Ensayo controlado y aleatorizado del uso de Heberkinasa® en el derrame pleural paraneumónico en niños / Randomized Controlled Trial of the Use of Heberkinase® in Parapneumonic Pleural Effusion in Children

Introducción: El derrame pleural paraneumónico resulta la complicación más frecuente de la neumonía bacteriana, de manejo complejo y muchas veces quirúrgico. No existen publicaciones en Cuba provenientes de ensayos clínicos controlados y aleatorizados ni del uso de la estreptoquinasa recombinante (Heberkinasa®) en el derrame pleural. Objetivo: Evaluar la eficacia y la seguridad de la Heberkinasa® en el tratamiento del derrame pleural paraneumónico complicado complejo y el empiema en niños. Métodos: Ensayo clínico fase III, abierto, aleatorizado (2:1), en grupos paralelos y controlado. Se concluyó la inclusión prevista de 48 niños (1-18 años de edad), que cumplieron los criterios de selección. Los progenitores otorgaron el consentimiento informado. Los pacientes se distribuyeron en dos grupos: I- experimental: terapia estándar y administración intrapleural diaria de 200 000 UI de Heberkinasa® durante 3-5 días y II-control: tratamiento estándar. Las variables principales: necesidad de cirugía y la estadía hospitalaria. Se evaluaron los eventos adversos. Resultados: Ningún paciente del grupo I-experimental requirió cirugía, a diferencia del grupo II-control en el que 37,5 por ciento necesitó cirugía video-toracoscópica, con diferencia altamente significativa. Se redujo la estadía hospitalaria (en cuatro días), las complicaciones intratorácicas y las infecciones asociadas a la asistencia sanitaria en el grupo que recibió Heberkinasa®. No se presentaron eventos adversos graves atribuibles al producto. Conclusiones: La Heberkinasa® en el derrame pleural paraneumónico complicado complejo y empiema resultó eficaz y segura para la evacuación del foco séptico, con reducción de la necesidad de tratamiento quirúrgico, de la estadía hospitalaria y de las complicaciones, sin eventos adversos relacionados con su administración(AU)

Introduction: Paraneumonic pleural effusion is the most frequent complication of bacterial pneumonia, with complex and often surgical management. There are no publications in Cuba from randomized controlled clinical trials or the use of recombinant streptokinase (Heberkinase®) in pleural effusion. Objective: To evaluate the efficacy and safety of Heberkinase® in the treatment of complex complicated parapneumonic pleural effusion and empyema in children. Methods: Phase III, open-label, randomized (2:1), parallel-group, controlled clinical trial. The planned inclusion of 48 children (1-18 years of age), who met the selection criteria, was completed. Parents gave informed consent. The patients were divided into two groups: I-experimental: standard therapy and daily intrapleural administration of 200,000 IU of Heberkinase® for 3-5 days; and II-control: standard treatment. The main variables: need for surgery and hospital stay. Adverse events were evaluated. Results: No patient in group I-experimental required surgery, unlike group II-control in which 37.5 percent required video-assisted thoracoscopic surgery, with a highly significant difference. Hospital stay (to 4 days), intrathoracic complications and infections associated to healthcare in the group that received Heberkinase® was reduced. No serious adverse events attributable to the product occurred. Conclusions: Heberkinase® in complex complicated parapneumonic pleural effusion and empyema was effective and safe for the draining of the septic focus, with reduction of the need for surgical treatment, hospital stay and complications, with no adverse events related to its administration(AU)

Factores pronósticos de fallo de trombólisis en pacientes con diagnóstico de infarto agudo de miocardio / Prognostic factors of thrombolytic failure in patients diagnosed with acute myocardial infarction

RESUMEN Introducción: La medida terapéutica más importante en pacientes con infarto agudo de miocardio con supradesnivel del segmento ST es la reperfusión del territorio isquémico; la fibrinólisis es la estrategia primaria en muchos hospitales. El diagnóstico temprano de aquellos pacientes con riesgo de fallo de trombólisis es vital. Objetivo: Identificar los factores pronósticos de fallo de trombólisis en pacientes con diagnóstico de infarto agudo de miocardio con supradesnivel del segmento ST. Métodos: Estudio descriptivo y prospectivo que incluyó a pacientes atendidos en la Emergencia del Hospital Clínico-Quirúrgico «Joaquín Albarrán¼, con diagnóstico de la enfermedad antes mencionada, y tratados con estreptoquinasa recombinante, entre noviembre de 2018 hasta mayo de 2020. Fueron incluidos 66 pacientes en la investigación. Las variables analizadas fueron: Edad, sexo, hipertensión arterial, diabetes mellitus, tiempo entre inicio de síntomas y comienzo de fibrinólisis, localización del infarto, duración del complejo QRS, duración y profundidad de onda. Resultados: Hubo fallo de trombólisis en 27 pacientes (40,9 %). Las variables: Tiempo de realización de trombólisis, duración y profundidad de la onda Q, así como la duración del QRS mostraron valores con diferencias significativas entre ambos grupos (p<0,05). El análisis multivariado confirmó la duración y profundidad de la onda Q como factores independientes, predictores de fallo de trombólisis: (OR= 14,50; IC 95 % 1,58-132,33); (OR: 1,69; IC 95 % 1,27-2,26), respectivamente. Conclusiones: El análisis de la profundidad y duración de la onda Q en el electrocardiograma inicial de los pacientes estudiados, permite predecir a una subpoblación de pacientes con riesgo de fallo de trombólisis.

