Translational Bioethics in China: Brain-Computer Interface Research as a Case Study.

The research and development of emerging technologies has potential long-term and societal impacts that pose governance challenges. This essay summarizes the development of research ethics in China over the past few decades, as well as the measures taken by the Chinese government to build its ethical governance system of science and technology after the occurrence of the CRISPR-babies incident. The essay then elaborates on the current problems of this system through the case study of ethical governance of brain-computer interface research, and explores how the transition from research ethics to translational bioethics, which encourages interdisciplinary collaboration and focuses on societal implications, may respond to the challenges of ethical governance of science and technology.

Comparison of the short-term efficacy of MIS-TLIF and Endo-LIF for the treatment of two-segment lumbar degenerative disease.

BACKGROUND: This study retrospectively compared short-term clinical outcomes and complications of minimally invasive surgery transforaminal lumbar interbody fusion(MIS-TLIF)and endoscopic lumbar interbody fusion(Endo-LIF))for two-segmental lumbar degenerative disease, aiming to guide spine surgeons in selecting surgical approaches. METHODS: From January 2019 to December 2023, 30 patients were enrolled,15 in the MIS-TLIF group and 15 in the Endo-LIF group. All patients were followed up for more than 3 months after surgery and the following information was recorded: (1)surgery time, difference in hemoglobin between preoperative and postoperative, surgical costs, first time out of bed after operation, postoperative hospitalization time, postoperative complication; (2) ODI score (The Oswestry Disability Index), leg and back VAS score (Visual Analogue Scale), and lumbar vertebra JOA score (Japanese Orthopaedic Association Scores); (3) MacNab score at final follow-up to assess clinical outcome, CT to evaluate lumbar fusion. RESULTS: There were significant differences between the two groups regarding operation time and cost, with the MIS-TLIF group performing significantly better. Intraoperative bleeding was considerably less in the Endo-LIF group compared to the MIS-TLIF group. However, there were no significant differences in the time of the first postoperative ambulation, postoperative hospitalization time, and postoperative complications. There was no significant difference in preoperative VAS, ODI, and JOA between the two surgical groups There were no significant differences in VAS(leg), ODI, and JOA scores between the two groups before and at 1 day,7 days, 1 month, 3 months and final follow-up. However, at 1 day postoperatively, the VAS( back)score in the Endo-LIF group was lower than that in the MIS-TLIF group, and the difference was statistically significant. At the final follow-up, all patients achieved grade III and above according to the Bridwell criteria, and there was no significant difference between the two surgical groups compared to each other. According to the MacNab score at the final follow-up, the excellent rate was 80.00% in the Endo-LIF group and 73.33% in the MIS-TLIF group, with no significant difference between the two groups. CONCLUSION: There was no significant difference in short-term efficacy and safety between Endo-LIF and MIS-TLIF for two-segment degenerative lumbar diseases. MIS-TLIF has a shorter operative time and lower costs, while Endo-LIF causes less tissue damage, blood loss, and early postoperative pain, aiding long-term recovery. Both MIS-TLIF and Endo-LIF are promising for treating two-segment lumbar degenerative disease. The choice of a surgical procedure depends on the patient's financial situation, their ability to tolerate surgery, and the surgeon's expertise.

Comparative analysis of percutaneous vertebroplasty and kyphoplasty in the treatment of Stage III Kummell's disease without neurological symptoms: a retrospective study.

OBJECTIVE: This study analyzes the safety and efficacy of percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) treatments for Stage III Kummell's disease without neurological symptoms, comparing the advantages and disadvantages of these two minimally invasive surgical methods. METHODS: A retrospective analysis was conducted on 53 patients with non-neurological Stage III Kummell's disease treated with PVP and PKP at our hospital from December 2018 to January 2023. Patients were divided into PVP (25 cases) and PKP (28 cases) groups based on the surgical method. There were no significant differences in general preoperative data between the two groups (all p > 0.05), ensuring comparability. The study compared surgical duration, volume of bone cement injected, distribution pattern of bone cement, rate of bone cement leakage, and preoperative, postoperative, and final follow-up scores of Visual analogue scale(VAS) and Oswestry disability index(ODI). Additionally, relative anterior height of the injured vertebrae, and Cobb angle of deformity, along with their changes at preoperative, postoperative, and final follow-up stages were calculated and analyzed. RESULTS: No significant preoperative differences were observed between the groups (p > 0.05). The PKP group had longer surgeries, higher cement volumes (p < 0.001), and lower leakage rates (p < 0.05), with primarily chunky cement distributions versus mixed distributions in the PVP group. No complications other than cement leakage occurred. VAS and ODI scores showed no significant changes at various time points (p > 0.05) but improved significantly from preoperative (p < 0.001). Both groups saw improved vertebral heights and Cobb angles post-surgery (p < 0.05), with more significant improvements in the PKP group (p < 0.05). Over time, both groups experienced gradual vertebral height loss and increased Cobb angles, more pronounced in the PKP group (p < 0.05). At the final follow-up, there were no statistical differences in vertebral height and Cobb angle between the two groups (p > 0.05). CONCLUSION: The study evaluates the safety and efficacy of PVP and PKP for Stage III Kummell's disease without neurological symptoms, comparing the merits of both minimally invasive techniques.

