The quantitative analysis methods validation of Paeonia Anomala L. Tincture / Монголын эм зүй, эм судлал

Introduction@#The development of analytical methods for evaluation of quality standard parameters of drugs and other health prophylactic, diagnostic, and therapeutic products is essential from the beginning in the process to release to the market finished product. Validation of developed analytical methods is one crucial part of the analysis.</br> Quantitative determination methods of the total main active compounds of the tincture prepared from the root and the herb of <i>Paeonia anomala</i> L. were developed. In order to verify whether the analytical procedure is suitable for its intended purpose parameters – accuracy, reproducibility, intermediate precision, and linearity were validated.@*Materials and methods@#The total phenolics in the tincture were determined by the reaction with Folin Chicolteau reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively. Based on the achieved results of the developed quantitative methods which were validated according to the accepted and pursued technical documents in our country the Eurachem guide “The Fitness for Purpose of Analytical Methods” and Russian Pharmacopoeia 13 “Validation of analytical methodology”, where parameters as accuracy, precision – reproducibility, intermediate precision, and linearity are involved.@*Conclusions@#Statistical analysis of total phenolic compounds and total monoterpene glycosides in the <i>Paeonia anomala</i> tincture demonstrated that the bias calculated was for accuracy 0.674% and 0.703%, relative standard deviations were for reproducibility 0.896% and 0.798%, for inter- mediate precision 0.922% and 0.696%, respectively and the linearity – R²=0.9985 and R²=0.9997. All achieved results validated the appropriateness of the developed quantitative methods for the intended purpose.

Variabilidad clínica del síndrome de ovario poliquístico / Clinical variability in polycystic ovary syndrome

Introducción: El síndrome de ovario poliquístico es la forma más común de anovulación crónica relacionada con exceso de andrógenos. La prevalencia oscila según el criterio diagnóstico utilizado entre 4-21 pòr ciento. Objetivo: Describir las características clínicas de las pacientes con síndrome de ovario poliquístico. Métodos: Se seleccionaron los consensos hasta ahora realizados y artículos originales de los último 10 años, disponibles en los siguientes buscadores: Pubmed, Medscape, Scielo, Bireme. Se consideraron otras publicaciones que por su importancia clínica no han sido replicados. Conclusiones: La variedad de fenotipos presentes en el SOP hace que las manifestaciones clínicas y factores de riesgo para otras morbilidades sean heterogéneas. La influencia que ejerce además su etiopatogenia, no completamente dilucidada, hace que el diagnóstico y por consiguiente el manejo actual de estas pacientes tenga un enfoque multidisciplinario, individualizado y enfocado a las prioridades e inconformidades que puedan afectar su calidad de vida(AU)

Introduction: Polycystic ovary syndrome (PCOS) is the most common form of chronic anovulation related to androgen excess. The prevalence ranges according to the diagnostic criteria used between 4-21 percent. Objective: To describe the clinical characteristics of patients with polycystic ovary syndrome. Methods: The consensuses and original articles of the last 10 years were selected, which were available in the following search engines: Pubmed, Medscape, Scielo, and Bireme. Other publications that due to their clinical importance have not been replicated were considered. Conclusions: The variety of phenotypes present in the polycystic ovary syndrome makes the clinical manifestations and risk factors for other morbidities heterogeneous. The influence exerted also by its etiopathogenesis, not completely elucidated, causes the diagnosis and therefore the current management of these patients to have a multidisciplinary approach which is individualized and focused on the priorities and nonconformities that may affect the patients' quality of life(AU)

Compassionate and standard operating procedure-based counseling and practice are essential in high-risk infantile anesthesia and managing death in eye surgery

Physicians have to play the role of a team leader and counselor and take written informed consent for high?risk surgeries in many cases. This is the first step toward initiating a mutually trustworthy relationship with the patient and family. The situation is more sensitive when vulnerable patients like small premature babies or the elderly are under consideration. In the event of a death, leadership and processes in place become extremely critical. We share our experience and practice pattern during this process, especially suited to India, but the broad principles would apply to most human situations. Hopefully, some of these can be incorporated into the existing training curriculum for team building and the art of effective physician?patient communication that should be intricately woven into the curriculum for the Science of Ophthalmic care.

