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1.
J Patient Saf ; 19(8): 508-516, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37707868

ABSTRACT

OBJECTIVE: The aim of the study was to construct and validate a reduced set of high-performance triggers for identifying adverse events (AEs) via electronic medical records (EMRs) review in primary care (PC). METHODS: This was a cross-sectional descriptive study for validating a diagnostic test. The study included all 262 PC centers of Madrid region (Spain). Patients were older than 18 years who attended their PC center over the last quarter of 2018. The randomized sample was n = 1797. Main measurements were as follows: ( a ) presence of each of 19 specific computer-identified triggers in the EMR and ( b ) occurrence of an AE. To collect data, EMR review was conducted by 3 doctor-nurse teams. Triggers with statistically significant odds ratios for identifying AEs were selected for the final set after adjusting for age and sex using logistic regression. RESULTS: The sensitivity (SS) and specificity (SP) for the selected triggers were: ≥3 appointments in a week at the PC center (SS = 32.3% [95% confidence interval {CI}, 22.8%-41.8%]; SP = 92.8% [95% CI, 91.6%-94.0%]); hospital admission (SS = 19.4% [95% CI, 11.4%-27.4%]; SP = 97.2% [95% CI, 96.4%-98.0%]); hospital emergency department visit (SS = 31.2% [95% CI, 21.8%-40.6%]; SP = 90.8% [95% CI, 89.4%-92.2%]); major opioids prescription (SS = 2.2% [95% CI, 0.0%-5.2%]; SP = 99.8% [95% CI, 99.6%-100%]); and chronic benzodiazepine treatment in patients 75 years or older (SS = 14.0% [95% CI, 6.9%-21.1%]; SP = 95.5% [95% CI, 94.5%-96.5%]).The following values were obtained in the validation of this trigger set (the occurrence of at least one of these triggers in the EMR): SS = 60.2% (95% CI, 50.2%-70.1%), SP = 80.8% (95% CI, 78.8%-82.6%), positive predictive value = 14.6% (95% CI, 11.0%-18.1%), negative predictive value = 97.4% (95% CI, 96.5%-98.2%), positive likelihood ratio = 3.13 (95% CI, 2.3-4.2), and negative likelihood ratio = 0.49 (95% CI, 0.3-0.7). CONCLUSIONS: The set containing the 5 selected triggers almost triples the efficiency of EMR review in detecting AEs. This suggests that this set is easily implementable and of great utility in risk-management practice.


Subject(s)
Medical Errors , Patient Safety , Humans , Cross-Sectional Studies , Electronic Health Records , Medical Errors/prevention & control , Primary Health Care , Adult
2.
Int J Qual Health Care ; 35(2)2023 Apr 29.
Article in English | MEDLINE | ID: mdl-37043330

ABSTRACT

Knowing the frequency and characteristics of adverse events (AEs) is key to implementing actions that can prevent their occurrence. However, reporting systems are insufficient for this purpose and epidemiological studies are also required. Currently, the reviewing of clinical records is the gold standard method for knowing the frequency and characteristics of AEs. Research on AEs in a primary care setting has been limited and primarily focuses on specific types of events (medication errors, etc.) or patients. Large studies that search for any kind of AE in all patients are scarce. This study aimed to estimate the prevalence of AEs in the primary care setting and their characteristics. SETTING: all 262 primary health-care centres in the Madrid region (Spain) during the last quarter of 2018. DESIGN: cross-sectional descriptive study. Eligible population: subjects over 18 years of age who attended medical consultation over the last year (N = 2 743 719); a randomized sample stratified by age. MAIN OUTCOMES: age, sex, occurrence of an AE, number of consultations in the study period, avoidability, severity, place of occurrence, type of event, and contributory factors. The clinical records were reviewed by three teams, each composed of one doctor and one nurse trained and with expertise in patient safety. The SPSS software package (version 26) was used for the statistical analyses. The evaluators reviewed 1797 clinical records. The prevalence of AEs over the study period was 5.0% [95% confidence interval (CI): 4.0%‒6.0%], with higher values in women (5.7%; 95% CI: 4.6%‒6.8%;P = 0.10) and patients over 75 years of age (10.3%; 95% CI: 8.9%‒11.7%; P < 0.001). The overall occurrence per hundred consultations was estimated to be 1.58% (95% CI: 1.28%‒1.94%). Of the detected AEs, 71.3% (95% CI: 62.1%‒80.5%) were avoidable. Additionally, 60.6% (95% CI: 50.7%‒70.5%) were categorized as mild, 31.9% (95% CI: 22.4%‒41.4%) as moderate, and 7.4% (95% CI: 2.1%‒12.7%) as severe. Primary care was the occurrence setting in 76.6% (95% CI: 68.0%‒85.2%) of cases. The overall incidence of AEs related to medication was 53.2% (95% CI: 50.9%‒55.5%). The most frequent types of AEs were prescription errors (28.7%; 95% CI: 19.5%‒37.9%), followed by drug administration errors by patients (17.0%; 95% CI: 9.4%‒24.6%), and clinical assessment errors (11.7%; 95% CI: 5.2%‒18.2%). The most common contributory factors were those related to the patient (80.6%; 95% CI: 71.1%‒90.1%) and tasks (59.7%; 95% CI: 48.0%‒71.4%). A high prevalence of AEs (1 in 66 consultations) was observed, which was slightly higher than that reported in similar studies. About 3 out of 4 such events were considered to be avoidable and 1 out of 13 was severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of AEs. Graphical Abstract.


