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Effect of discounting on estimation of benefits determined by hepatitis C treatment

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World Journal of Gastroenterology 2012年第23期18卷 3032-3034页

作者： Andrea Messori Valeria fadda Dario Maratea Sabrina Trippoli Laboratorio SIfO di farmacoeconomia Area Vasta Centro Toscana 59100 Prato Italy Dario Maratea Department of Pharmaceutical Sciences University of Firenze 50019 Sesto Fiorentino Italy

The combination of either boceprevir or telaprevir with ribavirin and interferon (triple therapy) has been shown to be more effective than ribavirin+interferon (dual therapy) for the treatment of genotype 1 hepatitis C. Since the benefit of these treatments takes place after years, simulation models are needed to predict long-term outcomes. In simulation models, the choice of different values of yearly discount rates (e.g., 6%, 3.5%, 2%, 1.5% or 0%) influences the results, but no studies have specifically addressed this issue. We examined this point by determining the long-term benefits under different conditions on the basis of standard modelling and using quality-adjusted life years (QALYs) to quantify the benefits. In our base case scenario, we compared the long-term benefit between patients given a treatment with a 40% sustained virologic response (SVR) (dual therapy) and patients given a treatment with a 70% SVR (triple therapy), and we then examined how these specific yearly discount rates influenced the incremental benefit. The gain between a 70% SVR and a 40% SVR decreased from 0.45 QA-LYs with a 0% discount rate to 0.22 QALYs with a 6% discount rate (ratio between the two values = 2.04).Testing the other discounting assumptions confirmed that the discount rate has a marked impact on the magnitude of the model-estimated incremental benefit. In conclusion, the results of our analysis can be helpful to better interpret cost-effectiveness studies evaluating new treatment for hepatitis C.

关键词：丙型肝炎模型估计贴现率治疗 C型利巴韦林仿真模型增量效益

Congruent responses of vascular plant and ant communities to pastoral land-use abandonment in mountain areas throughout different biogeographic regions

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Ecological Processes 2022年第1期11卷 469-482页

作者： Marcello Verdinelli Marco Pittarello Maria Carmela Caria Giovanna Piga Pier Paolo Roggero Gian Marco Marrosu Stefano Arrizza Maria Leonarda fadda Giampiero Lombardi Michele Lonati Ginevra Nota Maria Sitzia Simonetta Bagella Institute of BioEconomy(CNR IBE) National Research Council of Italy07100 SassariItaly Department of Agricultural Forestand Food Science(DIS-AFA)University of TorinoTorinoItaly Department of Chemistry and Pharmacy University of Sassari07100 SassariItaly Department of Agricultural Sciences University of Sassari07100 SassariItaly Desertification Research Center University of Sassari07100 SassariItaly AGRIS Sardegna Loc.Bonassai07100 SassariItaly

Background:There is a long-term trend towards the abandonment of agro-pastoral activities in the mountain areas of Europe:the following encroachment process of semi-natural grasslands by shrubs is one of the main severe threats to the conservation of biodiversity in mountain environments.To better understand the impact of land abandonment,we analysed the reliability of plant functional groups,ant traits,and ant functional groups as indicators of land use changes.We carried out the research in Italy at four sites along a latitudinal/altitudinal gradient in three biogeo-graphic regions(Mediterranean,Continental,Alpine).We identified three stages of a chronosequence at each site as representative of the plant succession in response to pastoral land-use abandonment.Results:As expected,both the plant and ant assemblages considerably differed across sites at the species level and,within each site,among the three stages.This trend was found also using ant traits,functional groups of ants,and plant functional groups.Ant and plant communities were related in terms of composition and functionality.Harvester ants and ants with collective foraging strategy were associated with annual legumes and grasses(Therophytes);ants with a strictly individual foraging strategy with Phanerophytes.Ant traits and plant functional groups indicated significant differences among the three stages of the chronosequence.However,ant functional groups could not discriminate between the stages represented by secondary grasslands currently grazed and shrub-encroached grasslands ungrazed.Conclusion:Despite some limitations of ant functional groups in explaining the succession stages of land abandonment,our results suggest that ants are a good surrogate taxon and might be used as bioindicators of land-use changes and ecosystem functioning.furthermore,our findings indicate that the functional group approach should be applied to other European ecosystems.finally,reducing the taxonomic complexity could contribute to developing predictive models to detect

关键词： Biodiversity conservation Bioindicators Cross-taxon congruence functional groups Land abandonment Monitoring Mountain pastures

Anionic liposomes for small interfering ribonucleic acid （siRNA） delivery to primary neuronal cells： Evaluation of alpha-synuclein knockdown efficacy

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Nano Research 2017年第10期10卷 3496-3508页

作者： Michele Schlich francesca Longhena Gaia faustini Caitriona M. O'Driscoll Chiara Sinico Anna Maria fadda Arianna Bellucci francesco Lai Department of Life and Environmental Sciences University of Cagliari Cagliari 09124 Italy Division of Pharmacology Department of Molecular and Translational Medicine University of Brescia Brescia 25123 Italy Pharmacodelivery Group School of Pharmacy University College Cork Cork Ireland

