Objective To evaluate the predicted value of APACHEⅡ score at admission for deep fungal infection（DFI） in patients with severe acute pancreatitis （SAP）.Methods The clinical data of 132 patients with SAP from January 2006 to June 2011 in our hospital were analyzed retrospectively. The receiver operating characteristic curve （ROC） was used for evaluating the predicted value.Results Thirty-nine patients with SAP infected DFI （29.5%）,of which 36 patients （92.3%） infected with Candida albicans,2 patients （5.1%） with Candida tropicalis,1 patient （2.6%） with pearl bacteria.And,among these 39 patients,27 patients （69.2%） infected at single site,12 patients （30.8%） infected at multi-site. The APACHEⅡ score in 39 patients with DFI was higher than that of 93 patients without DFI （17.1±3.8 versus 9.7±2.1, t=14.316,P=0.000）.The ROC for APACHEⅡ score predicting DFI was 0.745（P=0.000）, 95%CI was 0.641－0.849.When the cut off point was 15,it showed the best forecast performance,with specificity 0.81, sensitivity 0.72,Youden index 0.53. Conclusions The APACHEⅡ score at admission can preferably predict DFI in patients with SAP； when the APACHEⅡ score is greater than 15,it prompts highly possible of DFI,so preventive anti-fungal treatment may be necessary.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
Objective To determine whether B-type natriuretic peptide （BNP） levels combined with Spontaneous breathing trial (SBT) could improve the weaning outcome. Methods Eighty-three patients who were ready to undergo a 90-minute weaning trial （low-pressure support level） were enrolled .Weaning was considered to be successful if the patient passed the trial and sustained spontaneous breathing for more than 48 h after extubation. Plasma BNP was measured just before and at the end of the trial. All patients were divided into a weaning success group and a weaning failure group according to the outcomes of weaning. Categorical variables，expressed as percentages，were analyzed with a chi-square test or a Fisher’s exact test. Continuous variables were expressed as median （25th-75th percentile） and were compared using the Wilcoxon paired test （for related samples） or the Kolgomorov-Smirnov test （for independent samples）. A two-tailed p value of less than 0.05 was taken to indicate statistical significance. Receiver operating characteristic （ROC） curve analysis was performed to assess plasma BNP’s ability to discriminate the subjects who weaned succesfully or failed. Results Overall，13 patients （16.7%） failed the weaning process （6 patients passed the trial but failed extubation）. At the end of SBT，the BNP levels of the weaning failure group were significantly higher than the weaning success group. The BNP levels of the weaning failure group were significantly higher than the weaning success group （Plt;0.001）. The area under cure （AUC） of the ROC curve of BNP to predict the failure of weaning was 0.94±0.03 （Plt;0.001）.At a cut-off level of 123 pg/mL,BNP had a predictive efficiency in weaning outcome as Yourdon’s index of 0.837，sensitivity of 92.3%，and specificity of 91.4%. Conclusion Monitoring the change of BNP during a SBT may improve weaning outcome.
药物上市前须经过人体试验，参与药物临床试验的受试者将承担不同程度的风险，我国GCP明确规定要充分保障受试者的权益，伦理委员会和知情同意书是保障受试者权益的主要措施，但在实际中仍存在不少问题。为此，如何切实保障受试者的权益，是临床试验所要解决的一个重要问题。
ObjectiveTo investigate the feasibility of quantitative detection of WBC count and bacteria count with UF-1000i urinary sediment analyzer in rapid screening for urinary tract infection by receiver operator characteristic (ROC) curve. MethodsFrom August to December 2013, we used quantitative bacterial culture and UF-1000i automatic urine sediment analyzer respectively to examine asepsis urine specimens of 218 patients with suspected urinary tract infection. Among them, there were 95 males and 123 females, with an average age of 54.7 years old. ResultsAmong the 218 urinary samples, 65 were culture positive specimens. With positive urine culture as the gold standard for making ROC curve, the area under ROC curve for WBC count and bacterial numbers by UF-1000i urine sediment analyzer were respectively 0.839 and 0.894. The cut-off values of Youden index for optimal WBC cell count and bacterial count were ≥31.0/μL and 38.8/μL, respectively. When the above numbers were used as cut-off values, the WBC count sensitivity and specificity were 78.3% and 80.4%, the positive likelihood ratio was 3.99, and the negative likelihood ratio was 1.11. And the bacterial count sensitivity and specificity were 84.3% and 80.6%, the positive likelihood ratio was 4.30, and the negative likelihood ratio was 0.80. ConclusionUsing white blood cell count ≥31/μL and bacterial count ≥38.8/μL detected by UF-1000i urine sediment analyzer as the cut off values of noninvasive screening indexes has a very important value in screening for urinary tract infection in the early stage, determining whether there is a need for urine culture, and guiding clinical rational application of antibiotics
