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 screen the key genes in childhood therapy-resistant asthma by bioinformatic method, and to verify its expression and diagnostic value in peripheral blood of children with therapy-resistant asthma. Methods The transcriptome dataset GSE27011 of peripheral blood mononuclear cells from healthy children (healthy control group), mild asthma (MA) children (MA group) and severe asthma (SA) children (SA group) was downloaded from the Gene Expression Omnibus of the National Center for Biotechnology Information of the United States. Key genes were obtained by using R software for gene differential expression analysis, weighted gene co-expression network analysis (WGCNA) and clinical phenotypic correlation analysis. The differential expression levels of key genes were verified in children with asthma and immune cell transcriptome datasets. Seventy-eight children with asthma and 30 healthy children who were diagnosed in the Department of Pediatrics of Tangshan People’s Hospital between September 2020 and September 2021 were selected and divided into control group, MA group and SA group. Peripheral blood samples from children with asthma and healthy children who underwent physical examination were collected to detect the expression levels of key genes and inflammatory factors interleukin (IL)-4 and IL-17 in peripheral blood of children. Receiver operating characteristic curve was used to evaluate the sensitivity, specificity and accuracy of key genes in predicting childhood therapy-resistant asthma. Results The key gene GNA15 was obtained by bioinformatic analysis. Analysis of asthma validation dataset showed that GNA15 was up-regulated in asthma groups, and was specifically expressed in eosinophils. Clinical results showed that the expression levels of IL-4, IL-17 and GNA15 among the three groups were significantly different (P<0.05). The expression levels of IL-4 and IL-17 in the MA group and the SA group were higher than those in the control group (P<0.05). Compared with the control group and the MA group, the expression level of GNA15 in the SA group was up-regulated (P<0.05). Neither the difference in the expression level of IL-4 or IL-17 between the MA group and the SA group, nor the difference in the expression level of GNA15 between the control group and the MA group was statistically significant (P>0.05). The specificity, sensitivity and accuracy of GNA15 in predicting SA were 92.90%, 80.00% and 86.10%, respectively. Conclusion GNA15 has a significant clinical value in predicting the childhood therapy-resistant asthma, and may become a potential diagnostic marker for predicting the severity of asthma in children.
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).
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
ObjectivesTo explore the characteristics of Chinese methodological studies on patient compliance in clinical trials so as to provide reference for clinical trial of patient compliance in future.MethodsCNKI, VIP, CBM and WanFang Data databases were electronically searched to collect methodological studies on patient compliance in clinical trials published in Chinese language from January 2000 to December 2018. Two reviewers independently screened literature, extracted data and then, qualitative analysis of document characteristics was then performed.ResultsA total of 84 articles were included, in which 68 were studies on Western medicine and 16 were studies on traditional Chinese medicine (TCM). The results showed that: the quantity of studies on patient compliance increased along with time. However, those in TCM field did not increase. All included studies summarized their strategies to improve patient compliance, however key information for quality evaluation were missing.ConclusionsThere is still a lack of research on how to improve patients’ compliance in clinical trials to ensure the reliability of the results. Existing studies have not systematically and comprehensively explored the influencing factors of patients’ compliance. Clinical trials researchers in China have not focused sufficiently to patients’ compliance and lack the proper methodology to frame studies.
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.
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.
【摘要】 目的 应用受试者工作特征曲线（receiver operating characteristic curve，ROC曲线）探讨α-L-岩藻糖苷酶（AFU）对恶性腹水和非结核良性腹水的诊断价值。 方法 2004年7月—2008年1月对213例诊断明确的良、恶性腹水（其中良性腹水117例、恶性腹水96例）AFU活性进行检测。采用ROC曲线评价AFU的诊断灵敏度、特异度、准确性、阳性预测值、阴性预测值、阳性似然比、阴性似然比及Youden指数，评价其诊断效率。 结果 恶性腹水组AFU水平（164.96±87.72） μmol/（L•h），良性腹水组（104.02±62.07） μmol/（L•h），两者比较差异有统计学意义（Plt;0.01）。AFU诊断恶性腹水的ROC 曲线下面积为0.754±0.034，最佳分界值101.95 μmol/（L•h）。以AFU≥101.95 μmol/（L•h）来预测恶性腹水，其诊断的灵敏度为82.3%，特异度为63.2%，准确性为72.8%、阳性预测值为65.3%、阴性预测值为83.1%、阳性似然比为2.23、阴性似然比为0.28及Youden指数为0.455。 结论 腹水AFU活性检测有助于恶性腹水和非结核良性腹水的鉴别诊断，是一个比较理想的实用指标，适合于基层医院的临床应用。【Abstract】 Objective To assess the value of α-L-fucosidase (AFU) levels with receiver operating characteristic curve (ROC curve) in the diagnosis of malignant and non-tuberculous benign ascites. Methods Ascitic AFU activity was measured in 213 patients (117 with benign ascites and 96 with malignant ascites) diagnosed with benign or malignant ascites. The diagnostic sensitivity (SEN), specificity (SPE), accuracy, positive predictive value (PV+), negative predictive value (PV-), positive likelihood ratio (LR+), negative likelihood ratio (LR-) and Youden index (YI) of AFU were assessed with receiver operating characteristic curve, and the diagnostic effectiveness of AFU was evaluated. Results The average level of AFU in the malignant group [(164.96±87.72) μmol/(L•h)] was significantly higher than that in the benign group [(104.02±62.07) μmol/(L•h)] (Plt;0.01). The area under the curve (AUC) of the ROC curve of AFU was 0.754±0.034 for malignant ascites diagnosis, and the optimal cut-off value was 101.95 μmol/(L•h). When an AFU level equal to or higher than 101.95 μmol/(L•h) was used to predict malignant ascites, the diagnostic sensitivity was 82.3%, specificity was 63.2%, accuracy was 72.8%, PV+ was 65.3%, PV- was 83.1%, LR+ was 2.23, LR- was 0.28 and YI was 0.455. Conclusion Detection of AFU activity in ascites is helpful to differentiate the diagnose between malignant and non-tuberculous benign ascites, which is a relatively ideal index to fit for clinical application of local hospitals.
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。
Objective To explore the diagnostic value of a disintegrin-like and metalloproteinase with thrombospondin type 1 motifs (ADAMTS)-9 in acute aortic dissection (AAD). Methods A total of 328 patients with acute onset of chest pain within 24 hours were enrolled in West China Hospital from January 2015 to June 2016 and according to the results of computed tomography angiography they were divided into an AAD group (n=172, 107 males, 65 females, mean age of 50.4±13.1 years) and a control group (n=156, 89 males, 67 females, mean age of 54.9±14.7 years). The enzyme-linked immunosorbent assay (ELISA) test was used to measure the level of ADAMTS-9. Results Patients in two groups had no significant difference in age, gender, smoke history, hypertension history, total cholesterol, triacylglyceride and hemoglobin (P>0.05). But systolic and diastolic blood pressures were significantly higher in the AAD group than those in the control group (P<0.05, respectively). The level of ADAMTS-9 was significantly higher in the AAD group than that in the control group (249.4±186.8 ng/mlvs. 78.2±48.6 ng/ml,t=11.107, P<0.001). Receiver operating characteristic curve analysis showed that ADAMTS-9 (156.7 ng/ml) was predictive in the diagnosis of AAD with sensitivity of 0.942 and specificity of 0.628. Conclusion ADAMTS-9 might be an effective and important biomarker in diagnosis of AAD.