Leflunomide (LEF) shows promising effect in Takayasu arteritis (TAK), but evidence from randomized controlled trials is lacking. This study aims to investigate the efficacy and safety of LEF versus placebo combined with prednisone for the treatment of TAK. This is a multicenter, randomized, double-blind, placebo-controlled trial at six sites across China, conducting from December 22, 2016, to November 4, 2022. A total of 116 eligible patients were recruited and randomized 1:1 to receive LEF (20 mg/d, p.o.) or matched placebo for 24 weeks, with all patients having initial prednisone of 0.6 mg/kg/d and following a taper starting at week 4. By week 24, patients in the LEF group who did not achieve clinical remission discontinued the study; all other patients (both LEF and placebo groups) received LEF (20 mg/d) from week 25 to week 52. The primary outcome was clinical remission at week 24. Secondary outcomes were time-to-clinical remission, mean prednisone dose at week 24, clinical remission in those who switched to LEF from week 25, disease recurrence and time-to-recurrence, imaging changes, and safety. Fifty-four and 57, 45 and 48 patients were included in LEF and placebo group of modified intention-to-treat (mITT) and per-protocol set (PPS). In mITT set, clinical remission was achieved in 44/54 (81.5

Depression is underpinned by a complex pathogenesis that involves the hippocampus and dorsal raphe nucleus (DRN) of the central nervous system. Although electroacupuncture (EA) is proven to be safe and effective for alleviating depression symptoms and causes minimal side effects, its underlying therapeutic mechanism remains unclear. In this study, we performed targeted metabolomics to identify metabolite alterations in the hippocampus and DRN of Wistar Kyoto (WKY) rats and elucidate the role and potential mechanism of action of EA. Our results indicated that 3 weeks of consecutive EA significantly ameliorated depression-like behaviors in WKY rats. Targeted metabolomics revealed 42 differentially expressed metabolites (DEMs) in the hippocampus and 97 DEMs in the DRN between Wistar and WKY rats. In addition, we observed 19 hippocampal DEMs and 41 DRN DEMs between WKY and EA-treated rats. Subsequent pathway analyses indicated that these DEMs were primarily enriched in amino acid-related metabolic pathways. Moreover, six DEMs were found to be significantly associated with at least one depression-like behavior, indicating their involvement in the pathogenesis of depression. EA intervention modulated the levels of 1-methylhistidine, 3-methylhistidine, carnosine, and riboflavin in depressed rats. Collectively, these findings demonstrate that disturbances in cerebral metabolites, especially amino acids, may be one of the causes underlying depression in WKY rats, and the therapeutic effect of EA is potentially mediated through the modulation of the levels of these metabolites.

Background Pelvic venous disorder (PeVD) predominantly affects women, causing chronic pelvic pain, dyspareunia, and lower extremity varicose veins that severely impair quality of life (QoL). Owing to the lack of QoL assessment tools tailored to the impact of PeVD on female patients, diagnosis and management remain challenging. We developed a PeVD-specific QoL scale (PeVD-QoL) for women, providing a scientific basis to optimize diagnostic, therapeutic, and nursing strategies. Methods Using a mixed-methods design (literature review, qualitative interviews, Delphi expert consultations, and clinical testing), we developed and refined the scale. The preliminary 48-item version was validated in 527 Chinese women with PeVD to assess its validity (content, construct, convergent, and discriminant) and reliability (Cronbach’s α and test-retest reliability), thereby verifying its scientific rigor and reliability. Results The PeVD-QoL demonstrated a content validity index of 0.995. Exploratory factor analysis revealed that the 40 items of the PeVD-QoL loaded on six factors, accounting for 73.23% of the total variance; confirmatory factor analysis supported its six-factor structure with acceptable model fits. Each dimension exhibited acceptable convergent and discriminant validity (AVE = 0.38–0.93, CR = 0.82–0.98). The scale showed high internal consistency (Cronbach’s α = 0.96), with Cronbach’s α coefficients for each dimension ranging from 0.86 to 0.98. The test-retest reliability across dimensions after two weeks ranged from 0.82 to 0.90. Conclusions We developed and validated a novel scale for assessing QoL in PeVD women. This tool can comprehensively capture the effects of PeVD on women's health status, facilitating optimized diagnosis, treatment, and nursing strategies to improvetheir quality of life. Multicenter studies with larger, more diverse cohorts are needed to confirm the generalizability of the tool and establish minimal clinically important differences.

