Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes.

BACKGROUND: A significant improvement in clinical signs was demonstrated with abrocitinib relative to placebo in adolescents with moderate-to-severe atopic dermatitis (AD) in three phase 3, randomized, double-blinded, placebo-controlled studies (JADE TEEN [ClinicalTrials.gov, NCT03796676], JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]). OBJECTIVES: To evaluate the impact of abrocitinib on patient-reported signs/symptoms, including sleep loss and quality of life among adolescents with moderate-to-severe AD. METHODS: JADE TEEN, JADE MONO-1 and JADE MONO-2 were conducted in the Asia-Pacific region, Europe and North America and included patients aged 12-17 years with moderate-to-severe AD and inadequate response to ≥ 4 consecutive weeks of topical medication or treatment with systemic therapy for AD. Patients were randomly assigned (1 : 1 : 1, JADE TEEN; 2 : 2 : 1, JADE MONO-1/-2) to receive once-daily oral abrocitinib (200 or 100 mg) or placebo for 12 weeks in combination with topical therapy (JADE TEEN) or as monotherapy (JADE MONO-1/-2). Data from adolescent patients in JADE MONO-1/-2 were pooled for these analyses. RESULTS: At week 12, more adolescents treated with abrocitinib (200 or 100 mg) vs. placebo achieved a ≥ 4-point improvement from baseline in the Patient-Oriented Eczema Measure in JADE TEEN (83.9% and 77.0% vs. 60.2%) and JADE MONO-1/-2 (83.0% and 69.4% vs. 43.5%) and a ≥ 6-point improvement from baseline in the Children's Dermatology Life Quality Index in JADE TEEN (73.8% and 67.5% vs. 56.5%) and JADE MONO-1/-2 (70.0% and 57.1% vs. 19.0%). Significant improvements in SCORing Atopic Dermatitis Visual Analog Scale for sleep loss scores were demonstrated with abrocitinib vs. placebo at weeks 2-12 in JADE TEEN and JADE MONO-1/-2. CONCLUSIONS: Patient-reported signs/symptoms, including reduction of sleep loss and quality of life, were substantially improved with abrocitinib monotherapy or combination therapy relative to placebo in adolescents with moderate-to-severe AD.

Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis.

BACKGROUND: In JADE COMPARE, abrocitinib improved severity of atopic dermatitis (AD) and demonstrated rapid itch relief. OBJECTIVES: We examined clinically meaningful improvements in selected patient-reported outcomes (PROs). METHODS: JADE COMPARE was a multicentre, phase 3 randomized, double-blind, placebo-controlled trial. Adults with moderate-to-severe AD were randomized 2:2:2:1 to receive 16 weeks of oral abrocitinib 200 or 100 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo, with background topical therapy. PROs included Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), Night Time Itch Scale (NTIS), Pruritus and Symptoms Assessment for Atopic Dermatitis, Patient Global Assessment, SCORing Atopic Dermatitis, and Hospital Anxiety and Depression Scale. RESULTS: At week 16, the proportion of patients achieving POEM scores <3 was 21.3% and 11.7% for 200 and 100 mg abrocitinib, 12.4% for dupilumab, and 4.8% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.04). Proportion achieving ≥4-point improvement from baseline in NTIS severity was 64.3% and 52.4% for 200 and 100 mg abrocitinib, 54.0% for dupilumab, and 34.4% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.007). Proportion achieving ≥4-point improvement from baseline in DLQI was 85.0% and 74.4% for 200 and 100 mg abrocitinib, 83.4% for dupilumab, and 59.7% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.005). CONCLUSION: Significant improvements in PROs were demonstrated with both abrocitinib doses vs. placebo, and abrocitinib 200 mg provided numerically greater effects compared with dupilumab in patients with moderate-to-severe AD.

Plasmon coupling interactions and inhibition of nonlinear absorption in a complex system with Ag and Pt nanoparticles in silica.

