Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin.

The aim of this work was to assess the tolerability, safety, and efficacy of an ophthalmic topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% (HA) in patients with mild-to-moderate Dry Eye Disease (DED) exhibiting positive Matrix Metalloproteinase 9 (MMP-9) test results. Tolerability and safety were evaluated in 24 healthy subjects. Participants were instructed to apply one drop of the formulation three times a day in the study eye, for 2 weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/receiving the studied formulation) or Control (Group 2/Receiving HA 0.4% eye lubricant) groups for 1 month. Assessments included an MMP-9 positivity test, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive film tear breakup time (NIBUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer's test, and meibomiography. A crossover design with an additional 1-month follow-up was applied to both groups. Healthy subjects receiving the studied formulation exhibited good tolerability and no adverse events. Regarding the efficacy study, Group 1 exhibited a statistically significant reduction in the MMP-9 positivity rate compared to Group 2 (p < 0.001). Both Group 1 and Group 2 exhibited substantial improvements in OSDI and NIBUT scores (p < 0.001). However, Group 1 demonstrated a significant improvement in NI-Avg-BUT and Schirmer's test scores (p < 0.001), whereas Group 2 did not (p > 0.05). Finally, after the crossover, the proportion of MMP-9-positive subjects in Group 1 increased from 25% to 91.6%, while Group 2 showed a significant decrease from 87.5% to 20.8%. Overall, the topical formulation containing sesquiterpene helenalin from Arnica montana and hyaluronic acid was well tolerated and exhibited a favorable safety profile. Our formulation reduces DED symptomatology and modulates the ocular surface inflammatory process; this is evidenced by the enhancement of CIC, the improvement of DED-related tear film status, and the reduction of the MMP-9 positivity rate.

An Oral Polyphenol Formulation to Modulate the Ocular Surface Inflammatory Process and to Improve the Symptomatology Associated with Dry Eye Disease.

Due to their antioxidant, anti-inflammatory, neuroprotective, and anti-angiogenic effects, polyphenols are first-rate candidates to prevent or treat chronic diseases in which oxidative stress-induced inflammation plays a role in disease pathogenesis. Dry eye disease (DED) is a common pathology, on which novel phenolic compound formulations have been tested as an adjuvant therapeutic approach. However, polyphenols are characterized by limited stability and solubility, insolubility in water, very rapid metabolism, and a very short half-life. Thus, they show poor bioavailability. To overcome these limitations and improve their stability and bioavailability, we evaluated the safety and efficacy of an oral formulation containing among other compounds, polyphenols and omega-3 fatty acids, with the addition of a surfactant in patients with DED. Subjects were randomly assigned to one of four study groups including the study formulation (A), placebo (P), the study formulation + eye lubricant (A + L), and placebo + eye lubricant (P + L). Patients from the A and P groups were instructed to take two capsules every 24 h, while patients in the L groups also added one drop of lubricant twice a day for 12 weeks as well. Regarding safety, non-ocular abnormalities were observed during study formulation therapy. Liver function tests did not show any statistically significant difference (baseline vs. week 4). Concerning efficacy, there was a statistically significant difference between baseline, month 1, and month 3 in the OSDI (Ocular Surface Disease Index) test results in both treatment groups (group A and group A + L). Furthermore, both groups showed statistically significant differences between baseline and month 3 regarding the non-invasive film tear breakup time (NIF-BUT) score and a positive trend related to Shirmer's test at month 3. The non-invasive average breakup time (NIAvg-BUT) score showed a statistically significant difference at month 3 when compared with baseline in the A + L group. The P + L group showed a statistically significant difference in terms of the OSDI questionary between baseline and month 3. Regarding the lissamine green staining, the A + L group showed a statistical difference between baseline and month 3 (p = 0.0367). The placebo + lubricant group did not show statistically significant differences. Finally, the placebo group did not show any data with statistically significant differences. Consequently, this polyphenol formulation as a primary treatment outperformed the placebo alone, and the polyphenol oral formulation used as an adjuvant to artificial tears was superior to the combination of the placebo and the artificial tears. Thus, our data strongly suggest that this polyphenol oral formulation improves visual strain symptoms and tear film status in patients with mild to moderate DED.

Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia.

BACKGROUND: A single-group, phase 1-2 study indicated that eltrombopag improved the efficacy of standard immunosuppressive therapy that entailed horse antithymocyte globulin (ATG) plus cyclosporine in patients with severe aplastic anemia. METHODS: In this prospective, investigator-led, open-label, multicenter, randomized, phase 3 trial, we compared the efficacy and safety of horse ATG plus cyclosporine with or without eltrombopag as front-line therapy in previously untreated patients with severe aplastic anemia. The primary end point was a hematologic complete response at 3 months. RESULTS: Patients were assigned to receive immunosuppressive therapy (Group A, 101 patients) or immunosuppressive therapy plus eltrombopag (Group B, 96 patients). The percentage of patients who had a complete response at 3 months was 10% in Group A and 22% in Group B (odds ratio, 3.2; 95% confidence interval [CI], 1.3 to 7.8; P = 0.01). At 6 months, the overall response rate (the percentage of patients who had a complete or partial response) was 41% in Group A and 68% in Group B. The median times to the first response were 8.8 months (Group A) and 3.0 months (Group B). The incidence of severe adverse events was similar in the two groups. With a median follow-up of 24 months, a karyotypic abnormality that was classified as myelodysplastic syndrome developed in 1 patient (Group A) and 2 patients (Group B); event-free survival was 34% and 46%, respectively. Somatic mutations were detected in 29% (Group A) and 31% (Group Β) of the patients at baseline; these percentages increased to 66% and 55%, respectively, at 6 months, without affecting the hematologic response and 2-year outcome. CONCLUSIONS: The addition of eltrombopag to standard immunosuppressive therapy improved the rate, rapidity, and strength of hematologic response among previously untreated patients with severe aplastic anemia, without additional toxic effects. (Funded by Novartis and others; RACE ClinicalTrials.gov number, NCT02099747; EudraCT number, 2014-000363-40.).

Topical Triamcinolone Acetonide-Loaded Liposome Formulation Used as an Adjuvant to Intravitreal Ranibizumab Therapy for Neovascular Age-Related Macular Degeneration.

Novel strategies have been developed to reduce or avoid intravitreal injections (IVTs) of the antiangiogenic (ranibizumab (RBZ)) and anti-inflammatory (triamcinolone acetonide (TA)) agents used to treat vitreoretinal diseases. One of the strategies includes liposomes. This study evaluated the safety and efficacy of a topical triamcinolone-loaded liposome formulation (TALF) as an adjuvant to intravitreal RBZ therapy in treatment- naïve patients with neovascular age-related macular degeneration (nAMD). Subjects were randomly assigned to the RBZ-TALF or the RBZ-pro re nata (RBZ-PRN) groups. Patients from the RBZ-TALF group were instructed to apply TALF for 12 months after a single dose of RBZ. Patients from the RBZ-PRN group received three monthly RBZ-IVTs. Retreatment with RBZ was considered in the case of nAMD reactivation. Regarding safety, non-ocular abnormalities were observed during TALF therapy. Concerning efficacy, non-significant differences were identified in terms of visual acuity or central foveal thickness when the RBZ-PRN and RBZ-TALF groups were compared. It is worth noting that the average number of RBZ injections was significantly lower in the RBZ-TALF group (2.5 ± 1.4 vs. 6.1 ± 1.3 IVTs; p = 0.0004). Therefore, TALF used as an adjuvant to RBZ reduces the need for RBZ-IVT retreatment with optimal visual and anatomic results.

Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema.

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards.

Risk factors and outcome of COVID-19 in patients with hematological malignancies.

