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Biomolecules Mar 2022Cochlear implantation initiates an inflammatory cascade in which both acute insertion trauma and chronic foreign body reaction lead to intracochlear fibrosis and loss of... (Review)
Review
Cochlear implantation initiates an inflammatory cascade in which both acute insertion trauma and chronic foreign body reaction lead to intracochlear fibrosis and loss of residual hearing. Several strategies have been proposed to attenuate the local reactive process after implantation, including intracochlear drug delivery. The present study gives an overview of what is being investigated in the field of inner ear therapeutics and cochlear implant surgery. The aim is to evaluate its potential benefit in clinical practice. A systematic search was conducted in PubMed, Embase, and Cochrane Library databases identifying comparative prospective studies examining the effect of direct inner ear drug application on mechanical cochlear trauma. Both animal and human studies were considered and all studies were assessed for quality according to the validated risk of bias tools. Intracochlear administration of drugs is a feasible method to reduce the local inflammatory reaction following cochlear implantation. In animal studies, corticosteroid use had a significant effect on outcome measures including auditory brainstem response, impedance, and histological changes. This effect was, however, only durable with prolonged drug delivery. Significant differences in outcome were predominantly seen in studies where the cochlear damage was extensive. Six additional reports assessing non-steroidal agents were found. Overall, evidence of anti-inflammatory effects in humans is still scarce.
Topics: Animals; Cochlear Implantation; Cochlear Implants; Ear, Inner; Hearing; Prospective Studies
PubMed: 35454118
DOI: 10.3390/biom12040529 -
Frontiers in Pharmacology 2022To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA)...
To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA) implant, 0.2 µg/day, 0.59 and 2.1 mg; intravitreal bevacizumab, 1.25 mg; intravitreal ranibizumab, 0.5 mg; intravitreal triamcinolone acetonide (IVTA), 2 and 4 mg; and standard of care (SOC, systemic therapy) for noninfectious uveitis. We searched the Cochrane Library database, EMBASE, Medline, clinicaltrials.gov until April 2021 with 13 RCTs (1806 participants) identified and conducted a pairwise and Bayesian network meta-analysis with random effects. No specific regimen showed a statistically significant advantage or disadvantage to another treatment regimen with regard to efficacy. However, the FA implant, 0.59 mg was associated with a higher risk of cataract (RR 4.41, 95% CI 1.51-13.13) and raise in intraocular pressure (IOP) (RR 2.53 95% CI 1.14-6.25) compared with SOC at 24 months. IVTA, 4 mg at 6 months was associated with lower risk of IOP rising compared with FA implant, 0.2 µg/day at 36 months (RR 3.43 95% CI 1.12-11.35). No intravitreal therapeutic regimens showed a significant advantage or disadvantage with regard to efficacy. However, SOC was associated with lower risk of side effects compared with FA implants. IVTA, 4 mg, might be the best choice with lowest risk of IOP rising. clinicaltrials.gov, identifier CRD42020172953.
PubMed: 35450045
DOI: 10.3389/fphar.2022.749312 -
International Journal of Implant... Apr 2022The aim of this study was to systematically review the available evidence to evaluate the efficacy of vitamin D supplementation or vitamin D depletion on the... (Review)
Review
PURPOSE
The aim of this study was to systematically review the available evidence to evaluate the efficacy of vitamin D supplementation or vitamin D depletion on the osseointegration of implants in animals and humans.
METHODS
The focus questions addressed were "Do vitamin D deficient subjects treated with (dental) implants have an inferior osseointegration than subjects with adequate serum vitamin D level?" and "Do vitamin D supplemented subjects treated with (dental) implants have a superior osseointegration than subjects with adequate serum vitamin D level?" Humans and animals were considered as subjects in this study. Databases were searched from 1969 up to and including March 2021 using different combination of the following terms: "implant", "bone to implant contact", "vitamin D" and "osseointegration". Letters to the editor, historic reviews, commentaries and articles published in languages other than English and German were excluded. The pattern of the present systematic review was customize to primarily summarize the pertinent data.
RESULTS
Thirteen experimental studies with animals as subject, two clinical studies and three case reports, with humans as subjects, were included. The amount of inserted titanium implants ranged between 24 and 1740. Results from three animal studies showed that vitamin D deficiency has a negative effect on new bone formation and/or bone to implant contact (BIC). Eight animal studies showed that vitamin D supplementation has a enhancing effect on BIC and/or new bone formation around implants. Furthermore, enhancing the impact of vitamin D supplementation on the osseointegration of implants in subjects with diabetes mellitus, osteoporosis and chronic kidney disease (CKD) were assessed. Studies and case reports involving human subjects showed that patients with a low serum vitamin D level have a higher tendency to exhibit an early dental implant failure. When supplemented with vitamin D the osseointegration was successful in the case reports and a beneficial impact on the changes in the bone level during the osseointegration were determined.