The optical response exhibited by a complex hybrid system integrated by Pt ultrasmall fluorescent particles and plasmonic Ag nanoparticles is reported. The system was synthesized by coimplantation of Ag and Pt ions into a silica matrix followed by a proper thermal annealing. The energies and fluences were chosen in order to overlap the spatial regions of the Ag and Pt ion distributions below the silica surface. Optical absorption and emission spectroscopies show that the complex nanostructures exhibit an important plasmonic response, together with photoluminescence excited at 355 nm, which is enhanced when compared to the reference sample with only Pt particles. Off-resonance nonlinear transmission and Z-scan measurements were undertaken using ultrafast pulses. High-irradiance excitation at 1064 nm with picosecond pulses shows that the Pt or Ag nanoparticles exhibit a two-photon absorption effect, while the complex system shows the absence of any nonlinear absorption. Similar observations were made using femtosecond pulses at 800 nm wavelength. This inhibition of the two-photon absorption effect and enhancement in the emission of the complex hybrid samples by the synergic participation of Ag and Pt particles can be explained as a result of a plasmon coupling via the near-field interaction between plasmonic and emitting sources.

Third-order nonlinear optical properties of a multi-layer Al2O3/ZnO for nonlinear optical waveguides.

This is a report of a study of the nonlinear optical properties of samples based on multiple Al2O3/ZnO bilayers fabricated by atomic layer deposition (ALD) in silica. The multi-layer configuration for samples consists of alternated layers of constant thickness of Al2O3 (Δx) and ZnO (Δy) nanolaminates with a total thickness of ∼ 500 nm. The physical properties of the samples were characterized by means of TEM, spectrophotometry and variable angle spectroscopic ellipsometry. The absorptive and refractive contributions to the nonlinearity of the samples were studied by means of z-scan technique using a 100 fs at 800 nm. The nonlinear parameters, ß and n2, are studied using different values of the layers thickness, Δx and Δy, in the nanolaminated stack. The possible applications in optical signal processing system are discussed by means of the figures of merit W and T.

Nonlinear optical response of platinum nanoparticles and platinum ions embedded in sapphire.

We report on the fabrication of sapphire samples containing platinum nanoparticles (Pt-NPs) and platinum ions (Pt-ions) and the investigation of their third-order nonlinear (NL) optical properties. The presence of Pt-NPs was confirmed by electronic microscopy and by the linear absorption spectrum that shows a localized surface plasmon band centered at 290 nm. A sample without NPs but containing Pt-ions was also studied. The absorptive and refractive contributions to the nonlinearity were studied using the z-scan technique with 100 fs pulses at 800nm. The experiments revealed a NL refractive index, +3.8×10-13 < n2 < +1.3×10-12cm2/W and NL absorption coefficient (ß < 9.3 cm/GW). The results show enhancement of about five orders of magnitude with respect to the NL refractive index of sapphire.

Lack of clinical evidence on low-level laser therapy (LLLT) on dental titanium implant: a systematic review.

Low-level laser therapy (LLLT) has proved to have biostimulating effects on tissues over which they are applied, therefore accelerating the healing process. Most studies in implantology were focused on a reduction of the duration of osseointegration. There exist few articles analyzing the potential effects of these therapies on the osseointegration of titanium dental implants. The aim of this study was to assess the effect of LLLT on the interaction between the bone and the titanium dental implant and the methodological quality of the studies. We conducted an electronic search in PubMed, ISI Web, and Cochrane Library. From 37 references obtained, only 14 articles met the inclusion criteria. The analysis of the studies shows that most of the experiments were performed in animals, which have a high risk of bias from the methodological point of view. Only two studies were conducted in human bone under different conditions. Several protocols for the use of low-power laser and different types of laser for all studies analyzed were used. Although animal studies have shown a positive effect on osseointegration of titanium implants, it can be concluded that it is necessary to improve and define a unique protocol to offer a more conclusive result by meta-analysis.

Nanoparticle containing channel waveguides produced by a multi-energy masked ion-implantation process.

We present the fabrication and characterization of channel waveguides based on composites containing silver nanoparticles. The substrate employed is silica and the nanoparticles were produced by a masked ion-implantation technique. Multiple implantation processes were made at different energies in order to produce waveguides with an appropriate width. We also present results for the characterization of the waveguiding properties of the devices produced.