Analysis of Risk Factors for Postoperative Deep Vein Thrombosis in Traumatic Spinal Fracture Complicated with Spinal Cord Injury.

The purpose of this study is to investigate the risk factors for postoperative deep vein thrombosis (DVT) in patients with traumatic spinal fractures complicated with Spinal Cord Injury(SCI). We conducted a retrospective analysis of 110 patients with traumatic spinal fractures and SCI admitted to our hospital from March 2021 to April 2024. DVT was diagnosed using ultrasound. Patient history, general data, surgical data, laboratory tests, and thromboelastogram (TEG) results were collected. The patients were divided into a DVT group and a non-DVT group according to the results of ultrasound one week after surgery. The risk factors and diagnostic value were analyzed using binary logistic regression and receiver operating characteristic (ROC) curves in both univariate and multivariate analyses. Multivariate and ROC analysis results showed that D-dimer, lower extremity, duration of bedrest, and MA values of TEG were independent risk factors for DVT in SCI, with D-dimer having the highest diagnostic value (AUC = 0.883). The AUC values for lower extremity, duration of bedrest, and MA were 0.731, 0.750, and 0.625. In conclusion, Postoperative D-dimer > 5.065 mg/l, lower extremity < 3, duration of bedrest, and MA value of TEG are independent risk factors for postoperative DVT in SCI patients, D-dimer having the highest diagnostic value. When the above risk factors occur, clinicians need to be vigilant and take appropriate prevention and treatment measures.

Isolated Cryptococcal Infection of the Thoracic Spine in an Immunocompetent Patient.

Cryptococcus neoformans is a type of fungal infection, which primarily affects the central nervous system and lungs of immunocompromised individuals. Spinal infections are known to be a rare manifestation of cryptococcosis. Herein, we report a case of a patient with isolated nonspecific spinal lesions at the T10 vertebra. The patient received non-surgical treatment with antifungal drugs, resulting in satisfactory clinical outcomes.

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

Causal relationship between basal metabolic rate and intervertebral disc degeneration: a Mendelian randomization study.

BACKGROUND: The role of basal metabolic rate (BMR) in intervertebral disc degeneration (IVDD) is still uncertain. To address this gap, we conducted a Mendelian randomization (MR) study to comprehensively explore the causal relationship between BMR and IVDD. METHODS: BMR data were obtained from a large genome-wide association study (GWAS) database, while IVDD data were derived from the FinnGen project. The causal relationship between IVDD and BMR was investigated using MR, with inverse-variance weighting (IVW) as the primary estimate. MR-Egger weighed median and weighed mode were employed for robustness. Sensitivity analyses, including the Cochran Q test, leave-one-out analysis, and MR-Egger intercept analysis, were conducted. Furthermore, the study also identified causal relationships between IVDD and factors associated with BMR (hyperthyroidism, type 2 diabetes, standing height, weight, and body mass index). Multivariable MR was applied to further assess the direct effect of BMR on IVDD. RESULTS: Genetic predisposition to BMR (after removing outliers OR: 1.49; 95% CI: 1.37-1.63; P = 5.073e-21) were associated with an increased risk of IVDD. Additionally, IVDD risk increased with greater height, weight, and BMI. No causal relationship was observed between hy/thy and T2D and intervertebral disc degeneration (IVDD) (P > 0.05). In multivariable MR, a significant causal association between BMR and IVDD persisted, even after adjusting for BMI, height, and weight. CONCLUSION: In this study, we successfully identified that a higher BMR is independently and causally linked to IVDD, indicating an increased risk of developing IVDD. These findings suggest that managing BMR could potentially mitigate the risk of IVDD.