Introduction: Solid evidence generated from large studies supporting the recommendation of Shexiang Baoxin Pill (MUSKARDIA) as a promising treatment for angina and nonobstructive coronary arteries (ANOCA) populations is lacking. Objective: To evaluate the efficacy and safety of MUSKARDIA in patients with ANOCA. Methods: In this randomized, double-blind, placebo-controlled, phase IV trial, we enrolled 239 patients with ANOCA at 11 centers across China between May 2021 and July 2023. Patients were randomly assigned in a 1:1 ratio to receive MUSKARDIA or placebo (orally 4 pills thrice daily) based on conventional treatment for 12 weeks. The primary endpoint was the change in angina-related outcomes, assessed using the Seattle Angina Questionnaire (SAQ) scores for the treatment groups at week 12. Results: Among 239 randomized patients with ANOCA, 236 (MUSKARDIA group, n = 117; placebo group, n = 119) completed treatment and endpoint assessments. At week 12, patients in the MUSKARDIA group showed better angina-related outcomes, with a more rapid increase in SAQ scores, than those in the placebo group (all p < 0.0001). Statistically significant differences favoring MUSKARDIA over placebo were observed for change in angina attack frequency compared with baseline at week 12 (p < 0.0001). Meanwhile, according to the Canadian Cardiovascular Society grading of angina, the change in angina pectoris severity, compared with baseline, was significantly reduced in MUSKARDIA group compared with placebo group at week 12 (p < 0.0001). The percentage of patients who did not use sublingual nitroglycerin was noticeably higher in MUSKARDIA group than that in placebo group (84.16 % vs. 58.33 %; p < 0.001). The incidence of adverse events did not differ significantly between the two groups, and no serious adverse events occurred. Conclusion: This randomized, placebo-controlled clinical trial firstly confirmed that MUSKARDIA was an effective, safe, and well-tolerated treatment for patients with ANOCA in clinical settings.

Introduction: The community-based management of type 2 diabetes in China remains suboptimal. Incorporating family support presents a promising approach to enhancing facilitators and addressing barriers to effective diabetes self-management, particularly in the Chinese context where familial relationships and collective family responsibility play a central role in health-related decision-making and daily life. We aimed to validate a family support-based self-management behavioral intervention program, Systematic evaluation, core education, self-directed planning, triple feedback, and develop a habit program (SeCe-STRIVE). The program comprises 5 modules: systematic evaluation, core education, self-directed planning, triple feedback, and habit development. Research Design and Methods: We conducted a community-based, single-center, parallel randomized controlled trial in the Xietu community of Xuhui District, Shanghai. Eligible patients were randomly assigned to either the intervention or control group. Participants in the intervention group received the SeCe-STRIVE health management program based on family support, while those in the control group received the community-based follow-up management program for type 2 diabetes. The primary outcome measured was the total self-management behavior score and its changes across various dimensions from baseline. Secondary outcomes included family support, family function, diabetes knowledge, quality of life, self-efficacy, and biochemical markers. Post-intervention changes in both primary and secondary outcomes relative to baseline were analyzed using analysis of covariance. Results: The study ultimately included 113 participants in the intervention group and 112 in the control group. The intervention group's total self-management behavior score improved by 12.74 (95% CI = 10.07, 15.40, P < .001) points more than the control group. Across all dimensions of self-management behaviors, the intervention group showed greater improvement, including diet, exercise, blood glucose monitoring, foot care, and medication adherence. Participants with low family support exhibited greater improvements in self-management behaviors compared to those with high family support. The intervention group demonstrated significant improvements in family support, family function, diabetes knowledge, and self-efficacy. Although quality of life and biochemical indicators of glycated hemoglobin, fasting blood glucose, and blood lipids showed a decreasing trend, the differences were not statistically significant. Conclusions: Compared to the control group, patients with type 2 diabetes who received the SeCe-STRIVE program intervention showed significant improvements in self-management behaviors, accompanied by enhancements in family support, family functioning, and self-efficacy. Further large-scale, multi-center trials with longer follow-up periods are needed to confirm these results. Trial Registration: ChiCTR, ChiCTR2200060416. Registered 01 June 2022, https://www.chictr.org.cn/showproj.html?proj=167086

Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (EMZL) is an indolent B-cell lymphoma that can involve various anatomic sites. EMZL is derived from post-germinal center marginal zone B cells and typically lacks bcl-6 expression. Herein, we report two post-treatment cases of EMZL where unexpected bcl-6 protein expression was observed in specimens obtained following recurrence or progression. This contrasts with the primary specimens, which were negative for the bcl-6. Additionally, we confirm that the altered bcl6 expression observed in relapsed EMZL cases is independent of BCL6 gene rearrangement, as demonstrated by fluorescence in situ hybridization analysis. Relevant literature was reviewed and summarized to enhance the understanding of this phenomenon, particularly for pathologists.

