Efficacy of an emollient cream in the treatment of xerosis in diabetic foot: a double-blind, randomized, vehicle-controlled clinical trial.

BACKGROUND: Peripheral neuronal impairment compromises foot health in patients with diabetes. Clinically, xerosis is the most common mild complication, but it should not be underestimated. An effective treatment must be able to restore the cutaneous barrier and prevent water loss, to maintain adequate hydration and protection. OBJECTIVE: This study aimed to assess the efficacy of an emollient cream on foot xerosis in patients with diabetes. METHODS: This is a prospective, multicenter, randomized, double-blind contralateral vehicle-controlled study in 57 patients with diabetes. Patients were treated twice daily for 27 ± 2 days with the study emollient containing glycerol 15%, liquid and soft paraffin 10%, glycerol monostearate, stearic acid, polydimethylcyclosiloxane, silicone oil, macrogol 600, trolamine, propyl parahydroxybenzoate and purified water (Dexeryl® ; Pierre Fabre Medicament, Boulogne, France) or its vehicle (glycerol monostearate, stearic acid, polydimethylcyclosiloxane, silicone oil, macrogol 600, trolamine, propyl parahydroxybenzoate and purified water). Efficacy was assessed after a 28-day treatment period using a validated score [Xerosis Assessment Scale (XAS) score], instrumental measurements and subjective assessment. RESULTS: The XAS score decreased to 3.2 ± 2.6 points with the emollient and 4.1 ± 2.3 with the vehicle (P = 0.001). Improvement was observed from day 14 (P = 0.012). Compared with the vehicle, the emollient also significantly improved the overall skin score, hydration index, D-Squame® (CuDerm Corporation, Dallas, TX, USA) test, skin roughness and patients' opinions. CONCLUSION: Treatment with an emollient is effective for improving foot xerosis in patients with diabetes.

Simple template-based optimization for pediatric total lymphoid irradiation (TLI) radiotherapy treatments.

Total lymphoid irradiation (TLI) is used in the management of pediatric allogeneic hematopoietic stem cell transplantation (HSCT. This work aims to simplify the treatment planning process for TLI via a proposed template using the volumetric modulated arc therapy (VMAT) technique. Fifteen pediatric patients were planned, prescribed to 8 Gy in 4 fractions. Cost functions included in the template were the ones for the planning target volume (PTV), and conformality cost function (CCF) for the rest of the patient's volume. Conformity index (CI), homogeneity index (HI), conformation number (CN), gradient index (GI), integral dose, and doses to the organs at risk achieved with the template were reported. Cost function influence over various indexes was studied by Wilcoxon signed ranks test. Same 15 patients were planned with 3-dimensional conventional radiotherapy (3D-CRT) technique for comparison. Mean CI and HI were 1.33 and 0.13, respectively, which indicates good dose conformation and homogeneity. Mean CN and GI values were 0.69 and 4.51, respectively. Mean PTV coverage was reached (V100% > 95%). No correlation between the CCF and indexes values was found (p > 0.05). Doses to organs at risk (OARs) were as low as possible without losing PTV coverage. VMAT plan showed higher levels of conformation and similar homogeneity as 3D-CRT plans. Doses to OARs were inferior with VMAT except for the right kidney. The proposed template simplifies the planning of TLI treatments, and it is able to create acceptable plans with little modification in order to reduce doses to certain organs like the kidneys or the heart. VMAT technique showed higher conformation and lower doses to OAR compared to 3D-CRT.

TLI in pediatric patients.

