Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Biostatistics ; Clinical Trials as Topic ; Data Accuracy ; Databases, Factual ; Reproducibility of Results

Acupuncture Therapy ; instrumentation ; Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Hot Temperature ; Humans ; Male ; Mumps ; therapy ; Sulfur ; chemistry ; Young Adult

[ ABSTRACT] AIM:To investigate the effects of sinapic acid ( SA) on the proliferation and apoptosis of rat vas-cular smooth muscle cells (VSMCs) induced by high glucose (HG).METHODS:Cultured A7r5 cells were randomly di-vided and treated as indicated.The cell viability was determined by MTT assay.DNA synthesis was measured by BrdU as-say.Cell cycle progression and cell apoptotic rate were determined by flow cytometry analysis.The levels of reactive oxygen species (ROS) were detected by ELISA.The protein levels of cyclin D1, P21, P27, phosphorylated protein kinase C (p-PKC), p-P38 andβ-actin were evaluated by Western blot.RESULTS:Compared with control group, the viability of A7r5 cells was significantly enhanced, the DNA synthesis was increased, the cell cycle progression was promoted, the levels of ROS were elevated, the cell apoptotic rate was reduced, the protein expression of P21 and P27 was decreased, and the pro-tein levels of cyclin D1, p-PKC and p-P38 were increased in HG group (all P<0.05).These effects were reversed by SA (0.1, 1 and 10 μmol/L) treatment in a dose-dependent manner (all P<0.05).Both P38 inhibitor SB203580 and PKC inhibitor chelerythrine significantly inhibit HG-induced PKC/P38 activation and cell viability ( P <0.05).CONCLU-SION:SA inhibits HG-induced VSMCs proliferation and promotes cell apoptosis via reducing PKC/P38 activation.

OBJECTIVETo observe clinical therapeutic effect of moxibustion on abnormal blood lipids.

METHODSThe patients who did not take the medicine for regulating blood lipids and had still abnormal blood lipids after diet therapy for 3 months, were divided into 4 groups according to different types of abnormal blood lipids. Forty cases selected in each group were again divided randomly into a treatment group and a control group. The treatment group were treated with moxibustion at Shousanli (LI 10), Zusanli (ST 36) and Shenque (CV 3) on the basis of diet therapy, and the control group only with the diet therapy. Their therapeutic effects were observed and compared after treatment of 90 days.

RESULTSThere were significant differences between the treatment group and the control group in various groups of different types of abnormal blood lipids (P < 0.05).

CONCLUSIONMoxibustion at Shousanli (LI 10), Zusanli (ST 36) and Shenque (CV 3) has a better therapeutic effect on abnormal blood lipids.

Acupuncture Points ; Biomedical Research ; Humans ; Lipids ; blood ; Medicine, Chinese Traditional ; Moxibustion

Objective To explore the determinants of Alzheimer' s disease (AD) patients with depression.Methods The degree of depression on AD patients was assessed by the geriatric depression scale.Improved cumulative logistic regression (ICLR) was used to analyze the determinants of AD patients with depression.Results 196 AD patients were investigated.Among the 196 AD patients,there were 60(30.6％ ) males and 136(69.4％ ) females,at 58-89 years of age (72.3 ± 6.0).Physical activity,diabetes,MoCA,hearing,economic sources and alcohol were related to the degree of depression of AD patients (P＜0.10 ).The difference between “normal” and “mild depression” was smaller than difference between “mild depression” and “severe depression”.Conclusion AD patients with mild depression were the target population for prevention and they were influenced by several factors listed above.

