Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.

ObjectiveTo evaluate the daily vitamin intakes in diets of diabetic patients.MethodsUsing a food questionnaire,the contents of 63 type Ⅱ diabetics(group A) and 64 non diabetics(group B) were recorded and analysised by computer.The daily vitamin intakes were assessed and compared with the Recommend Dietary Allowance(RDA).ResultsThe daily intakes of vitamin B1 and vitamin B2 were both obviously deficient,less than 50% of the RDA.The daily intakes of vitamin E and A were significantly different between group A and group B.ConclusionsThe vitamin intakes of the senile diabetics in diets were inadequate.

Objective To investigate the expression of Rap1 GTPase-activating protein 1 (Rap1GAP),matrix metalloproteinase 2 (MMP-2) and matrix metalloproteinase 9 (MMP-9),and their relation with clinical patterns in colorectal carcinoma.Methods Immunohistochemistry was used to detect the expression of Rap1GAP,MMP-2 and MMP-9 in colorectal carcinoma,villous adenoma,tubular adenoma and normal colorectal tissue,and their relationship with clinicopathological parameters was analyzed.Results The positive rate of Rap1GAP expression was 30.4 ％ (14/46),77.8 ％ (14/18),69.6 ％ (16/23) and 95.2 ％ (20/21) in colorectal carcinoma,villous adenoma,tubular adenoma,and normal colorectal tissue,respectively (x2 =30.659,P=0.000).The figures were 71.7 ％ (33/46),55.6 ％ (10/18),52.2 ％ (12/16) and 9.5 ％ (2/21) for the positive rate of MMP-2 expression (x2 =22.459,P =0.000),as well as for 76.1％ (35/46),61.1％ (11/18),56.5 ％ (13/23) and 14.3 ％ (3/21) for the positive rate of MMP-9 expression,respectively (x2 =22.643,P =0.000).In patients with colorectal carcinoma,the expression of Rap1GAP was correlated with tumor differentiation (x2 =5.275,P =0.022),but not sex,age,or lymphatic metastasis (all P ＞ 0.05).The expression of MMP-2 and MMP-9 were correlated with lymphatic metastasis (x2 =6.661,P =0.010;x2 =8.475,P =0.040),but not sex,age or tumor differentiation(all P ＞ 0.05).There was a negative correlation between expression of Rap1GAP and MMP-2,MMP-9 in colorectal carcinoma,respectively (r =-0.424,P =0.003;r =-0.294,P =0.048),but no correlation between the expression of MMP-2 and MMP-9 (r =0.101,P =0.505).Conclusions Rap1GAP,MMP-2 and MMP-9 play important roles in the malignant biological behavior of colorectal carcinoma,and the expression of Rap1GAP is negatively correlated with MMP-2 and MMP-9.The interactions among the three affect the occurrence and development of colorectal carcinoma.

Objective To investigate the expression and significance of Periostin,VEGF and MMP-9 in breast invasive ductal carcinoma.Methods Immunohistochemistry was employed to detect the expression of Periostin,VEGF and MMP-9 in breast invasive ductal carcinoma and normal breast tissue.Results In breast invasive ductal carcinoma and normal breast tissue,the positive rates of Periostin were 63.8 ％ (37/58) and 0 (x2 =24.272,P =0.000).The figures were 69 ％ (40/58) and 8 ％ (2/25) for the positive rates of VEGF (x2 =25.977,P =0.000),respectively,as well as 70.69 ％ (41/58) and 16.0 ％ (4/25) for the positive rates of MMP-9 (x2 =21.050,P =0.000),respectively.There were significant differences among the groups (P ＜ 0.05).In breast invasive ductal carcinoma,the expression of Periostin was correlated with clinical stage (x2 =4.835,P =0.028),whereas not correlated with age (x2 =1.155,P=0.282),histological grade (x2 =0.05,P =0.972),lymphatic metastasis (x2 =1.660,P =0.198).The expression of VEGF was correlated with clinical stage (x2 =4.230,P =0.040),lymphatic metastasis (x2 =9.667,P =0.002),whereas not correlated with age (x2 =0.506,P =0.477),histological grade (x2 =0.532,P =0.767).The expression of MMP-9 was correlated with clinical stage (x2 =8.456,P =0.004),lymphatic metastasis (x2 =5.494,P =0.019),whereas not correlated with age (x2 =0.153,P =0.695),histological grade (x2 =0.224,P =0.894).The expression of Periostin,VEGF and MMP-9 were positively correlated with each other in breast invasive ductal carcinoma (r =0.348,P =0.001; r =0.303,P =0.021; r =0.469,P =0.000).Conclusion Periostin,VEGF and MMP-9 are correlated closely with the occurrence and development of breast invasive ductal carcinoma,which might be valuable in evaluating the invasiveness,metastasis and prognosis.