Rendimiento cognitivo en mujeres con síndrome de ovario poliquístico: un estudio piloto / Cognitive Performance in Women with Polycystic Ovarian Syndrome: A Pilot Study

Resumen El Síndrome de ovario poliquístico (SOP) es la enfermedad endocrina-metabólica más frecuente en las mujeres en edad reproductiva. A pesar de su alta prevalencia, hay pocas investigaciones que analizan los efectos de los cambios hormonales sobre la cognición de pacientes con SOP. Objetivo: comparar el rendimiento en habilidades cognitivas y los niveles de hormonas sexuales de un grupo de pacientes con SOP y con las de un grupo control. Método: Participaron 20 mujeres mayores de 21 años, sin tratamiento hormonal, dividas en dos grupos, el primero compuesto por 10 pacientes diagnosticadas con SOP según los criterios de Rotterdam (GSOP) y el otro, de control, compuesto por 10 mujeres sin diagnóstico de SOP (GCT). Se aplicaron las pruebas WAIS III y fluidez verbal semántica y fonológica de la batería NEUROPSI Atención y memoria, y se realizaron análisis sanguíneos de hormonas sexuales. Resultados: Las pacientes del GSOP obtuvieron puntajes inferiores a las del GCT en el CI Verbal (p=0.009), CI Total (p=0.029), índice de comprensión verbal (p=0.005), índice de memoria de trabajo (p=0.023) y en la prueba de fluidez verbal semántica (p=0.029). No se encontraron diferencias significativas en los niveles hormonales. Conclusión: el GSOP presentó menor rendimiento que el GCT en pruebas de tipo verbal, aunque no se presentó déficit en su ejecución. Se sugiere estudiar la relación de la insulinorresistencia con la cognición en pacientes con SOP.

Abstract Polycystic ovarian syndrome (PCOS) is the most common endocrine-metabolic disease in women of reproductive age. Despite its high prevalence, little research analyzes the effects of hormonal changes on cognition in patients with PCOS. Objective: To compare the performance in cognitive abilities and sexual hormone levels of a group of patients with PCOS and those of a control group. Method: Twenty women older than 21 years, without hormone treatment, divided in two groups, the first consisting by 10 patients diagnosed with PCOS according to the Rotterdam criteria (GSOP), and the other composed of 10 women without diagnosis of PCOS (GCT). WAIS III and semantic and phonological verbal fluency tests of the NEUROPSI attention and memory test battery were applied, and blood analyzes of sexual hormones were analyzed. Results: The GSOP patients obtained lower scores than the GCT in Verbal IQ (p=0.009), full scale IQ (p=0.029), verbal comprehension index (p=0.005), working memory index (p=0.023) and semantic verbal fluency test (p=0.029). No significant differences were found in sexual hormone levels. Conclusion: the GSOP showed lower performance than the GCT in verbal tests, although there was not deficit in its execution. It is suggested to study the relationship of insulin resistance with cognition in patients with GSOP.

La implementación de procedimientos estandarizados en la prevención de enfermedades transmitidas por los alimentos. Conteo microbiológico del Staphylococcus aureus en quesos frescos / Implementation of standardized procedures to prevent diseases transmitted by foodstuffs. Microbiological count of Staphylococcus aureus in freshcheese

