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1.
Hernia ; 26(5): 1231-1239, 2022 Oct.
Article in English | MEDLINE | ID: mdl-34057625

ABSTRACT

INTRODUCTION: The objective was to assess the effectiveness and safety of a bioabsorbable mesh at the time of closure of a midline laparotomy for IH prevention. MATERIALS AND METHODS: A multicenter, randomized clinical trial including patients undergoing abdominal surgical procedures through a midline laparotomy incision was designed. In the group of mesh (n = 167) the incision was closed using a continuous polydioxanone suture (PDS) plus a bioabsorbable mesh. In the control group (n = 165) a continuous PDS single layer suture was only used. Patients were randomly assigned (1:1) to the two groups. The primary outcome was the incidence of IH at 6, 12 and 24 months. Assessment of IH was done using a CT scan. RESULTS: At 6 months, the rates of IH were 15.2% and 24.8% in the experimental and control groups, respectively (relative risk [RR] 0.66, 95% confidence interval [CI] 0.38-0.98, P = 0.042). At 12 months, the rate of IH continued to be significantly lower in the experimental group (21.4% vs. 33.1%, P = 0.033), but at 24 months, there were no significant differences between the study groups with a follow-up rate of only 37.5%. The number needed to treat (NNT) was 11 and 9 at 6 and 12 months, respectively. CONCLUSION: The bioabsorbable mesh significantly prevented IH during the first year. Not reliable conclusions can be drawn across the second year. This may suggest that the any of the closing technique assessed in this study would have a "palliative" transient effect for preventing IH in the long-term.


Subject(s)
Abdominal Wound Closure Techniques , Incisional Hernia , Abdominal Wound Closure Techniques/adverse effects , Absorbable Implants , Herniorrhaphy/adverse effects , Humans , Incisional Hernia/epidemiology , Incisional Hernia/etiology , Incisional Hernia/prevention & control , Laparotomy/adverse effects , Polydioxanone , Surgical Mesh/adverse effects
2.
Surg Endosc ; 35(2): 754-762, 2021 02.
Article in English | MEDLINE | ID: mdl-32072284

ABSTRACT

BACKGROUND: Anastomotic leak (AL) is the most feared complication in colorectal surgery. Indocyanine green (ICG) fluorescence angiography allows for real-time intraoperative evaluation of bowel perfusion. This study aimed to assess the impact of ICG on perioperative outcomes in patients treated with transanal total mesorectal excision (TaTME) for rectal cancer. METHODS: Comparative study based on a retrospective analysis of prospectively collected data, to validate the use of ICG assessment (ICGA) during TaTME (November/2011-June/2018). The primary outcome was the clinical AL rate. The secondary outcomes included modification of proximal colonic transection, anastomotic redo, additional surgical maneuvers and surgical morbidity. RESULTS: Two hundred and eighty-four patients were included, 204 (71.8%) in non-ICG group and 80 (28.2%) in ICG group. No significant differences were found in patient and tumor features. Mean anastomotic height was 4.85 cm vs. 5.04 cm (p = 0.500), diverting stoma was constructed in 205 patients (72.1% vs. 72.5%; p = 0.941). Fluorescence angiography modified the surgical plan in 23 patients (28.7%). AL was diagnosed in 23 patients (11.3%) in the non-ICG group and in two patients (2.5%) in the ICG group (p = 0.020). Postoperative intraabdominal collection was diagnosed in 19 patients (7.4% vs. 5.1%; p = 0.490), and reintervention was needed in 24 patients (10.8% vs. 7.6%; p = 0.420). Median length of hospital stay was 6.0 (IQR 5.0-9) vs. 4.0 (IQR 3.0-8.5) (p = 0.005). ICGA was found as independent protective factor for AL in the multivariate analysis of the whole cohort (n = 284) (OR 0.142; 95% CI 0.032-0.633; p = 0.010). CONCLUSION: ICG fluorescence angiography modified the proximal colonic transection in more than one-quarter of patients, leading to a significant decrease of AL rate.


