Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

The advent of digital times promotes the evolution of clinical research from traditional mode to digital mode. Digital technologies， which are introduced to clinical research of traditional Chinese medicine （TCM）， can optimize the research design， improve research quality， and save research funds and time. The digital and remote control of clinical research recruitment and screening， disease diagnosis and treatment， informed consent， indicator measurement， and other processes can be realized by computers， networks， sensors， and other technologies. Artificial intelligence （AI） algorithms， wearable monitoring devices， data management tools， blockchain， and virtual clinical trials （VCTs） are key innovation technologies and research design methods. On this basis， this study summarized relevant literature on key digital technologies and research methods such as AI algorithms， wearable monitoring devices， data management tools， blockchain， and VCT， and the following discoveries were obtained： The future development of clinical research of TCM requires to attach importance to the changes in clinical research brought by digital technologies and to promote the utilization of digital technologies in clinical research of TCM. Digital technologies realize the medical ethical ideas of ''putting people first''， promote the decentralization of clinical research， simplify the participation process of participants， reduce the time and cost of clinical research， improve the efficiency of clinical research of TCM， and enhance the objectivity， authenticity， and stability of clinical research of TCM. Deepening the application of digital technologies in clinical research and realizing the interaction and fusion of various digital technologies are inevitable trends of future development of clinical research of TCM. Under the background of digitization， the digital innovation of clinical research of TCM can accelerate the development of clinical research of TCM and promote the internationalization of TCM.

In recent years， adaptive design has gradually emerged in clinical trials， gaining widespread application and expansion. Compared with traditional randomized controlled trials， appropriate adaptive design can save time and resources to some extent， improve the validity of the trial results and strength of the evidence， align better with ethical requirements， and facilitate subsequent drug market research. However， due to the greater flexibility of adaptive design， controlling type Ⅰ error rates and truly enhancing research efficiency are challenging aspects of its application. Therefore， the normative application and optimization of adaptive design in research deserve early focus， including adhering to good adaptive design principles， conducting rigorous pre-design planning， scientifically applying various statistical methods such as Bayesian dynamic models and simulation methods， and utilizing monitoring tools like monitoring committees to ensure the scientific integrity of the research process. Moreover， the flexibility of adaptive design aligns well with the practical realities of traditional Chinese medicine （TCM） clinical practice. The main characteristics of TCM， such as the holistic concept and treatment based on syndrome differentiation， determine that TCM provides a dynamic and personalized treatment plan. In contrast， the traditional fixed development approach of western medicine limits the application of "human experience" in TCM. To address this bottleneck in TCM research and development， the innovative use of adaptive design， a modern scientific theory and methodology with multiplicity and variability， offers a feasible new approach for TCM clinical research and the innovation of Chinese herbal medicine. By learning from successful cases such as the first Food and Drug Administration （FDA）-approved oral botanical drug， Crofelemer， researchers can explore optimal solutions for adaptive design in clinical research protocols and its role in the "three-combination" evaluation system for Chinese herbal medicines， further refine trial design， clarify key trial points， and develop innovative research and development applications that adapt to the clinical positioning of TCM and highlight the characteristics and advantages of TCM， paving the way for the clinical efficacy， pharmacological mechanism exploration， and post-market efficacy evaluation of Chinese herbal compounds.

