EClinicalMedicine最新文献

{"title":"Response to comment about article 'Systematic review and meta-analysis of goal-directed haemodynamic therapy algorithms during surgery for the prevention of surgical site infection'.","authors":"Hasti Jalalzadeh, Rick H Hulskes, Robert P Weenink, Niels Wolfhagen, Ingeborg van Dusseldorp, Roald R Schaad, Denise P Veelo, Markus W Hollmann, Marja A Boermeester, Stijn W de Jonge","doi":"10.1016/j.eclinm.2025.103237","DOIUrl":"10.1016/j.eclinm.2025.103237","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103237"},"PeriodicalIF":9.6,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12099763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial.","authors":"Jinhui Shu, Wei Xie, Chunli Mei, Anqi Ren, Sha Ke, Meilin Ma, Zisong Zhou, Yu Hu, Heng Mei","doi":"10.1016/j.eclinm.2025.103229","DOIUrl":"10.1016/j.eclinm.2025.103229","url":null,"abstract":"<p><strong>Background: </strong>Systemic lupus erythematosus (SLE) is a classic systemic autoimmune disease mediated by autoantibodies. Chimeric antigen receptor T (CAR-T) cell therapy, known for its success in cancer, has shown promise in achieving durable B cell depletion and long-term remission in SLE. Relmacabtagene autoleucel (relma-cel) is the second anti-CD19 CAR-T product approved for marketing by the National Medical Products Administration (NMPA) in China and demonstrates its long-term efficacy in relapsed/refractory (r/r) large B cell lymphoma (LBCL). We report the results from a phase I open-label clinical trial of relma-cel in treating patients with moderately to severely active SLE.</p><p><strong>Methods: </strong>Eligible patients were aged 18-70 years, a ≥6-month history of SLE, and the disease had to remain active after at least 2 months of stable SLE standard treatment prior to screening. We evaluated four dose levels (DL) of relma-cel in a dose-escalation scheme: total dose of 25 × 10<sup>6</sup>, 50 × 10<sup>6</sup>, 75 × 10<sup>6</sup>, and 100 × 10<sup>6</sup> anti-CD19 CAR-T cells. All patients received lymphodepletion chemotherapy with fludarabine and cyclophosphamide. The primary endpoints were the incidence of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints included the evaluation of standard cellular pharmacokinetic parameters, the SLE Responder Index (SRI) response rate, and changes from baseline in the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI), British Isles Lupus Assessment Group 2004 (BILAG-2004) and Physician's Global Assessment (PGA) scores post-treatment. This trial is registered with ClinicalTrials.gov, NCT05765006.</p><p><strong>Findings: </strong>Between March 28, 2023 and April 8, 2024, a total of 12 patients were screened for study inclusion, of whom 8 patients were enrolled and assigned to different dose levels: 25 × 10<sup>6</sup> cells (n = 3), 50 × 10<sup>6</sup> cells (n = 2), 75 × 10<sup>6</sup> cells (n = 2), and 100 × 10<sup>6</sup> cells (n = 1). No DLT was observed. The most common AEs included cytopenia (n = 8, 100%), cytokine release syndrome (CRS) (n = 7, 88%) and hypogammaglobulinemia (n = 5, 63%). No Grade 3 or higher immune effector cell-associated hematotoxicity (ICAHT) occurred. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported. CRS was predominantly grade 1, characterized mainly by mild fever and muscle soreness. A rare severe adverse event, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), was observed in one patient. The median time to reach maximum CAR-T cell expansion (C<sub>max</sub>) was 9.5 days (range: 8-22 days). The median C<sub>max</sub> was 18.74 CD3+CAR+ cells/μL (range: 7.94-228.36) by flow cytometry and 81766.5 copies/μg DNA (range: 50,979-1,140,893) by quantitative real-time PCR","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103229"},"PeriodicalIF":9.6,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evidence-based medical procedures to optimise caesarean outcomes: an overview of systematic reviews.","authors":"Virginia Diaz, Celina Gialdini, Mónica Chamillard, Julia Pasquale, Guillermo Carroli, Maria Regina Torloni, Ana Pilar Betran","doi":"10.1016/j.eclinm.2025.103212","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103212","url":null,"abstract":"<p><strong>Background: </strong>The use of caesarean sections (CS) is increasing to unprecedented levels worldwide. As with any surgery, it has risks, and understanding the evidence base for interventions involved in a CS is essential to optimise outcomes and inform recommendations. We conducted an overview of systematic reviews (SRs) of randomised controlled trials (RCTs) to summarise the evidence on medical procedures used in CS.