EClinicalMedicine最新文献

{"title":"Thyroid-stimulating hormone suppression in low-risk papillary thyroid cancer: a large-scale retrospective analysis of real-world data.","authors":"Xiao Shi, Haitao Tang, Tingting Zhang, Yunjun Wang, Cenkai Shen, Yan Zhang, Yuxin Du, Wenjun Wei, Zimeng Li, Chuqiao Liu, Xiaoqi Mao, Shaoyan Liu, Qinghai Ji, Jie Liu, Yu Wang","doi":"10.1016/j.eclinm.2024.102912","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102912","url":null,"abstract":"<p><strong>Background: </strong>Over 500,000 new cases are diagnosed with papillary thyroid cancer (PTC) globally per year, of whom the vast majority are in the low-risk stratification. Although thyroid-stimulating hormone (TSH) suppression is traditionally recommended for all postoperative PTCs in current guidelines, its necessity remains highly controversial in low-risk patients. Since relevant recommendations in current guidelines are still empirical, we aim to provide a direct, large-scale, real-world evidence.</p><p><strong>Methods: </strong>This large-scale real-world retrospective study included 11,140 low-risk PTC patients from two Chinese large-volume centers (Fudan University Shanghai Cancer Center [FUSCC] and Cancer Hospital of Chinese Academy of Medical Sciences [CH-CAMS]) treated from January 1, 2000 to June 30, 2022. The mean TSH level was calculated based on postoperative serum TSH values during follow-up. The primary outcome was the association between postoperative TSH level and structural recurrence assessed by Kaplan-Meier, log-rank, multivariate Cox regression analyses and equivalence testing by Two One-Sided Tests (TOST) procedure. Propensity score matching (PSM) was used to adjust for confounders among groups.</p><p><strong>Findings: </strong>A total of 11,140 patients with low-risk PTC were included with a median follow-up of 70 months. Based on the mean TSH level, we classified these patients into ≤0.5 (n = 1,504, 13.5%), (0.5-1] (n = 4,336, 38.9%), (1-2] (n = 4,285, 38.5%), (2-3] (n = 704, 6.3%) and >3 (n = 311, 2.8%) mU/L groups. After PSM adjusting for age, sex, T and N stage, 8991 patients were included in further analysis, for whom the log-rank analyses showed no significant differences between any two groups (all P > 0.05) in recurrence-free survival (RFS), locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS), and suppressed TSH was not associated with tumor recurrence in the multivariate Cox analysis (TSH > 2 group vs TSH ≤ 2 group: HR = 1.30, 95% CI = 0.85-2.01, P = 0.23). Furthermore, the TOST equivalence tests showed that tumor recurrence status of any two TSH groups were statistically comparable (all Bonferroni-corrected P values < 0.005). Subgroup multivariate analyses showed that TSH level did not impact tumor recurrence regardless of age, tumor size, lymph node metastasis, multifocality, surgical extent, biochemical evidence.</p><p><strong>Interpretation: </strong>Our results suggested that postoperative TSH level was not associated with tumor recurrence in patients with low-risk PTC, for whom deliberate TSH suppression may be exempted to avoid potential secondary complications. Maintaining a TSH level within the normal range may be safe for these patients.</p><p><strong>Funding: </strong>The study was supported by the National Natural Science Foundation of China (82072951 to Y.W.; 82373008 to X.S.), Shanghai Hospital Development Center (SHDC2020CR6003-001 to Y.W., SHDC202","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102912"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11555599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616880","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 tolerability of losartan to treat recessive dystrophic epidermolysis bullosa in children (REFLECT): an open-label, single-arm, phase 1/2 trial.","authors":"Dimitra Kiritsi, Franziska Schauer, Stella Gewert, Katja Reineker, Antonia Reimer-Taschenbrecker, Agnes Schwieger-Briel, Hagen Ott, Claudia Schmoor, Olga Grishina, Dedee Murrell, Brigitte Stiller, Tobias Zahn, Alexander Nyström, Leena Bruckner-Tuderman","doi":"10.1016/j.eclinm.2024.102900","DOIUrl":"10.1016/j.eclinm.2024.102900","url":null,"abstract":"<p><strong>Background: </strong>Recessive dystrophic epidermolysis bullosa (RDEB) is a skin fragility disorder characterised by life-long mechanically induced skin blistering, fibrosis-driven pseudosyndactyly, and multi-organ involvement. Preclinical studies have suggested mitigated progression by angiotensin II type I receptor blockade through losartan. We aimed to determine the safety and tolerability of systemic losartan treatment among children with RDEB, and to obtain initial data on its clinical benefit.