The official implementation of the Regulations on Clinical Research and Translation of New Biomedical Technologies (State Council Decree No.818, hereinafter referred to as the "Regulations") marks a new stage of legal governance, standardization, and whole-chain regulation for emerging biomedical fields such as cell and gene therapy (CGT) in China, exerting a profound impact on the development of transfusion medicine as a discipline. Within the framework of the core regulatory systems established by the Regulations, and drawing upon the extensive experience of transfusion medicine in comprehensive quality control, cell processing and handling, ethical compliance, and clinical translation, this study systematically elucidates the intrinsic alignment between transfusion medicine and CGT with respect to technical workflows, quality control rationale, and management systems. It further clarifies the discipline-specific advantages of the department of transfusion medicine to proactively undertake CGT engagement, while analyzing current shortcomings and transformational bottlenecks. By leveraging the existing institutional framework, the department of transfusion medicine is well positioned to evolve into a core platform for whole-process quality control and a pivotal hub for in-hospital clinical translation of CGT. However, this transformation must concurrently address multiple challenges, including heightened compliance responsibilities, lagging technical infrastructure, a shortage of interdisciplinary talent, and increasingly stringent standards for clinical research and translation. The Regulations provide a legal basis and policy support for the department of transfusion medicine to transcend its traditional, singular function of blood safety assurance and establish a synergistic development model integrating blood safety and cell therapy. Therefore, the department of transfusion medicine should proactively align with regulatory requirements, refine whole-process compliance systems, upgrade technical platforms, and cultivate interdisciplinary professionals to achieve high-quality transformative development as a core supporting discipline for biotherapy.

Objective:To investigate the current status of application of stereotactic body radiation therapy (SBRT) in China, aiming to provide reference for promoting the development of this technology.Methods:From January to March 2024, a questionnaire was designed and distributed online, targeting member units of the Professional Committee of Stereotactic Radiosurgery Treatment, which covers 175 radiotherapy units in 30 provinces and regions nationwide. The survey focused on the current application of SBRT technology and its utilization in the treatment of early-stage non-small cell lung cancer (NSCLC). A statistical description of the survey results was presented.Results:Of 175 questionnaires distributed, a total of 130 valid responses were collected, with an effective response rate of 74.3%. A total of 81.5% (106/130) of the units had implemented SBRT technology, and 99.1% of the respondents believed it was necessary to further promote SBRT technology, yet the actual training rate was only 67.0%. SBRT equipment configuration: there were a total of 267 SBRT equipment, featuring a diverse range of types, with traditional linear accelerators as the mainstays, accounting for 76.0% ( n=203), followed by 12.0% ( n=32) for TOMO, 6.4% ( n=17) for Cyber knife, 3.7% ( n=10) for Gamma knife, and proton/heavy ion equipment at 1.5% ( n=4), respectively. The percentage of units with multi-leaf collimator leaf widths ≤0.5 cm was 93.4% (99/106). The application of SBRT: the first radiotherapy unit commenced SBRT in 2000, and this technology entered a period of rapid growth after 2015, sustaining a steady increase over the past decade; SBRT technology was mainly applied in the brain, lung, liver, bone, adrenal gland, and kidney, with application rates of 97.2%, 94.3%, 86.8%, 71.7%, 56.6%, and 27.4%, respectively, while the application rates for the pancreas, metastatic lymph nodes, and other parts were less than 5%. Current status of SBRT technology application in early-stage NSCLC: 90.6% (96/106) of units had implemented SBRT; pre-treatment multi-disciplinary diagnosis and treatment accounted for 77% (74/96); the proportion of application units for peripheral and central type lung cancer lesions both exceeded 57.3%, whereas the application rate for ultra-central type and lesions > 5 cm lung cancer was less than 30%; there was significant variability in the selection of reference guidelines, dose fractionation patterns, and the concept of central type among units. Conclusions:The development of SBRT technology in China is in a period of steady growth, but several issues such as low training rate and lack of standardization still exist. The survey results provide important reference for clinical training and promotion of SBRT technology in China.