Subject(s)
Anastomotic Leak/etiology , Fluorescein Angiography/methods , Rectal Neoplasms/diagnostic imaging , Female , Humans , Male , Rectal Neoplasms/surgery , Retrospective Studies , Treatment Outcome
3.
BMC Cancer ; 20(1): 677, 2020 Jul 20.
Article in English | MEDLINE | ID: mdl-32689968

ABSTRACT

BACKGROUND: For patients with mid and distal rectal cancer, robust evidence on long-term outcome and causal treatment effects of transanal total mesorectal excision (TaTME) is lacking. This multicentre retrospective cohort study aimed to assess whether TaTME reduces locoregional recurrence rate compared to laparoscopic total mesorectal excision (LapTME). METHODS: Consecutive patients with rectal cancer within 12 cm from the anal verge and clinical stage II-III were selected from three institutional databases. Outcome after TaTME (Nov 2011 - Feb 2018) was compared to a historical cohort of patients treated with LapTME (Jan 2000 - Feb 2018) using the inverse probability of treatment weights method. The primary endpoint was three-year locoregional recurrence. RESULTS: A total of 710 patients were analysed, 344 in the TaTME group and 366 in the LapTME group. At 3 years, cumulative locoregional recurrence rates were 3.6% (95% CI, 1.1-6.1) in the TaTME group and 9.6% (95% CI, 6.5-12.7) in the LapTME group (HR = 0.4; 95% CI, 0.23-0.69; p = 0.001). Three-year cumulative disease-free survival rates were 74.3% (95% CI, 68.8-79.8) and 68.6% (95% CI, 63.7-73.5) (HR = 0.82; 95% CI, 0.65-1.02; p = 0.078) and three-year overall survival 87.2% (95% CI, 82.7-91.7) and 82.2% (95% CI, 78.0-86.2) (HR = 0.74; 95% CI, 0.53-1.03; p = 0.077), respectively. In patients who underwent sphincter preservation procedures, TaTME was associated with a significantly better disease-free survival (HR = 0.78; 95% CI, 0.62-0.98; p = 0.033). CONCLUSIONS: These findings suggest that TaTME may improve locoregional recurrence and disease-free survival rates among patients with mid and distal locally advanced rectal cancer.


Subject(s)
Adenocarcinoma/surgery , Rectal Neoplasms/surgery , Rectum/surgery , Adenocarcinoma/mortality , Adenocarcinoma/pathology , Aged , Disease-Free Survival , Female , Humans , Laparoscopy/methods , Male , Neoplasm Recurrence, Local , Organ Sparing Treatments , Rectal Neoplasms/mortality , Rectal Neoplasms/pathology , Retrospective Studies , Survival Rate , Time Factors , Transanal Endoscopic Surgery/methods , Treatment Outcome
5.
Actas urol. esp ; 42(9): 593-599, nov. 2018. tab
Article in Spanish | IBECS | ID: ibc-174860

ABSTRACT

Objetivo: Conocer la incidencia real de cáncer de próstata (CP) en las áreas sanitarias de Castilla y León en el año 2014. Material y métodos: Estudio multicéntrico en el que participan 7 de las 9 áreas sanitarias de Castilla y León. Se recogen datos con carácter retrospectivo que incluyen el 87,8% de la población diana (varones diagnosticados de CP con confirmación histopatológica en el año 2014). Se calculan incidencias brutas e incidencias ajustadas por edad según el método directo. Los datos epidemiológicos comunitarios y nacionales son consultados en el Instituto Nacional de Estadística. Resultados: Se diagnosticaron 1.198 nuevos casos de CP. La tasa de incidencia bruta comunitaria es 109,54 casos por 100.000 varones. Las tasas ajustadas a población española y europea resultan en 115,41 y 110,07, respectivamente. El grupo etario de mayor concentración diagnóstica fue el de 60-70 años, con el 41,97% de los diagnósticos, y el que mostró mayor incidencia fue el comprendido entre 70 y 80años, con 438,87 casos por 100.000 habitantes. Se objetivan diferencias en las incidencias brutas y ajustadas por grupo de edad, así como en el factor edad al diagnóstico entre las diferentes áreas sanitarias incluidas. Conclusiones: La tasa de incidencia bruta comunitaria resultó ser mayor que la mayoría de datos existentes previamente. Se aprecian importantes diferencias entre las distintas áreas geográficas que pueden ser explicadas principalmente por la distribución del factor edad y las políticas de cribado oportunista en cada una de ellas


