On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.

Objective:To understand the real feelings of oncology nurses in using arm port, so as to provide basis for taking targeted intervention measures to reduce the problems in the process of nurses using arm port and continuously improve the quality of intravenous therapy.Methods:Using the purposive sampling method, a total of 13 nurses from Oncology Department of Beijing Hospital were selected for in-depth interviews from October to November 2023, and the data were analyzed using Colaizzi's 7-step analysis method.Results:Three themes were extracted, including positive experiences (high sense of security and benefit), growth and reflection and negative experiences (concerns about unknown risks, tension and stress) .Conclusions:As a relatively safe route of administration, arm port is worthy of further promotion and application. There are many concerns among oncology nurses during the use of arm port. It is recommended that medical staff jointly strengthen comprehensive evaluations of patients and managers provide corresponding training and guidance for weak links to alleviate nurses' concerns during the use of arm port, in order to provide patients with higher quality intravenous treatment nursing services.

Critical care medicine-related treatment is an interdisciplinary and multi-professional process,often leading to secondary or concomitant mental disorders in clinical practice.Currently,there is no consensus on the pharmacological treatment of related mental illnesses in China.The Chinese Society of Psychosomatic Medicine collaborated with the Critical Care Medicine expert group to form a consensus writing expert group.After a systematic review of relevant literature,summarizing published domestic and foreign literature,and extensive discussions,the consensus was developed.The consensus elaborates on the principles and processes of the standardized use of psychotropic drugs in critical care medicine,as well as the clinical indications,precautions,and specific drug selection of various psychiatric medications,providing feasible suggestions and guidance for the clinical application of psychiatric medications in the intensive care unit.

Systematic reviews are the basis of evidence-based medical research, and high-quality systematic reviews represent the highest level of evidence for evaluating treatment effects. Traditional systematic reviews are mainly done manually, but the reading and screening of massive literature requires a lot of energy and time for clinicians, resulting in low efficiency, which cannot meet the needs of rapid decision-making. To address this problem, a number of automated tools have been developed. Thus, this article aims to systematically sort out existing automated tools for systematic review literature screening, and analyze their respective performance, characteristics, and usage to understand the current development status of this field and provide reference for related research and applications.

Objective:To develop the Nurse Managers Negative Leadership Behavior Scale and test its reliability and validity.Methods:This study is a cross-sectional study. The Nurse Managers Negative Leadership Behavior Scale item pool was formed through literature review and semi-structured interviews. A total of 28 nursing management experts from Hubei Province, Beijing, Guangdong Province and other places were selected for expert consultation to form the first draft of the scale. The scale was further revised through pre-experiment and item analysis. In May 2022, 300 nurses from the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology were selected by convenient sampling for a questionnaire survey to test the reliability and validity of the scale. A total of 300 questionnaires were distributed, and 265 valid questionnaires were recovered, with an effective recovery rate of 88.33%. One week after the survey, 20 nurses were randomly selected to re-issue the questionnaire for the retest reliability test of the scale.Results:Totally, 19 experts completed two rounds of expert consultation, with expert authority coefficient of 0.880, Kendall harmony coefficient of 0.160 and 0.130 ( P<0.05) . Exploratory factor analysis extracted six factors, including neglect of needs, personal attack, right satisfaction, unpredictable behavior, slack work and improper supervision, and the cumulative variance interpretation rate was 75.125%. The confirmatory factor analysis showed that the model fitted well and the factor structure was stable. The Nurse Managers Negative Leadership Behavior Scale included six dimensions and 36 items. The total Cronbach's α coefficient of the scale was 0.880, the split-half reliability coefficient was 0.895, and the retest reliability coefficient was 0.876. The content validity index of the scale was 0.930, and the content validity index of each item was 0.800 to 1.000. Conclusions:The Nurse Managers Negative Leadership Behavior Scale has good reliability and validity, and can be used to evaluate the negative leadership behavior of head nurses in China.

