1.Statistical approaches for evaluating and dealing with center effects in multi-center clinical trial
Chinese Journal of Clinical Pharmacology and Therapeutics 2004;0(09):-
To search the statistical approaches for evaluating and dealing with the center effects in multi-center clinical trial. Breslow-Day test was used for evaluating the differences of the virtual rating among the centers whose responses were binary, Cochran-Mantel-Haenszel test for dealing with the center effects whose responses were binary or ordinal, and logistic regression for evaluating and dealing with the center effects simultaneously. The results showed that Breslow-Day test is invalid in evaluating the center effects whose response is ordinal, and Cochran-Mantel- Haenszel test can not be used for dealing with the effects of other covariates meanwhile.
2.Oxidized low density lipoprotein increases the expression of matrix metalloproteinase-2 in vascular endothelial cells
Chinese Journal of Pathophysiology 1989;0(06):-
AIM: To investigate the effects of oxidized low density lipoprotein (OX-LDL) on expression of matrix metalloproteinase-2 (MMP-2) in human umbilical vein endothelial cells (HUVEC). METHODS: The MMP-2 mRNA was determined by reverse transcriptase-polymerase chain reaction (RT-PCR), MMP-2 protein was measured by western blotting and MMP-2 activity in conditioned medium was observed by gelatin zymography. RESULTS: In comparison with the control, there was no difference in the expression of MMP-2 between control and 25 mg/L LDL, whereas 25 mg/L OX-LDL increased MMP-2 activity in HUVEC ( P
3.Sample size calculation in dose-response research
Qigang DAI ; Feng CHEN ; Yongyue WEI ; Hao YU
Chinese Journal of Clinical Pharmacology and Therapeutics 1999;0(04):-
AIM:To introduce and evaluate two methods for sample size calculation in doseresponse research.METHODS:The methods used for sample size calculation in dose-response research include Cochran-Armitage trend(CAT) test proposed by Jun-mo Nam and the Unified contrast(CUC) method proposed by Chang. This paper takes the example of binary data,uses the two methods to calculate the required sample size and evaluate the power by simulation under the assumption that the response rate had a linear relationship with dosage under the logit scale.RESULTS:When the probability of response followed a linear trend on the logit scale, the sample sizes estimated from the two methods are approximately equal in various parameter's settings.The simulated power of CAT test was close to the expected one,however,the simulated power of CUC method was obviously affected by the values of contrast coefficient,if a contrast whose coefficients parallel the expected response, the CUC method was more powerful. CONCLUSION:When the probability of response follows a linear trend over dosage on the logit scale,the two methods reach almost the same result,in such circumstance,the Chang's unified contrast method will obtain an increasing power.
4.Relationship between hs-c-reactive protein and severity of coronary artery disease
Xueya GUO ; Hao HU ; Feng ZHAO ; Jing YU ; Bin ZHANG
Chinese Journal of Postgraduates of Medicine 2006;0(13):-
Objective To investigate the relationship between the hs-c-reactive protein and the severity of coronary artery disease.Methods All the 67 patients underwent coronary angiography and measured risk factors,the Gensini score was used to determine the results of the coronary angiography.The t test,One-Way ANOVA and multiple linear regression analysis were used to predict hs-CRP.Results Coronary artery disease group hs-CRP levels were significantly higher than those in non-coronary artery disease group(P
5.Correlation of head nurse's authentic leadership and degree of solidarity among nurses in operating room
Feng JIN ; Fengjie HAO ; Jing YU ; Fengxia XIAO ; Peiliang LI
Modern Clinical Nursing 2016;15(12):5-8
Objective To investigate the relationship between head nurse's authentic leadership and degree of solidarity among nurses in operating room.Method A total of 120 nurses in the operation room of 3 general hospitals in Jiamusi City were enrolled in the study by way of the questionnaire on authentic leadership and the scale of solidarity.Results The mean score on the head nurse's authentic leadership (41.28 ± 8.48) was above the middle-high level.The mean score on the solidarity (68.67 ± 8.82) was in the middle-high level.There was a positive correlation between the head nurses' authentic leadership and the degree of solidarity among nurses in the operating room.Conclusion Hospital and nursing administrators should take active and effective measures to improve the leadership of head nurses so as to improve the degree of solidarity among nurses in the operating room as well as the quality of nursing.