Objective: To determine the actual incidence of prostate cancer (PC) in the healthcare areas of Castilla-Leon in 2014. Material and methods: A multicentre study was conducted with the participation of 7 of the 9 healthcare areas of Castilla-Leon. We collected retrospective data that included 87.8% of the target population (men diagnosed with PC with histopathological confirmation in 2014). We calculated the raw and age-adjusted incidence rates based on the direct method and consulted the community and national epidemiological data in the Spanish National Institute of Statistics. Results: A total of 1198 new cases of PC were diagnosed, with a raw incidence rate in the community of 109.54 cases per 100,000 men. The adjusted rates for the Spanish and European populations were 115.41 and 110.07, respectively. The age group with the highest diagnostic concentration was the 60-70-year group, with 41.97% of the diagnoses. The group with the highest incidence was the 70-80-year group, with 438.87 cases per 100,000 inhabitants. There were differences in the raw and age-adjusted incidence rates and in the age at diagnosis among the various included healthcare areas. Conclusions: The community raw incidence rate was higher than most existing data. We observed significant differences among the various geographical areas, which could be explained mainly by the age distribution and the opportunistic screening policies for each area


Subject(s)
Humans , Male , Adult , Middle Aged , Aged , Aged, 80 and over , Prostatic Neoplasms/epidemiology , Prostatic Neoplasms/prevention & control , Early Diagnosis , Spain/epidemiology , Retrospective Studies , 17140 , Prostatic Neoplasms/pathology
6.
Actas Urol Esp (Engl Ed) ; 42(9): 593-599, 2018 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-29292039

ABSTRACT

OBJECTIVE: To determine the actual incidence of prostate cancer (PC) in the healthcare areas of Castilla-Leon in 2014. MATERIAL AND METHODS: A multicentre study was conducted with the participation of 7 of the 9 healthcare areas of Castilla-Leon. We collected retrospective data that included 87.8% of the target population (men diagnosed with PC with histopathological confirmation in 2014). We calculated the raw and age-adjusted incidence rates based on the direct method and consulted the community and national epidemiological data in the Spanish National Institute of Statistics. RESULTS: A total of 1198 new cases of PC were diagnosed, with a raw incidence rate in the community of 109.54 cases per 100,000 men. The adjusted rates for the Spanish and European populations were 115.41 and 110.07, respectively. The age group with the highest diagnostic concentration was the 60-70-year group, with 41.97% of the diagnoses. The group with the highest incidence was the 70-80-year group, with 438.87 cases per 100,000 inhabitants. There were differences in the raw and age-adjusted incidence rates and in the age at diagnosis among the various included healthcare areas. CONCLUSIONS: The community raw incidence rate was higher than most existing data. We observed significant differences among the various geographical areas, which could be explained mainly by the age distribution and the opportunistic screening policies for each area.


