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

Cardiac toxicity is found in frequently used chemotherapeutic agents.There are many factors related to the cardiac toxicity caused by chemotherapeutic agents.The common cardiovascular complications include heart failure,ischemia,hypertension,hypotension,edema,QT prolongation,pleural effusion,pericardial effusion,bradyarrhythmia and thromboembolism.It is necessary to monitor the left ventricular function before and after chemotherapy and take effective measures to protect myocardium.

Objective To investigate the cause of high cardiovascular lethality in patients with diabetics mellitus. Methods Sections from autopsied coronary arteries and myocardium of dead patients with non-insulin-dependent diabetics mellitus and 12 dead control subjects were used for histomorphometric studies. Results The coronary atherosclerotic lesion in diabetics patients was not different in severity from those in controls. Nor was there difference in number of myofibers or diameters of myocardic fibers and capillaries.But the capillary density and the ratio of capillary number to myocardic fiber number in diabetics group were significeantly reduced compared with control group(P<0.0 l),and the capillary basement membrane in the former was significantly thicker than in the latter(P<0.01).Conclision The decrease in number of capillaries and the thickening of basement membrane enhance myocardiac vulnerability to further ischemia and hypoxia,which may undelie high lethality of myocardiopathy in diabetic patients.

In this paper, the chloroplast psbK-psbI intergenic spacers of 18 species of Dendrobium and their adulterants were amplified and sequenced, and then the sequence characteristics were analyzed. The sequence lengths of chloroplast psbK-psbI regions of Dendrobium ranged from 474 to 513 bp and the GC contents were 25.4%-27.6%. The variable sites were 71 while the informative sites were 46. The inter-specific genetic distances calculated by Kimura 2-parameter (K2P) of Dendrobium were 0.006 1-0.058 1, with an average of 0.028 4. The K2P genetic distances between Dendrobium species and Bulbophyllum odoratissimum were 0.093 2-0.120 4. The NJ tree showed that the Dendrobium species can be easily differentiated from each other and 6 samples of the inspected Dendrobium species were identified successfully through sequencing the psbK-psbI intergenic spacer. Therefore, the chloroplast psbK-psbI intergenic spacer can be used as a candidate marker to identify Dendrobium species and its adulterants.
Chloroplasts ; DNA, Chloroplast ; genetics ; DNA, Plant ; genetics ; DNA, Ribosomal Spacer ; genetics ; Dendrobium ; classification ; genetics ; Plants, Medicinal ; classification ; genetics

OBJECTIVETo identify the Cynomorii Herba and its analogues species using DNA barcoding technique.

METHODTotal genomic DNA extracted from all materials using the DNA extraction kit. The internal transcribed spacer 2 (ITS2) regions were amplified using polymerase chain reaction (PCR), and purified PCR products were sequenced bi-directionally. Sequence assembly and consensus sequence generation were performed using the CodonCode Aligner 3.7.1. The Kimura 2-Parameter (K2P) distances and GC content were computed using MEGA 5. 0. Species identification analyses were conducted through the species identification system for traditional Chinese medicine and neighbor-joining (NJ) trees.

RESULTThe ITS2 sequence lengths of Cynomorii Herba were 229 bp. The average intra-specific genetic distances of Cynomorii Herba were 0.003. The average inter-specific genetic distances between Cynomorii Herba and its adulterants species were 0.760. The results showed that the minimum inter-specific divergence is larger than the maximum intra-specific divergence. The species identification system for traditional Chinese medicine and NJ trees results indicated that Cynomorii Herba and its adulterants species can be easily identification.

CONCLUSIONThe ITS2 region is an efficient barcode for identification of Cynomorii Herba, which provide a new technique to ensure clinical safety in utilization of traditional Chinese medicine.

In this paper, the chloroplast psbK-psbI intergenic spacers of 18 species of Dendrobium and their adulterants were amplified and sequenced, and then the sequence characteristics were analyzed. The sequence lengths of chloroplast psbK-psbI regions of Dendrobium ranged from 474 to 513 bp and the GC contents were 25.4%-27.6%. The variable sites were 71 while the informative sites were 46. The inter-specific genetic distances calculated by Kimura 2-parameter (K2P) of Dendrobium were 0.006 1-0.058 1, with an average of 0.028 4. The K2P genetic distances between Dendrobium species and Bulbophyllum odoratissimum were 0.093 2-0.120 4. The NJ tree showed that the Dendrobium species can be easily differentiated from each other and 6 samples of the inspected Dendrobium species were identified successfully through sequencing the psbK-psbI intergenic spacer. Therefore, the chloroplast psbK-psbI intergenic spacer can be used as a candidate marker to identify Dendrobium species and its adulterants.