CONCLUSIONS
Vitamin D deficiency seems to have a negative effect on the osseointegration of implants in animals. The supplementation of vitamin D appears to improve the osseointegration in animals with systemic diseases, such as vitamin D deficiency, diabetes mellitus, osteoporosis, and CKD. Slight evidence supports the hypothesis that humans similarly benefit from vitamin D supplementation in terms of osseointegration. Further investigation is required to maintain these assumptions.
Topics: Animals; Dental Implantation, Endosseous; Dental Implants; Diabetes Mellitus; Humans; Osseointegration; Osteoporosis; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins
PubMed: 35403929
DOI: 10.1186/s40729-022-00414-6 -
Urologia Internationalis 2022The aim of this study is to review the literature on the use of antifungal prophylaxis in penile prosthesis (PP) surgery and provide a summary on its efficacy as an...
OBJECTIVE
The aim of this study is to review the literature on the use of antifungal prophylaxis in penile prosthesis (PP) surgery and provide a summary on its efficacy as an adjunct to current prophylactic regimes in patients undergoing PP surgery.
MATERIALS AND METHODS
PubMed, Medline, and EMBASE databases were systematically searched up to May 2020. All included studies were analysed and the information extracted included author, title of study, year of publication, type of study, journal of publication, and main findings regarding post PP implantation fungal infections.
RESULTS
Nine relevant studies were included in this review, comprising retrospective single-centre studies and retrospective multicentre studies ranging from 2017 to 2020. Fungal infections were found responsible for 11.1% of all PP infections, with a greater risk in patients with diabetes, obesity, and from warmer climates. Current American Urological Association (AUA) and European Association of Urology (EAU) prophylaxis guidelines do not incorporate the use of antifungals. Trials of antifungal prophylaxis regimes combined with antibiotic prophylaxis have demonstrated a reduction in PP fungal infections.
CONCLUSIONS
Fungal infections represent a significant proportion of implant infections and therefore antifungal prophylaxis is warranted. Future studies comparing the efficacy of traditional antibiotic prophylaxis as set out by AUA/EAU with novel prophylaxis regimes including the addition of an antifungal may provide more definitive guidance on this issue. Until then antifungal prophylaxis in all patients undergoing PP procedures may provide a significant cost-effect benefit.
Topics: Antifungal Agents; Humans; Male; Mycoses; Penile Diseases; Penile Prosthesis; Retrospective Studies
PubMed: 35235938
DOI: 10.1159/000522173 -
Journal of Orthopaedic Surgery and... Feb 2022Present work was aimed to gather accessible evidence on the eradication rates and related postoperative complications of antibiotic-loaded calcium sulfate (CS) as an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Present work was aimed to gather accessible evidence on the eradication rates and related postoperative complications of antibiotic-loaded calcium sulfate (CS) as an implant in the treatment of chronic osteomyelitis (COM).
METHODS
Databases including PubMed, EMBASE, Medline, Ovid and Cochrane library were searched from their dates of initiation until November 2021. Two independent authors scrutinized the relevant studies based on the effectiveness of radical debridement combined with antibiotic-loaded CS for COM; data extraction and quality assessment of the Methodological Index for Non-Randomized Studies (MINORS) criteria were also performed by the authors. In addition, clinical efficacy mainly depended on the evaluation of eradication rates and complications, and all the extracted data are pooled and analyzed by STATA 16.0.
RESULTS
A total of 16 studies with 917 patients (920 locations) were recruited, with an overall eradication rate of 92%. Moreover, the overall reoperation rate, overall refracture rate, overall delayed wound healing rate, and the rate of aseptic wound leakage were 9.0%, 2.0%, 20.0%, and 12.0%, respectively. Moreover, the choice of tobramycin-loaded CS or vancomycin combined with gentamicin-loaded CS did not affect the eradication rate, and the incidence of postoperative complications in COM patients (all [Formula: see text]). The general quality of the included studies was fair.
CONCLUSIONS
Our meta-analysis indicated that the overall eradication rate of COM treated with antibiotic-loaded CS was 92%. Delayed healing is the most common postoperative complication. The choice of tobramycin-loaded CS or vancomycin combined with gentamicin-loaded CS did not affect the eradication rate and the incidence of postoperative complications in COM patients.
