Efectividad y seguridad del tratamiento de las enfermedades de depósito lisosomal: análisis de 22 pacientes / Effectiveness and safety of the treatment of lysosomal deposit diseases: Analysis of 22 patients

Objetivos: Los objetivos son: identificar variables de eficacia empleadas en fármacos para enfermedades de depósito lisosomal (EDL), evaluar la calidad de esta evidencia, y conocer la efectividad y seguridad de estos tratamientos.Material y métodosEstudio observacional retrospectivo que incluyó pacientes con EDL tratados con terapia de sustitución enzimática (TSE) o de reducción de sustrato (TRS). Se revisaron los ensayos clínicos (EC) publicados y guías de tratamiento de EDL para seleccionar las variables de eficacia. Se obtuvieron los datos para medirlas (y efectos adversos) de la historia clínica.ResultadosNo se encontraron EC en los que se evalúe la eficacia con variables finales, todas fueron subrogadas. Se incluyeron 22 pacientes: 8 con enfermedad de Gaucher, 6 con enfermedad de Niemann-Pick tipo C, 2 con enfermedad de Hunter, uno con enfermedad de Morquio-A y 5 con enfermedad de Pompe. Ocho pacientes respondieron a TSE y uno a TRS. La TSE no se relacionó con efectos adversos. Miglustat produjo problemas de tolerancia que requirieron cambio de tratamiento en un paciente.ConclusionesLa efectividad fue variable según la enfermedad. Respecto a seguridad, se asociaron reacciones adversas a TRS manejables con ajustes posológicos. (AU)

Objectives: Identify the efficacy variables collected in the literature for therapies used in lysosomal storage diseases (LDS), evaluate the quality of this evidence, and know the effectiveness and safety of these treatments.Material and methodsRetrospective observational study that included patients with LDS treated with enzyme replacement therapy (ERT) or substrate reduction therapy (SRT). Published clinical trials (CT) and LDS treatment guidelines were reviewed to select efficacy variables. Data to measure them (and adverse effects) were obtained from the medical history.ResultsNo CTs have been found in which efficacy is evaluated with final variables, all have been surrogated. Twenty-two patients were included: eight with Gaucher disease, six with Niemann–PickC disease, two with Hunter disease, one with Morquio-A disease, and five with Pompe disease. Eight patients have responded to ERT and one to SRT with eliglustat. ERT has not been associated with adverse effects. Miglustat has produced tolerance problems, requiring a change in a patient.ConclusionsThe effectiveness was variable according to the pathology. Regarding safety, manageable adverse reactions to SRT were associated with dosage adjustments. (AU)

Effectiveness and safety of the treatment of lysosomal deposit diseases: Analysis of 22 patients. / Efectividad y seguridad del tratamiento de las enfermedades de depósito lisosomal: análisis de 22 pacientes.

OBJECTIVES: Identify the efficacy variables collected in the literature for therapies used in lysosomal storage diseases (LDS), evaluate the quality of this evidence, and know the effectiveness and safety of these treatments. MATERIAL AND METHODS: Retrospective observational study that included patients with LDS treated with enzyme replacement therapy (ERT) or substrate reduction therapy (SRT). Published clinical trials (CT) and LDS treatment guidelines were reviewed to select efficacy variables. Data to measure them (and adverse effects) were obtained from the medical history. RESULTS: No CTs have been found in which efficacy is evaluated with final variables, all have been surrogated. Twenty-two patients were included: eight with Gaucher disease, six with Niemann-PickC disease, two with Hunter disease, one with Morquio-A disease, and five with Pompe disease. Eight patients have responded to ERT and one to SRT with eliglustat. ERT has not been associated with adverse effects. Miglustat has produced tolerance problems, requiring a change in a patient. CONCLUSIONS: The effectiveness was variable according to the pathology. Regarding safety, manageable adverse reactions to SRT were associated with dosage adjustments.

Intervention by a clinical pharmacist carried out at discharge of elderly patients admitted to the internal medicine department: influence on readmissions and costs.