</p><p><strong>Methods: </strong>We conducted an open-label, single-arm, phase 1/2 trial at the Medical Center-University of Freiburg, Germany. Children with molecularly-confirmed RDEB, aged 2-16 years (starting from the 25th month of life) were eligible. Key exclusion criteria comprised anaemia with haemoglobin <8 g/dl; hypotension (defined as age-related systolic blood pressure under the 5th percentile); cardiologic contraindications, requirement for any medications that are likely to cause interactions with losartan; renal artery stenosis or renal insufficiency with creatinine clearance <30 ml/min; severe liver failure; severe, untreated electrolyte disturbances; history of cancer or chronic viral infections; hypersensitivity to losartan or any of the excipients and known or persistent abuse of medication, drugs, or alcohol. Treatment duration with losartan comprised 10 months, encompassing 16 weeks up-dosing of losartan, 24 weeks full dose losartan (final target dose of 1.4 mg/kg), and 4 weeks losartan tapering, followed by 12 weeks follow-up without losartan. The primary endpoint was occurrence of a serious safety concern, defined as one of the following side effects of losartan: clinically relevant severe hypotension, immediate hypersensitivity reactions to the drug or clinical relevant severe hypo- and hyperkalaemia. EB-specific scores (the EBDASI activity and damage score, Birmingham Epidermolysis Bullosa Severity Score (BEBS)) and other clinical outcome parameters were evaluated at five clinical visits as secondary outcomes: pain (Wong-Baker FACES Scale for pain), quality of life (Quality Of Life in EB [QOLEB] questionnaire and Children's Dermatology Life Quality Index [CDLQI]), itch (Itch Assessment Scale for the Paediatric Burn Patients), dysphagia (Mayo Dysphagia Questionnaire-day 30 [MDQ-30]), pseudosyndactyly progression (our own morphometric scoring instrument), and hand function (Score of Colville and Terrill). All analyses (safety and efficacy) were performed in the safety population, defined as participants who received at least one dose of trial medication with losartan. This trial is registered with EudraCT, 2015-003670-32.</p><p><strong>Findings: </strong>Between Jul 28, 2017, and Feb 12, 2021, 29 children were enrolled. Of those 27 received the full treatment. Losartan was well tolerated, no treatment-related severe complications leading to a serious safety concern occurred. The patients revealed improvement in the RDEB","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102900"},"PeriodicalIF":9.6,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616876","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":"Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study.","authors":"Belinda A Campbell, H Miles Prince, Julia J Scarisbrick","doi":"10.1016/j.eclinm.2024.102896","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102896","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102896"},"PeriodicalIF":9.6,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11550127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616874","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 effect of prescription and over-the-counter medications on core temperature in adults during heat stress: a systematic review and meta-analysis.","authors":"Lily Hospers, Gabrielle A Dillon, Andrew J McLachlan, Lacy M Alexander, W Larry Kenney, Anthony Capon, Kristie L Ebi, Edward Ashworth, Ollie Jay, Yorgi Mavros","doi":"10.1016/j.eclinm.2024.102886","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102886","url":null,"abstract":"<p><strong>Background: </strong>Heat stress impacts are an escalating global health concern. Public health bodies such as the World Health Organization (WHO) warn that certain medications impair thermoregulation, with limited supporting evidence. Our aim was to investigate whether medications listed by the WHO increase core temperature responses during heat stress.</p><p><strong>Methods: </strong>For this systematic review and meta-analysis, MEDLINE, PubMed, Scopus, CINAHL, Web of Science, and EMBASE were searched up to Jan.30, 2024. Randomised studies exposing humans to exertional and/or passive heat stress that investigated a drug identified by WHO compared to no drug/placebo were eligible. The primary outcome was core temperature (e.g., rectal, oesophageal, aural, tympanic). We assessed risk of bias (Cochrane's Risk of Bias 2) and certainty of evidence (GRADE). The study was pre-registered on PROSPERO (CRD42020170684).