6.Effect of genistein on deposition of extracellular matrix in uremic rats
Hao WANG ; Bing FENG ; Chao ZHU ; Jianping YU ; Baozhuan HUANG
Chongqing Medicine 2017;46(7):879-882
Objective To investigate the effect of genistein on deposition of extracellular matrix(ECM) in uremic rats and its mechanism.Methods The uremic rat model was established by 5/6 nephrectomy.The model rats were divided into the genistein group(G) and control group (C).The sham-operation group served as the normal control(S).Urinary protein and biochemical indexes before operation,at postoperative 4,8 weeks were measured in various groups.The pathologic changes of renal tissue were observed.The glomerular sclerosis index(GSI) was evaluated by the semi-quantitative method.fibronectin(FN) and type Ⅳ collagen (ColⅣ) deposition situation were detected by using the immunohistochemical method.Western blot and RT-PCR were used to measure the protein expression and mRNA transcription of TGF-β1.Results Comparing postoperative 4 weeks with the group C,the urinary protein excretion amount was decreased[(11.63 ± 2.07) mg/d vs.(19.93 ± 3.19) mg/d,all P< 0.01],serum urea nitrogen and creatinine levels of the group G were decreased[(9.39±0.59)mmol/L vs.(12.09±0.78)mmol/L,(65.11±3.79)mmol/L vs.(77.63±3.20)μmol/L,all P<0.01].Until postoperative 8 weeks,the urinary protein excretion amount was decreased and the decrease of serum urea nitrogen and creatinine levels was more obvious.The deposition of ColⅣ and FN in renal glomerulus was lower than that of the control group[(17.30±1.96)% vs.(24.68±3.97)%;(18.26±2.31)% vs.(29.35±4.15)%,all P< 0.01].Glomerular sclerosis was significantly alleviated.The TGF-β1mRNA and protein expression were attenuated (P<0.05).Conclusion Genistein can reduce the deposition of ECM in uremic rats and has a protective effect on kidney.
7.Clinical effect of vagus nerve-preserving Da Vinci robot-assisted radical gastrectomy for gastric cancer
Chunyang LIU ; Yingxue HAO ; Peiwu YU ; Chen FENG ; Yuxing JIANG
Chinese Journal of Digestive Surgery 2017;16(3):251-256
Objective To explore the safety and feasibility of vagus nerve-preserving Da Vinci robotassisted radical gastrectomy for gastric cancer.Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 12 gastric cancer patients who underwent vagus nerve-preserving Da Vinci robotassisted radical gastrectomy at the Southwest Hospital of the Third Military Medical University from January 2015 to November 2016 were collected.All patients underwent vagus nerve-preserving Da Vinci robot-assisted radical gastrectomy for gastric cancer.During operation,lymph node dissection of the pyloric region,the right side of the cardia and the superior margin of the pancreas were noticed,and other surgical procedures were the same as the traditional Da Vinci robot-assisted radical gastrectomy.Observation indicators:(1) intra-and post-operative situations:surgical methods,digestive tract reconstruction,operation time,volume of intraoperative blood loss,number of lymph node dissected,results of postoperative pathological examination,recovery time of gastrointestinal function,time for liquid diet intake,duration of postoperative hospital stay,short-term surgery-related complications (postoperative bleeding,anastomotic fistula,obstruction and intra-abdominal infection);(2)follow-up situations:postoperative long-term complications (gastric retention,alkaline reflux gastritis,dumping syndrome,gallbladder disease and cholelithiasis),postoperative quality of life (diet,upper abdominal discomfort,nausea,vomiting and diarrhea),postoperative nutritional status [body weight,hemoglobin (Hb),total protein (TP),albumin (Alb)] and tumor recurrence.Follow-up using telephone interview and outpatient examination was performed up to December 2016.Telephone interview included detecting diet of patients,digestive tract symptoms and body weight.Routine blood test,liver and kidney functions,tumor markers,chest X-ray,abdominal computed tomography (CT) or color Doppler ultrasound and gastroscopy of outpatient examinations were performed to detect tumor recurrence and metastasis.Measurement data with normal distribution were represented as x±s and measurement data with skewed distribution were described as M (range).Results (1) Intra-and post-operative situations:all the 12 patients underwent successful vagus nerve-preserving Da Vinci robot-assisted radical gastrectomy for gastric cancer,without conversion to laparoscopic surgery or open surgery,including 2 patients with D1 lymphadenectomy,2 patients with extended D1 lymphadenectomy and 8 patients with D2 lymphadenectomy.Five and 7 patients underwent respectively Billroth Ⅰ anastomosis and Billroth Ⅱ anastomosis of digestive tract reconstruction.Operation time,volume of intraoperative blood loss and number of lymph node dissected of 12 patients were (247± 34) minutes,(94 ± 23) mL and 27 ± 7,respectively.Results of postoperative pathological examination showed that distal and proximal surgical margins of 12 patients were negative and achieved R0 resection;326 lymph nodes were dissected,6 patients didn't have lymph node metastasis and 18 positive lymph nodes were detected in 6 patients.Recovery time of gastrointestinal function,time for liquid diet intake and duration of postoperative hospital stay in 12 patients were (57±14)hours,(64± 14)hours and (7.3±0.9)days,respectively.There was no occurrence of short-term surgery-related complications.