ABSTRACT Introduction: the most important therapeutic measure in patients with ST-segment elevation acute myocardial infarction is reperfusion of the ischemic territory; fibrinolysis is the primary strategy in many hospitals. Early diagnosis of those patients with risk of failed thrombolysis is vital. Objective: to identify prognostic factors of thrombolytic failure in patients diagnosed with ST- segment elevation acute myocardial infarction. Methods: a descriptive and prospective study including patients treated in the Emergency department at "Joaquín Albarrán" Clinical and Surgical Hospital, who were diagnosed with the previously mentioned disease and treated with recombinant streptokinase, between November 2018 and May 2020. A number of 66 patients were included in the investigation. Age, gender, arterial hypertension, diabetes mellitus, time between onset of symptoms and onset of fibrinolysis, location of the infarction, QRS complex duration, duration and depth of the wave were the analyzed variables. Results: thrombolysis failed in 27 patients (40.9%). Time of performing thrombolysis, duration and depth of the Q wave, as well as the QRS duration showed values with significant differences between both groups (p<0.05). The multivariate analysis confirmed the duration and depth of the Q wave as independent factors, predictors of thrombolysis failure: (OR= 14.50; 95% CI 1.58-132.33); (OR: 1.69; 95% CI 1.27-2.26), respectively. Conclusions: the analysis of the depth and duration of the Q wave in the initial electrocardiogram of the studied patients allows us to predict a subpopulation of patients with risk of failed thrombolysis.

Perfil clínico y angiográfico de las mujeres con infarto agudo al miocardio en un hospital nacional / Clinical and angiographic profile of women with acute myocardial infarction in a national hospital

Resumen Justificación: La cardiopatía isquémica es la principal causa de muerte de mujeres en Costa Rica, y su incidencia ha aumentado con los años. A pesar de esto, hay pocos estudios clínicos a este respecto en nuestro país. El objetivo del presente trabajo es presentar las principales características clínicas y angiográficas de un grupo de pacientes con infarto agudo del miocardio con la idea de establecer no solo sus particularidades sino permitir comparaciones con otras poblaciones. Métodos: Se trató de un estudio observacional, descriptivo y retrospectivo, de un periodo de cinco años, en el cual se incluyeron a las pacientes ingresadas con infarto del miocardio a la Unidad de Cuidados Intensivos. Se registraron datos demográficos, de evolución clínica, complicaciones, hallazgos angiográficos, tratamiento y desenlace. El análisis estadístico fue cuantitativo descriptivo, realizado con el programa informático SPSS v.21 (IBM Corp., EEUU) y éste consistió en cálculos de frecuencia, tendencia central, medidas de variabilidad de rango, percentiles, y chi-cuadrado. El protocolo de la investigación fue aprobado por el Comité Ético Científico del Hospital Rafael Ángel Calderón Guardia (DG-3380-2020). Resultados: De 190 pacientes se incluyeron un total de 54. La edad promedio fue de 60 años, con una mortalidad del 17,9%, la cual fue 5,4 % más alta que en los hombres. La mayor parte de las pacientes padecía de hipertensión arterial (74%), 24 (44,5%) eran taba- quistas y 23 (42,5%) tenían diabetes mellitus. Los síntomas más frecuentes fueron: dolor torácico, criodiaforesis y disnea. Se consideró que hubo dolor torácico atípico en 8 casos (15%). A 48 pacientes se le llevó a angioplastia coronaria y solo 35% la recibieron en tiempo oportuno. A 17 pacientes se les aplicó trombólisis farmacológica y solo en 3 pacientes fue exitosa. La arteria coronaria derecha y la arteria descendente anterior fueron los vasos responsables en la mayoría de los casos (19 casos (39,5%) cada uno de ellas.) Conclusión: Esta población tuvo síntomas isquémicos claros, con enfermedad coronaria severa y una mortalidad mayor que los hombres. En general la terapia farmacológica, así como la mecánica se aplicaron en forma tardía.

Abstrac Justification: The ischemic heart disease is the main cause of death of women in Costa Rica, and its incidence has increased with the years. In spite of this, there are few clinical studies in this respect in our country. The aim of this paper is to present the main clinical and angiographic characteristics of a group of patients with acute myocardial infarction in order to establish not only their particularities but also to allow comparisons with other populations. Methods: An observational, descriptive and retrospective study was carried out over a period of five years, in which patients admitted with myocardial infarction to the Intensive Care Unit were included. Demographic data, clinical evolution, complications, angiographic findings, treatment, and outcome were recorded. Statistical analysis was quantitative and descriptive, performed with SPSS v.21 software (IBM Corp., USA) and consisted of calculations of frequency, central tendency, measures of variability, percentiles, and chi-square. The Ethical Committee of the Hospital Rafael Angel Calderon Guardia approved the research protocol (DG-3380-2020). Results: A total of 54 out of 190 patients were included. The average age was 60 years, with a mortality rate of 17.9%, which was 5.4% higher than in men. Most of the patients suffered from arterial hypertension (74%), 24 (44.5%) were smokers and 23 (42.5%) had diabetes mellitus. The most frequent symptoms were chest pain, cryodiaphoresis and dyspnea. It was considered that there was atypical chest pain in 8 cases (15%). Forty-eight patients were taken for coronary angioplasty and only 35% received it in time. Pharmacological thrombolysis was applied to 17 patients, and it was successful in only 3 patients. The right coronary artery and the anterior descending artery were the vessels responsible in most cases (19 cases (39.5%) each). Conclusión: This population had clear ischemic symptoms, with severe coronary disease and higher mortality than men. In general, pharmacological as well as mechanical therapy was applied late.