Purpose: To evaluate the use of signal intensity index (SII) of skull-base invasion in nasopharyngeal carcinoma (NPC) using magnetic resonance imaging (MRI), select a best cut-off SII value to predict the outcome of NPC. Materials and Methods: One hundred and twenty-two NPC patients (92 men, 30 women) with skull-base invasion were included. All patients underwent MRI, signal intensities on T1-weighted imaging (T1WI) were measured for each invaded site and its contralateral normal counterpart. The SIIs were calculated, receiver operating characteristic curves were constructed. The optimal cut-off values were extracted. The overall survival (OS) rates of 5-year follow-up were performed. Results: Sensitivities for differentiating skull-base invasion from normal contralateral anatomy were 98.9%, 88.5% and 70.0%, and specificities were 98.9%, 96.0% and 74.4%, respectively. There were three cut-off values for differentiating invasion from normal anatomy of skull-base, 49%, 98%, and 60%. Significant difference in OS rates (84.2% vs. 57.1%, p=0.007) was seen for SII threshold values > 60% and those ≤ 60%. Conclusions: The SII might be a useful means of differentiating invasion from normal tissue at the skull-base in NPC. The cut-off value of quantitative SII at the skull-base may aid in monitoring the response to treatment of NPC patients.

OBJECTIVETo investigate the clinical effect of atlantoaxial pedicle screw internal fixation for treatment of atlantoaxial dislocation.

METHODSSixteen patients with atlantoaxial dislocation were treated from Dec. 2005 to June 2007, included 10 males and 6 females, aged from 38 to 45 years old (means 40.5 years). Among them 12 patients combined with nerve injury, according to ASIA grade: there were 3 cases in grade B, 5 cases in grade C, 4 cases in grade D. All patients received preoperative CT, radiograph and skull traction. Intraoperative posterior approach general spine pedicle screw-rod orthopaedics fixation system used and iliac bone block were implanted in space of posterior atlantal arch and axial vertebral plate. The outcome and complications were observed in the near future.

RESULTSThere was no vascular or neural injury found. The patients were followed up for 12 to 24 months (means 18 months). All head pain, acid storm symptoms were improved after operation. According to the Odom's clinical efficacy evaluation standard, 12 cases were excellent, 4 were good. Eleven cases of 12 with nerve injury recovered significantly. By ASIA classification: 1 cases was in grade B, 2 cases were in grade C, 5 cases were in grade D, 4 cases were in grade E. No looseness or breakage of screw occurred. Bony fusion was achieved in all cases.

CONCLUSIONPosterior approach atlantoaxial pedicle screw internal fixation have the advantages of direct screw placement, short-segment fusion, intraoperative reduction, fixation reliable, high fusion rate, and it can restablish the upper cervical vertebrae stability and help to recover the spinal cord and nerve function.

Adult ; Atlanto-Axial Joint ; diagnostic imaging ; injuries ; physiopathology ; surgery ; Bone Screws ; Female ; Fracture Fixation, Internal ; instrumentation ; Humans ; Joint Dislocations ; diagnostic imaging ; physiopathology ; surgery ; therapy ; Male ; Middle Aged ; Tomography, X-Ray Computed ; Treatment Outcome

Objective To assese the healing of stoma after magnetic anastomosis for the reconstruction of biliary-enteric continuity under severe inflammation.
Methods Acute bile duct injury was constructed as a bile peritonitis model in mongrel dogs (n=32). Magnetic anastomosis (group A, n=16) and traditional suture anastomosis (group B, n=16) were performed to reconstruct the biliary-enteric continuity in one stage. Half of the dogs in each group were euthanized on the 30th postoperative day, and the other half on the 90th postoperative day to harvest the stoma region. The healing conditions of the stoma after the 2 anastomotic approaches were observed with naked eyes, under light microscope and scanning electron microscope.
Results The stoma leakage rate (50%versus 0%on the 30th postoperative day, 37.5%versus 12.5%on the 90th postoperative day, both P<0.05) and stenosis degree (13.9%±0.3%versus 7.1%±0.3%on the 30th postoperative day, 17.2%±0.4%versus 9.4%±0.4%on the 90th postoperative day, both P<0.01) were significantly higher in group B than in group A. Compared with traditional manual anastomoses, the histological analysis under light and electron microscope showed a more continuous stoma with more regular epithelium proliferation and collagen arrangement, less inflammation in group A.
Conclusions Magnetic anastomosis stent ensures better healing of the stoma even under the circumstance of severe inflammation.

