Specification for Quality Control in Traditional Chinese Medicine Clinical Trials（GB/T 47336-2026） is the first national standard in the field of clinical research on traditional Chinese medicine （TCM）， aims to address the core issue that the quality shortcomings of current TCM clinical research restrict the transformation of achievements and international recognition. Through the interpretation of the core contents of this standard， including its scope of application， graded quality control system， TCM-specific quality control requirements， implementation and responsible entities， responsibilities of quality control personnel， formulation of quality control plans， critical nodes of quality control， and quality control archive management， it is believed that the promotion and implementation of this standard are of great significance for improving the standard system of TCM clinical research， enhancing research quality， optimizing the quality management model， and promoting the internationalization process of TCM. Meanwhile， the implementation paths for the standard are discussed， including carrying out pilot applications in institutions， establishing publicity， implementation， and training mechanisms， encouraging multi-party collaborative supervision， and setting up implementation feedback mechanisms. On this basis， the challenges that may be encountered during implementation， such as resource input pressure， difficulties in implementing TCM-specific quality control， and a relative shortage of interdisciplinary composite talents， are sorted out， and corresponding strategies are proposed， which can provide references for relevant researchers and practitioners.

Alzheimer's disease(AD), a neurodegenerative disorder associated with aging, is the most prevalent form of dementia.As the aging population continues to expand, AD presents significant health and caregiving challenges for families and society, making it a pressing international public health concern.In recent years, numerous countries have implemented dementia prevention and treatment strategies that emphasize community-based comprehensive approaches.Currently, the community-based AD prevention and treatment model in China is still in the exploratory phase, with community efforts lacking organization.In alignment with China's action plan for advancing dementia prevention and treatment, and to achieve the strategic objective of "healthy aging, " this consensus is based on the principle of three-level prevention and is tailored to the characteristics of AD disease progression.It aims to develop a comprehensive prevention and treatment strategy for AD that is suitable for communities in China, providing technical guidance and support to establish a scientific basis for formulating community AD prevention and treatment models.

Objective To discuss the regulatory mechanism of nucleotide-binding oligomerzation domain 2(NOD2)/receptor interacting protein 2(RIP2)signaling pathway on inflammatory activation of macrophages in intestinal mucosa and provide experimental evidence for intestinal mucosal inflammation caused by bacterial products.Methods Using the THP-1 monocyte cell line,macrophages were stimulated with muramyl dipeptide(MDP)at varying concentrations and durations.mRNA and protein expression levels of NOD2 and RIP2 were detected.The secretion levels of tumor necrosis factor(TNF)-α and interleukin(IL)-1β in the cell culture supernatant were measured.The most effective siRNA targeting RIP2 and optimal transfection concentration were screened,and the impact of RIP2 gene silencing on MDP-induced inflammatory activation of macrophages was observed.Results After silencing the RIP2 gene,MDP induced a significant decrease in TNF-α and IL-1βsecretion in macrophages,but the changes in cell phenotype were not significantly affected.Conclusion This study revealed the important role of NOD2/RIP2 signaling pathway in inflammatory activation of macrophages,and it is possible to effectively inhibit inflammatory activation of macrophages by interfering with this signaling pathway.

Dysfunction of the interoceptive system is recognized as an important component of clinical symptoms, including anxiety, depression, psychosis, and other mental disorders. Non-invasive neuromodulation is an emerging clinical intervention approach, and over the past decade, research on non-invasive neuromodulation aimed at regulating interoception has rapidly developed. This review first outlines the pathways of interoceptive signals and assessment methods, then summarizes the interoceptive abnormalities in psychiatric disorders and current studies for non-invasive neuromodulation targeting interoception, including intervention modes, target sites, interoceptive measures, and potential neurobiological mechanisms. Finally, we discuss significant research challenges and future directions.
Humans ; Interoception/physiology* ; Mental Disorders/therapy*

Peri-implant keratinized mucosa (PIKM) augmentation refers to surgical procedures aimed at increasing the width of PIKM. Consensus reports emphasize the necessity of maintaining a minimum width of PIKM to ensure long-term peri-implant health. Currently, several surgical techniques have been validated for their effectiveness in increasing PIKM. However, the selection and application of PIKM augmentation methods may present challenges for dental practitioners due to heterogeneity in surgical techniques, variations in clinical scenarios, and anatomical differences. Therefore, clear guidelines and considerations for PIKM augmentation are needed. This expert consensus focuses on the commonly employed surgical techniques for PIKM augmentation and the factors influencing their selection at second-stage surgery. It aims to establish a standardized framework for assessing, planning, and executing PIKM augmentation procedures, with the goal of offering evidence-based guidance to enhance the predictability and success of PIKM augmentation.
Humans ; Consensus ; Dental Implants ; Mouth Mucosa/surgery* ; Keratins