Introducción: las enfermedades transmitidas por alimentos son una problemática mundial a la que la Organización Mundial de la Salud y los países brindan una atención especial. Dentro de los grupos de alto riesgo se encuentran los productos de origen animal, como la leche y sus derivados. Staphylococcus aureus es un microorganismo causante de brotes de las enfermedades transmitidas por alimentos, lo que genera la necesidad de estudiar la carga microbiana y establecer los controles adecuados. Objetivo: evaluar la calidad microbiológica en el proceso manufacturero en el área de producción de la Cooperativa de Producción Agropecuaria Chone LTDA, con el fin de asegurar la ausencia del Staphylococcus aureus en el queso fresco 100% chonero. Materiales y métodos: Se realizó un estudio de evaluación de la calidad en cuatro fases. Se realizaron exámenes microbiológicos iniciales, se identificaron las causas esenciales de contaminación identificadas por observación directa, revisión de documentos y entrevistas, como base para la elaboración e implementación de POE (Procedimientos Operativos Estandarizados) y POES (Procedimientos Operativos Estandarizados de Saneamiento). Se cumplieron los requerimientos éticos y se realizaron los análisis estadísticos utilizando porcentaje e índices como medida resumen y con el uso de IBM SPSS, versión libre, realizándose regresión logística binaria para determinar la probabilidad de éxito al aplicar dichos procedimientos. Resultados: los análisis microbiológicos iniciales (antes de implementación de POE y POES), dieron como resultado: 98, 116, 79, 120 y 13 UFC/g para las muestras: DiQ1, DiQ2, DiQ3, DiQ4 y DiQ5, respectivamente. Las causas esenciales de contaminación fueron falta de control microbiológico, falta de control del aspecto del personal y falta de control del agua) Una vez implementados los POE y POES, el análisis mostró ausencia en todas las muestras analizadas. Conclusiones: se concluye que la aplicación de POE y POES tiene un efecto significativo sobre la ausencia del Staphylococcus aureus, con probabilidad de éxito del 100% (AU).

Introduction: Diseases transmitted by foodstuffs (DTF) are a worldwide problem that receives special attention by WHO and different countries. High risk groups include foodstuff of animal origin, like milk and its by-products. Staphylococcus aureus is a microorganism responsible for DTF outbreaks which generates the necessity of studying its microbial burden and establishing the adequate controls. Objective: to evaluate the microbiological quality of the manufacturing process in the production area of the Farming and Stockbreeding Cooperative Chone LTDA, to assure the absence of Staphylococcus aureus in the manufacturing process of fresh cheese. Materials and methods: A study to assess the quality in four stages was carried out: initial microbiological tests, identification of the essential contamination causes by direct observation, documental review and inquires. They were used to elaborate and implement the Standardized Operational Procedures (SOP) and the Standardized Operational Procedures of Sanitation (SOPS). The ethical requirements were fulfilled and the statistical tests were performed using percentages and indexes as summary measures through IBM SPSS, free version; binary logistic regression was made to determine the success when applying those procedures. Results: initial microbiological controls (before implementing SOP and SOPS) gave these results 98, 116, 79, 120, and 13 UFC/g for samples DiQ1, DiQ2, DiQ3, DiQ4 and DiQ5 respectively. The main contamination causes were lack of microbiological control, lack of control on the staff's cleanliness and lack of control on the water. After implementing SOP and SOPS microbiological control found particularly clean samples. Conclusions: SOP and SOPS have a significant effect on the amount of Staphylococcus aureus, with 100% success probability (AU).

Estudios de laboratorio de diversos parámetros orientados a tratar de dilucidar la fisiopatología del síndrome de ovarios poliquísticos. Parte 1 / Laboratory studies of various parameters aimed at trying to elucidate the pathophysiology of polycystic ovary syndrome. Part 1

Esta revisión fue realizada con el fin de evaluar nuestros resultados de laboratorio así como aquellos de la literatura que constituyen, a nuestro entender, aportes significativos en el síndrome de ovarios poliquísticos (SOP). Nuestro especial énfasis será presentar las limitaciones de las metodologías empleadas por nuestro grupo, comparativamente a las reportadas por otros investigadores. La determinación de andrógenos, en particular de Testosterona (TT), es quizá la de mayor complejidad dado que los resultados con los diferentes inmunoensayos empleados en nuestro medio producen resultados muy variables por los diferentes métodos y aún entre laboratorios que usan la misma metodología. La técnica de referencia es la cromatografía líquida en tándem con espectrometría de masa (LC-MSMS), de difícil aplicación en laboratorios de análisis clínicos debido a su alto costo y la imposibilidad de resolver numerosas muestras. En estudios previos demostramos que de los métodos habitualmente usados para evaluar la TT circulante, solo en 2 inmunoensayos los resultados obtenidos fueron satisfactoriamente validados indirectamente según el criterio del Consenso de los Centros para el Control y Prevención de Enfermedades (CDC, USA) contra LC-MSMS, los cuales fueron comparables a dicha metodología con niveles superiores a 0,5 ng/ml. El SOP puede presentar factores de riesgo aumentados para la enfermedad cardiovascular y la diabetes II. Estos factores no están debidamente categorizados en función de los distintos fenotipos del SOP. Se evaluarán los principales analitos empleados con este objetivo y los nuevos que aporten elementos de mayor especificidad en este sentido