Alpha-synuclein （a-syn） deposition in Lewy bodies （LB） is one of the main neuropathological hallmarks of Parkinson＇s disease （PD）. LB accumulation is considered a causative factor of PD, which suggests that strategies aimed at reducing a-syn levels could be relevant for its treatment. In the present study, we developed novel nanocarriers suitable for systemic delivery of small interfering ribonucleic acid （siRNA） that were specifically designed to reduce neuronal α-syn by RNA interference. Anionic liposomes loaded with an siRNA-protamine complex for α-syn gene silencing and decorated with a rabies virus glycoprotein （RVG）-derived peptide as a targeting agent were prepared. The nanoparticles were characterized for their ability to load, protect, and deliver the functional siRNA to mouse primary hippocampal and cortical neurons as well as their efficiency to induce gene silencing in these cells. Moreover, the nanocarriers were evaluated for their stability in serum. The RVG-decorated liposomes displayed suitable characteristics for future in vivo applications and successfully induced α-syn gene silencing in primary neurons without altering cell viability. Collectively, our results indicate that RVG-decorated liposomes may be an ideal tool for further studies aimed at achieving efficient in vivo α-syn gene silencing in mouse models of PD.

关键词： rabies virus glycoprotein （RVG） peptide liposomes small interfering ribonudeic acid （siRNA） alpha-synuclein primary neuronal cells Parkinson＇s disease

Simplified figure to present direct and indirect comparisons:Revisiting the graph 10 years later

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World Journal of Methodology 2021年第4期11卷 228-230页

作者： Valeria fadda Laura Bartoli Elisa ferracane Sabrina Trippoli Andrea Messori HTA ESTAR ToscanaFirenze 50132Italy

A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary comparisons included superiority,inferiority and no significance difference;hence,they did not differentiate between no proof of difference vs proof of no difference.We updated the criteria employed in the original“simplified”figure in order to include this differentiation.A revised version of the simplified figure is proposed and described herein.An example of application is also presented.The example is focused on first-line treatments for paroxysmal atrial fibrillation.Three treatments(medical therapy,cryoballoon ablation,radiofrequency ablation)are compared with one another through direct and indirect comparisons.

关键词： Randomised controlled trials Outcome research Meta-analysis Direct comparisons Indirect comparison Statistics

Design and Synthesis of Some Enaminonitrile Derivatives of Antipyrine as Potential Novel Anti-Inflammatory and Analgesic Agents

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Journal of Biosciences and Medicines 2015年第11期3卷 114-123页

作者： Ahmed A. fadda Khaled M. Elattar Department of Chemistry Faculty of Science Mansoura University Mansoura Egypt

The starting (1,5-dimethyl-3-oxo-2-phenyl-2,3-dihydro-1H-pyrazol-4-yl)carbon-hydrazonoyl dicyanide (2) was used as a key intermediate for the syntheses of novel acyclic enaminonitriles 3-10. The newly synthesized compounds were characterized by elemental analyses and spectral data (IR, 1H NMR, 13C NMR and mass spectra). The anti-inflammatory activity data indicated that many of tested compounds protected rats from carrageenan-induced inflammation, and tested compounds 3, 4, 9 and 10 were the most potent among tested compounds. The analgesic activity was determined by the hot plate test (central analgesic activity) and acetic acid induced writhing assay. The results revealed that compounds 3, 4, 9, and 10 exhibited significant activity. However, compound 10 proved to have better or equivalent activities in comparison to the reference drug.

关键词： Aminoantipyrine Enaminonitriles Organic Synthesis Anti-Inflammatory and Analgesic Activities

Meta-regression of treatments for metastatic colorectal cancer:Quantifying incremental benefit from 2000 to 2012

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World Journal of Clinical Oncology 2014年第2期5卷 191-193页

作者： Andrea Messori Margherita Conti Valeria fadda Dario Maratea Sabrina Trippoli HTA Unit ESTAV Toscana Centro Regional Health Service

To evaluate the overall effectiveness of treatments for metastatic colorectal cancer, a meta-regression was undertaken in which randomized studies from 2000 to 2012 were evaluated and the temporal trend for both overall survival(OS) and progression-free survival(PfS) was determined. Our literature search was essentially based on Pub Med but information sources were scanned. Trials were included if a fluoropyrimidine regimen was given to at least one arm and information on PfS and OS was available. Medians for OS and PfS were our end-points. Covariates included temporal trend, arm allocation and Kirsten rat sarcoma status. In analyzing 130 treatment arms identified through our literature search, meta-regression showed an improvement with time for both OS(P fS(P from 14.9 mo in 2000 to 18.8 mo in 2012. Likewise, the improvement in PfS was from 5.7 to 8.1 mo. Multivariate analysis confirmed these findings. A post-hoc multivariate analysis was focused on patient arms treated with bevacizumab(n = 17) or without bevacizumab(n = 113); the multivariate-adjusted improvement attributable to bevacizumab was 1.66 mo for OS(P = 0.071) and 1.59 mo for PfS(P = 0.002). Overall, our results indicatethat OS and PfS have improved from 2000 to 2012 but the extent of this improvement is small and seems to have quite a questionable clinical relevance.

