Tag: pubmed

Invest New Drugs. 2025 Jan 30. doi: 10.1007/s10637-025-01506-x. Online ahead of print.

ABSTRACT

BACKGROUND: Immune checkpoint inhibitors (ICIs) combined with anti-vascular endothelial growth factor (VEGF) have been the standard first-line treatment of hepatocellular carcinoma (HCC). However, the efficacy of this combination in post-line treatment is still unknown. This study aimed to evaluate the efficacy and safety of the combination of anti-PD-L1 envafolimab and novel humanized anti-VEGF suvemcitug as second-line treatment for patients with HCC.

METHODS: This open-label, prospective phase II clinical study (NCT05148195) comprised safety run-in stage and dose expansion stage of HCC cohort. Eligible patients were aged ≥ 18 years and had undergone at least a prior line of treatment. Patients received fixed-dose envafolimab and suvemcitug until termination of disease progression, unacceptable toxicities, or withdrawal. The primary endpoint of safety run-in stage was recommended dose (RD), and dose expansion stage was objective response rate (ORR).

RESULTS: As of August 10, 2023, no dose-limiting toxicity was observed in six patients in the safety-run-in stage, and 2 mg/kg dose every 3 weeks was declared the RD of suvemcitug. Among 20 patients with HCC, the median age was 54.5 (range, 42-70) years. Of these patients, 20 (100.0%) received ≥ one prior line treatment, with 20 (100%) received tyrosine kinase inhibitor (TKI) treatment and 8 (40.0%) received prior ICI treatment. The ORR was 10.0% (95% confidence interval (CI), 1.2-31.7), DCR was 65.0% (95% CI, 40.8-84.6), and DoR was not reached (NR). With a median follow-up of 13.9 months, the median progression-free survival (PFS) and median overall survival (OS) were 4.3 months (95% CI, 1.4-8.1) and 10.7 months (95% CI, 6.0-not evaluable [NE]), respectively. Treatment-related adverse events (TRAEs) of grade ≥ 3 occurred in 40% patients, with proteinuria (20.0%, 4/20) being the most frequent. The ORR of no lung metastasis, prior first-line treatment and IO naïve treatment subgroup was 16.7%.

CONCLUSIONS: The combination of envafolimab and suvemcitug showed a tolerable safety profile and promising antitumor activity in HCC patients who failed later-line treatment.

PMID:39883265 | DOI:10.1007/s10637-025-01506-x

Lasers Med Sci. 2025 Jan 30;40(1):54. doi: 10.1007/s10103-025-04296-z.

ABSTRACT

To investigate the efficacy and safety of picosecond (PS) and nanosecond (NS) 1064-nm neodymium-doped yttrium aluminum garnet (Nd: YAG) laser in treating Café-au-lait macules (CALMs). We retrospectively analyzed the medical records of patients with CALMs, who were treated with PS or NS 1064-nm lasers from January 2020 to January 2022. The efficacy was determined based on the before and after pictures by two independent investigators. The incidence of adverse events and recurrence were explored after treatments. A total of 116 patients (83 in the PS group and 33 in the NS group) were recruited. For subjects in the PS group, after 1-9 sessions, the lesion clearance was poor in 15 patients (18.1%), fair in 29 (34.9%), good in 14 (16.9%), and excellent in 25 (30.1%). In the NS group, after 1-7 sessions, the lesion clearance was poor, fair, good, and excellent in 7 (21.2%), 8 (24.2%), 13 (39.4%), and 5 (15.2%) patients, respectively. There was no statistically significant difference in efficacy between the two lasers (p > 0.05). The incidence of complications (hyperpigmentation, hypopigmentation) in the PS group (16.9%) was numerically lower than in the NS group (24.2%) (p = 0.136). Among patients who responded well to the treatment, 10.3% of patients in the PS group experienced relapse, compared with 22.2% in the NS group (p = 0.926). The PS 1064-nm laser provided comparable efficacy and potentially fewer complications compared with the NS laser in treating CALMs.

PMID:39883241 | DOI:10.1007/s10103-025-04296-z

Parasitol Res. 2025 Jan 30;124(2):15. doi: 10.1007/s00436-024-08447-z.