Subject(s)
Medical Errors , Primary Health Care , Humans , Female , Adolescent , Adult , Medical Errors/prevention & control , Prevalence , Cross-Sectional Studies , Risk Factors
3.
J Healthc Qual Res ; 36(2): 121-122, 2021.
Article in English | MEDLINE | ID: mdl-33722356
4.
Aten. prim. (Barc., Ed. impr.) ; 52(4): 233-239, abr. 2020. tab, graf
Article in Spanish | IBECS | ID: ibc-197231

ABSTRACT

INTRODUCCIÓN Y OBJETIVO: El objetivo del presente estudio es describir los errores de medicación (EM) notificados en atención primaria analizando el ámbito, el daño y las causas, y orientando el análisis a las medidas para prevenir estos errores. MATERIAL Y MÉTODOS: Ámbito: Atención primaria. Servicio Madrileño de Salud. 2016. DISEÑO: Estudio descriptivo transversal. PARTICIPANTES: Todas las notificaciones de EM realizadas desde los centros de salud en el sistema de notificación de incidentes de seguridad entre el 1 de enero y el 17 de noviembre de 2016 (n = 1.839). Mediciones principales: Ámbito donde ocurrió el error, daño real, daño potencial y causa del error. Fueron clasificadas por un investigador. Se comprobó la concordancia con otro investigador. RESULTADOS: En el ámbito del centro de salud ocurrieron el 47% (IC95%: 44,8-49,3%) de los EM y en el entorno del paciente el 26,5% (IC95%: 24,5-28,6%). El 27,5% (IC95%: 24,1-30,8%) de los EM tenían potencialidad de daño grave. En el ámbito del centro de salud, la causa más frecuente fue la prescripción inadecuada: 27,4% (IC95%: 24,4-30,4%). En el entorno del paciente, la causa más frecuente fue el fallo en la comunicación profesional-paciente: 66% (IC95%: 61,8-70,2%), seguida por equivocaciones y despistes del paciente. CONCLUSIONES: La mitad de los errores de medicación notificados desde atención primaria tiene lugar en el centro de salud mientras que los EM del paciente son la cuarta parte. Uno de cada 4 es un error potencialmente grave. Las causas más importantes son la prescripción inadecuada (incluyendo indicación o dosis incorrecta, interacciones, contraindicaciones y alergias), los fallos en la comunicación profesional-paciente y los despistes en la autoadministración del paciente. Parece prioritario implantar sistemas de ayuda a la prescripción, prácticas seguras efectivas en comunicación profesional-paciente y ayudas que eviten los despistes en la autoadministración del paciente


