Objective To analyze the problems in the operation and management of drug clinical trials and put forward targeted suggestion. Methods An electronic questionnaire survey was conducted among medical staff in about 80 hospitals in the yangtze river delta region. Results 606 valid questionnaires were received. 71% of the respondents expressed their willingness to study and participate in drug clinical trials. There were significant differences in the cognitive demands, willingness and motivation of the respondents with different occupations and educational backgrounds about the drug clinical trial work （P<0.05）. During the operation of drug clinical trials, respondents reported the main factors affecting the quality of clinical trials which including good clinical practice (GCP) awareness and subjective enthusiasm of investigators （response rate 27%）, job stability of supervisors and research coordinators （27%）, compliance of subjects （45%）, quality control of the whole process of the circulation of test drugs, medical devices and biological samples （52%）, and the informatization level of clinical trial institutions （30%）. Conclusion Hospitals, institutions and project teams could take measures to cultivate and stabilize the drug clinical trial talent team, improve the quality management system of drug clinical trials, improve work efficiency, and promote the high-quality development of drug clinical trials in medical institutions.

Objective To observe the effect of Huoxin pill （concentrated pill） combined with Baduanjin on the prognosis of patients with acute myocardial infarction complicated by percutaneous coronary intervention （PCI）. Methods 120 patients with acute myocardial infarction complicated with heart failure who received emergency interventional treatment in our hospital from January 2022 to January 2023 were randomly divided into western medicine treatment group and Traditional Chinese Medicine （TCM）comprehensive treatment group. Western medicine treatment: standard western medicine treatment + five prescriptions for cardiac rehabilitation; based on western medicine treatment, Huoxin pill （concentrated pill） combined with Baduanjin therapy was added to the TCM comprehensive treatment group, and the follow-up was 6 months. The observed indexes were exertion angina pectoris scale, Chinese Medicine Syndrome Scale, Chinese medicine syndrome treatment effect evaluation, 6-minute walking test （6MWT）, left ventricular ejection fraction （LVEF）, and brain natriuretic peptide precursor （pro-BNP）. Results Sixty patients were enrolled in the two groups respectively. During the treatment, 2 cases fell off in the western medicine treatment group and 8 cases fell off in the TCM comprehensive treatment group, and a total of 110 cases were enrolled in the group. Compared with the western treatment group, TCM combined therapy significantly improved angina pectoris scale score, TCM Syndrome Scale score, pro-BNP, LVEF and 6MWT （P<0.001）. There were no significant differences in blood routine, liver and kidney function, potassium, blood glucose, blood lipids and cardiac Troponin I （cTnI） between the two groups （P>0.05）. No adverse cardiovascular events occurred during the entire treatment period in both groups. Conclusion Huoxin pill （concentrated pill） combined with Baduanjin was more effective than western therapy in improving LVEF, 6MWT distance, exercise tolerance and cardiac function in patients with acute myocardial infarction complicated with heart failure.

Objectives:To investigate the mid-term outcomes of percutaneous cement discoplasty(PCD)in the treatment of lumbar axial instability,and analyze its technical keypoints and indications.Methods:A retrospective analysis was conducted on 9 patients with axial lumbar instability treated with PCD from January 2018 to December 2019.There were 5 males and 4 females,aged 62-87 years(75.7±8.2 years),with a follow-up period of 0.5-3 years,averaged 2.3±1.0 years.Three cases had three-disc operation at the same time,three had double-space operation and three had single-space operation,involving L2/3 disc in 3 cases,L3/4 disc in 3 cases,L4/5 disc in 4 cases,and L5/S1 disc in 3 cases.Lumbar anteroposterior and lateral ra-diographs in supine and standing positions were performed before operation,at postoperative 1d,3,6,12 months and final follow-up to measure the height of intervertebral space of responsible level,as well as the sagittal area of intervertebral foramen at responsible level.Visual analogue scale(VAS)and Oswestry disability index(ODI)were used to evaluate the pain and function before surgery,at 1d,3 months,6 months,12 months and final follow-up after operation to assess the clinical efficacy.The amount of bone cement injected in each intervertebral disc,the time of operation and the amount of blood loss were recorded respectively.Results:All the patients successfully completed the operation,no bone cement leakage occurred.The VAS score and ODI after operation were significantly improved compared with those before operation(P＜0.05).The injection volume of bone cement per intervertebral disc was 3.50±0.73mL.The operative time of each disc was 16.33±1.28min,and the blood loss of each disc was 3.83±0.71mL.The height of intervertebral space of responsible level at various time points after operation was different from that before operation(P＜0.05),and there was no difference in any two time points after operation.The sagittal area of intervertebral foramen at each time point after operation was different from that before operation(P＜0.05),and there was difference be-tween postoperative 1d and the final follow-up values(P＜0.05).Conclusions:PCD can increase the height of the intervertebral space after surgery,relieve lumbar pain,and have a lasting effect in the treatment of lum-bar instability,which is safe with satisfactory mid-term effect,and not prone to bone cement leakage,but long-term large-sample follow-up is still needed.