ABSTRACT

Biting midges of genus Leptoconops Skuse 1889 are small blood-feeding insects recognized as highly irritating diurnal pests in certain regions around the globe. In Europe, their presence is poorly documented, except in France and Italy. Following reports of human discomfort in a tourist area of Menorca, Balearic Islands (Spain), a small-scale study was conducted to identify the biting species and assess their preferred biting sites using a human-landing assay along a habitat gradient in a coastal dune area. Leptoconops irritans (Noé, 1905) was identified based on morphological features and DNA barcoding. This species reached high densities (average rates of 3.3 landings/min), particularly near coastal dune vegetation. No statistically significant differences were found among the four main body sites for landings of L. irritans (F_3,6.023 = 1.80, p = 0.250): head (n = 91, 53.8%), lower extremities (n = 39, 23.1%), upper extremities (n = 37, 21.9%), and other covered areas (n = 2, 1.2%). Landing preferences varied among the three volunteers, and bites progressed differently. This study represents the second documented case of Leptoconops midges causing human discomfort in Spain. We hope this research will stimulate further interest in this understudied genus, which has been largely overlooked across much of Europe.

PMID:39883237 | DOI:10.1007/s00436-024-08447-z

J Mater Sci Mater Med. 2025 Jan 30;36(1):16. doi: 10.1007/s10856-024-06839-2.

ABSTRACT

The objective of this study is to fabricate and develop hydroxypropyl methylcellulose (HPMC) hydrogel (HG)-based composite bone cements with incorporation of hydroxyapatite (HA), beta-tricalcium phosphate (β-TCP), and with/without polymethylmethacrylate (PMMA) for vertebroplasty. For animal study, twenty female Wister rats (250-300 g, 12 weeks of age) were divided into four groups including a two non-ovariectomy (NOVX) groups and two ovariectomy (OVX)-induced osteoporosis groups. Two prepared biocomposites including HG/β-TCP/HA and HG/β-TCP/HA/PMMA were injected into the tibial defects of both OVX and NOVX rats for evaluating in vivo osteogenesis after 12 weeks. Micro-computed tomography and histological analysis using hematoxylin and eosin (H&E) and Masson’s trichrome stains of the two composite cements implanted into the tibial defects of OVX and NOVX rats revealed enhanced bone regeneration potential. However, no statistically significant differences were noted among the groups based on new bone formation, demonstrating that the injected composite cements showed similar osteogenesis effects in both OVX and NOVX rats. These findings suggest that the newly developed composite bone cement composed of HG, β-TCP, HA and/or PMMA may be a promising and professional tool for treating osteoporotic and non-osteoporotic vertebral fractures.

PMID:39883233 | DOI:10.1007/s10856-024-06839-2

Neurosurg Rev. 2025 Jan 30;48(1):107. doi: 10.1007/s10143-025-03259-w.

ABSTRACT

Pineal gland lesions pose a significant surgical challenge due to the deep-seated nature of the pineal gland, as well as the limited field of view, and the complex vascular anatomy. The mainstay of surgical treatment, when necessary, is always histopathological clarity and gross total resection (GTR). We evaluate the surgical outcomes for pineal gland lesions, shedding light on functional outcomes, histological findings, and surgical complications. We analyzed patients with pineal gland lesions who underwent surgical treatment in our institution between September 2013 and May 2022. Patient demographics, clinical symptoms, surgical approaches, resection extent, surgery-related complications, and histopathological diagnosis were studied. Pre- and postoperative functional outcomes were assessed using the modified Rankin Scale (mRS) and were compared using the Student´s t-test. 32 patients (13 males, 19 females) were included. The mean age was 39 years old. We adopted the infratentorial supracerebellar approach (ITSC) in a semi-sitting position. 2 of these patients received preoperatively an endoscopic third ventriculocisternostomy (ETV) combined with endoscopic biopsy. The mean operating time for the ITSC approach was 170 min, whereas 53 min for the ETV with endoscopic biopsy. The mean length of stay was 13 days. The most common histopathological diagnosis was pineal cysts (38%). Surgical mortality was 0%, and morbidity was 28%. GTR was possible in 72% of patients treated using the ITSC approach. There was a functional outcome improvement, with a statistical significance measured via the Student´s t-test (p = 0.047). The ITSC approach remains safe and feasible when performed by an experienced surgical team, yielding a histopathological diagnosis and improvement of functional status.