Objective To investigate the clinicopathological significance of periostin and MMP-2 in colorectal carcinoma.Methods Immunohistochemistry was used to detect the expression of periostin and MMP-2 in colorectal carcinoma,tubular adenoma,villous adenoma and normal colorectal tissue.The correlations between the expression of periostin and MMP-2 with clinicopathologic parameters were analyzed.Results In colorectal carcinoma,tubular adenoma,villous adenoma and normal colorectal tissue,the positive rates of periostin were 83.7 ％ (41/49),40.0 ％ (6/15),32.1％ (9/28),0 (0/15),respectively,while the positive rates of MMP-2 were 71.4 ％ (35/49),60.0 ％ (9/15),64.3 ％ (18/28),0(0/15),respectively.There were significant differences among the groups (x2 =41.252,P =0.000; x2 =24.811,P =0.000).The expression of periostin in colorectal carcinoma tissue were not correlated with sex (x2 =0.002,P =0.961),age (x2 =2.267,P =0.132),tumor sites (x2 =1.506,P =0.220),differentiation status (x2 =0.875,P =0.350) and lymphatic metastasis (x2 =3.315,P =0.069).The expression of MMP-2 in colorectal carcinoma were correlated with lymphatic metastasis (x2 =5.800,P =0.016),whereas not correlated with sex (x2 =0.562,P =0.453),age (x2 =0.138,P =0.711),tumor sites (x2 =0.408,P =0.532),differentiation degree (x2 =1.335,P =0.248).The expression of periostin and MMP-2 were positively correlated in colorectal carcinoma (r =0.332,P =0.020).Conclusion Periostin and MMP-2 are correlated closely with the development and progression of colorectal carcinoma.It might be helpful for evaluating the biological properties and prognosis of colorectal carcinoma,and it would be more accurate to use a combined analysis of the two indicators.

Objective To explore the methylation status of Rap1 GTPase activating protein (Rap1GAP) promoter in colon cancer, and to provide the oretical basis and research direction for the early diagnosis, targeted therapy, anti-multidrug resistance of colon cancer and so on. Methods The paraffin embedded specimens of 33 patients with colonic adenocarcinoma diagnosed by pathology were analyzed from Department of Pathology of Xinzhou City People′s Hospital from January 2010 to September 2014, including 19 males and 14 females, and aged 41-72 years old. The paraffin embedded specimens of 16 patients with colonic adenoma were enrolled, including 9 males and 7 females, and aged 34-58 years old. 13 normal tissues from the tumor distal margin (from the tumor > 15 cm) were selected. Quantitative methylation specific PCR (q-MSP) was applied to detect methylation level of Rap1GAP gene promoter. The methylation level differences of Rap1GAP gene promoter region among 3 groups or between different clinicopathologic factor subgroups were compared. Results The methylation rates [median (interquartile range)] of Rap1GAP promoter were 65.43 % (50.35 %), 21.37 % (8.39 %) and 17.43 % (15.71 %) in colonic adenocarcinoma group, colonic adenoma group and adjacent normal tissue group, respectively. The methylation rate of colonic adenocarcinoma group was significantly higher than that of colon adenoma group or that of adjacent normal tissue group (P< 0.05). The methylation rates of Rap1GAP promoter in colonic adenocarcinoma were not correlation with age, sex, differentiation and the stage of TNM [ male vs. female: 42.74 % (70.44 %) vs. 21.98%(80.00%);≤60yearsoldvs.>60yearsold:36.26%(62.62%)and26.23%(76.42 %);well-differentiated vs. moderately/poorly-differentiated: 21.98 % (40.32 %) vs. 42.74 % (74.20 %); TNM Ⅰ-Ⅱ vsⅢ-Ⅳ: 25.31 % (48.27 %) vs. 36.26 % (75.55 %); all P> 0.05]. Conclusion The methylation status of RAP1GAP promoter maybe associate with genesis and development of colon cancer, which might be used as a target for early diagnose of colon cancer.

