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

Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Pneumoconiosis ; diagnostic imaging ; Radiography, Thoracic ; methods ; Tomography, X-Ray Computed

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.

Objective To introduce a new classification system for femoral intertrochanteric fractures and propose classification to assist surgical management.Methods A total of 176 cases of femoral intertrochanteric fractures treated from September 2007 to October 2011 were enrolled in the study.X-ray and three-dimensional spiral CT reconstruction were performed to define fracture shape,location,number of major fragments and displaced direction.As combined with the intraoperative findings and cadaveric anatomical study,the femoral intertrochateric fractures was simulated using a three-dimensional entity of normal proximal femur produced by Mimics 11.1 program.A new classification system for femoral intertrochateric fractures was proposed.Results The new system categorized intertrochateric fractures of the femur into five types (Type Ⅰ,Type Ⅱ,Type Ⅲ,Type Ⅳ and Type Ⅴ) based on the integrity or destruction of the medial column,lateral column and posterior column set and divided on the basis of bone connection of femoral head-neck fracture fragments with the bone in intertrochanteric region.Conclusions The new classification system with introduction of three-column concept is brief and practical and has a clear definition of fracture stability.Besides,the new classification-based treatment is recommended.

OBJECTIVETo investigate the clinical effects of close reduction and minimally invasive percutaneous plate osteosynthesis in treating proximal humerus fractures in the aged.

METHODSFrom February 2012 to December 2013,39 patients with proximal humerus fractures were treated with minimally invasive percutaneous plate osteosynthesis (MIPPO group, 21 cases) and open reduction internal fixation (ORIF group, 18 cases). Including 17 males and 22 females in the study, and aged from 67 to 88 years old with an average of (71.8 ± 5.2) years old. In MIPPO group, there were 11 males and 10 females with an average age of (70.0 ± 5.3) years old;and in ORIF group, there were 10 males and 8 females with an average age of (72.0 ± 4.2) years old. Operation time, blood loss during operation, fracture healing time and postoperative complications were recorded. The functions of the shoulder joints were assessed according to Constant-Murley score at final follow-up.

RESULTSAll the patients were followed up from 11 to 27 months with an average of 18.1 months. The mean blood loss of the MIPPO group was (176.0 ± 57.4) ml,while the ORIF group was (356.0 ± 66.9) ml (t = 7.22,P = 0.01). The operation time of the MIPPO group was (47.4 ± 14.9) min, while the ORIF group was (92.7 ± 15.8) min (t = 0.79, P = 0.03). Fracture healing time in the MIPPO group and ORIF group was (17.6 ± 5.8), ( 21.7 ± 4.9) weeks, respectively (P < 0.05). The mean Constant-Murley score at final follow-up was 89.7 ± 14.5 in MIPPO group, and 81.8 ± 13.2 in ORIF group (P < 0.05).

CONCLUSIONMIPPO has advantages of little trauma, less blood loss, rapid recovery, less vascular damage and so on and can effectively treat the proximal humerus fracture in the aged.

Aged ; Aged, 80 and over ; Bone Plates ; Case-Control Studies ; Female ; Fracture Fixation, Internal ; methods ; Humans ; Male ; Minimally Invasive Surgical Procedures ; Shoulder Fractures ; surgery

OBJECTIVETo study the effect of Wenmaitong (WMT) and its disassembled formulas on the adhesion of monocytes to endothelial cells induced by hyperlipidemic serum to explore the mechanism of WMT on early arteriosclerosis obliterans (ASO).

METHODSSerums containing whole WMT and its disassembled formulas, including the formula consisted of warming Jing and boosting qi part (Wenjin Yiqi, WY) and that of promoting blood circulation part (Huoxue Tongmai, HT), as well as the serum contained high concentration of lipids were prepared conventionally, respectively. The adhesion of monocytes cell strain THP-1 to human umbilical vascular endothelial cells (HUVEC) was determined by rose bengal stain method, and ELISA was used to detect expressions of intercellular adhesion molecule (ICAM-1), vascular cellular adhesion molecule (VCAM-1) and P-selectin on HUVEC surface.

RESULTSWMT could inhibit THP-1 to HUVEC adhesion induced by hyperlipidemic serum, and down-regulate the expression of ICAM-1, VCAM-1, P-selectin on HUVEC surface, the two disassembled formulas could down-regulate different adhesion molecules.