(2) Follow-up situations:12 patients were followed up by telephone interview (10 receiving outpatient exaninations) for 9 months (range,1-20 months).Of 12 patients with long-term complications,2 had loss of appetite,1 had diarrhea,without occurrence of cholelithiasis,cholecystitis,gastric retention and dumping syndrome.Of 10 patients receiving outpatient examinations,body weight,Hb,TP and Alb were (56± 12) kg,(126± 10) g/L,(69.9±5.1) g/L,(43.2±3.3)g/L at 1 month postoperatively and (52±13)kg,(126±10)g/L,(72.1±2.4)g/L,(45.2±1.6)g/L at 3 months postoperatively,respectively,with negative carcinoembryonic antigen.There was no tumor recurrence and metastasis in 12 patients.Conclusion Vagus nerve-preserving Da Vinci robot-assisted radical gastrectomy is safe and feasible for gastric cancer,which has not affected the lymph node dissection and incidence of surgeryrelated complications,and it also can improve the postoperative quality of life and maintain good nutritional status.
8.Study on Tracheal Intubation's Circular Arc Radius Measuring Method Based on Machine Vision.
Dong YU ; Genchi LI ; Yunhao FENG ; Yonghuan YANG ; Xiali HAO
Chinese Journal of Medical Instrumentation 2015;39(3):206-215
It is difficult to measure the circular arc radius for central angle less than 30 degrees. The existing measuring methods are of low efficiency and big error. Through designing the machine vision system and studying the image detecting method for measurement, It is obtained good results by using the new measurement for tracheal intubation's circular arc radius, Realized a rapid and accurate measurement of the circular arc radius, and expanded the application in the field of machine vision.
Humans
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Imaging, Three-Dimensional
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instrumentation
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Intubation
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Trachea
9.Relationship of statistics and data management in clinical trials.
Feng CHEN ; Hua-long SUN ; Tong SHEN ; Hao YU
Acta Pharmaceutica Sinica 2015;50(11):1420-1424
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
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Clinical Trials as Topic
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statistics & numerical data
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Data Collection
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standards
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Quality Control
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Research Design
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standards
10.The effect of daidzein on extracellular matrix of uremic rats
Hao WANG ; Bing FENG ; Chao ZHU ; Jianping YU ; Baozhuan HUANG
International Journal of Traditional Chinese Medicine 2017;39(1):43-47
Objective To observe the effect of daidzein on extracellular matrix of uremic rats and to discuss its mechanism.Methods Uremic rat model were established by 5/6 nephrectomized. Model rats were devided into daidzein group, control group. Rats with sham-operation were regarded as the normal control. At time of baseline, 4th and 8th week after operation, urinary protein and biochemical detection were measured. The pathologic changes, fibronectin (FN) and typeⅣcollagen (ColⅣ) were investigated at 8th week. The Western-Blot and RT-PCR were used to measure protein expression and mRNA transcription of TGF-β1. Results At 8th week after operation, the urinary protein (12.35 ± 2.13 mg/24 hvs. 19.93 ± 3.19 mg/24 h), serum urea (10.11 ± 0.65 mmol/Lvs.12.09 ± 0.78 mmol/L) and creatinine (68.10 ± 2.51μmol/Lvs.77.63 ± 3.20μmol/L) in the daidzein group decreased significantly than those in the control group (P<0.01). The deposition of ColⅣ (16.33% ± 2.14%vs. 24.68% ± 3.97%) and FN (19.17 ± 2.68 vs. 29.35 ± 4.15) in the daidzein group decreased significantly than those in the control group (P<0.01). Compared with control group, the pathological lesion in the daidzein group was less serious. The mRNA transcription (0.37 ± 0.06vs. 0.64 ± 0.08) and protein expression of TGF-β1 (0.28 ± 0.09vs. 1.40 ± 0.13) in the daidzein group were attenuated significantly than those in the control group (P<0.05). ConclusionsDaidzein had a beneficial effect on uremic rats. It may be associated with a decrease of extracellular matrix accumulation.