This review was performed in order to evaluate our laboratory results as well as those of the literature that constitute, in our opinion, significant contributions in these pathophysiologies. Our special emphasis will be on presenting the limitations of the methodologies used by our group, compared to those reported by other researchers. The determination of androgens, in particular Testosterone (TT), is perhaps the most complex since the results with the different immunoassays used in our environment produce very variable results by the different methods and even between laboratories that use the same methodology. The reference technique is LC-MSMS, difficult to apply in clinical analysis laboratories because of its high cost and the inability to solve numerous samples. In previous studies, we demonstrated that, in comparison to LC-MSMS with the usual methods for evaluating circulating TT, the results obtained in only 2 immunoassays were satisfactorily validated indirectly according to the criteria of CDC against LC-MSMS, which were comparable to that methodology with levels higher than 0.5 ng/ml. PCOS may have increased risk factors for cardiovascular disease and diabetes II. These factors are not properly categorized according to the different phenotypes of PCOS. The main analytes used for this purpose will be evaluated and new ones that contribute elements of greater specificity in this sense

Practice and effect evaluation of"PICC fixed standard operation flow chart"in PICC fixed quality management / 中国实用护理杂志

Objective To evaluate the effects of"PICC fixed standard operation flow chart"in PICC fixed quality management. Methods Patients with PICC were admitted to the control group from January to June in 2014, given the routine PICC fixed method. PICC patients in the observation group who were enrolled from July to December 2014 were given new PICC fixed method that obey the"PICC fixed standard operation flow chart", which was established from relevant norms and guidelines and related literature. The incidence rate of medical adhesive related skin injury and unplanned extubation of PICC were compared with those of the two groups. Results The incidence rate of medical adhesive related skin injury was decreased from 35.20％(70034/198962) to 18.03％(37862/209955) (Z=-3.363, P<0.01) and PICC unplanned extubation decreased from 1.31‰(20/15384) to 0.37‰(7/18919) , the difference was statistically significant (χ2=6.940, P<0.05). Conclusions The PICC fixed standard operating flow chart can be used as a guide to implement the PICC fixation. Based on this, the quantitative management index is applied to the PICC fixed quality management, which can standardize the fixation of the PICC , reduce the related complications caused by the fixation of the catheter, prevent the occurrence of unplanned extubation of PICC , provide effective protection to ensure safe PICC long-term use and improve the patient's comfort.

Acupoint plaster therapy with midnight-noon ebb-flow hour-prescription method for senile osteoporosis:a randomized controlled trial / 中国针灸

