The ethical review of clinical research involving mental disorders in the ethical governance of scientific and technological has obvious particularities， especially in the field of artificial intelligence and brain-computer interfaces which are reflected in the impact on mental autonomy， the impaired informed consent ability of participants with severe mental disorders in research， and other aspects. In addition， the stigma of illness， the use of placebo， and psychological assessment methods in clinical research have also drawn attention to the ethical review of psychiatry. In 2020， the Beijing Municipal Health Commission issued the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders （Guidelines）. Shen Yucun’s Psychiatry， compiled in 2023， revised the application of the Guidelines in the context of ethical governance. An analysis was conducted on the purpose and significance of its issuance and revision， its scope of application， the principal responsibility of ethical review in medical and health institutions， and the key content of ethical review in psychiatry， to improve the quality of ethical review in clinical research involving mental disorders and promote the standardized development of clinical research in psychiatry.

Focal choroidal excavation(FCE)is an elusive clinical sign characterized by a localized structural depression in the choroid. It has been increasingly recognized with the widespread use of optical coherence tomography(OCT), though its pathogenesis remains incompletely understood and may involve congenital developmental anomalies or acquired factors(such as inflammation or tumor compression). Studies indicate that FCE can occur independently or secondary to various chorioretinal diseases(e.g., central serous chorioretinopathy, choroidal osteoma, age-related macular degeneration, etc.). Clinically, it has also been observed that FCE may be associated with the development of choroidal neovascularization(CNV). Potential mechanisms linking FCE and CNV include: 1)mechanical traction-hypoxia-signaling pathway activation; 2)disruption of the retinal pigment epithelium(RPE)-Bruch's membrane-choroid complex barrier; 3)structural collapse induced by inflammatory scar contraction. Anti-vascular endothelial growth factor(VEGF)therapy is currently the mainstay of treatment for CNV secondary to FCE. By reviewing relevant domestic and international literature, this paper seeks to elucidate the possible pathological relationship between FCE and CNV, with the goal of facilitating early identification of high-risk patients and optimizing anti-VEGF treatment strategies. It also highlights the limitations of current research(such as sample heterogeneity and lack of histological validation of typing criteria), and suggests future directions, such as multicenter studies and molecular mechanism investigations, to support the development of personalized diagnostic and therapeutic approaches.

Objective To analyze the clinical characteristics of C-TI-RADS 3 thyroid nodules with a diameter greater than 2 cm and explore their correlation with gender,nodule ingredient,contralateral cancer presence,diffuse echo changes,TPOAB and TGAB.Methods A retrospective analysis was made on the clinical and pathological information of 94 patients with thyroid nodules who were admitted to our department from September 2022 to March 2023.All the patients underwent cytological and/or histopathological examinations.The proportions of TBS I category,benign tumors,low-risk tumors,and malignant tumors were calculated.The proportion of TBS type Ⅰ,benign tumors,low-risk tumors,and malignant tumors was quantified.Subsequently,a comparative analysis was conducted among the benign,low-risk,and malignant groups in terms of clinical characteristics including gender distribution,nodule composition,contralateral cancer occurrence,diffuse echo changes presence,as well as TPOAB and TGAB levels.Results Seven cases in TBS I category were excluded.Among the remaining 87 cases with confirmed pathology results for nodules,there were 72 benign cases(38 cytology cases and 34 histology cases),5 low-risk thyroid tumors(2 cytology cases and 3 histology cases),10 malignant cases(8 PTC cases,1 FTC case,and 1 MTC case).There was a significant difference in nodule ingredient(cystic/solid)between different pathological types(x2=10.369,P=0.006).However,no statistical significance was found in terms of gender,diffuse echo changes,contralateral cancer presence,TPOAB or TGAB(P＞0.05).Further analysis showed that the proportion of solid component was higher in low-risk tumors than in benign nodules(x2=9.571,P=0.002).No statistical significance was found between malignant nodules and low-risk nodules(x2=2.143,P=0.143),or between malignant nodules and benign nodules(x2=2.165,P=0.141).Conclusion Although TI-RADS 3 nodules are generally considered as potentially benign according to various versions of thyroid imaging reporting and data system,malignant nodules still account for a certain proportion.Attention should be paid to thyroid nodules with a typical ultrasonic signs,such as cystic nodules,thyroid follicular tumors and medullary thyroid carcinoma.Ultrasound guided fine needle aspiration cytopathology is necessary for evaluating benign and malignant nodules.It is necessary to pay attention to unsatisfactory or undiagnosable specimens to improve the accuracy of diagnosis.

