Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.

AIMS: Both fasting (FPG) and postprandial plasma glucose (PPG) contribute to HbA1c levels. We investigated the relationship between achievement of American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) recommended FPG and/or PPG targets and glycaemic efficacy outcomes in two trials. METHODS: In this post hoc analysis, data from participants with Type 2 diabetes in the phase 3 LixiLan-O (NCT02058147) and LixiLan-L (NCT02058160) trials were evaluated to compare the relationship between achievement of society-recommended FPG and/or PPG targets and efficacy (HbA1c change, HbA1c goal attainment, weight change) and safety outcomes in the treatment groups. RESULTS: Across treatment arms, iGlarLixi achieved the highest proportion of participants meeting both ADA- and AACE-recommended FPG and PPG targets at study end in both trials. A higher proportion of participants in the iGlarLixi (fixed-ratio combination of insulin glargine and lixisenatide) vs. insulin glargine alone or lixisenatide alone treatment arms achieved HbA1c goals (P < 0.001 for overall comparisons), irrespective of ADA- or AACE-defined targets. Hypoglycaemia rates [any, documented symptomatic (plasma glucose ≤ 3.9 mmol/l), and clinically important (plasma glucose < 3.0 mmol/l)] were low across all groups. Participants treated with iGlarLixi tended to show weight loss or less weight gain compared with participants receiving insulin glargine alone. No differences were observed in average daily basal insulin dose at week 30 between the two treatment arms or across the different FPG and PPG target groups. CONCLUSION: Insulin glargine and lixisenatide as a fixed-ratio combination resulted in more participants reaching both FPG and PPG targets, leading to better HbA1c target attainment.

Advanced-stage mycosis fungoides: role of the signal transducer and activator of transcription 3, nuclear factor-κB and nuclear factor of activated T cells pathways.

BACKGROUND: The malignant mechanisms that control the development of cutaneous T-cell lymphoma (CTCL) are beginning to be identified. Recent evidence suggests that disturbances in specific intracellular signalling pathways, such as RAS-mitogen-activated protein kinase, T-cell receptor (TCR)-phospholipase C gamma 1 (PLCG1)-nuclear factor of activated T cells (NFAT) and Janus kinase (JAK)-signal transducer and activator of transcription (STAT), may play an essential role in the pathogenesis of CTCL. OBJECTIVES: To investigate the mechanisms controlling disease development and progression in mycosis fungoides (MF), the most common form of CTCL. METHODS: We collected 100 samples that were submitted for diagnosis of, or a second opinion regarding, MF between 2001 and 2018, 80% of which were in the early clinical stages of the disease. Formalin-fixed paraffin-embedded tissues were used for histological review and to measure the expression by immunohistochemistry of surrogate markers of activation of the TCR-PLCG1-NFAT, JAK-STAT and NF-κB pathways. Folliculotropism and large-cell transformation were also examined. RESULTS: NFAT and nuclear factor kappa B (NF-κB) markers showed a comparable activation status in early and advanced stages, while STAT3 activation was more frequent in advanced stages and was associated with large-cell transformation. Consistently with this observation, STAT3 activation occurred in parallel with MF progression in two initially MF-negative cases. A significant association of NFAT with NF-κB markers was also found, reflecting a common mechanism of activation in the two pathways. Genomic studies identified nine mutations in seven genes known to play a potential role in tumorigenesis in T-cell leukaemia/lymphoma, including PLCG1, JAK3 and STAT3, which underlies the activation of these key cell-survival pathways. A higher mutational allele frequency was detected in advanced stages. CONCLUSIONS: Our results show that STAT3 is activated in advanced cases and is associated with large-cell transformation, while the activation of NFAT and NF-κB is maintained throughout the disease. These findings could have important diagnostic and therapeutic implications. What's already known about this topic? Mycosis fungoides is characterized by a clonal expansion of T cells in the skin. The mechanisms controlling disease development and progression are not fully understood. What does this study add? An association of the nuclear factor of activated T cells and nuclear factor kappa B pathways was found, which could reflect a common mechanism of activation. These pathways were activated in early and advanced stages at the same level. Signal transducer and activator of transcription 3 activation was associated with large-cell transformation and was more frequent in advanced stages. A genomic analysis of cutaneous T-cell lymphoma-associated genes was performed. Nine mutations were detected. What is the translational message? These results could have important implications for the treatment of MF in the near future.