PURPOSE: Hematopoietic progenitor cell transplantation (HSCT) is a procedure used in different hematological diseases as part of the curative treatment, so the investigators propose a system of conditioning of reduced intensity based on total lymphoid irradiation (TLI) as an alternative to the classic total body irradiation (TBI) followed by haploidentical transplantation in patients compatible with a single HLA haplotype, as an alternative to patients who do not have an HLA compatible donor. MATERIALS AND METHODS: A cohort of 25 patients with hematological disease underwent haploidentical HSCT from February 2015 to May 2018, conditioned with TLI from day - 10 (2-4 days of treatment) followed by thiotepa (5 mg/kg/12 h) and melphalan (70 mg/m2/day) prior to HSCT and prophylaxis with ciclosporin (1.5 mg/kg/12 h). 2 Gy/fraction was administered to complete 8 Gy with IMRT and VMAT technique. RESULTS: 12% rejection of the transplant was obtained with acute GVHD < II (48%) and chronic GVHD 12%. No acute toxicity was recorded in irradiated patients and 56% survival of patients at the end of follow-up. CONCLUSION: Conditioning the haploidentical transplant with TLI, IMRT, and VMAT techniques compared with TBI and RT3D-C techniques is a feasible technique that helps inducing the necessary immunosuppression in patients with a high risk of graft rejection, minimal adverse effects, low incidence of GVHD, and high survival rate.

EUS-guided tissue acquisition in the study of the adrenal glands: Results of a nationwide multicenter study.

BACKGROUND: There are limited data about the role of endoscopic ultrasound-guided tissue acquisition (EUS-TA), by fine needle aspiration (EUS-FNA) or biopsy (EUS-FNB), in the evaluation of the adrenal glands (AG). The primary aim was to assess the diagnostic yield and safety. The secondary aims were the malignancy predictors, and to create a predictive model of malignancy. METHODS: This was a retrospective nationwide study involving all Spanish hospitals experienced in EUS-TA of AGs. Inclusion period was from April-2003 to April-2016. Inclusion criteria: all consecutive cases that underwent EUS-TA of AGs. EUS and cytopathology findings were evaluated. Statistical analyses: diagnostic accuracy of echoendoscopist's suspicion using cytology by EUS-TA, as gold standard; multivariate logistic regression model to predict tumor malignancy. RESULTS: A total of 204 EUS-TA of AGs were evaluated. Primary tumor locations were lung70%, others19%, and unknown11%. AG samples were adequate for cytological diagnosis in 91%, and confirmed malignancy in 60%. Diagnostic accuracy of the endosonographer's suspicion was 68%. The most common technique was: a 22-G (65%) and cytological needle (75%) with suction-syringe (66%). No serious adverse events were described. The variables most associated with malignancy were size>30mm (OR2.27; 95%CI, 1.16-4.05), heterogeneous echo-pattern (OR2.11; 95%CI, 1.1-3.9), variegated AG shape (OR2.46; 95%CI, 1-6.24), and endosonographer suspicion (OR17.46; 95%CI, 6.2-58.5). The best variables for a predictive multivariate logistic model of malignancy were age, sex, echo-pattern, and AG-shape. CONCLUSIONS: EUS-TA of the AGs is a safe, minimally invasive procedure, allowing an excellent diagnostic yield. These results suggest the possibility of developing a pre-EUS procedure predictive malignancy model.

Spontaneous pneumothorax. Long-term results with tetracycline pleurodesis.

The aim of this prospective study was to determine the rate of recurrence for spontaneous pneumothorax (SP) after tetracycline pleurodesis (TCP), using that of observation, tube thoracostomy alone, and thoracotomy as references. From 1985 to the end of 1991, 78 patients were treated with tetracycline pleurodesis and 135 patients served as control subjects. Pleurodesis was induced by instillation of tetracycline and ascorbic acid through the pleural drain. The indication was any SP treated with tube thoracostomy, without active pulmonary infection. Follow-up period was from 13 to 95 months (mean, 45 months); follow-up rate was 94 percent. Post-therapy surgery was necessary for eight patients in whom pleurodesis failed due to presence of a persistent air leak. The ipsilateral recurrence rate of patients treated with TCP was 9 percent (6/66) and recurrence time ranged from 2 days to 9 months. The recurrence rate for patients treated with observation was 36 percent, 35 percent for those having chest tube alone, and none for those undergoing surgery. No death occurred as a direct result of this procedure and all patients could be released from the hospital. Eleven subjects died during the follow-up period; the mean follow-up until death was 37 months (range, 2 to 87 months). Five deaths were due to respiratory causes and six were due to extrapulmonary causes. Tetracycline pleurodesis has been shown to be a good alternative for the prevention of recurrence of SP. Its recurrence rate is lower than that of tube drainage but higher than that of surgical treatment.

