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BMJ Open Aug 2023To systematically investigate the associations between vision impairment and risk of motor vehicle crash (MVC) involvement, and evaluate vision-related interventions to... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To systematically investigate the associations between vision impairment and risk of motor vehicle crash (MVC) involvement, and evaluate vision-related interventions to reduce MVCs.
DESIGN
Medline (Ovid), EMBASE and Global Health electronic databases were systematically searched from inception to March 2022 for observational and interventional English-language studies. Screening, data extraction and appraisals using the Joanna Briggs Institute appraisal tools were completed by two reviewers independently. Where appropriate, measures of association were converted into risk ratios (RRs) or ORs for meta-analysis.
PARTICIPANTS
Drivers of four-wheeled vehicles of all ages with no cognitive declines.
PRIMARY AND SECONDARY OUTCOMES
MVC involvement (primary) and driving cessation (secondary).
RESULTS
101 studies (n=778 052) were included after full-text review. 57 studies only involved older drivers (≥65 years) and 85 were in high-income settings. Heterogeneity in the data meant that most meta-analyses were underpowered as only 25 studies, further split into different groups of eye diseases and measures of vision, could be meta-analysed. The limited evidence from the meta-analyses suggests that visual field defects (four studies; RR 1.51 (95% CI 1.23, 1.85); p<0.001; I=46.79%), and contrast sensitivity (two studies; RR 1.40 (95% CI 1.08, 1.80); p=0.01, I=0.11%) and visual acuity loss (five studies; RR 1.21 (95% CI 1.02, 1.43); p=0.03, I=28.49%) may increase crash risk. The results are more inconclusive for available evidence for associations of glaucoma (five studies, RR 1.27 (95% CI 0.67, 2.42); p=0.47; I=93.48%) and cataract (two studies RR 1.15 (95% CI 0.97, 1.36); p=0.11; I=3.96%) with crashes. Driving cessation may also be linked with glaucoma (two studies; RR 1.62 (95% CI 1.20, 2.19); p<0.001, I=22.45%), age-related macular degeneration (AMD) (three studies; RR 2.21 (95% CI 1.47, 3.31); p<0.001, I=75.11%) and reduced contrast sensitivity (three studies; RR 1.30 (95% CI 1.05, 1.61); p=0.02; I=63.19%). Cataract surgery halved MVC risk (three studies; RR 0.55 (95% CI 0.34, 0.92); p=0.02; I=97.10). Ranibizumab injections (four randomised controlled trials) prolonged driving in persons with AMD.
CONCLUSION
Impaired vision identified through a variety of measures is associated with both increased MVC involvement and cessation. Cataract surgery can reduce MVC risk. Despite literature being highly heterogeneous, this review shows that detection of vision problems and appropriate treatment are critical to road safety.
PROSPERO REGISTRATION NUMBER
CRD42020172153.
Topics: Humans; Visual Acuity; Ranibizumab; Accidents, Traffic; Macular Degeneration; Vision Disorders; Cataract
PubMed: 37567751
DOI: 10.1136/bmjopen-2022-065210 -
Frontiers in Oncology 2023Zolbetuximab is a "first-in-class" chimeric lgG1 monoclonal antibody targeting Claudin18.2 (CLDN 18.2). In recent years, several important trials have been published...
Efficacy and safety of zolbetuximab for first-line treatment of advanced Claudin 18. 2-positive gastric or gastro-esophageal junction adenocarcinoma: a systematic review and meta-analysis of randomized controlled trials.
OBJECTIVE
Zolbetuximab is a "first-in-class" chimeric lgG1 monoclonal antibody targeting Claudin18.2 (CLDN 18.2). In recent years, several important trials have been published showing that zolbetuximab is associated with improved prognosis in patients with advanced gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma. This promises great change to the current treatment landscape. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of zolbetuximab for first-line treatment of advanced CLDN 18. 2-positive G/GEJ adenocarcinoma.