Objective To investigate the expression of signal-induced proliferation-associated gene 1 (SIPA1), Ezrin and E-cadherin (E-cad), and their relationship with clinical patterns in epithelial ovarian carcinoma.Methods Immunohistochemistry was used to detect the expression of SIPA1, Ezrin and E-cad in normal ovarian tissue, benign epithelial ovarian tumor, borderline epithelial ovarian tumor and epithelial ovarian carcinoma,respectively. Results The positive rate of SIPA1 expression was 44.2 % (23/52), 64.5 %(20/31), 93.3 % (28/30) and 100.0 % (15/15) in epithelial ovarian carcinoma, borderline epithelial ovarian tumor, benign epithelial ovarian tumor, and normal ovarian tissue, respectively, and there was a statistical difference (χ2 = 29.159, P= 0.000). The corresponding rates were 57.7 % (30/52), 61.3 % (19/31), 90.0 %(27/30) and 93.3 % (14/15) for the positive rate of Ezrin expression (χ2= 14.555, P= 0.002), as well as for 23.1 % (12/52), 58.1 % (18/31), 86.7 % (26/30) and 0 (0/15) for the positive rate of E-cad expression, respectively (χ2= 45.731, P= 0.000). In patients with epithelial ovarian carcinoma, the expression of SIPA1 was correlated with tumor differentiation (χ2=3.895, P=0.048), but not with histological type and clinical stage (all P>0.05). The expression of Ezrin was not correlated with histological type, tumor differentiation and clinical stage (all P>0.05). There was a positive correlation between expression of E-cad and SIPA1, Ezrin in epithelial ovarian carcinoma, respectively (r= 0.339, P= 0.014; r= 0.284, P= 0.041), but no correlation between the expression of SIPA1 and Ezrin (r= 0.214, P= 0.128). Conclusions SIPA1, Ezrin and E-cad play important roles in the occurrence and development of epithelial ovarian carcinoma. They cooperate in the progression and their combined detection can better evaluate the prognosis of epithelial ovarian carcinoma.

Objective To establish a method for the determination of forsy thin in Baohe Oral Liquid by HPLC.Methods The determination was carried out on a Diamonsil C18 column,with mobile phase of acetonitrile-water(29∶71) at room temperature.The flow rate was 1.0mL?min-1 and the detective wavelength at 277 nm.Results The calibration curves was linear in the range of 0.068～ 0.340 ? g(r=0.9996).The average recovery rate of tested sample was 99.7 %(RSD=2.1 %).Conclusion The method was specific,accurate and precise.It can be used for the quality control of Baohe Oral Liquid.

