Clinical data management,a critical part of clinical trials,plays a decisive role in assuring the accuracy and reliability of the trail results.This article discusses the quality standards of clinical data,introduces the important rules and principles for standardized clinical data management,and reviews the development and current status of clinical data management home and abroad.It is proposed that we should learn the advanced clinical data management modes from international partners and introduce standardized clinical management software from abroad,so as to improve the clinical data management in China.

Objective To explore the influence of structured lipid emulsion on inflammatory cell factors and immunologic function in gastrointestinal cancer patients after operation.Methods From July 2010 to February 2012,80 postoperative patients with gastrointestinal cancer were randomly divided into 2 groups with 40 cases each by stratified sampling method:structured lipid emulsion group (observation group),physical mixture of medium-chain/long-chain triglycerides group (control group).Both groups received isonitrogenous and isocaloric parenteral nutrition for 6 days after operation.The general conditions after operation were compared between two groups.Inflammatory cell factors and immunologic function were measured before operation,the 1st day and 7th day after operation.Results After 6 days parenteral nutrition,the vital sign data,blood routine,liver and renal function,blood fat etc was normal in two groups.There was no significant difference in the incidence of postoperative infection complication and hospitalization duration between observation group and control group [12.5％(5/40) vs.25.0％(10/40),[( 12.9 ± 0.7 d) vs.(13.1 ±0.9) d] (P ＞0.05).The serum levels of interleukin (IL)-1,IL-2,IL-6,tumor necrosis factor (TNF)-α on the 1st day after operation in two groups decreased,then gradually increasing.The serum levels of IL-2,IL-6,TNF- α on the 7th day after operation in observation group[(987 ± 203),(277 ± 107),( 197 ± 98) ng/L] were lower than those in control group [(1347 ± 195),(752 ± 187),(342 ± 106) ng/L](P＜0.05 ).The serum levels of IgG,IgA,IgM,CD3+,CD4+ and CD8+ on the 1st day after operation in two groups decreased,then gradually increasing.The serum levels of IgG,CD3+,CD4+ were higher in observation group [( 14.2 ± 1.8 ) g/L,0.746 ± 0.111,0.580 ± 0.067] than those in control group [( 12.1 ± 2.8) g/L,0.606 ±0.101,0.404 ± 0.072] (P ＜0.05).Conclusion Structured lipid emulsion can reduce immunological suppression and inflammation in gastrointestinal cancer patients after operation,regulate the inflammatory cell factors producing and releasing,improve the immunologic function.

Objective To observe the effect of patient-controlled intravenous analgesia (PCIA)with dezocine combined with sufentanil on inflammatory response and pain after laparoscopic hepatectomy for hepatocellular carcinoma.Methods Sixty patients (43 males,17 females,aged 18-60 years,ASA grade Ⅰ or Ⅱ) scheduled for laparoscopic hepatectomy for hepatocellular carcinoma were divided into sufentanil group (group S) and dezocine+sufentanil group (group DS) according to the random number table,n=30 each.Patients in group S were given 100 ml normal saline containing sufentanil 2.0 μg/kg and tropisetron 5 mg.Patients in group DS were given 100 ml normal saline containing sufentanil 2.0 μg/kg,dezocine 0.5 mg/kg and tropisetron 5 mg.VAS scores and numeric sedation scale (NSS) scores were recorded at 4,24,48 h after operation and patients' satisfaction scores were recorded at 48 h after operation.The levels of serum tumor necrosis factor-α (TNF-α),interleukin-2 (IL-2),interleukin-6 (IL-6) in blood samples harvested before induction of anesthesia and 0,4,24 and 48 h after operation were measured by ELISA.The times of efficient injection and incidence of adverse effect within 48 h after operation were recored.Results Compared with group S,the VAS scores in group DS were decreased significantly while the satisfaction of patients to analgesia were increased significantly at 4,24,48 h after operation (P<0.05).There were no obvious differences in NSS scores between two groups.Compared with before induction of anesthesia,the concentrations of TNF-α and IL-6 were increased significantly while the concentrations of IL-2 was decreased significantly in both groups at 4,24,48 h after operation (P<0.05).Compared with group S,the concentrations of TNF-α and IL-6 were decreased significantly while the concentrations of IL-2 was increased significantly in group DS at 24,48 h after operation (P<0.05).The times of efficient injection in group DS were less than that in group S significantly within 48 h after operation [(2.0±0.7) times vs.(7.2±1.3) times] (P<0.05).There were no obvious differences in adverse effects between two groups.Conclusion PCIA with dezocine 0.5 mg/kg combined with sufentanil 2.0 μg/kg can alleviate the inflammatory response to some extent in patients after laparoscopic hepatectomy for hepatocellular carcinoma,and it can offer a safe and effective analgesic effect.

Objective To investigate the level and influencing factors of caregivers′burden among primary caregivers of elderly stroke patients. Methods Totally 298 caregivers of elderly stroke patients were investigated with Zarit Burden Interview (ZBI), Hospital Anxiety and Depression Scale (HADS) and Simplified Coping Style Questionnaire(SCSQ). The patients were investigated with Modified Barthel Index (MBI). Results The caregivers′burden was in the mild level with a total score of 35.21±11.45. The influencing factors were the number of days of care, daily caring hours, hospital anxiety and depression score, the coping style and the ability of patients to perform ADL. Conclusions The primary caregivers of stroke patients have mild burden. The nurses should be synchronized to assess the health of patients and primary caregivers at the same time, understand the caregivers′burden, and provide specific care advice, in order to reduce the burden of their carer, so as to improve the quality of patients′life.

