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.Evaluation of diffusion effect of bone cement in vertebral body fracture in percutaneous vertebroplasty
Ruifei BAI ; Huanshi CHEN ; Hao FENG
Chinese Journal of Primary Medicine and Pharmacy 2017;24(16):2477-2479,后插4
Objective To evaluate the therapeutic effect of percutaneous vertebroplasty good cement dispersion within the vertebral body fracture line.Methods The clinical data of 105 osteoporotic compression fracture patients with single vertebral fractures treated by vertebroplasty were retrospectively analyzed.Including 51 males,54 females,aged 61 to 82 years,mean 75.18 years,duration of 1d to 2 months,compressed segments distributed in the T9-L3.Preoperative patients received X-ray film,routine CT scan and reconstruction and MRI examination to determine the responsibility of patients with vertebral fracture line position,intraoperative puncture position to the fracture line in the C arm guidance,and bone cement was injected,puncture used unilateral or bilateral,injection of bone cement in an amount of 3-5mL.The visual analogue pain score(VAS)was recorded before and after surgery for 48h and at the last follow-up.Results All patients were successfully completed without serious complications,intraoperative real-time C-arm fluoroscopy and postoperative review X-ray showed that bone cement in the fracture line was well dispersed.Operation time was 25-50min,average 36min.The amount of injection of bone cement within the vertebral body was 3-5mL,average 3.6mL.2 cases of bone cement leakage vertebrae forward,leakage to posterior vertebral body(vertebral canal)in 1 cases,cement leakage rate was 2.8%(3/105),no clinical symptoms.The follow-up period was 6-12 months and the mean follow-up was 7 months.The VAS score between postoperative 48 h and before operation had statistically significant difference[(2.3±0.4)points vs.(7.7±0.7)points,t=-38.72,P<0.05].The VAS score of the last follow-up was(2.2±0.5)points,which was significantly different compared with that before operation(t=-39.21,P<0.05).Conclusion PVP can effectively alleviate the pain caused by osteoporotic compression fractures and improve dysfunction,bone cement manipulation operation preferably dispersed in the fracture line can better improve efficacy.
3.Bibliometric analysis on research of Ebola virus and Ebola virus disease
Changying CHEN ; Li HAO ; Yating FENG
Chinese Journal of Infectious Diseases 2015;33(1):9-13
Objective To get a knowledge of the current status of international research on Ebola virus and Ebola virus disease (EVD).Methods All the articles about EVD from PubMed database were retrieved and analyzed.After core subject headings had been identified by BICOMB,the co-occurrence matrix was established.Cluster analysis about co-occurrence matrix was performed by SPSS 19.0.The visualized network image was drawn by Ucinet 6.0.Results A total of 1 384 literatures were involved in the analysis,with the earliest one published in 1979.The number of literatures was increasing along with time and disease outbreaks.Totally 1 213 (87.6%) literatures were published by Europe and U.S.There were 27 core subjects and they were clustered into 3 research areas from 1979 to 2014,including Ebola virus genome structure and viral proteins,especially the envelope protein; immunology of Ebola virus and animal models; epidemiology,diagnosis and treatment of Ebola hemorrhagic fever.The visualized social network reflected that the prevention of EVD,the genome and immunology of Ebola were the major concerns.Conclusion It has been 35 years since the literatures on Ebola virus and EVD emerged.The United States and the United Kingdom are the top two countries in this field.The present studies have laid a crucial foundations for developing effective vaccines and diagnostic reagents.