BACKGROUND: Prognostic factors of poor outcome in patients with hematological malignancies and COVID-19 are poorly defined. PATIENTS AND METHODS: This was a Spanish transplant group and cell therapy (GETH) multicenter retrospective observational study, which included a large cohort of blood cancer patients with laboratory-confirmed SARS-CoV-2 infection through PCR assays from March 1st 2020 to May 15th 2020. RESULTS: We included 367 pediatric and adult patients with hematological malignancies, including recipients of autologous (ASCT) (n = 58) or allogeneic stem cell transplantation (allo-SCT) (n = 65) from 41 hospitals in Spain. Median age of patients was 64 years (range 1-93.8). Recipients of ASCT and allo-SCT showed lower mortality rates (17% and 18%, respectively) compared to non-SCT patients (31%) (p = 0.02). Prognostic factors identified for day 45 overall mortality (OM) by logistic regression multivariate analysis included age > 70 years [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.2-3.8, p = 0.011]; uncontrolled hematological malignancy (OR 2.9, 95% CI 1.6-5.2, p < 0.0001); ECOG 3-4 (OR, 2.56, 95% CI 1.4-4.7, p = 0.003); neutropenia (< 0.5 × 109/L) (OR 2.8, 95% CI 1.3-6.1, p = 0.01); and a C-reactive protein (CRP) > 20 mg/dL (OR 3.3, 95% CI 1.7-6.4, p < 0.0001). In multivariate analysis of 216 patients with very severe COVID-19, treatment with azithromycin or low dose corticosteroids was associated with lower OM (OR 0.42, 95% CI 0.2-0.89 and OR 0.31, 95% CI 0.11-0.87, respectively, p = 0.02) whereas the use of hidroxycloroquine did not show significant improvement in OM (OR 0.64, 95% CI 0.37-1.1, P = 0.1). CONCLUSIONS: In most patients with hematological malignancies COVID-19 mortality was directly driven by older age, disease status, performance status, as well as by immune (neutropenia) parameters and level of inflammation (high CRP). Use of azithromycin and low dose corticosteroids may be of value in very severe COVID-19.

Topical Triamcinolone Acetonide-Loaded Liposomes as Primary Therapy for Macular Edema Secondary to Branch Retinal Vein Occlusion: A Pilot Study.

Purpose: To explore safety and therapeutic efficacy of a topical ophthalmic triamcinolone acetonide-loaded liposome formulation (TA-LF) as primary therapy in patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Methods: Twelve eyes of 12 patients with ME secondary to BRVO were exposed to a topical instillation of 1 drop of TA-LF (TA 0.2%) 6 times a day for 12 weeks to evaluate safety and efficacy. Best corrected visual acuity (BCVA) intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit. In addition, the morphology of TA-LF was analyzed using scanning electron microscopy (SEM) and transmission electron microscopy (TEM). Results: Patients presented a significant improvement of BCVA and CFT without significant IOP modification (P = 0.94). Treated eyes showed BCVA improvement from 40 ± 12.05 to 64.83 ± 15.97 letters and CFT reduction from 682.91 ± 278.60 to 271.58 ± 57.66 µm after 12 weeks of TA-LF therapy (P < 0.001). No adverse events, including IOP rising, were registered. SEM analysis of liposomal formulations showed that liposome (LP) size depends on its concentration. As the concentration of TA increased, the average size of LPs and the number of larger particles increased as well. TEM study displayed that LP formulation efficiently solubilizes TA crystals in nanoparticles and encapsulates them. Conclusion: LPs can function as nanocarriers of TA and they could be used as topical ophthalmic primary therapy instead of intravitreal drugs in patients with ME secondary to BRVO.

Novel Triamcinolone Acetonide-Loaded Liposomal Topical Formulation Improves Contrast Sensitivity Outcome After Femtosecond Laser-Assisted Cataract Surgery.