METHODS
The following databases were searched for relevant studies: PubMed, EMBASE, and Cochrane library (updated 10 June 2023). All randomized trials comparing zolbetuximab plus chemotherapy versus first-line chemotherapy alone for first-line treatment of advanced CLDN 18. 2-positive G/GEJ adenocarcinoma were eligible for inclusion. Data were analyzed using Review Manager 5.4.1 (Cochrane collaboration software). Primary outcomes and measures included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs).
RESULTS
This systematic review and meta-analysis included three randomized controlled studies involving 1,402 patients (699 receiving zolbetuximab plus chemotherapy and 703 receiving chemotherapy alone). Compared with chemotherapy alone, zolbetuximab plus chemotherapy significantly improved OS (HR = 0.73; 95% CI: 0.68-0.84) and PFS (HR = 0.64; 95% CI: 0.50-0.82), but did not result in a higher ORR (RR = 0.92; 95% CI: 0.82-1.03). Further analysis of CLDN 18.2 expression showed a more significant benefit for OS (HR = 0.69; 95% CI: 0.55-0.87; = 0.002) and PFS (HR = 0.61; 95% CI: 0.44-0.84; = 0.003) from zolbetuximab in patients with high expression, while there was significant benefit in patients with lower expression. In terms of AEs, zolbetuximab plus chemotherapy was associated with higher risk of grade 3 and higher AEs, but increased risk of nausea and vomiting were more common.
CONCLUSION
This systematic review and meta-analysis revealed that the effect of zolbetuximab plus chemotherapy was superior to that of chemotherapy alone for first-line treatment of advanced CLDN 18.2-positive G/GEJ adenocarcinoma. Thus, zolbetuximab plus chemotherapy represents a new first-line treatment for these patients. Zolbetuximab plus chemotherapy was associated with higher risk of grade 3 and higher AEs, but was generally manageable.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero, identifier (CRD42023437126).
PubMed: 37886169
DOI: 10.3389/fonc.2023.1258347 -
Journal of Ethnopharmacology Apr 2024Conventional treatments for Hashimoto's thyroiditis (HT) are limited. Herbal medicines (HM) are considered a potential intervention for the treatment of HT. (Meta-Analysis)
Meta-Analysis Review
ETHNOPHARMACOLOGICAL RELEVANCE
Conventional treatments for Hashimoto's thyroiditis (HT) are limited. Herbal medicines (HM) are considered a potential intervention for the treatment of HT.
AIM OF THE STUDY
This study aimed to investigate the efficacy and safety of HM for HT.
MATERIALS AND METHODS
A Bayesian network meta-analysis was conducted for patients with HT in randomized controlled trials identified in PubMed, Cochrane Library, Web of Science, EMBASE, Chinese Clinical Trial Registry (Chi CTR), China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (the VIP), China Chinese Biomedical Database (CBM), and Wanfang Database were searched from their inception to Oct 1, 2022. Outcomes included the primary outcome (TPOAb), secondary outcomes (TSH, TGAb, FT3, FT4, and traditional Chinese medicine symptom scores), and adverse events. This study was registered in PROSPERO (CRD42022363640).
RESULTS
Sixteen trials were reviewed and 16 HM formulae were compared. Compared with non-drug therapy (NDT), all therapies, except for Tiaoqi-Qingjie Therapy, reduced the primary outcome of TPOAb with different levels of effectiveness, ranging from 0.01 (95%CI 0.00, 0.02) to 0.92 (95%CI 0.56, 1.53). Ranking probability analysis indicated that Yiqi Huayu Recipe, Liqi Xiaoying decoction, and Shugan Sanjie therapy reduced thyroid antibody levels the most, including TPOAb (100.0%, 90.9%, and 90.3%, respectively) and TGAb (98.3%, 94.4%, and 87.3%, respectively). All HMs displayed a significant effect on the TCM Symptom score and possibly benefitted the treatment of HT, ranging from 6.62 (95% CI 2.06, 21.24) to 94.50 (95% CI 15.97, 559.14). No serious adverse events were reported.
