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41.
Aim: To evaluate the hypothesis of a correlation between the preoperative residual alveolar bone height (RBH) and graft maturation after maxillary sinus floor augmentation procedures using two different bone substitutes. Methods: A total of 20 patients who underwent unilateral maxillary sinus floor augmentation with either mineralized deproteinized bovine bone (DBBM) or a xenograft enriched with polymer and gelatin (NBS) were included in this prospective study. Six months after sinus surgery, bone biopsies were harvested with a 3.2 mm diameter trephine bur, prior to dental implant placement. Histomorphometric analysis was performed, and the results were correlated with the individual RBH. Implants were loaded after 5 months of insertion, and 1-year implant success and marginal bone level change were assessed. Results: RBH was 2.17 ± 1.11 mm (range 0.5–3.5 mm) and 2.14 ± 0.72 mm (range 0.5–3.0 mm) in the NBS and DBBM group, respectively. The biopsy analyses for the DBBM group showed woven bone increases by 5.08% per 1-mm increment of RBH; medullary spaces decreased by 9.02%, osteoid decreased by 4.4%, residual biomaterial decreased by 0.34%, and lamellar bone increased by 5.68% per 1-mm increase of RBH. In the NBS group, samples showed woven bone increases by 8.08% per 1-mm increase of RBH; medullary spaces decreased by 0.38%; osteoid increased by 1.34%, residual biomaterial decreased by 0.58%, and lamellar bone decreased by 5.50% per 1-mm increase of RBH. There was no statistically significant difference in the correlation between RBH and lamellar bone, woven bone, and osteoid, independently of the material used. Implant success was 100% in both groups, and marginal bone loss was 1.02 ± 0.42 mm in DBBM and 0.95 ± 0.31 mm in the NBS group after the 1-year follow-up. Conclusion: In spite of the absence of significance, the observed trend for woven bone to increase and medullary spaces to decrease when RBH increases deserves attention. Residual bone dimension might be a determinant in the bone graft maturation after maxillary sinus augmentation.  相似文献   
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43.
Immediately after the annual scientific meeting of the American Society of Hematology (ASH), a select group of clinical and laboratory investigators in myeloproliferative neoplasms (MPN) is summoned to a post-ASH conference on chronic myeloid leukemia and the BCR-ABL1-negative MPN. The 6th such meeting occurred on December 13–14,2011, in La Jolla, California, USA, under the direction of its founder,Dr. Tariq Mughal. The current document is the first of two reports on this post-ASH event and summarizes the most recent preclinical and clinical advances in polycythemia vera, essential thrombocythemia,and primary myelofibrosis.  相似文献   
44.
Randomized controlled trials (RCTs), typically, randomize participants to one of two intervention groups. It has been shown, however, that about 25% of RCTs published in the scientific literature randomize participants to three or more treatment groups. These studies are called ‘multi-arm’ trials: there may be, for instance, two or more experimental intervention groups with a common control group, or two control intervention groups such as a placebo group and a standard treatment group. A special case of multi-arm studies are factorial trials, which address two or more intervention comparisons carried out simultaneously, using four or more intervention groups.Key words: Factorial design, randomization, randomized controlled trial, study quality, treatment allocation

Randomized controlled trials (RCTs), typically, randomize participants to one of two intervention groups (Cipriani & Geddes, 2009). It has been shown, however, that about 25% of RCTs published in the scientific literature randomize participants to three or more treatment groups (Chan & Altman, 2005). These studies are called ‘multi-arm’ trials: there may be, for instance, two or more experimental intervention groups with a common control group, or two control intervention groups such as a placebo group and a standard treatment group. A special case of multi-arm studies are factorial trials, which address two (or more) intervention comparisons carried out simultaneously, using four (or more) intervention groups. Most factorial trials have two ‘factors’, each of which has two levels (i.e., two possible groups of allocation); these are called 2 × 2 factorial trials. In a hypothetical 2 × 2 factorial trial, participants are randomized to one of four groups: one group receives both treatments A and B (AB), one receives only treatment A (A0), one only treatment B (B0), and the remaining group receives neither treatment A nor B (00) (see