</p><p><strong>Methods: </strong>Searches were conducted in Cochrane Database of Systematic Reviews, PubMed, EMBASE, LILACSs and CINAHL without date or language restrictions from database inception to January 31, 2024, with an updated search performed on January 24, 2025. We included SRs of RCTs that examined the effectiveness and safety of medical procedures used in CS. AMSTAR 2 and GRADE were used to assess the methodological quality of the SRs and the certainty of evidence at outcome level, respectively. We classified each procedure-outcome pair into one of eight categories according to effect estimates and certainty of evidence. The overview was registered at PROSPERO (CRD 42023208306).</p><p><strong>Findings: </strong>We identified 29 SRs (15 Cochrane and 14 non-Cochrane) published between 2002 and 2024 involving 408 unique RCTs including over 116,000 participants. Most reviews included trials from low- and middle-income countries (n = 21, 72.4%), combined both elective and emergency CS (n = 19, 65.5%), and were of high quality (n = 18, 62%), while 24.3% (n = 7) were of low and 13.7% (n = 4) were of critically low quality. The SRs presented 512 procedure-outcome comparisons (271 procedure versus procedure, 241 procedure versus no treatment/placebo). There was insufficient or inconclusive evidence for 350 comparisons (68.4%), clear evidence of benefit for 97 (18.9%), possible benefit for 48 (9.3%), clear or possible no difference of effect for 9 (1.8%), clear evidence of harm for 4 (0.8%) and possible harm for 4 (0.8%). We found no SRs for 13 pre-specified procedures. Indwelling bladder catheter and its immediate removal, vaginal preparation with antiseptic solution, antibiotic prophylaxis, early oral intake, and abdominal binders are associated with benefits for some outcomes. There are no SRs on post-CS wound care, stitch removal, or time to resume sexual or physical activity, among others.</p><p><strong>Interpretation: </strong>There are numerous gaps in the available evidence on medical procedures used in CS that require additional research. There is an urgent need for international recommendations to guide healthcare providers and policymakers in ensuring safer, evidence-based, care for women undergoing CS.</p><p><strong>Funding: </strong>UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103212"},"PeriodicalIF":9.6,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12076788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dihydroartemisinin-piperaquine versus sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria in pregnancy: a systematic review and individual participant data meta-analysis.","authors":"Michelle E Roh, Julie R Gutman, Maxwell Murphy, Jenny Hill, Mywayiwawo Madanitsa, Abel Kakuru, Hellen C Barsosio, Simon Kariuki, John P A Lusingu, Frank Mosha, Richard Kajubi, Moses R Kamya, Don Mathanga, Jobiba Chinkhumba, Miriam K Laufer, Eulambius Mlugu, Appolinary A R Kamuhabwa, Eleni Aklillu, Omary Minzi, Roland Nnaemeka Okoro, Ado Danazumi Geidam, John David Ohieku, Meghna Desai, Prasanna Jagannathan, Grant Dorsey, Feiko O Ter Kuile","doi":"10.1016/j.eclinm.2025.103202","DOIUrl":"10.1016/j.eclinm.2025.103202","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;High-grade &lt;i&gt;Plasmodium falciparum&lt;/i&gt; resistance to sulfadoxine-pyrimethamine in east and southern Africa has prompted trials evaluating intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine as an alternative to sulfadoxine-pyrimethamine. We aimed to provide an updated and comprehensive review of trials conducted in areas of &lt;i&gt;high P. falciparum&lt;/i&gt; resistance that compared the efficacy of two types of IPTp regimens on maternal, birth, and infant outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted two-stage, individual participant data meta-analyses of randomised trials comparing IPTp with dihydroartemisinin-piperaquine to sulfadoxine-pyrimethamine on maternal, birth, and infant outcomes. We searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.Gov, PubMed, and the Malaria in Pregnancy Consortium Library, on July 30, 2020 (updated on September 24, 2024), without restrictions by publication date, peer-review status, or language. Eligible trials enrolled HIV-uninfected pregnant women, followed participants to delivery, included