</p><p><strong>Findings: </strong>Thirty-five studies were included enrolling 353 individuals (16 women; 4.5%). Twenty-seven unique medications were tested. The average age of participants across studies was <30 years, and only one study included a clinical population. Under heat stress, there was moderate quality evidence that drugs with high anticholinergic properties increased core temperature at air temperatures ≥30°C (+0.42°C; 95% CI 0.04, 0.79°C; p = 0.03) alongside reduced sweating, although evidence is limited to the drug atropine. Similarly, non-selective beta-blockers (+0.11°C; 95% CI 0.02, 0.19°C; p = 0.02), adrenaline (+0.41°C; 95% CI 0.21, 0.61°C) and anti-Parkinson's agents (+0.13°C; 95% CI 0.07, 0.19°C; p = 0.02) elevated core temperature. Antidepressants, diuretics, or drugs with weak anticholinergic effects did not alter core temperature responses.</p><p><strong>Interpretation: </strong>Current evidence supports strong anticholinergics, non-selective beta-blockers, adrenaline, and anti-Parkinson's agents impairing thermoregulation during heat stress. No evidence indicated thermoregulation is impacted by other WHO-listed medications. Evidence is predominantly limited to healthy young men, with short heat stress exposures. Studies over longer durations, in women, older adults and those with chronic diseases are required to better inform the pharmaceutical management of patients during hot weather.</p><p><strong>Funding: </strong>This study was supported by a National Health and Medical Research Council (NHMRC) Investigator Grant (2021/GNT2009507; Holder: O. Jay).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102886"},"PeriodicalIF":9.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603834","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":"Efficacy and safety of asunercept, a CD95L-selective inhibitor, in hospitalised patients with moderate-to-severe COVID-19: ASUNCTIS, a multicentre, randomised, open-label, controlled, phase 2 trial.","authors":"Maria Pilar Ruiz Seco, José Ramón Paño Pardo, Christian Schoergenhofer, Christiane Dings, Thorsten Lehr, Felix Herth, Andriy Krendyukov, Carola Straub, Martin Kappler, Bernd Jilma, Harald Fricke, Julian Pardo, Diego de Miguel, Meinolf Thiemann, Michael Bergmann, Henning Walczak, Thomas Hoeger","doi":"10.1016/j.eclinm.2024.102879","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102879","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The phase 2 ASUNCTIS study assessed the efficacy and safety of asunercept, a fully human CD95 (Fas) ligand-binding protein, in hospitalised patients with moderate-to-severe coronavirus disease (COVID-19) to assess the clinical benefit of CD95 ligand inhibition in this viral disease.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this open-label, multicentre, randomised, controlled, phase 2 trial, patients with COVID-19-induced pneumonia and respiratory deterioration were randomly assigned (1:1:1:1) in 12 Russian and Spanish hospitals using an interactive web-response system to receive standard of care (SOC) or SOC plus weekly asunercept 25 mg, 100 mg, or 400 mg, administered intravenously for up to 4 weeks, or until hospital discharge or death. The randomisation was stratified according to the respiratory support methods at the time of enrolment, corresponding to categories 4-6 of a clinical severity assessment scale comprising 9 levels that was recommended by the World Health Organization (WHO) at the time of the study. The main inclusion criterion was laboratory confirmed infection with SARS-CoV-2 OR typical radiological signs of SARS-CoV-2 infection. The primary endpoint was time from randomisation to clinical improvement on two consecutive days of at least one category on a WHO clinical severity assessment scale in the modified intent-to-treat population. All patients were subjected to regular safety analyses. This trial is registered with EudraCT (2020-001887-27) and ClinicalTrials.gov (NCT04535674).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between October 9, 2020, and September 24, 2021, 438 patients were randomly assigned to SOC (n = 110) or SOC plus asunercept 25 mg (n = 109), 100 mg (n = 109), or 400 mg (n = 110). The primary endpoint, time to sustained clinical improvement of one WHO category on two consecutive days from randomization, was in median [95% confidence interval]: 9 [6-12], 8 [7-12], 8 [7-11] and 13 [9-20] days for the 400 mg, 100 mg, 25 mg asunercept and SOC groups, respectively. The standard deviations for the 400 mg, 100 mg, 25 mg asunercept and SOC groups were 5.3, 4.9, 4.7 and 5 days, respectively. The observed differences between groups failed to reach statistical significance (one-sided p-value = 0.041). In total, 290 adverse events (AE) were registered in 145 patients who received at least one dose of the study treatment: 77 AEs in 37 (33.6%) patients in the SOC group, 80 AEs in 38 (34.9%) patients in the 25 mg group, 61 AEs in 35 (32.7%) patients in the 100 mg group and 72 AEs in 35 (32.1%) patients in the 400 mg group. There was no treatment-related death reported. In summary, asunercept was well tolerated at all doses tested and no specific safety signals were detected.