CONCLUSIONS
Herbal medicines may be effective in the treatment of HT, especially in reducing thyroid antibody levels and improving clinical symptoms without affecting thyroid function. However, these results should be considered preliminary and further verified using high-quality evidence.
Topics: Humans; Network Meta-Analysis; Bayes Theorem; Medicine, Chinese Traditional; Plants, Medicinal; Plant Extracts; Thyroiditis; Drugs, Chinese Herbal; Randomized Controlled Trials as Topic
PubMed: 38181936
DOI: 10.1016/j.jep.2023.117663 -
Digestive Diseases and Sciences May 2024Infliximab and vedolizumab are widely used to treat Crohn's disease (CD) and ulcerative colitis (UC). (Meta-Analysis)
Meta-Analysis Comparative Study
Comparative Efficacy of Subcutaneous and Intravenous Infliximab and Vedolizumab for Maintenance Treatment of TNF-naive Adult Patients with Inflammatory Bowel Disease: A Systematic Literature Review and Network Meta-analysis.
BACKGROUND
Infliximab and vedolizumab are widely used to treat Crohn's disease (CD) and ulcerative colitis (UC).
AIMS
This systematic review and network meta-analysis evaluated comparative efficacy of various regimens for intravenous or subcutaneous infliximab and vedolizumab during maintenance treatment in CD and UC.
METHODS
Parallel-group randomized controlled trials (RCTs) were identified by a systematic literature review (CRD42022383401) and included if they evaluated therapeutics of interest for maintenance treatment of adults with moderate-to-severe luminal CD or UC and assessed clinical remission between Weeks 30 and 60. Clinical remission rates in CD or UC and mucosal healing rates in UC were analyzed in a Bayesian network meta-analysis model. Endoscopic outcomes in CD were synthesized by proportional meta-analysis.
RESULTS
Overall, 13 RCTs were included in the analyses. All vedolizumab studies randomized induction responders to maintenance treatment; infliximab studies used a treat-through design. Subcutaneous infliximab 120 mg every 2 weeks had the highest odds ratio (OR) [95% credible interval] versus placebo for clinical remission during the maintenance phase (CD: 5.90 [1.90-18.2]; UC: 5.45 [1.94-15.3]), with surface under the cumulative ranking curve (SUCRA) values of 0.91 and 0.82, respectively. For mucosal healing in UC, subcutaneous infliximab 120 mg every 2 weeks showed the highest OR (4.90 [1.63-14.1]), with SUCRA value of 0.73, followed by intravenous vedolizumab 300 mg every 4 weeks (SUCRA value, 0.70). Endoscopic outcomes in CD were better with subcutaneous infliximab 120 mg every 2 weeks than intravenous infliximab 5 mg/kg every 8 weeks.
CONCLUSIONS
Subcutaneous infliximab showed a favorable efficacy profile for achieving clinical remission and endoscopic outcomes during maintenance treatment in CD or UC.
Topics: Humans; Infliximab; Antibodies, Monoclonal, Humanized; Injections, Subcutaneous; Gastrointestinal Agents; Colitis, Ulcerative; Crohn Disease; Administration, Intravenous; Treatment Outcome; Adult; Randomized Controlled Trials as Topic; Remission Induction; Network Meta-Analysis; Maintenance Chemotherapy
PubMed: 38499736
DOI: 10.1007/s10620-023-08252-1 -
Rheumatology (Oxford, England) May 2024To compare the efficacy and safety of bimekizumab 160 mg every 4 weeks, a selective inhibitor of IL-17F and IL-17A, with those of biologic/targeted synthetic DMARDs... (Meta-Analysis)
Meta-Analysis Comparative Study
OBJECTIVES
To compare the efficacy and safety of bimekizumab 160 mg every 4 weeks, a selective inhibitor of IL-17F and IL-17A, with those of biologic/targeted synthetic DMARDs (b/tsDMARDs) in non-radiographic axial SpA (nr-axSpA) and AS.
