Objective To study the feasibility of preoperative acute hypervolemic hemodilution for decreasing perioperative blood use. Methods Thirty two patients(ASAI-II) undergoing spinal surgery were randomized into AHH group and control group. After anesthesia 6% HES(200/0.5) was given through internal jugular vein for AHH. The blood volume was increased by about 25%. During the operation, blood loss was replaced by HES in equal volume. Blood was transfused when the Hct dropped below 25%. The HR, MAP, CVP, SPO2, Hb, Hct., Plt, FIB, APTT, PT, amount of blood loss, blood transfused and urine output, volume of drainage 24h after operation and VAS score (0 means no effect, 10 means maximal effect) were observed before AHH, at the end of AHH, at the end of operation, and 24h after the operation. Blood volume expansion was calculated. Results (1) HR increased significantly in both groups(P

Objective To investigate the expression of MMP-2 and TIMP-2 during the course of traumatic PVR treated with GM6001 and without GM6001,and to explore the potential role of MMP-2 and TIMP-2 during the course of traumatic PVR and to evaluate the effect of GM6001 on traumatic PVR prevention and treatment.Methods 360 SD rats were divided randomly into three groups: normal control group,the traumatic PVR group,the traumatic PVR treated with GM6001 group.The normal control group was intravitreous injected with normal saline.The traumatic PVR group was intravitreous injected with the PRP.The traumatic PVR treated with GM6001 group was intravitreous injected with the PRP and GM6001.The expression of MMP-2 and TIMP-2 were qualitativly and semiquantitativly analyzed with immunohistochemistry on day 1,3,7,14,21 and 28.Results 1.The results of immunohistochemistry showed that the expression of MMP-2,TIMP-2 was mainly located in the photoreceptor cells layer,out plexiform layer,inner plexiform layer and nerve fiber layer.2.The expression of MMP-2 in the normal group and the traumatic PVR treated with GM6001 group was weak at all time.The differences were statistical significance as compared with the normal group and the traumatic PVR treated with GM6001 group(P

The efficacy of growth hormone (GH) treatment in short children with small for gestational age (SGA) was evaluated and the association of serum insulin-like growth factor-1 (IGF) and IGF-binding protein-3 (IGFBP-3) levels with height increments was investigated.Fifty-five short children with SGA in our hospital from Sep 2009 to Sep 2013 were collected.Before GH treatment, insulin and arginine stimulation test were performed.The children were treated with recombinant GH with 0.15 U · kg-1 · d-1 for at least 12 months.After GH treatment, the height was (120.5 ± 17.63) cm, height SDS was (-1.53 ± 1.04) SDS, HtSDS was-2.04 ± 0.47, bone age was (6.19 ± 2.34) year, growth velocity was (7.24 ± 1.19) cm/year, all these parameters were significant higher than those before GH treatment.Pre-treatment serum levels of IGF-Ⅰ and IGFBP-3 were negatively correlated with post treatment growth velocity(r =-0.37 and r =-0.31;P =0.004 and P =0.021).GH treatment could effectively improve the height of short children with SGA.Children with lower pre-treatment serum levels of IGF-Ⅰ and IGFBP-3 may reach the higher growth velocity.

Objective To compare the clinical outcomes of different drains in total knee arthroplasty.Methods Fifty-five patients,who had accepted primary unilateral total knee arthroplasty from October 2010 to November 2012,were included in the comparative study.Based on different drainage ways,25 patients were arranged into autotransfusion drain group,18 into routine drain group,and 12 into delayed drain group.Same operative procedure and postoperative care were provided to all patients.The total amount of postoperative drainage (including intraoperative blood loss),information of allogenic blood transfusion,body temperatures of patients on postoperative 1st,3rd,7th day,pre-and post-operative hemoglobin level,and postoperative swelling,wound healing quality and range of motion were recorded and compared.Results The amount of drainage was significantly more in autotransfusion drain group (799.2±196.7ml)than those in other two groups (381.7±129.2 ml in delayed drain group and 666.1±155.0ml in routine drain group).The postoperative hemoglobin level in delayed drain group (91.50±7.92 g/L)was similar to that in autotransfusion group (91.96±9.57 g/L),while significantly higher than that in routine drain group (81.33±9.86 g/L).The highest body temperature of patients in autotransfusion drain group was higher than those in other two groups.Allogenic blood transfusion was performed in 8 patients (44.4％) in routine drain group,4 patients (16.0％) in autotransfusion drain group and 2 patients (16.7％) in delayed drain group.There were no differences between groups in swelling,wound healing quality,and range of motion.Conclusion Delayed release of drain in total knee arthroplasty could reduce blood loss,chances of allogenic blood transfusion and postoperative fever,and extra cost,which can bring more benefits to patients.

