients with VCS. Anteflexion activities of neck observed by functional position of X-ray films should be emphasized in diagnosis of VCS.

Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Radiculopathy ; diagnostic imaging ; Radiography ; Spondylosis ; diagnostic imaging ; Vertebral Artery ; X-Rays