Case Report: Technical description and clinical evaluation of three cases of unilateral biportal endoscopic decompression for symptomatic spinal epidural lipomatosis.

Objective: To investigate the clinical characteristics and outcomes of three patients with symptomatic Spinal epidural lipomatosis (SEL) treated using Unilateral Biportal Endoscopic (UBE) surgery. Methods: This report retrospectively analyzed the clinical data of three patients with SEL admitted to our hospital. The analysis covers onset characteristics, clinical manifestations, and the most recent radiologic grading system of neural compression (Manjila classification). Furthermore, it details the decompression accomplished through the application of a minimally invasive UBE surgical technique, specifically targeting the removal of proliferated fat responsible for nerve and spinal cord compression. Results: This technique was performed successfully in 3 patients with SEL. Radiating pain was reduced, and the functional disability and radiologic compression were improved in all three patients. Postoperative spinal instability and surgical complications related to the procedure were not observed. Conclusions: For SEL, timely diagnosis and appropriate intervention can prevent the progression of neurological disability. UBE is a minimally invasive muscle-preserving technique that achieves neural decompression directly by the removal of excessive intraspinal adipose tissue buildup.

Recent advances in melittin-based nanoparticles for antitumor treatment: from mechanisms to targeted delivery strategies.

As a naturally occurring cytolytic peptide, melittin (MLT) not only exhibits a potent direct tumor cell-killing effect but also possesses various immunomodulatory functions. MLT shows minimal chances for developing resistance and has been recognized as a promising broad-spectrum antitumor drug because of this unique dual mechanism of action. However, MLT still displays obvious toxic side effects during treatment, such as nonspecific cytolytic activity, hemolytic toxicity, coagulation disorders, and allergic reactions, seriously hampering its broad clinical applications. With thorough research on antitumor mechanisms and the rapid development of nanotechnology, significant effort has been devoted to shielding against toxicity and achieving tumor-directed drug delivery to improve the therapeutic efficacy of MLT. Herein, we mainly summarize the potential antitumor mechanisms of MLT and recent progress in the targeted delivery strategies for tumor therapy, such as passive targeting, active targeting and stimulus-responsive targeting. Additionally, we also highlight the prospects and challenges of realizing the full potential of MLT in the field of tumor therapy. By exploring the antitumor molecular mechanisms and delivery strategies of MLT, this comprehensive review may inspire new ideas for tumor multimechanism synergistic therapy.

Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Up-regulation of Core 1 Beta 1, 3-Galactosyltransferase Suppresses Osteosarcoma Growth with Induction of IFN-γ Secretion and Proliferation of CD8+ T Cells.

AIM: Abnormal glycosylation often occurs in tumor cells. T-synthase (core 1 beta 1,3- galactosyltransferase, C1GALT1, or T-synthase) is a key enzyme involved in O-glycosylation. Although T-synthase is known to be important in human tumors, the effects of T-synthase and T-antigen on human tumor responses remain poorly defined. METHODS: In this study, a T-synthase-specific short hairpin RNA (shRNA) or T-synthase-specific eukaryotic expression vector(pcDNA3.1(+)) was transfected into murine Osteosarcoma LM8 cells to assess the effects of T-synthase on T cells and cytokines. RESULTS: The up-regulation of T-synthase promoted the proliferation of osteosarcoma cells in vitro, but it promoted the proliferation of tumor initially up to 2-3 weeks but showed significant growth inhibitory effect after 3 weeks post-implantation in vivo. Osteosarcoma cells with high T-synthase expression in vitro promoted the proliferation and inhibited the apoptosis of CD8+ T cells. Further, T-synthase upregulation promoted CD8+ T-cell proliferation and the increased production of CD4+ T cell-derived IFN-γ cytokines to induce the increased tumor lethality of CTLs. CONCLUSION: Our data suggest that high T-synthase expression inhibits tumor growth by improving the body's anti-tumor immunity. Therefore, using this characteristic to prepare tumor cell vaccines with high immunogenicity provides a new idea for clinical immunotherapy of osteosarcoma.

Clinical Features and Outcomes of Spinal Tuberculosis in Central China.

