Objective To examine the effects of oxidative stress induced damage to the Prestin expression in HEI-OC1 cells,and to study the mechanism of sensory deafness.Methods We used different concentrations (50μM,100μM,200μM)of hydrogen peroxide canister to cultivate HEI-OC1 cells,and to detect the activity of su-peroxide dismutase(SOD).The quantitative real-time PCR and immunofluorescence were used to detect the prestin expression of mRNA.Results The SOD activity decreased in the HEI-OC1 cells damaged by oxidative stress.The high concentration of the infected group decreased more significantly(F= 9926.293,P<0.01).The expressions of Prestin mRNA and Prestin protein were decreased obviously in the HEI-OC1 cells.The high concentration of in-fected group decreased more significantly (F= 4065.046and7657.217,P<0.01).Conclusion Oxidative stress in-ducing damage inhibits the expression of prestin.Prestin protein may be used as a molecular marker of sensory deafness.

Testing of hypothesis was affected by statistical analysis set division which was an important data management work before data base lock-in. Objective division of statistical analysis set under blinding was the guarantee of scientific trial conclusion. All the subjects having accepted at least once trial treatment after randomization should be concluded in safety set. Full analysis set should be close to the intention-to-treat as far as possible. Per protocol set division was the most difficult to control in blinded examination because of more subjectivity than the other two. The objectivity of statistical analysis set division must be guaranteed by the accurate raw data, the comprehensive data check and the scientific discussion, all of which were the strict requirement of data management. Proper division of statistical analysis set objectively and scientifically is an important approach to improve the data management quality.
Clinical Trials as Topic ; standards ; Databases, Factual ; Research Design ; standards ; Statistics as Topic

Missing data is a common but unavoidable issue in clinical trials. It not only lowers the trial power, but brings the bias to the trial results. Therefore, on one hand, the missing data handling methods are employed in data analysis. On the other hand, it is vital to prevent the missing data in the trials. Prevention of missing data should take the first place. From the perspective of data, firstly, some measures should be taken at the stages of protocol design, data collection and data check to enhance the patients' compliance and reduce the unnecessary missing data. Secondly, the causes of confirmed missing data in the trials should be notified and recorded in detail, which are very important to determine the mechanism of missing data and choose the suitable missing data handling methods, e.g., last observation carried forward (LOCF); multiple imputation (MI); mixed-effect model repeated measure (MMRM), etc.
Clinical Trials as Topic ; Data Collection ; methods ; standards ; Humans ; Models, Theoretical ; Research Design

Objective The purpose of this study was to develop a high-throughput micro-plate radiobinding assay (RBA) of glutamic acid decarboxylase antibody (GAD-Ab) and to evaluate its clinical application. Methods 35labeled GAD65 antigen was incubated with sera for 24 h on a 96-well plate, and then transferred to the Millipore plate coated with protein A, which was washed with 4℃ PBS buffer, and then counted by a liquid scintillation counter. The GAD-Ab results were expressed by WHO standard unit (U/ml). A total of 224 healthy controls, 162 patients with type 1 diabetes mellitus(T1DM) and 210 patients with newly diagnosed type 2 diabetes (T2DM) were recruited. A total of 119 TI DM and healthy cases with gradually changing GAD-Ab levels were selected to compare the consistency of micro-plate RBA with conventional radioligand assay (RLA). Blood samples were obtained from the peripheral vein and finger tip in 32 healthy controls, 35 T1DM and 24 T2DM patients, and tested with micro-plate RBA and then compared with the conventional RLA to investigate the reliability of finger tip sampling. Linear correlation,student's t-test, variance analysis and receiver operating characteristic (ROC) curve were performed using SPSS 11.5. Results (1) The optimized conditions of micro-plate RBA included 2 μl serum incubated with3 ×104 counts/min 35S-GAD for 24 h under slow vibration, antigen-antibody compounds washed 10 times by 4℃ PBS buffer, and radioactivity counted with Optiphase Supermix scintillation liquid. (2)The intra-batch CV of the micro-plate RBA was 3.8%- 10.2%, and the inter-batch CV was 5.6%- 11.9%. The linearity analysis showed a good correlation when the GAD-Ab in serum samples ranged from 40.3 to 664 U/ml and the detection limit of measurement was 3.6 U/ml. The results from Diabetes Autoantibody Standardization Program (DASP) 2005 showed that the sensitivity and specificity for GAD-Ab were 78% (39 positive among 50 new-onset T1DM) and 98% (2 positive among 100 healthy controls). The results of GAD-Ab obtained with micro-plate RBA and RLA were closely correlated (r=0.915,P<0.001) with a high concordance level of 97.5% and a Kappa value of 0.95. (3)TI DM and T2DM patients showed higher positive rates for GAD-Ab than the healthy controls(46.9% and 5.2% vs 0.89% ,X2=123.5 and 10. 1 ,P <0.001 and <0.01, respectively). (4)The consistency of GAD-Ab measurement with RBA using finger tip blood and RLA measurement using venous blood was 96.7% (r =0.946,P <0.001, Kappa value: 0.905). Conclusions The micro-plate RBA of GAD-Ab has high sensitivity, specificity and reproducibility, and can be measured with finger tip blood sampling. It might be a better alternative for clinical practice.