BACKGROUND:The burden of type 2 diabetes mellitus (T2DM) in China continues to escalate. OBJECTIVE:To investigate the impact of family support system on the self-management behaviour of patients with T2DM. METHODS:In this cross-sectional study, 1,042 participants were sampled using a multistage stratified probability-proportionate-to-size method. On-site interviews were conducted using a structured questionnaire administered by 122 family doctors from 13 community health service centres in 8 administrative districts. A structural equation model was established to investigate the impact of individual factors and family support system on the self-management behaviour of T2DM patients. Statistical analysis was performed using the SPSS 25.0 software. RESULTS:The self-management behaviour pass rate among individuals with T2DM was 40.9%. In terms of individual factors, those with a high school education level or above demonstrated higher self-management behaviour scores than those with a junior high school education level or lower. The structural equation model revealed a path of interactions among individual factors, family support system-related factors, and the self-management behaviour of patients with T2DM: Family function → Family support → Patients' self-management behaviour → Quality of life. The coefficient of the direct path from family function to family support was 0.74 (P < 0.001), while the coefficient of the direct path from family support to self-management behaviour was 0.68 (P = 0.001). CONCLUSION:There is significant room for improvement in the self-management behaviour of T2DM patients in China. Family function can enhance the self-management behaviour of T2DM patients by promoting family support.

Purpose To assess the feasibility and outcomes of selective inguinal lymph node dissection (ILND) in stage III vulvar squamous cancer. Methods This study was approved by the Committee of Fudan University Shanghai Cancer Center. Ninety-one patients with stage III vulvar squamous cancer between 3/2018 and 3/2021 were included in this study. Thirty-one patients chose radical excision with selective ILND while 60 patients received radical excision with complete ILND voluntarily. After surgery, all the patients received postoperative external beam radiotherapy (EBRT). All the patients were invited to fill out two questionnaires: the EORTC QLQ-C30 and a vulvar specific questionnaire. Results The median follow-up time was 34 (16-50) months. There was no statistical difference in recurrence (p＞0.05) or overall survival (p＞0.05) in the two groups. Moreover, no difference in overall quality of life was observed between the two groups. The major difference was the increase in complaints of edema and body image after complete ILND. Conclusions Patients who underwent selective ILND reported less treatment related morbidity without affecting survival and overall quality of life compared to those who underwent complete ILND. Selective ILND may be a reasonable alternative for stage III vulvar squamous cancer in the future.

OBJECTIVE:To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting.DESIGN:Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial.SETTING:Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019 to June 2021.PARTICIPANTS:500 patients aged 18-80 years (including 91 (18.2%) women) who had elective coronary artery bypass grafting surgery and completed the DACAB trial.INTERVENTIONS:Patients were randomised 1:1:1 to ticagrelor 90 mg twice daily plus aspirin 100 mg once daily (dual antiplatelet therapy; n=168), ticagrelor monotherapy 90 mg twice daily (n=166), or aspirin monotherapy 100 mg once daily (n=166) for one year after surgery. After the first year, antiplatelet therapy was prescribed according to standard of care by treating physicians.MAIN OUTCOME MEASURES:The primary outcome was major adverse cardiovascular events (a composite of all cause death, myocardial infarction, stroke, and coronary revascularisation), analysed using the intention-to-treat principle. Time-to-event analysis was used to compare the risk between treatment groups. Multiple post hoc sensitivity analyses examined the robustness of the findings.RESULTS:Follow-up at five years for major adverse cardiovascular events was completed for 477 (95.4%) of 500 patients; 148 patients had major adverse cardiovascular events, including 39 in the dual antiplatelet therapy group, 54 in the ticagrelor monotherapy group, and 55 in the aspirin monotherapy group. Risk of major adverse cardiovascular events at five years was significantly lower with dual antiplatelet therapy versus aspirin monotherapy (22.6% v 29.9%; hazard ratio 0.65, 95% confidence interval 0.43 to 0.99; P=0.04) and versus ticagrelor monotherapy (22.6% v 32.9%; 0.66, 0.44 to 1.00; P=0.05). Results were consistent in all sensitivity analyses.CONCLUSIONS:Treatment with ticagrelor dual antiplatelet therapy for one year after surgery reduced the risk of major adverse cardiovascular events at five years after coronary artery bypass grafting compared with aspirin monotherapy or ticagrelor monotherapy.TRIAL REGISTRATION:NCT03987373ClinicalTrials.gov NCT03987373.

