{"title":"Prognosis of surgically resected clinical stage 1A non-small cell lung cancers manifesting as a subsolid nodule on computed tomography including pure ground glass nodules.","authors":"Renée Manser, Reem Malouf, Corynne Marchal, Diane Pascoe, Gavin M Wright, Asha Bonney","doi":"10.1002/14651858.CD016091","DOIUrl":"10.1002/14651858.CD016091","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (prognosis). The objectives are as follows: To quantify the risk of tumour relapse/recurrence after a surgical resection of stage 1A non-small cell lung cancer (NSCLC) as manifested on computed tomography (CT) imaging as a subsolid nodule.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD016091"},"PeriodicalIF":8.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143655953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas H Dierikx, Douwe H Visser, Tim de Meij, James Versalovic, Mariska Mg Leeflang, Chris Cooper, Mohan Pammi
{"title":"Molecular assays for the diagnosis of sepsis in neonates: a diagnostic test accuracy review.","authors":"Thomas H Dierikx, Douwe H Visser, Tim de Meij, James Versalovic, Mariska Mg Leeflang, Chris Cooper, Mohan Pammi","doi":"10.1002/14651858.CD011926.pub3","DOIUrl":"10.1002/14651858.CD011926.pub3","url":null,"abstract":"<p><strong>Background: </strong>Microbial cultures for diagnosis of neonatal sepsis have low sensitivity and reporting delay. Advances in molecular microbiology have fostered new molecular assays that are rapid and may improve neonatal outcomes.</p><p><strong>Objectives: </strong>To assess the diagnostic accuracy of various molecular methods for the diagnosis of culture-positive bacterial and fungal sepsis in neonates and to explore heterogeneity among studies by analyzing subgroups classified by gestational age and type of sepsis onset and compare molecular tests with one another.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase and trial registries in August 2023. We checked reference lists of included studies and systematic reviews where subject matter related to the intervention or population examined in this review.</p><p><strong>Selection criteria: </strong>We included studies that were prospective or retrospective, cohort or cross-sectional design, which evaluated molecular assays (index test) in neonates with suspected sepsis in comparison with microbial cultures (reference standard).</p><p><strong>Data collection and analysis: </strong>Two review authors independently screened studies, extracted data and assessed the methodological quality of the studies. We performed meta-analyses using the bivariate model and entered data into Review Manager.</p><p><strong>Main results: </strong>Seventy-four studies were eligible for inclusion, of which 68 studies provided data for meta-analysis. The total number of participants was 14,309 (1328 infants who were culture-positive and 12,981 infants who were culture-negative) from 68 studies that were included in the meta-analysis. The summary estimate of sensitivity was 0.91 (95% confidence interval (CI) 0.85 to 0.95) and of specificity was 0.88 (95% CI 0.83 to 0.92) (low-certainty evidence). We explored heterogeneity by subgroup analyses of type of test, gestational age, type of sepsis onset and prevalence of sepsis. We found insufficient explanations for the heterogeneity (low- to very low-certainty evidence). Sensitivity analyses including studies that analyzed blood samples, using good methodology and those that did not use multiple samples from the same participant revealed similar results (low-certainty evidence).</p><p><strong>Authors' conclusions: </strong>Molecular assays have the advantage of producing rapid results and have moderate diagnostic accuracy. Molecular assays may prevent overuse of antibiotics in neonates with suspected sepsis. The efficacy and cost-effectiveness of these molecular assays should be evaluated using randomized trials comparing molecular assays as an add-on test versus conventional methods without the add-on test in neonates with suspected sepsis.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD011926"},"PeriodicalIF":8.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kirstin L Wilkinson, Catherine Kimber, Alisha Allana, Carolyn Dorée, Rita Champaneria, Susan J Brunskill, Michael F Murphy