Collective optical Kerr effect exhibited by an integrated configuration of silicon quantum dots and gold nanoparticles embedded in ion-implanted silica.

The study of the third-order optical nonlinear response exhibited by a composite containing gold nanoparticles and silicon quantum dots nucleated by ion implantation in a high-purity silica matrix is presented. The nanocomposites were explored as an integrated configuration containing two different ion-implanted distributions. The time-resolved optical Kerr gate and z-scan techniques were conducted using 80 fs pulses at a 825 nm wavelength; while the nanosecond response was investigated by a vectorial two-wave mixing method at 532 nm with 1 ns pulses. An ultrafast purely electronic nonlinearity was associated to the optical Kerr effect for the femtosecond experiments, while a thermal effect was identified as the main mechanism responsible for the nonlinear optical refraction induced by nanosecond pulses. Comparative experimental tests for examining the contribution of the Au and Si distributions to the total third-order optical response were carried out. We consider that the additional defects generated by consecutive ion irradiations in the preparation of ion-implanted samples do not notably modify the off-resonance electronic optical nonlinearities; but they do result in an important change for near-resonant nanosecond third-order optical phenomena exhibited by the closely spaced nanoparticle distributions.

[Fast track protocol for children undergoing appendicectomy]. / Protocolo de alta precoz tras apendicectomía en niños.

BACKGROUND: Multiple approaches to the treatment of simple and complicated (gangrenous or perforated) appendicitis in children have been promoted. Our goal is to develop a new protocol for these patients that allows shorter hospital stays without increasing complications rates. METHODS: Prospective collected data of patients undergoing appendicitis treated according to the new protocol for a period of 7 months were reviewed. This protocol consists on antibiotic prophylaxis in all cases continued with triple antibiotic regimen in complicated appendicitis. Antibiotics were stopped when specific clinical and laboratory criteria were met. Outcomes are compared to a historical group of patients treated under standard protocol (antibiotic prophylaxis followed by 48 hours of dual antibiotic therapy in simple appendicitis or 5 day-course of triple antibiotic therapy in complicated as postooperative antibiotic regimen). RESULTS: A total of 196 patients (96 current group and 100 historical group) were reviewed. In simple appendicitis average length of postoperative hospitalization was significantly lower in the current group (no statistical difference). 52.9% of complicated appendicitis in the current group were discharged home before 5th day without increasing the complication rate. When a wound infection or intraabdominal abscess occurs thrombocytosis (52%) and prolonged vomiting are the most frequent symptoms. CONCLUSION: No further postoperative treatment is needed in simple appendicitis. In complicated appendictis a short course of antibiotics according to clinical and laboratory criteria allows early discharge without major morbidity. Prolonged postoperative vomiting and thrombocytosis suggest infectious complications.

OBJETIVOS: Existen múltiples modalidades de tratamiento antibioterápico tras una apendicectomía en niños. Nuestro objetivo es desarrollar un nuevo protocolo para el tratamiento de las apendicitis que permita acortar la estancia hospitalaria sin aumentar las complicaciones. MATERIAL Y METODOS: Estudio prospectivo que analiza a los pacientes intervenidos de apendicitis tratados según el nuevo protocolo de antibioterapia durante un periodo de 7 meses. Dicho protocolo consiste en profilaxis quirúrgica en todos los casos y continuar con triple antibioterapia en las evolucionadas, con una duración variable según criterios clínico-analíticos establecidos previamente. Se comparan los resultados con los de un grupo histórico de pacientes tratados con el protocolo clásico (profilaxis y 48 horas de doble antibioterapia en las flemonosas y 5 días de triple en las evolucionadas). RESULTADOS: Se estudian un total de 196 pacientes (96 grupo actual y 100 grupo histórico). En las apendicitis flemonosas la estancia hospitalaria postquirúrgica media es significativamente menor en el grupo actual sin encontrar diferencias estadísticas en la tasa de complicaciones. El 52,9% de las apendicitis evolucionadas del grupo actual fueron dadas de alta antes del 5º día sin aumentar la tasa de complicaciones. De los pacientes que presentaron una complicación infecciosa el 52% asociaban trombocitosis y la clínica más frecuente fue de vómitos prolongados. CONCLUSIONES: No es necesario tratamiento antibioterápico postoperatorio en apendicitis simples. En las evolucionadas un tratamiento corto de antibióticos según criterios clínico-analíticos permite un alta precoz sin mayor morbilidad asociada. Los vómitos prolongados y la trombocitosis son indicadores de complicaciones infecciosas postoperatorias.