关键词： Metastatic colorectal cancer Chemotherapy 5-fluorouracil Chemotherapy Irinotecan Oxaliplatin Bevacizumab Meta-analysis Meta-regression

Effects of Cold Storage on Quality Traits of Sardinian Myrtle （Myrtus communis L.） Berries and Their Alcoholic Extracts

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Journal of Agricultural Science and Technology(B) 2011年第6期1卷 790-798页

作者： A. Angioni f. Pirisi P. Caboni S. D＇Aquino A. fadda M. Schirra Department of Toxycology Food and Environmental Unit University of Cagliari via Ospedale 72 Cagliari 09124 Italy Institute of Sciences of food Production National Research Council Traversa La Crucca 3 Regione Baldinca. Li Punti 07040 Sassari Italy

Myrtus communis L. is a spontaneous aromatic plant typical of the Mediterranean area. Myrtle berries hydrodistilled products and ethanolic extracts are mainly used as flavouring agents and food supplements. This study evaluated the effect of long-term storage on the quality-related properties of myrtle berries. Storage at 2 °C for three months effectively preserved myrtle berries quality, both in the chemical composition and external appearance. No symptoms of chilling injury and decay occurred during the first two months of storage, at the end of storage only the 1.3% of rotting was detected. Total anthocyanic content and anthocyanin glycosides diminished whereas the antioxidant capacity increased in all samples till the end of storage. The antioxidant properties of myrtle berries were not correlated with the anthocyanic fraction. The pH of myrtle berries decreased, while gluconic acid levels increased. The results reported in this paper showed that the storage at 2 °C for three months appears to be an effective way to preserve myrtle berries quality. The changes in the chemical composition of the fruits subjected to storage had revealed the importance of gluconic acid and pH for myrtle quality assessment. These two parameters can be used as quality markers since a strong relationship has been found between myrtle decay and the changes in these parameters.

关键词：乙醇提取物浆果品质性状撒丁岛外观质量冷库酒精长期储存

Are Newer-Generation Drug-Eluting Stents More Effective in Women than Early-Generation Ones?

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World Journal of Cardiovascular Diseases 2014年第4期4卷 146-148页

作者： Andrea Messori Valeria fadda Dario Maratea Sabrina Trippoli HTA Unit ESTAV Toscana Centro Regional Health Service Firenze Italy

Evidence-based research is increasingly aimed at differentiating between no proof of difference (failed demonstration of superiority) and proof of no difference (demonstration of equivalence). The latter requires that equivalence margins are incorporated in the analysis of outcomes. We applied an analysis of equivalence to study the incremental benefit of newer-generation vs early-generation drug-eluting stents (DES) in women receiving percutaneous coronary intervention. The clinical material was derived from published data. Our equivalence testing was focused on the end-point of target-lesion revascularisation (TLR). Results were expressed as rate differences (RDs), while the equivalence margins (±2.9%) were derived from the statistical power calculations of a recent trial. Our results clearly indicated that, in women, there was an equivalent effectiveness between newer-generation and early-generation of DES.

关键词： Coronary Drug-Eluting Stents Equivalence Margins

Dexmedetomidine vs propofol in intensive care unit patients

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World Journal of Anesthesiology 2014年第1期3卷 134-136页

作者： Valeria fadda Dario Maratea Sabrina Trippoli Andrea Messori HTA Unit Area Vasta Centro Toscana Regional Health System 50100 Firenze Italy

Dexmedetomidine is indicated as a sedative agent in intensive care units(ICUs). While several clinical trials and two meta-analyses have compared this agent with propofol or midazolam, the results were variable depending on the specific end-point(e.g., duration of mechanical ventilation, ICU mortality, maintaining a target depth of sedation, incidence of delirium episodes, length of hospital stay). Hence, the effectiveness of this new agent vs the comparators seems to be controversial. Trial sequential analysis(TSA) is a statistical technique that can estimate the optimal, cumulative number of patients that would be needed to generate a conclusive result. We therefore applied a TSA model to the most recent meta-analysis evaluating dexmedetomidine. A total of 10 randomized controlled trials were included in our analysis. According to our results, the comparison of dexmedetomidine vs propofol showed no proof of incremental effectiveness for the end-points of length of ICUs stay and incidence of delirium episodes. In contrast, futility(i.e., proof of no incremental effectiveness) was demonstrated for the end-point of mechanical ventilation. Hence, the results for the comparison of dexmedetomidine vs propofol were inconclusive for the first two end-points; on the other hand, conclusiveness was reached for the third end-point. We conclude that the place of dexmedetomidine in therapy of critically ill patients is very uncertain and further controlled trials are still needed.

关键词： Dexmedetomidine Propofol Midazolam Sedation Intensive care unit Mechanical ventilation Hospital stay Meta-analysis Trial sequential analysis