METHODS
A systematic literature review identified randomized controlled trials until January 2023 for inclusion in Bayesian network meta-analyses (NMAs), including three b/tsDMARDs exposure networks: predominantly-naïve, naïve, and experienced. Outcomes were Assessment of SpondyloArthritis international Society (ASAS)20, ASAS40 and ASAS partial remission (PR) response rates at 12-16 weeks. A safety NMA investigated discontinuations due to any reason and serious adverse events at 12-16 weeks.
RESULTS
The NMA included 36 trials. The predominantly-naïve network provided the most comprehensive results. In the predominantly-naïve nr-axSpA analysis, bimekizumab had significantly higher ASAS20 response rates vs secukinumab 150 mg [with loading dose (LD)/without LD], and comparable response rates vs other active comparators. In the predominantly-naïve AS analysis, bimekizumab had significantly higher ASAS40 response rates vs secukinumab 150 mg (without LD), significantly higher ASAS-PR response rates vs secukinumab 150 mg (with LD) and comparable response rates vs other active comparators. Bimekizumab demonstrated similar safety to that of other b/tsDMARDs.
CONCLUSION
Across ASAS outcomes, bimekizumab was comparable with most b/tsDMARDs, including ixekizumab, TNF inhibitors and upadacitinib, and achieved higher response rates vs secukinumab for some ASAS outcomes in predominantly b/tsDMARD-naïve nr-axSpA and AS patients at 12-16 weeks. In a pooled axSpA network, bimekizumab demonstrated comparable safety vs other b/tsDMARDs.
Topics: Humans; Antirheumatic Agents; Network Meta-Analysis; Antibodies, Monoclonal, Humanized; Treatment Outcome; Axial Spondyloarthritis; Randomized Controlled Trials as Topic; Interleukin-17
PubMed: 37947318
DOI: 10.1093/rheumatology/kead598 -
Intraseasonal waning immunity of seasonal influenza vaccine - A systematic review and meta-analysis.Vaccine Jul 2023Recently, studies have suggested that influenza antibody titers decline with time since vaccination. Duration of vaccine protection is an important factor to determine... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recently, studies have suggested that influenza antibody titers decline with time since vaccination. Duration of vaccine protection is an important factor to determine the optimal timing of vaccination.
OBJECTIVE
We aimed to systematically evaluate the implication of waning immunity on the duration of seasonal influenza vaccine antibody response.
METHOD
Electronic databases and clinical trial registries were systematically searched to identify phase III/IV randomized clinical trials evaluating the immunogenicity of seasonal influenza vaccines measured by hemagglutination inhibition assay in healthy individuals six months of age and older. Meta-analyses were conducted to compare adjuvanted and standard influenza vaccine responses with time since vaccination.
RESULTS
1918 articles were identified, of which ten were included in qualitative synthesis and seven in quantitative analysis (children; n=3, older adults; n=4). All studies were deemed to be at low risk of bias, except one study deemed at high risk of bias due to missing outcome data. The majority of included studies found a rise in antibody titers at one-month followed by a decline at six-month post-vaccination. At six-months post-vaccination overall risk differences in seroprotection were significantly higher for children vaccinated with adjuvanted compared to standard vaccines (0.29; 95 % confidence interval (CI), 0.14-0.44). A small increase in seroprotection levels was observed among older adults vaccinated with an adjuvanted compared to standard vaccines, which remained constant over six-months (pre-vaccination: 0.03; 95 % CI, 0.00-0.09 and one- and six-months post-vaccination: 0.05; 95 % CI, 0.01-0.09).
CONCLUSIONS
Our results found evidence of persistent antibody responses following influenza vaccination over the course of a typical influenza season. Even if influenza vaccine responses wane over a six-month period, vaccination likely still provides a significant advantage in protection, which may be enhanced with adjuvanted vaccines, particularly in children. Further research is needed to identify the exact timing when the decline in antibody response begins to better inform the optimal timing of influenza vaccination programs.
TRIAL REGISTRATION
PROSPERO (CRD42019138585).