participants with no prior IPTp use during the current pregnancy, and were conducted in areas with high-level parasite resistance to sulfadoxine-pyrimethamine (i.e., PfDHPS 540E ≥ 90% and/or 581G&gt;0%). Only singleton pregnancies were analysed. The primary endpoint was a composite measure of any adverse pregnancy outcome defined as fetal or neonatal loss, small-for-gestational age, low birthweight, or preterm birth. Summary estimates were generated using a random-effects model. Gravidity subgroup analyses were performed. Causal mediation analyses were used to investigate the maternal mechanisms underlying the effect of IPTp regimens on birth outcomes. The meta-analysis is registered in PROSPERO (CRD42020196127).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Of 85 screened records, six trials (one multi-country trial) from Kenya, Malawi, Uganda and Tanzania contributed data on 6646 pregnancies. Compared to sulfadoxine-pyrimethamine, dihydroarteminsinin-piperaquine was associated with a 69% [95% CI: 45%-82%] lower incidence of clinical malaria during pregnancy, a 62% [37%-77%] lower risk of placental parasitaemia, and a 17% [0%-31%] lower incidence of moderate maternal anaemia. In contrast, sulfadoxine-pyrimethamine was associated with higher mean maternal weight gain (34 g/week [17-51]). There were no statistically significant differences in the composite adverse pregnancy outcome (RR = 1.05 [0.92-1.19]; &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;2&lt;/sup&gt; = 48%). Individual components of the primary outcome showed no statistically significant differences in the risks of fetal loss (RR = 0.94 [0.61-1.46]), preterm birth (RR = 0.93 [0.76-1.14]), low birthweight (RR = 1.09 [0.83-1.43]), or neonatal loss (RR = 0.73 [0.42-1.26]), though findings may have been underpowered. Small-for-gestational-age risk was 15% (3%-24%) lower in the sulfadoxine-pyrimethamine arm, particularly","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103202"},"PeriodicalIF":9.6,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12076784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prehospital application of remote ischaemic perconditioning in acute ischaemic stroke patients in Catalonia: the REMOTE-CAT clinical trial.","authors":"Francisco Purroy, Gloria Arqué, Xavier Jiménez-Fàbrega, Teresa Subirats, José Ramon Ropero, Mikel Vicente-Pascual, Pere Cardona, Manuel Gómez-Choco, Jorge Pagola, Sònia Abilleira, Àlex Rovira, Rafel Cirer-Sastre, Gerard Mauri-Capdevila","doi":"10.1016/j.eclinm.2025.103208","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103208","url":null,"abstract":"<p><strong>Background: </strong>Acute ischaemic stroke (IS) remains one of the leading causes of morbidity and mortality worldwide. Remote ischaemic perconditioning (RIperC) is a neuroprotective treatment with promising preclinical results, acting through humoral and neural mechanisms. This trial aimed to evaluate the clinical benefits of prehospital-initiated RIperC in acute IS patients.</p><p><strong>Methods: </strong>REMOTE-CAT was a multicentre, randomised, double-blind, sham-controlled trial across four Catalonian stroke centres. Patients over 18 years with stroke symptoms under 8 h, a pre-stroke modified Rankin Scale (mRS) score <3, and motor deficits (RACE motor score ≥1) were randomised 1:1 to active RIperC or sham. RIperC was applied via an automated cuff on the unaffected arm in five 5-min inflation-deflation cycles. Investigators and participants were blinded to treatment. The primary outcome was the proportion of patients with a favourable outcome (mRS <3) at 90 days. The intention-to-treat analysis included all patients receiving at least one inflation-deflation cycle and had a final diagnosis of ischaemic stroke or transient ischaemic attack (ClinicalTrials.gov: NCT03375762).</p><p><strong>Findings: </strong>Between August 2019 and December 2023, 350 patients were screened, with 200 randomised. After 78 exclusions (29 haemorrhagic strokes, 41 stroke mimics, and 8 patients with mRS >3), 122 patients were included in the primary analysis (RIperC group, n = 57; sham group, n = 65). The RIperC group had a higher proportion of mRS <3 at 90 days (64.9%) than the sham group (47.3%), though not statistically significant in the unadjusted analysis (OR 2.03 [95% CI 0.98-4.21], p = 0.057 However, statistical significance was achieved in the post-hoc analysis adjusted for age, baseline status (determined by pre-stroke mRS score), and initial stroke severity (measured by baseline RACE score by paramedics) (OR 2.94 [95% CI 1.21-7.16], p = 0.017). No serious adverse events were observed.