PMID:39883229 | DOI:10.1007/s10143-025-03259-w

Rheumatol Int. 2025 Jan 30;45(2):39. doi: 10.1007/s00296-025-05791-w.

ABSTRACT

This systematic review aims to summarise the association between skin disease and quality of life (QoL) in people with psoriatic arthritis (PsA) and identify areas for future research and management. This review was registered on PROSPERO (CRD42024500994). Databases were searched for articles in English published until 7th January 2025. All study types were included except editorials, conference abstracts and reviews. Data gathered included demographics, treatment, type and severity of skin disease and QoL. Data were analysed using descriptive statistics and summarised using vote-counting. 2338 articles were retrieved with 18 ultimately included (10 cross-sectional; 7 observational cohort; 1 randomised controlled trial). A pooled total of 16,960 patients with PsA were included, with 48.1% male and mean age of 47.6 years (SD 5.78). Tools for assessing psoriasis included the Psoriasis-Area-Severity-Index (PASI, n = 9), Body-Surface-Area (BSA, n = 7), with four using others, and several using a combination. PASI scores ranged from 2.6 (mild) to 9.88 (moderate); BSA was reported as ≥ 3%, 5-10%, or ≥ 10%. QoL was assessed using Dermatology-Life-Quality-Index (DLQI; n = 10); EuroQol-5 Dimension (EQ-5D; n = 3); 36-Item-Short-Form-Survey (SF-36; n = 3); and four studies used other measures. 13 studies reported an association between worse skin disease and poorer QoL in PsA. Three studies reported no association between severity of skin disease and quality of life, while two were undecided. This review highlights that there is an association between dermatological symptoms and QoL in PsA patients, even in milder disease, indicating the importance of multidiscplinary management to facilitate greater QoL and patient outcomes.

PMID:39883198 | DOI:10.1007/s00296-025-05791-w

J Oncol Pharm Pract. 2025 Jan 29:10781552251316184. doi: 10.1177/10781552251316184. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: Complex pharmacotherapy in cancer patients increases the likelihood of drug-drug interactions (DDIs). Pharmacists play a critical role in the identification and management of DDIs. The aim of present study was to evaluate the role of pharmacist in identifying antifungal drug interactions in cancer patients and providing relevant recommendations.

METHODOLOGY: A retrospective, cross-sectional study was conducted to identify antifungal drug interactions over the period of 5 years (2019-2023) among cancer patients. Electronic medical record of 384 hospitalized patients receiving systemic antifungal therapy were reviewed. Severity of interactions and risk classification were made using UptoDate^® Lexidrug^TM software. Pharmacists’ recommendations regarding DDIs were also documented. Descriptive statistics and logistic regression were applied to interpret results.

RESULTS: Antifungals were more frequently prescribed to adult patients (53.9%). Female cancer patients were significantly more likely to encounter DDIs than males (p < 0.003). Type of cancer and fungal infections were significantly associated with incidence of DDIs (p < 0.01; p = 0.000). Pharmacist identified DDIs in 53.9% antifungal prescriptions with 22.2% classified as major interactions. A substantial proportion of these interactions involved voriconazole (40.1%). Majority of pharmacist’s recommendations included dose optimization of voriconazole (10.4%), close monitoring of RFTs (8.9%) and withholding amphotericin (5.2%) during chemotherapy. All of the recommendations made by pharmacists were accepted by physicians (100%).

CONCLUSION: The findings indicate that pharmacists identified DDIs in 53.9% of prescriptions and all of their recommendations were accepted by physicians. This highlights the critical role of pharmacists in detecting potential interactions, ensuring medication safety, and minimizing adverse effects associated with complex pharmacotherapy.

PMID:39881425 | DOI:10.1177/10781552251316184

Radiat Oncol. 2025 Jan 29;20(1):15. doi: 10.1186/s13014-025-02589-9.

