Migraine is a common chronic neurological disease，faces still certain limitations in the design of some clinical trials of migraine in China. Based on the principle of “PICO” in clinical research， this article summarizes the core contents of Guidelines for controlled trials of preventive treatment of episodic migraine in adults published by International Headache Society and its Clinical Trials Standing Committee， including subject selection， key points of trial design， and endpoint evaluation indicators. This article also discusses the deficiencies in current clinical trial design， so as to provide a basis for the design of clinical trials for migraine.

BackgroundChildhood represents a critical stage for cognitive development. Accurate assessment of children's cognitive abilities and understanding their developmental characteristics are essential for promoting healthy growth. However， traditional cognitive assessment methods typically rely on manual administration， presenting limitations such as low efficiency and insufficient engagement. These methods struggle to meet the assessment needs of children and are difficult to scale up for large-scale applications. ObjectiveTo develop a digital cognitive assessment tool for children， so as to provide a more convenient approach for evaluating children's cognitive functions. MethodsBased on classic psychological paradigms （Stroop Task， N-back， digit span， spatial orientation， and face-name matching）， a digital cognitive assessment tool was developed. This tool includes five tasks including color matching， shape matching， greening the home， great collector， and face-name matching， designed to assess core cognitive functions such as inhibitory control， working memory， short-term memory， spatial orientation， and semantic processing， respectively. From August 2024 to March 2025， a total of 750 students aged 9–12 yeas old from a primary school in Chengdu were enrolled and assessed using the digital cognitive assessment tool. Three months later， 40 children were randomly selected for retesting using both the digital tool and its corresponding standardized psychological paradigms. Pearson correlation analysis was conducted to examine the correlation between the pre-test and retest scores of the digital cognitive assessment tool， as well as the correlation between the digital cognitive task scores and the corresponding psychological paradigm assessment results， in order to evaluate the reliability and validity of the digital cognitive assessment tool. Additionally， differences in scores across the cognitive tasks were compared among children of different age groups and genders. ResultsA total of 699 valid samples were included. The younger age group consisted of children aged 9–10 years old （n=460）， while the older age group comprised those aged 11–12 years old （n=239）. There were 356 boys （50.93%） and 343 girls （49.07%）. In the reliability analysis， the Pearson correlation coefficients between the pre-test and retest scores of each assessment task ranged from 0.732 to 0.970 （P<0.01）， indicating statistically significant results. In the validity analysis， the Pearson correlation coefficients between each task and its corresponding standard cognitive test ranged from 0.679 to 0.988 （P<0.01）. In the color-matching task， both the main effects of age and gender were statistically significant （F=31.071， 21.198， P<0.01）. In the shape-matching task， the main effects of age， gender， and their interaction were all statistically significant （F=20.933， 5.926， 4.318， P<0.05 or 0.01）. In the greening the home task， the main effect of age was significant （F=5.243， P=0.023）. In the great collector task， the main effect of age was significant （F=33.697， P<0.01）. In the face-name matching task， only the main effect of gender was significant （F=27.016， P<0.01）. Further analysis showed that within the female group， older group scored significantly higher than younger group in five tasks（P<0.05 or 0.01）. Within the male group， younger group scored lower than older group in both the color-matching and great collector tasks （P<0.05 or 0.01）. Within the younger group， boys scored significantly higher than girls in color-matching and shape-matching tasks （P<0.01）. In the older group， girls scored significantly higher than boys in face-name matching task （P<0.01）. ConclusionThe digital cognitive assessment tool developed in this study demonstrates good reliability and validity. The development of cognitive functions in children aged 9–12 years old showed significant differences in age and gender， with specific developmental trajectories across different cognitive dimensions. At younger ages， boys outperformed girls in inhibitory control and working memory tasks， though this advantage diminished with age. At older ages， girls exhibited superior performance in semantic processing compared with boys.