Background: Parkinson's disease (PD) patients suffer from progressive gray matter volume (GMV) loss, but whether distinct patterns of atrophy progression exist within PD are still unclear. Objective This study aims to identify PD subtypes with different rates of GMV loss and assess their association with clinical progression. Methods: This study included 107 PD patients (mean age: 60.06 +/- 9.98 years, 70.09% male) with baseline and >= 3-year follow-up structural MRI scans. A linear mixed-effects model was employed to assess the rates of regional GMV loss. Hierarchical cluster analysis was conducted to explore potential subtypes based on individual rates of GMV loss. Clinical score changes were then compared across these subtypes. Results: Two PD subtypes were identified based on brain atrophy rates. Subtype 1 (n = 63) showed moderate atrophy, notably in the prefrontal and lateral temporal lobes, while Subtype 2 (n = 44) had faster atrophy across the brain, particularly in the lateral temporal region. Furthermore, subtype 2 exhibited faster deterioration in non-motor (MDS-UPDRS-Part I, beta = 1.26 +/- 0.18, P = 0.016) and motor (MDS-UPDRS-Part II, beta = 1.34 +/- 0.20, P = 0.017) symptoms, autonomic dysfunction (SCOPA-AUT, beta = 1.15 +/- 0.22, P = 0.043), memory (HVLT-Retention, beta = -0.02 +/- 0.01, P = 0.016) and depression (GDS, beta = 0.26 +/- 0.083, P = 0.019) compared to subtype 1. Conclusion: The study has identified two PD subtypes with distinct patterns of atrophy progression and clinical progression, which may have implications for developing personalized treatment strategies.

Background Little is known about the long-term courses of loneliness, associated risk factors and effect on mental health in adolescents during the COVID-19 pandemic. This study aimed to explore the trajectories of loneliness among Chinese adolescents during the last phase of the pandemic. We also aimed to identify risk factors in each loneliness course and the impact of loneliness on emotional problems, peer problems, hyperactivity and conduct problems. Methods We conducted longitudinal analyses using four waves of data from 2347 Chinese adolescents covering a period of 20 months (October 2021 – May 2023). Loneliness was assessed using the UCLA 3-Item Loneliness Scale. The self-reported version of the Strengths and Difficulties Questionnaire was utilized to evaluate participants’ mental health outcomes. Growth mixture modelling was employed to identify latent classes of loneliness trajectories. Associated risk factors were investigated using multinomial logistic regression model. Mixed-effects logistic regression models were constructed to examine the long-term impact of loneliness classes on mental health outcomes. Results Three courses of loneliness were identified: Decreasing Low Loneliness (58.71%), Increasing Medium Loneliness (36.52%), and Increasing High Loneliness (4.77%). Risk factors for poorer loneliness trajectories included lack of physical exercise habits, poorer mental health literacy, medium or low perceived social support, having study difficulties, being female, higher grades, and lower economic status. Loneliness courses were associated with the severity and variability of emotional problems, peer problems, hyperactivity and conduct problems. Individuals in the higher loneliness classes experienced a significant increase in these mental health problems over time. Conclusions During the last phase of the pandemic, a large proportion of adolescents in our study endured medium to high levels of loneliness with no signs of improvement. Both unfavorable loneliness trajectories adversely affected internalizing and externalizing problems and displayed an upward trend in these difficulties. Results highlight the importance of considering how to tackle loneliness both within the context of COVID-19 and more generally.