Objective To determine the diagnostic value of fractional exhaled nitric ( FeNO)measurement in diagnosis of bronchial asthma. Methods The patients with unkown-cause respiratory symptoms including wheezing, cough, and breathlessness were enrolled from August to September in 2008.FeNO was measured by nitric oxide analyzer ( NIOX; Aerocrine AB; Solna, Sweden) . Bronchial challenge test ( BCT) or bronchodilator test was defined as golden standard for asthma diagnosis. The value of FeNO was assessed and the optimal operating point of FeNO testing was determined by the means of the receiver operating characteristic ( ROC) curves. Results A total of 101 patients were enrolled, in which 48 cases were diagnosed as asthma by positive yield in BCT ( in 38 cases) or bronchodilator test ( in 10 cases) . The severity of airway hyperresponsiveness ( AHR) judged by BCT was mild in 15 cases, moderate in 15 cases and severe in 8 cases. The levels of FeNO of asthma group were higher than those of non-asthma group [ ( 68. 19 ±43. 00) ppb vs ( 19. 52 ±10. 60) ppb, P lt; 0. 05] . A linear correlation of FeNO with lnPD20 FEV1 was revealed in the cases with AHR. Area under ROC curve was 0. 9. The optimal diagnostic cutoff point was 36. 5 ppb which was capable of differentiating asthma and non-asthma with sensitivity of 92. 7% ,specificity of 83. 3% , positive predictive value of 79. 17% , negative predictive value of 94. 34% and accuracy of 87. 13% . Conclusion FeNO test may be helpful in the diagnosis of asthma with high sensitivity and specificity.
Objective To evaluate the diagnostic value of creatinine, as an indicator of glomerular filtration function injury. Methods MEDLINE, EMBASE and CBM-disc were searched from 1993 to 2003. Thirty four articles that described biomedical markers to indicate glomerular filtration function injury were selected according to specified inclusion criteria. These articles were evaluated systematically using SPSS, EXCEL, and RevMan software. Results The odds ratios of creatinine was 24.23. Areas under summarized receiver operator characteristic curve were 0.871. Selected articles were divided to groups for analysis according to diagnostic standards, such as inulin, iohexol, 125I-iothalamate, 51Cr-EDTA, 99mTc-DTPA and sodium thiosulfate. Inter-group analysis of creatinine was not statistically different (P=0.32). Intra-group analysis of inulin, 51Cr-EDTA, 99mTc-DTPA, and iohexol was not statistically different, P value were 0.61, 0.50, 0.36, 0.32, respectively. Intra-group analysis of 125I-iothalamate was statistically different (P=0.02). Selected articles were sub-grouped according to different analytic techniques of creatinine. Intra-group analysis by the Jaffe method was statistically different (P=0.03), intra-group analysis of enzymatic method was not statistically different (P=0.22). Conclusion The diagnostic value of creatinine was not qualified enough to indicate glomerular filtration function injury. Enzymatic methods are recommended to measure creatinine. Inulin or 51Cr-EDTA is suggusted to measure glomerular filtration rate in investigation of creatinine，and feedforward cohort is recommended to apply.
In order to realize brain-computer interface (BCI), optimal features of single trail motor imagery electroencephalogram (EEG) were extracted and classified. Mu rhythm of EEG was obtained by preprocessing, and the features were optimized by spatial filtering, which are estimated from a set of data by method of common spatial pattern. Classification decision can be made by Fisher criterion, and classification performance can be evaluated by cross validation and receiver operating characteristic (ROC) curve. Optimal feature dimension determination projected by spatial filter was discussed deeply in cross-validation way. The experimental results show that the high discriminate accuracy can be guaranteed, meanwhile the program running speed is improved. Motor imagery intention classification based on optimized EEG feature provides difference of states and simplifies the recognition processing, which offers a new method for the research of intention recognition.