Objective To investigate the relationship between cerebrospinal fluid albumin/serum albumin(C-ALB/S-Alb)and the systemic immune inflammatory index(SII)and postoperative delirium(POD)in elderly patients with general anesthesia combined with epidural anesthesia.Methods Elderly patients who un-derwent elective hip replacement surgery and received general anesthesia combined with epidural anesthesia in this hospital from October 2023 to June 2024 were selected.According to the assessment results of the Chi-nese version of the 3-Minute Delirium Diagnostic Scale(3D-CAM),the patients were divided into the POD group(68 cases)and the non-POD group(76 cases).The general information of the patients was collected,the cerebrospinal fluid and venous blood specimens were detected.The levels of cerebrospinal fluid albumin(C-Alb),serum albumin(S-Alb),α-synuclein(α-syn),β-amyloid protein(Aβ)1-42,Aβ1-40,total Tau protein(t-Tau),phosphorylated Tau protein(p-Tau)were detected by enzyme-linked immunosorbent assay(ELISA).The neutrophil count,platelet count and lymphocyte count of the patients were detected by the fully automatic blood analyzer,and the SII was calculated.Results Compared with the non-POD group,the levels of C-Alb,α-syn,t-Tau,p-tau,SII and C-Alb/S-Alb in the POD group increased,while Aβ1-42 and Aβ1-40 were significantly decreased,and the differences were statistically significant(P＜0.05).C-Alb,t-Tau,SII and C-Alb/S-Alb were all independent risk factors for the occurrence of POD.The results of the receiver operating characteristic(ROC)curve analysis showed that the areas under the curve(AUC)of the ROC curves of SII,t-Tau,C-Alb,C-Alb/S-Alb and C-Alb/S-Alb combined with SII for predicting delirium were 0.824,0.818,0.723,0.862 and 0.926,respectively.The AUC predicted by C-Alb/S-Alb combined with SII was the highest(all P＜0.05).Conclusion High SII and C-Alb/S-Alb are independent risk factors for POD occurrence in eld-erly patients with general anesthesia combined with epidural anesthesia.Both have good predictive efficacy for POD,and the combined use has better predictive efficacy.

Objective:To investigate the impact and potential mechanisms of Sorbin and SH3 domain-containing protein 2 (Sorbs2) on ventricular arrhythmias in mice.Methods:In the animal experiments, mating was performed using six 8-week-old Sorbs2 +/- mice (3 males and 3 females) weighing 20-22 g. Wild-type (Sorbs2 +/+, n=8) and homozygous (Sorbs2 -/-, n=6) offspring were selected as experimental subjects through genotyping. Echocardiography was performed at 16 weeks of age to record cardiac function parameters in both groups. Resting-state and caffeine-dobutamine-induced electrocardiograms were also conducted. Real-time quantitative reverse transcription polymerase chain reaction was used to detect Sorbs2 messenger RNA expression in the heart, liver, spleen, lung, kidney, brain, small intestine, and skeletal muscle tissues of wild-type mice. Western blotting was employed to measure the protein expression levels of Sorbs2 and voltage-dependent sodium channel alpha subunit 1.5 (Na v1.5) in myocardial tissues from both groups. In the cell experiments, H9C2 cells were transfected with Sorbs2 small interfering RNA as the si-Sorbs2 group, with a corresponding si-negative control group established. Western blot was performed to detect the protein expression levels of Sorbs2 and Na v1.5 in both groups. Results:Sorbs2 was abundantly expressed in cardiac tissue. Compared with wild-type mice, homozygous mice exhibited larger left ventricular end-systolic diameter, along with lower left ventricular ejection fraction and fractional shortening ( P all<0.05). Resting-state electrocardiograms revealed no spontaneous arrhythmias in either group; however, homozygous mice showed shorter RR intervals but longer QRS and QTc intervals versus wild-type mice ( P all<0.05). Following caffeine and dobutamine induction, homozygous mice demonstrated a higher incidence of ventricular arrhythmias, longer arrhythmia duration, and higher ventricular arrhythmia scores than wild-type mice ( P all<0.05). Western blot analysis revealed that Na v1.5 protein expression was markedly lower in myocardial tissues of homozygous mice compared to wild-type mice. Similarly, si-Sorbs2-transfected H9C2 cells exhibited lower Na v1.5 protein levels compared to the si-negative control group ( P<0.05). Conclusion:Sorbs2 plays a critical role in maintaining normal cardiac electrophysiological function. Deficiency of Sorbs2 may lead to impaired cardiac function and increased susceptibility to ventricular arrhythmias in mice, which could be associated with reduced expression of Na v1.5 protein.