Increasing evidence suggests that Parkinson’s disease (PD) exhibits disparate spatial and temporal patterns of progression. Here we used a machine-learning technique—Subtype and Stage Inference (SuStaIn) — to uncover PD subtypes with distinct trajectories of clinical and neurodegeneration events. We enrolled 228 PD patients and 119 healthy controls with comprehensive assessments of olfactory, autonomic, cognitive, sleep, and emotional function. The integrity of substantia nigra (SN), locus coeruleus (LC), amygdala, hippocampus, entorhinal cortex, and basal forebrain were assessed using diffusion and neuromelanin-sensitive MRI. SuStaIn model with above clinical and neuroimaging variables as input was conducted to identify PD subtypes. An independent dataset consisting of 153 PD patients and 67 healthy controls was utilized to validate our findings. We identified two distinct PD subtypes: subtype 1 with rapid eye movement sleep behavior disorder (RBD), autonomic dysfunction, and degeneration of the SN and LC as early manifestations, and cognitive impairment and limbic degeneration as advanced manifestations, while subtype 2 with hyposmia, cognitive impairment, and limbic degeneration as early manifestations, followed later by RBD and degeneration of the LC in advanced disease. Similar subtypes were shown in the validation dataset. Moreover, we found that subtype 1 had weaker levodopa response, more GBA mutations, and poorer prognosis than subtype 2. These findings provide new insights into the underlying disease biology and might be useful for personalized treatment for patients based on their subtype.

BACKGROUND:Noninvasive energy-based device (NI-EBD) aesthetic procedures has recently gained widespread usage for treating various skin conditions, enhancing skin texture and performing rejuvenation-related procedures. However, practically all NI-EBD procedures result in variable degrees of damage to the skin barrier, inducing pathological and physiological processes such as oxidative stress and inflammation, and only a small percentage of individuals possess the innate ability to restore it. OBJECTIVE:To introduce the concept of integrated skincare and establish standardized operational procedures for perioperative integrated skincare, and furnish a theoretical basis for clinical diagnosis and treatment performed by professional medical aestheticians. METHODS:The author leveraged domestic and international guidelines, clinical practice expertise and evidence-based research, adapting them to suit the specific circumstances in China. RESULTS:The consensus were provided four parts, including concept and essence of integrated skincare, integrated skincare significance during the perioperative phase of NI-EBD procedures, active ingredients and functions of effective skincare products, standardized perioperative skincare procedure for NI-EBD procedures and precautions. For the standardized perioperative skincare procedure, four recommendations were listed according to different stages during NI-EBD procedures. CONCLUSION:These recommendations create the 'Expert Consensus on Perioperative Integrated Skincare for Noninvasive Energy-Based Device Aesthetic Procedures in Clinical Practice in China'.

Premature ovarian insufficiency (POI) refers to the decline of ovarian function before the age of 40. POI causes a reduction in or loss of female fertility, accompanied by different degrees of menopausal symptoms, which increases the risk of chronic diseases related to early menopause and seriously affects patients' quality of life and health. It is conservatively estimated that at least one million prepubertal girls and women of reproductive age in China are at risk of iatrogenic POI caused by radiotherapy and chemotherapy every year. With the development of medical technology and the breakthrough of scientific and technological advances, preventing and treating iatrogenic POI have become possible. International and national guidelines consider cryopreserved ovarian tissue transplantation to be the most promising method of preserving the ovarian function and fertility of prepubertal girls and women of reproductive age who cannot delay radiotherapy and chemotherapy. In order to guide the clinical application of ovarian tissue cryopreservation and transplantation technology in China, the Guideline Working Group finally included 14 scientific questions and 18 recommendations through a questionnaire survey, field investigation, and consultation of a large number of Chinese and English literature databases in order to provide a reference for colleagues in clinical practice.