Objective:This study aimed to explore the status of radiological Kashin-Beck disease (KBD) among school-aged children in Chamdo City, Tibet, through a 3-year monitoring survey, providing epidemiological evidence for prevention and control strategies.Methods:The target areas for this study were Luolong, Bianba, and Basu counties in Chamdo City, Tibet Autonomous Region, identified as having the most severe historical cases of KBD. Children aged 7-12 years attending school were enrolled as study subjects. Anteroposterior X-ray films of the right-hand were taken, and radiological diagnoses were made based on the "Diagnosis of Kashin-Beck Disease" criteria (WS/T 207-2010). Two experienced researchers independently reviewed the X-rays, and intra- and inter-group consistency were assessed using weighted Kappa values and percentage agreement. Cross-sectional surveys were conducted in 2017 and 2020 to describe the X-ray detection rates of KBD, and logistic regression analysis was employed to construct a predictive model of risk factors for radiological KBD cases.Results:In 2017, a total of 5,711 children aged 7-12 years in Chamdo City, Tibet, participated in the baseline cross-sectional survey (average age 9.2 years, 48.0% female), with 28 cases of radiological KBD. The age- and gender-standardized prevalence rate was 0.527%. In 2020, 6,771 participants (average age 9.3 years, 49.5% female) underwent a second cross-sectional survey, with 9 cases of radiological KBD and a standardized prevalence rate of 0.134%. Logistic regression analysis indicated that older age [ OR=2.439, 95% CI(1.299, 4.580), P=0.006] and female gender [ OR=8.157, 95% CI(1.016, 65.528), P=0.048] were independent risk factors for radiological KBD cases. Conversely, higher residential altitude, under the premise of Tibet's high altitude, was a protective factor [ OR=0.995, 95% CI(0.990, 0.999), P=0.032). Conclusion:The radiographically positive detection rate of KBD among school-aged children in Chamdo City, Tibet Autonomous Region, is at an extremely low level and showing a declining trend, reaching the historical standard in 2020. Considering the absence of positive signs in affected children, it suggests that local KBD has been effectively eliminated.

Background and purpose:Limbs soft tissue sarcoma(STS)is a common malignant tumor,and surgical resection is the main treatment method for it.The concept of barrier made us realize the blocking effect of natural barrier on STS,and we aimed to search for tissues that can act as barrier,and to perform complete resection of surgical margins around the tissue barrier.This study aimed to investigate the feasibility,safety and prognosis of barrier resection in the treatment of limbs STS.Methods:From December 2013 to September 2016,data of 72 patients who underwent barrier resection of STS of extremities in department of oncosurgery,Minhang Branch,Fudan University Shanghai Cancer Center were retrospectively analyzed,and the resection margin was sampled.All 72 patients underwent preoperative magnetic resonance imaging(MRI)or computed tomography(CT)design,and the physiological barrier or at least 3 cm distance was found outward from the anatomical location of the tumor.And en bloc excision was performed outside this barrier or at a distance of 3 cm.The influence of postoperative pathological margin,musculoskeletal tumor society(MSTS)score and postoperative complications on the patients were analyzed.The 1-and 3-year locoregional recurrence-free survival(LRFS)rates and sarcoma-specific survival(SSS)rates were evaluated,and the influencing factors were analyzed.This study was approved by the Ethics Committee of Fudan University Shanghai Cancer Center(number:1212117-12&1212117-12-1301).Results:All patients had negative margins.The 1-and 3-year LRFS rates were 98.2%and 93.3%,respectively.The 1-and 3-year SSS rates were 98.4%and 94.2%,respectively.The mean MSTS scores were 28.3 preoperatively and 25.5 postoperatively.Surgical complications were grade 1 to 2 in 20 cases and grade 3 in 1 case,and there were no grade 4 to 5 complications.Conclusion:Based on the combination of clinical,imaging and pathology data,barrier resection,including tumor resection and functional reconstruction,can be applied to the surgical treatment of STS,with good feasibility and safety,reliable margin and satisfactory local control.