Chinese medicine self-assembly nano-strategies（CSAN） is to utilize the self-assembly property of Chinese medicine components， so that the Chinese medicine components can self-assemble to form structurally stable nano-preparations through non-covalent interactions. The formation of Chinese medicine self-assembly nano-preparations is often a synergistic result of a variety of non-covalent interactions， and many Chinese medicine monomers are susceptible to self-assembly due to their structural characteristics， and the phenomenon of self-assembly of Chinese medicine is also common in the decoction of single or compound Chinese medicine， which has attracted the attention of researchers. It is found that CSAN can improve the solubility and bioavailability of active components in Chinese medicine， which is of positive significance for the development and application of insoluble components of Chinese medicine. The self-assembly phenomenon of Chinese medicine decoction is closely related to the therapeutic efficacy， and the study of self-assembly phenomenon of Chinese medicine will bring a new perspective for the explanation of the mechanism of Chinese medicine decoction. At the same time， traditional Chinese medicine（TCM） has unique advantages in the field of anti-tumor. The application of CSAN in the field of oncology can not only exert the anti-tumor effect of the active components of Chinese medicine directly， but also act as a natural nano-carrier to carry chemotherapy drugs for combination chemotherapy， improve the targeting of drugs， enhance the anti-tumor efficacy， and reduce the side effects of chemotherapy， which has excellent anti-tumor potential. The preparation method of Chinese medicine self-assembly nano-preparations is simple， low cost， and has better safety than traditional nano-preparations， which is conducive to the promotion of the clinical transformation of nano-preparations， and also helps to provide new strategies and perspectives for promoting the modernization of TCM. Therefore， based on a large number of researches in this field in recent years， this paper reviewed the formation mechanism， different assembly forms， formation conditions and stability of Chinese medicine self-assembly nano-preparations by searching databases such as China national knowledge infrastructure（CNKI）， PubMed， WanFang data and VIP， and summarized the application of CSAN in different tumor therapies， providing a reference for further research on CSAN.

Ankylosing spondylitis (AS) combined with spinal fractures with thoracic and lumbar fracture as the most common type shows characteristics of unstable fracture, high incidence of nerve injury, high mortality and high disability rate. The diagnosis may be missed because it is mostly caused by low-energy injury, when spinal rigidity and osteoporosis have a great impact on the accuracy of imaging examination. At the same time, the treatment choices are controversial, with no relevant specifications. Non-operative treatments can easily lead to bone nonunion, pseudoarthrosis and delayed nerve injury, while surgeries may be failed due to internal fixation failure. At present, there are no evidence-based guidelines for the diagnosis and treatment of AS combined with thoracic and lumbar fracture. In this context, the Spinal Trauma Academic Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate the Clinical guideline for the diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture ( version 2023) by following the principles of evidence-based medicine and systematically review related literatures. Ten recommendations on the diagnosis, imaging evaluation, classification and treatment of AS combined with thoracic and lumbar fracture were put forward, aiming to standardize the clinical diagnosis and treatment of such disorder.

The acute combination fractures of the atlas and axis in adults have a higher rate of neurological injury and early death compared with atlas or axial fractures alone. Currently, the diagnosis and treatment choices of acute combination fractures of the atlas and axis in adults are controversial because of the lack of standards for implementation. Non-operative treatments have a high incidence of bone nonunion and complications, while surgeries may easily lead to the injury of the vertebral artery, spinal cord and nerve root. At present, there are no evidence-based Chinese guidelines for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults. To provide orthopedic surgeons with the most up-to-date and effective information in treating acute combination fractures of the atlas and axis in adults, the Spinal Trauma Group of Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field of spinal trauma to develop the Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults ( version 2023) by referring to the "Management of acute combination fractures of the atlas and axis in adults" published by American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) in 2013 and the relevant Chinese and English literatures. Ten recommendations were made concerning the radiological diagnosis, stability judgment, treatment rules, treatment options and complications based on medical evidence, aiming to provide a reference for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults.