Purpose: To assess visual results, macular modifications, and the incidence of clinically significant macular edema (CSME) in patients using a topical triamcinolone acetonide-loaded liposomal formulation (TA-LF) after femtosecond laser-assisted cataract surgery (FLACS). Methods: Fifty-six eyes after FLACS were selected. Twenty-eight eyes in the combined therapy group (P + N) were treated with prednisolone 1% and nepafenac 0.1% for 21 days postoperatively, whereas 28 eyes in the TA-LF group received a liposomal formulation containing 2 mg/mL of TA (0.2%) for the same period of time. Follow-up visits at 1 day, 6 weeks, and 12 weeks after surgery consisted of visual acuity, contrast sensitivity (CS), central foveal thickness (CFT), total macular volume (TMV) measurements, and the detection of CSME. Results: CS improved in the TA-LF group (basal value: 1.087 ± 0.339 vs. 1.276 ± 0.147 at week 12, P = 0.0346), whereas in the P + N group, CS was not different from the baseline (basal value: 1.130 ± 0.331 vs. 1.274 ± 0.133 at week 12, P = 0.1276). There were similar increases in postoperative CFT and TMV in both groups. CFT and TMV significantly correlate with CS only in the TA-LF group. The r2 for CFT and CS was 0.1963 (P = 0.0206), whereas the r2 for TMV and CS was 0.3615 (P = 0.0007) at 12 weeks. No difference was observed in the incidence of CSME between the groups. Conclusion: TA-LF is associated with better CS outcomes compared to combined therapy after FLACS.

Novel Triamcinolone Acetonide-Loaded Liposomes Topical Formulation for the Treatment of Cystoid Macular Edema After Cataract Surgery: A Pilot Study.

PURPOSE: To report tolerability, safety, and efficacy of a topical triamcinolone acetonide-loaded liposomes formulation (TA-LF) in targeting the macular area in patients with refractory pseudophakic cystoid macular edema (PCME). METHODS: For tolerability, safety and efficacy evaluation, 12 eyes of 12 patients with refractory PCME were exposed to one drop of TA-LF (TA at 0.2%) every 2 h for 90 days or until best-corrected visual acuity (BCVA) was achieved. Intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit. RESULTS: Patients with refractory PCME under TA-LF therapy showed a significant improvement in BVCA and CFT without significant IOP modification (P = 0.94). On average CFT decreased to 206.75 ± 135.72 µm and BCVA improved to 20.08 ± 10.35 letters (P < 0.0005). BCVA was achieved at 10.58 ± 6.70 weeks (range 2-18). TA-LF was well tolerated in all cases. Neither ocular surface abnormalities nor adverse events were recorded. CONCLUSION: TA-LF was well tolerated and improved BCVA and CFT on patients with refractory PCME.

Feasibility and safety of vitrectomy under topical anesthesia in an office-based setting.

Purpose: The purpose of this study was to evaluate the feasibility and safety of office-based vitreoretinal procedures. Methods: Patients undergoing primary elective pars plana vitrectomy were elected for surgery in an office-based setting (performed in a minor procedure room under topical anesthesia [TA] and oral anxiolysis). Rates of surgical objective achievement, surgical timing, and comfort were recorded to evaluate feasibility. Intraoperative and postoperative adverse events were assessed to evaluate safety. Results: Office-based vitrectomy surgery was performed in 34 eyes of 30 patients. The mean surgical time was 12.351 ± 8.21 min. Surgical objectives were achieved in 100% of cases. The mean best-corrected visual acuity improvement was 9.08 letters (P < 0.0001). During most parts of the procedure, no patient reported pain or discomfort. Neither intraoperative nor postoperative adverse events were reported until the final follow-up visit. Conclusion: Office-based vitreoretinal procedures under TA could be as feasible and as safe as vitreoretinal procedures under conventional anesthesia.

Detecting unknown attacks in wireless sensor networks that contain mobile nodes.

As wireless sensor networks are usually deployed in unattended areas, security policies cannot be updated in a timely fashion upon identification of new attacks. This gives enough time for attackers to cause significant damage. Thus, it is of great importance to provide protection from unknown attacks. However, existing solutions are mostly concentrated on known attacks. On the other hand, mobility can make the sensor network more resilient to failures, reactive to events, and able to support disparate missions with a common set of sensors, yet the problem of security becomes more complicated. In order to address the issue of security in networks with mobile nodes, we propose a machine learning solution for anomaly detection along with the feature extraction process that tries to detect temporal and spatial inconsistencies in the sequences of sensed values and the routing paths used to forward these values to the base station. We also propose a special way to treat mobile nodes, which is the main novelty of this work. The data produced in the presence of an attacker are treated as outliers, and detected using clustering techniques. These techniques are further coupled with a reputation system, in this way isolating compromised nodes in timely fashion. The proposal exhibits good performances at detecting and confining previously unseen attacks, including the cases when mobile nodes are compromised.