Insuficiencia renal aguda transitoria después de trombólisis coronaria con estreptoquinasa / Transient acute renal failure after coronary thrombolysis with streptokinase

Introducción: En la actualidad existen más de 150 medicamentos relacionados con la aparición de rabdomiólisis e insuficiencia renal aguda transitoria. La estreptoquinasa puede ser uno de ellos. Objetivo: Presentar un caso en el cual la administración de trombólisis con estreptoquinasa pudiera estar relacionado con una insuficiencia renal aguda transitoria. Caso clínico: Paciente de 38 años, con antecedentes de salud anterior y creatinina de 81 mg/L días antes del ingreso, sufrió infarto miocárdico agudo y después de la trombólisis con estreptoquinasa presentó dolores musculares intensos, náuseas, vómitos y lumbalgia intensa. La creatinina ascendió progresivamente; tuvo oligoanuria progresiva que evolucionó hasta las dos semanas y luego se recuperó. A los 21 días, la creatinina estaba en 116 mg/L. En la coronariografía, las coronarias son normales. Comentarios: Las causas de insuficiencia renal aguda transitoria pudieran ser, rabdomiólisis asociada con alteraciones del metabolismo del ATP y trastornos inmunológicos provocados por la administración de estreptoquinasa. La coronariografía resultó normal(AU)

Introduction: There are currently more than 150 medications related to the appearance of rhabdomyolysis and transient acute renal failure. Streptokinase can be one of them. Objective: Presenting a case the administration of streptokinase as a possible cause of acute, transient renal failure. Case report: A 38-year-old patient with a previous health history and 81 mg creatinine per liter days before admission, suffers acute myocardial infarction and after streptokinase thrombolysis he suffers severe muscle pain, nausea, vomiting, severe low back pain, creatinine ascends progressively and progressive oligoanuria that evolves until two weeks when it begins to return. At 21 days with 116 mg creatinine per liter, coronary angiography was performed with normal coronaries. Comments: The causes of transient acute renal failure may be rhabdomyolysis associated with abnormalities of the metabolism of ATP and immune disorders, caused by the administration of streptokinase. His coronary angiography was completely normal(AU)

Administración intrapleural de estreptoquinasa recombinante en tres niños graves con derrame pleural paraneumónico complicado / Intrapleural administration of recombinant streptokinase in three seriously ill children with complicated parapneumonic pleural effusion

Introducción: El derrame pleural paraneumónico es la enfermedad pleural más frecuente de la infancia, el 40-60 por ciento de los casos se presenta como complicación de neumonía adquirida en la comunidad. Ante la aparición de líquido pleural viscoso, con fibrina o tabiques, la fibrinólisis intrapleural aporta beneficios en la resolución de esta grave afección. Objetivo: Describir la evolución clínica e imagenológica de tres niños graves con derrame pleural paraneumónico complicado complejo y empiema. Presentación de casos: Pacientes ingresados en la Unidad de Terapia Intensiva del Hospital Pediátrico Provincial "Dr. Eduardo Agramonte Piña" con el diagnóstico de neumonía adquirida en la comunidad complicada con derrame pleural paraneumónico complicado complejo, tratados con estreptoquinasa recombinante por vía intrapleural; la primera paciente presentó crecimiento de Pseudomona en el cultivo de líquido pleural, patógeno no habitual en las infecciones respiratorias agudas procedentes de la comunidad. El segundo caso, se recibió complicada con shock séptico y el tercer paciente con ecografía torácica que mostró derrame pleural multitabicado, con grandes bolsones y gruesos tabiques. Los tres casos evolucionaron satisfactoriamente, sin necesidad de tratamiento quirúrgico, ni aparición de reacciones adversas atribuibles al fibrinolítico. Conclusiones: La administración intrapleural de la estreptoquinasa recombinante en niños graves con derrame pleural paraneumónico complicado complejo y empiema, resulta un método eficaz y seguro en la evacuación del foco séptico pleural, lo que favorece el control de la infección, sin aparición de complicaciones. Los casos presentados tuvieron evolución satisfactoria y en ninguno se produjo evento adverso relacionado con la administración de la estreptoquinasa recombinante intrapleural(AU)

Introduction: Parapneumonic pleural effusion is the most common pleural disease in childhood; 40-60 percent of cases occur as a complication of community-acquired pneumonia. Given the onset of viscous pleural fluid, with fibrin or septums, intra-pleural fibrinolysis provides benefits to solve this serious condition. Objective: Describe the clinical and imaging evolution of three seriously ill children with complex complicated parapneumonic pleural effusion and empyema. Case presentation: Patients admitted to the Intensive Therapy Unit of "Dr. Eduardo Agramonte Piña" Provincial Pediatric Hospital with the diagnosis of pneumonia acquired in the community worsen with complex complicated parapneumonic pleural effusion, and treated in the intrapleural way with recombinant streptokinase. The first patient showed growth of Pseudomona in the culture of pleural fluid, a pathogen which is not common in acute respiratory infections from the community. The second case was complicated with septic shock; and the third patient had a chest ultrasound that showed multi-sited pleural effusion, with large bags and thick septums. All three cases evolved satisfactorily, without needing surgical treatment, or having adverse reactions attributable to fibrinolytic ones. Conclusions: Intrapleural administration of recombinant streptokinase in seriously ill children with complex complicated parapneumonic pleural effusion and empyema is an effective and safe method in the evacuation of pleural septic focus, which favors infection control, without complications. The cases presented had satisfactory evolution and none of them occurred adversely related to the administration of intrapleural recombinant streptokinase(AU)