<p><b>OBJECTIVE</b>To compare the clinical efficacy differences between acupoint plaster therapy with midnight-noon ebb-flow hour-prescription method and traditional acupoint plaster therapy for senile osteoporosis (SOP).</p><p><b>METHODS</b>With randomized controlled blind design, 76 SOP patients with deficiency of liver and kidney syndrome were randomly divided into an observation group and a control group, 38 cases in each one. Based on oral administration of caltrate D, the patients in the observation group were treated with acupoint plaster therapy with midnight-noon ebb-flow hour-prescription method at Yingu (KI 10), Taixi (KI 3), Dazhong (KI 4), Fuliu (KI 7) and Zhiyin (BL 67), while the patients in the control group were treated with traditional acupoint plaster therapy. Each plaster therapy lasted for 6 h, once a day; there was an interval of 2 d after consecutive 5-day treatment; 4 weeks were taken as one course, and totally 2 courses were given. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) were used to evaluate the pain and dysfunction before intervention, after 4 weeks and 8 weeks intervention. Osteoporosis symptom rating sale and quality of life questionnaire of the European foundation for Osteoporosis (QUALEFFO-41) were adopted to evaluate the TCM syndrome and quality of life before and after 8-week intervention.</p><p><b>RESULTS</b>All the outcomes were significantly improved after treatment in the two groups (<0.01,<0.05); after 4 weeks and 8 weeks of treatment, the VAS and ODI in the observation group were lower than those in the control group (all<0.05). Repeated ANOVA indicated the VAS and ODI were significant in group effect, time effect and interaction effect (all<0.01). Further comparison showed that VAS and ODI at later time points were lower than those in the early time points (all<0.01). After the treatment, the scores of TCM syndrome and QUALEFFO-41 in the observation group were lower than those in the control group (all<0.05). The effective rate was 85.7% (30/35) in the observation group, which was superior to the effective rate in the control group[74.3%(26/35),<0.05].</p><p><b>CONCLUSIONS</b>The acupoint plaster therapy with midnight-noon ebb-flow hour-prescription method is superior to traditional acupoint plaster therapy in improving pain, dysfunction, TCM syndrome and quality of life in SOP patients; in addition, its clinical efficacy is significant.</p>

Correspondencia clínica, hormonal y ecográfica en el diagnóstico del síndrome de ovarios poliquísticos / Clinical, hormonal and echographic correspondence in the diagnosis of polycystic ovary syndrome

Introducción: el síndrome de ovarios poliquísticos es el trastorno endocrino más frecuente en la mujer en edad reproductiva. Se caracteriza por trastornos menstruales, hiperandrogenismo y ovarios poliquísticos por ultrasonido, y afecta la fertilidad y el metabolismo femeninos. Objetivo: determinar la frecuencia de aparición de los criterios diagnósticos de síndrome de ovarios poliquísticos en mujeres con sospecha de esta afección, y la posible correspondencia entre el diagnóstico clínico, hormonal y ecográfico. Métodos: se realizó un estudio descriptivo correlacional en 140 mujeres. Se les practicó interrogatorio y examen físico, ultrasonido diagnóstico y estudio de las hormonas folículo estimulante, luteinizante y testosterona. Para el análisis estadístico se utilizaron tablas de frecuencia y la prueba de chi cuadrado (p< 0,05). Resultados: la edad media fue 26,3 años. De 96 mujeres (68,5 por ciento) con alteraciones del ciclo menstrual, 76 (79,2 por ciento) refirieron oligomenorrea. Hubo sobrepeso en 64 pacientes (45,7 por ciento). La testosterona elevada fue la alteración hormonal predominante (52,7 por ciento). El 84,3 por ciento presentó volumen ovárico ≥ 10 cc. Hubo asociación significativa entre las alteraciones menstruales y la presencia de ovarios poliquísticos (p= 0,000), hirsutismo (p= 0,001) y acné (p= 0,000), pero no ocurrió así con las variables hormonales. Hubo coincidencia entre el diagnóstico ecográfico y la testosterona elevada en el 46,2 por ciento de las pacientes. Conclusiones: Existe asociación entre las variables clínicas y el diagnóstico de síndrome de ovarios poliquísticos, pero no así entre los criterios diagnósticos ecográficos y hormonales, ni entre las alteraciones hormonales y el diagnóstico clínico y ecográfico del síndrome de ovarios poliquísticos, en estas pacientes(AU)

Introduction: polycystic ovary syndrome is the most common endocrine disorder in a woman at reproductive age. It is characterized by menstrual disorders, hyperandrogenism and CT-detected polycystic ovaries and it has an effect on fertility and metabolism. Objective: to determine the frequency of occurrence of diagnostic criteria of polycystic ovary syndrome in women suspected of suffering this disease, and the possible correspondence among the clinical, hormonal and echographic diagnoses. Methods: a correlational descriptive study was conducted in 140 women. They were questioned and physically examined in addition to performing diagnostic ultrasound and study of the follicle-stimulating hormone, the luteinizing hormone and testosterone. For the statistical analysis, the frequency tables and the Chi-square test (p< 0.05) were used. Results: the average age was 26.3 years. Of 96 women (68.5 percent) with menstrual disorders, 76 (79.2 percent) said they had oligomenorrhea. Sixty four were overweighed (45.7 percent). Elevated testosterone was the predominant hormonal alteration (52.7 percent). In the group, the ovary volume was equal to or higher than 10 cc in 84.3 percent of the group. Significant association was observed between the menstrual disorders and the presence of polycystic ovaries (p= 0.000), hirsutism (p= 0.001) and acne (p= 0.000), but this did not occur with the hormonal variables. The echographic diagnosis and the elevated testosterone showed correspondence in 46.2 percent of patients. Conclusions: there is association between the clinical variables and the diagnoses of polycystic ovary syndrome, but neither the echographic and hormonal diagnostic criteria, nor the hormonal alterations and the clinical and echographic diagnosis of polycystic ovary syndrome were related(AU)

