Objective:To construct an prediction model based on magnetic resonance imaging (MRI) machine learning algorithm and radiomics and investigate its application value in predicting lymphovascular invasion (LVI) status of rectal cancer without lymph node metastasis.Methods:The retrospective cohort study was conducted. The clinicopathological data of 204 rectal cancer patients without lymph node metastasis who were admitted to Gansu Provincial Hospital from February 2016 to January 2024 were collected. There were 123 males and 81 females, aged (61±7)years. All 204 patients were randomly divided into the training dataset of 163 cases and the testing dataset of 41 cases by a ratio of 8∶2 using the electronic computer randomization method. The training dataset was used to construct the prediction model, and the testing dataset was used to validate the prediction model. The clinical prediction model, radiomics model and joint prediction model were constructed based on the selected clinical and/or imaging features. Measurement data with normal distribution were represented as Mean± SD. Count data were described as absolute numbers, and the chi-square test or Fisher exact probability were used for comparison between the groups. Comparison of ordinal data was conducted using the nonparameter rank sum test. The inter-class correlation coefficient (ICC) was used to evaluate the consistency of the radiomics features of the two doctors, and ICC >0.80 was good consistency. Univariate analysis was conducted by corres-ponding statistic methods. Multivariate analysis was conducted by Logistic stepwise regression model. The receiver operating characteristic (ROC) curve was drawn, and the area under the curve (AUC), Delong test, decision curve and clinical impact curve were used to evaluate the diagnostic efficiency and clinical utility of the model. Result:(1) Analysis of factors affecting LVI status of patients. Of the 204 rectal cancer patients without lymph node metastasis, there were 71 cases with positive of LVI and 133 cases with negative of LVI. Results of multivariate analysis showed that gender, platelet (PLT) count and carcinoembryonic antigen (CEA) were independent factors affecting LVI status of rectal cancer without lymph node metastasis in training dataset [ odds ratio=2.405, 25.062, 2.528, 95% confidence interval ( CI) as 1.093-5.291, 2.748-228.604, 1.181-5.410, P<0.05]. (2) Construction of clinical prediction model. The clinical prediction model was conducted based on the results of multivariate analysis including gender, PLT count and CEA. Results of ROC curve showed that the AUC, accuracy, sensitivity and specificity of clinical prediction model were 0.721 (95% CI as 0.637-0.805), 0.675, 0.632 and 0.698 for the training dataset, and 0.795 (95% CI as 0.644-0.946), 0.805, 1.000 and 0.429 for the testing dataset. Results of Delong test showed that there was no significant difference in the AUC of clinical prediction model between the training dataset and the testing dataset ( Z=-0.836, P>0.05). (3) Construction of radiomics model. A total of 851 radiomics features were extracted from 204 patients, and seven machine learning algorithms, including logistic regression, support vector machine, Gaussian process, logistic regression-lasso algorithm, linear discriminant analysis, naive Bayes and automatic encoder, were used to construct the prediction model. Eight radiomics features were finally selected from the optimal Gaussian process learning algorithm to construct a radiomics prediction model. Results of ROC curve showed that the AUC, accuracy, sensitivity and specificity of radiomics prediction model were 0.857 (95% CI as 0.800-0.914), 0.748, 0.947 and 0.642 for the training dataset, and 0.725 (95% CI as 0.571-0.878), 0.634, 1.000 and 0.444 for the testing dataset. Results of Delong test showed that there was no significant difference in the AUC of radiomics prediction model between the training dataset and the testing dataset ( Z=1.578, P>0.05). (4) Construction of joint prediction model. The joint prediction model was constructed based on the results of multivariate analysis and the radiomics features. Results of ROC curve showed that the AUC, accuracy, sensitivity and specificity of radiomics prediction model were 0.885 (95% CI as 0.832-0.938), 0.791, 0.912 and 0.726 for the training dataset, and 0.857 (95% CI as 0.731-0.984), 0.854, 0.714 and 0.926 for the testing dataset. Results of Delong test showed that there was no significant difference in the AUC of joint prediction model between the training dataset and the testing dataset ( Z=0.395, P>0.05). (5) Performance comparison of three prediction models. Results of the Hosmer-Lemeshow goodness-of-fit test showed that all of the clinical prediction model, radiomics prodiction model and joint prediction model having good fitting degree ( χ2=1.464, 12.763, 10.828, P>0.05). Results of Delong test showed that there was no signifi-cant difference in the AUC between the clinical prediction model and the joint prediction model or the radiomics model ( Z=1.146, 0.658, P>0.05), and there was a significant difference in the AUC between the joint prediction model and the radiomics model ( Z=2.001, P<0.05). Results of calibra-tion curve showed a good performance in the joint prediction model. Results of decision curve and clinical impact curve showed that the performance of joint prediction model in predicting LVI status of rectal cancer without lymph node metastasis was superior to the clinical prediction model and the radiomics model. Conclusions:The clinical prediction model is constructed based on gender, PLT count and CEA. The radiomics predictive model is constructed based on 8 selected radiomics features. The joint prediction model is constructed based on the clinical prediction model and the radiomics predictive model. All of the three models can predict the LVI status of rectal cancer with-out lymph node metastasis, and the joint prediction model has a superior predictive performance.