Pharmacometabolomics applied to zonisamide pharmacokinetic parameter prediction.

INTRODUCTION: Zonisamide is a new-generation anticonvulsant antiepileptic drug metabolized primarily in the liver, with subsequent elimination via the renal route. OBJECTIVES: Our objective was to evaluate the utility of pharmacometabolomics in the detection of zonisamide metabolites that could be related to its disposition and therefore, to its efficacy and toxicity. METHODS: This study was nested to a bioequivalence clinical trial with 28 healthy volunteers. Each participant received a single dose of zonisamide on two separate occasions (period 1 and period 2), with a washout period between them. Blood samples of zonisamide were obtained from all patients at baseline for each period, before volunteers were administered any medication, for metabolomics analysis. RESULTS: After a Lasso regression was applied, age, height, branched-chain amino acids, steroids, triacylglycerols, diacyl glycerophosphoethanolamine, glycerophospholipids susceptible to methylation, phosphatidylcholines with 20:4 FA (arachidonic acid) and cholesterol ester and lysophosphatidylcholine were obtained in both periods. CONCLUSION: To our knowledge, this is the only research study to date that has attempted to link basal metabolomic status with pharmacokinetic parameters of zonisamide.

Correction to: Pharmacometabolomics applied to zonisamide pharmacokinetic parameter prediction.

The original version of this article contains a mistake.

Esophagocardioplasty, vagotomy-antrectomy and Roux-en-Y gastrojejunostomy: indication in cases with severe esophageal motor disfunction.

Almost 10% of patients with Crest syndrome associated with severe gastroesophageal reflux and 5-10% of patients with failed cardiomyotomy for achalasia present with cardial or distal esophageal organic stricture. Some of these cases are poor risk patients for surgery and therefore the surgeon must offer a safe procedure with low morbimortality, keeping in mind the pathophysiological motor pattern of these patients.In order to treat the stricture to improve the esophageal transit we treated patients with esophagocardioplasty associated with vagotomy-antrectomy and Roux-en-Y gastrojejunostomy, thereby avoiding the potential acid or biliary reflux in poor risk patients in whom esophagectomy would be a very deleterious procedure. All four patients had a good postoperative evolution and late control demonstrated good esophagogastric transit with no postoperative esophagitis.

A multistrategic approach in the development of sourdough bread targeted towards blood pressure reduction.

Rising prevalence of hypertension is pushing food industry towards the development of innovative food products with antihypertensive effects. The aim was to study the effect of reduced sodium content and 21% addition of wholemeal wheat sourdough (produced by Lactobacillus brevis CECT 8183 and protease) on proximate composition, γ-aminobutyric acid (GABA) and peptide content of wheat bread. Angiotensin converting enzyme I (ACE) inhibitory and antioxidant activities were also evaluated. Sodium replacement by potassium salt did not affect chemical composition and biological activities of bread. In contrast, GABA and peptides <3 kDa contents in sourdough bread (SDB) were 7 and 3 times higher, respectively, than the observed in control. ACE inhibitory and antioxidant activities of the peptide fraction < 3 kDa from SDB was 1.7 and 2.6-3.0 times higher than control. Therefore, the combination of reduced sodium content with enriched concentrations of bioactive compounds in bread making may provide interesting perspectives for development of innovative breads towards blood pressure reduction.