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;The primary endpoint of time to sustained clinical improvement for distinct asunercept arms compared to SOC failed to meet statistical significance. The compound was safe and well tolerated.&lt;/p&gt;&lt;p&gt;","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102879"},"PeriodicalIF":9.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603795","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":"Non-invasive prediction of human embryonic ploidy using artificial intelligence: a systematic review and meta-analysis.","authors":"Xing Xin, Shanshan Wu, Heli Xu, Yujiu Ma, Nan Bao, Man Gao, Xue Han, Shan Gao, Siwen Zhang, Xinyang Zhao, Jiarui Qi, Xudong Zhang, Jichun Tan","doi":"10.1016/j.eclinm.2024.102897","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102897","url":null,"abstract":"<p><strong>Background: </strong>Embryonic ploidy is critical for the success of embryo transfer. Currently, preimplantation genetic testing for aneuploidy (PGT-A) is the gold standard for detecting ploidy abnormalities. However, PGT-A has several inherent limitations, including invasive biopsy, high economic burden, and ethical constraints. This paper provides the first comprehensive systematic review and meta-analysis of the performance of artificial intelligence (AI) algorithms using embryonic images for non-invasive prediction of embryonic ploidy.</p><p><strong>Methods: </strong>Comprehensive searches of studies that developed or utilized AI algorithms to predict embryonic ploidy from embryonic imaging, published up until August 10, 2024, across PubMed, MEDLINE, Embase, IEEE, SCOPUS, Web of Science, and the Cochrane Central Register of Controlled Trials were performed. Studies with prospective or retrospective designs were included without language restrictions. The summary receiver operating characteristic curve, along with pooled sensitivity and specificity, was estimated using a bivariate random-effects model. The risk of bias and study quality were evaluated using the QUADAS-AI tool. Heterogeneity was quantified using the inconsistency index (<i>I</i> ^<i>2</i> ), derived from Cochran's Q test. Predefined subgroup analyses and bivariate meta-regression were conducted to explore potential sources of heterogeneity. This study was registered with PROSPERO (CRD42024500409).</p><p><strong>Findings: </strong>Twenty eligible studies were identified, with twelve studies included in the meta-analysis. The pooled sensitivity, specificity, and area under the curve of AI for predicting embryonic euploidy were 0.71 (95% CI: 0.59-0.81), 0.75 (95% CI: 0.69-0.80), and 0.80 (95% CI: 0.76-0.83), respectively, based on a total of 6879 embryos (3110 euploid and 3769 aneuploid). Meta-regression and subgroup analyses identified the type of AI-driven decision support system, external validation, risk of bias, and year of publication as the primary contributors to the observed heterogeneity. There was no evidence of publication bias.</p><p><strong>Interpretation: </strong>Our findings indicate that AI algorithms exhibit promising performance in predicting embryonic euploidy based on embryonic imaging. Although the current AI models developed cannot entirely replace invasive methods for determining embryo ploidy, AI demonstrates promise as an auxiliary decision-making tool for embryo selection, particularly for individuals who are unable to undergo PGT-A. To enhance the quality of future research, it is essential to overcome the specific challenges and limitations associated with AI studies in reproductive medicine.</p><p><strong>Funding: </strong>This work was supported by the National Key R&D Program of China (2022YFC2702905), the Shengjing Freelance Researcher Plan of Shengjing Hospital and the 345 talent project of Shengjing Hospital.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102897"},"PeriodicalIF":9.