Aim To observe the timed analgesic effects by butabital (B), acetaminophen(A) and caffeine (C) in combination (BAC), in which the proportion was fixed as1. 25∶ 8. 1∶1. Method Three types of experimental methods, including the tailflicking method, the hot plate method and the pressurizing tail method, weretaken to determine indices at different times after the animals were adminstered(ig) high, median and low BAC dose. Results and conclusion BAC had a stronganalgesic effect in three types of experiments. The effect began 30 min after ad-ministration, arrived maximum at 1 h, decreased at 2 h and disappeared at 4 h.There was a dose-effect relationship between large and little BAC dose.

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Clinical Trials, Phase III as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Medical Informatics

Due to a great amount of data in clinical trials, the data cleansing needs to adopt a variety of measures, including the latest developed visual check approach. According to the different types of clinical data and the different stages in the course of clinical data management, this study reviews 8 types of visual graphics that show the relevance and trend among the data. The series of graphics can rapidly detect abnormal data, monitor clinical research in real-time, make the data management process much easier and improve the clinical trial efficiency and data quality.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; methods

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 analyze risk factors of cancer patients with Pseudomonas aeruginosa bloodstream infections and drug resistance. Methods:Clinical data of 30 cancer patients with P. aeruginosa bloodstream infection and 90 without infection who were ad-mitted in the Tianjin Medical University Cancer Institute and Hospital between January 2010 and December 2012 were retrospectively analyzed. Whonet 5.6 and SPSS19.0 software were used for statistical analysis of the data. Results:The infection group consisted of 20 male and 10 female patients with a mean age of 60.9±11.2 years. The control group consisted of 60 males and 30 females with a mean age of 51.3 ± 15.9 years. Multivariate logistic regression analysis showed that the number of hospitalization, combined with infection of other sites, and more than two types of antibiotics were independent risk factors of cancer patients with P. aeruginosa bloodstream infec-tions. P. aeruginosa showed high sensitivity(>80%) to carbapenems, ceftazidime, cefepime, aminoglycosides, and fluoroquinolones. The mortality rate of cancer patients with P. aeruginosa bloodstream infections was 60%. Conclusion:Cancer patients with P. aerugino-sa bloodstream infections have high mortality. Therefore, comprehensive prevention and control measures must be implemented in clini-cal practice to reduce P. aeruginosa bloodstream infections.

Objective To determine the value of differential time to positivity ( DTTP ) of blood culture for the diagnosis of catheter-related bloodstream infection ( CRBSI ) in patients with solid tumors in intensive care unit ( ICU ). Methods A retrospective study was conducted. 615 pairs of peripheral vein blood cultures and instantaneous catheter tip blood culture of 615 patients admitted to ICU of Tianjin Medical University Cancer Institute and Hospital were collected from August 2011 to March 2014. The DTTP method and ( or ) semi quantitative culture of catheter tip were compared. CRBSI was diagnosed when both cultures were positive for the same microorganism and DTTP ≥2 hours ( 120 minutes ). The result of this procedure was compared with that of organism obtained using the semi quantitative culture of blood at catheter tip with≥15 cfu. Based on the clinical diagnosis, the reliability of two kinds of laboratory examination was compared for the diagnosis of CRBSI by plotting receiver operator characteristic curve ( ROC curve ). Results The result of 615 cases suspected of having CRBSI were analyzed during the study period. Of these, 440 episodes were excluded because cultures were negative for blood obtained through peripheral vein and central vein. Eight episodes were excluded because only peripheral vein blood culture was positive and 57 episodes were excluded because of only central vein blood culture was positive, 68 pairs of blood cultures were excluded due to the presence of multiple catheters and repeated blood withdrawals. Two cases of polymicrobial cultures were excluded from the final analysis due to the difficulty in determining the time of positive result for each individual microorganism. Ten cases in 42 cases of suspected cases of CRBSI were excluded from analysis because catheter was not removed, therefore culture from catheter tip could not be obtained. Using the DTTP method, 14 out of 17 CRBSI cases were diagnosed with DTTP≥120 minutes, while 3 cases were missed;the semi quantitative catheter tip culture was positive in 13 cases, and in 4 cases it was neglected. In 2 cases of CRBSI it was missed by both methods. The area under the ROC curve ( AUC ) of DTTP, catheter tip culture and the combination method was 0.912, 0.882 and 0.941 for diagnosis of CRBSI, respectively. Validity values for the diagnosis of CRBSI for DTTP were:sensitivity 82.35%, specificity 92.31%, positive predictive value 93.33%and negative predictive value 80.00%, and they were higher than those of the catheter tip culture method only ( 76.47%, 84.62%, 86.67% and 73.33%). The specificity and positive predictive CRBSI combination of the two methods in the diagnosis value were up to 100%, the sensitivity ( 88.24%) and negative predictive value ( 86.67%) was also increased, but no significant differences were found with DTTP method (χ2=0.00, P=1.00;χ2=0.00, P=0.98;χ2=0.00, P=0.98;χ2=0.00, P=0.98 ). Conclusions DTTP can be a valid method recommended for CRBSI diagnosis in critically ill patients with acceptable sensitivity, good specificity as well as positive predictive value. DTTP combined with other clinical symptoms can not only avoid unnecessary catheter withdrawal, but it also can help obtain the optimal treatment time and strategy.