Subject(s)
Prostatic Neoplasms/epidemiology , Adult , Aged , Aged, 80 and over , Catchment Area, Health , Humans , Incidence , Male , Middle Aged , Registries , Spain/epidemiology
7.
Auto Immun Highlights ; 8(1): 8, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28631225

ABSTRACT

PURPOSE: In the last two decades, thyroglobulin autoantibodies (TgAb) measurement has progressively switched from marker of thyroid autoimmunity to test associated with thyroglobulin (Tg) to verify the presence or absence of TgAb interference in the follow-up of patients with differentiated thyroid cancer. Of note, TgAb measurement is cumbersome: despite standardization against the International Reference Preparation MRC 65/93, several studies demonstrated high inter-method variability and wide variation in limits of detection and in reference intervals. Taking into account the above considerations, the main aim of the present study was the determination of TgAb upper reference limit (URL), according to the National Academy of Clinical Biochemistry guidelines, through the comparison of eleven commercial automated immunoassay platforms. METHODS: The sera of 120 healthy males, selected from a population survey in the province of Verona, Italy, were tested for TgAb concentration using eleven IMA applied on as many automated analyzers: AIA-2000 (AIA) and AIA-CL2400 (CL2), Tosoh Bioscience; Architect (ARC), Abbott Diagnostics; Advia Centaur XP (CEN) and Immulite 2000 XPi (IMM), Siemens Healthineers; Cobas 6000 (COB), Roche Diagnostics; Kryptor (KRY), Thermo Fisher Scientific BRAHMS, Liaison XL (LIA), Diasorin; Lumipulse G (LUM), Fujirebio; Maglumi 2000 Plus (MAG), Snibe and Phadia 250 (PHA), Phadia AB, Thermo Fisher Scientific. All assays were performed according to manufacturers' instructions in six different laboratories in Friuli-Venezia Giulia and Veneto regions of Italy [Lab 1 (AIA), Lab 2 (CL2), Lab 3 (ARC, COB and LUM), Lab 4 (CEN, IMM, KRY and MAG), Lab 5 (LIA) and Lab 6 (PHA)]. Since TgAb values were not normally distributed, the experimental URL (e-URL) was established at 97.5 percentile according to the non-parametric method. RESULTS: TgAb e-URLs showed a significant inter-method variability. Considering the same method, e-URL was much lower than that suggested by manufacturers (m-URL), except for ARC and MAG. Correlation and linear regression were unsatisfactory. Consequently, the agreement between methods was poor, with significant bias in Bland-Altman plot. CONCLUSIONS: Despite the efforts for harmonization, TgAb methods cannot be used interchangeably. Therefore, additional effort is required to improve analytical performance taking into consideration approved protocols and guidelines. Moreover, TgAb URL should be used with caution in the management of differentiated thyroid carcinoma patients since the presence and/or the degree of TgAb interference in Tg measurement has not yet been well defined.

8.
Int J Lab Hematol ; 39(4): 418-422, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28318106

ABSTRACT

INTRODUCTION: Activated protein C resistance (APCr) leads to hypercoagulability and is due, often but not exclusively, to Factor V Leiden (FVL). The aim of this study was to assess the ex vivo and in vitro interference of the direct factor Xa inhibitor rivaroxaban (RIV) on a prothrombinase-based assay for APCr detection. METHODS: An ex vivo study was performed on fresh plasma samples obtained from 44 subjects with FV wild-type and seven with FVL heterozygous, all treated with RIV. An in vitro study was performed on 15 plasma samples (six from normal subjects, six from heterozygous, and three from homozygous FVL carriers, all frozen specimens) spiked with RIV. RIV concentration was evaluated using a chromogenic assay, and APCr was evaluated by a prothrombinase-based assay. RESULTS: No significant interference of RIV on APCr results obtained by a prothrombinase-based assay was observed for drug concentrations up to 400 ng/mL in FV wild-type and FVL carriers (homozygous and heterozygous). These results were confirmed both ex vivo and in vitro. CONCLUSIONS: RIV did not significantly interfere with the prothrombinase-based assay used for the assessment of APCr, and this was observed to occur independently of FV status. However, only concentrations up to 400 ng/mL were tested and, therefore, what occurs in the presence of higher doses remains to be investigated.