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603810","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":"Response to Campbell et al.'s comments on our study \"Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study\".","authors":"Alizée Bozonnat, Arnaud Serret-Larmande, Marie Beylot-Barry, Martine Bagot, Adèle de Masson","doi":"10.1016/j.eclinm.2024.102895","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102895","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102895"},"PeriodicalIF":9.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603833","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":"Risk factors associated with post-tuberculosis sequelae: a systematic review and meta-analysis.","authors":"Temesgen Yihunie Akalu, Archie C A Clements, Alemneh Mekuriaw Liyew, Beth Gilmour, Megan B Murray, Kefyalew Addis Alene","doi":"10.1016/j.eclinm.2024.102898","DOIUrl":"10.1016/j.eclinm.2024.102898","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Post-tuberculosis (TB) sequelae present a significant challenge in the management of TB survivors, often leading to persistent health issues even after successful treatment. Identifying risk factors associated with post-TB sequelae is important for improving outcomes and quality of life of TB survivors. This systematic review and meta-analysis aims to identify risk factors associated with long-term physical sequelae among TB survivors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We systematically searched Medline, Embase, PROQUEST, and Scopus for studies on long-term physical sequelae among TB survivors up to December 12, 2023. The primary outcome of interest was to quantify risk factors of long-term physical sequelae (i.e., respiratory, hepatic, hearing, neurological, visual, renal, and musculoskeletal sequelae). We included all forms of TB patients who experienced long-term physical sequelae. We used narrative synthesis for risk factors reported once and random-effect meta-analysis for primary outcomes with two or more studies. Findings were presented with odds ratios (OR) and 95% confidence intervals (CI). Publication bias was assessed using funnel plots and Egger regression, and heterogeneity was examined with a Galbraith radial plot. The protocol was registered on Prospero (CRD42021250909).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;A total of 73 articles from 28 countries representing 31,553 TB-treated patients were included in the narrative synthesis, with 64 of these studies included in the meta-analysis. Risk factors associated with post-TB lung sequelae include older age (OR = 1.62, 95% CI: 1.07-2.47), previous TB treatment history (OR = 3.43, 95% CI: 2.37-4.97), smoking (OR = 1.41, 95% CI: 1.09-1.83), alcohol consumption (OR = 1.84, 95% CI: 1.04-3.25), smear-positive pulmonary TB diagnosis (OR = 3.11, 95% CI: 1.77-6.44), and the presence of radiographic evidence of pulmonary lesions at the commencement of treatment (OR = 2.04, 95% CI: 1.07-3.87). Risk factors associated with post-TB liver injury included pre-existing hepatitis (OR = 2.41, 95% CI: 1.16-6.08), previous TB treatment (OR = 2.64, 95% CI: 1.22-6.67), hypo-albuminemia (OR = 2.10, 95% CI: 1.53-2.88), HIV co-infection (OR = 2.72, 95% CI: 1.66-4.46), and CD4 count &lt;200 mm&lt;sup&gt;3&lt;/sup&gt; in HIV-infected individuals (OR = 2.03, 95%CI: 1.26-3.27). Risk factors associated with post-TB hearing loss include baseline hearing problems (OR = 1.72, 95% CI: 1.30-2.26), and HIV co-infection (OR = 3.02, 95% CI: 1.96-4.64).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;This systematic review and meta-analysis found that long-term physical post-TB sequelae including respiratory, hepatic, and hearing impairment were associated with a range of socio-demographic, behavioral, and clinical factors. Identification of these risk factors will help to identify patients who will benefit from interventions to reduce the burden of suffering from post-TB treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Funding: &lt;/strong&gt;Healy Med","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102898"},"PeriodicalIF":9.6,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582352","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":"Clinical update on acute cholecystitis and biliary pancreatitis: between certainties and grey areas.","authors":"Paola Fugazzola, Mauro Podda, Brian Wca Tian, Lorenzo Cobianchi, Luca Ansaloni, Fausto Catena","doi":"10.1016/j.eclinm.2024.102880","DOIUrl":"10.1016/j.eclinm.2024.102880","url":null,"abstract":"<p><p>Acute calculous cholecystitis (ACC) and acute biliary pancreatitis (ABP) are significant complications of gallstone disease. This review aims to provide a