In drug clinical trials,the protection of subjects'privacy should take precedence over scientific exploration and societal benefits.This paper compared the differences in legal systems for the protection of subjects'privacy in China and abroad by employing methods such as literature review,case analysis,and comparison of domestic and foreign situations.It also elucidated the current ethical challenges faced by the protection of subjects'privacy,which primarily included imperfect laws and regulations,insufficient protection awareness among relevant personnel,risks of privacy breaches in critical links,and increased difficulty in data confidentiality under emerging technologies.From the perspective of responsible innovation,specific paths were proposed to protect subjects'privacy by using the four-dimensional structure of"prediction-reflection-negotiation-feedback,"maintaining a balance between ethical principles and technological innovation,ensuring the ethical and compliant nature of drug clinical trials,and thus better contributing to the cause of human health.

BACKGROUND: This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting. METHODS: This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate. RESULTS: A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs. CONCLUSIONS A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans ; Carcinoma, Non-Small-Cell Lung/metabolism* ; Male ; Female ; Retrospective Studies ; Middle Aged ; Lung Neoplasms/metabolism* ; Aged ; B7-H1 Antigen/metabolism* ; Programmed Cell Death 1 Receptor/metabolism* ; Adult ; Aged, 80 and over ; Immune Checkpoint Inhibitors/therapeutic use*

In drug clinical trials,the protection of subjects'privacy should take precedence over scientific exploration and societal benefits.This paper compared the differences in legal systems for the protection of subjects'privacy in China and abroad by employing methods such as literature review,case analysis,and comparison of domestic and foreign situations.It also elucidated the current ethical challenges faced by the protection of subjects'privacy,which primarily included imperfect laws and regulations,insufficient protection awareness among relevant personnel,risks of privacy breaches in critical links,and increased difficulty in data confidentiality under emerging technologies.From the perspective of responsible innovation,specific paths were proposed to protect subjects'privacy by using the four-dimensional structure of"prediction-reflection-negotiation-feedback,"maintaining a balance between ethical principles and technological innovation,ensuring the ethical and compliant nature of drug clinical trials,and thus better contributing to the cause of human health.

Objective:To investigate the clinical efficacy and immunological mechanism of herbal cake-partitioned moxibustion for aging process.Method:The herbal cake-partitioned moxibustion was adopted for 223 cases to observe the aging scores before and after the treatment.Apart from that,the T-lymphocyte subsets and changes of IL-2 and 3-EP were also detected.Results:After treatment,the aging scores of 223 cases were all substantially reduced,along with an improvement of clinical symptoms,a strengthened cellular immune function,and an increase of total T-lymphocyte count.In addition,the CD4+/CD8+ ratio Was restored normal,the synthesis or secretion of IL-2 was increased and the β-EP(as the neurotransmitter to modulate immune function)was substantially improved.Conclusion:The aging process is closely associated with the immune function.Moxibustion Can modulate abnormal immune function and stabilize homeostasis and thus delay the aging process.

Objective: To observe the influence of moxibustion sertma of mice on the expression of Fas, bcl-2 mRNA and protein of EL-4 lymphoma cells in vitro. Method: The EL-4 lymphoma cells were cultivated for 24 h in the moxibustion serum of mice. The expression of Fas and bcl-2 mRNA of EL-4 lymphoma cells were detected by in-situ hybridization method, and the protein expression of Fas and bcl-2 were observed by the immuocytochemistry method. Results: The expression of bcl-2 mRNA and protein decreased, and the expression of Fas rnRNA and protein increased significantly in EL-4 cells, which were cultivated in the moxibustion serum compared those cultivated in normal mice serum (P<0.05). Conclusion: Moxibustion serum could down-regulate the bcl-2 mRNA and protein and up-regulate the Fas mRNA and protein of EL-4 cells.

Objective To study the cognitive disorder in acute brain infarction. MethodCognition was meaured by P300 Peak Latency and The MMSE Scale for 32 patients with acute brain infarction. Results There are significant difference in P300 Peak Latency and The MMSE Scale scores between the patients and controls. ConclusionP300 Peak Latency could indicate the cognitive disorder in patients with acute brain infarction.

Objective To investigate the impact of the gestational diabetes mellitus and abnormal glucose challenge test (GCT) on macrosomia. Methods Clinical data of 8656 pregnant women who had antenatal care and delivered in the Department of Obstetrics and Gynecology of the First Hospital of Peking University from Jan 1995 to Mar 2001 were retrospectively analyzed. All of them underwent 50 g GCT. Results The incidence of macrosomia was 8.1% (700/8656). The incidence of macrosomia in GDM or IGT women was 12.5%(69/552), which was significantly higher than that of other women with normal glucose level 7.8%(631/8104, P