Objective To investigate the efficacy and safety of cerebrolysin in patients with acute cerebral infarction(ACI).Methods A randomized,open-label,controlled trial ofcerebrolysin in the treatment of ACI within 48 h of onset was performed; these 108 patients were randomly divided into treatment group(n=64)and control group(n=44); the control group was only given routine therapy and the treatment group was allocated 30 mg cerebrolysin for 14 d.Therapeutic effect was evaluated by the National Institutes of Health Stroke Scale(NIHSS)and the Bathal index(BI).The liver and renal function,levels of blood and urinary routine,and electrocardiogram(ECG)were detected.Results As compared with those in the control group,significant difference on scores of NIHSS and BI was noted in the treatment group the treatment group(P＜0.05).Conclusion Cerebrolysin is efficacious in the treatment of AIC due to the improvement of neurological deficits of the patients.

Objective To investgate prevalence and clinical significance of antiproteinase 3(PR3)an- tibodies in Wegener's granulomatosis(WG)and other vasculitis patients.Methods One hundred and eleven systemic vasculitis patients with WG(9 cases,including 21 serums of tracking WG patients)and other systemic vasculitis(102 cases),403 secondnary vasculitis CTD(SLE 213 cases,RA 135 cases),nephritis 62 cases,30 healthy subjects were examined for anti-PR3 and anti-MPO antibody by enzyme-linked immunosorbent assay (ELISA)and ANCA by indirect immunofluorescence(IIF)was performed.Result Anti-PR3 positive were 23 in 588 serums of patients.The prevalence of anti-PR3 positive was WG(16/21,71.4 %),other systemic vas- culitis were not found anti-PR3,SLE(6/213,2.8%),RA(1/135,0.7%).In particular,the prevalence of anti- PR3 and cANCA with WG tended to be higher in the patients with other systemic and secondnary vasculitis (P＜0.05).The sensitivity and specificity of anti-PR3 for diagnosis of WG were 71.42% and 98.58%.The sensi- tivity and specificity of combination anti-PR3 and cANCA were 61.90% and 99.82%.Anti-PR3 and cANCA are associated with treament of WG.Conclusion Anti-PR3 antibody has high specificity for diagnosis of RA. Detection of anti-PR3 and cANCA at the same time can improve the specificity considerably.As sensitive markers of WG,anti-PR3 antibody may be useful for diagonosis and early treament.Anti-PR3 also may be useful for activity and relapse of WG.

OBJECTIVETo assess the impacts of acupuncture and moxibustion on carotid arterial vascular structure and blood flow parameters for the patients with carotid arteriosclerosis.

METHODSSixty-eight cases were randomized into an acupuncture-moxibustion group (35 cases) and a medication group (33 cases). In the acupuncture-moxibustion group, Renying (ST 9), Neiguan (PC 6), Zusanli (ST 36), etc. were selected, moxibustion was applied at Zusanli (ST 36). In the medication group, Enteric-coated aspirin was taken orally. The high-frequency ultrasonography was applied to detect common carotid artery (CCA), intima-media thickness (IMT), peak systolic velocity (PSV), end diastolic velocity (EDV), pulsatility index (PI) and resistance index (RI) before and after treatment for the comparative analysis.

RESULTSAfter treatment, in comparison between acupuncture-moxibustion group and medication group, CCA got bigger [(8.16 +/- 0.80) mm vs (7.69 +/- 0.61) mm, P < 0.01], IMT became thinner [(1.05 +/- 0.09) mm vs (1.10 +/- 0.09) mm, P < 0.05], PSV and EDV were accelerated (all P < 0.01), and PI and RI were down-regulated (P < 0.05, P < 0.01).

CONCLUSIONAcupuncture and moxibustion provides a good efficacy on the improvement in carotid arteriosclerosis and blood flow in carotid artery, which contributes to the alleviation of ischemic cerebrovascular diseases and prevention from the occurrence and development of them.

Acupuncture Therapy ; Adult ; Aged ; Carotid Arteries ; physiopathology ; Carotid Artery Diseases ; physiopathology ; therapy ; Female ; Humans ; Male ; Middle Aged ; Moxibustion ; Regional Blood Flow

OBJECTIVETo study the content of mineral elements and the principal components in Gastrodia elata.

