Iskanje po repozitoriju

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Objavljeno v DiRROS: 28.01.2026; Ogledov: 113; Prenosov: 0

Povzetek: The term Advanced Combination Treatment (ACT) involves the combination of at least two biologics or the use of a biologic with a small molecule drug, each with different mechanisms of action. This narrative review evaluates the current evidence supporting ACT in inflammatory bowel disease (IBD), focusing on preclinical studies, real-world evidence, and randomized controlled trials. A systematic review of randomized controlled trials has concluded that ACT significantly improves clinical outcomes, without significant safety concerns in patient with IBD. However, variability in trial designs and the lack of standardized outcome measures have led to initiatives aimed at mitigating these issues through a clear expert consensus. While the evidence for ACT in IBD is compelling, substantial challenges remain in standardizing treatment protocols and ensuring long-term safety. In the meantime, the use of ACT in clinical practice remains off-label and requires careful consideration of patient-specific factors. Future clinical trials should consider robust biomarkers for patient selection and leverage mechanistic insights to select combination components.
Ključne besede: immune-mediated inflammatory diseases, therapeutic ceiling, Crohn's diseaseulcerative colitis
Objavljeno v DiRROS: 16.01.2026; Ogledov: 226; Prenosov: 86
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Povzetek: Background and aims: We assessed placebo rates and associated factors using individual patient data (IDP) from randomised clinical trials (RCTs) in ulcerative colitis (UC). Methods: We conducted an IPD meta-analysis using Vivli and Yale University Open Data Access data-sharing platforms. Phase 2 and 3 RCTs of advanced biologics in adults with moderate-to-severe UC published since 2010 were included. Pooled placebo rates and 95% CIs were estimated using one-and two-stage meta-analytical approaches. Significant patient-level factors (P < 0·05) were identified using regression analyses. Primary outcomes were clinical response and remission. Results: Data were available for 1703 patients from nine studies. For induction trials, overall placebo response and remission rates were 33% (95% CI 29%–38%) and 9% (95% CI 7%–11%). Overall placebo response and remission rates in maintenance trials were 28% (95% CI 18%–41%) and 14% (95% CI 9%–20%). A lower body mass index reduced odds of placebo response and remission, while higher baseline albumin levels and left-sided (compared to extensive) UC increased the odds of these outcomes. A one-point increase in the Mayo Clinic Score (MCS) and adapted MCS was associated with a 26% and 27% reduction in odds of clinical remission. For induction trials, prior biologic exposure was associated with lower odds of response and remission. Multi-centre trials have lower placebo effects than single-centre trials. Conclusions: These results enable future trials to incorporate design elements that reduce placebo rates as well as a precise benchmark for expected rates in clinical trials that do not include placebo.
Ključne besede: inflammatory bowel disease, placebo effect, clinical trials, ulcerative colitis
Objavljeno v DiRROS: 13.01.2026; Ogledov: 134; Prenosov: 96
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Povzetek: A colorectal-vaginal fistula (CRVF) can occur as a complication of rectal cancer surgery. They can cause discomfort, repeated infection, need for treatment/further surgery, and a permanent stoma (an opening in the abdomen to collect bowel contents). This study looked at how often CRVF happened after surgery complicated by a leak where bowels ends have been joined together, how they were treated, and how likely patients were to live without a stoma 1 year after surgery. Researchers collected data on women from around the world who had rectal cancer surgery between 2014 and 2018 and developed a bowel leak (called anastomotic leakage). They compared those with and without a CRVF. A total of 88 out of 694 patients (12.7%) developed a CRVF. These patients more often had major surgery involving removal of nearby organs, including part of the vagina. They were more likely to have ongoing problems and needed more surgeries to manage them. Most had a temporary stoma, but only 29.5% could live without it after 1 year, compared with 48.7% of women without CRVF. CRVF is a serious complication that makes recovery harder. These patients are less likely to live without a stoma and usually need more surgery. However, if the leak is small, the chances of recovery without a permanent stoma are better.
Ključne besede: rectal fistula, rectal cancer, rectal resections, postoperative complications, anastomotic leak
Objavljeno v DiRROS: 05.01.2026; Ogledov: 351; Prenosov: 92
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Povzetek: Background: Data on multinational 90-day mortality and morbidity rates after surgery for gastric cancer is limited in the literature. This study aimed to understand the 90-day mortality and morbidity outcomes among patients undergoing elective gastric cancer surgery, as in the GASTRODATA Registry, and to identify associated risk factors. Methods: We conducted an international prospective study on patients aged ≥ 18 years undergoing elective surgery for gastric cancer with curative intent from January 4 to September 30, 2022. Known metastatic disease, concurrent secondary cancers, gastrointestinal stromal tumour (GIST) and Siewert type I/II oesophagogastric junction malignancies were excluded. Univariate and multivariate logistic regression were used to identify variables associated with the 90-day outcome. Results: 380 collaborators from 47 countries submitted data on 1538 patients. Median age was 65 years (IQR: 19–94), and 58.5% were males. 90-day morbidity and mortality rates were 38.2% (n = 587) and 2.9% (n = 45), respectively. Pre-operative higher Charlson Comorbidity Index, higher ASA score, pre-operative weight loss > 10%, positive specimen margin, and post-operative pathological IV staging (p value < 0.05) were significantly associated with clinically relevant complications and mortality. Conclusion: Elective gastric cancer surgery has a 90-day morbidity of 38.2% and a 90-day mortality of 2.9% globally. This study provided the most comprehensive international 90-day prospective data to date regarding gastric cancer surgery. Several factors associated with higher morbidity were identified, highlighting the importance of a unified language on surgical morbidity, prehabilitation, and ongoing audits to enhance patient outcomes.
Ključne besede: gastric cancer, elective surgery, morbidity, mortality, 90-day postoperative outcomes, multinational audit, surgical complications, anastomotic leaks, patient safety
Objavljeno v DiRROS: 16.12.2025; Ogledov: 287; Prenosov: 109
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