Objective:To explore the current status and influencing factors of intrinsic capacity in elderly patients with Parkinson's disease.Methods:Convenience sampling was used to select 306 elderly patients with Parkinson's disease who attended Xuanwu Hospital of Capital Medical University from March to September 2024 for the study. Influencing factors were screened based on the health ecology model. Elderly patients with Parkinson's disease were surveyed using the General Information Questionnaire, Connor-Davidson Resilience Scale, Family APGAR Scale, Social Support Rating Scale, and Intrinsic Capacity Assessment Tool. Multiple linear regression was used to analyze the factors influencing the total score and the scores of each dimension of intrinsic capacity in elderly patients with Parkinson's disease.Results:A total of 306 questionnaires were distributed and 301 valid questionnaires were recovered, with a valid recovery rate of 98.37% (301/306). The total intrinsic capacity score of 301 elderly patients with Parkinson's disease was (67.21±11.47), of which 297 elderly patients with Parkinson's disease had impaired intrinsic capacity, and the rate of impaired intrinsic capacity was 98.7% (297/301). The dimensions in descending order of impairment were motor [89.7% (270/301) ], mental [76.1% (229/301) ], sensory [70.4% (212/301) ], vitality [38.2% (115/301) ], and cognitive [25.6% (77/301) ]. Multiple linear regression analysis showed that age, Hoehn-Yahr staging, levodopa equivalent dosage, activity of daily living, history of falls, regular exercise, psychological resilience, social support, and monthly income were the factors influencing the total intrinsic capacity score of elderly patients with Parkinson's disease ( P<0.05) and heterogeneity of influencing factors in each dimension. Conclusions:Elderly patients with Parkinson's disease have a high rate of impaired intrinsic capacity, with the motor dimension being the most severely impaired. Healthcare professionals should pay attention to the assessment of the intrinsic capacity of elderly patients with Parkinson's disease, and customize interventions according to the influencing factors to promote the functioning of elderly patients so as to reduce the burden of care on families and society.

Objective:To explore the current status and influencing factors of intrinsic capacity in elderly patients with Parkinson's disease.Methods:Convenience sampling was used to select 306 elderly patients with Parkinson's disease who attended Xuanwu Hospital of Capital Medical University from March to September 2024 for the study. Influencing factors were screened based on the health ecology model. Elderly patients with Parkinson's disease were surveyed using the General Information Questionnaire, Connor-Davidson Resilience Scale, Family APGAR Scale, Social Support Rating Scale, and Intrinsic Capacity Assessment Tool. Multiple linear regression was used to analyze the factors influencing the total score and the scores of each dimension of intrinsic capacity in elderly patients with Parkinson's disease.Results:A total of 306 questionnaires were distributed and 301 valid questionnaires were recovered, with a valid recovery rate of 98.37% (301/306). The total intrinsic capacity score of 301 elderly patients with Parkinson's disease was (67.21±11.47), of which 297 elderly patients with Parkinson's disease had impaired intrinsic capacity, and the rate of impaired intrinsic capacity was 98.7% (297/301). The dimensions in descending order of impairment were motor [89.7% (270/301) ], mental [76.1% (229/301) ], sensory [70.4% (212/301) ], vitality [38.2% (115/301) ], and cognitive [25.6% (77/301) ]. Multiple linear regression analysis showed that age, Hoehn-Yahr staging, levodopa equivalent dosage, activity of daily living, history of falls, regular exercise, psychological resilience, social support, and monthly income were the factors influencing the total intrinsic capacity score of elderly patients with Parkinson's disease ( P<0.05) and heterogeneity of influencing factors in each dimension. Conclusions:Elderly patients with Parkinson's disease have a high rate of impaired intrinsic capacity, with the motor dimension being the most severely impaired. Healthcare professionals should pay attention to the assessment of the intrinsic capacity of elderly patients with Parkinson's disease, and customize interventions according to the influencing factors to promote the functioning of elderly patients so as to reduce the burden of care on families and society.