INTRODUCTION AND OBJECTIVES: Aim of this study is to determine the setting, causes, and the harm of medication errors (ME) which are notified by Primary Health Care. MATERIAL AND METHODS: SETTING: Primary Care Regional Health Service of Madrid. 2016. DESIGN: Descriptive and cross-sectional study. PARTICIPANTS: All ME (1,839) which were notified by Primary Care Centres by notification system of safety incidents between January 1st 2016 and November 17th 2016. MAIN MEASUREMENTS: Setting, real harm, potential harm, and cause of error. These items were classified by one researcher. Concordance was checked with another researcher. RESULTS: Just under half (47%) (95% CI: 44.8%-49.3%) of ME occurred in Primary Care Centre, 26.5% (95% CI: 24.5%-28.6%) of ME were patient medication errors, and 27.5% (95% CI: 24.1%-30.8%) of ME were potential severe harm errors. Prescribing errors were the cause of most ME in Primary Care Centre [27.4% (95% CI: 24.4%-30.4%)]. Communication between patients and doctors were the cause of most patient medication errors [66% (95% CI: 61.8%-70.2%)]. Patient mistakes and forgetfulness were also causes of patient medication errors. CONCLUSIONS: Half of all mediation errors hppened at Primary Care Center while one quarter of them were patient medication errors. One quarter of all ME were potential severe harm errors. The main causes were prescribing errors, failure of communication between patients and doctors, and patient mistakes and forgetfulness. Prescribing aid systems, communication improvements and patients aids should be implemented


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Medication Errors/statistics & numerical data , Primary Health Care , Notification , Cross-Sectional Studies
5.
Aten Primaria ; 52(4): 233-239, 2020 04.
Article in Spanish | MEDLINE | ID: mdl-30935679

ABSTRACT

INTRODUCTION AND OBJECTIVES: Aim of this study is to determine the setting, causes, and the harm of medication errors (ME) which are notified by Primary Health Care. MATERIAL AND METHODS: Setting: Primary Care Regional Health Service of Madrid. 2016. DESIGN: Descriptive and cross-sectional study. PARTICIPANTS: All ME (1,839) which were notified by Primary Care Centres by notification system of safety incidents between January 1st 2016 and November 17th 2016. MAIN MEASUREMENTS: Setting, real harm, potential harm, and cause of error. These items were classified by one researcher. Concordance was checked with another researcher. RESULTS: Just under half (47%) (95% CI: 44.8%-49.3%) of ME occurred in Primary Care Centre, 26.5% (95% CI: 24.5%-28.6%) of ME were patient medication errors, and 27.5% (95% CI: 24.1%-30.8%) of ME were potential severe harm errors. Prescribing errors were the cause of most ME in Primary Care Centre [27.4% (95% CI: 24.4%-30.4%)]. Communication between patients and doctors were the cause of most patient medication errors [66% (95% CI: 61.8%-70.2%)]. Patient mistakes and forgetfulness were also causes of patient medication errors. CONCLUSIONS: Half of all mediation errors hppened at Primary Care Center while one quarter of them were patient medication errors. One quarter of all ME were potential severe harm errors. The main causes were prescribing errors, failure of communication between patients and doctors, and patient mistakes and forgetfulness. Prescribing aid systems, communication improvements and patients aids should be implemented.


Subject(s)
Medication Errors/statistics & numerical data , Primary Health Care/statistics & numerical data , Aged , Communication , Community Health Centers/statistics & numerical data , Confidence Intervals , Cross-Sectional Studies , Drug Prescriptions/statistics & numerical data , Female , Humans , Male , Medication Adherence/statistics & numerical data , Medication Errors/adverse effects , Medication Errors/classification , Pharmacies/statistics & numerical data
6.
J Investig Med ; 68(3): 807-810, 2020 03.
Article in English | MEDLINE | ID: mdl-31852749