Subject(s)
Activated Protein C Resistance/genetics , Blood Coagulation/drug effects , Factor V Deficiency/blood , Factor V Deficiency/genetics , Factor V/genetics , Heterozygote , Rivaroxaban/pharmacology , Thromboplastin/metabolism , Aged , Aged, 80 and over , Blood Coagulation Tests , Drug Monitoring , Factor V Deficiency/diagnosis , Factor V Deficiency/drug therapy , Female , Homozygote , Humans , Italy , Male , Rivaroxaban/therapeutic use
11.
Transplant Proc ; 48(2): 631-4, 2016 Mar.
Article in English | MEDLINE | ID: mdl-27110018

ABSTRACT

BACKGROUND: CYP3A5 gene polymorphism rs776746 has been associated with lower tacrolimus dose requirements and bioavailability in both adults and children. This variant causes a loss of CYP3A5 activity owing to a splice site variant leading to a truncated inactive enzyme. The aim of this study was to determine if the rs776746 gene polymorphism is related to the time to reach tacrolimus therapeutic levels in renal transplant children. METHODS: A prospective study was performed in renal transplant children receiving tacrolimus as part of their immunosuppressive regime. CYP3A5 genotype was determined by direct sequencing. Tacrolimus trough levels and serum creatinine at 1 week and 1 month after renal transplantation was obtained from clinical chart. RESULTS: A total of 42 patients were included; 19 (45.2%) were female, 23 (54.8%) received living-donor transplants, and 21 patients expressed CYP3A5*1/*1 or CYP3A5*1/*3. Tacrolimus dose was higher in expressers at week 1 (0.13 vs 0.10 mg/kg/d; P = .011), and week 4 after transplantation (0.17 vs 0.09 mg/kg/d; P < .0001). At 4 weeks after renal transplantation, only 9 patients from the expressers group (42.8%) had levels ≥7 ng/mL, in contrast to 18 in the nonexpressers group (85.7%; Fisher exact P = .008). CONCLUSIONS: Tacrolimus dose was significant higher in functional CYP3A5 expressers. Only 42.8% of such expressers had tacrolimus trough levels ≥7 ng/mL at 1 month after transplantation despite dose adjustments. Long-term follow up is needed to address the consequences of early post-transplantation bioavailability differences due to CYP3A5 genotype.


Subject(s)
Cytochrome P-450 CYP3A/genetics , Graft Rejection/genetics , Immunosuppressive Agents/pharmacokinetics , Kidney Transplantation , Polymorphism, Genetic/genetics , Tacrolimus/pharmacokinetics , Adolescent , Alternative Splicing/genetics , Biological Availability , Child , Dose-Response Relationship, Drug , Female , Genotype , Graft Rejection/blood , Graft Survival/genetics , Humans , Immunosuppressive Agents/administration & dosage , Male , Prospective Studies , Tacrolimus/administration & dosage , Tissue Donors
12.
AJNR Am J Neuroradiol ; 36(6): 1109-15, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25678478

ABSTRACT

BACKGROUND AND PURPOSE: The accuracy of automatic tissue segmentation methods can be affected by the presence of hypointense white matter lesions during the tissue segmentation process. Our aim was to evaluate the impact of MS white matter lesions on the brain tissue measurements of 6 well-known segmentation techniques. These include straightforward techniques such as Artificial Neural Network and fuzzy C-means as well as more advanced techniques such as the Fuzzy And Noise Tolerant Adaptive Segmentation Method, fMRI of the Brain Automated Segmentation Tool, SPM5, and SPM8. MATERIALS AND METHODS: Thirty T1-weighted images from patients with MS from 3 different scanners were segmented twice, first including white matter lesions and then masking the lesions before segmentation and relabeling as WM afterward. The differences in total tissue volume and tissue volume outside the lesion regions were computed between the images by using the 2 methodologies. RESULTS: Total gray matter volume was overestimated by all methods when lesion volume increased. The tissue volume outside the lesion regions was also affected by white matter lesions with differences up to 20 cm(3) on images with a high lesion load (≈50 cm(3)). SPM8 and Fuzzy And Noise Tolerant Adaptive Segmentation Method were the methods less influenced by white matter lesions, whereas the effect of white matter lesions was more prominent on fuzzy C-means and the fMRI of the Brain Automated Segmentation Tool. CONCLUSIONS: Although lesions were removed after segmentation to avoid their impact on tissue segmentation, the methods still overestimated GM tissue in most cases. This finding is especially relevant because on images with high lesion load, this bias will most likely distort actual tissue atrophy measurements.