Pain as a mutual experience for patients, nurses and families: a perspective from Valencia, Spain.

The Spanish data collection was consistent with the overall study design and drew from three groups: laboring women, children and elderly patients. The Valencia data was amongst the most detailed, specific and complete in this international study. This is most likely due to the experienced nature of the Spanish research team. The study results revealed more commonalities than differences in all age groups with regard to pain identification and pain alleviation. Across age groups, pain was identified by study participants through observation and listening.

Síndrome de Kartagener, importancia de detectar la tríada diagnóstica característica / Kartagener syndrome, the importance of detecting the characteristic diagnostic triad

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Argan oil nanoemulsions as new hydrophobic drug-loaded delivery system for transdermal application.

This research work deals with the development of argan oil-based nanoemulsions as vehicle of hydrophobic drugs such as diclofenac used as model. Nanoemulsions of oil in water were prepared using the ultrasonication method in order to obtain submicron size colloidal dispersion. The size, zeta potential and encapsulation efficiency of the dispersions obtained were investigated. In addition, the ability of sorbitan ester derivatives to form nanovesicles (niosomes), which in turn were used for encapsulating drug in oily solutions forming stable nanoemulsions, was particularly examined. Thus, additional stabilizing agents were not required in the recipe and formulations using only sorbitan monolaurate, argan oil and water lead to attractive results. Their submicronic size (<250 nm), high negative zeta potential (between -40 and -50 mV) and drug-encapsulation efficiency (higher than 85%) allow predicting both a good physical stability and a good performance as drug carriers.

Influence of process and formulation parameters on the formation of submicron particles by solvent displacement and emulsification-diffusion methods critical comparison.

Solvent displacement and emulsification-diffusion are the methods used most often for preparing biodegradable submicron particles. The major difference between them is the procedure, which results from the total or partial water miscibility of the organic solvents used. This review is devoted to a critical and a comparative analysis based on the mechanistic aspects of particle formation and reported data on the influence of operating conditions, polymers, stabilizing agents and solvents on the size and zeta-potential of particles. In addition, a systematic study was carried out experimentally in order to obtain experimental data not previously reported and compare the data pertaining to the different methods. Thus the discussion of the behaviors reported in the light of the results obtained from the literature takes into account a wide range of theoretical and practical information. This leads to discussion on the formation mechanism of the particles and provides criteria for selecting the adequate method and raw materials for satisfying specific objectives in submicron particle design.

Polymer-based nanocapsules for drug delivery.

A review of the state of knowledge on nanocapsules prepared from preformed polymers as active substances carriers is presented. This entails a general review of the different preparation methods: nanoprecipitation, emulsion-diffusion, double emulsification, emulsion-coacervation, polymer-coating and layer-by-layer, from the point of view of the methodological and mechanistic aspects involved, encapsulation of the active substance and the raw materials used. Similarly, a comparative analysis is given of the size, zeta-potential, dispersion pH, shell thickness, encapsulation efficiency, active substance release, stability and in vivo and in vitro pharmacological performances, using as basis the data reported in the different research works published. Consequently, the information obtained allows establishing criteria for selecting a method for preparation of nanocapsules according to its advantages, limitations and behaviours as a drug carrier.

Prevalence of Barrett's esophagus by endoscopy and histologic studies: a prospective evaluation of 306 control subjects and 376 patients with symptoms of gastroesophageal reflux.