ABSTRACT

Previous studies have shown the potential of microRNAs (miRNA) in the pathological process of stroke and functional recovery. Bone marrow mononuclear cell (BM-MNC) transplantation improves recovery in experimental models of ischemic stroke that might be related with miRNA modifications. However, its effect on circulating miRNA has not been described in patients with stroke. We aimed to evaluate the circulating levels of miRNAs after autologous BM-MNC transplantation in patients with stroke. We investigate the pattern of miRNA-133b and miRNA-34a expression in patients with ischemic stroke included in a multicenter randomized controlled phase IIb trial (http://www.clinicaltrials.gov; unique identifier: NCT02178657). Patients were randomized to 2 different doses of autologous intra-arterial BM-MNC injection (2×106/kg or 5×106/kg) or control group within the first 7 days after stroke onset. We evaluate plasma concentration of miRNA-113b and miRNA-34a at inclusion and 4, 7, and 90 days after treatment. Thirteen cases (8 with 2×106/kg BM-MNC dose and 5 with 5×106/kg dose) and 11 controls (BM-MNC non-treated) were consecutively included. Mean age was 64.1±12.3 with a mean National Institutes of Health Stroke Scale score at inclusion of 14.5. Basal levels of miRNA were similar in both groups. miR-34a-5p and miR-133b showed different expression patterns. There was a significant dose-dependent increase of miRNA-34a levels 4 days after BM-MNC injection (fold change 3.7, p<0.001), whereas miRNA-133b showed a significant increase in the low-dose BM-MNC group at 90 days. Intra-arterial BM-MNC transplantation in patients with ischemic stroke seems to modulate early circulating miRNA-34a levels, which have been related to precursor cell migration in stroke and smaller infarct volumes.


Subject(s)
Bone Marrow Transplantation , Circulating MicroRNA/blood , Ischemic Stroke/therapy , Leukocytes, Mononuclear/transplantation , Aged , Female , Humans , Injections, Intra-Arterial , Male , Middle Aged , Transplantation, Autologous
7.
Aten. prim. (Barc., Ed. impr.) ; 49(4): 240-247, abr. 2017. graf, tab
Article in Spanish | IBECS | ID: ibc-161979

ABSTRACT

OBJETIVOS: 1) Analizar la concordancia entre la clasificación por niveles de riesgo del agrupador grupos de morbilidad ajustados (GMA) y el nivel de intervención asignado por los médicos de familia (MF). 2) Estudiar la utilidad del agrupador como herramienta de ayuda en historia clínica electrónica (HCE) para la toma de decisiones clínicas. DISEÑO: Estudio observacional transversal de concordancia. Emplazamiento: Atención Primaria, Servicio Madrileño de Salud. PARTICIPANTES: Veintiocho MF. Se seleccionó una muestra de 840 pacientes adscritos a cupos de los MF participantes por muestreo aleatorizado estratificado no proporcional (kappa 0,65, precisión 0,125, porcentajes positivos 5%, nivel de confianza 95%). Mediciones principales: Índice kappa de Cohen ponderado para el grado de concordancia entre el nivel (bajo, medio o alto) de riesgo de ingreso hospitalario/consumo de recursos del paciente propuesto por el agrupador GMA y el nivel (bajo, medio o alto) de intervención (autocuidado, gestión de la enfermedad, gestión del caso) asignado por el MF. A través de un cuestionario autoadministrado elaborado ad hoc los MF valoraron la utilidad del agrupador. RESULTADOS: El índice de kappa ponderado obtenido fue de 0,60 (IC 95% 0,55-0,65). En un 3% el grado de desacuerdo fue máximo. El MF consideró en el 76% de los casos que el agrupador había sido útil para la asignación de los niveles de intervención. CONCLUSIÓN: La fuerza de concordancia obtenida fue moderada/buena; la incorporación de un agrupador en la HCE puede servir de ayuda como recordatorio para una toma de decisiones más proactiva/integrada según las necesidades sociosanitarias de las personas con enfermedades crónicas


OBJECTIVES: 1) To analyse concordance between the level of risk classification using the Adjusted Groups Morbidity (GMA) tool and the assigned level of intervention by general practitioners (GP). 2) To study the usefulness of the GMA tool as an aid in electronic medical records (EMR) for decision making. DESIGN: Cross-sectional observational study of concordance. LOCATION: Primary Care. Madrid Health Service. PARTICIPANTS: Twenty eight GPs. A sample of 840 patients assigned to participating GPs was selected by disproportionate stratified random sampling (0.65 kappa, 0.125 precision, 5% positive rate, 95% confidence level). MAIN MEASUREMENTS: Weighted Cohen Kappa index for the degree of concordance between the GMA tool and the GPs. The usefulness of the tool was assessed using an ad hoc developed questionnaire. RESULTS: Kappa weighted index obtained was 0.60 (95% CI: 0.55-0.65). In 3% of cases the disagreement was maximum. The GPs found that the grouping tool had been useful in 76% of cases. CONCLUSION: Moderate strength/good concordance; incorporating a grouping tool in the EMR helps as a reminder for taking more proactive/integrated decisions based on social and health needs of people with chronic diseases


