Zhuzhou Central Hospital

ObjectiveTo evaluate the safety and effectiveness of lurasidone in Chinese patients with schizophrenia in a 12-week post-marketing study.MethodsThis 12-week, multicenter, prospective, open-label, single-arm study included schizophrenia patients from 36 sites in Mainland China, who initiated lurasidone between September 2019 and December 2023. Adverse events (AEs) and adverse drug reactions (ADRs) were primary safety endpoints. Other safety assessments included extrapyramidal symptoms (EPS) and weight gain. Effectiveness was evaluated using the Brief Psychiatric Rating Scale (BPRS) at baseline and week 12. Patients were also stratified to assess differences across ages.ResultsA total of 3170 patients were included in the Full Analysis Set (FAS) and 3178 in the Safety Set (SS). The mean daily lurasidone dose was 59.9±20.93 mg. ADRs occurred in 7.9% of patients, with incidences of 8.1%, 8.9%, 5.9%, and 2.3% in the <18, 18–45, 45–65, and >65-year age groups, respectively. EPS was the most common ADR (3.2%), typically emerging in weeks 3–4. Metabolic-related AEs occurred in 4.3% and 2.2% of patients with and without metabolic affecting agents. BPRS scores significantly improved at weeks 2/4, 6/8, and 12 compared with baseline (all P < 0.05): total score (−8.9 ± 9.62, −14.0 ± 12.16, −17.5 ± 13.61), anxiety-depression (−1.5 ± 2.37, −2.5 ± 2.88, −3.3 ± 3.31), anergia (−1.5 ± 2.34, −2.4 ± 2.83, −3.1 ± 3.11), thought disturbance (−2.4 ± 2.98, −3.8 ± 3.72, −4.7 ± 4.07), activation (−1.2 ± 1.97, −1.7 ± 2.38, −2.1 ± 2.63), and hostility-suspiciousness (−2.4 ± 2.81, −3.6 ± 3.44, −4.3 ± 3.76). In <18 years group, BPRS total score also significantly decreased from 46.1±15.10 at baseline to 26.3±9.72 at week 12.ConclusionThis real-world study demonstrated a favorable safety profile and significant clinical effectiveness of lurasidone in both adult and adolescent population with schizophrenia in China in real-world clinical settings, supporting its use across diverse patient populations.Trial RegistrationShanghai Clinical Research Center for Mental Health (SCRC-MH) NCT04432688. URL: www.smhc.org.cn/.

Purpose This study aims to enhance the sealing efficiency and prolong the service life of concrete sealing bodies by optimizing the lip cross-section geometry, which plays an important role in contact pressure distribution and stress evolution during operation. Design/methodology/approach A finite element model of the concrete pumping process was established based on an initial single-cone-angle lip design. To improve sealing performance, a double-cone-angle lip cross-section was proposed and optimized with respect to three design parameters: interference amount, first cone angle and its length. A multi-objective evaluation framework integrating sealing performance, frictional heat generation, stress level and operational stability was developed. Finite element simulations combined with design of experiments were used to construct surrogate models, and the optimal model (BP neural network) was coupled with a genetic algorithm to obtain the optimal design. Findings The optimized sealing body significantly improved all performance indices: the comprehensive performance index increased by 0.2179, the frictional heat generation index by 0.5889, the stress index by 0.2586 and the operational stability index by 0.2288. These improvements were achieved while maintaining sufficient sealing integrity. Originality/value This work introduces a design optimization framework for rubber sealing components used in concrete pumps, integrating finite element analysis with surrogate modeling and evolutionary algorithms. The proposed biconical lip design not only enhances contact pressure uniformity but also reduces internal stress and thermal load, providing valuable insights into the structural optimization of dynamic sealing systems. Peer review The peer review history for this article is available at: https://publons.com/publon/10.1108/ILT-07-2025-0328/