To investigate the γ pass rate limit of plan verification equipment for volumetric modulated arc therapy (VMAT) plan verification and its sensitivity on the opening and closing errors of multi-leaf collimator (MLC), 50 cases of nasopharyngeal carcinoma VMAT plan with clockwise and counterclockwise full arcs were randomly selected. Eight kinds of MLC opening and closing errors were introduced in 10 cases of them, and 80 plans with errors were generated. Firstly, the plan verification was conducted in the form of field-by-field measurement and true composite measurement. The γ analysis with the criteria of 3% dose difference, distance to agreement of 2 mm, 10% dose threshold, and absolute dose global normalized conditions were performed for these fields. Then gradient analysis was used to investigate the sensitivity of field-by-field measurement and true composite measurement on MLC opening and closing errors, and the receiver operating characteristic curve (ROC) was used to investigate the optimal threshold of γ pass rate for identifying errors. Tolerance limits and action limits for γ pass rates were calculated using statistical process control (SPC) method for another 40 cases. The error identification ability using the tolerance limit calculated by SPC method and the universal tolerance limit (95%) were compared with using the optimal threshold of ROC. The results show that for the true composite measurement, the clockwise arc and the counterclockwise arc, the descent gradients of the γ passing rate with per millimeter MLC opening error are 10.61%, 7.62% and 6.66%, respectively, and the descent gradients with per millimeter MLC closing error are 9.75%, 7.36% and 6.37%, respectively. The optimal thresholds obtained by the ROC method are 99.35%, 97.95% and 98.25%, respectively, and the tolerance limits obtained by the SPC method are 98.98%, 97.74% and 98.62%, respectively. The tolerance limit calculated by SPC method is close to the optimal threshold of ROC, both of which could identify all errors of ±2 mm, while the universal tolerance limit can only partially identify them, indicating that the universal tolerance limit is not sensitive on some large errors. Therefore, considering the factors such as ease of use and accuracy, it is suggested to use the true composite measurement in clinical practice, and to formulate tolerance limits and action limits suitable for the actual process of the institution based on the SPC method. In conclusion, it is expected that the results of this study can provide some references for institutions to optimize the radiotherapy plan verification process, set appropriate pass rate limit, and promote the standardization of plan verification.
ObjectiveTo compare the predictive value of six thrombotic risk assessment scales, including Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT, for the deep venous thrombosis (DVT) of lower extremity in patients with gastrointestinal tumors. MethodsThe patients with gastrointestinal tumors who received surgical treatment in the General Surgery Department of Lanzhou University Second Hospital from March 2023 to October 2023 were collected. The risk of DVT on day 3 after surgery for the patient with gastrointestinal tumors was prospectively evaluated using the Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT assessment scales. And the DVT was detected by ultrasound examination. The pionts of six thrombotic risk assessment scales were compared between the patient with DVT and without DVT based on the ultrasound examination results. The predictive value of the six thrombotic risk assessment scales for the lower extremity DVT in the patients with gastrointestinal tumors was evaluated by the area under receiver operating characteristic curve (AUC). ResultsA total of 108 patients who met the criteria, including 71 males and 37 females, were enrolled, age ranged from 18 to 85 years old, (58.3±11.2) years old. Fourty-two cases (38.9%) of DVT occurred. The age of patients with DVT was older than that of patients without DVT (P<0.05), but there were no statistical differences in the gender, body mass index, tumor location, comorbidities, and so on (P>0.05). The points of Autar, Padua, and Caprini in the patients with DVT were higher than those in the patients without DVT (P<0.05), while there were no statistical differences in the points of Wells, Khorana, and COMPASS-CAT between the two (P>0.05). The AUC for differentiating the occurrence of DVT in the patients with gastrointestinal tumors using the Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT assessment scales were 0.907, 0.548, 0.636, 0.627, 0.589, and 0.535, respectively; The sensitivities were 97.6%, 14.3%, 52.4%, 83.3%, 47.6%, and 21.4%; The specificities were 2.4%, 85.7%, 47.6%, 16.7%, 52.4%, and 78.6%, respectively. ConclusionAccording to the abilities of Autar, Wells, Padua, Caprini, Khorana, and COMPASS-CAT to distinguish the occurrence of DVT in patients with gastrointestinal tumors after surgery, only the Autar evaluation scale is found to be more effective, while the other five evaluation scales are generally able to distinguish the occurrence of DVT.