ABSTRACT

BACKGROUND: For radiotherapy of head and neck cancer (HNC) magnetic resonance imaging (MRI) plays a pivotal role due to its high soft tissue contrast. Moreover, it offers the potential to acquire functional information through diffusion weighted imaging (DWI) with the potential to personalize treatment. The aim of this study was to acquire repetitive DWI during the course of online adaptive radiotherapy on an 1.5 T MR-linear accelerator (MR-Linac) for HNC patients and to investigate temporal changes of apparent diffusion coefficient (ADC) values of the tumor and subvolume levels.

METHODS: 27 patients treated with curative RT on the 1.5 T MR-Linac with at least weekly DWI in treatment position were included into this prospective analysis and divided in four risk groups (HPV-status and localisation). Tumor and lymph node volumes (GTV-P/GTV-N) were delineated on b = 500 s/mm² images while ADC maps were calculated using b = 150/200 and 500 s/mm² images. Absolute and relative temporal changes of mean ADC values, tumor volumes and a high-risk subvolume (HRS) defined by low ADC tumor voxels (600 < ADC < 900 × 10^-6 mm²/s) were analyzed. Relative changes of mean ADC values, tumor volumes and HRS were statistically tested using Wilcoxon-signed-rank test.

RESULTS: Median pretreatment ADC value for all patients resulted in 1167 × 10^-6 mm²/s for GTV-P and 1002 × 10^-6 mm²/s for GTV-N while absolute pretreatment tumor volume yielded 9.1 cm³ for GTV-P and 6.0 cm³ for GTV-N, respectively. Pretreatment HRS volumes were 1.5 cm³ for GTV-P and 1.3 cm³ for GTV-P and GTV-N. Median ADC values increase during 35 fractions of RT was 49% for GTV-P and 24% for GTV-N during RT. Median tumor volume decrease was 68% and 52% for GTV-P and GTV-N with a median HRS decrease of 93% and 87%. Significant differences from 0 for mean ADC were observed starting from week 1, for tumor volumes from week 2 for GTV-P and week 1 for GTV-N and for HRS in week 1 for GTV-P and week 2 for GTV-N.

CONCLUSION: Longitudinal DWI acquisition in HNC is feasible on a MR-Linac during the course of online adaptive MR-guided radiotherapy. Changes in ADC and volumes can be assessed, but future work needs to explore the potential for biologically guided treatment individualization.

TRIAL REGISTRATION: NCT04172753, actual study start: 09.05.2018.

PMID:39881423 | DOI:10.1186/s13014-025-02589-9

Confl Health. 2025 Jan 29;19(1):5. doi: 10.1186/s13031-025-00646-4.

ABSTRACT

BACKGROUND: Non-communicable diseases (NCDs) are the leading cause of death globally, and many humanitarian crises occur in countries with high NCD burdens. Peer support is a promising approach to improve NCD care in these settings. However, evidence on peer support for people living with NCDs in humanitarian settings is limited. We evaluated the implementation of peer support groups (PSGs) for people with diabetes and/or hypertension as part of an integrated NCD care model in four primary care centers in Lebanon.

METHODS: Our objectives were to: (1) evaluate the reach of the PSGs; (2) evaluate the association of PSGs with patient-reported outcomes; and (3) evaluate the association of PSGs with clinical outcomes (blood pressure, HbA1c, and BMI). We used a before-after study design and included a control group for clinical outcomes. The PSG intervention began in December 2022 and was carried out in two waves. The first wave was implemented from December 2022 to July 2023, and the second wave from July 2023 to January 2024. For the control group on clinical outcomes, we used data collected from January 2023 to January 2024. We used routinely collected programmatic and administrative data. The patient reported outcomes (PROMs) were collected at baseline and at six months by trained volunteers for all PSG participants. We performed a before-after analysis of PROMs for all patients who completed the PSG sessions. T-tests were used to analyze the differences in PROMs from baseline. Change in PROMs, together with 95% confidence intervals (CIs), and p-values for the changes were reported. To assess the association between the implementation of the PSG strategy and changes in clinical outcomes, including systolic blood pressure (SBP), glycated hemoglobin A1c (HbA1c), and body mass index (BMI), analysis of covariance (ANCOVA) models were used, adjusting for age, sex, and the baseline values of the outcome being analyzed (baseline SBP and baseline HbA1c, respectively).