{"title":"Red blood cell transfusion management for people undergoing cardiac surgery for congenital heart disease.","authors":"Kirstin L Wilkinson, Catherine Kimber, Alisha Allana, Carolyn Dorée, Rita Champaneria, Susan J Brunskill, Michael F Murphy","doi":"10.1002/14651858.CD009752.pub3","DOIUrl":"10.1002/14651858.CD009752.pub3","url":null,"abstract":"<p><strong>Background: </strong>Congenital heart disease is the most common neonatal congenital condition. Surgery is often necessary. Patients with congenital heart disease are potentially exposed to red cell transfusion preoperatively, intraoperatively and postoperatively when admitted for cardiac surgery. There are a number of risks associated with red cell transfusion that may increase morbidity and mortality.</p><p><strong>Objectives: </strong>To evaluate the association of red blood cell transfusion management with mortality and morbidity in people with congenital heart disease who are undergoing cardiac surgery.</p><p><strong>Search methods: </strong>We searched multiple bibliographic databases and trials registries, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Transfusion Evidence Library, ClinicalTrials.gov and the World Health Organization (WHO) ICTRP. The most recent search was on 2 January 2024, with no limitation by language of publication.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing red blood cell transfusion interventions in patients undergoing cardiac surgery for congenital heart disease. Participants of any age (neonates, paediatrics and adults) and with any type of congenital heart disease (cyanotic or acyanotic) were eligible for inclusion. No comorbidities were excluded.</p><p><strong>Data collection and analysis: </strong>Two of five (AA, CK, KW, SB, SF) review authors independently extracted data and assessed the risk of bias in the trials. We contacted study authors for additional information. Two review authors (CK, KW) used GRADE methodology to assess evidence certainty for critical outcomes and comparisons.</p><p><strong>Main results: </strong>We identified 19 relevant trials. The trials had 1606 participants, all of whom were neonates or children. No trials were conducted in the preoperative period or with adults. The trials compared different types of red blood cell transfusions. No trial compared red blood cell transfusion versus no red blood cell transfusion. None of the trials was at low risk of bias overall. Eight trials had a high risk of bias in at least one domain, most commonly, blinding of participants and personnel. For our critical outcomes, we judged the certainty of the evidence based on GRADE criteria to be low or very low. Five trials (497 participants) compared a restrictive versus a liberal transfusion-trigger. It is very uncertain whether a restrictive transfusion-trigger has an effect on all-cause mortality in the short-term (0 to 30 days post-surgery) (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.42 to 3.00; 3 RCTs, 347 participants; very low certainty evidence) or long term (31 days to two years post-surgery) (RR 0.33, 95% CI 0.01 to 7.87; 1 RCT, 60 participants; very low certainty evidence). The evidence is also very uncertain on the incidence of severe adv","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD009752"},"PeriodicalIF":8.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Themistoklis Paraskevas, Georgios Gakis, Michail Papapanou, Theodoros N Sergentanis, Alexandros Sotiriadis, Charalampos S Siristatidis
{"title":"Statins for preventing preeclampsia.","authors":"Themistoklis Paraskevas, Georgios Gakis, Michail Papapanou, Theodoros N Sergentanis, Alexandros Sotiriadis, Charalampos S Siristatidis","doi":"10.1002/14651858.CD016133","DOIUrl":"10.1002/14651858.CD016133","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the relative benefits and harms of statins for preeclampsia prevention in pregnant women.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD016133"},"PeriodicalIF":8.8,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11915783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Nonsteroidal anti-inflammatory drugs (NSAIDs) for acute renal colic.","authors":"Kourosh Afshar, Jagdeep Gill, Hanan Mostafa, Maryam Noparast","doi":"10.1002/14651858.CD006027.pub3","DOIUrl":"10.1002/14651858.CD006027.pub3","url":null,"abstract":"<p><strong>Background: </strong>Urolithiasis (urinary stones) is a common disease with an increasing incidence globally. It often presents with renal colic, which is characterised by acute and intense abdominal pain. The first step in the management of renal colic is pain control. Various medications, including narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), antispasmodics, and others, have been used for this condition. NSAIDs are amongst the most commonly used drugs for renal colic. They act by reducing inflammation and lowering the pressure inside the urinary collecting system. This review updates a previous Cochrane Systematic Review (Afshar 2015), focusing exclusively on NSAIDs.</p><p><strong>Objectives: </strong>To assess the benefits and harms of different nonsteroidal anti-inflammatory drugs (NSAIDs) for the management of pain in adults with acute renal colic.