Objective:To investigate the effect of staphylococcus aureus on expressions of inducible nitric oxide synthase (iNOS) and interleukin-1 beta (IL-1β) in THP-1 monocytes under high glucose concentrations. Methods:THP- 1 monocytes were incubated at different surroundings with 2×2 factorial design. There were 4 experimental groups in the study, which were analyzed by univariate analysis of variance. The total RNA was distilled. The expressions of iNOS and IL-1β were examined by SQ-RT-PCR. Results:The expressions of iNOS and IL-1β were affected by high glucose concentration, bacteria and both of them together in THP-1 monocytes. The expressions of iNOS and IL-1β were weakened in high glucose concentration compared with that of control(P < 0.01). The expressions of iNOS and IL-1β were weakened in the high glucose concentration and bacterial infection compared with that of the high glucose concentration only(P < 0.01). The expressions of iNOS and IL-1β increased in bacterial infection compared with that of control(P < 0.01). The expression of IL-1β increased in high glucose concentration and bacterial infection compared with that of the high glucose concentration only(P < 0.01) but the expression of iNOS was not distinct. Conclusion:When staphylococcus aureus infected monocytes, the expressions of iNOS and IL-1β were weakened in high glucose concentration, which suggested that the depressed function of immunocyte was related with high glucose concentration.

Objective To investigate the effects of iodine excess on mitochondrial superoxide production and mitoehondrial membrane potential(△ψ)changes in Fisher rat thyroid cell line(FRTL)cells.Methods FRTL cells were treated with 10-4mol/L potassium iodine(KI),10 U/L thyrotropin(TSH),10-4 mol/L KI+10 U/L TSH respectively for 24 h.Effects on cell proliferation were assayed by methyl thiazolyl tetrazolium(MTT)colorimetric method.Changes of mitochondrial superoxide production and △ψ were measured by live cell imaging and spectrofluorometer using MitoSOX and rhodamine 123(rh123)respectively.Results Absorbance(A)in the KI group (0.794±0.144)showed a significant decline compared to the control group(1.000 ±0.183,P<0.05),whereas a significant elevation was observed in the TSH group(1.215±0.156,P<0.05).No significant differences was found between the KI+TSH group(1.025±0.254)and the control group(P>0.05),but the former was marked higher than the KI group(P<0.05).Compared to the control group(9.74±3.24).MitoSOX mean fluorescence intensity (MFI)in the KI and KI+TSH groups(18.16±6.57,13.33±2.92)were significantly increased(all P<0.05),which was a significant decline in the TSH group(6.64±2.15,P<0.05).MitoSOX MFI in the KI+TSH group was lower than the KI group(P<0.05).Rh123 MFI in the KI and KI+TSH groups(210 593±31 328,295 525±34 243)showed significant decline than the control group(407 824±37 198,all P<0.05).Compared with the KI group.the KI+TSH group pronouncedly attenuated the reduction of Rh 123 MFI(P<0.05).No significant differences of Rh 123 MFI were found between the TSH group(411 187 ± 72 852) and the control group(P > 0.05). Conclusion Iodine excess (10-4 mol/L KI) may lead to peroxide damage on the mitochondria of FRTL cells, and cell proliferation is inhibited. Combining treatment with 10 U/L TSH may attenuate mitochondrial peroxide damage and inhibition of cell proliferation caused by iodine excess.

Objective To compare the efficacy of ureteroscopic lithotripsy(URL)combined with occlusion device and the supine and lithotomy position mini-invasive percutaneous nephrolithotomy(mPCNL)in the treatment of upper incarcerated ureteral stones. No difference could be found in age,sex and size of stones between the two groups. Method From Jan. 2014 to Dec. 2016 in our hospital,all cases of upper incarcerated ureteral stones were diviede into two groups:52 in ureteroscopic lithotripsy combined with occlusion device group and 45 in mini-inva-sive percutaneous nephrolithotomy group. Result The hospitalization and operation time in URL group were(5.5 ± 1.4)days and(53.3 ± 12.4)mins,which were significantly shorter than that in mPCNL group with(9.1 ± 3.2)days and(78.2 ± 14.1)mins,(P<0.05). There were no differences between mPCNL and URL groups in the success rate of operation(97.8% vs 94.2%,P > 0.05),stone clearance rate(100% vs 91.8,P > 0.05)and complication rate (4.4%vs 3.9%,P>0.05). Conclusion URL combined with occlusion device can obtain satifactory results as well as the supine and lithotomy position mPCNL in the treatment of upper incarcerated ureteral stones.

Objective To examine the effect function of platelet(Pt)assemble rate(PLTAR) and the change of protein kinase B(PKB) active by cilostazol (CS)and aspirin (AS)on elderly patients with acute coronary sydrome(ACS). Methods Forty-eight elderly patients with ACS were divided randomly into two groups:CS group (100 mg,n=26),AS group (300 mg,n=22).Twenty-six healthy elderly were into the group of normal control(NC group) . The CS group and AS group were treated by routine anticoagulation and antiplatelet.PLTAR and PKB activity were measured at 10 minutes before treatment and at 7 days after treatment 3.5,6.0,24.0 hours. Results The maximum PLTAR in elderly CS group and AS group was elevated significantly compared with NC group(P