Improving social odometry robot networks with distributed reputation systems for collaborative purposes.

The improvement of odometry systems in collaborative robotics remains an important challenge for several applications. Social odometry is a social technique which confers the robots the possibility to learn from the others. This paper analyzes social odometry and proposes and follows a methodology to improve its behavior based on cooperative reputation systems. We also provide a reference implementation that allows us to compare the performance of the proposed solution in highly dynamic environments with the performance of standard social odometry techniques. Simulation results quantitatively show the benefits of this collaborative approach that allows us to achieve better performances than social odometry.

Improving Security for SCADA Sensor Networks with Reputation Systems and Self-Organizing Maps.

The reliable operation of modern infrastructures depends on computerized systems and Supervisory Control and Data Acquisition (SCADA) systems, which are also based on the data obtained from sensor networks. The inherent limitations of the sensor devices make them extremely vulnerable to cyberwarfare/cyberterrorism attacks. In this paper, we propose a reputation system enhanced with distributed agents, based on unsupervised learning algorithms (self-organizing maps), in order to achieve fault tolerance and enhanced resistance to previously unknown attacks. This approach has been extensively simulated and compared with previous proposals.

Using reputation systems and non-deterministic routing to secure wireless sensor networks.

Security in wireless sensor networks is difficult to achieve because of the resource limitations of the sensor nodes. We propose a trust-based decision framework for wireless sensor networks coupled with a non-deterministic routing protocol. Both provide a mechanism to effectively detect and confine common attacks, and, unlike previous approaches, allow bad reputation feedback to the network. This approach has been extensively simulated, obtaining good results, even for unrealistically complex attack scenarios.

Inicio del programa de implantes cocleares en el Hospital Vozandes quito / Launching the program cochlear implant at the Hospital Vozandes Quito

El advenimiento de nuevas tecnologías ha llevado al equipo médico a un trabajo multidisciplinario coordinado, así como al adiestramiento en nuevas técnicas quirúrgicas. Pacientes niños y adultos se han visto beneficiados de opciones terapéuticas impensables hasta hace poco, siendo los criterios de selección cuidadosos los que han permitido un inicio exitoso del programa de implantes cocleares en el Hospital Vozandes Quito. Por medio de la presente revisión de casos se reporta nuestra experiencia en el inicio de del programa de implantes cocleares.

Rinosinusitis Fúngica, relato de un caso y revisión de la literatura / Fungal rhinosinusitis, case report and literature review

La rinosinusitis fúngica es una entidad poco sospechosa. Se le ha clasificado en invasiva y no invasiva; cada una, con distinto criterio diagnóstico, tratamiento y pronóstico. Presentamos el caso clínico de una paciente femenina de 27 años que consulta por presentar rinosinusitis crónica refractaria a tratamientos repetidos. La TC SPN inicial revela velamiento integral del seno maxilar derecho con una imagen de mayor densidad radiológica en su interior, velamiento parcial de etmoides anterior, posterior y esfenoidal del mismo lado. Se inicio tratamiento clínico con antibioticoterápia descongestionantes nasales e irrigación nasal con lo que la paciente tuvo alivio sintomático parcial. Luego de dos meses y medio la TC SPN de control demuestra solo mejoría del seno esfenoidal, entonces, la paciente fue sometida a cirugía endoscópica nasal encontrando una mas amarillo - marrón en seno maxilar que fue extraida. El cultivo no reportó crecimiento de hongos. El diagnóstico final fue de un micetoma o bola fúngica en seno maxilar derecho más conchas medias bulosas. la paciente evolucionó sin complicaciones. Concluimos que el micetoma así como los otros tipos de RSF son entidades no tan raras como se cree y debe ser siempre considerada dentro de los diagnósticos diferenciales de todo proceso de RSC.