To quantify temporal trends in chronic kidney disease (CKD) burden attributable to adverse metabolic risk factors among Chinese adults aged≥20years during 1990-2019. We used Global Burden of Disease Study 2019 (GBD 2019) estimates for China to assess five CKD causes (CKD due to type 1 diabetes, type 2 diabetes, hypertension, glomerulonephritis, and other/unspecified causes) and three metabolic risks (high systolic blood pressure (SBP), high body mass index (BMI), and high fasting plasma glucose (HFPG)). Outcomes were deaths and disability-adjusted life years (DALYs) (numbers and rates per 100,000), stratified by sex and 13 age groups. Joinpoint regression was used to estimate annual percent change (APC) and average annual percent change (AAPC) in rates from 1990 to 2019. In 2019, the mortality rate for CKD attributable to these metabolic risks was 6.87 per 100,000, and total attributable DALYs were 4201 (thousand). Hypertensive nephropathy had the largest attributable burden (mortality 2.5/100,000; DALY rate 59.2/100,000), followed by CKD due to type 2 diabetes. From 1990 to 2019, the overall attributable CKD mortality rate increased (AAPC=0.55%) while the DALY rate decreased slightly (AAPC=-0.27%). High SBP remained the leading contributor to attributable burden in 2019, whereas high BMI showed the fastest increase in attributable mortality burden over time. Attributable burden increased steeply with age and was higher in males than in females. High SBP remains a major driver of CKD burden in China, but the rapidly rising high-BMI-attributable burden highlights the need for integrated prevention focused on blood pressure control and obesity prevention, particularly among older adults and men.

Adding daratumumab to initial therapy in randomized controlled trials (RCTs) for newly diagnosed multiple myeloma (MM) enhances deep remission and prolongs progression-free survival (PFS). Given the differences between trial-eligible and real-world patients, and healthcare access variability in developing countries, real-world data are essential to complement RCT evidence. We analyzed 761 newly diagnosed MM patients treated with (n = 177) or without (n = 584) daratumumab as first-line therapy from 2017 to 2023 across southern China. Propensity score matching (PSM) generated cohorts of 158 and 278 patients, respectively, matched for stage, cytogenetic abnormalities, and regimen type. Responses were evaluated per International Myeloma Working Group criteria, and measurable residual disease (MRD) was assessed via next-generation multiparameter flow cytometry. The daratumumab group demonstrated significantly higher rates of ≥ very good partial response (85.0% vs. 61.3%; P < 0.001) and MRD negativity (73.0% vs. 51.9%; P = 0.024) at the end of induction. Additionally, 3-year PFS (75.6% vs. 55.0%, hazard ratio [HR] 0.49, 95% confidence interval [95% CI] 0.36-0.66, P < 0.001) and overall survival (OS) rates (78.3% vs. 74.4%; HR 0.56 [95% CI 0.36-0.86], P = 0.008) were superior in the daratumumab group, and these results remained consistent after PSM. Daratumumab improved PFS in patients with gain/amp(1q21) but not in those with del17p or t(4;14). Survival benefit was also observed in the addition of daratumumab to bortezomib/lenalidomide/dexamethasone combined treatment subgroup. In real-world settings, daratumumab-based first-line therapy improved the depth of response, PFS, and OS, though not all patients benefited.

Approximately 85-90% patients with small for gestational age (SGA) experience catch-up growth (CUG) by the age of 2, with their height reaching - 2 standard deviation scores (SDS) or 3% of the height of children of the same age and sex. However, SGA patients with CUG (CUG-SGA) tend to be at a higher risk of developing insulin resistance, obesity, metabolic syndrome, and cardiovascular diseases. This study explored the metabolic conditions of CUG-SGA patients in East China and analyzes the risk factors that may contribute to metabolic issues. This multi-center study in East China involved 151 SGA patients aged 2-8 years. Patients were categorized into two groups: CUG-SGA (height not below - 2 SDS among the children of the same age and gender) and NCUG-SGA (SGA patients without CUG, height below - 2 SDS among the children of the same age and gender). Tests for insulin-like growth factor 1 (IGF-1), blood glucose (BG), insulin (INS), triglycerides (TG), total cholesterol (TC), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), and leptin (LEP) were conducted after a 12-hour fast. Body mass index (BMI) and homeostatic model assessment for insulin resistance (HOMA-IR) were calculated. (1) Out of 151 SGA patients, 82 were girls and 69 were boys. There were 85 patients in CUG-SGA group, including 38 girls and 47 boys. There were 66 patients in NCUG-SGA group, including 44 girls and 22 boys. The height SDS (H-SDS) and weight SDS (W-SDS) of CUG-SGA group were significantly higher than those of NCUG-SGA group (P < 0.05). (2) The level of IGF-1 SDS, ALT, and GGT in the CUG-SGA group were significantly higher than those in the NCUG-SGA group (P < 0.01). The level of W-SDS, LEP, INS, and HOMA-IR in the CUG-SGA group are significantly higher than those of the NCUG-SGA group (P < 0.05). (3) Correlation analysis in SGA patients indicated positive correlations between BG and W-SDS, LEP, and GGT (P < 0.05). INS was positively correlated with IGF-1 SDS, GGT (P < 0.01), and W-SDS (P < 0.05). HOMA-IR was positively correlated with IGF-1 SDS (P < 0.01). TC was positively correlated with LEP (P < 0.05), and TG was negatively correlated with IGF-1 SDS (P < 0.01). (4) After further controlling for confounding factors and performing multiple regression analyses, the results showed that BMI-SDS had a significant positive effect on INS and a significant negative effect on HOMA-IR. IGF-1 had a significant positive effect on INS and HOMA-IR, and a significant negative effect on TG. LEP had a significant positive effect on BG, INS, HOMA-IR, TC, and TG. ALT had a significant negative effect on INS and HOMA-IR, and a significant positive effect on TC and TG. GGT had a significant positive effect on BG, INS, HOMA-IR, TC, and TG. (1) IGF-1 SDS was significantly positively correlated with fasting INS (FINS) and HOMA-IR, and exerted a significant positive effect on fasting BG. If IGF-1 levels in CUG-SGA infants remain persistently high, careful monitoring of changes in glucose metabolism is warranted. (2) CUG-SGA patients had higher LEP resistance compared to NCUG-SGA patients, potentially contributing to future metabolic issues. (3) Elevated ALT and GGT levels in SGA patients may warrant close monitoring of glucose metabolism, particularly in CUG-SGA patients.