Eficacia y seguridad de la estreptoquinasa recombinante en niños con derrame pleural paraneumónico / Effectiveness and security of recombinant streptokinase in children with parapneumonic pleural efussion

Introducción: El derrame pleural paraneumónico como complicación de neumonías adquiridas en la comunidad en la población pediátrica constituye un problema de salud mundial y en Cuba. El empleo de fibrinolíticos intrapleurales es una acertada opción terapéutica. Objetivo: Evaluar la eficacia y seguridad de la utilización de la estreptoquinasa recombinante en el tratamiento del derrame pleural paraneumónico complicado complejo en niños. Métodos: Ensayo clínico confirmatorio fase III, monocentro, abierto, aleatorizado y controlado (RPCEC00000292), realizado entre septiembre 2018 - octubre 2019. Se incluyeron niños (1 - 18 años de edad), que cumplieron los criterios de selección, incluida la voluntariedad. Todos recibieron el tratamiento convencional establecido y se distribuyeron en dos grupos: I-experimental (estreptoquinasa recombinante, dosis diaria intrapleural de 200 000 UI, 3-5 días); II-control (terapia convencional). Las variables principales fueron: necesidad de cirugía y la estadía hospitalaria. Se evaluaron también los eventos adversos. Resultados: Se evaluaron 55 niños con la enfermedad referida, de ellos, 34 (61,8 por ciento) se incluyeron en el estudio. Ningún paciente del grupo experimental requirió cirugía, a diferencia del grupo control que lo requirió en 25 por ciento. Se redujo significativamente la estadía hospitalaria en el grupo que recibió estreptoquinasa recombinante. No se presentaron eventos adversos graves atribuibles al tratamiento experimental. Conclusiones: La estreptoquinasa recombinante administrada en el derrame pleural paraneumónico complicado complejo resultó un método eficaz y seguro para la evacuación del foco séptico, con un impacto positivo expresado en la reducción de complicaciones, la necesidad de tratamiento quirúrgico y la estadía hospitalaria, sin la ocurrencia de eventos adversos relacionados con su uso(AU)

in the community by the pediatric population represents a health problem in the world and in Cuba. The use of intrapleural fibrinolytics is a good therapeutic option. Objective: To evaluate the effectiveness and security of the use of recombinant streptokinase in the treatment of complex parapneumonic pleural efussion in children. Methods: Phase III confirmatory clinical trial, monocentric, open, randomized and controlled (RPCEC00000292) - named as DENIS study- carried out from September 2018 to October, 2019. There were included children (from 1 to 18 years old) that met the selection criteria including voluntariness. All of them received the established conventional treatment and were distributed in two groups: I- experimental (recombinant streptokinase, intrapleural daily dose of 200 000 UI, 3 - 5 days); II- control (conventional therapy). The main variables were need of surgery and hospital stay. There were also assessed the adverse events. Results: 55 children with the above mentioned disease were assessed; 34 of them (61.8 percent) were included in the study. Any of the patients of the experimental group required surgery, opposite to the control group that required it in a 25 percent. The hospital stay was significantly reduced in the group that had treatment with recombinant streptokinase. There were not any severe adverse events related to the experimental treatment. Conclusions: When recombinant streptokinase was administered in the complex parapneumonic pleural efussion resulted in an efficient and safe method for the elimination of the septic focus, with a positive impact expressed in the reduction of complications, the need of surgical treatment and the hospital stay without presenting related adverse events while using it(AU)

Efficacy and safety of thrombolytic therapy in prosthetic valve thrombosis

Background: There is limited data available about the effectiveness of thrombolysis in prosthetic valve thrombosis (PVT). Therefore, this study aimed to evaluate the efficacy and safety of thrombolytic treatment in PVT patients.Methods: This was an observational study conducted at a tertiary-care centre in India between March 2013 and April 2014. Total of 56 patients with either recurrent PVT or with confirmed left-sided PVT was included in the study. Thrombolytic therapy was administered as an intravenous infusion of streptokinase or urokinase, initially at a loading dose of 2.5L IU/hour over 30 minutes, followed by 1L IU/hour for 48–78 hours depending upon the clinical and 2D-Echo observation. Primary endpoint was considered as the occurrence of a complete clinical response. Secondary endpoint was considered as a composite of death, major bleeding or embolic stroke.Results: Mean age of the patients was 37±13 years. Most of the patients presented with NYHA-II (51.7%), III (39.2%), and IV (8.9%) symptoms. Mitral and aortic valve thrombosis were observed in 40(71.4%) and 11(28.6%) patients. Forty-nine (73.3%) patients were treated with streptokinase. Whereas, rethrombosis patients were treated with urokinase [6(16%)] and tenecteplase [1(1.3%)]. Two (3.6%) patients died, 1(1.8%), 1(1.8%), 2(3.6%), and 1(1.8%) patient had peripheral embolism, central nervous system bleeding, stroke, and embolic complications.Conclusions: Thrombolytic therapy can be used as the first-line treatment for thrombolysis in PVT patients. All PVT patients can be treated with streptokinase unless specific contraindications exist. Urokinase or tenecteplase is an alternative thrombolytic agent in rethrombosis patients.