Subject(s)
Brain/pathology , Image Enhancement/methods , Image Interpretation, Computer-Assisted/methods , Magnetic Resonance Imaging/methods , Multiple Sclerosis/diagnosis , Multiple Sclerosis/pathology , White Matter/pathology , Atrophy/diagnosis , Atrophy/pathology , Gray Matter/pathology , Humans , Organ Size/physiology , Sensitivity and Specificity , Software
13.
Neuroscience ; 282: 86-100, 2014 Dec 12.
Article in English | MEDLINE | ID: mdl-24881574

ABSTRACT

Midbrain dopamine (DA) neurons play a central role in a wide range of behaviors, from attention and motivation to motor control and reinforcement. The release of DA is modulated by a number of factors, and its deregulation has been implicated in multiple psychiatric disorders, such as addiction. In particular, nicotinic acetylcholine receptors (nAChRs) are key modulators of DA cells. Nicotine, the main addictive component in tobacco, strongly interacts with these receptors in the midbrain DA systems, resulting in reinforcing effects that are at the core of tobacco addiction. nAChRs are virtually expressed on every cell of the DA system, both at pre-, post- and extra-synaptic locations. The complex issue of interpreting the role of the large portfolio of different nAChR subtypes expressed on ventral tegmental area (VTA) and substantia nigra pars compacta (SNc) neurons, and especially their role in defining functional DAergic subpopulations, is far from being solved. In this review we will try to provide the reader with an integrative view of the nicotinic modulation of DA neurons and its influence at the cellular, systemic and behavioral levels (exploratory behavior), as well as its implication in the reinforcing effects of nicotine.


Subject(s)
Behavior, Animal/physiology , Dopaminergic Neurons/metabolism , Nicotine/metabolism , Receptors, Nicotinic/physiology , Substantia Nigra/physiology , Ventral Tegmental Area/physiology , Animals , Substantia Nigra/metabolism , Ventral Tegmental Area/metabolism
14.
Minerva Endocrinol ; 38(3): 329-36, 2013 Sep.
Article in English | MEDLINE | ID: mdl-24126553

ABSTRACT

In type 3 polyendocrine syndrome (PAS3), autoimmune thyroiditis occurs with other organ-specific autoimmune disease, but not with autoimmune adrenalitis. In this report we described a family from Pakistan in which mother and three daughters were affected by a PAS3. We studied a family from Pakistan: Father MMu age 44, mother KN aged 44, three daughters MM age 20, MH age 16 and MA age 14 and a son MU age 18. These subjects were tested for thyroids function, metabolic function, adrenal function, autoimmune disease. In this family the four females were shown hypothyroidism with presence of anti thyroid autoantibodies (AA) and high TSH serum concentration in association with the presence of anti transglutaminase AA. Moreover KN, MM and MH were positive for anti nuclear AA (granular pattern) and for antibodies against Saccaromyces cerevisiae. MM was positive for AA against nuclear extractable antigens (SSA and SSB) too. No diabetes or pernicious anemia were observed. Adrenal and Pituitary function were normal. PAS 3C is an uncommon disease. In this family from Pakistan we observed a PAS3C in the four female members: mother and three daughters while father and son were unaffected.