CONCLUSIONOne mechanism of WMT on ASO may be its inhibition on arteriosclerosis by way of down-regulating the expression of vascular endothelial cells adhesion molecules to decrease the adhesion of monocyte to VEC, therefore to inhibit the monocytes migrating into vascular intima to develop foam cells.

Animals ; Cell Adhesion ; drug effects ; Cell Line ; Down-Regulation ; drug effects ; Drugs, Chinese Herbal ; pharmacology ; Endothelial Cells ; cytology ; drug effects ; metabolism ; Enzyme-Linked Immunosorbent Assay ; Humans ; Hyperlipidemias ; blood ; Intercellular Adhesion Molecule-1 ; biosynthesis ; Male ; Monocytes ; cytology ; drug effects ; metabolism ; Rabbits ; Serum ; Vascular Cell Adhesion Molecule-1 ; biosynthesis

OBJECTIVETo discuss the efficacy of the myogenic elephant skin cream combining with VSD for treating severe bedsores.

METHODSTwenty-nine cases of III and IV degree bedsores were treated from June 2009 to June 2013. Among them, 15 cases were treated by myogenic elephant skin cream combined with VSD (VSD group) including 7 males and 8 females with an average age of (69.0±5.3) years old ranging from 17 to 96 years;other 14 cases were treated by the treatment of conventional dressing change (control group) including 6 males and 8 females with an average age of (71.0±4.2) years old ranging from 40 to 86 years. At 7, 14, 21, 28 d after treatments, specimens of wound two groups were respectively taken to examine immunohistochemical CD34 adopted SABC, the number of wild vascular cross were observed as capillary density value under high magnification microscope. It was used to assess the hyperplasia of granulation tissue of wound. The capillary density value and the visual wound observation were indicators for evaluation of clinical efficacy.

RESULTSSeventeen of 19 cases got complete data of specimens of wound at 7, 14, 21, 28 d,included 9 cases of VSD group,8 of control group. In the microscope view, the capillary density of VSD group was higher than that of control group significantly (P<0.05), it showed the application of VSD technology improved hyperplasia of granulation tissue much faster than conventional dressing change. In VSD group, 13 cases with 15 wounds healed, 2 cases with 3 wounds improved; in control group,3 cases with 3 wounds healed,7 cases with 9 wounds improved, 4 cases with 5 wounds were unhealed.

CONCLUSIONUsing the VSD technology with continuous high pressure suction to clean the drainage of wound and lacuna thoroughly can effectively control infection,promote the growth of granulation tissue, and then applying myogenic elephant skin cream to improve partial blood supply while prompting rapid growth of new granulation tissue and epithelial cell. The risk of this treatment is low,and the course of treatment is short, this provides a safe and effective method for treating bedsores.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Drainage ; methods ; Female ; Humans ; Male ; Middle Aged ; Pressure Ulcer ; therapy ; Skin Cream ; therapeutic use

Objective To observe the primary clinical results of Gore （R） Viabahn endoprosthesis for atherosclerotic stenosis or occlusion in superficial femoral artery (SFA).Methods From March 2013 to November 2013,45 consecutive patients (54 limbs) who had ischemic symptom due to stenosis or occlusion of superficial femoral artery were treated by endovascular deployment of Gore （R） Viabahn endoprosthesis.We observed patency rate,improvement of Rutherford classification and ankle-brachial index,limb salvage rate and survival rate after 1,3 and 6 months.Results 43 patients (52 limbs)were followed-up,among which 32 patients(38 limbs)belonged to TASC Ⅱ type C or type D lesion.The mean (± SD) length of treated segment in 52 limbs was(19 ±4)cm.The rate of postoperative patency on duplex ultrasonography:one month,3 months and 6 months were 96.15％ (50 limbs),92.31％ (48 limbs)and 90.38％ (47 limbs) ; Ankle-brachial index increased from(0.32 ±0.20)to(0.68 ±0.18) (t =3.180,P ＜ 0.005) after 6 months ; at 6 months limb salvage rate was 96.08 percent (49 limbs),and survival rate was 97.67％ (42 patients).Conclusions Implantation of Gore （R） Viabahn endoprosthesis in atherosclerotic stenotic or occluded superficial femoral artery safely achieves a definite primary clinical effectiveness.