Objective:To investigate the impact and potential mechanisms of Sorbin and SH3 domain-containing protein 2 (Sorbs2) on ventricular arrhythmias in mice.Methods:In the animal experiments, mating was performed using six 8-week-old Sorbs2 +/- mice (3 males and 3 females) weighing 20-22 g. Wild-type (Sorbs2 +/+, n=8) and homozygous (Sorbs2 -/-, n=6) offspring were selected as experimental subjects through genotyping. Echocardiography was performed at 16 weeks of age to record cardiac function parameters in both groups. Resting-state and caffeine-dobutamine-induced electrocardiograms were also conducted. Real-time quantitative reverse transcription polymerase chain reaction was used to detect Sorbs2 messenger RNA expression in the heart, liver, spleen, lung, kidney, brain, small intestine, and skeletal muscle tissues of wild-type mice. Western blotting was employed to measure the protein expression levels of Sorbs2 and voltage-dependent sodium channel alpha subunit 1.5 (Na v1.5) in myocardial tissues from both groups. In the cell experiments, H9C2 cells were transfected with Sorbs2 small interfering RNA as the si-Sorbs2 group, with a corresponding si-negative control group established. Western blot was performed to detect the protein expression levels of Sorbs2 and Na v1.5 in both groups. Results:Sorbs2 was abundantly expressed in cardiac tissue. Compared with wild-type mice, homozygous mice exhibited larger left ventricular end-systolic diameter, along with lower left ventricular ejection fraction and fractional shortening ( P all<0.05). Resting-state electrocardiograms revealed no spontaneous arrhythmias in either group; however, homozygous mice showed shorter RR intervals but longer QRS and QTc intervals versus wild-type mice ( P all<0.05). Following caffeine and dobutamine induction, homozygous mice demonstrated a higher incidence of ventricular arrhythmias, longer arrhythmia duration, and higher ventricular arrhythmia scores than wild-type mice ( P all<0.05). Western blot analysis revealed that Na v1.5 protein expression was markedly lower in myocardial tissues of homozygous mice compared to wild-type mice. Similarly, si-Sorbs2-transfected H9C2 cells exhibited lower Na v1.5 protein levels compared to the si-negative control group ( P<0.05). Conclusion:Sorbs2 plays a critical role in maintaining normal cardiac electrophysiological function. Deficiency of Sorbs2 may lead to impaired cardiac function and increased susceptibility to ventricular arrhythmias in mice, which could be associated with reduced expression of Na v1.5 protein.

The American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the American Society of Regional Anesthesia and Pain Medicine collaborated to develop an evidence-based study about the safe and effective use of Ketamine in total joint arthroplasty(TJA). Based on the systematic review and Meta-analysis of several studies, the following conclusions are drawn: Ketamine can effectively relieve the postoperative pain of patients; Ketamine can effectively reduce the occurrence of postoperative nausea and vomiting; Ketamine can reduce the use of postoperative opioids; intraoperative use of Ketamine does not increase the incidence of postoperative adverse reactions. The above conclusions are graded according to the strength of evidence support. This article interprets the guidelines to provide reference for addressing the effectiveness and safety of Ketamine use in TJA.