To evaluate the efficacy,safety and acceptability of different drugs in the treatment of mixed states in bipolar disorder using the Cochrane systematic review method. The results showed that for the treatment of bipolar depression with mixed features,there is evidence to support the efficacy of lurasidone and quetiapine. Lurasidone has low metabolic and sedative side effects,and can be used in children and adolescents with bipolar depression with mixed features. Quetiapine has balanced anti-depressant and anti-manic effects,with low risk of phase transition. There is evidence to support the efficacy of olanzapine in the treatment of bipolar manic with mixed features. However,it is necessary to balance the efficacy and side effects of olanzapine,and pay attention to the risk of phase transition. For mixed episode in Bipolar disorder,aripiprazole had most research evidence. Aripiprazole has fewer side effects on metabolism and prolactin,and can be used in children with bipolar disorder. Valproate and lithium are recommended by experts for the treatment of mixed state in bipolar disorder. The inconsistency between current studies is still significant,and high-quality randomized controlled trials are urgently needed to provide more comprehensive evidence-based support for the treatment of mixed states in bipolar disorder.

To evaluate the efficacy,safety and acceptability of different drugs in the treatment of mixed states in bipolar disorder using the Cochrane systematic review method. The results showed that for the treatment of bipolar depression with mixed features,there is evidence to support the efficacy of lurasidone and quetiapine. Lurasidone has low metabolic and sedative side effects,and can be used in children and adolescents with bipolar depression with mixed features. Quetiapine has balanced anti-depressant and anti-manic effects,with low risk of phase transition. There is evidence to support the efficacy of olanzapine in the treatment of bipolar manic with mixed features. However,it is necessary to balance the efficacy and side effects of olanzapine,and pay attention to the risk of phase transition. For mixed episode in Bipolar disorder,aripiprazole had most research evidence. Aripiprazole has fewer side effects on metabolism and prolactin,and can be used in children with bipolar disorder. Valproate and lithium are recommended by experts for the treatment of mixed state in bipolar disorder. The inconsistency between current studies is still significant,and high-quality randomized controlled trials are urgently needed to provide more comprehensive evidence-based support for the treatment of mixed states in bipolar disorder.

Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.

Objective:To evaluate the efficacy and safety of sodium hyaluronate gel in preventing adhesion after prophylactic enterostomy.Methods:One hundred and twenty four patients from 6 hospitals were enrolled in this prospective multi-center randomized controlled trial. Patients were randomized into the study group ( n=59) or the control group ( n=65).All patients underwent prophylactic enterostomy. Patients of study group received odium hyaluronate gel for adhesion-prevention,while those in control group did not receive any adhesion-prevention treatment. The incidence of moderate to severe adhesion around the incision in the stoma area were evalutated during stoma reduction surgery. Results:The incidence of moderate to severe adhesion around the incision in the stoma area was 6.3% in the study group, the difference was statistically significant ( P<0.05) compared to that of the control group (32.6%). Conclusion:Sodium hyaluronate gel can safely and effectively reduce the incidence of moderate and severe adhesions after abdominal surgery.