4.Study on focal distance of II type uterine fibroids under mucous membrane treated by high intensity focused ultrasound ablation
Rujian ZHANG ; Xiangdong CHEN ; Minqing FENG ; Liting CHEN ; Hao WANG
Chinese Journal of Primary Medicine and Pharmacy 2016;23(12):1835-1839,1840
Objective To assess the relationship between endometrium damage and focal distance of high intensity focused ultrasound ablation(HIFU).Methods 150 patients with requirement of atoke from Ⅱ type uterine fibroids under HIFU were collected and divided into two groups by the location of fibroids,one was antetheca group, and the other was posterior group,which were further divided into three groups,A group(25 cases),B group(25 cases), and C group(25 cases),in which their distance were 15mm,18mm,and 20mm from endometrium respectively.Those patients were treated with HIFU,and improvement of symptoms was assessed by uterine fibroids symptom (UFS) score,energy efficiency factor(EEF)was served as total energy required by treatment,the closest distance from mar-gin of necrosis of fibroids to endometrium and the rate of ablation were detected by MRI,as well as integrity of endo-metrium and vaginal bleeding were observed on postoperative 2 days and 3 months.Results After treatment by HIFU,significant improvement of symptoms was found,especially for the fibroids in antetheca(t =3.868,P =0.01), moreover,as for the fibroids in antetheca,the obvious efficacy was found in B group and C group(F =4.711,P <0.05),while for posterior fibroids,the efficacy was not associated with the location of HIFU(F =3.898,P >0.05).In addition,high rate of ablation and low EEF for the fibroids in antetheca was found(t =9.818,11.224,respectively,all P <0.01),and the highest rate of ablation in A group was revealed(F =105.673,P <0.01),followed by that of B group,the worse was C group.While in posterior fibroids,the distance was not associated with the rate of ablation(F =0.485,P >0.05).There was significant difference of integrity rate for endometrium between antetheca and posterior fibroids on postoperative 2 days(93.33% vs.77.33%,χ2 =7.67,P <0.05),and the rate in antetheca fibroids was higher than that of posterior fibroids(94.67% vs.82.67%)on postoperative 3 months.After postoperative 2 days,as for the fibroids in antetheca,the rate of integrity in B group(100.00%)and C group(100.00%)was higher than that in A group(80.00%),while in posterior fibroids,the highest rate was in C group(100.00%),followed by B group, which of A group was the worst(60.00%);After postoperative 3 months,in the fibroids of antetheca,there was no sig-nificant difference of rate between B group and C group,which were higher than that in A group(84.00%),while in posterior fibroids,the highest rate was in C group(100.00%),followed by B group(84.00%).In addition,significant difference between varied focal distance and improvement of vaginal bleeding existed in antetheca and posterior fibroids(P <0.05),for example the score of vaginal bleeding in B group and C group at postoperative 3 months was lower than that in A group(F =7.292,P <0.01),while for posterior fibroids,the efficacy of C group was higher than that of B group(F =14.559,P <0.05 ).Conclusion Although improved efficacy of Ⅱ type uterine fibroids is offered by HIFU,for the minimum damage of endometrium,its focal distance is varied with the locations of fibroids, namely,the safe distance in antetheca is more than 18mm,while that in posterior fibroids is more than 20mm.
5.The effects of additional L-carnitine supplement on plasma free carnitine in preterm infants and its clinical significance
Desheng WANG ; Liyan FENG ; Yanmei CHEN ; Hu HAO ; Zhili CHEN
The Journal of Practical Medicine 2016;32(20):3429-3431
Objective To investigate the changes of plasma free carnitine (FC) concentrations in preterm infants supplemented with L-carnitine, and to provide a reference for routine preterm infants L-carnitine supplements. Methods A total of 99 preterm infants supplemented with 10 mg/(kg·d) L-carnitine on days 2 and 5 after birth, and 65 full term infants from Department of Neonatology, the Fifth People′s Hospital of Dongguan during July 2014 to December 2015 were recruited in this study , and filter-paper blood spots were collected by heel prick on days 1, 3 and 7. FC was measured using electron spray ionization (ESI) tandem mass spectrometry (MS-MS). Results Concentrations of FC decreased steadily from day 1 to day 7 in full term infants , while it remained the same level during the first week after birth as at birth. Additionally, concentrations of FC were significantly higher in preterm infants than full term infants on day 1 after birth. Conclusions The reasonable L-carnitine supplements may keep the levels of plasma FC at the levels at birth , which is important for fatty acid metabolism in preterm infants.