Fungal rhinosinusitis is a little suspicious entity. It has been classified as invasive and non-invasive; each, with different diagnostic criteria, treatment and prognosis. We present the clinical case of a 27-year-old female patient who consults for presenting chronic rhinosinusitis refractory to repeated treatments. The initial SPN CT reveals complete veiling of the right maxillary sinus with an image of higher radiological density inside, partial veiling of the anterior, posterior, and sphenoid ethmoids on the same side. Clinical treatment was started with nasal decongestant antibiotics and nasal irrigation, with which the patient had partial symptomatic relief. After two and a half months, the control SPN CT showed only improvement of the sphenoid sinus, so the patient underwent nasal endoscopic surgery, finding a more yellow-brown one in the maxillary sinus that was removed. The culture did not report fungal growth. The final diagnosis was a mycetoma or fungal ball in the right maxillary sinus plus bullous mid-shells. the patient evolved without complications. We conclude that the mycetoma as well as the other types of RSF are not so rare entities as it is believed and should always be considered within the differential diagnoses of any CSR process.

Control de epistaxis en la enfermedad Derendu-Weber-Osler: Relato de un caso y revisión de la literatura / Epistaxis control in Derendu-Weber-Osler disease: A case report and literature review

La enfermedad de Rendu-Osler-Weber-(ROW) es un padecimiento hereditario causante de sangrados de variadas localizaciones siendo lo más frecuente la epistaxis, puede comprometer la vida del paciente si las hemorragias son abundantes y muy frecuentes. Presentamos el caso de un paciente que acudió a la consulta externa de ORL del Hospital Vozandes Quito en el mes de septiembre del año 2002, presentando una epistaxis severa de fosa nasal derecha que fue controlada en forma efectiva en base a una adecuada exploración endoscópica y utilización de cauterización eléctrica solamente en el sitio del sangrado y bajo visión directa. El paciente salió del hospital sin ningún taponamiento y hasta la fecha no a vuelto a presentar sangrados importantes. Concluimos que durante una epistaxis causada por la enfermedad de ROW o por otra causa, se debe realizar una valoración adecuada de la cavidad nasal sea por un examen convencional o por endoscopía, con el fin de identificar el sitio de la hemorragia y actuar sobre el; no recomendamos ante una epistaxis realizar taponamientos nasales a ciegas como procedimiento estándar.

Rendu-Osler-Weber disease (ROW) is an inherited condition that causes bleeding from various locations, epistaxis being the most frequent, it can compromise the patient's life if bleeding is abundant and very frequent. We present the case of a patient who attended the ENT outpatient clinic at the Hospital Vozandes Quito in September 2002, presenting a severe right nostril epistaxis that was effectively controlled based on adequate endoscopic examination and use. of electric cauterization only at the bleeding site and under direct vision. The patient left the hospital without any tamponade and to date has not returned to show significant bleeding. We conclude that during an epistaxis caused by ROW disease or another cause, an adequate evaluation of the nasal cavity should be carried out either by a conventional examination or by endoscopy, in order to identify the site of the hemorrhage and act on it; We do not recommend blind episodes of nasal plugging as a standard procedure.

Analise das emissoes otoacusticas transientes em criancas com e sem risco auditivo