Objective:To investigate the current status of application of stereotactic body radiation therapy (SBRT) in China, aiming to provide reference for promoting the development of this technology.Methods:From January to March 2024, a questionnaire was designed and distributed online, targeting member units of the Professional Committee of Stereotactic Radiosurgery Treatment, which covers 175 radiotherapy units in 30 provinces and regions nationwide. The survey focused on the current application of SBRT technology and its utilization in the treatment of early-stage non-small cell lung cancer (NSCLC). A statistical description of the survey results was presented.Results:Of 175 questionnaires distributed, a total of 130 valid responses were collected, with an effective response rate of 74.3%. A total of 81.5% (106/130) of the units had implemented SBRT technology, and 99.1% of the respondents believed it was necessary to further promote SBRT technology, yet the actual training rate was only 67.0%. SBRT equipment configuration: there were a total of 267 SBRT equipment, featuring a diverse range of types, with traditional linear accelerators as the mainstays, accounting for 76.0% ( n=203), followed by 12.0% ( n=32) for TOMO, 6.4% ( n=17) for Cyber knife, 3.7% ( n=10) for Gamma knife, and proton/heavy ion equipment at 1.5% ( n=4), respectively. The percentage of units with multi-leaf collimator leaf widths ≤0.5 cm was 93.4% (99/106). The application of SBRT: the first radiotherapy unit commenced SBRT in 2000, and this technology entered a period of rapid growth after 2015, sustaining a steady increase over the past decade; SBRT technology was mainly applied in the brain, lung, liver, bone, adrenal gland, and kidney, with application rates of 97.2%, 94.3%, 86.8%, 71.7%, 56.6%, and 27.4%, respectively, while the application rates for the pancreas, metastatic lymph nodes, and other parts were less than 5%. Current status of SBRT technology application in early-stage NSCLC: 90.6% (96/106) of units had implemented SBRT; pre-treatment multi-disciplinary diagnosis and treatment accounted for 77% (74/96); the proportion of application units for peripheral and central type lung cancer lesions both exceeded 57.3%, whereas the application rate for ultra-central type and lesions > 5 cm lung cancer was less than 30%; there was significant variability in the selection of reference guidelines, dose fractionation patterns, and the concept of central type among units. Conclusions:The development of SBRT technology in China is in a period of steady growth, but several issues such as low training rate and lack of standardization still exist. The survey results provide important reference for clinical training and promotion of SBRT technology in China.

Objective:To investigate the correlation factors of complete clinical response in idiopathic inflammatory myopathies(IIMs)patients receiving conventional treatment.Methods:Patients diagnosed with IIMs hospitalized in Peking University People's Hospital from January 2000 to June 2023 were in-cluded.The correlation factors of complete clinical response to conventional treatment were identified by analyzing the clinical characteristics,laboratory features,peripheral blood lymphocytes,immunological indicators,and therapeutic drugs.Results:Among the 635 patients included,518 patients finished the follow-up,with an average time of 36.8 months.The total complete clinical response rate of IIMs was 50.0％(259/518).The complete clinical response rate of dermatomyositis(DM),anti-synthetase syn-drome(ASS)and immune-mediated necrotizing myopathy(IMNM)were 53.5％,48.9％and 39.0％,respectively.Fever(P=0.002)and rapid progressive interstitial lung disease(RP-ILD)(P=0.014)were observed much more frequently in non-complete clinical response group than in complete clinical re-sponse group.The aspartate transaminase(AST),lactate dehydrogenase(LDH),D-dimer,erythrocyte sedimentation rate(ESR),C-reaction protein(CRP)and serum ferritin were significantly higher in non-complete clinical response group as compared with complete clinical response group.As for the treat-ment,the percentage of glucocorticoid received and intravenous immunoglobin(IVIG)were significantly higher in non-complete clinical response group than in complete clinical response group.Risk factor analysis showed that IMNM subtype(P=0.007),interstitial lung disease(ILD)(P=0.001),eleva-ted AST(P=0.012),elevated serum ferritin(P=0.016)and decreased count of CD4+T cells in peripheral blood(P=0.004)might be the risk factors for IIMs non-complete clinical response.Conclu-sion:The total complete clinical response rate of IIMs is low,especially for IMNM subtype.More effec-tive intervention should be administered to patients with ILD,elevated AST,elevated serum ferritin or decreased count of CD4+T cells at disease onset.