Subject(s)
Polyendocrinopathies, Autoimmune/genetics , Adolescent , Adult , Antibody Specificity , Autoantibodies/blood , Autoantigens/immunology , Celiac Disease/genetics , Female , HLA Antigens/genetics , Hormones/blood , Humans , Male , Pakistan , Pedigree , Phenotype , Polyendocrinopathies, Autoimmune/blood , Polyendocrinopathies, Autoimmune/classification , Sjogren's Syndrome/genetics , Thyroiditis, Autoimmune/genetics , Thyrotropin/blood
15.
Pediatr Transplant ; 16(3): 274-9, 2012 May.
Article in English | MEDLINE | ID: mdl-22309031

ABSTRACT

The aim of the study was to evaluate whether or not serum levels of soluble interleukin 2 receptor (sIL-2R) predict acute rejection in pediatric recipients. We studied 51 pediatric renal transplant recipients divided into three groups: Group 1) Biopsy-proven cellular acute rejection (n = 19), Group 2) Graft dysfunction with histological diagnosis other than acute rejection (n = 8) and Group 3) Patients with stable graft function, no biopsy (n = 24). Serum samples for sIL-2R measurement by sandwich ELISA were obtained at the time of renal transplant and at the time of renal biopsy due to graft dysfunction (Groups 1 and 2) or at six months post-transplant in the case of Group 3. The mean ± s.e. serum values of sIL-2R were higher in patients during acute rejection (6539 ± 1802 pg/mL) compared to patients with other causes of graft dysfunction (2217 ± 256 pg/mL) or stable graft function at six months (2183 ± 283 pg/mL) (Kruskal-Wallis p = 0.004). When the sIL2-R levels at the time of transplant were compared to those at the time of biopsy (Groups 1 and 2) or at six months post-transplant in Group 3, there was no significant difference between baseline and biopsy in the acute rejection group (paired t-test = 0.07), whereas there was a significant reduction in Groups 2 and 3.


Subject(s)
Gene Expression Regulation , Graft Rejection , Kidney Transplantation/methods , Receptors, Interleukin-2/blood , Adolescent , Biopsy , Child , Enzyme-Linked Immunosorbent Assay/methods , Female , Glomerular Filtration Rate , Graft Survival , Humans , Kidney Transplantation/adverse effects , Male , Prospective Studies , ROC Curve , Reproducibility of Results
16.
Clin Chim Acta ; 413(7-8): 814-6, 2012 Apr 11.
Article in English | MEDLINE | ID: mdl-22285776

ABSTRACT

BACKGROUND: In this study, we evaluated the GeneXpert HemosIL Factor II and Factor V assay, an innovative assay for the detection of Factor V Leiden (FVL) and prothrombin G20210A mutation (GPRO). PATIENTS AND METHODS: We evaluated 132 patients that were previously classified (with a concordant result) using two commercial real-time PCR assays supplied, by Applied Biosystems and Roche Molecular Biochemicals. The cohort comprised 75 normal subjects, 10 FVL homozygous, 35 FVL heterozygous, 7 GPRO heterozygous, 2 GPRO homozygous and 3 double heterozygous FVL and GPRO subjects. All of the samples were evaluated using the GeneXpert HemosIL Factor II and Factor V assay. RESULTS: All of the samples were correctly identified using the GeneXpert HemosIL Factor II and Factor V assay; therefore, in this patient series, the specificity and sensitivity of the test under evaluation was 1.00. DISCUSSION: We have shown that the GeneXpert HemosIL Factor II and Factor V assay, a rapid fully automated assay, can accurately characterise the presence of FV G1691A and FII G20210A polymorphisms with specificity and sensitivity that are comparable to other current real-time PCR-based methods. The theoretical advantages of such an assay include improved standardisation across varying healthcare environments, more thorough sample manipulation and reduced human error.