Objective: To evaluate the prognostic significance of minimal residual disease (MRD) monitoring by 10-color flow cytometry in multiple myeloma (MM) patients after treatment. Methods: 150 patients with MM who were admitted to the First Affiliated Hospital of Soochow University from July 2015 to July 2017 were retrospectively analyzed. Clinical data, MRD data monitoring by 10-color flow cytometry and prognosis were analyzed. Results: 39.1% (34/87) patients were MRD negative after induction chemotherapy, and 49.3% (34/69) patients were MRD negative within 1 year after autologous hematopoietic stem cell transplantation (ASCT) . MRD-negative patients after induction chemotherapy or after transplantation have better progress-free survival (PFS) than MRD-positive patients (P=0.022 and P<0.001) . According to the changes of MRD pre-ASCT and after ASCT, the patients were divided into 4 groups: patients with MRD continued negativity,improved from MRD positive to MRD negative, MRD continued positivity, transformed from MRD negative to MRD positive. The two-year PFS of the four groups were 83%, 82%, 44%, 0, respectively, (P=0.002) . Multivariate analysis showed that the level of MRD after induction chemotherapy was an independent factor for PFS (P=0.002) , HR=4.808 (95%CI 1.818-12.718) . Conclusion: Patients with MRD negative after treatment is a better prognosis marker than complete remission or even the best marker, which can evaluate prognosis by combining R-ISS and cytogenetic changes.
Flow Cytometry ; Humans ; Multiple Myeloma/diagnosis* ; Neoplasm, Residual ; Prognosis ; Retrospective Studies ; Transplantation, Autologous

BACKGROUND AND OBJECTIVEThe most effective therapy against renal cell carcinoma (RCC) is surgical treatment; however, there have been few large-scale studies that focused on the oncological outcome of this disease in China. The aim of the current study was to report the clinicopathological results and cancer-specific survival (CSS) rate in RCC patients after surgical treatment in our center.

METHODSWe retrospectively analyzed the clinicopathological data of 336 RCC patients who underwent radical or partial nephrectomy between 1999 and 2006. Of the 336 patients, 226 were male and 110 were female; the median age was 51 years. Univariate and multivariate analyses were conducted to identify the independent prognostic predictors for this cohort of RCC patients.

RESULTSDuring follow-up, the overall 5-year CSS rate was 81.4%. The 5-year CSS rates for patients with stage-I, -II, -III, and -IV RCC were 94.7%, 88.9%, 68.8%, and 19.3%, respectively. The patients with T1N0M0 (T1) and T2N0M0 (T2) tumors had similar survival curves. For patients with T1 category tumor, the survival rate did not differ significantly between the radical nephrectomy and nephron-sparing surgery groups. For the 21 patients with metastasis confined to the local lymph nodes, the 5-year survival rate was 31.6% after radical nephrectomy and lymph node dissection. For the 15 patients with vena caval tumor thrombus, the 5-year survival rate was 52.5% after radical nephrectomy and tumor thrombus extirpation. Multivariate Cox regression showed that stage was an independent predictor for CSS (hazard ratio, 3.359; P < 0.001).

CONCLUSIONSFor localized RCC, the oncological outcome of this cohort is comparable to that reported in the Western literature. For some patients with locally advanced RCC, aggressive surgical treatment can lead to better long-term survival. However, the prognosis of the patients with metastasis still needs to be improved.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Carcinoma, Renal Cell ; pathology ; surgery ; Child ; Child, Preschool ; Cohort Studies ; Female ; Follow-Up Studies ; Humans ; Kidney Neoplasms ; pathology ; surgery ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Neoplastic Cells, Circulating ; Nephrectomy ; methods ; Retrospective Studies ; Survival Rate ; Treatment Outcome ; Young Adult