Randomization of treatment A
Yes (A)No (0)
Randomization of treatment B
Yes (B)Both A and B (AB)B alone (B0)All B (AB and B0)
No (0)A alone (A0)Neither A nor B (00)All non-B (A0 and 00)
All A (AB and A0)All non-A (B0 and 00)Analysis ‘at the margins’
Open in a separate windowWhen designing a factorial trial, the main intention of researchers is to achieve ‘two trials for the price of one’. To do so, an important assumption is that the effects of the different active interventions are independent. In other words, there should be no interaction (no synergy or antagonism) between the treatments. From this point of view, a 2 × 2 factorial trial can be seen as two trials addressing different questions on the same study population. It is important that both parts of the trial are reported as if they were just a two-arm parallel group trial. For this reason, the treatments selected for investigation in a factorial trial should have no known clinical interactions and, perhaps, different mechanisms of action. Consistently, it has been suggested that properly conducted factorial trials may be the best available way to investigate whether an interaction exists between treatments (McAlister et al. 2003). This is an interesting point of increasing importance in an era of multiple treatments. To assess the presence of interaction, McAlister et al. suggested the use of ‘interaction ratio’ – a comparison of the effect of each treatment in the presence or absence of the other treatment. The interaction ratio is 1 in the presence of no interaction, above 1 in the presence of synergy and below 1 when there is antagonism.Factorial trials are usually done for reasons of efficiency, because their design is also statistically more powerful. Together with the standard analysis ‘inside the table’, the main analysis in factorial trials compares the outcomes in all patients who received treatment A (with or without treatment B) with the outcomes of all patients receiving treatment B (with or without treatment A). As reported in 2003). However, it is worth noting that combining two treatments in the same arm does not necessarily mean that an RCT is a factorial trial. For instance, if a trial is carried out specifically to investigate whether there is an interaction between two treatments, this study should compare each of two active treatments on its own with both combined, without a placebo group. Such a trial is not a factorial trial (Higgins & Green, 2011).In the scientific literature, factorial trials are difficult to find because there is no MeSH term (MEDLINE Subject Heading) to identify them, so a great deal of manual searching is usually required. In terms of study quality, even if the main methodological issues to assess quality (randomization, allocation concealment, blinding, etc) are similar in all RCTs, the reporting of factorial trials has yet to be agreed and standardized. The CONSORT Statement was intended to improve the reporting of RCTs, enabling readers to understand trial''s methodological features and to assess the validity of its results, however, the main CONSORT Statement is based on the standard 2-group parallel design (www.consort-statement.org). There are several different designs of randomized trials, but only cluster trials, non-inferiority and equivalence trials, and pragmatic trials are covered by a specific CONSORT Statement. The reporting of factorial trial is often variable (McAlister et al. 2003): both ‘inside the table’ and ‘at the margins’ data are required for the proper interpretation of factorial trials and this is not always the case (2011).  相似文献   
45.
Benzodiazepines and risk of dementia: true association or reverse causation?     
C. Barbui  C. Gastaldon  A. Cipriani 《Epidemiology and psychiatric sciences》2013,22(4):307
  相似文献   
46.
Effects of the association of potassium citrate and agropyrum repens in renal stone treatment: results of a prospective randomized comparison with potassium citrate     
Brardi S  Imperiali P  Cevenini G  Verdacchi T  Ponchietti R 《Archivio italiano di urologia, andrologia》2012,84(2):61-67
  相似文献   
47.
Femtosecond laser-assisted implantation of corneal stroma lenticule for keratoconus     
Fasolo  Adriano  Galzignato  Alice  Pedrotti  Emilio  Chierego  Chiara  Cozzini  Tiziano  Bonacci  Erika  Marchini  Giorgio 《International ophthalmology》2021,41(5):1949-1957
International Ophthalmology - To review recent progress, challenges, and future perspectives of stromal keratophakia for the treatment of advanced keratoconus. We systematically reviewed the...  相似文献   
48.