OBJECTIVE: To validate the effectiveness of a novel comprehensive classification for intertrochanteric fracture (ITF). METHODS: The study included 616 patients with ITF, including 279 males (45.29%) and 337 females (54.71%); the age ranged from 23 to 100 years, with an average of 72.5 years. Two orthopaedic residents (observers Ⅰ and Ⅱ) and two senior orthopaedic surgeons (observers Ⅲ and Ⅳ) were selected to classify the CT imaging data of 616 patients in a random order by using the AO/Orthopaedic Trauma Association (AO/OTA) classification of 1996/2007 edition, the AO/OTA classification of 2018 edition, and the novel comprehensive classification method at an interval of 1 month. Kappa consistency test was used to evaluate the intra-observer and inter-observer consistency of the three ITF classification systems. RESULTS: The inter-observer consistency of the three classification systems evaluated by 4 observers twice showed that the 3 classification systems had strong inter-observer consistency. Among them, the κ value of the novel comprehensive classification was higher than that of the AO/OTA classification of 1996/2007 edition and 2018 edition, and the experience of observers had a certain impact on the classification results, and the inter-observer consistency of orthopaedic residents was slightly better than that of senior orthopaedic surgeons. The intra-observer consistency of two evaluations of three classification systems by 4 observers showed that the consistency of the novel comprehensive classification was better for the other 3 observers, except that the consistency of observer Ⅳ in the AO/OTA classification of 2018 version was slightly higher than that of the novel comprehensive classification. The results showed that the novel comprehensive classification has higher repeatability, and the intra-observer consistency of senior orthopaedic surgeons was better than that of orthopaedic residents. CONCLUSION The novel comprehensive classification system has good intra- and inter-observer consistency, and has high validity in the classification of CT images of ITF patients; the experience of observers has a certain impact on the results of the three classification systems, and those with more experiences have higher intra-observer consistency.
Male ; Female ; Humans ; Young Adult ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Observer Variation ; Reproducibility of Results ; Hip Fractures/surgery* ; Tomography, X-Ray Computed/methods* ; Radiography

ObjectiveTo explore the effect of Anmeidan on the sleep quality and serum levels of brain-derived neurotrophic factor （BDNF）， glial fibrillary acidic protein （GFAP）， and irisin in the patients with chronic insomnia. MethodA multicenter， randomized， double-blind， placebo-controlled clinical study was carried out， including 480 patients with chronic insomnia （deficiency syndrome） in Wuhan （Hubei）， Guangzhou （Guangdong）， and Lanzhou （Gansu）. They were randomized into an observation group and a control group at a ratio of 1∶1. The observation group was orally administered with Anmeidan granules at a dose of 11 g， 3 times per day， and the control group with Anmeidan simulant at a dose of 11 g， 3 times per day， Both groups of patients received sleep education after enrollment. After 4 weeks of medication， the Athens insomnia scale （AIS） scores， Spiegel scale scores， and serum levels of BDNF， GFAP， and irisin were compared between the two groups as well as between before and after treatment. ResultA total of 480 adult patients with chronic insomnia were enrolled in this study， with 64 patients falled off. Finally， the 415 patients were included in the analysis， including 213 patients in the observation group and 202 patients in the control group. There was no difference in age or sex between the two groups of patients. Compared with before treatment， the treatment in both groups decreased the AIS and Spiegel scores （P<0.01）. After treatment， the observation group had lower AIS and Spiegel scores than the control group （P<0.01）. The treatment in the observation group slightly lowered the level of BDNF， elevated the level of irisin （P<0.05）， and lowered the level of GFAP （P<0.05） in the serum. After treatment， the observation group showed higher level of irisin （P<0.05） and lower levels of BDNF and GFAP in the serum than the control group. ConclusionAnmeidan may improve the sleep quality of patients with chronic insomnia by elevating the irisin level and lowering the GFAP level in the serum.