Objective To analyse the plasma glucose change in the patients with severe acute respiratory syndrome (SARS) and to discuss its possible mechanism. Methods The clinical data of 61 cases with SARS in Tianjin were retrospectively analysed. Results Plasma glucose level increased in 26 cases with SARS, among them, 2 cases suffered from diabetes before SARS onset, 24 cases were diagnosed as the secondary diabetes whose blood glucose level recovered normal after SARS were cured, except 4 cases who were dead. All of the 61 cases were treated with glucocorticoids. If the patients were grouped by the dose of methylprednisolone they received, 9 out of 14 cases with large dose, 14 out of 26 cases with middle dose and 1 out of 21 cases with small dose were led to secondary diabetes. There was significant difference in the incidence of the secondary diabetes between the small dose group and middle/large dose groups (P

Validation is a documented process that provides a high degree of assurance. The computer system does exactly and consistently what it is designed to do in a controlled manner throughout the life. The validation process begins with the system proposal/requirements definition, and continues application and maintenance until system retirement and retention of the e-records based on regulatory rules. The objective to do so is to clearly specify that each application of information technology fulfills its purpose. The computer system validation (CSV) is essential in clinical studies according to the GCP standard, meeting product's pre-determined attributes of the specifications, quality, safety and traceability. This paper describes how to perform the validation process and determine relevant stakeholders within an organization in the light of validation SOPs. Although a specific accountability in the implementation of the validation process might be outsourced, the ultimate responsibility of the CSV remains on the shoulder of the business process owner-sponsor. In order to show that the compliance of the system validation has been properly attained, it is essential to set up comprehensive validation procedures and maintain adequate documentations as well as training records. Quality of the system validation should be controlled using both QC and QA means.
Clinical Trials as Topic ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards ; Software Validation

AIM:To study the mechanism of the unique export of one of human basic fibroblast growth factor (hbFGF) forms lacking the N-terminal nuclear localization signal (NLS),we high expressed and purified this hbFGF form in E.coli strain BL21(DE3).METHODS:The cDNA fragment of the hbFGF amplified by polymerase chain reaction (PCR) was cloned into the expression vector pET3c and expressed in BL21(DE3) by IPTG induction.The expressed hbFGF was purified by ionic exchange and heparin affinity chromatography from the supernatant of bacteria lysate.The mitogenic activity was measured by MTT.RESULTS:The expression level of hbFGF in E.coli was about 20% of the total cellular protein.The appreciable mitogenic activity of the purified hbFGF was comparable to that of hbFGF standard.CONCLUSION:The BL21(DE3)/ pET3c expression system could be used to high express hbFGF lacking NLS.The purified recombinant hbFGF was prepared and sufficient for further study.

Objective To investigate the effects of neutrophil gelatinase associated lipocalin(NGAL) on renal tubular epithelial cells apoptosis and apoptosis-regulated protein fas,bcl-2 in rat renal ischemia reperfusion injury (IRI).Methods Renal IRI models of rats were established.Rats were randomly divided into 3 groups,including control group,IRI model group and NGAL group.The pathological change of kidney tissue was investigated by hemotoxylin-eosin staining.Renal tubular epithelial cells apoptosis was detected by TUNEL method.Expression of fas and bcl-2 was measured by real-time PCR and Western blotting.Results Compared with IRI model group,NGAL group showed a decreased number of renal tubular epithelial cells apoptosis [(8.6±3.4)/HP vs (20.8±3.7)/HP,P＜0.05],down-regulated fas mRNA (2.34±0.51 vs 6.84±2.34,P＜ 0.05),fas protein (0.65±0.05 vs 0.95±0.08,P＜0.05) and up-regulated bcl-2 protein (0.33±0.05 vs 0.24±0.03,P＜0.05),but the bcl-2 mRNA had no significant change.Conclusion NGAL can protect renal tubular epithelial cells in renal IRI,which may be associated with decreasing cell apoptosis and adjusting protein expression by apoptosis-regulated cytokines.

Objective To explore the relationship between polymorphism of catechol-O-methyltransferase (COMT) gene valine (Val) 158 methionine (Met) (G to A transition)and the distribution in population and esophageal squamous cell carcinoma (ESCC) in Yili prefecture of Xinjiang.Methods A hospital based case-control study was adopted, a total of 622 subjects, which including 214 ESCC patients and 408 age, gender and ethnicity-matched normal control individuals.The polymorphism of COMT gene G to A transition was analyzed with PCR-restriction fragment length polymorphism approaches.Results The COMT genotype frequencies in 622 subjects in Yili prefecture were GG genotype accounted for 47.3%, GA type for 42.3% and AA type for 10.4%, G allele was 68.4% and A allele was 31.6%.There was no statistical difference in the COMT genotype and frequencies of allele distribution between ESCC group and control group.Furthermore, stratified analysis indicated that there was statistical difference between ESCC group and control group in subjects less than 60 years old.There was statistical difference in the allele distribution among Kazak,Uygur and Han ESCC groups.The COMT genotype and frequency of allele distribution among normal control groups of the three ethnic groups were statistically different.After corrected age and gender,there was no statistical difference in COMT Val158Met polymorphisms among Kazakh, Uygur and Han ethnic groups in both ESCC and control groups in Yili Prefecture of Xinjiang.Conclusion COMT gene Val158Met single nucleotide polymorphism may not be the genetic markers of ESCC risk in Yili Prefecture of Xinjiang.

Objective To study the effect of single chain variable fragment (ScFv) antibody to EC3-4 fragment of desmoglein (Dsg) 3 in a mouse model of pemphigus vulgaris.Methods The ScFv an- tibody to EC3-4 fragment of Dsg-3 was injected subcutaneously into neonatal BALB/c mice at different time points;the mice were then evaluated clinically,histopathologically and by direct immunoflorescence exami- nation for the development of lesions.Results When injected alone,the ScFv antibody did not induce the appearance of key clinical features of pemphigus vulgaris.The antibody also did not prevent the develop- ment of pemphigus vulgaris features induced by sera of patients with pemphigus vulgaris,regardless of the time point of injection of ScFv antibody.Conclusion The ScFv antibody to EC3-4 fragment of Dsg-3 lacks pathogenicity in neonatal BALB/c mice,and also could not inhibit the development of lesions induced by sera from patients with pemphigus vulgaris.