OBJECTIVE: To select the most effective method among different masking treatments, such as different thickness and transparence, tissue surface's opaque coating, and opaque resin cement to restore discolored teeth esthetically by porcelain veneer. METHODS: Four extracted intact maxillary central incisors were prepared for porcelain veneer restoration and each three heat pressed porcelain veneers from three thicknesses (0.8 mm, 1.0 mm, 1.2 mm) and two transparency(high transparence, HT and low transparence, LT))in Vita shade A2 were fabricated for each tooth, in total of 72 pieces. The surfaces of three prepared teeth were then painted to mimic situations of severe dental fluorosis, severe tetracycline teeth, and necrotic teeth. Each of the veneers was temporarily cemented to the corresponding tooth surface using try-in cements with three different colors (transparent, opaque, and yellow), then used the shade guide (3D master) and electronic colorimeter (easy shade) to record the shade of each porcelain veneer through hue, lightness, and chroma reading. After that, high-transparence porcelain veneers in thickness of 0.8 mm was fused with a layer of opaque porcelain in tissue surface, and were shade matched again after cementation. Statistic treatments were performed to analyze the difference in each masking method. RESULTS: For each 0.2 mm increase in the veneer thickness of porcelain, the average lightness was reduced by 1 unit, while the chroma was not changed which was independent of the type of the resin cements. When the thickness of the porcelain veneer was decreased to 0.8 mm, the opacity effect was not remarkable even if a low-transparence porcelain veneer was used. Transparent and yellow resin cements had poor opaque performance, while opaque resin cement could reduce the lightness by 2 units and the chroma was also reduced. The opaque layer of the tissue surface could be applied uniformly, and the lightness and chroma could be reduced to Vita 2M1 to 2M1.5 levels regardless of the color of resin cements, which suggested a stable opacity effect for different discolored teeth in this study. CONCLUSION For porcelain veneer restoration of discolored teeth, thickened veneers are the most effective means to display a natural transmittance and color. Tissue surface's opacity coatings and opaque resin cements can also be used to reduce grayscale and increase lightness.
Color ; Humans ; Materials Testing ; Prosthesis Coloring ; Resin Cements ; Tooth Discoloration/therapy*

OBJECTIVETo investigate the effects of total flavonoids of Litsea Coreana (TFLC) on the gap junction (GJ) intercellular communication in TM3 testicular Leydig cells and whether TFLC can reduce the cytotoxicity of oxaliplatin (OHP) in vitro.

METHODSWe detected the effect of TFLC on the dye spread of the in vitro cultured TM3 cells by parachute assay, observed changes in the expression of connexin 43 (Cx43) total protein in the TFLC-treated TM3 cells by Western blot, and determined the effects of TFLC on the expression of Cx43 on the membrane of the TM3 cells by immunofluorescence assay and on the cytotoxicity of OHP by MTT assay.

RESULTSTFLC obviously enhanced the GJ function with the increasing of the TFLC concentration in the TM3 cells. Western blot and immunofluorescence assay confirmed that TFLC significantly enhanced the expression of Cx43 total protein and Cx43 expression on the membrane of the TM3 cells. MTT assay showed that at a high cell density (confluent with GJ formation), 20 microg/ml TFLC enhanced the GJ function of the TM3 cells and reduced the cytotoxicity of OHP (P < 0.05), while at a low density (preconfluent with no GJ formation), TFLC exhibited no effect on the cytotoxicity of OHP (P > 0.05).

CONCLUSIONTFLC increases the Cx43 expression and GJ function in normal TM3 Leydig cells, and the enhancement of GJ function reduces the cytotoxicity of OHP.

Antineoplastic Agents ; toxicity ; Cell Communication ; drug effects ; physiology ; Cell Count ; Connexin 43 ; metabolism ; Flavonoids ; pharmacology ; Gap Junctions ; drug effects ; Humans ; In Vitro Techniques ; Leydig Cells ; drug effects ; ultrastructure ; Litsea ; chemistry ; Male ; Organoplatinum Compounds ; antagonists & inhibitors ; toxicity ; Proteins ; metabolism