Mechanical unfolding of a simple model protein goes beyond the reach of one-dimensional descriptions.

We study the mechanical unfolding of a simple model protein. The Langevin dynamics results are analyzed using Markov-model methods which allow to describe completely the configurational space of the system. Using transition-path theory we also provide a quantitative description of the unfolding pathways followed by the system. Our study shows a complex dynamical scenario. In particular, we see that the usual one-dimensional picture: free-energy vs end-to-end distance representation, gives a misleading description of the process. Unfolding can occur following different pathways and configurations which seem to play a central role in one-dimensional pictures are not the intermediate states of the unfolding dynamics.

Optical Kerr phase shift in a nanostructured nickel-doped zinc oxide thin solid film.

The optical Kerr effect exhibited by a nickel doped zinc oxide thin solid film was explored with femto- and pico-second pulses using the z-scan method. The samples were prepared by the ultrasonic spray pyrolysis technique. Opposite signs for the value of the nonlinear refractive index were observed in the two experiments. Self-defocusing together with a two-photon absorption process was observed with 120 ps pulses at 1064 nm, while a dominantly self-focusing effect accompanied by saturated absorption was found for 80 fs pulses at 825 nm. Regarding the nanostructured morphology of the resulting film, we attribute the difference in the two ultrafast optical responses to the different physical mechanism responsible of energy transfer generated by multiphoton processes under electronic and thermal effects.

[Postoperative anal prolapse in patients with anorectal malformations: 16 years of experience]. / Prolapso anal postoperatorio en pacientes con malformaciones anorrectales: 16 años de experiencia.

INTRODUCTION: Anal prolapse is a common postoperative complication related to anorectal malformations (MAR) surgery, which is sometimes considered to be insignificant and/or not worthy of further intervention. We analysed the causes of this complication and our current surgical protocols. MATERIAL AND METHODS: Since 1995, 26 patients with anal prolapse have been operated secondary to surgical correction of an anorectal pathology. The most common MAR in girls (12) was cloaca (10), and in boys (14) was anorectal atresia with prostate fistula (8). The symptoms were anal pain and bleeding associated with alterations in bowel control alterations. The diagnosis in most patients was made in the first months after surgery, during the period of anal dilatations period. The surgical procedure involves prolapse resection of the prolapse and a new anoplasty. In 18 patients (69%) the prolapse was corrected before the colostomy closure on an outpatient basis. The other 8 patients (31%) underwent prolapse surgery after colostomy closure, requiring hospitalisation. RESULTS: There were no immediate postoperative complications, improving continence and aesthetic anus appearance. In 4 patients the prolapse recurred, requiring further surgical correction. CONCLUSIONS: Anal prolapse is a possible minor complication after anorectal correction. MAR type, the quality of the perineal musculature and defects in surgical technique are the main factors determining ia prolapse will appearance. The anal prolapse surgery indication has been recently increased (including small unilateral prolapses) as long as they are done before the colostomy closure, due to good aesthetic and functional results, requiring only outpatient surgery.

[Surgical wound infections in newborns: analysis of risk factors]. / Infección de la herida quirúrgica neonatal: análisis de factores de riesgo.