Objective:To compare the clinical efficacy and effects on cognitive function of magnetic seizure therapy (MST) and modified electroconvulsive therapy (MECT) in the treatment of major depressive episode (MDE).Methods:From January 1, 2019 to December 31, 2021, 40 patients who met the MDE diagnostic criteria in the fifth edition of the Diagnostic Statistical Manual of Mental Disorders (DSM-5) were selected in Shanghai Mental Health Center. Participants were randomly assigned to MECT therapy group (20 patients) and MST therapy group (20 patients) using the random number table method. Both groups received MECT or MST while using serotonin reuptake inhibitors (SSRIs), 3 times a week for 4 weeks. The 17-items Hamilton Depression Rating Scale (HAMD 17) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) were performed before and after treatment. HAMD 17 reduction rate and effective rate were the main assessment indicators, while RBANS total score and factor scores were considered as the secondary assessment indicators. T-test was used to compare the reduction rate of HAMD 17 between the two groups, and corrected Chi-square test or Fisher′s exact probability method was used to compare the effective rate of treatment between the two groups. HAMD 17 scores and RBANS scores before and after treatment were compared using two-factor repeated measure ANOVA. Results:There were no significant differences in baseline HAMD 17 scores and RBANS scores between 2 groups( t=0.29, P=0.773; t=0.67, P=0.509). The treatment effective rate in the MECT group was 90% (18/20), and the average reduction rate of HAMD 17 was 67.9%. Meanwhile, the effective rate of MST group was 75% (15/20), and the average reduction rate of HAMD 17 was 60.9%. There was no significant difference in the reduction rate and effective rate of HAMD 17 between the two groups ( t=0.69, P=0.493; χ2=0.16, P=0.693). The total scores and factor scores of RBANS after treatment were lower than those before treatment, with statistical significance(total scores: F=19.29, P<0.001;immediate memory score: F=6.22, P=0.020; language function score: F=9.13, P=0.006;attention score: F=5.23, P=0.031;delayed memory score: F=35.90, P<0.001). There was no significant difference in the total scores and factor scores of RBANS before and after treatment in MST group(total scores: F=0.49, P=0.490;immediate memory score: F=2.25, P=0.147;language function score: F=1.22, P=0.280;attention score: F=0.23, P=0.640;delayed memory score: F=0.02, P=0.887). Conclusions:The efficacy of MST treatment and MECT treatment in treating MDE patients seems to be comparable. MDE patients receiving MST had less impact on cognitive function compared to those treated with MECT.

Melatonin is widely used as an over-the-counter medication to treat insomnia in children with autism spectrum disorder (ASD) and neurogenetic disorders (NGD). However, there is still a lack of research on its efficacy and safety, and clinical practice standards are to be established. In response, the International Pediatric Sleep Association (IPSA) convened an expert panel and developed a consensus statement:"Melatonin Use in Managing Insomnia in Children with Autism and Other Neurogenetic Disorders-an Assessment by the International Pediatric Sleep Association (IPSA)", which was published in Sleep Medicine, April 2024. The consensus focused on the efficacy and adverse effects of melatonin treatment for insomnia in children with ASD and NGD-including Smith-Magenis syndrome, Rett syndrome, Angelman syndrome, and tuberous sclerosis complex. It systematically reviews randomized controlled trials (RCTs) conducted between 2012 and 2022, and integrates current best clinical practices to formulate 10 consensus recommendations. Despite these contributions, the consensus has limitations: a small number of included RCTs, a lack of grading for evidence quality, and recommendation strength. Furthermore, the study population is primarily composed of children from Western countries. This article seeks to interpret the consensus to improve standardized use of melatonin for insomnia in Chinese children with ASD and NGD, and to provide a reference for the future development of localized evidence-based guidelines.