Subject(s)
Humans , Decision Support Techniques , Triage/organization & administration , Health Priorities/classification , Chronic Disease/therapy , Primary Health Care/organization & administration , Risk Adjustment/methods
8.
Aten Primaria ; 49(4): 240-247, 2017 Apr.
Article in Spanish | MEDLINE | ID: mdl-27592535

ABSTRACT

OBJECTIVES: 1) To analyse concordance between the level of risk classification using the Adjusted Groups Morbidity (GMA) tool and the assigned level of intervention by general practitioners (GP). 2) To study the usefulness of the GMA tool as an aid in electronic medical records (EMR) for decision making. DESIGN: Cross-sectional observational study of concordance. LOCATION: Primary Care. Madrid Health Service. PARTICIPANTS: Twenty eight GPs. A sample of 840 patients assigned to participating GPs was selected by disproportionate stratified random sampling (0.65 kappa, 0.125 precision, 5% positive rate, 95% confidence level). MAIN MEASUREMENTS: Weighted Cohen Kappa index for the degree of concordance between the GMA tool and the GPs. The usefulness of the tool was assessed using an ad hoc developed questionnaire. RESULTS: Kappa weighted index obtained was 0.60 (95%CI: 0.55-0.65). In 3% of cases the disagreement was maximum. The GPs found that the grouping tool had been useful in 76% of cases. CONCLUSION: Moderate strength/good concordance; incorporating a grouping tool in the EMR helps as a reminder for taking more proactive/integrated decisions based on social and health needs of people with chronic diseases.


Subject(s)
Clinical Decision-Making/methods , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Risk Assessment
9.
Liver Int ; 33(9): 1378-85, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23701583

ABSTRACT

BACKGROUND & AIMS: Several pharmaceutical compounds have been shown to exert inhibitory effects on the bile salt export pump (BSEP) encoded by the ABCB11 gene. We analysed the combined effect on drug-induced liver injury (DILI) development of the ABCB11 1331T>C polymorphism and the presence of specific chemical moieties, with known BSEP inhibiting properties, in the causative drug. METHODS: Genotyping using a TaqMan 5' allelic discrimination assay was performed in 188 Spanish DILI patients, 219 healthy controls and 91 sex-, age- and drug-matched controls. A chemical structure analysis was performed for each individual causative drug. RESULTS: The CC genotype was significantly associated with hepatocellular damage [odds ratio (OR) = 2.1, P = 0.001], particularly in NSAID DILI cases (OR = 3.4, P = 0.007). In addition, the CC genotype was found to be significantly linked to DILI development from drugs causing <50% BSEP inhibition (OR = 1.8, Pc = 0.011). Of the BSEP inhibitory chemical moieties, 59% of the causative drugs contained a carbocyclic system with at least one aromatic ring, corresponding to 61% of the total cases. The C allele was significantly more frequent in DILI cases containing this chemical moiety, which appear to be conditioned on the ABCB11 1331T>C polymorphism in the absence of other BSEP inhibitory structures. CONCLUSION: Patients carrying the C allele in the ABCB11 1331T>C polymorphism are at increased risk of developing hepatocellular type of DILI, when taking drugs containing a carbocyclic system with aromatic rings.


Subject(s)
ATP-Binding Cassette Transporters/genetics , Chemical and Drug Induced Liver Injury/genetics , Drug-Related Side Effects and Adverse Reactions/genetics , Genetic Predisposition to Disease/genetics , Pharmaceutical Preparations/chemistry , Polymorphism, Single Nucleotide/genetics , ATP Binding Cassette Transporter, Subfamily B, Member 11 , Acids, Carbocyclic/chemistry , Female , Gene Frequency , Genotype , Humans , Hydrocarbons, Aromatic/chemistry , Male , Odds Ratio , Quantitative Structure-Activity Relationship , Spain
10.
Scand J Infect Dis ; 39(6-7): 623-5, 2007.
Article in English | MEDLINE | ID: mdl-17577831

ABSTRACT

Isolated CNS Whipple disease (WD) carries a poor prognosis, particularly if untreated. We describe 2 patients with isolated CNS WD who presented unusually with an acute onset followed by a relapsing-remitting course. Neither was diagnosed with WD until they had had several relapses.