PurposeThe objective was to evaluate the influence of low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) [Lp(a)] on clinical outcomes in patients undergoing coronary artery bypass grafting (CABG).MethodsThis is a secondary analysis of a 5-year follow-up of the DACAB trial (NCT02201771), in which 500 patients who underwent primary isolated CABG were randomized to three-antiplatelet therapy for 1 year after surgery. Of them, 459 patients were recruited in this secondary analysis. Baseline LDL-C and Lp(a) levels were collected, and repeated measurement of LDL-C levels during the follow-up were recorded. Cut-off values for LDL-C were set at 1.8 and 2.6 mmol/L; thus, the patients were stratified into LDL-C <1.8, 1.8–<2.6, and ≥2.6 mmol/L subgroups. Cut-off value for Lp(a) was 30 mg/dL; thus, the patients were divided into Lp(a) <30 and ≥30 mg/dL subgroups. The primary outcome was 4-point major adverse cardiovascular events (MACE-4), a composite of all-cause death, myocardial infarction, stroke, and repeated revascularization. Median follow-up time was 5.2 (interquartile range, 4.2–6.1) years.ResultsDuring the follow-up, 129 (28.1%) patients achieved the attainment of LDL-C <1.8 mmol/L, 186 (40.5%) achieved LDL-C 1.8–<2.6 mmol/L, and 144 (31.4%) remained LDL-C ≥2.6 mmol/L. Compared with the postoperative LDL-C <1.8 mmol/L group, the risk of MACE-4 was significantly higher in the LDL-C 1.8–<2.6 mmol/L group [adjusted hazard ratio (aHR) = 1.92, 95% CI, 1.12–3.29; P = 0.019] and LDL-C ≥2.6 mmol/L group (aHR = 3.90, 95% CI, 2.29–6.64; P < 0.001). Baseline Lp(a) ≥30 mg/dL was identified in 131 (28.5%) patients and was associated with an increased risk of MACE-4 (aHR = 1.52, 95% CI, 1.06–2.18; P = 0.022).ConclusionsFor CABG patients, exposure to increased levels of postoperative LDL-C or baseline Lp(a) was associated with worse mid-term clinical outcomes. Our findings suggested the necessity of achieving LDL-C target and potential benefit of adding Lp(a) targeted lipid-lowering therapy in CABG population.

Few-shot semantic segmentation (FSS) has been widely used in the field of information medicine and intelligent diagnosis. Due to the high cost of medical data collection and the privacy protection of patients, labeled medical images are difficult to obtain. Compared with other semantic segmentation dataset which can be automatically generated in a large scale, the medical image data tend to be continually generated. Most of the existing FSS techniques require abundant annotated semantic classes for pre-training and cannot deal with its dynamic nature of medical data stream. To deal with this issue, we propose a dynamic few-shot learning framework for medical semantic segmentation, which can fully utilize the features of newly-collected/generated data stream. We introduce a new pseudo-label generation strategy for continuously generating pseudo-labels and avoiding model collapse during self-training. Furthermore, an efficient consistency regularization strategy is proposed to fully utilize the limited data. The proposed framework is iteratively trained on three tasks: abdominal organ segmentation for CT and MRI, and cardiac segmentation for MRI. Experiments results demonstrate significant performance gain on medical data stream mining compared with the baseline method.

Abstract Introduction With regard to the esthetics and comfort of orthodontic treatment, the requirement for removable clear aligners (CAs) is increasing. Unlike conventional fixed orthodontic appliances, CAs were made of thermoplastic film by thermoforming on the personalized dental models. The construction of orthodontic thermoplastic is a critical factor for orthodontic tooth movement (OTM). Polyethylene terephthalate glycol-modified (PETG) and thermoplastic polyurethane (TPU) are the most commonly orthodontic thermoplastics; however, the evidence of the differences between different orthodontic thermoplastic are limited to vitro environment and the evidence in vivo environment is not available. Therefore, this trial aims to provide reliable evidence for orthodontists’ personalized treatment plans whether the two most commonly used orthodontic thermoplastics of PETG and TPU have differences in the efficiency of OTM. Methods and analysis This randomized controlled clinical study will recruit 44 orthodontic patients for orthodontic treatment. All the subjects will be randomized into two groups (PETG and TPU, n = 22 for each group). In the first stage (M0 to M1), clear aligners will be made of two orthodontic thermoplastics and move the maxillary first or second premolars 2 mm. In the second stage, patients will take the standard orthodontic treatments. The primary outcome will be the efficiency of clear aligners made of different materials on the digital models. The secondary outcome will be the efficiency of clear aligners made of different materials on the cone-beam computed tomography (CBCT). The efficiency will be calculated through the superimposition of the digital models and CBCT. Discussion The results from this trial will serve as evidence for orthodontists and manufacturers and clarify whether the difference in orthodontic thermoplastics significantly impacts the efficiency of OTM. Trial registration number ChiCTR2300070980. Registered on 27 April 2023. https://www.chictr.org.cn/showproj.html?proj=186253