Saturation Oxygen Pressure Index for Assessment of Pulmonary Disease in Neonates on Noninvasive Ventilation.

This prospective observational study on 36 neonates aimed to estimate the correlation between the new Saturation Oxygen distending Pressure Index (SOPI) and Oxygenation index. SOPI had high correlation (r=0.94) with oxygenation index. SOPI of <2, 2, and 3.7 represented mild, moderate and severe pulmonary disease, respectively with high sensitivity and specificity.

Síndrome de ovario poliquístico: una revisión de sus correlatos patológicos en el ánimo y en el rendimiento cognitivo / Polycystic ovary syndrome: a review of its pathological correlates in mood and cognitive performance

El Síndrome de ovario poliquístico (SOP) constituye la endocrinopatía más frecuente en las mujeres en edad reproductiva. En los últimos años se avanzó considerablemente en la comprensión clínica y fisiopatológica del SOP. Sin embargo los aspectos comportamentales del SOP continúan siendo menos claros. El objetivo del actual trabajo radicó en revisar las alteraciones en el ánimo y en el rendimiento cognitivo en mujeres con SOP. Se buscaron artículos originales publicados en las bases de datos Pubmed y Science direct (lapso 2006-2015). Se concluye que las mujeres con SOP experimentan con frecuencia depresión y trastornos de ansiedad. El índice de masa corporal resultó el principal predictor de psicopatología. Un estudio longitudinal de grandes dimensiones desestimó un mayor riesgo para trastornos bipolares. Por otro lado algunos estudios señalaron dificultades en el rendimiento cognitivo en mujeres con SOP, particularmente en funciones verbales. En cuanto a un supuesto perfil cognitivo más masculino en el SOP, existen evidencias a favor y evidencias en contra. En fin, no es posible confirmar la presencia de déficits cognitivos, ni tampoco un perfil específico en el SOP, ya que la investigación sobre sus aspectos cognitivos continúa siendo muy escasa. Respecto a los mecanismos explicativos de las alteraciones comportamentales del SOP, se propone la existencia tanto de factores biológicos como psicosocioculturales. Por último, y a raíz de la revisión actual, se sugiere asignar mayor relevancia clínica a los trastornos asociados al ánimo en mujeres con SOP e incrementar la investigación sobre los aspectos cognitivos de esta enfermedad...

Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disease in women of reproductive age. In recent years substantial progress was made in the clinical and pathophysiological understanding of PCOS. However the behavioral aspects of PCOS are still less clear. The aim of the present work was to review the changes in mood and cognitive performance in women with PCOS. We searched for original articles published in the databases Pubmed and Science direct (period 2006-2015). It is concluded that women with PCOS frequently experience depression and anxiety disorders. The body mass index was the main predictor of psychopathology. Meanwhile, a large longitudinal study dismissed an increased risk for bipolar disorder. On the other hand, some studies reported difficulties in cognitive performance in women with PCOS, particularly in verbal functions. As for a course more masculine cognitive profile in the PCOS, there are evidences in favor and against. It is not possible to confirm the presence of cognitive deficits in PCOS , nor a specific profile, because the research on the cognitive aspects of PCOS remains scarce. Regarding mechanisms explanatory of behavioral disturbances in PCOS, it is proposed the existence of biological and psychosocial/cultural factors. Following the current review, it is suggested allocate clinical relevance for mood disorders in women with PCOS and increase research of its cognitive aspects...