Topics: Child; Humans; Aged; Influenza Vaccines; Influenza, Human; Seasons; Antibodies, Viral; Vaccination; Adjuvants, Immunologic; Hemagglutination Inhibition Tests
PubMed: 37331840
DOI: 10.1016/j.vaccine.2023.06.038 -
Hepatology Communications Oct 2023Progressive familial intrahepatic cholestasis (PFIC) is a heterogeneous rare congenital cholestatic liver disease. Disease progression might necessitate liver... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Progressive familial intrahepatic cholestasis (PFIC) is a heterogeneous rare congenital cholestatic liver disease. Disease progression might necessitate liver transplantation (LT). The aim of this study was to describe the outcome of PFIC1-4 patients after LT.
METHODS
Electronic databases were searched to identify studies on PFIC and LT. Patients were categorized according to PFIC type, genotype, graft type, age at LT, time of follow-up, and complications and treatment during follow-up.
RESULTS
Seventy-nine studies with 507 patients met inclusion criteria; most patients were classified as PFIC1-3. The median age at LT was 50 months. The overall 5-year patient survival was 98.5%. PFIC1 patients with diarrhea after LT were at significant risk of developing graft steatosis ( p < 0.0001). Meta-analysis showed an efficacy of 100% [95% CI: 73.9%-100%] for surgical biliary diversion to ameliorate steatosis and 94.9% [95% CI: 53.7%-100%] to improve diarrhea (n = 8). PFIC2 patients with bile salt export pump (BSEP)2 or BSEP3-genotype were at significant risk of developing antibody-induced BSEP deficiency (AIBD) ( p < 0.0001), which was reported in 16.2% of patients at a median of 36.5 months after LT. Meta-analysis showed an efficacy of 81.1% [95% CI: 47.5%-100%] for rituximab-based treatment regimens to improve AIBD (n = 18). HCC was detected in 3.6% of PFIC2 and 13.8% of PFIC4 patients at LT.
CONCLUSIONS
Fifty percent of PFIC1 patients develop diarrhea and steatosis after LT. Biliary diversion can protect the graft from injury. PFIC2 patients with BSEP2 and BSEP3 genotypes are at significant risk of developing AIBD, and rituximab-based treatment regimens effectively improve AIBD. PFIC3 patients have no PFIC-specific complications following LT.
Topics: Humans; Child, Preschool; Liver Transplantation; Rituximab; Carcinoma, Hepatocellular; Liver Neoplasms; Fatty Liver; Diarrhea; Cholestasis; Cholestasis, Intrahepatic; Steroid Metabolism, Inborn Errors
PubMed: 37756114
DOI: 10.1097/HC9.0000000000000286 -
Nutrients Oct 2023The incidence of type 1 diabetes mellitus in children is considerably increasing in western countries. Thus, identification of the environmental determinants involved... (Review)
Review
AIMS AND HYPOTHESIS
The incidence of type 1 diabetes mellitus in children is considerably increasing in western countries. Thus, identification of the environmental determinants involved could ultimately lead to disease prevention. Here, we aimed to systematically review (PROSPERO ID: CRD42022362522) the current evidence of the association between maternal dietary factors during gestation and the risk of developing type 1 diabetes and/or islet autoimmunity (IA) in murine and human offspring.
METHODS
In accordance with PRISMA guidelines, the present systematic review searched PubMed and Scopus ( = 343) for different combinations of MeSH terms, such as type 1 diabetes, diet, islet autoimmunity, prenatal, nutrient, gluten, gliadin, vitamin, milk, and fibers.
RESULTS
We found that the most investigated dietary factors in the present literature were gluten, dietary advanced glycosylated end products (dAGEs), vitamin D, fatty acids, and iron. The results concerning prenatal exposure to a gluten-free environment showed a consistently protective effect on the development of IA. Prenatal exposures to vitamin D and certain fatty acids appeared to protect against the development of IA, whereas in utero iron and fat exposures correlated with increased risks of IA.
CONCLUSION
We conclude that a definite association is not established for most factors investigated as the literature represents a heterogeneous pool of data, although fetal exposures to some maternal dietary components, such as gluten, show consistent associations with increased risks of IA. We suggest that human prospective dietary intervention studies in both cohort and clinical settings are crucial to better evaluate critical and protective prenatal exposures from the maternal diet during pregnancy.