Comparison of Microcystis aeruginosa (PCC7820 and PCC7806) growth and intracellular microcystins content determined by liquid chromatography-mass spectrometry, enzyme-linked immunosorbent assay anti-Adda and phosphatase bioassay.

Cyanobacteria are able to produce several metabolites that have toxic effects on humans and animals. Among these cyanotoxins, the hepatotoxic microcystins (MC) occur frequently. The intracellular MC content produced by two strains of Microcystis aeruginosa, PCC7806 and PCC7820, and its production kinetics during the culture time were studied in order to elucidate the conditions that favour the growth and proliferation of these toxic strains. Intracellular MC concentrations measured by liquid chromatography (LC) coupled to electrospray ionization mass spectrometer (MS) were compared with those obtained by enzyme-linked immunosorbent assay (ELISA) anti-Adda and protein phosphatase 2A (PP2A) inhibition assays. It has been demonstrated there are discrepancies in the quantification of MC content when comparing ELISA and LC-MS results. However, a good correlation has been obtained between PP2A inhibition assay and LC-MS. Three MC were identified using LC-MS in the PCC7806 strain: MC-LR, demethylated MC-LR and a new variant detected for the first time in this strain, [L-MeSer(7)] MC-LR. In PCC7820, MC-LR, D-Asp(3)-MCLR, Dglu(OCH3)-MCLR, MC-LY, MC-LW and MC-LF were identificated. The major one was MC-LR in both strains, representing 81 and 79% of total MC, respectively. The total MC content in M. aeruginosa PCC7820 was almost three-fold higher than in PCC7806 extracts.

Proton pump inhibitors are associated with hypersensitivity reactions to drugs in hospitalized patients: a nested case-control in a retrospective cohort study.

BACKGROUND: Previous research has shown that gastric acid suppression by antacid drugs can promote allergic reactions to acid-labile food proteins. No data are available about whether antacid drugs can promote drug hypersensitivity reactions. The most potent and longer lasting inhibition of gastric secretion is provided by proton pump inhibitors (PPIs). We hypothesized that gastric acid suppression by proton pump inhibitors could be causative of drug hypersensitivity reactions during hospitalization. OBJECTIVE: To estimate the risk of developing drug hypersensitivity reactions during the hospitalization of patients treated with proton pump inhibitors, and other associated factors. METHODS: A nested case-control in a retrospective cohort study of hospitalized patients from September 2008 to December 2010 (70 771 admissions) was conducted using the registry of cases of interconsultations to the Allergy Department (161 confirmed cases of drug hypersensitivity reactions). A total of 318 controls were matched by first drug suspected in the hypersensitivity reaction, time of admission, age, gender and hospitalization wards. RESULTS: The relative risk of drug hypersensitivity reaction occurrence during hospitalization of patients treated with PPIs compared with those not treated in the period of study was significant (RR: 3.97; 95% CI: 1.97-8.29). After controlling for confounders in the nested case-control cohort, the use of PPIs persists as a predisposing factor (OR: 4.35; 95% CI: 2-9.45). Personal history of drug allergy and a long hospitalization time were other predisposing factors of drug hypersensitivity reactions (DHRs). The hazard that a DHR has occurred during PPI treatment was 3.7% per day. The hazard for immediate or accelerated reactions was 1.706 (P = 0.003) times that of delayed reactions. CONCLUSION AND CLINICAL RELEVANCE: In hospitalized patients, the use of proton pump inhibitors was associated with a significant increase risk of drug hypersensitivity reactions along with a personal history of drug allergies and long hospitalization time.

Extruded flaxseed meal enhances the nutritional quality of cereal-based products.