Complications and residual pleural thickening after intrapleural instillation of streptokinase with pigtail catheter drainage of tuberculous pleural effusion

Background: Tuberculosis is the most common cause of exudative lymphocytic pleural effusion in India. Residual pleural thickening (RPT) is observed in about 50 percent of patients even after proper treatment with ATT. Pleural fluid drainage either with simple aspiration or with intercostal drainage and addition of corticosteroids along with antitubercular drugs have not shown to influence the incidence of RPT. The present study was undertaken to study the complications and residual effects of tubercular pleural effusion on the patients during the follow up period following intrapleural streptokinase instillation.Methods: Clinical profile, hospital course and outcome of tuberculous pleural effusion patients at the end of six months of anti-tubercular treatment of 50 patients from January 2009 to June 2010 were analyzed. These patients were randomly divided into two groups. One group (n=25) received intrapleural streptokinase via pigtail catheter and the other group (n=25) received intercostal drainage without intrapleural streptokinase instillation. All the patients received standard daily anti TB regimen of 2HERZ/4HR for a total duration of six months. All the patients were followed up for a total duration of 1 year for evidence of any residual pleural thickening.Results: Majority of the patients were above 40 years of age (60%). The male to female ratio was 2.3:1. The major symptoms of the patients were, fever in 44 patients (88%), cough in 42 patients (84%), breathlessness in 33 patients (66%), loss of appetite in 25 patients (50%) and chest pain in 25 patients (50%). Most of the patients had ADA levels between 40-70IU/L (48%) and only 6% had ADA levels below 40IU/L. The incidence of residual pleural thickening in the study group was less as compared to the control group (2.36�49mm vs 9.28�50mm) (p <0.0001).Conclusion: Intrapleural streptokinase instillation with pigtail catheter drainage less number of complications associated with study group and is successful with the decreased incidence of residual pleural thickening during the follow up period.

Efficacy of intrapleural instillation of streptokinase with pigtail catheter drainage in the treatment of tuberculous pleural effusion

Background: Tuberculosis is the most common cause of exudative lymphocytic pleural effusion in India. The present study was undertaken to evaluate the efficacy of intrapleural instillation of streptokinase with pigtail catheter drainage in the treatment of tuberculous pleural effusion.Methods: Clinical profile, hospital course and outcome of tuberculous pleural effusion patients at the end of six months of anti-tubercular treatment of 50 patients from January 2009 to June 2010 were analyzed. These patients were randomly divided into two groups. One group (n=25) received intrapleural streptokinase via pigtail catheter and the other group (n=25) received intercostal drainage without intrapleural streptokinase instillation. All the patients received standard daily anti TB regimen of 2HERZ/4HR for a total duration of six months.Results: Majority of the patients were above 40 years of age (60%). The male to female ratio was 2.3:1. The major symptoms of the patients were, fever in 44 patients (88%), cough in 42 patients (84%), breathlessness in 33 patients (66%), loss of appetite in 25 patients (50%) and chest pain in 25 patients (50%). Most of the patients had ADA levels between 40-70 IU/L (48%) and only 6% had ADA levels below 40 IU/L. The mean pleural drainage was 2615±126.1 ml in the study group (intrapleural streptokinase) and 1858 ± 93.3 ml in the control group (p <0.0001). Mean duration of intercostal drainage in the study group was 3.76 ± 0.144 days and it was 5.08±0.199 days in the control group (p <0.0001). The mean duration of hospitalization in the study group was 6.60±0.91 days and it was 8.60 ± 0.57 days in the control group (p=0.06).Conclusion: Intrapleural streptokinase instillation is successful in increasing the total drainage of pleural fluid and results in effective drainage of tuberculous pleural effusion. It is also associated with increased amount of pleural fluid drainage, decreased duration of intercostal drainage, decreased length of hospital stay.

Study of prosthetic heart valve thrombosis and outcomes after thrombolysis

Background: The study aimed to evaluate the clinical presentation, diagnostic features, treatment strategies, and complications of prosthetic heart valve thrombosis (PHVT) and to determine efficacy, outcomes and complications of thrombolytic therapy during hospital stay.Methods: This was a prospective, observational, single-centre study carried out between March, 2016 and December, 2017 at a tertiary care centre in India. Total 110 patients with history of prosthetic heart valve replacement and symptoms related to PHVT were included in the study. Patients underwent thrombolysis, surgery or conservative management for treatment of PHVT, as per their individual clinical presentation. Clinical profile and treatment outcomes were assessed using a pre-tested, semi-structured questionnaire and clinical assessment.Results: Mean age of the patients was 39.4±12.5 years. Most of the patients presented with NYHA class II and III (85.4%) symptoms. Total 20.9% of patients were poorly compliant with anticoagulants. Thrombolysis was initial treatment in 105 (95.5%) patients. Five (4.6%) patients were treated with heparin. Two patients underwent surgery after failed thrombolysis. Mortality in the thrombolysis group was 6.6%. Embolism occurred in 8.6% of the group and major bleeding in 1.9%. One patient who underwent surgery died.Conclusions: In light of these results, it can be concluded that most cases of PHVT are due to inadequate anticoagulation and poor monitoring mainly in patients belonging to the lower socioeconomic group. Thrombolysis can be considered as first line therapy where the immediate surgical options are remote.