Topics: Anti-Bacterial Agents; Calcium Sulfate; Gentamicins; Humans; Incidence; Osteomyelitis; Postoperative Complications; Tobramycin; Vancomycin
PubMed: 35183215
DOI: 10.1186/s13018-022-02980-2 -
Alzheimer's Research & Therapy Feb 2022The NIA-AA research framework proposes a purely biological definition of Alzheimer's disease (AD). This implies that AD can be diagnosed based on biomarker...
BACKGROUND
The NIA-AA research framework proposes a purely biological definition of Alzheimer's disease (AD). This implies that AD can be diagnosed based on biomarker abnormalities, irrespective of clinical manifestation. While this brings opportunities, it also raises challenges. We aimed to provide an overview of considerations regarding the disclosure of AD pathology before the onset of dementia.
METHODS
A systematic literature review was conducted and reported according to PRISMA guidelines. We searched PubMed, Embase, APA PsycINFO, and Web of Science Core Collection (on 10 December 2020) for references on conveying AD biomarker results to individuals without dementia. Our query combined variations on the terms Alzheimer's disease, disclosure, or diagnosis, preclinical or prodromal, and biomarkers. Two reviewers independently screened the resulting 6860 titles and abstracts for eligibility and examined 162 full-text records for relevance. We included theoretical articles in English, on communicating amyloid and/or tau results to individuals with mild cognitive impairment, subjective cognitive decline, or normal cognition. MAXQDA-software was used for inductive data analysis.
RESULTS
We included 27 publications. From these, we extracted 26 unique considerations, which we grouped according to their primary relevance to a clinical, personal, or societal context. Clinical considerations included (lack of) validity, utility, and disclosure protocols. Personal considerations covered psychological and behavioral implications, as well as the right to (not) know. Finally, societal considerations comprised the risk of misconception, stigmatization, and discrimination. Overall, views were heterogeneous and often contradictory, with emphasis on harmful effects.
CONCLUSIONS
We found 26 diverse and opposing considerations, related to a clinical, personal, or societal context, which are relevant to diagnosing AD before dementia. The theoretical literature tended to focus on adverse impact and rely on common morality, while the motivation for and implications of biomarker testing are deeply personal. Our findings provide a starting point for clinicians to discuss biomarker-based diagnosis with their patients, which will become even more relevant in light of the conditional approval of a first disease-modifying drug for AD.
Topics: Alzheimer Disease; Amyloid; Biomarkers; Cognitive Dysfunction; Dementia; Disease Progression; Humans
PubMed: 35144684
DOI: 10.1186/s13195-022-00971-3 -
BMC Oral Health Dec 2021Microbial biofilm accumulation is the main cause of peri-implantitis. The majority of surgical peri-implantitis treatment protocols suggests adjunctive use of systemic...
BACKGROUND
Microbial biofilm accumulation is the main cause of peri-implantitis. The majority of surgical peri-implantitis treatment protocols suggests adjunctive use of systemic antibiotics to target specific putative bacteria. The aim of this systematic review was to critically evaluate the adjunctive use of systemically administered antibiotics in surgical treatment of peri-implantitis by reviewing previously published systematic reviews and primary studies.
METHODS
A systematic literature search was conducted in four electronic databases (MEDLINE, The Cochrane Library, EMBASE, and Web of Science) for randomised controlled trials, cohort studies, case-control studies, and systematic reviews reporting surgical treatment of peri-implantitis with and without adjunctive systemically administered antibiotic therapy. The included systematic reviews and primary studies were qualitatively assessed using AMSTAR and GRADE, respectively. No restrictions were set for date of publication, journal, or language.
RESULTS
The literature search identified 681 papers. Only seven systematic reviews and two primary studies met the inclusion criteria. Four out of seven included systematic reviews concluded that no evidence exists for use of systemic antibiotics to improve the clinical outcomes in surgical treatment of peri-implantitis. One review did not estimate the level of evidence, one did not clearly state any beneficial effect, whereas one reported a limited adjunctive effect. Further, the two included primary studies did not show a long-term significant benefit of adjunctive use of systemically administrated antibiotics. However, one study reported a short-term adjunctive effect in patients with modified surface implants. Due to heterogeneity in study design, low number of included primary studies, and grade of bias, no meta-analysis was performed.
CONCLUSION
The use of systemically administered antibiotics as an adjunct to surgical interventions of peri-implantitis cannot be justified as a part of a standard treatment protocol. A pervasive problem is the lack of uniform diagnosis criteria for peri-implantitis, deficient information about patient characteristics, absence of high quality long-term randomised controlled trials, and authors' declaration on conflict of interest.