Objective:To investigate the clinical effect of 3D printing combined with O-arm navigation assisted posterior hemivertebrae resection and orthopedic fixation in the treatment of congenital cervicothoracic scoliosis.Methods:A retrospective study was conducted on the clinical data of 14 patients with congenital cervicothoracic kyphosis caused by hemivertebra treated in Henan Provincial People's Hospital from January 2015 to June 2021, including 9 males and 5 females, aged 8.9±3.2 years (range, 1-15 years). Operation time, intraoperative blood loss and fusion stage were recorded. Intraoperative O-arm scanning and postoperative CT scanning were performed to evaluate the accuracy of nail placement. The cervicothoracic scoliosis Cobb angle, compensatory scoliosis Cobb angle, local kyphosis Cobb angle, torticollis angle, T 1 tilt angle and clavicular angle were measured before operation, model design, 1 week after operation and at the last follow-up to evaluate the effect of surgical design, intraoperative orthosis and the correction loss at follow-up. The Society for Scoliosis Research-22 (SRS-22) questionnaire was used to evaluate the functional and treatment effect. At the last follow-up, the osteotomy fusion was evaluated by Eck criterion. Results:All patients successfully completed the operation, the operation time was 228.5±41.8 min, the intraoperative blood loss was 355.6±46.7 ml, and the number of fusion segments was 5.5±0.8. Follow-up duration was 35.5±13.2 months. A total of 140 pedicle screws were inserted, with an accuracy of 97.1% (136/140). The Cobb angle of cervicothoracic scoliosis was 53.9°±17.9° preoperatively, 11.3°±4.4° in the model design, 10.8°±2.6° one week postoperatively, and 14.5°±3.5° at the last follow-up, with statistical significance ( P<0.001). The preoperative and postoperative one week difference was statistically significant ( P<0.001) with a correction rate of 78.6%±6.7%. The Cobb angle of compensatory scoliosis was 33.1°±12.1° before surgery, 11.9°±2.4° for model design, 10.5°±3.4° for one week after surgery, and 14.1°±2.5° for the last follow-up, with statistically significant differences ( P<0.001). The postoperative correction rate was 65.2%±16.2%. The Cobb angle of local kyphosis was 27.8°±9.8° preoperatively, 10.1°±2.1° in the model design, 9.8°±1.9° one week postoperatively, and 12.7°±1.6° at the last follow-up, with statistical significance ( P<0.001). The preoperative and postoperative one week difference was statistically significant ( P<0.001) with a correction rate of 59.2%±18.9%. The preoperative and postoperative one week difference was statistically significant ( P<0.001) with a correction rate of 78.6%±6.7%. The neck tilt angle was 20.6°±6.7° preoperatively, 6.2°±1.9° in the model design, 5.9°±2.1° one week postoperatively, and 7.1°±1.4° at the last follow-up, with statistical significance ( P<0.001). The preoperative and postoperative one week difference was statistically significant ( P<0.001) with a correction rate of 70.0%±11.1%. The T 1 inclination angle was 20.2°±5.8° preoperatively, 11.5°±3.1° in the model design, 10.2°±2.3° one week postoperatively, and 9.5°±3.0° at the last follow-up, with statistical significance ( P<0.001). The preoperative and postoperative one week difference was statistically significant ( P<0.001) with a correction rate of 53.2%±10.4%. There was no significant difference between preoperative design and actual measurement one week after surgery ( P>0.05). At the last follow-up, the scores of self-image (4.6±0.7), mental health (4.7±0.6) and treatment satisfaction (4.6±0.6)in SRS-22 scale were significantly improved compared with those before operation ( P<0.05). The symptoms of hemivertebra ipilateral C 8 nerve root injury occurred in 1 patient, who was treated conservatively with dehydration, hormones and nutraceutical drugs, and recovered to normal at 3 months follow-up. At the last follow-up, the appearance of the head, neck and shoulders of the patients was improved compared with that before surgery, the bone grafts have achieved osseous fusion in all patients. All fusion were grade I by Eck criterion. No complications such as serious neurological or vascular injury occurred during perioperative period. No pseudoarthrosis formation, internal fixation loosening or fracture occurred during follow-up. Conclusion:The application of 3D printing combined with O-arm navigation assistance technology in posterior hemivertebra resection and correctional surgery for cervicothoracic hemivertebra deformities can display the deformities in advance, stereoscopic and real-time, accurately place pedicle screws and complete hemivertebra resection, improve surgical safety and deformity correction rate.