Enhanced Production Of Streptokinase By Chemical Mutagenesis Of Streptococcus agalactiae EBL-20

Abstract Streptokinase (SK) is an enzyme that is used for the treatment of cardiovascular diseases. The current study focused on the enhanced production of SK by inducing mutation in Streptococcus agalactiae EBL-20 and optimization of medium components and culture conditions for the maximum growth of mutant derived strain. S. agalactiae EBL-32 was selected as a potent mutant after exposure of S. agalactiae EBL-20 to EMS for 180 minutes. SK activity obtained from mutant derived strain was found to be 1.6 fold higher as compared to the activity achieved by wild strain. Nutritional requirements of the mutated strain were optimized by single factor analysis method suggesting glucose as the optimum carbon source; yeast extract and peptone as a suitable nitrogen sources and corn steep liquor (CSL) as an appropriate substrate for the maximum SK production. The culture conditions determined by response surface methodology (RSM) suggested that a temperature value of 37.5⁰C and pH 7 of the fermentation medium with 2.50 mL inoculum size for 36 hours of incubation was optimum for maximum yield of SK. Hence the optimization studies resulted into 1.92 fold increase in the yield of SK suggesting the new isolate suitable for commercial scale production of SK.

Uso de estreptoquinasa recombinante intrapleural en una mujer embarazada con empiema pleural / Use of intrapleural recombinant streptokinase in a pregnant woman with pleural empyema

RESUMEN Fundamento: la neumonía complica el 0,78-2,7 por 1 000 embarazos al estar en riesgo la madre y el feto. El empiema como complicación de una neumonía en una paciente embarazada agrega un alto índice de morbimortalidad para la madre y el feto si no se actúa de forma rápida. Objetivo: describir el caso de una mujer de 33 semanas de embarazo, la cual desarrolló un empiema pleural producto de una complicación de una neumonía adquirida en la comunidad tratada con fibrinólisis intrapleural. Caso clínico: paciente gestada de 33 semanas, asmática ingresada en el servicio de terapia intensiva del Hospital Universitario Manuel Ascunce Domenech con el diagnóstico de neumonía grave adquirida en la comunidad complicada con derrame paraneumónico el cual evolucionó hacia el empiema. El mismo fue tratado con tubo de toracostomía y terapia fibrinolítica, con buena evolución clínica y radiológica. Conclusiones: la estreptoquinasa recombinante se puede utilizar de manera segura y efectiva para el manejo del empiema pleural, como agente fibrinolítico intrapleural, durante el embarazo.

ABSTRACT Background: pneumonia complicates 0,78-2,7 per 1 000 pregnancies placing the mother and the fetus at risk. Empyema as a complication of pneumonia in a pregnant patient adds a high rate of morbidity and mortality to the mother and the fetus if one does not act quickly. Objective: to present the case of a pregnant woman of 33 weeks who developed a pleural empyema resulting from acquired pneumonia. Clinical case: 33-week gestated patient, asthmatic admitted to the intensive care unit of the University Hospital Manuel Ascunce Domenech with the diagnosis of severe pneumonia acquired in the community complicated with para-pneumonic effusion, which evolved into empyema. It was treated with a thoracotomy tube and fibrinolytic therapy, with good clinical and radiological evolution. Conclusions: Recombinant streptokinase can be used safely and effectively for the management of PE, as an intrapleural fibrinolytic agent, during pregnancy.

ST elevated myocardial infarction: clinical manifestation and outcomes of thrombolysis in a tertiary care hospital

Background: Acute myocardial infarction has reached enormous proportion in the developing countries and it is speculated that atherosclerotic heart disease will replace infectious disease as the leading cause of death in India. It has been shown that the thrombolytic therapy is underutilized. So, the study was taken to study the clinical manifestations and outcome of thrombolytic therapy in STEMI.Methods: The study was conducted for a period of 18 months in a tertiary care centre during which 100 cases of STEMI admitted to ICCU were included in the study, after fulfilling the inclusion criteria for thrombolysis, data related to clinical profile and outcome of thrombolysis was collected. SPSS 16 was used to analyse the data. Descriptive statistics like proportions mean and SD were computed.Results: Incidence of STEMI was high among subjects in the age group 51-60 years. Males were more affected (72%). Smoking, hypertension, hyperlipidemia and diabetes mellitus were the most common risk factors. Chest pain (92%) was the most common symptom. Majority (56%) were admitted within 6 hours of onset of symptoms. Anterior wall infarction was most common type of myocardial infarction. Majority (82%) were admitted in either Killips I/II class. Left Ventricular failure and Arrhythmias were most common complication. 64% patients had objective evidence in a form of ECG with ST-T resolution (>50%) between 1-6 hours, 18% between 6-24 hours and 18% patients had no significant resolution even after 24 hours. Echocardiography showed good left ventricle function (LVEF >45%) in 70% and 30% of the patients showed reduced ejection fraction (LVEF<45%). Mortality was seen in 8% of cases.Conclusions: Smoking, hyperlipidemia, diabetes mellitus and hypertension were most important risk factors for MI in the study. Coronary pain relief was most frequent and early marker of reperfusion. The ST segment elevation resolution has been widely accepted as most reliable objective criteria of coronary reperfusion. Hence ST segment resolution is regarded as a marker of salvaged myocardium by post-thrombolytic reperfusion. Early reperfusion of the ischaemic myocardial tissue with thrombolytic therapy decreases the morbidity and mortality.