RESULTS: A total of 445 patients were approached for enrolment in wave 1, 259 (58%) consented, of whom 81 were enrolled. In wave 2, 169 patients were approached, 92 (54%) consented of whom 91 were enrolled. We found some statistical evidence that PSG improved certain PROMs, including potentially clinical meaningful improvements in overall quality of life (wave 1), physical quality of life (wave 1), social quality of life (wave 2), environmental quality of life (wave 1), adherence (wave 2), patient centeredness (wave 1), and exercise (wave 1). However, we did not find strong statistical evidence of an improvement in clinical outcomes (SBP, HbA1c, or BMI) in participants of the PSGs compared to the control group. We found differences in the association of PSGs and outcomes between the two waves.

CONCLUSION: Our study showed mixed results. In terms of reach, over 50% of those approached consented to participate. Regarding the impact on PROMs, we observed improvements in most outcomes; however we found some statistical evidence only for some. We did not find strong statistical evidence of improvement in clinical outcomes compared to the control group. Differences between the two waves may be due to differences in the populations, the way the intervention was delivered, or the individuals implementing it. Additionally, as multiple outcomes were measured, some observed differences may be due to chance. We demonstrated that it is feasible to implement PSGs in humanitarian settings and found some statistical evidence of improvement in quality of life. Further studies should assess the implementation and impact of PSGs in ways that are well accepted by local stakeholders (including humanitarian actors and people living with NCDs) and are potentially amenable to scale-up.

PMID:39881420 | DOI:10.1186/s13031-025-00646-4

BMC Med Educ. 2025 Jan 29;25(1):148. doi: 10.1186/s12909-025-06755-1.

ABSTRACT

BACKGROUND: Research shows that trauma team formation could potentially improve effectiveness of injury care in rural settings. The aim of this study was to determine the feasibility of rural trauma team training amongst medical trainees and traffic law enforcement professionals in Uganda.

METHODS: Prospective multi-centre interrupted time series analysis of an interventional training based on the 4th edition of rural trauma team development course of the American College of Surgeons. Trauma related multiple choice questions (MCQs), and trauma non-technical skills were assessed pre-and post-training between September 2019- August 2023. Acceptability of the training for promulgation to other rural regions and its relevance to participants’ work needs were evaluated on 5- and 3-point Likert scales respectively. The median MCQ scores (IQR) were compared before and after training at 95% CI, regarding p < 0.05 as statistically significant. Triangulation with open-ended questions was obtained. Time series regression models were applied to test for autocorrelation in performance using Stata 15.0. Ethical approval was obtained from Uganda National Council for Science and Technology (Ref: SS 5082).

RESULTS: A total of 500 participants including: 66 (13.2%) traffic police officers, 30 (6.0%) intern doctors, 140 (28.0%) fifth year and 264 (52.8%) third-year medical students were trained. Among the 434 medical trainees who completed the trauma-based MCQ assessment, the median pre- and post-test scores were 60%, IQR (50-65) and 80%, IQR (70-85) respectively. Overall, the mean difference between pre- and post-test scores was statistically significant (z = 16.7%, P|z|=<0.0001). Most participants strongly agreed to promulgate 389 (77.8%), relevance to their educational 405 (81.0%), and work needs 399 (79.8%). Each of the course components was rated above 76.0% as being very relevant. There was an overall increment in median (IQR) trauma-nontechnical skills team performance scores from 12 (9-14) to 17 (15-20) after the training (p < 0.001), with police teams advancing from 9.5 (6.0-12.5) to 19.5 (17.0-21.5) (p < 0.001).

CONCLUSION: This study demonstrates that rural trauma team development training had a positive effect on the test scores of course participants. The training is feasible, highly acceptable and regarded as relevant amongst medical trainees and traffic law enforcement professionals who provide first-aid to trauma patients in resource-limited settings. The findings could inform the design of future trauma teams in rural communities.

TRIAL REGISTRATION: Retrospective registration (UIN: researchregistry9450).

PMID:39881413 | DOI:10.1186/s12909-025-06755-1