METHODMineral elements were determined by ICP and the data was analyzed by SPSS.

RESULTK element has the highest content-and the average content was 15.31 g x kg(-1). The average content of N element was 8.99 g x kg(-1), followed by K element. The coefficient of variation of K and N was small, but the Mn was the biggest with 51.39%. The highly significant positive correlation was found among N, P and K . Three principal components were selected by principal components analysis to evaluate the quality of G. elata. P, B, N, K, Cu, Mn, Fe and Mg were the characteristic elements of G. elata.

CONCLUSIONThe content of K and N elements was higher and relatively stable. The variation of Mn content was biggest. The quality of G. elata in Guizhou and Yunnan was better from the perspective of mineral elements.

Drugs, Chinese Herbal ; analysis ; Gastrodia ; chemistry ; Minerals ; analysis ; Principal Component Analysis

Objective To review the techniques used in biliary reconstruction for adult-adult living donor liver transplantation using a right lobe graft. Methods The clinical data of 21 pairs of donor and recipient who underwent right lobe living donor liver transplantation from April 2007 to May 2009 at Beijing Youan Hospital were analyzed retrospectively. Biliary anastomoses consisted of 10 single right hepatic duct to common hepatic duct anastomoses, 5 donor double branched ducts to recipient double branched ducts anastomoses, 5 single anastomoses between a donor double branched duct which had been converted to a single duct by ductoplasty to a single recipient bile duct, and 1 hepaticojejunostomy. A T-tube was inserted through the anterior wall of the common hepatic duct and splinted across the anastomosis in 2 recipients and a Y-tube was used in 1 recipient. Results 4 recipients died during the first post-transplant month. Another recipient received a retransplantation for acute liver necrosis. The remaining recipients were alive. The 1-year survival rate of the recipients was 77.65 %.5 patients developed biliary leakage and 2 patients developed biliary stricture. The 7 biliary complications were treated and cured by further surgical procedures. There was no significant difference in the biliary complications among the three different types of biliary anastomotic groups (x2 = 0. 659,P=0. 719). Conclusion The different types of biliary anastomoses can be used in living donor liver transplantation depending on the situations found in the donors and recipients. Continuous suturing on the posterior wall of the bile duct, interrupted suturing on the anterior wall and microsurgical techniques in biliary reconstruction are effective modalities to minimize biliary complications.

Objective To investigate technical skills on outflow reconstruction in right lobe graft adult-adult living donor liver transplantation for avoiding of venous congestion. Methods The clinical data of 21 donors and recipients who underwent right lobe living donor liver transplantation were analyzed retrospectively. Donor's standard liver volume was between 1150. 1 and 1629. 8 cm3,graft weight was between 585 and 920 g, the ratio of graft volume to recipient's estimated standard liver volume (GV/ESLV) was between 43 % and 67 %, graft-recipient weight ratio (GRWR) was between 0. 82 % and 1.59 %, the ratio of remnant liver volume to donor's standard liver volume(RLV/SLV) was between 32 % and 55 %, all graft macrosteatosis was less than 10 %. For graftwith middle hepatic vein (MHV), a triangle large orifice was made by joining MHV to right hepatic vein (RHV), then anastomosed to recipient' s enlarged orifice of RHV. For graft without MHV, if tributary of MHV＞5 mm, autologous or allogenic blood vessel was used as interposition graft to connect to IVC, and if no large MHV tributary, graft RHV was anastomosed to IVC directly. Graft's right portal vein was anastomosed to main trunk of recipient's portal vein, graft's right hepatic artery to recipient's hepatic artery, and graft's right hepatic duct to recipient's right hepatic duct. Results Among the 21 right lobe grafts, 4 right lobe grafts had MHV, 17 right lobe grafts had no MHV.Autologous greater saphenous veins were adopted in 2 cases, cryopreserved iliac arteries were adopted in 5 cases, and RHV was anastomosed directly to IVC in 10 cases. Outflow was all patent in 7 cases having reconstruction of MHV tributaries one month after operation. One-year survival rate was 75 %, 85. 7 % and 70 % respectively in MHV group, MHV tributaries reconstructed group and RHV directly anastomosed to IVC group with the difference being not significance among these three groups (P＞0. 05). Biliary complications occurred in 7 cases during the follow-up period. One case developed small-for-size syndrome, which was cured by splenic artery embolization. No severe complication occurred in donors. All donors returned to normal life during a follow-up period of 6 to 31 months. Conclusion If outflow tract was reconstructed properly, right lobe graft without MHV has equivalent clinical outcomes to right lobe graft with MHV. Using of autologous or allogenic blood vessel as interposition vessel graft for right lobe graft without MHV is an effective modality to prevent hepatic congestion and secure functional graft volume to meet recipients metabolic demand.