</p><p><strong>Interpretation: </strong>Despite the small sample size, our findings suggest that prehospital application of RIPerC is safe and may confer clinical benefit, as indicated in the post hoc adjusted analysis. However, larger, adequately powered trials are required to validate these results, and to determine potential differential effects across underrepresented patient subgroups.</p><p><strong>Funding: </strong>Institute of Health Carlos III (ISCIII) of the Spanish Ministry of Health and Government of Catalonia-Agència de Gestió d'Ajuts Universitaris i de Recerca (AGAUR).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103208"},"PeriodicalIF":9.6,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143962433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing IBD counsellors in low- and middle-income countries: bridging gaps in patient care.","authors":"Arshdeep Singh, Arshia Bhardwaj, Riya Sharma, Vandana Midha, Ajit Sood","doi":"10.1016/j.eclinm.2025.103218","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103218","url":null,"abstract":"<p><p>The global burden of inflammatory bowel disease (IBD) is progressively increasing, with a particularly sharp rise in newly industrialized and resource-limited settings. These regions face unique and pressing challenges in IBD care, including a shortage of trained specialists, delayed or missed diagnoses, financial and geographic barriers to access, and the persistent stigma surrounding the disease. Furthermore, cultural dynamics; especially the prominent role of family in healthcare decisions; profoundly influence patient engagement, treatment adherence, and overall outcomes. However, current healthcare models and global guidelines are largely shaped by Western systems that prioritize individual patient autonomy and may not fully align with the sociocultural realities of resource-limited settings. This viewpoint aims to highlight the need for culturally contextualized, scalable solutions to improve IBD care. Specifically, we propose the development and integration of IBD counsellors as a novel and pragmatic approach to bridge existing gaps in care. These counsellors, trained in the nuances of IBD and sensitive to local sociocultural norms, can serve as critical intermediaries; facilitating communication among patients, families, and providers; supporting adherence and follow-up; and offering tailored psychosocial and dietary guidance. By presenting this model, we seek to stimulate discourse around innovative, culturally adaptive strategies and advocate for policy-level recognition and investment to promote health equity in IBD care globally.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103218"},"PeriodicalIF":9.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143962425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The relationship between obesity and obstructive sleep apnea in four community-based cohorts: an individual participant data meta-analysis of 12,860 adults.","authors":"Neda Esmaeili, Laura Gell, Théo Imler, Mohammadreza Hajipour, Luigi Taranto-Montemurro, Ludovico Messineo, Katie L Stone, Scott A Sands, Najib Ayas, John Yee, John Cronin, Raphael Heinzer, Andrew Wellman, Susan Redline, Ali Azarbarzin","doi":"10.1016/j.eclinm.2025.103221","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103221","url":null,"abstract":"<p><strong>Background: </strong>Obesity is a well-established risk factor for obstructive sleep apnea (OSA). We assessed the reciprocal prevalence of obesity and OSA and how it varies by age and sex.</p><p><strong>Methods: </strong>Following a systematic review through March 27, 2025, the final sample included four community-based cohort studies in the US and Switzerland. OSA severity was quantified using the apnea-hypopnea index (AHI, all apneas plus hypopneas with ≥4% oxygen desaturation/hour). Random effects individual participant data (IPD) meta-analyses estimated prevalences. Logistic regression compared odds of OSA across weight groups.