O registro das Emissoes Otoacusticas (EOA) e um exame objetivo para avaliar o funcionamento coclear atraves da medicao da atividade biomecanica das celulas ciliadas externas do orgao de Corti. Trata-se de um metodo valido para triagem neonatal. Nas EOA transientes (EOA-T) em termos de triagem, podem-se obter respostas presentes, parciais e ausentes, considerando-se a incidencia de apresentacao e a magnitude de resposta. A magnitude de resposta em decibeis (dB) e maior quanto mais alta a atividade biomecanica coclear. O objetivo foi comparar a incidencia de apresentacao de respostas e a magnitude de respostas das EOA-T em criancas com e sem risco auditivo; comparar as diferencas nas intensidades de respostas em criancas com e sem risco auditivo; determinar se o risco auditivo tem importancia sobre os resultados obtidos. Foram estudadas, de agosto de 1997 a julho de 1998, 96 criancas com idade menor de 12 meses, sendo 184 ouvidos testados com EOA-T. Desses, 81 ouvidos com risco e 103 sem risco auditivo. Nas criancas sem risco, a incidencia de respostas normais foi de 90,3 por cento, com uma magnitude de resposta de 21,6 dBSPL em media, 2,9 por cento tiveram resposta parcial e 6,8 por cento respostas ausentes. Nas criancas com risco auditivo, a incidencia de apresentacao de respostas normais foi de 81,5 por cento, com uma magnitude de respostas de 16,8 dBSPL em media, 4,9 por cento respostas parciais e 13,5 por cento ausentes. Foi observada uma incidencia maior de respostas normais com uma magnitude significativamente nas criancas sem risco auditivo, sendo essa diferenca significativa (p<0,01). Nas criancas com risco, a incidencia de apresentacao de respostas normais foi menor do que no grupo sem risco. As intensidades de respostas nas criancas com risco foram menores do que no grupo sem risco. A presenca de risco auditivo tem influencia na incidencia de apresentacao e nas intensidades de respostas das EOA-T.

Estudio clínico comparativo de los efectos indeseables de los anticonceptivos orales / Comparative clinical study of the undesirable effects of the oral contraceptives

Se estudiaron 31 pacientes seleccionadas de entre 45 mujeres usuarias de anticonceptivos orales de las comunidades de San Simón y San Juan (provincia de Bolívar), que fueron divididas en dos grupos homogéneos y comparables, según si usaron un preparado monofásico (16 pacientes) o trifásicos (15 pacientes), se registro la frecuencia de efectos indeseables en cada uno de los grupos. En el grupo monofásico se presentaron efectos indeseables en cada uno de los grupos. En el grupo monofásico se presentaron efectos indeseables en el 87.5xciento, en el trifásico 40xciento, diferencia estadísticamente significativa (alfa=0.05). El incremento de peso se registro, para el grupo monofásico, en 4 pacientes (25xciento) con una media de 14.75xciento, y en el trifásico 3 (20xciento) con una media de 8.66xciento, el incremento de presión arterial media se registro para el grupo monofásico en 5 pacientes (31,25xciento) con un promedio de 13.5mm de Hg. Solo hubo diferencia significativa de efectos indeseables monofásico vs. trifásico en la presencia de cloasma y várices. Se concluye que el preparado monofásico presenta mayor índice de efectos indeseables que el trifásico, esa diferencia es muy acentuada al comparar la presencia de cloasma y várices, por tanto consideramos que la indicación de uno u otro preparado debe ser hecha tomando en cuenta, sobre todo, estos aspectos.

Estudio clínico comparativo de efectos indeseables de los anticonceptivos orales / Comparative clinical study of undesirable effects of the oral contraceptives

Se analizó a 31 pacientes, seleccionadas de entre 45 mujeres usuarias de anticonceptivos orales de las comunidades de San Simón y San Juan (provincia de Bolívar), divididas en 2 grupos homogéneos y comparables, según si usaron un preparado monofásico (16 pacientes) o trifásico (15 pacientes), se registro la frecuencia de efectos indeseables en cada uno de los grupos. Resultados: en el grupo monofásico se presentaron efectos indeseables en el 87.5xcto, en el trifásico 40xcto, fue significativo. (alfa=0.05). Incremento de peso se registró, para el grupo monofásico en 4 pacientes (25xcto) y en el trifásico 3 (20xcto), Incremento de presión arterial media, se registró para el grupo monofásico en 5 pacientes (31,25xcto) y en el trifásico de 13,5mm de Hg. Solo hubo diferencia significativa de efectos indeseables monofásico presenta la presencia de cloasma y várices, por tanto consideramos que la indicación de uno u otro preparado debe ser hecha tomando en cuenta, sobre todo, estos aspectos.