Topics: Anti-Bacterial Agents; Case-Control Studies; Dental Implants; Humans; Peri-Implantitis
PubMed: 34961495
DOI: 10.1186/s12903-021-02020-1 -
Eye (London, England) Dec 2022To compare outcomes of cataract surgery combined with either anti-Vascular Endothelial Growth Factor (anti-VEGF) therapy or dexamethasone implant (DEX) in patients with... (Meta-Analysis)
Meta-Analysis
Intravitreal dexamethasone implant versus anti-vascular endothelial growth factor therapy combined with cataract surgery in patients with diabetic macular oedema: a systematic review with meta-analysis.
OBJECTIVE
To compare outcomes of cataract surgery combined with either anti-Vascular Endothelial Growth Factor (anti-VEGF) therapy or dexamethasone implant (DEX) in patients with diabetic macular oedema (DMO).
METHODS
Pubmed and Embase databases were searched for studies reporting outcomes of diabetic cataract surgery combined with either anti-VEGF or DEX, with a follow-up ≥3 months. The primary outcome was the mean change in central macular thickness (CMT). Mean change in best corrected visual acuity (BCVA) was considered as a secondary outcome. The mean difference between baseline and post-treatment values (MD) with 95%-Confidence Interval (95%CI) was calculated and meta-analyses were performed.
RESULTS
Nine-teen studies were included, 8 in the DEX group and 11 in the anti-VEGF group. A significant reduction of macular thickness was shown in the DEX group at 3 months (MD = -98.35 µm; 95% CI, -147.15/-49.54), while mean CMT change was non-significant in the anti-VEGF group (MD = -21.61 µm; 95% CI, -59.46/16.24; test of group differences, P < 0.001). At 3 months, no difference in visual gain was found between the two groups (P = 0.13).
CONCLUSIONS
In DMO patients, cataract surgery combined with DEX seems to provide better anatomical outcomes compared with cataract surgery combined with anti-VEGF therapy. However, our evidence was limited by significant heterogeneity. Randomised trials comparing these two different combined approaches are warranted.
Topics: Humans; Macular Edema; Endothelial Growth Factors; Bevacizumab; Vascular Endothelial Growth Factor A; Visual Acuity; Diabetic Retinopathy; Dexamethasone; Cataract; Diabetes Mellitus
PubMed: 34795415
DOI: 10.1038/s41433-021-01847-w -
European Cells & Materials Oct 2021Osteomyelitis is an inflammatory bone disease caused by an infecting microorganism leading to a gradual bone loss. Due to the difficulty in studying osteomyelitis...
Osteomyelitis is an inflammatory bone disease caused by an infecting microorganism leading to a gradual bone loss. Due to the difficulty in studying osteomyelitis directly in patients, animal models allow researchers to investigate the pathogenesis of the infection and the development of novel prophylactic, anti-inflammatory and antimicrobial treatment strategies. This review is specifically focused on the in vivo mouse osteomyelitis studies available in literature. Thus, a systematic search on Web of Science and PubMed was conducted using the query "(infection) AND (mice OR mouse OR murine) AND (model OR models) AND (arthroplasty OR fracture OR (internal fixator) OR (internal fixation OR prosthesis OR implant OR osteomyelitis)". After critical assessment of the studies according to the inclusion and exclusion criteria, 135 studies were included in the detailed analysis. Based on the model characteristics, the studies were classified into five subject groups: haematogenous osteomyelitis, post-traumatic osteomyelitis, bone-implant-related infection, peri-prosthetic joint infection, fracture-related infection. In addition, the characteristics of the mice used, such as inbred strain, age or gender, the characteristics of the pathogens used, the inoculation methods, the type of anaesthesia and analgesia used during surgery and the procedures for evaluating the pathogenicity of the infecting micro-organism were described. Overall, the mouse is an excellent first step in vivo model to study the pathogenesis, inflammation and healing process of osteomyelitis and to evaluate novel prophylaxis and treatment strategies.
Topics: Animals; Anti-Bacterial Agents; Disease Models, Animal; Humans; Inflammation; Mice; Osteomyelitis; Staphylococcal Infections
PubMed: 34672359
DOI: 10.22203/eCM.v042a22 -
PloS One 2021In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty.
METHODS
Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported.
RESULTS
From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37).
CONCLUSIONS
This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.
Topics: Arthroplasty; Biocompatible Materials; Carbon; Evaluation Studies as Topic; Humans; Joint Prosthesis; Medical Device Legislation; Patient Selection
PubMed: 34665802
DOI: 10.1371/journal.pone.0257497