Human consumption of flaxseed is increasing due to its health benefit properties and extrusion processes can enhance its nutritional quality. Extruded flaxseed meal (EFM) obtained in a pilot plant was characterized and incorporated in flour mixes and cereal-based bars to demonstrate its nutritious usefulness. Amino acid content was not affected by extrusion and, despite lysine was the limitating amino acid, the chemical score (CS) was 83 %. Thiamin and riboflavin decreased slightly as consequence of extrusion, phytic acid did not change and trypsin inhibitor activity was undetectable. Proximate composition and nutritional quality determined by biological and chemical indexes were compared among EFM, flour mixes (FM) and cereal bars (CB). They presented high protein levels (26, 20 and 17 %, respectively), good biological value (BV) (80, 79 and 65, respectively), acceptable true protein digestibility (TD) (73, 79 and 78, respectively), and high dietary fiber (33, 20.5 and 18 %, respectively). The ratio of ω6:ω3 for CB was within the WHO/FAO recommendations. These results open a new venue for the usefulsess of nutritious/healthy extruded flaxseed flours into ready-to-eat cereal-based products with improved nutritional quality.

Zooplankton exposure to microplastic contamination in a estuarine plume-influenced region, in Northeast Brazil.

This work describes the spatio-temporal distribution of suspected plastic and microplastic (MP) particles in estuarine plumes and analyzes the microplastic/zooplankton ratio. Subsurface hauls with a conical-cylindrical net were deployed in the coastal area of Tamandare (Pernambuco, Brazil), covering the plume of two rivers and a bay adjacent to coral reefs. A total of 2079 suspected plastic particles were detected, mostly fibers and fragments (>60%). Organic matter digestion was made using a 30% hydrogen peroxide solution, of which approximately 50% of suspected particles were validated as MPs. The average MP abundance was significantly higher during the high rainfall season (53.8 ± 89.6 and 18.8 ± 32.3 particles/m³, respectively), with higher values registered in the plume area (108.9 ± 158.5 and 44.6 ± 55.5 particles/m³). Polymer identification using FT-IR confirmed that suspected particles were mainly polypropylene, polyamide, and polyurethane. These results confirm the hypothesis of a temporal transport variation of MPs from the river to the coastal environments, particularly since the plume influences debris input. Eleven animal phyla were identified, and the subclass Copepoda was predominant (90%), particularly the nauplius stage (70%). Over 70% of verified MPs range between 20 and 2000 µm, equivalent to the most common size of zooplanktonic organisms. Results support that coastal areas near estuarine plumes are exposed to microplastic contamination, affecting species dependent on zooplankton in marine coastal food webs.

Multi-analytical characterization of an oncoid from a high altitude hypersaline lake using techniques employed in the Mars2020 and Rosalind Franklin missions on Mars.

In this work, a geological sample of great astrobiological interest was studied through analytical techniques that are currently operating in situ on Mars and others that will operate in the near future. The sample analyzed consisted of an oncoid, which is a type of microbialite, collected in the Salar Carachi Pampa, Argentina. The main peculiarity of microbialites is that they are organo-sedimentary deposits formed by the in situ fixation and precipitation of calcium carbonate due to the growth and metabolic activities of microorganisms. For this reason, the Carachi Pampa oncoid was selected as a Martian analog for astrobiogeochemistry study. In this sense, the sample was characterized by means of the PIXL-like, SuperCam-like and SHERLOC-like instruments, which represent instruments on board the NASA Perseverance rover, and by means of RLS-like and MOMA-like instruments, which represent instruments on board the future ESA Rosalind Franklin rover. It was possible to verify that the most important conclusions and discoveries have been obtained from the combination of the results. Likewise, it was also shown that Perseverance rover-like remote-sensing instruments allowed a first detailed characterization of the biogeochemistry of the Martian surface. With this first characterization, areas of interest for in-depth analysis with Rosalind Franklin-like instruments could be identified. Therefore, from a first remote-sensing elemental identification (PIXL-like instrument), followed by a remote-sensing molecular characterization (SuperCam and SHERLOC-like instruments) and ending with an in-depth microscopic analysis (RLS and MOMA-like instruments), a wide variety of compounds were found. On the one hand, the expected minerals were carbonates, such as aragonite, calcite and high-magnesium calcite. On the other hand, unexpected compounds consisted of minerals related to the Martian/terrestrial surface (feldspars, pyroxenes, hematite) and organic compounds related to the past biological activity related to the oncoid (kerogen, lipid biomarkers and carotenes). Considering samples resembling microbialites have already been found on Mars and that one of the main objectives of the missions is to identify traces of past life, the study of microbialites is a potential way to find biosignatures protected from the inhospitable Martian environment. In addition, it should be noted that in this work, further conclusions have been obtained through the study of the results as a whole, which could also be carried out on Mars.