BACKGROUND: Patient education on pharmacological treatment could reduce readmissions. Our objective was to carry out a pharmacist intervention focused on providing information about high-risk medications to chronic patients and to analyse its influence on readmissions and costs. METHODS: A single-centre study with an intervention group and a retrospective control group was conducted. The intervention was carried out in all polymedicated patients ≥ 65 years who were admitted to internal medicine and signed the informed consent between June 2017 and February 2018. Patients discharged to nursing homes or long-term hospitals were excluded. The control group were all the patients who were admitted during the same months of 2014 who met the same inclusion criteria. The patients were classified according to the HOSPITAL score as having a low, intermediate, or high risk of potentially avoidable readmission. Outcome measures were 30-day readmission and cost data. To analyse the effect of the intervention on readmission, a logistic regression was performed. RESULTS: The study included 589 patients (286 intervention group; 303 control group). The readmission rate decreased from 20.13% to 16.43% in the intervention group [OR = 0.760 95% CI (0.495-1.166); p = 0.209)]. The incremental cost for the intervention to prevent one readmission was €3,091.19, and the net cost saving was €1,301.26. In the intermediate- and high-risk groups, readmissions were reduced 10.91% and 10.00%, and the net cost savings were €3,3143.15 and €3,248.71, respectively. CONCLUSIONS: The pharmacist intervention achieved savings in the number of readmissions, and the net cost savings were greater in patients with intermediate and high risks of potentially avoidable readmission according to the HOSPITAL score.

[Controlled supply of tocilizumab during the COVID-19 pandemic and its influence on the treatment of rheumatological patients.] / Suministro controlado de tocilizumab durante la pandemia de COVID-19 e influencia sobre el tratamiento de pacientes reumatológicos.

OBJECTIVE: Intravenous (IV) tocilizumab has been used to stop the inflammatory phase of SARS-CoV-2 infection. To preserve the largest number of IV units for this use, the Spanish Agency for Medicines and Health Products (AEMPS) carried out a controlled supply of it and recommended the change to a subcutaneous presentation (SC) of tocilizumab or sarilumab in all those patients in IV tocilizumab treatment for rheumatologic indications. The objective of this study was to evaluate the change from IV tocilizumab to SC presentation due to its controlled supply during the COVID-19 pandemic. METHODS: Retrospective observational study of adult patients (>18 years old) under treatment with IV tocilizumab follow-up by the Rheumatology Service of the Hospital 12 de Octubre. The follow-up period was 3 months (March 2020-June 2020) and 39 patients were included in the study. Variables related to the patients and their treatment were collected. A descriptive analysis of the data was carried out. RESULTS: In 69.23% (n=27) of the patients, treatment was changed to SC tocilizumab (n=23) or sarilumab (n=4). 44% of patients (n=12) switched back to their original IV tocilizumab treatment. The reasons for stopping treatment with SC tocilizumab were: drug intolerance (n=4), disease worsening (n=4), and patient preference (n=1). Regarding sarilumab, the reasons were drug intolerance (n=2) and patient preference (n=1). CONCLUSIONS: Almost half of the patients had to return to the original treatment. The main reason was intolerance to the new treatment, followed by ineffectiveness and patient preferences.

OBJETIVO: El tocilizumab intravenoso (IV) ha sido empleado para frenar la fase inflamatoria de la infección por SARS-CoV-2. Para reservar el mayor número de unidades IV para este uso, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) realizó una distribución controlada del mismo y recomendó el cambio a una presentación subcutánea (SC), fuera tocilizumab o sarilumab, en todos aquellos pacientes en tratamiento con tocilizumab IV para indicaciones reumatológicas. El objetivo de este trabajo fue evaluar el cambio de tocilizumab IV a una presentación SC debido a su suministro controlado durante la pandemia de COVID-19. METODOS: Se realizó un estudio observacional retrospectivo de pacientes adultos (mayores de 18 años) en tratamiento con tocilizumab IV en seguimiento por el Servicio de Reumatología del Hospital 12 de octubre (Madrid). El periodo de seguimiento fue de tres meses (marzo 2020-junio 2020) y se incluyeron 39 pacientes en el estudio. Se recogieron variables relacionadas con el paciente y su tratamiento. Se realizó un análisis descriptivo de los datos. RESULTADOS: En el 69,23% (n=27) de los pacientes se cambió el tratamiento a tocilizumab SC (n=23) o sarilumab (n=4). El 44% (n=12) de los pacientes volvieron a cambiar a su tratamiento original con tocilizumab IV. Los motivos de interrupción de tratamiento con tocilizumab SC fueron: intolerancia al fármaco (n=4), empeoramiento de la enfermedad (n=4) y preferencia del paciente (n=1). Respecto al sarilumab, los motivos fueron intolerancia al fármaco (n=2) y preferencia del paciente (n=1). CONCLUSIONES: Casi la mitad de los pacientes tuvieron que volver al tratamiento original. El principal motivo fue intolerancia al nuevo tratamiento, seguido de ineficacia y preferencias del paciente.