The classic endoscopic diagnosis of a Barrett's esophagus (BE) is based on the finding of > or =3 cm, of distal esophagus covered by specialized columnar epithelium. However, currently, it is based on the finding of intestinal metaplasia (IM) at the squamous-columnar mucosal junction, independent of its extent. The aim of this study was to determine the prevalence of Barrett's esophagus by endoscopic and histological findings in control subjects and in patients with symptoms of gastroesophageal reflux (GER). Three hundred and six control subjects and 376 patients with symptoms of gastroesophageal reflux were included in this prospective study. Patients with Barrett's esophagus were classified in three groups as follows. 1. Intestinal metaplasia at the cardia. When endoscopy showed non-Barrett's esophagus, but histological intestinal metaplasia was found. 2. Short-segment Barrett's esophagus. When <3 cm, was covered with tongues or finger-like or creeping substitution of distal esophagus. 3. Long-segment Barrett's esophagus. When > 3 cm, of distal esophagus was covered by specialized columnar epithelium. Two biopsies at the antrum, four biopsies at the squamous-columnar junction and one or two at the distal esophagus were taken. In control subjects, 1.6% showed histological IM at the esophagogastric junction. In patients with GER without esophagitis or with erosive esophagitis, IM was found in 18% and 10.7% respectively. 'Short-segment' Barrett's esophagus was three times more frequent than 'long-segment' Barrett's esophagus. Patients with Barrett's esophagus were significantly older than the other groups. The presence of complications or erosions, peptic ulcer or stricture were significantly more frequent among patients with 'long-segment' Barrett's esophagus (p < 0.0001). The prevalence of dysplasia was similar in all groups of patients with Barrett's esophagus. Complications such as ulcers, stricture and dysplasia were exclusively seen among patients with BE, whereas non-Barrett's patients did not exhibit these complications. In control subjects, IM can be found in a low percentage of cases. Among patients with symptoms of GER, the classic endoscopic diagnosis of a Barrett's esophagus can underestimate this condition in 80% of the cases. Patients with intestinal metaplasia at the cardia already present 17% of the cases with low-grade dysplasia. In all patients with symptoms of GER, systematic biopsies at the squamous-columnar junction should be taken.

Late results of a randomized clinical trial comparing total fundoplication versus calibration of the cardia with posterior gastropexy.

BACKGROUND: The aim was to perform a prospective randomized study in patients with chronic gastro-oesophageal reflux treated either by total fundoplication or calibration of the cardia with posterior gastropexy. Late follow-up considered subjective and objective parameters, and related outcome to the presence of Barrett's oesophagus. METHODS: A total of 164 patients were randomized to fundoplication (n = 76) or calibration of the cardia (n = 88). They were evaluated by clinical questionnaire, upper gastrointestinal endoscopy with biopsies, oesophageal manometry and gastro-oesophageal reflux studies, including scintigraphy and 24-h oesophageal pH monitoring. RESULTS: There were no operative deaths. There was 95 per cent follow-up at a mean of 85 months. The mean recurrence rate for both operations was near 40 per cent at 10 years, but patients without Barrett's oesophagus had a recurrence rate after both operations of around 23 per cent compared with 83 per cent after 10 years for those with Barrett's oesophagus (P < 0.0001). Low-grade dysplasia developed in 13 per cent of the patients with Barrett's oesophagus. There were significant differences in all objective parameters in a comparison of patients with Visick I or II and those with Visick III or IV disease at the late assessment. CONCLUSION: Both total fundoplication and calibration of the cardia with posterior gastropexy had similar subjective and objective late results. However, results were significantly worse in patients with Barrett's oesophagus.

[Clinical and laboratory characteristics of patients with pathologic chronic gastroesophageal reflux]. / Características clínicas y de laboratorio de pacientes con reflujo gastroesofágico crónico patológico.

BACKGROUND: Sixty percent of adults has typical symptoms of gastroesophageal reflux in Chile. AIM: To report the clinical and laboratory features of patients with gastroesophageal reflux. PATIENTS AND METHODS: Five hundred thirty-four patients (255 male) with gastroesophageal reflux were included in a prospective protocol that included clinical analysis, manometry and endoscopy in all patients, barium swallow in 427, scintigraphy in 195, acid reflux test in 359, 24 h pH in 175, and differential potential of gastroesophageal mucosa in 73 patients. RESULTS: There was no correlation between the severity of symptoms and the endoscopical severity. Patients with Barret esophagus were 12 years older, were male in a greater proportion and had a higher proportion of manometrically incompetent sphincters than patients with esophageal reflux but without esophagitis or with erosive esophagitis. Severity of acid reflux, measured with 24 h pH monitoring was proportional to the endoscopical damage of the mucosa. There was a close relationship between the mucosal change limit determined with differential potentials and with endoscopy. No short esophagi were found. CONCLUSIONS: Patients with symptoms of gastroesophageal reflux must be assessed using several objective measures to determine the severity of their pathological alterations.