In response to the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance， Innovation， and Development of traditional Chinese medicine（TCM） and the spirit of the National Conference on TCM， Chinese Association of Chinese Medicine organized experts in Otorhinolaryngology Head and Neck Surgery of traditional Chinese and western medicine to discuss the clinical advantages of TCM and integrated traditional Chinese and western medicine in the treatment of allergic rhinitis （AR） and they reached a basic consensus. In recent years， the prevalence of AR has been on the rise， threatening the quality of life of patients and giving rise to a heavy burden to both the patients and the society. AR is resulted from immune imbalance rather than reduced immunity or hyperimmunity， and the imbalance is similar to the Yin-yang disharmony in TCM. In the treatment of this disease， western medicine features rapid onset. However， it is cost-intensive and causes severe surgical trauma， and the recurrence is common. TCM boasts diverse methods for AR， which can be used in all stages of this disease. It has advantages in controlling symptoms such as nasal congestion， runny nose， or dysosmia in the attack stage， preventing recurrence in the remission stage， and treating refractory AR or steroid-resistant AR. In particular， acupuncture enjoys a reputation in treatment of AR， which has been supported by evidence-based medicine and recommended by guidelines. While treating local symptoms of AR， TCM regulates the psychosomatic conditions， which facilitates chronic disease management and long-term follow-up. We should integrate the advantages of TCM and western medicine， give full play to the unique nonnegligible and irreplaceable advantages of TCM， formulate a comprehensive diagnosis and treatment scheme for learning and promotion， and summarize the research outcomes to promote the theoretical innovation of TCM on AR from the perspective of integrated traditional Chinese and western medicine.

Objective:To investigate the predictive value of thrombus enhancement (TE) and thrombus permeability in cardioembolic thrombus with acute middle cerebral artery occlusion based on CT.Methods:The clinical and image data of 93 patients with acute middle cerebral artery occlusion who were admitted to the First Affiliated Hospital of Soochow University within 12 hours after onset from January 2020 to July 2022 were retrospectively analyzed. According to the TOAST criteria, the patients were divided into the cardioembolism (CE) group (43 cases) and the large artery atherosclerosis (LAA) group (50 cases). All patients received noncontrast CT and CT angiography, and then thrombus permeability [thrombus attenuation increase (TAI), void fraction (ε)] and TE were assessed. Independent sample t-test, Mann-Whitney U test and χ2 test were used in univariable analysis between two groups. Multivariable logistic regression analysis was used to explore the independent influencing factors for cardioembolic stroke and establish a logistic model. The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the predictive value of TAI, ε, TE and the logistic model in cardioembolic thrombus with acute middle cerebral artery occlusion. Results:There were statistically significant differences in sex, atrial fibrillation, hypertension, diabetes mellitus, smoking, baseline National Institutes of health stroke scale (NIHSS), TAI, ε and TE between the CE group and the LAA group ( P<0.05). Binary logistics regression analysis showed that TAI (OR=1.300, 95%CI 1.147-1.473, P<0.001), hypertension (OR=0.116, 95%CI 0.025-0.535, P=0.006) and baseline NIHSS (OR=1.165, 95%CI 1.040-1.304, P=0.008) were independent influencing factors for cardioembolic thrombus. The ROC curve indicated that the logistic model predicted cardioembolic thrombus with the highest AUC of 0.907 (95%CI 0.848-0.966). TE predicted cardioembolic thrombus with the highest sensitivity of 90.7%. Conclusion:TE and thrombus permeability have application value for predicting cardioembolic thrombus with acute middle cerebral artery occlusion based on CT.