Objective:To investigate the diagnostic efficacy of MRI-based or CT-based measurements and the combined evaluation methods for preoperative bone quality assessment in patients with cervical degenerative diseases.Methods:Patients who underwent spine surgery for cervical degenerative diseases at the Department of Orthopedics, Huashan Hospital, Fudan University from September 2020 to March 2022 with available preoperative X-ray, CT, MRI and dule energy X-Ray absorptiometry (DEXA) data were included in this study. Vertebral bone quality score (VBQ) based on MRI T1-weightedimages and CT Hounsfiled unit (HU) values of the cervical spine were measured, and a combined diagnostic formula based on the binary logistic regression was constructed. The patients were divided into normal bone mass (T≥-1.0) and osteopenia/osteoporosis groups (T<-1.0). The student's t-test and Chi-square test were performed for comparisons between groups. The Pearson correlation coefficient was also used to investigate the correlation between DEXA-T scores, cervical VBQ and CT HU values. In addition, receiver operating characteristic curve (ROC) were plotted to explore the diagnostic efficacy of VBQ, CT HU and their combined diagnosis. Meanwhile, the corresponding sensitivity and specificity were obtained. Results:A total of 71 patients were included in this study (17 in the normal group and 54 in the osteopenia/osteoporosis group). The student's t-test showed that VBQ (2.90±0.70 vs. 3.83±0.83, t=4.23, P<0.001) and CT HU values (370.26±85.38 vs. 295.20±67.96, t=3.73, P=0.002) were significantly different between the two groups. The area under the ROC curve (AUC) for VBQ and CT values of the cervical spine were 0.81 and 0.75, respectively, and the AUC for the combined diagnostic value constructed on the basis of both was 0.85. Applying VBQ scores alone had a diagnostic sensitivity of 80% and a specificity of 70%, and the combined diagnosis with VBQ and CT HU had a sensitivity of 90% and a specificity of 75%. Person correlation analysis showed a significant correlation between DEXA T value, cervical VBQ value and CT HU value. The detailed formula was: DEXA T score=-0.63×cervical VBQ+0.64 ( r=-0.55, P<0.001), CT HU value=-40.20×cervical VBQ+458.40 ( r=-0.45, P<0.001), DEXA T score=0.006×CT HU-3.47 ( r=0.45, P<0.001). Conclusion:This study confirmed the feasibility of using cervical VBQ values, CT HU values and combined diagnostics for preoperative bone density screening in patients with degenerative cervical spine diseases. This method allows surgeons to perform an initial preoperative bone density screening based on the patient's existing imaging data, and thus could aid in confirming the indication and scheme of surgery. The method could be a powerful tool for preoperative bone density assessment screening in patients with cervical degenerative diseases.

Traditional Chinese medicine(TCM)regulatory science,as an emerging interdisciplinary science,evaluates the safety,effectiveness,quality,and risk-benefit profile of regulated Chinese medicinal products,including Chinese medicinal materials,Chinese medicinal slices,and Chinese patent medicines.It highlights the development of new tools,standards,and methods that align with the unique characteristics of TCM.TCM regulatory science plays a crucial role in establishing a TCM scientific regulatory system that suits the features of TCM,accelerating the transformation of emerging TCM technologies and facilitating innovation in the inheritance and development of TCM.Sichuan,known as the"hometown of TCM therapies and the treasure trove of TCM",has built the first national modernized TCM technology industrial base and one of the first national comprehensive TCM reform demonstration zones.It plays a demonstrative and leading role in the high-quality development of the TCM industry in China.Based on the latest progress in new tools,standards,and methods of TCM regulatory science,this article overviewed its significant role and prospects in enhancing the efficiency of TCM regulation,accelerating the transformation and application of new TCM technologies and products,and promoting the high-quality development of the TCM industry in Sichuan.It is of great significance for ensuring and improving the regulatory capabilities of TCM and driving the healthy development of the TCM industry.

【Objective:】 To understand the current situation and influencing factors of ethical knowledge, attitude, and practice (KAP) among clinical researchers, enhance their ethical awareness, and improve the quality of clinical researches. 【Methods:】 A self-designed questionnaire was used to conduct a convenient sampling survey of medical staff who have participated in clinical study. 【Results:】 A total of 6,021 subjects were investigated, with males accounting for 28.46% and females accounting for 71.53%. The average age of them was (37.47±11.46) years old. The total score of ethics and the mean scores of the three dimensions of knowledge, attitude and practice were (70.62±12.99), (59.63±12.50), (79.55±19.62) and (74.92±18.29), respectively. Multiple linear regression analysis showed that researchers with male, tertiary hospitals, doctors, ethics-related part-time jobs, postgraduate education, associate senior title or above, and training experience scored higher (P<0.05). 【Conclusion:】 Ethical attitudes have a significant mediating effect between knowledge and practice, accounting for 62.72% of the total effect. Researchers recognize the importance of ethics, but it is urgent to strengthen their knowledge learning and practical application.