Subject(s)
Factor V/genetics , Prothrombin/genetics , Cohort Studies , Humans , Mutation , Reference Values
17.
Biomacromolecules ; 11(7): 1763-72, 2010 Jul 12.
Article in English | MEDLINE | ID: mdl-20527810

ABSTRACT

New therapeutic strategies for the treatment of neoplastic pathologies and, in particular, metastasis processes are based on the inhibitory effect of angiogenic processes. The present article deals with the design, preparation, and application of new "polymer drugs" with a clear inhibitory effect of the activation of fibroblast growth factors, which plays an important role in the proliferation of vascular cells and, consequently, in tumor angiogenesis. Two different copolymer systems based on 5-methacrylamide-2-naphthalenesulfonic acid (MANSA) and butylacrylate (BA) or vinylpyrrolidone (VP) were prepared by free radical copolymerization and exhaustively characterized. The molecular weight of the copolymers was moderate but both families presented very homogeneous macromolecular populations with a polydispersity index very close to unity, which indicates that MANSA presents a noticeable effect on the polymerization processes. The system poly(BA-co-MANSA) provides amphiphilic copolymers that give rise to the formation of oriented micelles with a core of the hydrophobic BA segments and a shell of MANSA components. The average size of these self-assembling nanoparticles is between 20 and 100 nm, depending on the composition of the copolymer system. However, poly(VP-co-MANSA) systems are more hydrophilic and give more homogeneous and water-soluble macromolecules. The bioactivity of both systems was studied by the analysis of proliferation of Balb/c 3T3 fibroblasts in the presence of acidic fibroblast growth factor (aFGF) as a function of the concentration of poly(BA-co-MANSA) or poly(VP-co-MANSA), and the results obtained demonstrated that the MANSA-containing polymers were not toxic for cells, but induced a clear inhibition of cell proliferation in the presence of aFGF. The effect was polymer-concentration dependent, but the activity was noticeably higher for poly(BA-co-MANSA) copolymers, owing to the self-assembled micellar morphology of the nanoparticles, which placed the sulfonic groups in the more adequate position to interact with the growth factor. These systems offer a good alternative for low toxicity treatments of angiogenic, processed based on inhibition of the activity of growth factors.


Subject(s)
Drug Carriers/chemistry , Polymers/chemistry , Polymers/therapeutic use , 3T3 Cells , Acrylamides , Animals , Biocompatible Materials , Cell Proliferation/drug effects , Fibroblast Growth Factor 1/antagonists & inhibitors , Mice , Micelles , Nanoparticles , Naphthalenesulfonates , Neovascularization, Pathologic/drug therapy
18.
Pediatr Transplant ; 14(6): 746-52, 2010 Sep 01.
Article in English | MEDLINE | ID: mdl-20412508

ABSTRACT

The aim of the study was to evaluate the efficacy and safety of the conversion of MMF to EC-MPS in pediatric renal transplant recipients. We included 12 patients with stable graft function who were receiving MMF treatment. In the first visit, a complete medical examination was performed, which included a GSRS, a nine-point pharmacokinetic profile, samples for renal, liver and hematological tests and evaluation of IMPDH2 gene expression. The patients were transferred to an equimolar dose of EC-MPS. Two wk later, a clinical evaluation and blood collection, as in the first visit were performed. There was no change in serum creatinine, leukocyte count, serum albumin, or transaminase levels, but we found a statistically significant reduction of hemoglobin after conversion (13.2 +/- 1.6 g/dL with MMF vs. 12.5 +/- 1.3 g/dL when receiving EC-MPS). The GSRS total mean score was 16 +/- 12 with MMF vs. 8 +/- 5 with EC-MPA (p < 0.05). There was no statistically significant difference between formulations in the gene expression of IMPDH 2, in the AUC(0-12h) or in C(max). However, peak concentration occurred later with EC-MPS.


Subject(s)
Drug Substitution , Immunosuppressive Agents/pharmacokinetics , Kidney Transplantation , Mycophenolic Acid/analogs & derivatives , Mycophenolic Acid/pharmacokinetics , Adolescent , Area Under Curve , Child , Female , Humans , Immunosuppressive Agents/therapeutic use , Kidney Transplantation/immunology , Male , Mycophenolic Acid/therapeutic use , Prospective Studies , Tablets, Enteric-Coated
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