Embolismo de líquido amniótico / Amniotic fluid embolism

Se valoró un caso de una femenina quien es internada por embarazo en vías de prolongación para inducción del mismo, posterior a su labor presenta sangrado transvaginal abundante por lo que es ingresada a sala de operaciones, no se le encuentra sitio de sangrado, le realizan histerectomía y fallece; es enviada para su respectiva autopsia, se determina como causa de muerte: embolismo de líquido amniótico. Este artículo pretende revisar la etiología de esta patología, fisiopatología, criterios diagnósticos del mismo, factores de riesgo, diagnósticos diferenciales y su tratamiento.

A case of a female who is hospitalized for pregnancy-way extension for induction thereof, after their work presents TVB abundant so it is entered into operating room were assessed, you will not find the bleeding site, we performed hysterectomy and dies; is sent to the respective autopsy determined the cause of death: amniotic fluid embolism. This article reviews the etiology of this pathology, pathophysiology, diagnostic criteria thereof, risk factors, differential diagnosis and treatment.

Standard operating procedure for raw materials of Reduning Injection-- Lonicerae Japonicae Flos / 中草药

In order to ensure the superior quality and safety of the raw materials of Reduning Injection-Lonicerae Japonicae Flos, a standard operating procedure was established on the base of Good Agriculture Practice (GAP) of Chinese herbal medicine as well as practice investigation and experiments. This standard operating procedure provides the technical requirements for the production suitability, growing, field management, diseases and pests controlling, harvesting and processing, packing and storing, transporting, and quality monitoring of Lonicerae Japonicae Flos. The experiences and problems in the process of the standardized planting were analyzed and discussed.

Estrategia para la preparación de unidades de salud en buenas prácticas clínicas / Strategy for the preparation of health units for good clinical practices

Introducción: El entorno regulatorio mundial es cada vez más exigente para establecer, implementar y mantener el cumplimiento de las buenas prácticas clínicas (BPC). En Cuba, una respuesta necesaria derivada del desarrollo creciente de la industria farmacéutica y biotecnológica nacional fue la creación del Centro Nacional Coordinador de Ensayos Clínicos (CENCEC). Una de las misiones del CENCEC es preparar a las unidades-sitios clínicos seleccionados que realizan investigaciones clínicas, para su posterior certificación en BPC por la autoridad reguladora nacional, con la finalidad de avalar la calidad que corresponde al proceso de investigación clínica que redunda en una esmerada atención y protección al paciente objeto de estudio. Objetivo: Describir la estrategia del CENCEC para la preparación en BPC de los sitios clínicos seleccionados del Sistema Nacional de Salud (SNS) que participan en ensayos clínicos. Métodos: Se revisan más de 250 documentos normativos emitidos por Europa, Estados Unidos, Japón y los países nórdicos relacionados con aspectos prácticos y éticos para la implementación de las BPC...

Background: The global regulatory environment is increasingly demanding to establish, implement, and maintain the compliance with Good Clinical Practices (GCP). In Cuba, The National Coordinating Center for Clinical Trials (CENCEC) was created as a necessary response derived from the increasing development of the national pharmaceutical and biotechnological industry. One of the missions of the CENCEC is to prepare selected clinical units/sites that conduct clinical research for a further certification in GCP by the national regulatory authority in order to guarantee the quality that corresponds to the process of clinical research, resulting in a careful attention and protection of the patient under study. Objective: To describe the strategy of the CENCEC for the preparation of good clinical practices in the selected clinical sites of the National Health System (SNS) that participate in clinical trials. Methods: More than 250 regulatory documents issued by Europe, the United States, Japan and the Nordic countries, related to ethical and practical aspects for the implementation of good clinical practices, were reviewed...

Quality assessment of sputum for Acid Fast Bacilli(AFB) test in microbiology laboratories before and after implementation of Standard Operating Procedure (SOP): a comparative study.