Topics: Child; Pregnancy; Female; Humans; Animals; Mice; Diabetes Mellitus, Type 1; Autoimmunity; Islets of Langerhans; Vitamin D; Vitamins; Fatty Acids; Glutens; Iron; Autoantibodies; Risk Factors
PubMed: 37892409
DOI: 10.3390/nu15204333 -
Journal of the European Academy of... Jan 2024Mogamulizumab is a first-in-class IgG1k monoclonal antibody that selectively targets the chemokine receptor type 4. The drug has received Food and Drug administration... (Review)
Review
Mogamulizumab is a first-in-class IgG1k monoclonal antibody that selectively targets the chemokine receptor type 4. The drug has received Food and Drug administration authorisation for mycosis fungoides and Sézary syndrome following failure of at least one previous course of systemic therapy and now is available in Europe. One of the most common treatment-related side effects observed has been the mogamulizumab-associated rash (MAR), which affects up to a quarter of patients and is the most frequent adverse event leading to drug discontinuation. The aim of this study is to perform a systematic review of the literature on patients diagnosed with MAR and other mogamulizumab-related cutaneous events to describe the clinical and histological characteristics, the management in clinical practice and to assess whether these events have prognostic implications. In total, 2073 records were initially identified through a literature search, 843 of which were duplicates. After screening for eligibility and inclusion criteria, 49 articles reporting mogamulizumab-associated cutaneous events were included. Totally, 1516 patients were retrieved, with a slight male prevalence as for the available data (639 males and 570 females, i.e. 52.9% vs. 47.1%). Regarding the reported clinicopathological findings of the cutaneous reactions, the five most common patterns were spongiotic/psoriasiform dermatitis (22%), eruptions characterized by the presence of papules and/or plaques (16.1%), cutaneous granulomatosis (11.4%), morbilliform or erythrodermic dermatitis (9.4%) and photodermatitis (7.1%). Our results highlight how the majority of the reported cutaneous adverse events on mogamulizumab are of mild-to-moderate entity and generally manageable in clinical practice, though prompt recognition is essential and case-by-case assessment should be recommended. Future research will need to focus on the MAR prognostic implications and to identify genomic and molecular markers for a more rapid and accurate diagnosis.
PubMed: 38279614
DOI: 10.1111/jdv.19801 -
Human Vaccines & Immunotherapeutics Dec 2024Pertussis is a vaccine-preventable infectious disease; however, data on pertussis antibody levels in a nationwide population are still limited in China. We aimed to pool... (Meta-Analysis)
Meta-Analysis Review
Pertussis is a vaccine-preventable infectious disease; however, data on pertussis antibody levels in a nationwide population are still limited in China. We aimed to pool the seropositivity rates of IgG antibodies against pertussis toxin (PT-IgG) across the country. We systematically searched PubMed, Web of Science, Embase, and the China National Knowledge Infrastructure Database for studies published between January 1, 2010, and June 30, 2023. Studies reporting the seroprevalence of PT-IgG among a healthy Chinese population were included. Pooled estimates were obtained using random-effects meta-analyzes. The meta-analysis included 39 studies (47,778 participants) reporting anti-PT IgG seropositivity rates. The pooled rate for all ages was 7.06% (95% CI, 5.50%-9.07%). Subgroup analyzes showed rates ranging from 6.36% to 12.50% across different age groups. This meta-analysis indicated a low anti-PT IgG seropositivity rate in the Chinese population, particularly among school-aged children and young adults. This finding underscores the urgent need to refine immunization strategies.
Topics: Humans; Seroepidemiologic Studies; Pertussis Toxin; Immunoglobulin G; Whooping Cough; China; Antibodies, Bacterial; Child; Adult; Young Adult; Adolescent; Child, Preschool; Middle Aged; Pertussis Vaccine; East Asian People
PubMed: 38695296
DOI: 10.1080/21645515.2024.2341454