</p><p><strong>Findings: </strong>Among 12,860 adults (mean ± SD age: 66.6 ± 7.3 years), 7222 (56.2%) had OSA (AHI ≥5 events/h) and 3309 (25.7%) had obesity (BMI ≥30 kg/m²). IPD meta-analysis showed 31.5% [95% CI: 16.8-48.5] of individuals with OSA had obesity and 44.4% [36.5-52.5] had overweight status (25 ≤ BMI < 30). Among subgroups of individuals with obesity and overweight, 74.3% [63.8-83.5] and 59.8% [46.5-75.7] had any OSA, respectively. Obesity was higher in females than males with OSA, and in younger (<65 years) vs. older individuals. Odds ratios for OSA in subgroups of individuals with overweight and obesity compared to BMI <25 kg/m² were 2.18 [1.73-2.76] and 4.84 [3.09-6.00], respectively.</p><p><strong>Interpretation: </strong>Our analyses show that most adults with OSA do not have obesity, with 44.4% having overweight and 23.5% having normal weight or underweight. Obesity was more prevalent among females compared to males and in younger individuals (<65 years) compared to older individuals with OSA. Recognizing OSA is not exclusive to obesity highlights the need for personalized treatment plans.</p><p><strong>Funding: </strong>American Academy of Sleep Medicine, National Heart, Lung, and Blood Institute, and Apnimed.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103221"},"PeriodicalIF":9.6,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12051718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safeguarding the right to die.","authors":"eClinicalMedicine","doi":"10.1016/j.eclinm.2025.103223","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103223","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"82 ","pages":"103223"},"PeriodicalIF":9.6,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12034066/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interaction of brain imaging features and effects of intensive blood pressure lowering after endovascular treatment for acute ischaemic stroke: the pre-specified secondary analyses of ENCHANTED2/MT trial.","authors":"Xiaoxi Zhang, Xinwen Ren, Yongxin Zhang, Yongwei Zhang, Lei Zhang, Hongjian Shen, Zifu Li, Pengfei Xing, Ping Zhang, Weilong Hua, Fang Shen, Bing Tian, Wenhuo Chen, Hongxing Han, Liyong Zhang, Chenghua Xu, Tong Li, Yu Gao, Yu Zhou, Qiao Zuo, Dongwei Dai, Rui Zhao, Qiang Li, Qinghai Huang, Yi Xu, Xiaoying Chen, Qiang Li, Lili Song, Craig S Anderson, Pengfei Yang, Jianmin Liu","doi":"10.1016/j.eclinm.2025.103197","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103197","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The second Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED2/MT) was terminated early when the intensive blood pressure lowering to a systolic level of 120 mm Hg or lower, compared to 140-180 mm Hg, was harmful in patients who received successful endovascular therapy for acute ischaemic stroke due to large-vessel occlusion. We aimed to determine the interaction of key brain imaging features and the effect of treatment on clinical outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;ENCHANTED2/MT was a prospective, randomised, open-label, blinded-endpoint, controlled trial that aimed to assess the effectiveness of different intensities of blood pressure control on the functional independence in patients who had received successful endovascular therapy for acute ischaemic stroke from large-vessel occlusion at 44 hospitals in China between July 20, 2020 and March 7, 2022. In these pre-specified secondary analyses, neuroradiologists reviewed the baseline brain images of participants (computerised tomography [CT], CT with angiography [CTA] and digital subtraction angiography [DSA]) blind to treatment allocation, to determine the degree of cerebral infarction on the Alberta Stroke Program Early CT Score (ASPECTS), collateral status according to modified TAN score, and degree of reperfusion on the expanded Treatment In Cerebral Infarction (eTICI) scale. The primary outcome was functional independence, according to the distribution of scores on the modified Rankin scale (range 0 [no symptoms] to 6 [death]) at 90 days. Multivariable logistic regression analysis was done according to the modified intention-to-treat principle in all participants with available outcome data. ENCHANTED2/MT is registered with ClinicalTrials.gov, NCT04140110.