Primary balloon angioplasty of small (≤2 mm) cephalic veins improves primary patency of arteriovenous fistulae and decreases reintervention rates     
Pierfrancesco Veroux  Alessia Giaquinta  Tiziano Tallarita  Nunziata Sinagra  Carla Virgilio  Domenico Zerbo  Peter Gloviczki  Massimiliano Veroux 《Journal of vascular surgery》2013
  相似文献   
49.
Hemoglobin Concentration Affects Electroencephalogram During Cardiopulmonary Bypass: An Indication for Neuro‐Protective Values          下载免费PDF全文
Alessandra Del Felice  Maddalena Tessari  Emanuela Formaggio  Tiziano Menon  Giuseppe Petrilli  Gianluigi Gamba  Simona Scarati  Stefano Masiero  Oscar Bortolami  Giuseppe Faggian 《Artificial organs》2016,40(2):169-175
  相似文献   
50.
Continuous Metabolic Monitoring in Infant Cardiac Surgery: Toward an Individualized Cardiopulmonary Bypass Strategy          下载免费PDF全文
Salvatore Torre  Elisa Biondani  Tiziano Menon  Diego Marchi  Mauro Franzoi  Daniele Ferrarini  Rocco Tabbì  Stiljan Hoxha  Luca Barozzi  Giuseppe Faggian  Giovanni Battista Luciani 《Artificial organs》2016,40(1):65-72
Cardiopulmonary bypass (CPB) in infants is associated with morbidity due to systemic inflammatory response syndrome (SIRS). Strategies to mitigate SIRS include management of perfusion temperature, hemodilution, circuit miniaturization, and biocompatibility. Traditionally, perfusion parameters have been based on body weight. However, intraoperative monitoring of systemic and cerebral metabolic parameters suggest that often, nominal CPB flows may be overestimated. The aim of the study was to assess the safety and efficacy of continuous metabolic monitoring to manage CPB in infants during open‐heart repair. Between December 2013 and October 2014, 31 consecutive neonates, infants, and young children undergoing surgery using normothermic CPB were enrolled. There were 18 male and 13 female infants, aged 1.4 ± 1.7 years, with a mean body weight of 7.8 ± 3.8 kg and body surface area of 0.39 m2. The study was divided into two phases: (i) safety assessment; the first 20 patients were managed according to conventional CPB flows (150 mL/min/kg), except for a 20‐min test during which CPB was adjusted to the minimum flow to maintain MVO2 >70% and rSO2 >45% (group A); (ii) efficacy assessment; the following 11 patients were exclusively managed adjusting flows to maintain MVO2 >70% and rSO2 >45% for the entire duration of CPB (group B). Hemodynamic, metabolic, and clinical variables were compared within and between patient groups. Demographic variables were comparable in the two groups. In group A, the 20‐min test allowed reduction of CPB flows greater than 10%, with no impact on pH, blood gas exchange, and lactate. In group B, metabolic monitoring resulted in no significant variation of endpoint parameters, when compared with group A patients (standard CPB), except for a 10% reduction of nominal flows. There was no mortality and no neurologic morbidity in either group. Morbidity was comparable in the two groups, including: inotropic and/or mechanical circulatory support (8 vs. 1, group A vs. B, P = 0.07), reexploration for bleeding (1 vs. none, P = not significant [NS]), renal failure requiring dialysis (none vs. 1, P = NS), prolonged ventilation (9 vs. 4, P = NS), and sepsis (2 vs. 1, P = NS). The present study shows that normothermic CPB in neonates, infants, and young children can be safely managed exclusively by systemic and cerebral metabolic monitoring. This strategy allows reduction of at least 10% of predicted CPB flows under normothermia and may lay the ground for further tailoring of CPB parameters to individual patient needs.  相似文献   
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