</p><p><strong>Search methods: </strong>We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, Google Scholar, trial registries, and conference proceedings up to 25 August 2023. We applied no restrictions on publication language or status.</p><p><strong>Selection criteria: </strong>We included randomised (or quasi-randomised) controlled trials (RCTs) assessing the effects of NSAIDs in the management of renal colic adult patients (i.e. study participants over 16 years of age). We included studies that compared NSAIDs versus placebo, one NSAID versus another, or different doses or routes of administration of the same NSAID.</p><p><strong>Data collection and analysis: </strong>Two review authors independently classified studies and abstracted data from the included studies. Primary outcomes included pain up to one hour after treatment as measured by a validated patient-reported tool, the need for rescue medication up to six hours after treatment, and serious adverse events up to one week after treatment. Secondary outcomes included pain recurrence, significant pain relief, and minor adverse events. We performed meta-analysis using the random-effects model. We rated the certainty of evidence according to the GRADE approach.</p><p><strong>Main results: </strong>Our search identified 29 RCTs for inclusion in the review. The 29 studies involved a total of 3593 participants who were randomly allocated to treatment with an NSAID or placebo. The mean age of participants ranged from 27 to 47 years across the studies. Participants used a 10 cm visual analogue scale (VAS) to indicate the extent of their pain. NSAIDs versus placebo NSAIDs may reduce renal colic pain in 30 minutes compared to placebo (mean difference (MD) -3.84 cm, 95% confidence interval (CI) -6.41 to -1.27; I<sup>2</sup> = 95%; 3 studies, 250 participants; low-certainty evidence). The evidence is very uncertain about the effect of NSAIDs on the need for rescue medication (risk ratio (RR) 0.24, 95% CI 0.11 to 0.53; I<sup>2</sup> = 73%; 4 studies, 280 participants; very low-certainty evidence). NSAID","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD006027"},"PeriodicalIF":8.8,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rachel H Robertson, Kylie Russell, Vanessa Jordan, Sanjay Pandanaboyana, Dong Wu, John Windsor
{"title":"Postoperative nutritional support after pancreaticoduodenectomy in adults.","authors":"Rachel H Robertson, Kylie Russell, Vanessa Jordan, Sanjay Pandanaboyana, Dong Wu, John Windsor","doi":"10.1002/14651858.CD014792.pub2","DOIUrl":"10.1002/14651858.CD014792.pub2","url":null,"abstract":"<p><strong>Background: </strong>Resection of the head of the pancreas is most commonly done by a pancreaticoduodenectomy, known as a Whipple procedure. The most common indication for pancreaticoduodenectomy is malignancy, but can include benign tumours and chronic pancreatitis. Complete surgical resection, with negative margins, provides the best prospect of long-term survival. Pancreaticoduodenectomy involves specific and unique alterations to the digestive system and maintaining nutritional status (optimising outcomes and achieving resumption of a normal diet) in patients with cancer after major surgery is a challenge. Malnutrition is a risk factor following pancreaticoduodenectomy, due to the magnitude of the operation and the frequency of complications. Postoperatively, patients are fed either orally, enterally or parenterally. Oral intake may start with fluids and then progress to solid food, or may be ad libitum. Enteral feeding may be via a nasojejunal tube or feeding tube jejunostomy. Parenteral nutrition can be delivered via a central or peripheral intravenous line, and may provide full nutrition (TPN) or partial nutrition (supplemental PN).</p><p><strong>Objectives: </strong>To assess the effects of postoperative nutritional support strategies on complications and recovery in adults after pancreaticoduodenectomy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, LILACS and CINAHL (from inception to October 2022), ongoing trials registers and other internet databases. We searched previous systematic reviews, relevant publications on the same topic and the references of included studies.</p><p><strong>Selection criteria: </strong>Randomised controlled trials of postoperative nutritional interventions in an inpatient setting for patients undergoing pancreaticoduodenectomy. We specifically looked for studies comparing route or timing rather than nutritional content.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed studies for inclusion, judged the risk of bias and extracted data. Studies requiring translation were assessed for inclusion, risk of bias and data extraction by an external translator and another author. We used GRADE to evaluate the certainty of the evidence.