Subject(s)
Central Nervous System Diseases/microbiology , Whipple Disease/diagnosis , Adult , Central Nervous System Diseases/pathology , Diagnosis, Differential , Disease Progression , Fatal Outcome , Female , Humans , Male , Middle Aged , Whipple Disease/pathology
11.
J Clin Microbiol ; 45(1): 88-92, 2007 Jan.
Article in English | MEDLINE | ID: mdl-17093034

ABSTRACT

No commercial viral load assay has yet been approved for use for measurement of human immunodeficiency virus type 2 (HIV-2) RNA levels in plasma. We assessed the performance of the NucliSens EasyQ (version 1.1) assay (EasyQ; bioMérieux, Boxtel, The Netherlands) to quantify HIV-2 viremia. A viral stock was prepared from an HIV-2 (subtype A)-infected patient. Culture supernatant was subjected to viral particle counting by electron microscopy. Serial dilutions of the viral stock were made in HIV-negative plasma and were used to test EasyQ for its sensitivity, linearity, and reproducibility. RNA was quantified by the NucliSens EasyQ (version 1.1) assay. Plasma samples from 75 HIV-2-infected patients were further tested. EasyQ was able to quantify HIV-2 RNA in a reproducible manner. Overall, estimates of the number of HIV-2 RNA copies/ml obtained with EasyQ were lower than those obtained by electron microscopy; however, the differences were always less than 0.7 log (mean, 0.55 +/- 0.19 log(10)). The assay showed good linearity (r(2) = 0.964; P < 0.0001). The agreement between both measures was assessed by use of a Bland-Altman plot; the narrow limits (0.158 to 0.952), defined as the mean difference +/- 2 standard deviations, indicated good agreement. The reproducibility was also good, since the between-run coefficients of variation were 1.49, 3.60, and 12.25% for samples containing 6.30, 4.30, and 2.30 log(10) HIV-2 RNA copies/ml, respectively. HIV-2 RNA was detected in 34 of 75 (45%) plasma specimens (mean, 2.72 log RNA copies/ml; range, 1.74 to 4.11 log RNA copies/ml); the rest of the specimens were considered to have undetectable viremia. A negative correlation was found between the number of HIV-2 RNA copies/ml and CD4 counts. In summary, EasyQ was shown to be reliable for the measurement of plasma HIV-2 subtype A RNA levels and may be a feasible tool for routine clinical monitoring of HIV-2 subtype A-infected patients.


Subject(s)
HIV Infections/virology , HIV-2/isolation & purification , RNA, Viral/blood , Reagent Kits, Diagnostic , Viral Load , HIV Infections/diagnosis , HIV-2/genetics , Humans , RNA, Viral/analysis , Reproducibility of Results , Sensitivity and Specificity
12.
Rev Esp Cardiol ; 58(3): 253-61, 2005 Mar.
Article in Spanish | MEDLINE | ID: mdl-15766447

ABSTRACT

INTRODUCTION AND OBJECTIVES: This study reports the findings in a group of 13 patients aged 53+/-8 years with anterior wall acute myocardial infarction who were revascularized with stents and treated with recombinant human granulocyte colony stimulating factor (G-CSF). PATIENTS AND METHOD: Patients were initially treated with intravenous thrombolytics. The first cardiac catheterization was performed between days 0 and 5 after acute myocardial infarction, when the left anterior descending artery was stented. A 10-day course of 10 .g/kg/day G-CSF was started 5 days after acute myocardial infarction. Blood cell counts and immunophenotyping were done to assess the total number of circulating CD34+ cells and their subpopulations in serial fashion. At 3-month follow-up, cardiac catheterization was repeated. Functional recovery was defined as an increase in ejection fraction. RESULTS: All patients did well initially, but 1 had spontaneous spleen rupture on day 8 of G-CSF administration, which required emergency splenectomy. The gain in ejection fraction varied among patients from -22 to +18 (mean, 6.2%+/-12%), and correlated directly with the total number of circulating CD34+ CD38- cells/microL on the fifth day of G-CSF treatment (r=0.78; P<.003). The gain in ejection fraction correlated inversely with peak MB fraction creatine kinase (r=-0.82; P<.002). CONCLUSION: Stem-cell mobilization with G-CSF is a feasible and safe treatment for patients with revascularized acute myocardial infarction. However, because of the possibility of acute splenitis induced by massive cell mobilization, future studies should be designed with due caution to take this eventuality into account.


