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OBJECTIVE:To analyze the results of national evaluation inspection for 83 batches of Compound jiegeng mahuangjian syrup(Ⅱ)from 4 manufacturers,and to evaluate their quality. METHODS:Legal inspection method and exploratory research were adopted to test,analyze and evaluate sample statistically. The contents of exploratory research included HPLC method was used to determine the contents of preservative benzoic acid and ephedrine hydrochloride;antibacterial efficacy examination of formulation was studied;pH value of solution was determined;the content of sucrose was determined by polarimetry photometry;the relationship of the content of ammonium chloride with microbial contamination was studied;headspace GC method was used to determine the contents of menthol and ethanol;Platycodon grandiflorum extractum was identified and studied by TLC. RESULTS:Results of legal inspection showed that among 83 batches of sample,80 batches were qualified and 3 batches were unqualified,with qualified rate of 96.4%. Unqualified items were loading capacity,microbial limit and content ofammonium chloride,content of ammonium chloride. The results of legal test combined with exploratory research showed thatantibacterial efficacy of formulation of one manufacturer was not in accordance with the regulations;Some raw materials were notfed according to formulation, and the quality of products was not even. It is recommended to revise the quality standard:identificatied the Campanulaceae by TLC; determination the pH, preservative content, menthol content; revision ephedrinehydrochloride assay method to HPLC. CONCLUSIONS:The overall quality of Compound jiegeng mahuangjian syrup(Ⅱ)is notsatisfactory;there is a big flaw in the production process and quality control of some manufacturers;quality standards needed to beimproved.
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PURPOSE: InterStim device is an U.S. Food and Drug Administration approved minimal invasive therapy for sacral neuromodulation for lower urinary tract dysfunction. Before InterStim implantation, a trial with the appropriate screening tests is required to determine patient therapy eligibility. There are two different techniques for patient screening: percutaneous nerve evaluation (PNE) test and staged test. Few studies have reported success and failure rates for each technique. However, test sensitivity and predictive values of either test have not been studied. The aim of our study was to determine the sensitivity and specificity of each test and to establish a decision algorithm for the most appropriate testing method to be used as a screening test. METHODS: This cross-sectional study was conducted from August 2009 to February 2012 and included patients with lower urinary tract dysfunction who participated in the stimulation test trial. Patients underwent PNE as the first stimulation test, while those who encountered technical difficulty during PNE or electrode migration underwent staged testing. RESULTS: A total of 213 patients, including 172 female and 41 male subjects, underwent PNE. The patients’ diagnoses included refractory overactive bladder (47.9%), nonobstructive urinary retention (29.6%), and frequency urgency syndrome (22.1%). A total of 202 patients were screened with PNE and 10 patients with staged testing. Overall sensitivity of PNE was 87.3%, and it was 90% for staged test. PNE specificity was 98.5% as compared to 92.9% for staged test. Positive and negative predictive values for PNE were 99% and 82.1% and for staged test were 90% and 92.9%, respectively. CONCLUSIONS: PNE test has high specificity and positive predictive value. We recommend PNE, a simple office-based, less expensive procedure as the first option for screening.
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Female , Humans , Male , Cross-Sectional Studies , Diagnosis , Electrodes , Mass Screening , Methods , Sensitivity and Specificity , United States Food and Drug Administration , Urinary Bladder, Overactive , Urinary Retention , Urinary TractABSTRACT
Introducción: La prueba Evaluación del Desarrollo Infantil (EDI) es un instrumento de tamizaje de problemas en el desarrollo diseñado y validado en México. La calificación obtenida se expresa como semáforo. Se consideran positivos tanto el resultado amarillo como el rojo, aunque se plantea una intervención diferente para cada uno. El objetivo de este trabajo fue evaluar la capacidad de la prueba EDI para discriminar entre los niños identificados con semáforo amarillo y los identificados con rojo al compararse con el Inventario de Desarrollo de Battelle 2.ª edición (IDB-2) en cuanto al cociente de desarrollo del dominio (CDD). Métodos: El análisis se llevó a cabo utilizando la información obtenida para el estudio de la validación. Se excluyeron los pacientes con resultado normal (verde) en EDI. Se utilizaron 2 puntos de CDD (IDB-2) por dominio: < 90 para incluir normal-bajo y < 80 para diagnóstico de retraso. Se analizó el resultado con base en la correlación del resultado del semáforo de EDI (amarillo o rojo) y el IDB-2, total y por subgrupos de edad. Resultados: Al considerar un CDD < 90 en amarillo, el 86.8% tuvo al menos un dominio afectado, y el 50%, 3 o más dominios, en comparación con el 93.8% y el 78.8% para el resultado en rojo, respectivamente. Hubo diferencias en todos los dominios entre amarillos y rojos (p < 0.001) para el porcentaje de niños con un CDD < 80: cognitivo (36.1 vs. 61.9%); comunicación (27.8 vs. 50.4%); motor (18.1 vs. 39.9%); personal-social (20.1 vs. 28.9%); y adaptativo (6.9 vs. 20.4%). Conclusiones: Los resultados de semáforo (amarillo o rojo) permiten identificar diferente magnitud de los problemas en el desarrollo y apoyan intervenciones diferenciadas.