Objective:To verify the reliability and validity of the Chinese Version of Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN-C) in patients with major depressive disorder(MDD).Methods:A total of 122 patients with MDD and 122 controls were recruited and measured with the BRIAN-C, 16-Item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16), 7-Item Generalized Anxiety Disorder Scale(GAD-7) and 6-Item Short Form Health Survey(SF-6). The index D and correlation analysis were conducted to evaluate the discrimination and homogeneity of the items, respectively. The Cronbach′s α coefficient, Spearman-Brown coefficient, intraclass correlation coefficient ( ICC) and retest correlation coefficient were conducted to evaluate the reliability.Confirmatory factor analysis, correlation analysis and the receiver operating characteristic (ROC) curve were conducted to evaluate the construct validity, criterion validity and prediction validity, respectively. Results:The item distinction and homogeneity analysis showed significant differences ( P<0.05). The Cronbach′s α coefficient and the Spearman-Brown coefficient were 0.911 and 0.807, while the ICC and the correlation coefficient r of test-retest reliability were 0.639 (95% confidence interval( CI):0.375-0.729) and 0.43 ( P=0.001), respectively. Confirmatory factor analysis showed that the fit indexes χ 2/dF=1.937, goodness-of-fit index(GFI)=0.822, comparative fit index (CFI)=0.877, Tucker-lewis index (TLI)=0.855, and root mean square error of approximation (RMSEA)=0.088. The score of BRIAN-C was significantly correlated with that of QIDS-SR16, GAD-7 or SF-6 ( r=0.74, 0.46, -0.69, all P<0.05).The ROC curve suggested that the area under curve (AUC) was 0.939 (95% CI: 0.909-0.970, P<0.05) for distinguishing MDD patients from controls. The optimal cut-off was 29, with 0.861 sensitivity and 0.926 specificity. Conclusions:The BRIAN-C scale has good reliability and validity, which is supposed to be used in Chinese cultural background to evaluate the biorhythms in patients with MDD.

Objective:To verify the reliability and validity of the Chinese Version of Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN-C) in patients with major depressive disorder(MDD).Methods:A total of 122 patients with MDD and 122 controls were recruited and measured with the BRIAN-C, 16-Item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16), 7-Item Generalized Anxiety Disorder Scale(GAD-7) and 6-Item Short Form Health Survey(SF-6). The index D and correlation analysis were conducted to evaluate the discrimination and homogeneity of the items, respectively. The Cronbach′s α coefficient, Spearman-Brown coefficient, intraclass correlation coefficient ( ICC) and retest correlation coefficient were conducted to evaluate the reliability.Confirmatory factor analysis, correlation analysis and the receiver operating characteristic (ROC) curve were conducted to evaluate the construct validity, criterion validity and prediction validity, respectively. Results:The item distinction and homogeneity analysis showed significant differences ( P<0.05). The Cronbach′s α coefficient and the Spearman-Brown coefficient were 0.911 and 0.807, while the ICC and the correlation coefficient r of test-retest reliability were 0.639 (95% confidence interval( CI):0.375-0.729) and 0.43 ( P=0.001), respectively. Confirmatory factor analysis showed that the fit indexes χ 2/dF=1.937, goodness-of-fit index(GFI)=0.822, comparative fit index (CFI)=0.877, Tucker-lewis index (TLI)=0.855, and root mean square error of approximation (RMSEA)=0.088. The score of BRIAN-C was significantly correlated with that of QIDS-SR16, GAD-7 or SF-6 ( r=0.74, 0.46, -0.69, all P<0.05).The ROC curve suggested that the area under curve (AUC) was 0.939 (95% CI: 0.909-0.970, P<0.05) for distinguishing MDD patients from controls. The optimal cut-off was 29, with 0.861 sensitivity and 0.926 specificity. Conclusions:The BRIAN-C scale has good reliability and validity, which is supposed to be used in Chinese cultural background to evaluate the biorhythms in patients with MDD.