Subject(s)
Granulocyte Colony-Stimulating Factor/therapeutic use , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Stem Cell Transplantation , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Prospective Studies , Recombinant Proteins , Recovery of Function
13.
Rev. esp. cardiol. (Ed. impr.) ; 58(3): 253-261, mar. 2005. tab, graf
Article in Es | IBECS | ID: ibc-037172

ABSTRACT

Introducción y objetivos. En este estudio se muestran los hallazgos observados en un grupo de 13 pacientes con infarto agudo de miocardio (IAM) que fueron revascularizados con stent intracoronario y posteriormente tratados con factor estimulante de colonias granulocíticas recombinado (G-CSF).Pacientes y método. Todos los pacientes recibieron tratamiento trombolítico. El primer cateterismo cardíaco tuvo lugar entre los días 0 y 5 del IAM, y se realizó una revascularización con stent de la arteria descendente anterior. Al quinto día del infarto se empezó tratamiento subcutáneo con G-CSF (10 µg/kg/día durante 10 días).Se efectuaron recuentos sanguíneos e inmunofeno tipificación y se determinó el número total de CD34+ circulantes y de sus subpoblaciones de una forma seriada. A los3 meses de seguimiento se realizó un nuevo cateterismo cardíaco. El grado de recuperación funcional se definió como la ganancia en la fracción de eyección. Resultados. Todos los pacientes evolucionaron favorablemente, sin complicaciones cardíacas. Un paciente presentó una rotura esplénica espontánea al octavo día del tratamiento con G-CSF que precisó una esplenectomía de urgencia. La ganancia en la fracción de eyección osciló entre -22 y +18 (media ± desviación estándar, 6,2± 12%), y se correlacionó de forma directa con el número total de células CD34+ y CD38- circulantes en el quinto día de tratamiento con G-CSF (r = 0,78; p < 0,003) y de forma inversa con el pico de la fracción MB de la creatincinasa (r = -0,82; p < 0,002). Conclusión. La movilización de células madre con GCSF es factible y segura en pacientes con IAM anterior revascularizado. No obstante, la posibilidad de que se produzca una esplenitis aguda inducida por la movilización célular masiva debe ser tratada con cautela en futuros diseños


Introduction and objectives. This study reports the findings in a group of 13 patients aged 53±8 years with anterior wall acute myocardial infarction who were revascularized with stents and treated with recombinant human granulocyte colony stimulating factor (G-CSF).Patients and method. Patients were initially treated with intravenous thrombolytics. The first cardiac catheterization was performed between days 0 and 5 after acute myocardial infarction, when the left anterior descending artery was stented. A 10-day course of 10 µg/kg/day G-CSF was started 5 days after acute myocardial infarction. Blood cell counts and immune phenotyping were done to assess the total number of circulating CD34+ cells and their subpopulations in serial fashion. At 3-month follow up, cardiac catheterization was repeated. Functional recovery was defined as an increase in ejection fraction. Results. All patients did well initially, but 1 had spontaneous spleen rupture on day 8 of G-CSF administration, which required emergency splenectomy. The gain in ejection fraction varied among patients from -22 to +18(mean, 6.2%±12%), and correlated directly with the total number of circulating CD34+ CD38- cells/µL on the fifth day of G-CSF treatment (r=0.78; P<.003). The gain in ejection fraction correlated inversely with peak MB fraction creatine kinase (r=-0.82; P<.002). Conclusion. Stem-cell mobilization with G-CSF is a feasible and safe treatment for patients with revascularized acute myocardial infarction. However, because of the possibility of acute splenitis induced by massive cell mobilization, future studies should be designed with due caution to take this eventuality into account


Subject(s)
Humans , Granulocyte Colony-Stimulating Factor/therapeutic use , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Stem Cell Transplantation , Combined Modality Therapy , Prospective Studies , Recovery of Function
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