Objective To explore the interventional effect of repetitive transcranial magnetic stimulation (rTMS) on tardive dyskinesia (TD) in schizophrenic patients. Methods A total of 105 schizophrenic patients were selected as subjects and randomly divided into 1 Hz treatment group, 10 Hz treatment group and control group, with 35 patients in each group. All three groups received rTMS treatment for 12 weeks. The Abnormal Involuntary Movement Scale (AIMS), Scale for the Assessment of Negative Symptoms (SANS), Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) scores were compared among the three groups. Physiological indicators such as electrocardiogram, blood routine, blood biochemistry and hormone levels were monitored. Results After treatment, the total AIMS scores in the 1 Hz and 10 Hz treatment groups were significantly lower than before treatment, and those in the 1 Hz and 10 Hz treatment groups were significantly lower than those in the control group (P < 0.05). The reduction rates of AIMS scores in the 1 Hz and 10 Hz treatment groups were 68.6% and 65.7%, respectively, which were significantly higher than the 22.9% in the control group (P < 0.05). After treatment, the total SANS and PANSS scores in the 1 Hz and 10 Hz treatment groups were significantly lower than before treatment, and those in the 1 Hz and 10 Hz treatment groups were significantly lower than those in the control group (P < 0.05). There was no statistically significant difference in the total AIMS score, efficacy and total PANSS score between the 1 Hz and 10 Hz treatment groups (P>0.05). There were no significant differences in the total TESS scores and physiological indicators among the three groups before and after treatment (P>0.05). Conclusion Both 1 Hz and 10 Hz rTMS can effectively improve TD in schizophrenic patients with good safety and have no significant side effects or physiological damage.

Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans ; Anti-Bacterial Agents/therapeutic use* ; China ; Drug Monitoring/methods* ; Polymyxin B ; Practice Guidelines as Topic