Impact of a Pharmaceutical Care Program at Discharge on Patients at High Risk of Readmission According to the Hospital Score.

Background: A significant percentage of hospital readmissions within 30 days of discharge are a result of avoidable drug-related problems. Stratifying patients according to readmission risk is key to pharmaceutical intervention (PI) design strategies to improve treatment outcomes. Objective: To assess whether a pharmaceutical care (PC) program at discharge in polymedicated patients at high potentially avoidable readmission (PAR) risk, according to the HOSPITAL score, improves 30-day readmission rate (30-dRR). Methods: This prospective controlled, quasi-experimental, 11-month study included 163 chronic polymedicated patients (>5 medications) at high PAR risk according to the HOSPITAL score. We calculated the 30-dRR and number of medication variations and Medication Regimen Complexity Index-E (MRCI-E) after PI. Results were compared with a retrospective cohort of chronic patients at high PAR risk. Results: The 30-dRR was 18.4% in the intervention group and 25.6% in the control group (odds ratio [OR] = 0.66; 95% CI = 0.38 to 1.14). Total medication reduction (-1.28; 95% CI = -1.88 to -0.68), number of high-risk medications in chronic patients (-0.58; 95% CI = -0.9 to -0.26), and MRCI-E (-6.42; 95% CI = -8.07 to -4.76) were statistically significant (P < .001). The number of medications at discharge was associated with an increased readmission risk (OR = 1.07; 95% CI = 1.01 to 1.14). Conclusions: The degree of polypharmacy and patients' treatment complexity after hospital discharge significantly reduced as a result of the PC program compared with the control group. This highlights the need for patient selection and prioritization strategies for implementing PIs focused on reducing polypharmacy and preventing drug-related problems that may cause PAR.

Paediatric viral myocarditis successfully treated with interferon beta-1b and corticoids.

WHAT IS KNOWN AND OBJECTIVE: In paediatrics, evidence regarding the treatment of viral myocarditis using interferon beta-1B is restricted to four children older than two years and there are no reported cases of infants. The objective was to describe the efficacy and safety of interferon beta-1B in two infants under one year of age with viral myocarditis. CASE SUMMARY: Two infants were admitted to the hospital presenting with respiratory symptoms. Echocardiogram showed myocardial damage. Parvovirus-B19 was detected using a PCR assay, and treatment with interferon beta-1B was initiated. Six months later, the cardiac function had recovered in both cases. WHAT IS NEW AND CONCLUSION: This is the first published series of cases of infants less than 1 year of age with viral myocarditis treated with interferon beta-1B.

Desarrollo de una fórmula magistral de clofazimina para el tratamiento de tuberculosis extremadamente resistente en paciente lactante / Clofazimine suspension formulation for treating extremely resistant tuberculosis in a nursing patient

No disponible

Programa para la adecuación del uso de paracetamol a dosis menores y más seguras: implantación y resultados / Program for the adaptation of the use of paracetamol to lower and safer doses: Implementation and results

No disponible

Clinical impact of gastric acid suppressing medication on the effectiveness of tyrosine kinase inhibitors in lung cancer patients.

PURPOSE: Erlotinib and gefitinib are both tyrosine kinase inhibitors (TKIs) approved for the treatment of non-small cell lung cancer (NSCLC). Although it is well known that the increase of gastric pH may decrease the solubility of TKIs, there is limited evidence about the clinical repercussion of this fact. The purpose of this study was to determine if the use of gastric acid suppressive therapy (As) concomitantly with TKIs has an adverse impact on progression-free survival (PFS) and to determine whether the type of drug used (proton pump inhibitors/PPIs or histamine-2 receptors antagonists (H2RAs) may influence it. METHODS: In this retrospective observational study included were patients treated for ≥1 week with erlotinib or gefitinib from January 2012 to December 2015. Demographic, diagnostic and therapeutic variables were collected. Patients were divided into two groups (As users and non-As users). For the calculation of the PFS the Kaplan Meier and multivariate Cox regression analysis were used. RESULTS: 163 patients with mean age 70 years were included. 72.397percnt; (n=118) received TKIs and As concomitantly. The mean PFS was 84 days (95% CI, 65-101) and 221 days (95% CI, 125-429; p <0.0001) in As users and non-As users, respectively. Regarding the type of As used, no significant differences were observed. CONCLUSION: Concomitant use of As and TKIs adversely impacted the PFS outcomes in NSCLC patients regardless of the type of As used. Further studies are needed to determine the clinical impact of interactions between antiacids and antineoplastics.