UNLABELLED: The incidence of surgical wound infections in neonates is high and it has an associated morbidity which extends hospital stay and gets a worse prognosis. The purpose of this study is to analyze the risk factors associated with the development of surgical wound infection and to identify susceptible patients with modifiable factors. MATERIAL AND METHODS: Case-control study of 90 surgical procedures underwent in newborns. We analyze pre-, intra- and postoperative risk factors. MAIN RESULTS: There are statically significant differences in terms of wound infection in dirty and contaminated surgery, reoperation, lavage of abdominal cavity, preoperative hospital stay longer than 8 days and wound closure with reabsorbable material. Furthermore, the surgical site infection is more likely in preterms patients, with a previous positive culture infection and the use of invasive devices as mechanical ventilation or central venous access. We found no relationship between wound infection and surgical time, bleeding during surgery and preoperative skin preparation with antiseptics. CONCLUSIONS: Reoperative patients, in which dirty and contaminated surgery is performed, absorbable material for skin is used and who have a preoperative hospital stay longer than 8 days, are in risk of developping wound infection and they will require an aggressive antibiotic treatment and special postsurgical care.

Ultrafast nonlinear optical response of photoconductive ZnO films with fluorine nanoparticles.

The absorptive and refractive third order nonlinear optical properties exhibited by a ZnO thin solid film with fluorine nanoparticles were studied with picosecond and femtosecond pulses using different techniques. We were able to evaluate the photoconductivity of the material and the quenching of the induced birefringence observed in the presence of two-photon absorption. The samples were prepared by a chemical spray deposition technique. In order to investigate the different contributions of the third order nonlinearities of the film, we analyzed the vectorial self-diffraction effect and the optical Kerr transmittance observed in the sample. A dominantly absorptive nonlinearity was measured at a 532 nm wavelength with 50 ps pulses, while nonlinear refraction was found to be negligible in this regime. On the other side, a pure electronic refractive third order nonlinearity without the contribution of nonlinear absorption was detected at 830 nm with 80 fs pulse duration. A quasi-instantaneous optical response and a strong enhancement in the ultrafast nonlinear refraction with the inhibition of the picosecond two-photon absorption mechanism were measured for the case of the femtosecond excitation.

Ultrafast optical phase modulation with metallic nanoparticles in ion-implanted bilayer silica.

The nonlinear optical response of metallic-nanoparticle-containing composites was studied with picosecond and femtosecond pulses. Two different types of nanocomposites were prepared by an ion-implantation process, one containing Au nanoparticles (NPs) and the other Ag NPs. In order to measure the optical nonlinearities, we used a picosecond self-diffraction experiment and the femtosecond time-resolved optical Kerr gate technique. In both cases, electronic polarization and saturated absorption were identified as the physical mechanisms responsible for the picosecond third-order nonlinear response for a near-resonant 532 nm excitation. In contrast, a purely electronic nonlinearity was detected at 830 nm with non-resonant 80 fs pulses. Regarding the nonlinear optical refractive behavior, the Au nanocomposite presented a self-defocusing effect, while the Ag one presented the opposite, that is, a self-focusing response. But, when evaluating the simultaneous contributions when the samples are tested as a multilayer sample (silica-Au NPs-silica-Ag NPs-silica), we were able to obtain optical phase modulation of ultra-short laser pulses, as a result of a significant optical Kerr effect present in these nanocomposites. This allowed us to implement an ultrafast all-optical phase modulator device by using a combination of two different metallic ion-implanted silica samples. This control of the optical phase is a consequence of the separate excitation of the nonlinear refracting phenomena exhibited by the separate Au and Ag nanocomposites.

Occurrence of different species of fusarium from wheat in relation to disease levels predicted by a weather-based model in Argentina pampas region.