BACKGROUND:Existing studies have compared patients with degenerative lumbar spondylolisthesis with healthy populations,but comparative studies focusing on differences in this aspect of the parameter between these different lumbar spondylolisthesis are lacking.OBJECTIVE:To explore the differences in paraspinal muscle degeneration between isthmic spondylolisthesis and degenerative lumbar spondylolisthesis,and their correlation with low back pain symptoms.METHODS:A total of 107 patients with lumbar spondylolisthesis treated in Affiliated Hospital of Xuzhou Medical University between February 2019 and August 2023 were analyzed retrospectively.They were divided into the isthmic spondylolisthesis group(39 patients)and the degenerative lumbar spondylolisthesis group(68 patients)according to the type of spondylolisthesis.Paravertebral muscle tissue parameters were compared and analyzed as well as functional scores(visual analog scale for low back pain)in both groups.According to the visual analog scale score,the two groups of patients were divided into two subgroups:those with a visual analog scale score＜45 mm and those with a visual analog scale score＞45 mm,and the relationship between the difference in visual analog scale score and the parameters of paraspinal muscle tissue degeneration was analyzed.RESULTS AND CONCLUSION:(1)The percentage of fat infiltration in the multifidus muscle was higher in the degenerative lumbar spondylolisthesis group than in the isthmic spondylolisthesis group(P=0.003).(2)The percentage of fat infiltration in the multifidus muscle was significantly lower in patients with a visual analog scale score of＜45 mm than in patients with a visual analog scale score of＞45 mm in both groups(P=0.021,P＜0.001).(3)Patients in the isthmic spondylolisthesis group also showed a significantly lower percentage of fat infiltration in patients with visual analog scale score＜45 mm compared with those with visual analog scale score＞45 mm(P=0.002).(4)These results showed that there was a significant difference in paraspinal muscle tissue degeneration between isthmic spondylolisthesis patients and degenerative lumbar spondylolisthesis patients,and that degenerative lumbar spondylolisthesis patients demonstrated more severe paraspinal muscle degeneration compared to isthmic spondylolisthesis patients.In addition,the percentage of fatty infiltration of the multifidus muscle was relatively greater in those with higher pain scores in both groups of lumbar spondylolisthesis patients.

Objective To discuss the regulatory mechanism of nucleotide-binding oligomerzation domain 2(NOD2)/receptor interacting protein 2(RIP2)signaling pathway on inflammatory activation of macrophages in intestinal mucosa and provide experimental evidence for intestinal mucosal inflammation caused by bacterial products.Methods Using the THP-1 monocyte cell line,macrophages were stimulated with muramyl dipeptide(MDP)at varying concentrations and durations.mRNA and protein expression levels of NOD2 and RIP2 were detected.The secretion levels of tumor necrosis factor(TNF)-α and interleukin(IL)-1β in the cell culture supernatant were measured.The most effective siRNA targeting RIP2 and optimal transfection concentration were screened,and the impact of RIP2 gene silencing on MDP-induced inflammatory activation of macrophages was observed.Results After silencing the RIP2 gene,MDP induced a significant decrease in TNF-α and IL-1βsecretion in macrophages,but the changes in cell phenotype were not significantly affected.Conclusion This study revealed the important role of NOD2/RIP2 signaling pathway in inflammatory activation of macrophages,and it is possible to effectively inhibit inflammatory activation of macrophages by interfering with this signaling pathway.

Objective To elucidate the role of let-7 in the pathogenesis of oral squamous cell carcinoma(OSCC)and its underlying molecular mechanism.Methods The expression of let-7 in human oral keratinocyte(HOK),OSCC tissues,and OSCC cells(CAL-27,SCC-25,and SCC-9)was detected by quantitative real-time PCR.Colony formation,scratch,Transwell,and flow cytometry assays were used to examine the effects of let-7 on the proliferation,migration,invasion,and apoptosis of SCC-25 cells.Western blotting was used to detect the expression of Wnt and β-catenin proteins.The correlation between let-7 expression and the clinicopathological cha-racteristics and prognosis of OSCC patients was analyzed.Results let-7 was downregulated in OSCC tissues and cells.let-7 over-expression effectively inhibited the proliferation,migration,and invasion of SCC-25 cells while promoting apoptosis by suppressing acti-vation of the Wnt/β-catenin pathway.let-7 expression was closely associated with tumor stage,lymph node metastasis,and patient survival status.Patients with low let-7 expression exhibited lower overall survival rate.Conclusion let-7 targets and regulates the Wnt/β-catenin pathway,thereby inhibiting proliferation,migration,and invasion of OSCC cells while promoting apoptosis.