Spinal cord injury (SCI) results in rapid bone loss and osteoporosis development. This study investigated the synergistic effects of a combination of thymoquinone (TQ) and coenzyme Q10 (CoQ10) on SCI-induced osteoporosis. Thirty male Wistar rats underwent complete spinal cord transection at T10 and were divided into five groups: sham, untreated SCI, TQ-treated (100mg/kg/day), CoQ10-treated (10mg/kg/day), and combination therapy (TQ + CoQ10). After 21 days of treatment, combination therapy significantly improved BBB locomotor scores (12.1±0.7vs. 2.1±0.4 in untreated SCI; p < 0.001) and increased femoral BMD and BMC by 32.8% and 37.9%, respectively. Micro-CT analysis revealed 45.2% higher bone volume/total volume ratio and enhanced trabecular architecture. The combination therapy significantly downregulated SOST expression (76.2% reduction) while upregulating periostin (184.7% increase). Osteoclast markers decreased (CTR: 57.3%, cathepsin K: 63.1%) while osteoblast markers increased (ALP: 143.8%, osterix: 127.4%). Oxidative stress markers improved substantially, with 47.3% lower MDA levels and 86.5% higher SOD activity. TQ + CoQ10 combination therapy produces both synergistic and additive effects that ameliorates SCI-induced osteoporosis in association with altered expression of Wnt/β-catenin signaling components, enhancing bone formation, and reducing oxidative stress, demonstrating superior therapeutic efficacy compared to monotherapies.

Sex, location, and visceral adipose tissue (VAT) influence the course of Crohn’s disease (CD). However, the combined impact of these factors has not been consistently or thoroughly considered in anti-tumour necrosis factor-α (anti-TNF-α) therapy. This study aims to investigate how sex, location, and VAT levels affect the efficacy of IFX treatment in CD patients. This retrospective multicenter study included 182 CD patients (120 males and 62 females) who received IFX therapy between January 2014 and January 2024. There was a statistically significant difference in remission rates between male visceral obesity group (M-VATH) and male non-visceral obesity group (M-VATL) at 6 months (p < 0.001) and 12 months (p < 0.001). Similar differences in remission rates were observed between the male colon-uninvolved visceral obesity group and the male colon-uninvolved non-visceral obesity group at 6 months (p < 0.001) and 12 months (p < 0.001). Additionally, serum TNF-α concentrations (p = 0.010)and IFX trough concentrations (p = 0.003) showed significant differences between M-VATH and M-VATL. The VAT area was identified as a predictor of IFX efficacy in male patients, with an area under the receiver operating characteristic curve of 0.813, sensitivity of 73.9%, and specificity of 78.1% (95% CI, 0.730–0.896). Sex and location influence the predictive function of VAT for IFX efficacy. VAT may be an accurate predictor of IFX efficacy in male colon-uninvolved CD patients.