Fusarium head blight (FHB) is an important disease throughout many of the world wheat-growing areas that have humid to semi-humid climate. The infection happens mainly during the anthesis of the wheat, when there have been favorable conditions of moisture and temperature. The direct relation of the infection to environmental factors makes possible the formulation of mathematical models that predict the disease. The causal agent of the FHB of the spike of wheat is attributed principally to Fusarium graminearum. High economic losses due yield decrease have been recorded in Argentina. In the present work, 67 isolates of Fusarium spp. were obtained from samples of wheat grains from Pampas region from 15 locations distributed in Buenos Aires, Entre Ríos, Santa Fe and Córboba provinces during 2006 and 2007 wheat-growing seasons. The identification of species from monosporic isolates was carried out by morphological characterization and use of species-specific PCR-based assays. Both identification criteria were necessary and complementary for the species determination, since in some cases the molecular identification was not specific. Scanty presence of F. graminearum was observed in 2006 wheat-growing season coinciding with the lack of favorable meteorological conditions for producing FHB infection events. High presence of F. graminearum isolates was observed in 2007 wheat-growing season, in accordance with moderate incidence of the disease according to spatial distribution of FHB incidence values. The aim of this report was to identify the causal agent of the FHB disease by different taxonomic criteria and to relate its occurrence with disease incidence values predicted by a weather-based model in Argentina.

[Role of peritoneal drainage in necrotizing enterocolitis in critical infants with extremely low birth weight]. / Papel del drenaje peritoneal en la enterocolitis necrotizante de prematuros críticos de bajo peso.

INTRODUCTION: Peritoneal drainage is one of the options for treatment in necrotizing enterocolitis (NEC). Currently its role is controversial as an alternative to laparotomy in low birthweight and mortality associated with both procedures is high (35-55%). MATERIAL AND METHODS: We reviewed 30 low-weight premature (< 1000 g) with NEC treated surgically. We evaluate the hemodynamic, respiratory and metabolic status of the patients, as well as multi-organ involvement and the need for inotropic drugs. These data were analyzed previos to surgery and at 6 and 12 hours. We divided the sample into two groups: those who underwent peritoneal drainage (PD) input or laparotomy (LAP). RESULTS: In the series the average birth weight was 754 +/- 156 g and gestational age was 26.1 +/- 2.1 weeks. We carry on 10 peritoneal drainage and 20 laparotomies. The DP group before the intervention showed increased heart rate, FiO2 and acidosis (p < 0.05). The needs of dopamine were similar in both groups. Following the peritoneal drainage, we found breathing improvement (adequate ventilation and oxygenation, decreased FiO2) and hemodynamic improvement (blood pressure maintained, reduced heart rate, reduced requirements for dopamine) at 6 and 12 h. DP was not the definitive treatment in any of the patiens, and all survivors (80%) of this group required further laparotomy. 62% of them died. Overall mortality was 47% (70% DP and 35% LAP, p = 0.07). CONCLUSIONS: Peritoneal drainage allowed the stabilization of low-weight premature in critical condition. The hemodynamic and respiratory stabilization was transient and did not prevent the definitive surgical treatment, although it improved the conditions for doing so. In our series, the peritoneal drainage did not improve long-term survival, questioning its role as an alternative to surgery for NEC.

[Opicapone for the treatment of Parkinson's disease: real-life data in Spain]. / Opicapona para el tratamiento de la enfermedad de Parkinson: datos de vida real en España.

Opicapone is a catechol-O-methyl-transferase (iCOMT) inhibitor authorized in Europe in 2016 and indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. The efficacy of opicapone in these patients has been demonstrated in two pivotal randomized clinical trials, BIPARK I and BIPARK II, in which it has demonstrated its superiority versus placebo and non-inferiority versus entacapone. Although they constitute the gold standard for the evaluation of interventions, randomized clinical trials present limitations of external validity due to the use of strict eligibility criteria. Therefore, it is considered necessary to have a more comprehensive evaluation of the efficacy of the drug, complementing the information obtained from randomized clinical trials with that of "real world or real clinical practice" studies. The objective of this review has been to collect and put into perspective the information available on opicapone coming from real clinical practice studies in Spain. The data from Spain with opicapone in 18 series with more than 1,000 patients in total, confirm the safety and efficacy previously reported with this iCOMT. Furthermore, they show that opicapone is especially useful in patients with a less advanced stage of the disease and mild motor fluctuations, which would suggest that the earlier its introduction in the therapeutic scheme for the management of motor fluctuations, the better is the benefit-risk ratio for the drug.