Tenecteplase versus streptokinase thrombolytic therapy in patients with mitral prosthetic valve thrombosis

Objective Prosthetic valve thrombosis (PVT) is a dreadful complication of mechanical prosthetic valves. Thrombolytic therapy (TT) for PVT is an alternative to surgery and currently making a leading role. This study compares TT with tenecteplase (TNK) and streptokinase (SK) head to head in patients with mitral PVT. Methods In this single center, observational study, patients with mitral PVT diagnosed by clinical data, transthoracic echocardiography, transesophageal echocardiography, and fluoroscopy were included. After excluding patients with contraindications for thrombolysis, they were randomly assigned to receive either SK or TNK regimen. Patients were monitored for success or failure of TT and for any complications. Results Among 52 episodes (47 patients with 5 recurrences) of mechanical mitral PVT, 40 patients were thrombolyzed with SK and 12 patients were thrombolyzed with TNK. Baseline characteristics including demographic profile, clinical and echocardiographic features, and valve types were not statistically significant between the groups. Complete success rate was 77.5% in SK group and 75% in TNK group (p = 0.88). Partial success rate, failure rate, and major complications were not statistically significant between the two groups. Within 12 h of therapy, TNK showed complete success in 33.3% of patients compared to 15% in SK group (p-value <0.02). Minor bleeding was more common in TNK group. Conclusion Slow infusion of TNK is equally efficacious but more effective than SK in the management of mitral mechanical PVT. 75% to 77.5% of PVT patients completely recovered from TT and it should be the first line therapy where the immediate surgical options were remote.

Tromboembolia venosa en el embarazo: Reporte de un caso / Venous thromboembolism in pregnancy: A case report / Tromboembolia venosa na gravidez: Relato de caso

La tromboembolia venosa es una enfermedad relativamente frecuente con importante morbimortalidad. En pacientes embarazadas presentan un riesgo incrementado en 5 veces respecto de las no embarazadas, siendo la segunda causa de muerte en dicha población. La prevención, el diagnóstico y el manejo terapéutico se ven complicados por la escasez de abordajes y evidencia validados. Presentamos el caso de una gestante de 9,2 semanas de embarazo con diagnóstico de tromboembolia venosa que evoluciona con compromiso hemodinámico y necesidad de uso de trombolíticos.

Venous thromboembolism is a relatively frequent condition with a high morbidity and mortality rate. The risk in pregnant patients is five times greater than in not pregnant ones. It's the second cause of death amongst them. Prevention, diagnosis and therapeutic management are complicated by scarcity of approaches and validated evidence. We report the case of a pregnant 9.2 weeks of pregnancy diagnosed with venous thromboembolism evolving with hemodynamic compromise and the need for use of thrombolytics.

A tromboembolia venosa é uma doença relativamente comum com significativa morbidade e mortalidade. Em pacientes grávidas, o risco é 5 vezes maior em comparação com não-grávidas, sendo a segunda causa de morte nesta população. Prevenção, diagnóstico e manejo terapêutico são complicados pela carência de abordagens e provas validadas. Relatamos o caso de uma paciente grávida de 9,2 semanas de gravidez com diagnóstico de tromboembolia venosa evoluindo com comprometimento hemodinâmico e a necessidade de uso de trombolíticos.

Estreptoquinasa a casi 30 años de demostrada su eficacia en el infarto agudo de miocardio / Streptokinase almost 30 years after its demonstrated efficacy in acute myocardial infarction

Fundamento: a partir del estudio del Grupo Italiano per lo Studio del la Strepto-chinasi nell’Infarto Miocardico en el año 1986, el enfoque del tratamiento del infarto agudo de miocardio cambió. No obstante, actualmente existe controversia acerca de la opción de tratamiento. Objetivo: comparar las ventajas y desventajas de los diferentes trombolíticos en el tratamiento del infarto agudo de miocardio, así como el uso de estos versus tratamiento de intervención coronaria percutánea. Métodos: se realizó una revisión bibliográfica de un total de 310 artículos publicados en Pubmed, Hinari y Medline mediante el localizador de información Endnote. De ellos se utilizaron 34 citas seleccionadas para realizar la revisión, 17 de ellas de los últimos cinco años. Desarrollo: existen dos estrategias de reperfusión en el tratamiento del infarto agudo de miocardio: la farmacológica y la intervencionista. Entre los fibrinolíticos (fármacos) se encuentran los que tienen acción lítica generalizada como la estreptoquinasa y la uroquinasa y otro grupo con lisis localizada como la anistreplasa, alteplasa, tenecteplasa y reteplasa. Los del primer grupo con respecto a los del segundo tienen como desventaja el riesgo de sangramiento y la acción antigénica de la estreptoquinasa que no tienen el resto de los fibrinolíticos. En las primeras dos horas no existe diferencia significativa en la reducción de la mortalidad con una u otra estrategia; después de este tiempo mejora con el intervencionismo. Conclusiones: la intervención coronaria percutánea es la forma óptima de reperfusión en los pacientes con infarto agudo de miocardio, pero a la vez no es una práctica habitual aun en los países desarrollados. La reperfusión con trombolíticos sigue siendo la primera alternativa de los hospitales de segundo nivel y la estreptoquinasa es una opción segura en el tratamiento.

Background: from the study of the Italian Group per lo Studio del la Strepto-chinasi nell’Infarto Miocardico, in 1986 the approach of the treatment of acute myocardial infarction changed; however, there is currently controversy about the choice of treatment. Objective: to compare the advantages and disadvantages of the different thrombolytic in the treatment of acute myocardial infarction and their use versus percutaneous coronary intervention. Methods: a review of 310 articles published in PubMed, Hinari and Medline was made using the reference management software Endnote. Thirty-four citations were selected to make the review, 17 of them from the last five years. Development: there are two reperfusion strategies in the treatment of acute myocardial infarction: the pharmacologic and the interventional. Among the fibrinolytic (drugs) are those with lytic action, as streptokinase and urokinase, and other group with localized lysis as anistreplase, alteplase, tenecteplase and reteplase. The first ones, with respect to the second group, have the disadvantage of the risk of bleeding and the antigenic activity of streptokinase, not presented by the rest of fibrinolytic drugs. In the first two hours there is no significant difference regarding the mortality reduction with both strategies; after this time, it improves with the intervention. Conclusions: percutaneous coronary intervention is the ideal form of reperfusion in patients with acute myocardial infarction but, at the same time, it is not yet a common practice in developed countries. Reperfusion with thrombolytic remains the first alternative in second-level hospitals and streptokinase is a safe treatment option. Thus, it is demonstrated that the GISSI study is updated.