Pericarditis refractaria tratada con éxito con anakinra en un paciente pediátrico / Refractory pericarditis successfully treated with anakinra in a pediatric patient

No disponible

Uso de antineoplásicos orales en situaciones especiales en un hospital de tercer nivel: resultados en la vida real / Use of oral antineoplastic in special situations in a third level hospital: real life results

Objetivo: Analizar la efectividad y seguridad de los antineoplásicos orales (ANEO) autorizados en situaciones especiales en un hospital de tercer nivel y comparar los resultados obtenidos con los de la evidencia disponible empleada para autorizar el uso de estos fármacos. Método: Estudio descriptivo observacional y retrospectivo. Se incluyeron todos los pacientes adultos que iniciaron tratamiento con ANEO en situaciones especiales durante el año 2016. Se recogieron variables demográficas, relacionadas con el tratamiento, y clínicas (supervivencia global (SG), supervivencia libre de progresión (SLP)). Se recogieron reacciones adversas e interacciones detectadas. Se realizó una comparación no ajustada entre los resultados de la evidencia disponible y los de los pacientes del estudio. Resultados: Treinta y cuatro pacientes recibieron tratamiento, el 50% eran hombres, la mediana de edad fue de 58 años (38-80), y presentaron ECOG 1 el 64,7%. La mayoría de los pacientes tratados presentaban diagnóstico de cáncer colorrectal avanzado, tratados con trifluridina-tipiracil, seguidos de palbociclib en cáncer de mama, obteniendo resultados similares a los de la evidencia. La mediana de SLP fue de 2,8 meses (IC 95% 0,8-4,8) y la SG de 8 meses (IC 95% 3,4-12,5) para todos los pacientes. El 26% de los pacientes requirieron una reducción de la dosis debido a la toxicidad del tratamiento. Se encontraron 13 interacciones, que afectaron a 15 pacientes; solo dos de categoría X. Conclusiones: La efectividad de los ANEO en situaciones especiales en nuestro centro es similar al de la evidencia disponible. El impacto en la supervivencia es bajo y los efectos adversos son comunes (AU)

Objective: To analyse the effectiveness and safety of oral antineoplastic drugs (ANEOs) that are authorized in special situations in a third-level hospital and to compare the results obtained with the clinical evidence used for this authorization. Method: Descriptive observational and retrospective study. We included all adult patients who started treatment with ANEO in special situations during the year 2016. We collected demographic, treatment-related and clinical variables (overall survival (OS), progression-free survival (PFS)). Adverse reactions and detected interactions were collected. An unadjusted comparison was made between the results of the available evidence and those of the study patients. Results: 34 patients were treated, 50% were men, the median age was 58 years (38-80) and they presented ECOG 1 in 64.7%. Most of the treated patients were diagnosed with advanced colorectal cancer, treated with trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8-4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients. 26% of patients required dose reduction because of treatment toxicity. We found 13 interactions, which affected 15 patients, only two of category X. Conclusions: The effectiveness of ANEO in special situations in our center is similar to that of available evidence. The impact on survival is low and adverse effects are common (AU)

Use of oral antineoplastic in special situations in a third level hospital: real life results.