Background: The Child Development Evaluation (CDE) is a screening tool designed and validated in Mexico for detecting developmental problems. The result is expressed through a semaphore. In the CDE test, both yellow and red results are considered positive, although a different intervention is proposed for each. The aim of this work was to evaluate the reliability of the CDE test to discriminate between children with yellow/red result based on the developmental domain quotient (DDQ) obtained through the Battelle Development Inventory, 2nd edition (in Spanish) (BDI-2). Methods: The information was obtained for the study from the validation. Children with a normal (green) result in the CDE were excluded. Two different cut-off points of the DDQ were used (BDI-2): < 90 to include low average, and developmental delay was considered with a cut-off < 80 per domain. Results were analyzed based on the correlation of the CDE test and each domain from the BDI-2 and by subgroups of age. Results: With a cut-off DDQ <90, 86.8% of tests with yellow result (CDE) indicated at least one domain affected and 50% 3 or more compared with 93.8% and 78.8% for red result, respectively. There were differences in every domain (P < 0.001) for the percent of children with DDQ < 80 between yellow and red result (CDE): cognitive 36.1% vs. 61.9%; communication: 27.8% vs. 50.4%, motor: 18.1% vs. 39.9%; personal-social: 20.1% vs. 28.9%; and adaptive: 6.9% vs. 20.4%. Conclusions: The semaphore result yellow/red allows identifying different magnitudes of delay in developmental domains or subdomains, supporting the recommendation of different interventions for each one.
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Background: The Child Development Evaluation (CDE) Test is a screening instrument for developmental problems. In the validation study, a sensitivity of 81% and a specificity of 61% were reported, considering a cut-off value for both a total development quotient (TDQ) of 90. Given that the TDQ is obtained by calculation of the five evaluated fields in the Battelle Development Inventory, 2nd edition (BDI-2), it may occur that a child is classified as a false positive (TDQ ≥90) and may have a developmental delay in at least one of the fields (true positive). The objective of this work was to evaluate if the properties of the CDE Test are different when analyzing each field for the probability of a developmental delay. Methods: The information obtained for the study from the validation (Rizzoli-Córdoba, 2013) was analyzed. In the CDE Test, a true positive was considered when the result was yellow or red. A developmental delay was considered per domain with a scale score <80 in the BDI-2. The results were analyzed based on the correlation of what was evaluated between the CDE Test and the BDI-2. Results: For 438 children of 1- to 60-months of age, sensitivity (S) and specificity (Sp) per field were as follows: a) Motor: S=84.3% and Sp=87%; b) Communication: S=79.5% and Sp=79.4%; c) Personal-Social: S=86.9% and Sp=85%; d) Adaptive: S=91.7% and Sp=85.1%; and e) Cognitive: S=83.6% and Sp=88.8%. Conclusions: When analyzing each field separately, better scores for the CDE are observed compared with those reported for the TDQ in both sensitivity and specificity.
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Com o objetivo de avaliar a distribuição de sementes de milho e soja por uma semeadora-adubadora de precisão em função da velocidade de trabalho e da densidade de sementes, foi conduzido um experimento em pista de areia conforme norma internacional. Os tratamentos constaram da combinação entre quatro velocidades, três densidades de semeadura para o milho e quatro para a soja, sendo avaliadas a distribuição transversal, a distribuição longitudinal e a densidade final de sementes. Foi observado que as elevações da velocidade de trabalho de 3,5 para 7,0km h-1, para milho, e de 4,3 para 11,0km h-1, para soja, não reduziram significativamente as densidades finais de semeadura. O aumento na densidade de semeadura de três para sete sementes m-1, para milho, e de oito para 20, para soja, reduziu o percentual de espaçamentos aceitáveis para ambas as culturas, independentemente da velocidade de trabalho.
With the objective to evaluate the distribution of corn and soybean seeds by a precision seeder in function of the displacement speed and seeds density, an experiment was made in track of sand according to international standard. The treatments consisted of the combination among four speeds, three sowing densities for the corn and four for the soybean, being appraised the transversal distribution, longitudinal distribution and final seeds density. It was observed that the elevations of the displacement speed from 3.5 to 7.0km h-1 for the corn and from 4.3 to 11.0km h-1 for the soybean did not reduce significantly the final densities of sowing. The increase in the sowing density from 3 to 7 seeds m-1 for the corn and from 8 to 20 for the soybean reduced the percentile of acceptable spacing's for both the cultures, independent of the displacement speed.
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Objective To organize the 14th ISBT Platelet Immunology Workshop and Cooperative Research Project,and proficiency evaluation on the techniques and quality level of platelet alloantiboby analysis will be taken effect for the 42 platelet immunology laboratories around the world. Methods Organized and confirmed by Nanning Institute of Transfusion Medicine,9 quality control samples contained the Human Platelet Antigen (HPA) specificity antibody have been supplied to all the participated laboratories in this project. The participants could use the In-House technology or/and market kits to test these quality control samples. The forms and sheets have been provided for recording of results. Results There were 36 laboratories from 23 countries participated in this Cooperative Research Project,and 35 laboratories have reported their results. The appraised consistent rate of the 9 quality control samples ranges from 20% to 97.14%,the HPA antibody specificities have been showed as anti HPA-1a,anti HPA-1b,anti HPA-3a,anti HPA-3a,anti HPA-3b,anti HPA-5b,anti HPA-5a,anti GPIV and anti HPA-5b+15b,respectively. Among the appraised consistent rate,the anti HPA-3b were the lowest and the anti HPA-5b and anti HPA-5a was the highest. Over 10 technologies of platelet alloantiboby analysis were used by the laboratories. Conclusion This international cooperative research project has successfully made the proficiency evaluation and report on the techniques and quality level of platelet alloantiboby analysis for the 35 international platelet immunology laboratories.
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Objective: To revise FNE (fear of negative evaluation) scale primarily and to explore the relationship between fear of negative evaluation and test anxiety Method: A sample of 200 middle school students was administrated with FNE and TAS (test anxiety scale) Result:The Chinese version of FNE had good psychometric parameters The score of our sample had no significant difference to that originally reported abroad There was positive correlation (r=0 45, P