</p><p><strong>Main results: </strong>We included 17 studies (1897 participants). Of these, eight studies could be included in a meta-analysis. The route, timing and target of nutritional support varied widely between studies. Enteral feeding (jejunostomy, nasojejunal or gastrojejunostomy) was used in at least 13 studies (one study did not specify the method of enteral route), parenteral nutrition (PN) was used in at least 10 studies (two studies had a control of 'surgeon's preference' and no further details were given) and oral intake was used in seven studies. Overall, the evidence presented in this review is of low to very low certainty. Four studies compared jejunostomy feeding with total parenteral","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD014792"},"PeriodicalIF":8.8,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ana Carolina Nl Fernandes, Cristine H Jorge, Mark Weatherall, Isadora V Ribeiro, Sheila A Wallace, E Jean C Hay-Smith
{"title":"Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women.","authors":"Ana Carolina Nl Fernandes, Cristine H Jorge, Mark Weatherall, Isadora V Ribeiro, Sheila A Wallace, E Jean C Hay-Smith","doi":"10.1002/14651858.CD009252.pub2","DOIUrl":"10.1002/14651858.CD009252.pub2","url":null,"abstract":"<p><strong>Background: </strong>Pelvic floor muscle training (PFMT), compared to no treatment, is effective for treating urinary incontinence (UI) in women. Feedback and biofeedback are additional resources that give women more information about their pelvic floor muscle contraction. The extra information could improve training performance by increasing capability or motivation for PFMT. The Committee on Conservative Management from the 7th International Consultation on Incontinence states that the benefit of adding biofeedback to PFMT is unclear. This review is an update of a Cochrane review last published in 2011.</p><p><strong>Objectives: </strong>The primary objective was to assess the effects of PFMT with feedback or biofeedback, or both, for UI in women. We considered the following research questions. Are there differences in the effects of PFMT with feedback, biofeedback, or both versus PFMT without these adjuncts in the management of stress, urgency or mixed UI in women? Are there differences in the effects of feedback versus biofeedback as adjuncts to PFMT for women with UI? Are there differences in the effects of different types of biofeedback?</p><p><strong>Search methods: </strong>We searched the Cochrane Incontinence Specialised Register (searched 27 September 2023), which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP as well as handsearching of journals and conference proceedings, and the reference lists of relevant articles.</p><p><strong>Selection criteria: </strong>We included only randomised controlled trials (RCTs), cluster-RCTs and quasi-RCTs in women with UI. We excluded studies that recruited women with neurological conditions, who were pregnant or less than six months postpartum. Eligible studies made one of the following comparisons: PFMT plus feedback versus PFMT alone, PFMT plus biofeedback versus PFMT alone, PFMT plus feedback or biofeedback versus PFMT alone, PFMT plus feedback versus PFMT plus biofeedback, and one type of biofeedback versus another.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed studies for eligibility, extracted data onto a prepiloted form, and assessed risk of bias using RoB 1. We used the GRADE approach to assess the certainty of evidence in each comparison by outcome. Our primary outcome was lower urinary tract symptom-specific quality of life. We pooled data using a standardised mean difference (SMD). Secondary outcomes were leakage episodes in 24 hours (mean difference (MD)), leakage severity (MD), subjective cure or improvement (odds ratio (OR)), satisfaction (OR), and adverse events (descriptive summary).</p><p><strong>Main results: </strong>We included 41 completed studies with 3483 women. Most (33 studies, 3031 women) investigated the effect of PFMT with biofeedback versus PFMT alone. Eleven studies were at low risk of bias overall, 27 at unclear risk of bias, and three at ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD009252"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Graziella Filippini, Jera Kruja, Cinzia Del Giovane