Introduction Compensatory mouth breathing, caused by nasopharyngeal obstructive diseases, is the main cause of hyperdivergent mandibular retrognathia in children. Such deformities require effective growth guidance before pubertal growth peaks. The traditional mandibular advancement device, twin block (TB), can guide the forward development of the mandible. However, the side effect of increasing the vertical dimension of the lower facial third, worsens the facial profile of children with divergent growth trends. To solve this problem, a modified TB (LLTB) appliance was designed to control the vertical dimension by intruding incisors and inhibiting the elongation of posterior teeth during the advancement of the mandible, which could avoid the side effects of traditional appliances and effectively guide the growth of the mandible in a normal direction.Methods and analysis The study was designed as a single-centre, single-blind, randomised, parallel controlled trial. We aim to enrol 60 children aged 9–14 years with hyperdivergent skeletal class II malocclusion, using a 1:1 allocation ratio. The participants were will be randomly assigned to receive either the TB or LLTB treatment. The primary outcome will be a change in the angle of the mandibular plane relative to the anterior cranial base. The secondary outcomes will include changes in the sagittal maxillomandibular relation, occlusal plane, facial height, morphology of the mandible and upper airway width. Safety endpoints will also be evaluated.Ethics and dissemination Ethical approval was obtained from the ethics committee of Shanghai Stomatological Hospital. Both participants and their guardians will be fully informed of the study and sign an informed consent form before participating in the trial. The results will be publicly available in peer-reviewed scientific journals.Trial registration number ChiCTR2000035882.

Background: We conducted this randomized controlled trial (RCT) to evaluate the effectiveness and safety of moxibustion at Sanyinjiao (SP6) acupoint for treatment of negative mood and sleep quality in healthcare workers during the 2019 coronavirus disease (COVID-19).Methods: A total of 180 participants were divided in a 1:1 ratio into two groups, the treatment group (for moxibustion) and the control group (for no treatment). The treatment group had a 30-minute moxibustion therapy once a day for two weeks, followed by a two-week follow-up. The Hamilton Anxiety Scale (HAMA) was used to assess the degree of the participants' anxiety, and the Patient Health Questionnaire-9 (PHQ-9) was utilized to examine their depressed condition. The Maslach Burnout Inventory-General Survey (MBI-GS) was used to measure the level of burnout among healthcare workers. To determine the severity of insomnia, the Sleep Dysfunction Rating Scale (SDRS) was utilized. At baseline, week 2, and week 4, all scales were evaluated.Results: Compared to the control group, the treatment group improved more significantly in the HAMA at week 2 (MD =-19.01, 95% CI:-21.89 to-16.14; P < 0.001) and at week 4 follow-up visits (MD =-8.96, 95% CI: -11.19 to-6.73; P < 0.001). A subgroup study of HAMA scores revealed that position and education had significant impact on treatment effectiveness. During the 2-week intervention period, the treatment group showed more significant improvements in depressive symptoms measured by PHQ-9 (13.00 +/- 2.41 vs. 15.60 +/- 3.65; P < 0.001), work burnout symptoms measured by MBI-GS (MD =-11.88, 95% CI,-15.73 to-8.03; P < 0.001), and insomnia symptoms measured by SDRS (MD =-2.45, 95% CI,-4.24 to-0.66; P < 0.01). There were no significant adverse effects reported.Conclusion: Moxibustion at SP6 may be an effective treatment to improve anxiety, depression, sleep quality, and quality of life for healthcare workers during COVID-19.

Purpose To investigate the association of subjects with refractive error and diabetic retinopathy (DR) in the United States comparing results between different race groups. Methods All data were derived from National Health and Nutrition Examination Survey (NHANES) from 2005 to 2008. The data were divided into four groups (emmetropia, mild myopia, high myopia, hypertropia) according to the spherical equivalent (SE), and those who met the enrollment conditions were selected as the study subjects. Multivariable logistic regression analysis was used to evaluate the relationship between refractive error and diabetic retinopathy risk. Results A total of 1317 participants were included in the study, including 331 participants with diabetic retinopathy, and 986 without diabetic retinopathy. After adjustment for potential confounders, subjects with high myopia were associated with a lower risk of diabetic retinopathy. The odds ratio (OR) was 0.44, 95% confidence interval (CI): (0.20–0.96), P -value = 0.040 in the multivariate regression analysis. Subgroup analyses showed that subjects with high myopia in the non-Hispanic Black group were associated with decreased odds of diabetic retinopathy. (OR was 0.20, and 95% CI: 0.04–0.95, P -value = 0.042). Conclusion The results show that high myopia is associated with diabetic retinopathy in diabetic patients.