comprehensive analysis of current management practices for ACC and ABP. The Tokyo Guidelines (TG) and World Society of Emergency Surgery (WSES) guidelines recommend early laparoscopic cholecystectomy (ELC) as the treatment of choice for ACC. High-risk patients may benefit from alternative treatments like biliary drainage, with emerging techniques such as endoscopic drainage showing promise. ABP requires prompt diagnosis and intervention. The Revised Atlanta Classification (RAC) criteria are used for diagnosis, with endoscopic retrograde cholangiopancreatography (ERCP) and cholecystectomy as primary treatments. Minimally invasive approaches are preferred for managing complications like infected pancreatic necrosis, with the endoscopic step-up method showing superior outcomes. The management of ACC and ABP continues to evolve. Future research is needed to refine guidelines further and address existing controversies, ultimately improving patient outcomes in these acute biliary conditions.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102880"},"PeriodicalIF":9.6,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11513689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142524067","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":"Treatment for essential tremor: a systematic review and Bayesian Model-based Network Meta-analysis of RCTs.","authors":"Junjiao Zhang, Rui Yan, Yusha Cui, Dongning Su, Tao Feng","doi":"10.1016/j.eclinm.2024.102889","DOIUrl":"10.1016/j.eclinm.2024.102889","url":null,"abstract":"<p><strong>Background: </strong>Essential tremor (ET) significantly impacts patients' daily lives and quality of life, presenting a considerable challenge in clinical practice. In recent years, novel therapeutic regimens have been investigated in randomized controlled trials (RCTs). This study aims to investigate and evaluate the relative efficacy and safety of various therapeutic interventions for ET.</p><p><strong>Methods: </strong>We did a systematic review and Bayesian Model-based Network Meta-analysis (NMA) of RCTs. Following PRISMA-NMA guidelines, a comprehensive database search was conducted up to April 1, 2024 to identify RCTs focused on ET treatments. The Bayesian Markov Chain Monte Carlo (MCMC) method was utilized for the analysis, evaluating the relative efficacy and safety of treatments using standardized mean difference (SMD) and log odds ratios (log ORs), respectively. Additionally, the Surface Under the Cumulative Ranking Curve (SUCRA) was applied to assess the relative efficacy of the treatment modalities. PROSPERO registration: CRD42023415752.</p><p><strong>Findings: </strong>This study included 33 RCTs involving 1251 patients, covering 19 oral medication treatments and six non-oral medication treatments. NMA showed that deep brain stimulation (DBS) (SMD = -4.93; 95% CI: [-7.73, -2.13]), CX-8998 (SMD = -2.69; 95% CI: [-5.26, -0.14]), atenolol (SMD = -2.36; 95% CI: [-4.70, -0.10]), and propranolol (SMD = -1.59; 95% CI: [-2.25, -0.67]) showed relative efficacy compared to placebo, with DBS demonstrating relative efficacy compared to 15 other treatment methods. However, GRADE assessment indicated that the evidence level for these conclusions was \"low\" or \"very low.\" According to SUCRA rankings, DBS (0.97) ranked first in relative efficacy, followed by CX-8998 (0.80), thalamotomy (0.79), atenolol (0.76), metoprolol (0.66), propranolol (0.64), magnetic resonance guided focus ultrasound (MR-FUS) (0.624), ICI-118551 (0.620), nimodipine (0.61) and phenobarbitone (0.59). In terms of safety, as a network graph could not be constructed, DBS and thalamotomy were excluded from the NMA, while other effective treatments showed no significant differences in safety compared to placebo.</p><p><strong>Interpretation: </strong>Our study results indicate that CX-8998, propranolol, and atenolol demonstrate relative efficacy and safety in treating ET. DBS is effective for medication-resistant ET and ranks first in relative efficacy, though our NMA lacks safety data for DBS. Given the low overall grade of evidence, these results should be applied cautiously in clinical practice. Further large-scale, head-to-head RCTs are needed.</p><p><strong>Funding: </strong>This work was supported by grants from the National Nature Science Foundation of China (Grant No. 82271459).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"77 ","pages":"102889"},"PeriodicalIF":9.6,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11533039/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575575","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}