【Objective】 To study the clinical practice and early outcome of percutaneous full-endoscopic modified posterior lumbar interbody fusion（mPLIF）combined with pedicle screw fixation through paraspinal muscle clearance. 【Methods】 A retrospective study was conducted to analyze the clinical data of patients with lower lumbar spinal diseases treated from May 2019 to April 2020. All the enrolled patients received mPLIF combined with pedicle screw fixation through paraspinal muscle clearance. The follow-up period was more than 1 year； the general parameters included age， gender， duration of disease， diagnosis of disease， surgery segment， and postoperative hospitalization time. Operation parameters included operation time and blood loss. We obtained the clinical parameters such as visual analogue scale （VAS） score for back and lower extremity， Oswestry disability index （ODI） score， and Macnab satisfaction score at the last follow-up. We evaluated the imaging parameters including intervertebral disc height， segmental lordosis angle， lumbar lordosis angle， as well as fusion outcome of patients with single segmental lumbar disease. In addition， intraoperative and postoperative complications were recorded. 【Results】 Totally 18 patients met the inclusion criteria， among whom 8 were male and 10 were female， with the average age of （53.3±8.3） years old and the average duration of disease being （28.9±36.6） months. Among them 16 patients were diagnosed as lumbar degenerative disease and the other 2 had lumbar disc infection. One patient received L3-L4 and L4-L5 intervertebral fusion； the others had one-segmental fusion， among which 11 cases were L4-L5 and 6 cases were L5-S1. The average operation time was （207.8±31.7） min， and the average blood loss was （25.6±7.8） mL， and the mean postoperative hospitalization time was （6.56±2.30） days. VAS scores of back and lower extremities at postoperative 1 week， 6 months and the last follow-up were statistically significantly improved from the preoperative scores. ODI scores at postoperative 6 months and the last follow-up were also statistically significantly improved. The rate of excellent and good according to the Macnab criteria was 94.4%. For the 17 single-level fusion patients， intervertebral height was significantly higher postoperatively and at the last follow-up compared with that of the preoperative one （P<0.05）. Segmental lordosis angle was bigger postoperatively and at the last follow-up （P>0.05）， which was not statistically significant. Lumbar lordosis angle was significantly bigger postoperatively （P<0.05） and bigger at the last follow-up， but with no statistical significance （P>0.05）. The fusion rate at the last follow-up was 88.2%. The cage broke in the process of implantation in one patient. A cage retroposition occurred in one patient at the follow-up. 【Conclusion】 Percutaneous full-endoscopic modified posterior lumbar interbody fusion combined with pedicle screw fixation through bilateral paraspinal muscle clearance by one incision showed excellent clinical outcomes in treating many kinds of lower lumbar diseases. This operation should be an excellent option for lower lumbar fusion.

Objective:To compare the clinical effects of oblique lumbar interbody fusion (OLIF) and transforaminal lumbar interbody fusion (TLIF) in the treatment of lumbar degenerative scoliosis.Methods:A retrospective study was performed in 116 patients with lumbar degenerative scoliosis and spinal stenosis, who were admitted to Beijing Jishuitan Hospital from January 2015 to May 2018. The patients were divided into two groups according to the surgical method. Among them, 56 patients underwent the OLIF approach (OLIF group), consisting of 21 men and 35 women, with an average age of 65.2±8.7 years. According to Lenke-Silva classification, there were 41 cases of type II and 15 cases of type III in OLIF group. 60 cases underwent the TLIF approach (TLIF group), consisting of 19 men and 41 women, with an average age of 61.3±11.6 years. There were 43 cases of type II and 17 cases of type III in TLIF group. The preoperative and last follow up visual analogue scale (VAS) and Oswestry disability index (ODI) were compared between the two groups. The coronal and sagittal Cobb angle changing and the offset distance for apical midline of the lumbar vertebrae between pre-operation and last follow-up were measured. The respective complications of the two groups were collected.Results:For OLIF group, VAS decreased from 7.7±1.6 at pre-operation to 1.9±1.5 at the last follow up; for TLIF group, VAS decreased from 8.1±1.2 at pre-operation to 2.2±0.9 at the last follow up. Although there were obvious improve for both group compared pre-operation to last follow-up, there was no significant difference between the two groups. For OLIF group, ODI decreased from preoperative 47.5%±9.1% to last follow up 22.4%±6.7%; for TLIF group, ODI decreased from preoperative 52.6%±5.8% to last follow up 25.1%±8.4%. Obvious changes were foundin both group between pre-operation and last follow up, but there was no significant difference between the two groups. For sagittal lumbar cobb angle, OLIF group changed from preoperative 8.6°±5.7° to last follow-up 23.6°±4.3°. TLIF group changed from pre-operation 9.2°±4.2° to last follow-up 21.3°±4.8°. Obvious changes were found in both group between pre-operation and last follow up, while OLIF group had better improvement than TLIF group ( P=0.01). For lumbar coronal Cobb angle, OLIF group changed from preoperative 16.4°±9.6° to last follow-up 2.8°±2.1°, and TLIF group from preoperative 15.2°±7.8° to last follow-up 6.4°±2.7°. Obvious changes were found in both group comparing pre-operation to last follow up, while OLIF group had better improvement. The offset distance for apical midline of the lumbar vertebrae in OLIF group improved from preoperative 26.3±9.4 mm to 4.3±1.9 mm; TLIF group improved from preoperative 23.4±5.5 mm to 7.5±4.2 mm. Obvious changes were found between pre-operation and last follow up for both group, while OLIF group has better improvement compared to TLIF group ( t=-5.26, P=0.03). The fusion rate was 97.7% (127/130) in OLIF group, and 91.1% (164/180) in TLIF group. There was no statistically significant difference between the two groups ( χ2=1.15, P=0.097). The neural complication rate was 16.1% (9/56) in OLIF groupand 8.3% (5/60) in TLIF group. There was no statistical difference between the two groups ( χ2=1.63, P=0.201). The cage subsidence was 12.3% (16/130) in OLIF group and 21.9% (35/180) in TLIF group. There was statistically significant difference between the two groups ( χ2=4.53, P=0.03). Conclusion:OLIF can be considered as an effectivesurgical option for the treatment of lumbar degenerative scoliosis with spinal stenosis, since it can achieve similar clinical effects and better correction of coronal and sagittal imbalances compared to TLIF.