6.Expression and clinical significance of long chain non-coding RNA LOC285194 in human breast cancer tissue
Qiuxia HUANG ; Gang CHEN ; Zhenbo FENG ; Kanglai WEI ; Hao CHEN
Chongqing Medicine 2017;46(9):1223-1225
Objective To investigate the expression of long chain non-coding(lnc) RNA LOC285194 in breast cancer tissue and paracancerous tissue and its clinical significance.Methods Forty-two samples of paraffin embedded breast cancer tissue and 16 samples of paraffin embedded paracancerous tissue were selected.The expression of lncRNA LOC285194 in these tissue were detected by using quantitative real-time polymerase chain reaction(PCR).Then its correlation with clinicopathological features was analyzed.Results The expression level of lncRNA LOC285194 in breast cancer tissue was significantly lower that in the paracancerous tissue (P<0.01);the level of lncRNA LOC285194 in human epidermal growth factor receptor-2(HER2)overexpression tissues was up-regulated compared with HER2 negative breast cancer tissue(P =0.013),there was a positive correlation between them(r=0.385,P=0.012).Conclusion lncRNA LOC285194 may play the role of cancer suppressor gene and may be involved in the generation of breast cancer by HER2 association,which may become a target gene of breast cancer treatment.
7.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
8.Development of a computerized three-dimension system for displaying and analyzing mandibular helical axis pathways.
Li CHEN ; Hao ZHANG ; Hailan FENG ; Fengjun ZHANG
Journal of Biomedical Engineering 2014;31(6):1233-1237
This paper is aimed to develop a computerized three dimensional system for displaying and analyzing mandibular helical axis pathways. Mandibular movements were recorded using a six-degrees-of-freedom ultrasonic jaw movement recording device. The three-dimensional digital models of the midface and the mandible were reconstructed and segmented from CT skull images. The digital models were then transformed to the coordinate system of mandibular motion data by using an optical measuring system. The system was programmed on the base of the Visualization ToolKit and Open Scene Graphics Library. According to the motion data, transformation matrices were calculated to simulate mandibular movements. Meanwhile, mandibular helical axis pathways were calculated and displayed three dimensionally by means of an eigenvalues method. The following parameters of mandibular helical axis were calculated: the rotation around instantaneous helical axis, the translation along it, its spatial orientation, its position and distance relative to any special reference point. These parameters could be exported to describe comprehensively the whole mandiblular movements. It could be concluded that our system would contribute to the study of mandiblular helical axis pathways.
Humans
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Imaging, Three-Dimensional
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Mandible
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Models, Anatomic
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Movement
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Rotation
9.The relation between acute biliary pancreatitis and anomalous pancreaticobiliary ductal union
Xiaofei JIANG ; Feng CHEN ; Lei CAI ; Weiyan XU ; Hao YUAN
Chinese Journal of Pancreatology 2008;8(3):162-164
Objective To investigate the relationship between acute biliary pancreatitis (ABP) and anomalous pancreaticobiliary duetal union (APBDU). Methods 131 patients with ABP were enrolled to test the serum total bilirubin (TB), alanine amintransferase (ALT), aspartate amintransferase (AST), alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT). All the patients received medical treatment, and then these tests were performed again. Thereafter, all the patients underwent selective surgery and intra-operative cholangiography was performed to observe the pancreaticobiliary duetal union. Results 27 patients (20.6%) with APBDU were found in 131 patients. Among them, 8 cases (29.6%) was B-P subtype (TypeⅠ), 16 cases (59.3%) was P-B subtype (TypeⅡ) , and the remaining 3 cases was mixed subtype (TypeⅢ). A significant decrease of ALT, AST, ALP, γ-GT after non-surgical treatment in both group of APBDU and NAPBDU was noted (P<0.05). The serum levels of ALT, AST,γ-GT in APBDU patients were (71.81± 23.19) U/L, (47.85±27.87) U/L, (52.86±31.49) U/L, respectively; and in NAPBDU patients were (51.96±15.40) U/L, (40.77±16.58) U/L, (34.86±26.47) U/L. The difference was statistically significant (P<0.05). Condusions APBDU is an important etiology of ABP.
10.Relationship of statistics and data management in clinical trials.
Feng CHEN ; Hualong SUN ; Tong SHEN ; Hao YU
Acta Pharmaceutica Sinica 2015;50(11):1420-4
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.