Use of antifungal agents in pediatric and adult high-risk areas.

The purpose of this investigation was to describe the characteristics of the use of systemic antifungal agents (AFAs) and to evaluate their appropriateness of use. A prospective drug-utilisation study was conducted in intensive-care areas: haematology-oncology services and transplant units. Data were collected in three periods over 9 months. The required sample size was determined to be 113 patients (margin of error ±7%, 95% confidence interval [CI]), assuming a variability of 50%. Two different investigator groups evaluated the appropriateness of use separately; Cohen's Kappa index was used to calculate the degree of agreement between groups. A total of 114 patients we included, of which 62 (54.4%) were children. A total of 150 prescriptions were administered; fluconazole was the most frequently prescribed (38%), followed by liposomal amphotericin B (22.7%) and caspofungin (18.7%). The indications were: (1) pre-emptive treatment of Candida in non-neutropaenic critically ill patients (35.1%), (2) treatment of systemic fungal infection (24.6%), (3) prophylaxis for systemic fungal infection (SFI) in immunocompromised patients (16.7%), (4) prophylaxis of SFI in transplant recipients (12.3%), (5) prophylaxis of SFI in preterm infants (5.3%), (6) treatment of SFI in neonates (6.1%). The Kappa index showed a substantial agreement (Kappa = 0.73). The indications were considered to be inappropriate in 71 (47.3%) episodes. The indications or dosages were inappropriate in 79 cases (52.7%). The indications, dosages or duration of treatment were inappropriate in 83 cases (55.3%). We conclude that AFAs are prescribed for a significant number of inappropriate indications.

Homogeneity assessment of the SuperCam calibration targets onboard rover perseverance.

The SuperCam instrument, onboard the Perseverance rover (Mars 2020 mission) is designed to perform remote analysis on the Martian surface employing several spectroscopic techniques such as Laser Induced Breakdown Spectroscopy (LIBS), Time-Resolved Raman (TRR), Time-Resolved Fluorescence (TRF) and Visible and Infrared (VISIR) reflectance. In addition, SuperCam also acquires high-resolution images using a color remote micro-imager (RMI) as well as sounds with its microphone. SuperCam has three main subsystems, the Mast Unit (MU) where the laser for chemical analysis and collection optics are housed, the Body Unit (BU) where the different spectrometers are located inside the rover, and the SuperCam Calibration Target (SCCT) located on the rover's deck to facilitate calibration tests at similar ambient conditions as the analyzed samples. To perform adequate calibrations on Mars, the 22 mineral samples included in the complex SCCT assembly must have a very homogeneous distribution of major and minor elements. The analysis and verification of such homogeneity for the 5-6 replicates of the samples included in the SCCT has been the aim of this work. To verify the physic-chemical homogeneity of the calibration targets, micro Energy Dispersive X-ray Fluorescence (EDXRF) imaging was first used on the whole surface of the targets, then the relative abundances of the detected elements were computed on 20 randomly distributed areas of 100 × 100 µm. For those targets showing a positive Raman response, micro-Raman spectroscopy imaging was performed on the whole surface of the targets at a resolution of 100 × 100 µm. The %RSD values (percent of relative standard deviation of mean values) for the major elements measured with EDXRF were compared with similar values obtained by two independent LIBS set-ups at spot sizes of 300 µm in diameter. The statistical analysis showed which elements were homogeneously distributed in the 22 mineral targets of the SCCT, providing their uncertainty values for further calibration. Moreover, nine of the 22 targets showed a good Raman response and their mineral distributions were also studied. Those targets can be also used for calibration purposes of the Raman part of SuperCam using the wavenumbers of their main Raman bands proposed in this work.