Objective To explore the effect of spinal sagittal balance on secondary vertebral fracture after percutaneous kyphoplasty (PKP) for osteoporotic vertebral compression fractures (OVCF).Methods The data were reviewed of the patients with single segmental OVCF who had undergone PKP at Department of Spine Surgery,Second Hospital of Lanzhou University from March 2014 to December 2015.Of them,21 had secondary vertebral fracture after PKP.As an observational group,they were matched with another 21 patients without secondary vertebral fracture after PKP as a control group (ratio:1:1) for age,gender,body mass index (BMI) and bone mineral density (BMD).Their standard standing plain radiographs of the whole spine were used to measure the parameters of spine-pelvis sagittal balance.The 2 groups were compared in sagittal balance parameters.Results The sagittal vertical axis (26.86 ± 33.55 mm) and thoracic kyphosis (47.62° ± 10.73°) in the observational group were significantly larger than those (4.05 ± 31.93 mm and 41.10 °±8.17°) in the control group (P ＜0.05);the lumbar lordosis (35.29°±8.77 °),sacral slope (22.71 ° ± 5.80°) and pelvic incidence (45.38° ± 7.49°) in the former were significantly smaller than those in the control group (41.71°±9.19°,27.43°±5.29° and 51.19°±8.44°) (P ＜0.05);there were no significant differences between the 2 groups in pelvic tilt or thoracolumbar kyphosis (P ＞ 0.05).Conclusions The OVCF patients with larger sagittal vertical axis,larger thoracic kyphosis and smaller lumbar lordosis may be more likely to suffer secondary vertebral fracture after PKP.A larger pelvic incidence may be a protective factor against secondary vertebral fracture after PKP for OVCF patients.

Objective Vascular mild cognitive impairment(VaMCI) refers to mild cognitive impairment caused by or associated with vascular causes.This study aims to investigate the characteristics of the cognitive impairment in patients with vascular mild cognitive impairment (VaMCI).Methods Seventy-five patients with VaMCI(VaMCI group) and 38 healthy old subjects whose age, sex and education level match the VaMCI group patients(control group) were recruited from the department of Neurology, Beijing Chaoyang Hospital, Capital Medical University between Jan 2016 and June 2016.The neuropsychological examinations were used to evaluate the severity of cognitive impairment, specifically including the Minimum Mental State Examination(MMSE), Montreal cognitive assessment scale(MoCA), Clinical Dementia Rating(CDR), Activity of Daily Living Scale(ADL), Hachinski ischemic score table, Hamilton Depression Scale(HAMD) and Auditory Verbal Learning Test(AVLT).The Fazekas scale was used to assess the severity of white matter lesions, and the medial temporal lobe atrophy rating scale(MTA) was used to evaluate the atrophic severity of medial temporal lobe.Results The overall cognitive function score in VaMCI group was significantly lower than the control group [MMSE [25.7±2.3 vs 28.4±2.0] MoCA [22.8±3.9 vs 26.3±3.7]], the differences was statistically significant(P<0.05);as well as the AVLT-I [5.1±1.0 vs 8.9±1.9], AVLT-D [3.7±1.0 vs 9.8±1.5] and AVLT-R [7.6±1.9 vs 12±1.5] scores in VaMCI group was significantly lower than the control group, the differences was statistically significant(P<0.05), which suggested patients with VaMCI have overall cognitive impairment, especially memory impairment.But Fazekas and MTA scores in VaMCI groups were higher than the control group, the differences was statistically significant(P<0.05).Correlation analysis showed that the scale of medial temporal lobe atrophy had a negative relationship with the performance of MoCA (r=-0.434,P=0.002).Conclusion Our findings demonstrate patients with VaMCI have significant cognitive impairment, especially memory impairment, which may be correlated to the severity of the white matter lesions and the medial temporal lobe atrophy.