TITLE: Opicapona para el tratamiento de la enfermedad de Parkinson: datos de vida real en España.Resumen. La opicapona es un inhibidor de la catecol-O-metiltransferasa (iCOMT) autorizado en Europa en 2016 como terapia adyuvante a las preparaciones de levodopa/inhibidores de la dopa descarboxilasa en pacientes adultos con enfermedad de Parkinson y fluctuaciones motoras de final de dosis que no puedan ser estabilizados con esas combinaciones. La eficacia de la opicapona en estos pacientes ha sido demostrada en dos ensayos clínicos pivotales, BIPARK I y BIPARK II, en los que se ha demostrado la superioridad frente al placebo y la no inferioridad frente a la entacapona. A pesar de que constituyen el estándar para la evaluación de intervenciones, los ensayos clínicos aleatorizados presentan limitaciones de validez externa debidas a la utilización de criterios estrictos de elegibilidad. Por tanto, se considera necesario disponer de una evaluación más amplia de la eficacia general del fármaco, complementando la información de los ensayos clínicos aleatorizados con estudios de 'vida real o práctica clínica real'. El objetivo de esta revisión ha sido recopilar y poner en perspectiva la información disponible sobre los resultados de la opicapona en estudios de práctica clínica real en España. Los datos acumulados en España con opicapona en 18 series con más de 1.000 pacientes confirman la seguridad y la eficacia de este iCOMT comunicadas previamente. Además, muestran que la opicapona es especialmente útil en pacientes en un estadio de la enfermedad menos avanzado y fluctuaciones motores leves, lo que sugeriría una mejor relación beneficio-riesgo cuanto más temprana sea su introducción en el esquema terapéutico para el tratamiento de las fluctuaciones motoras.

Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial.

Infantile colic is a prevalent condition characterised by excessive crying with no effective treatment available. We aimed to evaluate the efficacy of Bifidobacterium breve CECT7263 and a combination of this and Lactobacillus fermentum CECT5716 versus simethicone in reducing the daily time spent crying in colicky infants. A multicentre randomised, open-label, parallel, controlled trial of 28 days was performed in 150 infants who were diagnosed with colic according to the Rome III criteria and who randomly received simethicone (80 mg/day; Simethicone group), B. breve CECT7263 (2×108 cfu/day, Bb group), or a combination of L. fermentum CECT5716 and B. breve CECT7263 (1×108 cfu/day per strain, Bb+Lf group). The main outcomes were minutes of crying per day and the percentage of reduction in daily crying from baseline. Data were analysed per intention to treat. All treatments significantly decreased the daily crying time at the end of the intervention (P-time <0.001). However, the infants in the Bb group had significantly decreased crying time from the first week of the study (P<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (P<0.05). The percentage of reduction in the minutes of crying from baseline in the Bb group was significantly higher than that in the Simethicone group every week of the intervention (-40.3 vs -27.6% at 1-week; -59.2 vs -43.2% at 2-weeks; -64.5 vs -53.5% at 3-week and -68.5 vs -59.5% at 4-weeks, P<0.05). Additionally, in the Bb group, infants had better night sleep, and parents reported a more positive mood at the end of the intervention. All the products used in the study were safe and well tolerated. In conclusion, the breastmilk-isolated probiotic strain B. breve CECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone.

Inhibition of the two-photon absorption response exhibited by a bilayer TiO2 film with embedded Au nanoparticles.

We use two different synthesis approaches for the preparation of TiO(2) films in order to study their resulting third order optical nonlinearity, and its modification by the inclusion of Au nanoparticles in one of the samples. An ultrasonic spray pyrolysis method was used for preparing a TiO(2) film in which we found two-photon absorption as a dominant nonlinear effect for 532 nm and 26 ps pulses; and a purely electronic nonlinearity at 830 nm for 80 fs pulses. A strong optical Kerr effect and the inhibition of the nonlinear optical absorption in 532 nm can be obtained for the first sample if Au nanoparticles embedded in a second TiO(2) film prepared by a sol-gel technique are added to it. We used an optical Kerr gate, z-scan, a multi-wave mixing experiment and an input-output transmittance experiment for measuring the optical nonlinearities.