Objective: To construct nomogram to predict the risk of bone metastasis in patients with non-small cell lung cancer(NSCLC). Methods: The clinical data of NSCLC patients diagnosed in the hospital were retrospectively analyzed, including the occurrence of bone metastasis, age, gender, pathological type, smoking status, PS score, TN stage, metastasis of other sites before bone metastasis, carcinoembryonic antigen(CEA) level, alpha fetoprotein(AFP) level, serum calcium(Ca2+), serum phosphorus(P), alkaline phosphatase(ALP) level, which were determined by univariate and multivariate logistic regression analysis. Receiver operating characteristic curve(ROC) and decision curve analysis were used, DCA was used to verify the accuracy and clinical benefit of the model, and nomogram was used to visualize the model. Results: Area under the ROC curve(AUC) showed that in the modeling group(n=138) and the validation group(n=92), the AUC value predicted by combined indicators(age, gender, pathological type, CEA, ALP)(modeling group=0.792, validation group=0.629) was higher than that predicted by single indicator. Conclusion The prediction model constructed in this study has good effect and can provide reference for clinical screening of high-risk patients with bone metastasis of NSCLC.

Objective:The aMAP score is a hepatocellular carcinoma (HCC) risk prediction model based on an international cooperative cohort, which can be applied to various liver diseases. The aim of this study is to use the aMAP score to stratify the risk of HCC in patients with chronic liver disease (combined or non-combined metabolic diseases) admitted to People's Hospital of Yudu County, Ganzhou City, Jiangxi Province, in order to guide personalized HCC screening.Methods:The demographic information, laboratory test results (platelets, albumin, and total bilirubin) and combined disease information of patients with chronic liver disease who were admitted to People's Hospital of Yudu from January 2016 to December 2020 were collected, and the aMAP score was calculated to stratify HCC risk in this population.Results:A total of 3629 cases with chronic liver disease were included in the analysis, including 3 452 (95.1%) cases with hepatitis B virus (HBV) infection, 177 (4.9%) cases with fatty liver, and 22 (0.6%) cases with HBV infection and fatty liver. There were 2 679 (73.8%) male and the median age was 44 (35, 54). In the overall population, low, medium and high risk of HCC accounted for 52.6%, 29.0%, and 18.4% respectively. In the HBV-infected population, the proportion of high risk of HCC was significantly higher than that of fatty liver (18.9% vs. 9.6%, P = 0.001). The proportion of chronic liver disease patients with combined hypertension or diabetes was significantly higher than that of those with non-combined metabolic diseases (combined hypertension: 32.3% vs. 17.9%, P < 0.001; combined diabetes: 36.5% vs. 18.1%, P < 0.001). Moreover, the proportion of high-risk population with two metabolic diseases was significantly higher than that with one and no metabolic diseases (40.9% vs. 31.8% vs. 17.7%, P < 0.001). Conclusion:The aMAP score can be used as a simple tool for HCC screening and management of chronic liver disease in primary hospitals, and it is helpful to improve the personalized follow-up management system of chronic liver disease population. Chronic liver disease patients with metabolic diseases have a higher risk of HCC, and people with high risk of HCC should be given special priority in follow-up visits, so as to improve the rate of HCC early diagnosis and reduce the mortality rate.

Objective: To study the clinical efficacy of microsurgical clipping treatment for intracranial aneurysm rupture and optimal timing. Methods: From January 2016 to December 2017, 80 patients with intracranial aneurysm rupture in Taizhou Enze Medical Center(Group) Hospital were randomly divided into the control group (24-72h after rupture) and the observation group (within 24h after rupture) according to the digital table, with 40 patients in each group.The pre- and intra-surgical re-rupture and surgical clipping, post-surgical complications, and clinical efficacy of 6-month follow-up in the two groups were observed and compared. Results: Compared with the control group, the incidence rate of pre-surgical re-rupture was significantly reduced in the observation group (0.0% vs.10.0%, χ²=4.21, P<0.05). Compared with the control group, the incidence rate of post-surgical complications was obviously reduced in the observation group (20.0% vs.42.5%, χ²=4.71, P<0.05). Compared with the control group, the excellent rate of treatment was significantly improved in the observation group (87.5% vs.65.0%, χ²=5.59, P<0.05). Conclusion The microsurgical clipping treatment can improve the clinical efficacy of intracranial aneurysm rupture and sooner surgery with better prognosis.