Objective:To investigate the clinical efficacy of satellite rod revision surgery via a combined anterior and posterior approach for rod fracture after posterior vertebral column resection (PVCR) in patients with severe thoracolumbar kyphosis.Methods:A retrospective case series study was conducted on the clinical data of 11 patients with rod fracture after PVCR for severe thoracolumbar kyphosis, who were treated in Henan Provincial People′s Hospital from January 2013 to January 2021. There were 6 males and 5 females, with the age range of 21-62 years [(35.4±13.0)years]. Among them, 4 patients had traumatic kyphosis, 4 presented congenital kyphosis and 3 showed tuberculous kyphosis. All the patients had obvious low back pain. According to the American Spinal Injury Association (ASIA) score, 2 patients were found with grade C, 2 with grade D and 7 with grade E. All the patients underwent revision surgery for internal fixation using satellite rod via a combined anterior and posterior approach. The operation time, intraoperative blood loss and postoperative hospital stay were recorded. The imaging parameters such as kyphosis Cobb angle, scoliosis Cobb angle, distance between C 7 plumb line and central sacral vertical line (C 7-CSVL), and distance between C 7 plumb line and sagittal vertical axis (SVA) were measured preoperatively, at 1 week postoperatively and at latest follow-up. At the same time, the visual analogue scale (VAS), Oswestry dysfunction index (ODI), and simplified Chinese version of the scoliosis research society-22 (SRS-22) questionnaire were used to evaluate the clinical efficacy. At the latest follow-up, the osteotomy fusion was evaluated by Suk criterion and ASIA score was used to evaluate the recovery of neurological function. The complications were also recorded for the patients. Results:All the patients were followed up for 24-84 months [(47.5±16.2)months]. The operation time was 100-220 minutes [(149.4±37.6)minutes], with the intraoperative blood loss of 150-350 ml [(246.3±64.6)ml] and the postoperative hospital stay of 5-8 days [(6.1±1.1)days]. The kyphosis Cobb angles [(18.5±3.2)° and (19.3±2.9)°] and the scoliosis Cobb angles [(11.8±2.2)°, (11.1±2.2)°] at 1 week post-operation and at the latest follow-up were all improved significantly compared with the preoperative ones [(60.4±6.3)°, (21.7±5.5)°] (all P<0.01), with the average correction rates being 69.4% and 45.6%, respectively, with no significant differences between 1 week post-operation and latest follow-up (all P>0.05). The C 7-CSVL was reduced from preoperative (21.2±4.3)mm to (15.7±2.4)mm at 1 week post-operation, and to (15.9±2.2)mm at the latest follow-up (all P<0.01). The SVA was improved from preoperative (51.0±6.8)mm to (16.6±3.6)mm at 1 week post-operation, and to (15.3±3.9)mm at the latest follow-up (all P<0.01). There were no significant differences in C 7-CSVL or SVA at 1 week post-operation or at the latest follow-up (all P>0.05). The VAS [(2.5±0.9)points, (1.9±0.9)points], ODI (20.1±5.4, 18.4±5.2) and SRS-22 [(83.4±5.8)points, (85.0±4.1)points] at 1 week post-operation and at the latest follow-up were significantly improved compared with the preoperative ones [(6.0±1.4)points, 57.2±8.7, (62.0±9.1)points] (all P<0.01), but no significant differences were found between 1 week post-operation and latest follow-up (all P>0.05). At the latest follow-up, the bone grafts achieved osseous fusion in all the patients, and the ASIA grade was improved from grade C to grade D in 2 patients and from grade D to grade E in 2 patients. No complications such as serious neurological or vascular injury occurred during perioperative period. No pseudoarthrosis formation, internal fixation loosening or fracture occurred during follow-up. Conclusion:Satellite rod revision surgery via a combined anterior and posterior approach for rod fracture after PVCR in patients with severe thoracolumbar kyphosis has the advantages of less trauma and faster convalescence, excellent results of deformity correction, significant pain relief, functional improvement, and fewer complications.

Objective:To investigate the clinical efficacy and precautions of O-arm combined with navigation-assisted steotomy and hemivertebra resection for congenital cervicothoracic hemivertebra.Methods:From February 2016 to October 2020, the clinical data of 12 patients with cervicothoracic hemivertebra admitted in Henan Provincial People's Hospital were retrospectively analyzed, including 5 males and 7 females, aged 9.4±2.6 years (range, 4-15 years). Intraoperative neural monitoring system was used to ensure the safety of surgical correction process and O-arm navigation system assisted the implantation of pedicle screws,hemivertebra resection, and scoliosis deformity correction. Postoperative CT was used to evaluate the accuracy of screw placement, and routine preoperative and postoperative X-ray films of the full-length spine in standing position were taken to measure the coronal and sagittal Cobb angles. The correction rate of scoliosis and kyphosis, internal fixation, shoulder height difference and bone graft fusion were calculated at the final follow-up.Results:A total of 108 pedicle screws were inserted in 12 patients, and the screw placement accuracy rate was 96.3% (104/108). The follow-up time was 37.9±10.2 months (range, 24-61 months). The number of fused segments was 5.4±1.1 (range, 4-7). One week after surgery, the correction rate of Cobb angle was 78.5%±3.2% for scoliosis and 70.1%±5.4% for kyphosis. There were statistically significant differences in side and kyphosis Angle and Scoliosis Research Society (SRS)-22 score between preoperative and 1 week after surgery ( P<0.05). There was no significant difference between the operation and the last follow-up ( P>0.05). At the last follow-up, all the 12 patients achieved gradeⅠ fusion. SI was 2.4±0.8 cm before operation, 1.0±0.6 cm at 1 week after operation, and 0.7±0.5 cm at last follow-up, and the difference was statistically significant ( F=38.30, P<0.001). No pseudojoint formation, significant loss of correction Angle, or rupture of internal fixation relaxant occurred during the operation or during follow-up. Conclusion:O-arm combined with navigation-assisted steotomy and hemivertebra resection for the treatment of congenital cervicothoracic hemivertebra has the advantages of good orthopedic effect, reduced radiation exposure and fewer complications, and accurate pedicle screw implantation and hemivertebra resection.