Purpose: The appropriate management of spinal tuberculosis (TB) is challenging for clinicians and the key to treat spinal TB. Surgery and long course anti-TB chemotherapy may not be necessary to all situations. This study aimed to characterize the clinical features and factors affecting treatment outcomes. Patients and Methods: A retrospective study of patients with spinal TB over a 5-year period at a teaching hospital in central China was conducted. Features of patients with spinal TB who received different treatment modalities and factors associated with patient outcomes at the end of chemotherapy were analyzed. Results: Forty-five patients (21 men and 24 women) with spinal TB were available for analysis. The mean age was 55.39 ± 14.94 years. The most common vertebral area involved was the lumbar (42.2%). The mean number of vertebrae involved was 2.20 ± 0.59. 27 patients (60.0%) received surgical treatment, of which 21 (77.8%) received radical surgical treatment. Thirty-five patients (77.8%) had achieved a favorable status. Statistically, there was no significant correlation between favorable status and surgery, but among 27 surgical patients with spinal tuberculosis, patients receiving radical surgery tended to achieve good prognosis (P = 0.010; odds ratio = 0.053; 95% confidence interval 0.006-0.493). Moreover, there was no significant difference between long course and short course of anti-TB chemotherapy in prognosis in different treatment modalities. Conclusion: Although the patients with spinal TB who needed surgical treatment often got a better prognosis when they had radical surgery, surgery was not actually a factor for the favorable outcomes of patients with spinal TB. In different treatment modalities, there was no additional benefit in longer anti-TB chemotherapy periods.

Correlation between 5-HTTLPR gene polymorphism and cognitive function of traumatic stress in Chinese Han children.

Background: Post-traumatic stress disorder (PTSD) is a trauma-related psychological disorder with serious social and familial impacts. The involvement of 5-hydroxytryptamine transporter gene-linked polymorphic region (5-HTTLPR) in numerous mental disorders has been documented. This study explored the correlation between 5-HTTLPR gene polymorphism and cognitive function in Chinese Han children with PTSD. Methods: A total of 60 PTSD children treated from December 2019 to December 2021 were selected as study participants, with another 60 healthy children selected as controls. We assessed the cognitive function of participants using the Mini-Mental State Examination (MMSE). Additionally, the PTSD level was estimated by the Children's Revised Impact of Event Scale (CRIES). The 5-HTTLPR gene polymorphism was detected by reverse transcription quantitative polymerase chain reaction (RT-qPCR). The genotype and allele frequency were evaluated via case-control association analysis. Results: Children in the PTSD group showed low MMSE scores and high CRIES scores. In terms of genotype, cases of LL, LS, and SS in PTSD children were 4 (6.67%), 20 (33.3%), and 36 (60.00%), and 18 (30.00%), 28 (46.67%), and 14 (23.33%) cases in healthy controls. In terms of allele gene frequency, incidences of L and S were 23.33% and 76.67% in PTSD children, respectively, and were 53.33% and 46.67% in healthy controls, respectively. Moreover, the CRIES and MMSE scores of LS and SS genotypes were evidently different from those of LL genotype in PTSD children. Conclusions: Polymorphism of the 5-HTTLPR gene is correlated with cognitive dysfunction in Chinese Han children with PTSD.

Stem cell translational medicine: The Tianjin model revisited.

Stem cells hold great promise for cell therapy to treat a wide spectrum of intractable diseases. Despite enthusiasm for stem cell therapy, the clinical and translational research of stem cells overall has been a slow and cumbersome process. This article uses the "technological system" as a framework to analyze the Tianjin model of stem cell translational medicine. It shows how heterogeneous elements interact with one another and relate to scientific, technological, social, economic, and political variables in order to fulfill the system goal of producing cell therapy in China. Then the strengths and weaknesses of the Tianjin model are compared with translational programs in other countries and the implications for the cell therapy industry are discussed.

Privacy in breast cancer biobank: Chinese patients' perceptions.

Drawing on 40 in-depth interviews with Chinese breast cancer patients who participated in the breast cancer biobank at a hospital in Beijing, China, this paper explores these patients' perceptions of privacy. The analysis indicates that these patients primarily perceived privacy as informational privacy; they were concerned about the disclosure of contact information, cancer diagnosis, and genetic testing results; further, their views on disclosing different kinds of personal information were dynamic and heterogeneous in various relationships and contexts, which differs from the stereotypical beliefs of privacy in China. This paper provides situated understanding of why these patients had such privacy perceptions and what strategies they adopted to cope with their privacy. It then discusses the international similarities and differences in the disclosure of cancer and genetic testing results.

Public involvement in the governance of population-level biomedical research: unresolved questions and future directions.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.