Ethical problems arising from the use of placebo in clinical trials with drugs for migraine. Their analysis by the moral deliberation method.

INTRODUCTION: Migraine is characterised as episodes of headache plus a variety of accompanying symptoms. Its pharmacological control remains unsatisfactory for some patients. The use of placebo in drug clinical trials on migraine commonly leads to numerous ethical uncertainties. METHODS: The purpose of this paper is to illustrate how the deliberation method helps in analysing the issues and finding solutions to selected ethical problems. Ethical decisions that try to solve conflicts arising from placebo use in clinical trials may be adopted using the moral deliberation method. Thus, the conflict is systematically assessed by identifying the following: Relevant facts; Values in conflict; Duties, or in other words, possible courses of action. Moral duty is following the optimal course of action. To identify this, it is recommended to state extreme courses of action, then intermediate courses of action, and then to proceed to the optimal course(s) of action. RESULTS AND CONCLUSIONS: In this paper, the application of this method is shown in several conflicting situations arising in two placebo-controlled clinical trials with drugs under development for the prophylaxis and acute treatment of migraine.

Detection of new biohints on lichens with Raman spectroscopy after space- and Mars like conditions exposure: Mission Ground Reference (MGR) samples.

The extremophile lichen Circinaria gyrosa (C. gyrosa) is one of the selected species within the BIOMEX (Biology and Mars Experiment) experiment. Here we present the Raman study of a biohint found in this lichen, called whewellite (calcium oxalate monohydrate), and other organic compounds and mineral products of the biological activity of the astrobiologically relevant model system C. gyrosa. Samples were exposed to space- and simulated Mars-like conditions during the EXPOSE-R2 mission parallel ground reference experiment MGR performed at the space- and planetary chambers of DLR-Cologne to study Mars' habitability and resistance to real space conditions. In this work, we complete the information of natural C. gyrosa about the process of diagenesis by the identification of carbonate crystals in the inner medulla together with the biomineral whewellite. The analysis by Raman spectroscopy of simulated Space and Mars exposed samples confirm alterations and damages of the photobiont part of the lichen and changes related to the molecular structure of whewellite. The conclusions of this work will be important to understand what are the effects to consider when biological systems are exposed to space or Mars-like conditions and to expand our knowledge of how life survives in most extreme conditions that is a prerequisite in future planetary exploration projects.

Perseverance rover reveals an ancient delta-lake system and flood deposits at Jezero crater, Mars.

Observations from orbital spacecraft have shown that Jezero crater on Mars contains a prominent fan-shaped body of sedimentary rock deposited at its western margin. The Perseverance rover landed in Jezero crater in February 2021. We analyze images taken by the rover in the 3 months after landing. The fan has outcrop faces, which were invisible from orbit, that record the hydrological evolution of Jezero crater. We interpret the presence of inclined strata in these outcrops as evidence of deltas that advanced into a lake. In contrast, the uppermost fan strata are composed of boulder conglomerates, which imply deposition by episodic high-energy floods. This sedimentary succession indicates a transition from sustained hydrologic activity in a persistent lake environment to highly energetic short-duration fluvial flows.

Inactivation of Escherichia coli by ozone treatment of apple juice at different pH levels.