OBJECTIVE: To analyse the effectiveness and safety of oral antineoplastic drugs  (ANEOs) that are authorized in special situations in a third-level hospital and to  compare the results obtained with the clinical evidence used for this  authorization. METHOD: Descriptive observational and retrospective study. We included all  adult patients who started treatment with ANEO in special situations during the  year 2016. We collected demographic, treatment-related and clinical variables  (overall survival (OS), progression-free survival (PFS)). Adverse reactions and  detected interactions were collected. An unadjusted comparison was made  between the results of the available evidence and those of the study patients. RESULTS: 34 patients were treated, 50% were men, the median age was 58  years (38-80) and they presented ECOG 1 in 64.7%. Most of the treated  patients were diagnosed with advanced colorectal cancer, treated with  trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results  similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8- 4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients. 26% of patients  required dose reduction because of treatment toxicity. We found 13 interactions,  which affected 15 patients, only two of category X. CONCLUSIONS: The effectiveness of ANEO in special situations in our center is  similar to that of available evidence. The impact on survival is low and adverse  effects are common.

Objetivo: Analizar la efectividad y seguridad de los antineoplásicos orales  (ANEO) autorizados en situaciones especiales en un hospital de tercer nivel y  comparar los resultados obtenidos con los de la evidencia disponible empleada  para autorizar el uso de estos fármacos.Método: Estudio descriptivo observacional y retrospectivo. Se incluyeron todos  los pacientes adultos que iniciaron tratamiento con ANEO en situaciones  especiales durante el año 2016. Se recogieron variables demográficas,  relacionadas con el tratamiento, y clínicas (supervivencia global (SG),  supervivencia libre de progresión (SLP)). Se recogieron reacciones adversas e  interacciones detectadas. Se realizó una comparación no ajustada entre los  resultados de la evidencia disponible y los de los pacientes del estudio.Resultados: Treinta y cuatro pacientes recibieron tratamiento, el 50% eran  hombres, la mediana de edad fue de 58 años (38-80), y presentaron ECOG 1 el  64,7%. La mayoría de los pacientes tratados presentaban diagnóstico de cáncer colorrectal avanzado, tratados con trifluridina-tipiracil, seguidos de  palbociclib en cáncer de mama, obteniendo resultados similares a los de la evidencia. La mediana de SLP fue de 2,8 meses (IC 95% 0,8-4,8) y la SG de 8  meses (IC 95% 3,4-12,5) para todos los pacientes. El 26% de los pacientes  requirieron una reducción de la dosis debido a la toxicidad del tratamiento. Se  encontraron 13 interacciones, que afectaron a 15 pacientes; solo dos de  categoría X.Conclusiones: La efectividad de los ANEO en situaciones especiales en nuestro  centro es similar al de la evidencia disponible. El impacto en la supervivencia es  bajo y los efectos adversos son comunes.

Factores de riesgo y comportamiento de la retinopatía de la prematuridad / Risk factors and behavior of retinopathy of prematurity

Introducción: la retinopatía de la prematuridad constituye una causa importante de morbilidad a nivel mundial, evolucionando a la ceguera si no se diagnostica y trata adecuadamente. Objetivo: evaluar el comportamiento de la retinopatía de la prematuridad en recién nacidos pretérmino del servicio de Neonatología del Hospital General Docente "Abel Santamaría" de Pinar del Río, de enero de 2007 a diciembre del 2011. Método: se realizó un estudio observacional, transversal y retrospectivo en 402 pacientes menores de 35 semanas y/o menores de 1700 gramos, así como aquellos que sobrepasaron esta edad gestacional y peso, pero que presentaron factores de riesgo para desarrollar la enfermedad. Se utilizaron como variables la edad gestacional, peso al nacer, grados de retinopatía y factores de riesgo asociados. La recopilación de datos se obtuvo de la historia clínica individual y se procesaron utilizando el sistema Microstad y Epi-info. Resultados: la frecuencia de retinopatía fue de 7.5%, el grado I en zona 1,2 ó 3 se presentó en 6.7%, el 6.8% de los pacientes nacieron con menos de 34 semanas, y el 7.8% con peso menor a 1700 gramos; el 100% de los casos recibió oxígeno suplementario, el 50% presentó distress respiratorio y un 23.3% sepsis. Conclusiones: la incidencia de retinopatía del prematuro en la provincia ha disminuido, el grado I fue el más frecuente, se afectaron más los nacidos con menos de 34 semanas y menos de 1700 gramos, y los factores de riesgo asociados fueron el tratamiento con oxígeno, distress respiratorio y la sepsis neonatal.

