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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.
Fallico, M, Lotery, A, Maugeri, A, Favara, G, Barchitta, M, Agodi, A, Russo, A, Longo, A, Bonfiglio, V, Avitabile, T, et al
Eye (London, England). 2022;(12):2239-2246
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Abstract
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.
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Fluocinolone acetonide vitreous insert for chronic diabetic macular oedema: a systematic review with meta-analysis of real-world experience.
Fallico, M, Maugeri, A, Lotery, A, Longo, A, Bonfiglio, V, Russo, A, Avitabile, T, Furino, C, Cennamo, G, Barchitta, M, et al
Scientific reports. 2021;(1):4800
Abstract
We conducted a meta-analysis of real-world studies on the 0.19 mg Fluocinolone Acetonide (FAc) intravitreal implant for chronic diabetic macular oedema (DMO), comparing these findings with the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) study. The primary outcome was mean change of best corrected visual acuity (BCVA) at 24 months. Secondary outcomes were 36-month mean BCVA, mean central macular thickness (CMT) change, rates of eyes receiving supplementary intravitreal therapy, cataract surgery, intraocular pressure (IOP)-lowering drops and glaucoma surgery. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Nine real-world studies were included. The FAc implant yielded a significantly improved BCVA at 24 and 36 months (24-month MD = 4.52; 95% CI 2.56-6.48; 36-month MD = 8.10; 95% CI 6.34-9.86). These findings were comparable with the FAME study. The FAc implant yielded significantly reduced 24- and 36-month CMT. Pooled proportions of cataract surgery, IOP-lowering drops and glaucoma surgery were 39%, 27% and 3%, respectively, all lower than the FAME study. Pooled estimate of supplementary intravitreal therapy was 39%, higher than the 15.2% of the FAME study. This meta-analysis of real-world studies confirms favorable visual and anatomical outcomes following FAc insert for chronic DMO. In real-life studies more than one third of patients received supplementary intravitreal therapy, an issue that needs to be further explored.
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Effects of Vitamin D Supplementation During Pregnancy on Birth Size: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Maugeri, A, Barchitta, M, Blanco, I, Agodi, A
Nutrients. 2019;11(2)
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Vitamin D deficiency may affect mother and neonatal outcomes, increasing the risk of pregnancy complications, preterm birth, low birth weight (LBW), small for gestational age (SGA), and poor offspring health. This systematic review and meta-analysis evaluates the effects of oral vitamin D supplementation during pregnancy on foetal growth and incidence of LBW and SGA births. 13 randomised controlled trials (RCTs), published between 1980 and 2016, were included in the meta-analysis, including in total 2016 newborns (1184 from mothers in the intervention groups and 832 from controls). Dosages ranged from 200-4000 IU for daily intakes and 35000 IU to 600000 IU for single or intermittent administration. Whilst there was no evidence for publication bias (e.g. an over-reporting of positive outcomes), overall, the quality of the reviewed studies varied from very low (head circumference) to moderate (birth weight, birth length, LBW, and SGA). All studies evaluating the effect of vitamin D supplementation on blood 25-hydroxyvitamin D (OHD) levels showed that intervention significantly increased 25-OHD concentration in both mothers and infants. The meta-analysis showed that vitamin D supplementation significantly increased birth weight and length, independent of dosage and whether vitamin D was administered daily or in single/intermittent high dosages. Head circumference was increased in a non-dose dependent way with daily but not with single/intermittent vitamin D supplementation. Effects on all three parameters were seen when vitamin D was supplemented alone, but not in combination with other nutrients. Both, risk of LBW and SGA, were also significantly reduced with vitamin D supplementation.
Abstract
During pregnancy, vitamin D supplementation may be a feasible strategy to help prevent low birthweight (LBW) and small for gestational age (SGA) births. However, evidence from randomized controlled trials (RCTs) is inconclusive, probably due to heterogeneity in study design and type of intervention. A systematic literature search in the PubMed-Medline, EMBASE, and Cochrane Central Register of Controlled Trials databases was carried out to evaluate the effects of oral vitamin D supplementation during pregnancy on birthweight, birth length, head circumference, LBW, and SGA. The fixed-effects or random-effects models were used to calculate mean difference (MD), risk ratio (RR), and 95% Confidence Interval (CI). On a total of 13 RCTs, maternal vitamin D supplementation had a positive effect on birthweight (12 RCTs; MD = 103.17 g, 95% CI 62.29⁻144.04 g), length (6 RCTs; MD = 0.22 cm, 95% CI 0.11⁻0.33 cm), and head circumference (6 RCTs; MD:0.19 cm, 95% CI 0.13⁻0.24 cm). In line with these findings, we also demonstrated that maternal vitamin D supplementation reduced the risk of LBW (3 RCTs; RR = 0.40, 95% CI 0.22⁻0.74) and SGA (5 RCTS; RR = 0.69, 95% CI 0.51⁻0.92). The present systematic review and meta-analysis confirmed the well-established effect of maternal vitamin D supplementation on birth size. However, further research is required to better define risks and benefits associated with such interventions and the potential implications for public health.
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Single Nucleotide Polymorphisms in Vitamin D Receptor Gene Affect Birth Weight and the Risk of Preterm Birth: Results From the "Mamma & Bambino" Cohort and A Meta-Analysis.
Barchitta, M, Maugeri, A, La Rosa, MC, Magnano San Lio, R, Favara, G, Panella, M, Cianci, A, Agodi, A
Nutrients. 2018;(9)
Abstract
The effect of vitamin D receptor gene (VDR) polymorphisms on adverse pregnancy outcomes-including preterm birth (PTB), low birth weight and small for gestational age-is currently under debate. We investigated 187 mother-child pairs from the Italian "Mamma & Bambino" cohort to evaluate the association of maternal VDR polymorphisms-BsmI, ApaI, FokI and TaqI-with neonatal anthropometric measures and the risk of PTB. To corroborate our results, we conducted a meta-analysis of observational studies. For the FokI polymorphism, we showed that gestational duration and birth weight decreased with increasing number of A allele (p = 0.040 and p = 0.010, respectively). Compared to the GG and GA genotypes, mothers who carried the AA genotype exhibited higher PTB risk (OR = 12.049; 95% CI = 2.606⁻55.709; p = 0.001) after adjusting for covariates. The meta-analysis confirmed this association under the recessive model (OR = 3.67, 95%CI 1.18⁻11.43), and also pointed out the protective effect of BsmI polymorphism against the risk of PTB under the allelic (A vs. G: OR = 0.74; 95%CI 0.59⁻0.93) and recessive (AA vs. GG + AG: OR = 0.62; 95%CI 0.43⁻0.89) models. Our results suggest the association between some maternal VDR polymorphisms with neonatal anthropometric measures and the risk of PTB.