This research investigated the efficacy of gaseous ozone on the inactivation of Escherichia coli ATCC 25922 and NCTC 12900 strains in apple juice of a range of pH levels, using an ozone bubble column. The pH levels investigated were 3.0, 3.5, 4.0, 4.5 and 5.0. Apple juice inoculated with E. coli strains (10(6)CFU/mL) was treated with ozone gas at a flow rate of 0.12L/min and ozone concentration of 0.048 mg/min/mL for up to 18 min. Results show that inactivation kinetics of E. coli by ozone were affected by pH of the juice. The ozone treatment duration required for achieving a 5-log reduction was faster (4 min) at the lowest pH than at the highest pH (18 min) studied. The relationship between time required to achieve 5log reduction (t(5d)) and pH for both strains was described mathematically by two exponential equations. Ozone treatment appears to be an effective process for reducing bacteria in apple juice and the required applied treatment for producing a safe apple juice is dependant on its acidity level.

Polytetrafluoroethylene versus polypropylene mesh during laparoscopic totally extraperitoneal (TEP) repair of inguinal hernia: short- and long-term results of a double-blind clinical randomized controlled trial.

PURPOSE: Aim of the study is to compare macroporous (> 1 mm2) polytetrafluoroethylene mesh (LP-PTFE) versus microporous (< 1 mm2) polypropylene mesh (SP-PPL) in terms of postoperative acute and chronic discomfort and pain, difficulty in mesh handling and long-term recurrence rate. METHODS: Fifty-two patients with bilateral hernia were enrolled in this double-blind randomized controlled trial (NCT02023203). Each hernia, in the same patient, was randomized to implant LP-PTFE or SP-PPL mesh during totally extraperitoneal laparoscopic hernia repair. Patients were followed at 7 days, 1, 3, 6, 12 and 60 months after surgery. Visual analog scale (VAS) score was employed to evaluate the outcomes. Student's t test was used in case of normally distributed continuous variables, while the nonparametric Mann-Whitney U test was used in case of not normally distributed variables. Chi square test was used for analysis of categorical variables. RESULTS: Median VAS discomfort score with SP-PPL was significantly higher than LP-PTFE at 1 and 3 months after surgery (p = 0.003 in both cases). LP-PTFE showed significantly lower median score than SP-PPL at 7 days after surgery (p = 0.025) regarding pain at movement. Testicular pain was lower in case of LP-PTFE than SP-PPL at 7 days, 1 and 3 months after surgery (p = 0.005, p = 0.004 and p = 0.004, respectively). LP-PTFE was significantly more difficult to handle (p = 0.001). At 60 months, one recurrence was observed in the LP-PTFE group (p = 1.0000). CONCLUSIONS: LP-PTFE has less postoperative discomfort and pain up to 3 months after surgery, without differences after that period, although it shows more difficulty in handling and recurrences occur even if not statistically significant.

Interpretation of a serial Mantoux test taking into account the annual risk of tuberculous infection.

BACKGROUND: Interpretation of tuberculin tests (TSTs) can be difficult. However, it is even more difficult to classify an individual as infected or non-infected if he or she has undergone a prior TST, as the difference between the booster effect and true conversion is not always clear. OBJECTIVE: To determine the size of the induration that is indicative of true infection after a second Mantoux test, based on the fact that the annual risk of tuberculous infection (ARTI) is equivalent, regardless of whether it is calculated directly or indirectly. METHOD: We performed two TSTs in the same population (aged 6 years at the first examination) with a 1-year interval. We calculated the prevalence of infection the first year (1.16%, 95%CI 0.67-1.65) and the ARTI using the indirect method (0.18%, 95%CI 0.00-0.37). For the second year, we considered different induration sizes and finally accepted a diameter of >10 mm as the criterion according to which the ARTI, calculated directly, corresponded to the value of the previous year (0.18%). CONCLUSION: Although they served as an aid in the interpretation of the TST, calculations of this type will probably be unnecessary in the future, when in vitro diagnostic tests for tuberculosis are made available in every health centre, thus enabling the classification of those individuals with indurations of intermediate size in the TST.