Introduction: retinopathy of prematurity constitutes an important cause of morbidity worldwide, leading to blindness if it is not diagnosed and treated appropriately. Objective: to assess the behavior of retinopathy of prematurity in preterm newborn infants at "Abel Santamaria Cuadrado" University Hospital in Neonatology Service, Pinar del Rio province, from January 2007 to December 2011. Method: an observational, cross-sectional and retrospective study that included 402 patients younger than 35 weeks of pregnancy and/or under 1700 grams, or those over this gestational age and weight, but presenting risks factors to develop the disease. Gestational age, weight at birth, degree of retinopathy and associated risk factors were the variables used. The collection of data were taken from the individual clinical history, and processed by means of Microstad and Epi-info. Results: the frequency of retinopathy was 7.5%, degree I prevailed in zones 1,2 or 3, and was present in 6.7% and 6.8% of the patients who were born with less than 34 weeks and 7.8% with less than 1700 grams; 100% of the cases underwent supplementary oxygenation, 505 presented respiratory distress and 23.3% suffered from sepsis. Conclusions: the incidence of retinopathy of prematurity diminished in Pinar del Rio province, degree I was the most frequent, those who were born with less than 34 weeks and 1700 grams were the most affected, the associated risk factors were: oxygen treatment, respiratory distress and neonatal sepsis.

Factores de riesgo y comportamiento de la retinopatía de la prematuridad / Risk factors and behavior of retinopathy of prematurity

La retinopatía de la prematuridad constituye una causa importante de morbilidad a nivel mundial, evolucionando a la ceguera si no se diagnostica y trata adecuadamente. El objetivo fue evaluar el comportamiento de la retinopatía de la prematuridad en recién nacidos pretérmino del servicio de Neonatología del Hospital General Docente Abel Santamaría de Pinar del Río, de enero de 2007 a diciembre del 2011. Se realizó un estudio observacional, transversal y retrospectivo en 402 pacientes menores de 35 semanas y/o menores de 1700 gramos, así como aquellos que sobrepasaron esta edad gestacional y peso, pero que presentaron factores de riesgo para desarrollar la enfermedad. Se utilizaron como variables la edad gestacional, peso al nacer, grados de retinopatía y factores de riesgo asociados. La recopilación de datos se obtuvo de la historia clínica individual y se procesaron utilizando el sistema Microstad y Epi-info. La frecuencia de retinopatía fue de 7.5 por ciento, el grado I en zona 1,2 ó 3 se presentó en 6.7 por ciento, el 6.8 por ciento de los pacientes nacieron con menos de 34 semanas, y el 7.8 por ciento con peso menor a 1700 gramos; el 100 por ciento de los casos recibió oxígeno suplementario, el 50 por ciento presentó distress respiratorio y un 23.3 por ciento sepsis. La incidencia de retinopatía del prematuro en la provincia ha disminuido, el grado I fue el más frecuente, se afectaron más los nacidos con menos de 34 semanas y menos de 1700 gramos, y los factores de riesgo asociados fueron el tratamiento con oxígeno, distress respiratorio y la sepsis neonatal (AU)

Retinopathy of prematurity constitutes an important cause of morbidity worldwide, leading to blindness if it is not diagnosed and treated appropriately. The objective was to assess the behavior of retinopathy of prematurity in preterm newborn infants at "Abel Santamaria Cuadrado" University Hospital in Neonatology Service, Pinar del Rio province, from January 2007 to December 2011. An observational, cross-sectional and retrospective study that included 402 patients younger than 35 weeks of pregnancy and/or under 1700 grams, or those over this gestational age and weight, but presenting risks factors to develop the disease. Gestational age, weight at birth, degree of retinopathy and associated risk factors were the variables used. The collection of data were taken from the individual clinical history, and processed by means of Microstad and Epi-info. The frequency of retinopathy was 7.5 per cent, degree I prevailed in zones 1,2 or 3, and was present in 6.7 per cent and 6.8 per cent of the patients who were born with less than 34 weeks and 7.8 per cent with less than 1700 grams; 100 per cent of the cases underwent supplementary oxygenation, 505 presented respiratory distress and 23.3 per cent suffered from sepsis. The incidence of retinopathy of prematurity diminished in Pinar del Rio province, degree I was the most frequent, those who were born with less than 34 weeks and 1700 grams were the most affected, the associated risk factors were: oxygen treatment, respiratory distress and neonatal sepsis (AU)