Objective:To investigate the correlation between paraspinal muscle atrophy, morphological changes of facet joints and adjacent segment disease (ASDis) after lumbar fusion operation.Methods:A retrospective study was conducted among 195 patients who underwent posterior lumbar fusion again for ASDis at this institution from January 2014 to December 2020, including 29 patients with ASDis whose initial surgical fusion segment was L 4,5. According to Roussouly's staging, there were 5 cases of type I, 9 cases of type II, 10 cases of type III, and 5 cases of type IV. Another 29 cases were selected from patients without ASDis after lumbar fusion as a control group. The control group was paired 1∶1 with the ASDis group according to gender, fusion segment, and Roussouly typing of the lumbar spine. The cross-sectional area (CSA) and fat infiltration (FI) of paravertebral muscle, facet joint angle (F-J) and pedicle facet (P-F) angle before the first (second) operation were measured and compared between the two groups. Then logistic regression analysis was used to determine the predictors of ASDis after posterior lumbar fusion. Finally, the receiver operation characteristic (ROC) curve was described, and the area under the curve (AUC) and cut-off point were calculated. At the same time, the paraspinal muscle atrophy before the second operation in ASDis group was measured. Results:The average follow-up time of 98 patients was 59.25±6.38 months (range, 49-73 months). The average body mass index (BMI) of ASDis group was 24.76±3.64 kg/m 2, which was higher than that in control group (22.24±2.92 kg/m 2) ( t=2.481, P=0.041). The average CSA and relative cross-sectional area (rCSA) of paraspinal muscle in ASDis group were 3 214.32± 421.15 mm 2 and 1.69±0.36 respectively, which were less than 3 978.91±459.87 mm 2 and 2.26±0.29 in control group ( t=10.22, P=0.012; t=9.47, P=0.038). The FI degree of paraspinal muscle in ASDis group (21.95%±5.89%) was significantly higher than that in control group (14.64%±7.11%) ( t=7.32, P=0.002). The F-J angle in ASDis group was 35.06°±3.45°, which was less than 38.39°±4.67° in control group ( t=4.76, P=0.027). The P-F angle in ASDis group was 117.39°±8.13°, which was greater than 111.32°±4.78° in control group ( t=5.25, P=0.031). Multivariate logistic regression analysis showed that higher BMI ( OR=1.34, P=0.038), smaller rCSA of paraspinal muscle ( OR=0.02, P=0.017) and higher FI of paraspinal muscle ( OR=1.58, P=0.032) were the risk factors of postoperative ASDis. The ROC curve showed that the AUC of BMI was 0.680 and the cut-off point was 22.58 kg/m 2; The AUC of the FI of paraspinal muscle was 0.716 and the cut-off point was 15.69%; The AUC of rCSA of paraspinal muscle was 0.227 and the cut-off point was 1.92. For ASDis patients, the paraspinal muscle before the second operation had a higher degree of FI (25.47%±6.59% vs. 21.95%±5.89%, t=3.99, P=0.042) and a smaller rCSA (1.52±0.28 vs. 1.69±0.36, t=3.85, P=0.038) than that before the first operation. The difference between the FI degree of paraspinal muscle before the second operation and the first operation was negatively correlated with the occurrence time of ASDis ( r=-0.53, P=0.039) , and the difference of rCSA was positively correlated with the occurrence time of ASDis ( r=0.64, P=0.043) . Conclusion:When BMI >22.58 kg/m 2, FI of paraspinal muscle >15.69%, and rCSA of paraspinal muscle <1.92, it suggests that ASDis is more likely to occur after operation. And the more obvious paraspinal muscle atrophy after the first operation, the earlier ASDis may occur. Morphological changes of facet joints cannot be used as an index to predict the occurrence of ASDis.