Prostate cancer is the most prevalent malignant tumor among men, ranking first in incidence and second in mortality globally. Novel hormone therapies (NHT) targeting the androgen receptor (AR) pathway have become the standard of care for metastatic prostate cancer. This review offers a comprehensive overview of NHT, including abiraterone, enzalutamide, apalutamide, darolutamide, and rezvilutamide, which have demonstrated efficacy in delaying disease progression and improving patient survival and quality of life. Nevertheless, resistance to NHT remains a critical challenge. The mechanisms underlying resistance are complex, involving AR gene amplification, mutations, splice variants, increased intratumoral androgens, and AR-independent pathways such as the glucocorticoid receptor, neuroendocrine differentiation, DNA repair defects, autophagy, immune evasion, and activation of alternative signaling pathways. This review discusses these resistance mechanisms and examines strategies to counteract them, including sequential treatment with novel AR-targeted drugs, chemotherapy, poly ADP-ribose polymerase inhibitors, radionuclide therapy, bipolar androgen therapy, and approaches targeting specific resistance pathways. Future research should prioritize elucidating the molecular basis of NHT resistance, optimizing existing therapeutic strategies, and developing more effective combination regimens. Additionally, advanced sequencing technologies and resistance research models should be leveraged to identify novel therapeutic targets and improve drug delivery efficiencies. These advancements hold the potential to overcome NHT resistance and significantly enhance the management and prognosis of patients with advanced prostate cancer.

Objectives:To investigate the mid-term outcomes of percutaneous cement discoplasty(PCD)in the treatment of lumbar axial instability,and analyze its technical keypoints and indications.Methods:A retrospective analysis was conducted on 9 patients with axial lumbar instability treated with PCD from January 2018 to December 2019.There were 5 males and 4 females,aged 62-87 years(75.7±8.2 years),with a follow-up period of 0.5-3 years,averaged 2.3±1.0 years.Three cases had three-disc operation at the same time,three had double-space operation and three had single-space operation,involving L2/3 disc in 3 cases,L3/4 disc in 3 cases,L4/5 disc in 4 cases,and L5/S1 disc in 3 cases.Lumbar anteroposterior and lateral ra-diographs in supine and standing positions were performed before operation,at postoperative 1d,3,6,12 months and final follow-up to measure the height of intervertebral space of responsible level,as well as the sagittal area of intervertebral foramen at responsible level.Visual analogue scale(VAS)and Oswestry disability index(ODI)were used to evaluate the pain and function before surgery,at 1d,3 months,6 months,12 months and final follow-up after operation to assess the clinical efficacy.The amount of bone cement injected in each intervertebral disc,the time of operation and the amount of blood loss were recorded respectively.Results:All the patients successfully completed the operation,no bone cement leakage occurred.The VAS score and ODI after operation were significantly improved compared with those before operation(P＜0.05).The injection volume of bone cement per intervertebral disc was 3.50±0.73mL.The operative time of each disc was 16.33±1.28min,and the blood loss of each disc was 3.83±0.71mL.The height of intervertebral space of responsible level at various time points after operation was different from that before operation(P＜0.05),and there was no difference in any two time points after operation.The sagittal area of intervertebral foramen at each time point after operation was different from that before operation(P＜0.05),and there was difference be-tween postoperative 1d and the final follow-up values(P＜0.05).Conclusions:PCD can increase the height of the intervertebral space after surgery,relieve lumbar pain,and have a lasting effect in the treatment of lum-bar instability,which is safe with satisfactory mid-term effect,and not prone to bone cement leakage,but long-term large-sample follow-up is still needed.

Radiation recall pneumonitis is an inflammatory reaction of previously radiated lung parenchyma triggered by systemic pharmacological agents (such as chemotherapy and immunotherapy) or vaccination. Patients present with non-specific symptoms such as cough, shortness of breath, or hypoxia soon after the initiation of medication or vaccination. Careful assessment of the patient’s history, including the thoracic radiation treatment plan and timing of the initiation of the triggering agent, in conjunction with CT findings, contribute to the diagnosis. Once a diagnosis is established, treatment includes cessation of the causative medication and/or initiation of steroid therapy. Differentiating this relatively rare entity from other common posttherapeutic complications in oncology patients, such as recurrent malignancy, infection, or medication-induced pneumonitis, is essential for guiding downstream clinical management.