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Of 816 participants in the trial, in whom 407 were assigned to more intensive blood pressure lowering and 409 were assigned to less intensive blood pressure lowering treatment, there were 533, 372, and 757 participants with available data for ASPECTS, collateral flow, and eTICI analyses, respectively. Intensive blood pressure lowering was associated with worse functional independence in participants with complete reperfusion (eTICI 3: adjusted odds ratio [aOR] 1.51, 95% CI 1.14-2.02) but not in those with incomplete reperfusion (eTICI 2b/c: aOR 1.29, 95% CI 0.73-2.28), without significant interaction (p&lt;sub&gt;interaction&lt;/sub&gt; = 0.82). There was no significant interaction between blood pressure treatment and ASPECTS (0-5 vs. 6-10: aOR 1.27, 95% CI 0.77-2.11 vs. aOR 1.37, 95% CI 0.91-2.07; p&lt;sub&gt;interaction&lt;/sub&gt; = 0.14) on functional independence. However, more intensive blood pressure lowering treatment was associated with worse functional independence in participants with poor collateral status (aOR 1.99, 95% CI 1.11-3.57) compared to those with good collateral status (aOR 0.87, 95% CI 0.53-1.45), with a moderate level of interaction (p&lt;sub&gt;inte","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103197"},"PeriodicalIF":9.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12051051/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): long-term follow-up of a randomised controlled, phase 2-3 trial.","authors":"Nicklas Oscarsson, Anders Rosén, Bernd Müller, Lotta Renström Koskela, Daniel Giglio, Anders Kjellberg, Otto Ettala, Helén Seeman-Lodding","doi":"10.1016/j.eclinm.2025.103214","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103214","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Chronic radiation-induced cystitis is a common and often debilitating complication of radiotherapy for pelvic cancers, affecting approximately 5-10% of patients. Symptoms such as haematuria, urinary urgency, frequency, and dysuria significantly affect quality of life. Although hyperbaric oxygen (HBO2) alleviates symptoms, evidence regarding its long-term benefits is limited. This study reports on the 5-year follow-up of the RICH-ART trial, evaluating whether the therapeutic effects of HBO2 on chronic radiation-induced cystitis are sustained over a longer follow-up period.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;RICH-ART is a multicentre, open-label, phase 2-3 trial, conducted at five Nordic hospitals: Sahlgrenska and Karolinska (Sweden), Haukeland (Norway), Rigshospitalet (Denmark), and Turku (Finland). Eligible patients were aged 18-80 years, had completed pelvic radiotherapy at least 6 months earlier, had chronic radiation-induced cystitis, and an Expanded Prostate Cancer Index Composite (EPIC) urology score &lt;80. Patients were randomised to receive HBO2 (30-40 sessions, 100% oxygen, breathed at 240-250 kPa, for 80-90 min daily) or standard of care with no restrictions for other medications or interventions (control group). No masking was applied. The primary outcome-change in EPIC urinary total score from baseline to 6 months- has been previously reported. After this point, patients in the control group were offered HBO2. Here, we report the secondary outcome: long-term symptom relief in all patients who received HBO2, measured as change in EPIC urinary total score from baseline to 5 years post-HBO2. Adverse events were recorded only during the period patients received HBO2. Follow-up was terminated 6 months early, in May 2022, due to administrative constraints, primarily lack of funding. RICH-ART is registered with ClinicalTrials.gov (NCT01659723), and with EudraCT (2012-001381-15).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 were enrolled and randomised. One patient in the intervention group and 7 patients in the control group withdrew consent immediately after randomisation. Of the remaining 79 patients, 74 completed the first part of the study. One patient in the control group declined HBO2 and three had missing data for the first year, making 70 patients eligible for follow-up. The mean EPIC urinary total score improved 18.0 points (95% CI 14.2-21.8) from 46.6 (SD 18.4) pre-HBO2 to 64.6 (SD 24.1) at 6 months, and the improvement remained stable at 19.1 points (95% CI 13.3-24.9) at year 5. Responders (n = 48; 68.6%), defined as those with ≥9-point improvement post-HBO2, maintained a mean increase of 22.9 (95% CI 16.2-29.6; p &lt; 0.0001) at 5 years. Non-responders (n = 22; 31.4%) showed no early benefit (43.5 [SD 15.6] to 44.6 [SD 16.6]). Nine of the 70 patients (12.8%) received additional HBO2 for recurring symptoms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Our find","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"83 ","pages":"103214"},"PeriodicalIF":9.6,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12033922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}