Objective To investigate the species distribution characteristics of nontuberculous mycobacteria(NTM)in acquired immunodeficiency syndrome(AIDS)patients in Shanghai,and to provide evidences for clinical treatment.Methods A total of 775 Mycobacteria strains were isolated from patients(including 129 isolates from AIDS patients and 646 isolates from HIV-negative patients)admitted to Shanghai Public Health Clinical Center during 2015.All the species were identified by the sequence analysis of 16S rRNA gene and hsp65 gene.Differences in the species distribution were compared between patients with and without HIV infection.CD4+T lymphocyte count was detected by flow cytometry and its relation with mycobacteria infection was also analyzed.Chi-square test was used for comparison between groups.Results The ratio of NTM isolation from HIV-negative patients was 15.79%(102/646),while that was 46.51% in AIDS patients(60/129),and the difference was statistically significant(x2=61.38,P <0.01).Among the 60 NTM strains isolated from AIDS patients,mycobacterium avium-intracelluare complex(MAC)and Mycobacterium gordonae were the predominant species(43.33% and 20.00%,respectively).Moreover,five Mycobacterium colombiense strains,which were relatively rare,were also obtained.A total of 102 NTM were identified from HIV-negative patients,of which Mycobacterium gordonae(32 isolates,31.37%)and MAC(30 isolates,29.41%)were the most frequently isolated.In addition,the positive rates of NTM and MAC were significantly higher in patients with CD4+T lymphocyte counts ≤50 cells/μL(58.33% and 76.92%,respectively)than those with CD4+T lymphocyte counts>50 cells/μL(20.00% and 15.38%,respectively)(x2=4.048 and 6.524,respectively,both P<0.05).Four out of five Mycobacterium colombiense infected patients died of disseminated infections,except the remaining one whose CD4+T lymphocyte counts>50 cells/μL.Conclusions The prevalence of NTM isolation is significant higher in AIDS patients than HIV-negative patients in Shanghai,and the most prevalent NTM species is MAC.The NTM infection in AIDS patients is related with low CD4+T lymphocyte counts.

Objective: The study assessed the clinical characteristics and response to acute intravenous antiarrhythmic drug therapy of supraventricular tachycardia (SVT) in children. Methods: This was a multicenter prospective descriptive study including 257 children from First Hospital of Tsinghua University, Peking University First Hospital, Children's Hospital Affiliated to Capital Institute of Pediatrics and Beijing Anzhen Hospital who received intravenous antiarrhythmic drug therapy for SVT from July 2014 to February 2017. The clinical and tachycardia features, response to intravenous antiarrhythmic drug therapy of these children were characterized. Statistical analyses were performed using t test, Mann-Whitney U test, χ² test and H test. Results: The onset of SVT occurred at any age with a distribution with positive skewness, 57.6% (n=148) children<1 year, 17.5% (n=45) children1~<3 years, 10.5% (n=27) children 3~<6 years and 14.4% (n=37) children ≥ 6 years of age. The percentages of SVT types were 49.4% (n=127) for atrioventricular reentry tachycardia (AVRT), 4.3% (n=11) for atrioventricular nodal reentry tachycardia (AVNRT), 26.8% (n=69) for unclassified paroxysmal SVT and 19.5% (n=50) for atrial tachycardia (AT), respectively. Tachycardia-induced cardionyopathy (TIC) secondary to SVT developed in 30 of 225 (13.3%). Left ventricular ejection fraction (LVEF) of the 27 children attacked by TIC returned to normal after successful control of SVT (41.1%±6.3% vs. 60.3%±9.2%, t=-10.397, P=0.000). Complete termination of SVT by antiarrhythmic drugs was achieved in 164 of 257 (63.8%), partial termination rate was 18.7% (48 of 257) and failure to terminate rate was 17.5% (45 of 257). Propafenone (complete cardioversion in 98 (73.1%) of 134) and amiodarone (complete cardioversion in 23 (76.7%) of 30) showed better efficacy for SVT termination than adenosine (complete cardioversion in 26 (44.1%) 59) (χ²=20.524, P=0.000). Paroxysmal SVT had a higher termination rate on pharmacological therapy than AT (67.1% vs. 50.0%, χ²=6.337, P=0.042). Patients of different age groups had significantly different response to antiarrhythmic therapy (χ²=13.904, P=0.031). Children<1 year of age showed the least response to antiarrhythmic drug therapy with complete termination in 51 (55.4%) of 92. Adverse effects occurred in 9 patients (3.5%): Four patients had severe hypotensive shock using propafenone (n=3) and adenosine (n=1), and 3 patients had sinus arrest using adenosine. Conclusion Most (57.6%) children with SVT have their first clinical episode within 1 year of age, and AVRT is the most common type. TIC occurs in 13.3% of children with SVT. Intravenous antiarrhythmic drug therapy has a 63.8% complete termination rate for children with SVT and incidence of adverse effects is 3.5%. Propafenone and amiodarone are more effective for SVT termination in children than adenosine. Serious adverse effects may occur when using propafenone.