Objective To investigate the current status of delivery room transitional care management for very/extremely preterm infants in Shenzhen City.Methods A cross-sectional survey was conducted in November 2022,involving 24 tertiary hospitals participating in the Shcnzhen Neonatal Data Network.The survey assessed the implementation of transitional care management in the delivery room,including prenatal preparation,delivery room resuscitation,and post-resuscitation management in the neonatal intensive care unit.Very/extremely preterm infants were divided into four groups based on gestational age:＜26 weeks,26-28+6 weeks,29-30+6 weeks,and 31-31+6 weeks.Descriptive analysis was performed on the results.Results A total of 140 very/extremely preterm infants were included,with 10 cases in the＜26 weeks group,45 cases in the 26-28+6 weeks group,49 cases in the 29-30+6 weeks group,and 36 cases in the 31-31+6 weeks group.Among these infants,99(70.7％)received prenatal counseling,predominantly provided by obstetricians(79.8％).The main personnel involved in resuscitation during delivery were midwives(96.4％)and neonatal resident physicians(62.1％).Delayed cord clamping was performed in 52 cases(37.1％),with an average delay time of(45±17)seconds.Postnatal radiant warmer was used in 137 cases(97.9％)for thermoregulation.Positive pressure ventilation was required in 110 cases(78.6％),with 67 cases(60.9％)using T-piece resuscitators and 42 cases(38.2％)using a blended oxygen device.Blood oxygen saturation was monitored during resuscitation in 119 cases(85.0％).The median time from initiating transitional care measures to closing the incubator door was 87 minutes.Conclusions The implementation of delivery room transitional care management for very/extremely preterm infants in the hospitals participating in the Shenzhen Neonatal Data Network shows varying degrees of deviation from the corresponding expert consensus in China.It is necessary to bridge the gap.through continuous quality improvement and multicenter collaboration to improve the quality of the transitional care management and outcomes in very/extremely preterm infants.[Chinese Journal of Contemporary Pediatrics,2024,26(3):250-257]

Humans ; Lung Transplantation/adverse effects* ; Risk Factors

Background::While type 2 diabetes mellitus (T2DM) is considered a putative causal risk factor for coronary artery disease (CAD), the intrinsic link underlying T2DM and CAD is not fully understood. We aimed to highlight the importance of integrated care targeting both diseases by investigating the phenotypic and genetic relationships between T2DM and CAD.Methods::We evaluated phenotypic associations using data from the United Kingdom Biobank ( N = 472,050). We investigated genetic relationships by leveraging genomic data conducted in European ancestry for T2DM, with and without adjustment for body mass index (BMI) (T2DM: Ncase/ Ncontrol = 74,124/824,006; T2DM adjusted for BMI [T2DM adjBMI]: Ncase/ Ncontrol = 50,409/523,897) and for CAD ( Ncase/ Ncontrol = 181,522/984,168). We performed additional analyses using genomic data conducted in multiancestry individuals for T2DM ( Ncase/ Ncontrol = 180,834/1,159,055). Results::Observational analysis suggested a bidirectional relationship between T2DM and CAD (T2DM→CAD: hazard ratio [HR] = 2.12, 95% confidence interval [CI]: 2.01–2.24; CAD→T2DM: HR = 1.72, 95% CI: 1.63–1.81). A positive overall genetic correlation between T2DM and CAD was observed ( rg = 0.39, P = 1.43 × 10 -75), which was largely independent of BMI (T2DM adjBMI–CAD: rg = 0.31, P = 1.20 × 10 –36). This was corroborated by six local signals, among which 9p21.3 showed the strongest genetic correlation. Cross-trait meta-analysis replicated 101 previously reported loci and discovered six novel pleiotropic loci. Mendelian randomization analysis supported a bidirectional causal relationship (T2DM→CAD: odds ratio [OR] = 1.13, 95% CI: 1.11-1.16; CAD→T2DM: OR = 1.12, 95% CI: 1.07-1.18), which was confirmed in multiancestry individuals (T2DM→CAD: OR = 1.13, 95% CI: 1.10-1.16; CAD→T2DM: OR = 1.08, 95% CI: 1.04-1.13). This bidirectional relationship was significantly mediated by systolic blood pressure and intake of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, with mediation proportions of 54.1% (95% CI: 24.9-83.4%) and 90.4% (95% CI: 29.3-151.5%), respectively. Conclusion::Our observational and genetic analyses demonstrated an intrinsic bidirectional relationship between T2DM and CAD and clarified the biological mechanisms underlying this relationship.