Objective To explore the effect and mechanism of Cyclosporin A (CsA) and cholic acid on reducing the human liver cell damage induced by α-amanitin (AMA).Methods According to the previous research results,the minimum hepatocellular survival concentration against αt-AMA (1.4 g/L),the experiment was conducted in 5 groups:control group,damage group,glycochenodeoxycholic acid group,CsA group,and CsA combined with cholic acid group (CsA+ taurocholic acid,CsA+ chenodeoxycholic acid,CsA+ glycocholic acid,CsA+ glycochenodeoxycholic acid,and CsA+ taurochenodeoxycholic acid).For each group,there were 3 time points for observation (24 h,48 h and 72 h after attacking),CsA and CsA+ glycochenodeoxycholic acid was used to protect hepatocytes,respectively,and morphological changes in cells were observed with inverted phase contrast microscope,and the live cells were counted by 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2-H-tetrazolium bromide (MTT) method,and aspertate aminot ransferase (AST) and alanine aminotransferase (ALT) in the culture supernatant were detected by biochemical method.Results Compared with the control group,hepatocellular growth in the injury group was obviously suppressed,with progressive cellular apoptosis and significantly decreased absorbance value of MTIT (0.345 ± 0.021);the activity of AST and ALT increased gradually,reaching the highest after 72 h [(98.4 ± 6.7) U/L and (116.2 ± 9.5) U/L,respectively].Compared with injury group,broken organelles decreased significantly and absorbance value elevated in glycochenodeoxycholic acid group,CsA group and CsA combined with cholic acid group,and at each time point,the highest absorbance value in the CsA+ taurochenodeoxycholic acid group [the highest was (0.656 ± 0.014),P ＜ 0.05];at the same time,the activity of AST and ALT didn't increase obviously,at each time point,the lowest in CsA+ taurochenodeoxycholic acid group [the lowest was (22.3 ± 6.2) U/L and (20.2 ± 5.4) U/L,P ＜ 0.05,respectively].Conclusions CsA,as well as cholic acid,can protect human liver cells from the attack of α-AMA.The mechanism may be CsA,as an organic anion transfer peptide in humans (OATP1B1 and OATP1B3) suppressant,inhibits the absorption of α-AMA.The joint application of CsA and taurochenodeoxycholic acid is superior to the single OATP substrate or inhibitor.

Objective:To investigate the effect of segmental Le FortⅠosteotomy and bilateral sagittal split ramus osteotomy ( BSSRO ) on the condyle position in skeletal class Ⅲ malocclusion patients . Methods:In this retrospective study , 19 patients with skeletal class Ⅲmalocclusion who met the inclu-sion criteria were enrolled .All the patients underwent the segmental Le FortⅠ osteotomy and BSSRO . Cone beam computed tomography ( CBCT) scans were performed in the following phases:T1:within one week before the surgeries;T2:within one week post-surgery;T3:three months post-surgery;T4:6 to 14 months post-surgery .The posterior spaces , anterior spaces and the superior spaces of the bilateral tem-poromandibular joints were measured according to the Kamelchuk method respectively .The fossa ratios of the condyle and the distribution of the condyle positions related to the glenoid fossa ( anterior , concentric and posterior position ) were calculated .The results were analyzed statistically .Results:The posterior space , the anterior space and the superior space of bilateral temporomandibular joints in T 2 phase [ right:(2.78 ±1.23) mm, (2.47 ±0.89) mm, (3.07 ±0.85) mm; left: (2.93 ±0.83) mm, (2.69 ± 1.14) mm, (3.44 ±1.16) mm] showed significantly larger spaces than those in T 1 phase [right:(1.81 ±0.95) mm, (1.65 ±0.55) mm, (2.13 ±0.52) mm;left:(2.12 ±1.05) mm, (1.79 ±0.59) mm, (2.15 ±0.93) mm],in T3 phase [right:(2.08 ±1.25) mm, (1.79 ±0.68) mm, (1.80 ±0.76) mm;left: (2.05 ±0.75) mm, (1.99 ±0.94) mm, (2.14 ±0.71) mm] and in T4 phase [right:(1.94 ±0.77) mm, (1.81 ±0.69) mm, (2.05 ±0.69) mm;left:(1.89 ±0.69) mm, (1.80 ±0.61) mm, (2.19 ±0.75) mm], P<0.05.No significant differences were observed among T 1,T3 and T4 pha-ses in the terms of the joint spaces of both sides ( P >0.05).The fossa ratio and the condyle position related to the glenoid fossa had no significant difference in all the four phases (P>0.05).The results suggested that the condyle moved downward in T 2 phase and changed to the original pre-surgery position in T3 phase, then keot stable in T4 phase.Conclusion:Segmental Le FortⅠ osteotomy and BSSRO caused significant and transient changes of the condyle position in skeletal class Ⅲmalocclusion patients . However , the condyle tended to move back to the original pre-surgery position and might keep stable .