{"title":"Rituximab for people with multiple sclerosis.","authors":"Graziella Filippini, Jera Kruja, Cinzia Del Giovane","doi":"10.1002/14651858.CD013874.pub3","DOIUrl":"10.1002/14651858.CD013874.pub3","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is the most common neurological cause of disability in young adults. Off-label rituximab for MS is used in most countries surveyed by the International Federation of MS, including high-income countries where on-label disease-modifying treatments (DMTs) are available. This updates the 2021 version of the review.</p><p><strong>Objectives: </strong>To assess the benefits and harms of rituximab as 'first choice' and 'switching' treatment for adults with any form of MS.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, and three trials registers on 31 December 2023, together with reference checking and contacting study authors to identify unpublished studies.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) and controlled non-randomised studies of interventions (NRSIs) comparing rituximab with placebo or another DMT for adults with any form of MS.</p><p><strong>Data collection and analysis: </strong>We followed standard Cochrane methods. We used RoB 1 to assess risk of bias in RCTs and ROBINS-I in NRSIs. We assessed the certainty of evidence for critical and important prioritised outcomes using GRADE: disability worsening, relapse, serious adverse events (SAEs), health-related quality of life (HRQoL), common infections, cancer, and mortality. We conducted separate analyses for rituximab as 'first choice' or as 'switching' treatment, relapsing or progressive MS, comparison with placebo or another DMT, and RCTs or NRSIs.</p><p><strong>Main results: </strong>In this update, the number of study participants increased from 16,429 (15 studies) to 37,443 (28 studies; 13 new studies: 1 RCT and 12 NRSIs). The studies were conducted worldwide; most originated from high-income countries (25 studies). Public institutions funded 22 (79%) of the studies. Most studies investigated the effects of rituximab on people with relapsing MS (19 studies; 27,500 (73%) participants). We identified 12 ongoing studies. Rituximab as 'first choice' for active relapsing MS None of the included studies compared rituximab to placebo. One RCT compared rituximab to dimethyl fumarate, with 24 months' follow-up. Rituximab may reduce the recurrence of relapse (odds ratio (OR) 0.16, 95% confidence interval (CI) 0.04 to 0.57; 195 participants; low-certainty evidence). The evidence is very uncertain on disability worsening and SAEs. Rituximab may result in little to no difference in upper respiratory tract infections (rate ratio (RR) 1.03, 95% CI 0.79 to 1.34; low-certainty evidence). The evidence is very uncertain for urinary tract, skin, and viral infections. HRQoL, cancer, and mortality were not reported. One NRSI compared rituximab to other DMTs, with 24 months' follow-up. Disability worsening was not reported. Compared with interferon beta or glatiramer acetate, rituximab likely delays relapse (hazard ratio (HR) 0.14, 95% CI 0.05 to 0.39; 1 study, 335 part","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD013874"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Linlin Fan, Jin Xu, Tao Wang, Kun Yang, Xuesong Bai, Wuyang Yang
{"title":"Sulfonylurea drugs for people with severe hemispheric ischemic stroke.","authors":"Linlin Fan, Jin Xu, Tao Wang, Kun Yang, Xuesong Bai, Wuyang Yang","doi":"10.1002/14651858.CD014802.pub2","DOIUrl":"10.1002/14651858.CD014802.pub2","url":null,"abstract":"<p><strong>Background: </strong>Large hemispheric infarction (LHI), caused by occlusion of the internal carotid or middle cerebral artery, is the most malignant type of supratentorial ischemic stroke. Due to severe intracranial edema, mortality fluctuates between 53% and 78%, even after the most effective medical treatment. Decompressive craniectomy can reduce mortality by approximately 17% to 36%, but the neurological outcomes are not satisfactory, and there are contraindications to surgery. Therapeutic hypothermia shows promising effects in preclinical research, but it causes many complications, and clinical studies have not confirmed its efficacy. Glibenclamide is a type of sulfonylurea. Preclinical research shows that glibenclamide can reduce mortality and brain edema and improve neurological outcomes in animal models of ischemic stroke. Sulfonylureas may be a promising treatment for individuals with LHI.</p><p><strong>Objectives: </strong>To evaluate the effects of sulfonylurea drugs in people with large hemispheric ischemic stroke.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, five other databases, and three trials registers. We also searched gray literature sources, checked the bibliographies of included studies and relevant systematic reviews, and used Cited Reference Search in Google Scholar. The latest search date was 23 March 2024.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) that compared sulfonylureas with placebo, hypothermia, or usual care in people with severe hemispheric ischemic stroke.