Aims: To evaluate the present status of microbiology laboratory by comparing the test results of investigator with that of laboratory staff for sputum for Acid Fast Bacilli (AFB) withZiehl-NeelsenStaining (Z-N Staining) at primary and secondary level andto assess the present status of a microbiology laboratory for sputum for Acid Fast Bacilli (AFB) withZiehl-NeelsenStaining (Z-N Staining) at tertiary level. Material and Methods: Type of study : Cross sectional, descriptive type of study. Place of study: Department of Microbiology of Dhaka Medical College,Narsingdi Sadar Hospital,Narsingdi,PolashUpzilla Health Complex ,Polash, Narsingdi andDOTS centers. Duration of study: From July, 2007 to June,2008 Method of sampling: Non probability, purposive and convenient sampling Sample Size: Sputum for AFB: 300 sputum samples were collected for detection of AFB by direct Z-N staining, Z-N staining after bleach centrifugation and Auramine phenol staining before implementing SOP. After following SOP 150 sputum samples were collected and tested in direct Z-N method. Results: In the present study, before SOP out of 100 sputum smear at each level, discrepancy was found in 3% cases at primary level, 2% cases at secondary level and 1% case at tertiary level.After following SOP out of 50 sputum smear at each level, discrepancy was reduced to 2% cases at primary level and no discrepancy was found at secondary and tertiary level. Conclusion: Each laboratory must have SOP for laboratory testing to set the minimum acceptable standard for every test in order to improve and maintain the quality of laboratory services.

Sleep Onset Period from the EEG Point of View / 수면정신생리

In accordance with the development of EEG and polysomnography in the field of sleep research, the sleep onset period (SOP) between wakefulness and sleep has been considered an important part for understanding the physiology of sleep. SOP in the transition from wakefulness to sleep is a gradual process integrating various viewpoints such as behavior, EEG, physiology and subjective report. Particularly, based on understanding of EEG changes during sleep, SOP has been regarded as a pattern of topographical change in specific frequency and specific state in EEG. Studies on quantitative EEG (qEEG) and event-related potential (ERP) have suggested that SOP shows the changes of functional coordination at the specific cortical areas in qEEG and the changes of regular patterns in response to environmental stimulation in ERP. The development of sleep EEG and topographic mapping of EEG is expected to integrate various viewpoints of SOP and clarify the neurophysiologic mechanism of SOP further.

Studies of 4500 Umbilical Cord Blood Units Banking / 中国肿瘤生物治疗杂志

Objective: To prepare and cryopreserve umbilical cord blood (UCB) units for clinical hematopoietic stem cell transplantation. Methods; HSC of UCB units that met our standards were collected, separated cryopreserved and tested. Results: 4 500 (72. 2%) of 6 232 cord blood units were suitable for preservation. Average net volume, numbers of total nucleated cells, percentage of CD34~+ cells and CFU-C of the UCB units were 90. 7?22. 2 ml, 10. 5?3. 4?10~8, 0. 24?0. 15%, 78.9?44. 14/10~5 NC, respectively. After separation, the cell recovery of nucleated cells, CD34~+ cells and CFU-C were 82. 1?6. 52%, 92. 5?6. 15% and 90?9. 67%, respectively. The cell viability after separating was over 95%. After thawing, the recovery of nucleated cells, CD34~+ cells and CFU-C were 84. 2?10. 1%, 96. 5?21. 8% and 115. 1?23. 3%, respectively. The cell viability was 93. 8?4. 4%. Among the 569 searching cases,532 (93%) cases could found 4/6 of HLA-A, B and DR loci matched UCB units in our bank, including 39 (6. 58%) found 6 loci matched and 237 (41. 65%) found 5 loci matched. Conclusion: These results indicated that we can supply high quality cord blood HSC for clinical transplantation.

Studies on standard operating procedure (SOP) for Alisma plantago-aquatica / 中草药

Object To study the standard operating procedure (SOP) for Alisma plantago aquatica L. so as to make its high quality, high yield and public nuisance free, and correspond to international standards, then enter into world market. Methods The historical culture, essential ecological environment, species resources and seed selection for the plant were investigated, the content of index components and active components in the plant was determined. Results The traditional cultural manner was improved and SOP for the plant was set up. Conclusion The plant cultured under SOP is excellent.