Enzyme Therapy: Current Perspectives.

Enzymes control all metabolic processes in human system from simple digestion of food to highly complex immune response. Physiological reactions occuring in healthy individuals are disturbed when enzymes are deficient or absent. Enzymes are administered for normalizing biological function in certain pathologies. Initially, crude proteolytic enzymes were used for the treatment of gastrointestinal disorders. Recent advances have enabled enzyme therapy as a promising tool in the treatment of cardiovascular, oncological and hereditary diseases. Now, a spectrum of other diseases are also covered under enzyme therapy. But, the available information on the use of enzymes as therapeutic agents for different diseases is scanty. This review details the enzymes which have been used to treat various diseases/disorders.

Failure of Thrombolysis with Streptokinase In Acute Myocardial Infarction Using ECG Criteria: An Observational Study.

Abstract To Study failure of thrombolysis with streptokinase in acute myocardial infarction using E.C.G criteria a prospective study of patients presenting with acute myocardial infarction in G.M.C Jammu for a period of one year. A total of 220 patients who presented with acute myocardial infarction were included in the study . Out of 220 patients 193(87.7%) males and 27 (12.3%) females participated in the study. All the patients underwent thrombolysis with streptokinase. Out of 220 patients who were being thrombolysed with streptokinase, most of them (97; 41.1%) were in the age group of 56-65 years. Out of all the patients who underwent thrombolysis (n=220), thrombolytic failure was observed in 121 (55%) patients. Failure rate was significantly higher in the age group of 56-65 years (88; 72.7%). Significantly higher prevalence of thrombolytic failure with streptokinase was observed among diabetic patients (65.2% ) as compared to non diabetics (52.3%).

Efficacy and safety concerns with thrombolysis in acute myocardial infarction in Insein General Hospital (ESCORT-IGH).

Background - Although patients with ST elevation myocardial infarction should be ideally treated with primary coronary intervention (PCI), due to limited availability of PCI capable hospitals, thrombolysis remains the mainstay treatment in Myanmar. It is imperative that evidence is necessary to prove the efficacy and safety of thrombolysis in district hospital setting in Myanmar. Methods - Patients with acute myocardial infarction were studied during a period of 21 months in the medical ward of Insein General Hospital (IGH), a (300 bedded) hospital which has no facilities for PCI. Streptokinase was used for thrombolysis. Study was set up to achieve “call to needle time of 25 minutes”. Primary endpoint was ST resolution at 90 minutes post-thrombolysis and secondary endpoint was 7 days survival post-thrombolysis. Adverse reactions including haemorrhage were recorded. Results - One hundred and eighteen patients (78%) out of one hundred and fifty one study cases were eligible for thrombolysis. Among the thrombolysis patients, male to female ratio was 1.63 and mean age was 60 years (22 - 86 yr). Median time of thrombolysis since onset of pain was 4.7 hours. Primary end point of ST resolution at 90 min was achieved in 58% (69/118) in thrombolysis group and 0% (0/33) in non-thrombolysis group. Secondary end point of 7 day survival was achieved in 89% (105/118) in thrombolysis group and 6% (2/33) in non-thrombolysis group. Thrombolysis favours ST resolution (p < 0.0001) and 7 day survival (p < 0.0001) better than non-thrombolysis. Statistically non-significant minor bleeding (gum bleeding and epistaxis) was observed in 3% (4/118) (p = 0.52) in the treatment group but there was no fatal bleeding and anaphylaxis. Conclusion - Thrombolysis using streptokinase is safe and highly effective in acute ST-elevation myocardial infarction in district hospital setting.

Treatment of ST Elevation Myocardial Infarction from Fibrinolysis to Primary PCI: In Terms of Risks and Benefits.

The treatment of ST elevation myocardial infarction (STEMI) has undergone significant advances over the past three decades. Current practice guidelines raise the importance of promptly restoring normal coronary blood flow and myocardial perfusion in the infarct zone after the onset of chest pain, through either pharmacologic or mechanical reperfusion strategies. Fibrinolytic therapy remains the most widely used reperfusion strategy worldwide. With the development of newer fibrinolytic agents and adjuvant potent anti-platelets therapies, this approach carries an increased risk of bleeding complications. The current research present up-date review of the use of reperfusion strategies for the treatment of STEMI, using data through the search of MEDLINE, PubMed, EMBASE, as well as related extracts from the annual report of the American Heart Association, the American College of Cardiology, and the European Society of Cardiology. We summarized data from the available studies conducted over the past last 30 years in relation to pharmacologic reperfusion therapy in regards to risks and benefits. Conclusion: Fibrinolytic therapy remains the main reperfusion strategy used for the treatment of STMI worldwide. In the current era, there is a lack of fibrinolytic therapy trials, mainly because of increased focus in mechanical reperfusion therapies’ studies in the developed world. Clinical trials on the use of the fibrinolytics with newer platelet agents are urgently needed.