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were neurological and functional outcomes. Our secondary outcomes were death, quality of life, adverse events, and complications. We used GRADE to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>This review includes two RCTs (N = 621): the GAMES-RP trial (glyburide advantage in malignant edema and stroke) and the CHARM trial (phase 3 study to evaluate the efficacy and safety of intravenous BIIB093 (glibenclamide) for severe cerebral edema following large hemispheric infarction). Both studies compared the effects of intravenous glyburide (0.13 mg bolus intravenous injection for the first 2 minutes, followed by an infusion of 0.16 mg/h for the first 6 hours and then 0.11 mg/h for the remaining 66 hours) to placebo. The GAMES-RP trial (N = 86) was conducted in 18 hospitals in the USA (mean age: intervention = 58 ± 11 years; control = 63 ± 9 years); the CHARM trial (N = 535) was conducted in 20 countries across North and South America and Eurasia (mean age: intervention = 60.5 ± 11.17 years; control = 61.6 ± 10.81 years). The overall risk of bias was high in both trials. Neither trial reported neurological outcomes. Compared with placebo, glyburide may result in little to no difference in functional outcomes, assessed with t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD014802"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Esther King, Delia Horn, Nina Gluchowski, Deirdre O'Reilly, Matteo Bruschettini, Chris Cooper, Roger F Soll
{"title":"Safety and efficacy of proton pump inhibitors in preterm infants with gastroesophageal reflux disease.","authors":"Esther King, Delia Horn, Nina Gluchowski, Deirdre O'Reilly, Matteo Bruschettini, Chris Cooper, Roger F Soll","doi":"10.1002/14651858.CD015127.pub2","DOIUrl":"10.1002/14651858.CD015127.pub2","url":null,"abstract":"<p><strong>Background: </strong>Although physiological reflux is seen in nearly all newborns to varying degrees, symptoms can be severe and cause gastroesophageal reflux disease (GERD). In preterm infants, one symptom that is often attributed to GERD is apnea and associated cardiorespiratory events, such as bradycardia and oxygen desaturation. Although the relationship between GERD and apnea, bradycardia, and desaturation events remains a subject of ongoing investigation, trials of agents that reduce gastric acidity, such as proton pump inhibitors (PPI), have been conducted to assess the effect of these agents on GERD.</p><p><strong>Objectives: </strong>To assess the benefits and harms of PPIs for the treatment of preterm infants with diagnosed or suspected GERD.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, two trial registries, and Epistemonikos in October 2023. We checked reference lists of included studies, and studies and systematic reviews in which the subject matter was related to the intervention or population examined in this review.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials, quasi-randomized controlled trials, cross-over trials, and cluster-randomized trials that assessed the use of PPIs (including esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole) alone or in combination. Infants had to receive treatment for a minimum of three days. We considered the following comparisons: (1) PPIs versus no treatment, (2) PPI versus positioning changes (elevated head of bed or prone positioning), (3) PPI versus dietary changes (thickened feeds). We excluded studies examining alginates and histamine receptor blockers. Studies including other non-pharmacological interventions for GERD were included if these interventions were available to infants in all study groups.</p><p><strong>Data collection and analysis: </strong>Two review authors independently identified eligible trials, reviewed the methodological quality of each trial, and extracted data on prespecified outcomes. Data were compared and differences resolved. We used standard methods of Cochrane Neonatal to synthesize data using relative risk (RR), risk difference (RD), and mean difference (MD).</p><p><strong>Main results: </strong>After screening 1217 articles, only two studies, enrolling a total of 62 infants, met our criteria. Both studies compared the use of PPIs to no treatment (placebo). One study included ten infants with a mean gestational age of 36.1 ± 0.7 weeks, who were treated with seven days of PPI or placebo, and then crossed over to the other study arm for seven days, with gastric pH monitoring performed at the end of each week. The other study included 52 infants with a mean gestational age of 31 weeks, who were randomized to a PPI or placebo for 14 days, with various outcomes measured at baseline and after 14 days. Both studies were judged to be at low risk of bias. Only one study (N = 52","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"3 ","pages":"CD015127"},"PeriodicalIF":8.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}