Background::The role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in children with high-risk (HR) T-cell acute lymphoblastic leukemia (T-ALL) in first complete remission (CR1) is still under evaluation. Moreover, relapse is the main factor affecting survival. This study aimed to explore the effect of allo-HSCT (especially haploidentical HSCT [haplo-HSCT]) on improving survival and reducing relapse for HR childhood T-ALL in CR1 and the prognostic factors of childhood T-ALL in order to identify who could benefit from HSCT.Methods::A total of 74 newly diagnosed pediatric T-ALL patients between January 1, 2012 and June 30, 2018 were enrolled in this retrospective study. Patients were stratified into the low-risk chemotherapy cohort ( n = 16), HR chemotherapy cohort ( n = 31), and HR transplant cohort ( n = 27). Characteristics, survival outcomes, and prognostic factors of all patients were then analyzed. Results::Patient prognosis in the HR chemotherapy cohort was significantly worse than that in the low-risk chemotherapy cohort (5-year overall survival [OS]: 58.5% vs. 100%, P = 0.003; 5-year event-free survival [EFS]: 54.1% vs. 83.4%, P = 0.010; 5-year cumulative incidence of relapse [CIR]: 45.2% vs. 6.3%, P = 0.011). In HR patients, allo-HSCT improved the 5-year EFS and CIR compared to that of chemotherapy (5-year EFS: 80.1% vs. 54.1%, P = 0.041; 5-year CIR: 11.6% vs. 45.2%, P = 0.006). The 5-year OS was higher in the HR transplant cohort than that in the HR chemotherapy cohort (81.0% vs. 58.5%, P = 0.084). Minimal residual disease re-emergence was an independent risk factor for 5-year OS, EFS, and CIR; age ≥10 years was an independent risk factor for OS and EFS; and high white blood cell count was an independent risk factor for EFS and CIR. Conclusion::Allo-HSCT, especially haplo-HSCT, could effectively reduce relapse of children with HR T-ALL in CR1.

Objective:To observe the safety and efficacy of one-stage bilateral temporal lobe lesions resection in patients with severe bilateral radiation-induced temporal lobe injury after radiotherapy for nasopharyngeal carcinoma.Methods:Clinical data of 12 patients with severe bilateral radiation-induced temporal lobe injury after radiotherapy for nasopharyngeal carcinoma underwent one-stage bilateral temporal lobe lesions resection in our hospital from January 2013 to December 2017 were retrospectively analyzed. Karnofsky Performance Scale (KPS) scores were used as predictors of surgical outcomes before and two weeks after surgery. Imaging changes of radiation-induced brain injury lesions after surgery before and 3 months after surgery, surgical-related complications, and death were observed.Results:All 12 patients (100%) had improved postoperative KPS scores, which showed significant difference as compared with the preoperative KPS scores ( P<0.05). Two patients had pulmonary infection after operation, one patient had poor wound healing, and one patient had intracranial infection; all of them recovered after expectant treatment. None of the 12 patients had new neurological symptoms after surgery. During the follow-up period, the postoperative cranial MR imaging showed that the lesions were completely removed, and the leukoencephalopathy was alleviated or completely subsided. Conclusion:One-stage bilateral temporal lobe lesions resection is feasible for bilateral radiation-induced temporal lobe injury after radiotherapy for nasopharyngeal carcinoma.

Objective:The reliability and validity of the Chinese version of Mini International Neuropsychiatric Interview (Hypo-) Manic Episode with Mixed Features- DSM-5 module (MINI-M) were tested in patients with a hypomanic or manic episode.Methods:After sinicization of MINI-M, a total of 110 patients with hypomanic or manic episode were recruited into this multiple-centre study through a convenience sampling, and completed the questionnaires by themselves. The reliability of MINI-M was analyzed with Cronbach′s α and Spearman′s r of item-to-total and test-retest correlations. Principal component analysis (PCA) and exploratory factor analysis (EFA) were conducted to explore the structural validity of MINI-M. questionnaire. The receiver operating characteristic curve (ROC) based on clinical diagnosis was used to analyze the predictive validity.Results:The internal consistency Cronbach′s α of the MINI-M was 0.840, the correlation coefficients of item-to-total were 0.549-0.834 ( P<0.05), the test-retest reliability over one-week interval was 0.621 ( P<0.05). The PCA and EFA supported a single factor with strong loadings for all 6 items, which could explain 55.795% of the total variance. The ROC analysis showed that the optimal cut-off was 2 for distinguishing mixed features from the manic episode with a sensitivity of 0.800 and a specificity of 0.711. The MINI-M determined 38.2%(42/110) of patients with mixed features, which was higher than 18.2% (20/110) diagnosed by routine psychiatric interview. Conclusions:The findings demonstrate that the Chinese version of MINI-M is a reliable and valid tool for recognizing mixed features in patients with a hypomanic or manic episode, and helpful for raising the clinical diagnosis of mixed features.