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 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

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 investigate the effect of physician guidance on cigarette cessation in current smokers with chronic obstructive pulmonary disease(COPD).Methods Cigarette cessation education and routine telephone follow-up was provided for 70 COPD patients.Pulmonary function and exhaled carbon monoxide level were detected every 3 months.Results After 6 months' follow-up,28 participants(40.00%) successfully quitted cigarette smoking.Seventeen subjects (24.28%) experienced relapse,with mean cessation time(3.08±0.33) months.Once receiving physician guidance,5 re-attempted to quit cigarette smoking,and 12 reduced tobacco consumption. Sixteen subjects(22.86%) did not quit smoking,although the mean cigarette consumption per day was decreased by 60%.Nine participants (12.86%) showed no change in smoking habit. Conclusion Physician guidance could impreve the rate of cigarette cessation in COPD patients.Intensive intervention may be correlated with successful smoking cessation.

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

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 evaluate mortality associated with simultaneous bilateral or staged bilateral TKA, and better understand the risks involved in the simultaneous versus staged bilateral procedures.Methods A systematic review was conducted, following an a priori protocol, according to the methods recommended by the Cochrane Musculoskeletal Group in the Cochrane Collaboration. Eligible studies were identified in PubMed (1990-2010), OVID MEDLINE (1990-2010), and the Cochrane library, concerning postoperative complications of bilateral or staged bilateral total knee arthroplasty. All of the English-language abstracts were obtained, and retrieval words including bilateral total knee arthroplasty, staged total knee arthroplasty, and total knee arthroplasty, etc. An extensive analysis was then performed to identify articles fulfilling the inclusion criteria for the study. The details of the reported data were extracted and evaluated by two reviewers independently. Data analyses were conducted with Stata 10.0. Results Six studies met our inclusion criteria for review. The combined results showed that the prevalence of mortality[OR=2.925, 95% CI (2.352, 3.638)], mortality 30 days postoperatively[OR=5.078, 95% CI (2.192, 1 1.763)]and mortality in 70 years or older patients[OR=4.087, 95% CI (1.947, 8.582)]were statistically higher in the population that had undergone simultaneous TKA compared with staged TKA. Conclusion Compared with staged bilateral TKA, simultaneous bilateral TKA might carries a higher potential risk of postoperative mortality. Patients should be aware of this information when deciding whether to proceed with simultaneous bilateral TKA. Further well-designed and large-scale randomized controlled trials are required to confirm these findings.

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.