OBJECTIVE To evaluate the clinical significance of quantitative analysis of EBV DNA in plasma,CYFRA21-1 and VCA-IgA in serum of nasopharyngeal carcinoma patients.METHODS EBV DNA in plasma,CRFRA21-1 and VCA-IgA in serum of 62 patients were analyzed using RealTime PCR technique,electrochemiluminescence immunoassay(ECI),and immunoenzyme assay respectively.And these were compared among clinical remission,recurrent or metastasis groups.RESULTS The positive rate of preoperative radiotherapy group was significantly higher than clinical remission group(P

Objective To explore the more secure and available methods in replacing traeheostomy tube.Methods Sixty patients with incision of trachea were divided into group A(29 eases)and group B (31 cases)randomly.The new method was used in group A with putting a catheter into the old tracheostomy tube before taking it out,and placing the new tracheostomy tube under the guide of catheter.While the traditional method was used in group B.The heart rate,SpO2,manipulation time,perioperative haemorrhage, and the condition of entering the false passage were recorded.Results The heart rate,SpO2 were no significant difference before and after manipulation in group A,but the heart rate increased and SpO2 decreased in group B(P<0.01 or<0.05).The manipulation time was(50.5±4.2) s in group A,and (84.9±5.3) s in group B(P<0.05).The perioperative haemorrhage >3 ml and the condition of entering the false passage in group A(2 Cases,o cage)were less than those in group B(15 cases.5 cases)(P<0.01 or<0.05).Conclusion The new method in replacing tracheostomy tube which use an input catheter is more security and more availability.

Objective To study the quick triage assessment system for emergency nurse, establish evaluation model and method, select indicators and contents, guide triage nurses to be accurate, fast, convenient and practical, and also to optimize the use of emergency medical resources. Methods Screening the target population to conduct the research, collecting main indicators and features covered with main symptom and characteristics of severe critical emergency patients, selecting manifestation form of triage assessment system. Results The selected indicators and contents were demonstrated by a table-based form, and the quick triage assessment form for emergency nurse was established to instruct triage work. Conclusions This established quick triage assessment form is simple, intuitive and can improve the quality of emergency triage work. It possesses feasibility, practicality and achieves the optimal medical services with the limited emergency medical resources, which shows both social and economic effect.

Objective To evaluate the effects of penehyclidine hydrochloride on the oxidative stress and cell apoptosis during endotoxin-induced acute lung injury (ALI) in neonatal rats.Methods Forty 7-day-old Wistar rats weighing 12-18 g were randomly divided into 3 groups (n=10 each) using a random number table: penehyclidine hydrochloride group (group PHC), acute lung injury (group AKI) and normal saline group (group NS).The ALI model was induced with intraperitoneal endotoxin 5.0 mg/kg in groups PHC and ALI.In group PHC, penehyclidine hydrochloride 2.0 mg/kg was injected intraperitoneally at 1 h before ALI respectively, while the equal volume of normal saline was administered in groups NS and ALI.At 4 h after endotoxin injection,the rsts were sacrificed.The lungs were collected to determine the wet/dry (W/D) lung weight ratio.The expression of SOD was detected by xanthine oxidase method.The expression of MDA was detected by sulfuretted barbitone method.Levels of cytochrome C (Cyt-C) and Caspase-3 were determined with immunohistochemical method (IHC), and cell apoptosis (by TUNEL).Apoptotic index was calculated.Results Compared with group NS, the W/D ratio and the contents of MDA were significantly increased, the contents of SOD were significantly decreased in groups ALI and PHC (P＜0.05).Compared with group ALI, the W/D ratio and the contents of MDA were significantly decreased, the contents of SOD were significantly increased in group PHC (P＜0.05).Compared with group NS, the contents of Cyt-C, Caspase-3, and apoptotic index were significantly increased in groups ALI and PHC (P＜0.05).Compared with group ALI, the contents of Cyt-C, Caspase-3, and apoptotic index were significantly decreased in group PHC (P＜0.05).Conclusion Penehyclidine hydrochloride ameliorates endotoxin-induced ALI by inhibiting oxidative stress and cell apoptosis in neonatal rats.

In order to improve the scientific research capability of medical graduates,help them cultivate scientific statistical mind and the ability to resolve actual medical scientific research issues,we made a teaching reform on the teaching objectives,curriculum system,teaching material and informational teaching of Medical Statistics teaching,established a diversified teaching pattern and improved the teaching quality.

As the final link of quality evaluation of postgraduates'cultivation,academic oral defense system should be strictly organized to promote the training quality. Many problems such as formality of pre-defense,high proportion of personal relations and difficulty invitation for defensive experts exist in the current academic oral defense system. Aiming at the problems,the author puts forward corresponding countermeasures for the actual improvement including establishment of defensive experts bank,double-blind evaluation system of papers ,twice arrangements of pre-defense and unified organization of defensive experts on hospital level.