AIM: To observe the combined effects of nano red elemental selenium (Nse) and glucurolactone (Glu) on forming liver fibrosis in rats, and to search for a low dose of Nse with therapeutic effect. METHODS: According to the weighted modification method, six compound-dose groups and 2 control groups were set. The rats were given (sc) CCl4 for 10 wk, and the administration began at 4 wk. The indices related to acute liver damage were determined 3 wk after the administration, and to chronic liver damage 6 wk after the administration. RESULTS: At the stage of acute liver damage and within the therapeutic duration of 3 wk, Nse should be used at a larger dose in combination with Glu. Theoretical analysis showed that Nse 200 μg·kg-1 alone was available by the weighted modification method. However, in the combination of Nse and Glu for the chronic liver injury, Nse should be given at a low dose. There was a synergism between Nse and Glu, and some compound-dose groups showed the preventive and therapeutic effect, especially in a dose of Nse 100 μg·kg-1 + Glu 60 mg·kg-1. But theoretical analysis exhibited that Nse 100 μg · kg-1 + Glu 60 mg·kg-1 (ig) might be an optimal combination. CONCLUSION: The combination of Nse and Glu has significant effect in prevention and treatment of the live fibrosis in rats, and it can decrease dose of Nse used.

Methods: (i) Animal experiments. This study conducted experiments using specific pathogen-free (SPF) grade male C57BL/6J wild-type (WT) mice and APP/PS1 double transgenic mice. The animals were divided into three groups: WT group (WT mice, n = 5, receiving distilled water daily), APP/PS1 group (APP/PS1 double transgenic mice, n = 5, receiving distilled water daily), and BSTSD group [APP/PS1 double transgenic mice, n = 5, treated with BSTSD suspension at a dosage of 27 g/(kg·d) for 90 d]. Cognitive function was assessed using the Morris water maze (MWM). Post-experiment, hippocampal tissues were collected for analysis of pyramidal cell and synaptic morphology through hematoxylin-eosin (HE) staining and transmission electron microscopy (TEM). (ii) Cell experiments. The HT-22 cells were divided into control group (untreated), Aβ25-35 group (treated with 20 μmol/L Aβ25-35 for 24 h), icariin group (pre-treated with 20 μmol/L icariin for 60 min, followed by 20 μmol/L Aβ25-35 for an additional 24 h), and icariin + LY294002 group [treated with 20 μmol/L icariin and 20 μmol/L LY294002 (an inhibitor of the phosphoinostitide 3-kinases (PI3K) signaling pathway) for 60 min, then exposed to 20 μmol/L Aβ25-35 for 24 h], and cell viability was measured. Western blot was used to detect the expression levels of synapse-associated proteins [synaptophysin (SYP) and postsynaptic density-95 (PSD-95)] and PI3K signaling pathway associated proteins [phosphorylated (p)-PI3K/PI3K, p-protein kinase B (Akt)/Akt, and p-mechanistic target of rapamycin (mTOR)/mTOR]. Results: (i) Animal experiments. Compared with APP/PS1 group, BSTSD group showed that escape latency was significantly shortened (P < 0.01) and the frequency of crossing the original platform was significantly increased (P < 0.01). Morphological observation showed that pyramidal cells in the hippocampal CA1 region were arranged more regularly, nuclear staining was uniform, and vacuole-like changes were reduced after BSTSD treatment. TEM showed that the length of synaptic active zone in BSTSD treatment group was increased compared with APP/PS1 group (P < 0.01), and the width of synaptic gap was decreased (P < 0.01). (ii) Cell experiments. Icariin had no obvious toxicity to HT-22 cells when the concentration was not more than 20 μmol/L (P > 0.05), and alleviated the cell viability decline induced by Aβ25-35 (P < 0.01). Western blot results showed that compared with Aβ25-35 group, the ratios of p-PI3K/PI3K, p-Akt/Akt and p-mTOR/mTOR in icariin group were significantly increased (P < 0.01), while the protein expression levels of SYP and PSD-95 were increased (P < 0.01). These effects were blocked by LY294002 (P < 0.01). Conclusion BSTSD and icariin enhance cognitive function and synaptic integrity in AD models and provide potential therapeutic strategies through activation of the PI3K/Akt/mTOR pathway.

Objective To study the voice function rehabilitation by mucosa tube performed in operation of late laryngocarcinoma and to improve the survival quality of patients with Iate laryngocarcinoma.Methods Forty-six patients were treated between Oct.1991 and May 2006,including 4l males and 5females.The average age of the patients Wa8 54.Seventeen cases were glottic carcinomas(T3 NOM0 12,T3NIM0 5),27 cases were supraglottic carcinomas(T3N1M0 16,T4N1M0 5,T3N0M0 6),2 cases were pyriform sinus cancer(T4NlM0 2).For those patients with late laryngocarcinoma, who had lost the chance of partial laryngectomy, mucosa tube shaping during the operation could realize voice functional rehabilitation. Only the survive arytenoids of healthy side was preserved, in order to rehabilitate voice, amucosa tube Was sutured using healthy survive arytenoids and a mucosa strip Was connected to the trachea and the mucosa of hypopharynx. Survival analysis was performed by using Kaplan-Meier method. Results Forty-one out of 46 patients obtained almost normal voice and swallow function. The 5-years survival was76%.Conclusions The operation of voice function rehabilitation by mucosa tube performed can get good voice and swallow function to patients with late laryngo carcinoma.

Objective To evaluate three-axis otoconia maneuver (TOM) for benign paroxysmal positional vertigo (BPPV). Methods The data from twenty BPPV patients who received three-axis otoconia maneuver treatment and 20 BPPV patients who received canalith repositioning (CRP) maneuver treatment were analyzed retrospectively. Results There were 17 patients received 1 TOM session and 3 patients received 2 TOM sessions while 16 patients received 1 CRP session and 4 patients received 2 CRP sessions. The chi-square (x2) test was used in evaluating the association between two independent samples in a contingency table. Both methods had no statistically significant. The significance level for statistical tests was 5% (α = 0. 05). Conclusions Three-axis otoconia maneuver could be effective used in benign paroxysmal positional vertigo with the advantage of repeatedly practicable and instrumental.