Six novel minimally invasive therapies for benign prostatic hyperplasia / 浙江大学学报·医学版

Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in men. When drug treatment is ineffective or conventional surgery is not suitable, novel minimally invasive therapies can be considered. These include prostatic urethral lift, prostatic artery embolisation, water vapor thermal therapy, Aquablation-image guided robotic waterjet ablation, temporary implantable nitinol device and prostatic stents. These novel therapies can be performed in outpatient setting under local anesthesia, with shorter operative and recovery times, and better protection of ejaculatory function and erectile function. General conditions of the patient and advantages and disadvantages of the each of these therapies should be fully considered to make individualized plans.

Safety and efficacy of Rezūm water vapor thermal therapy system in the treatment of benign prostatic hyperplasia / 中华泌尿外科杂志

Objective:To evaluate the efficacy and safety of Rezūm Water Vapor Thermal Therapy system in the treatment of patients with benign prostatic hyperplasia (BPH).Methods:The clinical data of 22 patients with benign prostatic hyperplasia treated with Rezūm Water Vapor Thermal Therapy system in Boao Yiling Life Care Center in Hainan from December 2020 to January 2021 were retrospectively analyzed, with age of (61.0±5.9) years, prostate volume of (43.7±8.4) ml. international prostate symptom score (IPSS) of (19.3±3.7), quality of life (QOL) score of (4.2±0.8), maximum urinary flow rate (Q max) of (11.9±3.4) ml ml/s, and residual urine volume (PVR) of (14.0±19.0). For 19 patients with sexual life, the International Index of Erectile Function Questionnaire-5 (IIEF-5) were 17.0±5.5, the Men's Sexual Health Questionnaire-Ejaculatory Dysfunction Score (MSHQ-EjD) ejaculatory function score were 10.0±3.2, and the ejaculatory satisfaction score were 1.5±1.0. Twenty-two patients underwent Rezūm Water Vapor Thermal Therapy under intravenous anesthesia (general anesthesia without intubation) in the dorsal lithotomy position. The Rezūm system consisted of reusable thermal steam treatment device and disposable prostate thermal steam treatment instrument. The thermal steam treatment device used radiofrequency energy to heat sterile distilled water, generating high-temperature steam at 103℃. In a 9-second timeframe, the tissue temperature within each treatment area was raised approximately 70℃, causing cell death and resulting in a shrink in prostate tissue volume. The disposable prostate thermal steam treatment instrument could be inserted through a cystoscope and had a retractable needle tip that extends to a length of 10.25 mm. The needle tip had 12 evenly distributed holes arranged in three rows of four holes each, with a spacing of 120° between rows, allowing for even diffusion of thermal steam along the circumference. The patient was placed in a lithotomy position, and the disposable prostate thermal steam treatment instrument was used to examine the prostate, urethra, and bladder via cystoscopy, assessing the lateral lobes and median lobe of the prostate. The tissue spacing within each field of view of the treatment instrument is 0.5 cm, and the distance from the bladder neck to the verumontanum is calculated. The first needle was injected at 3 o’clock along the left lobe, withdrawing 2 fields of view each time. During the release of thermal steam, the needle tip was positioned perpendicular to the prostate urethral mucosa, and each needle injection delivered 0.42 ml of sterile distilled water-formed thermal steam into the prostate tissue. The thermal steam injection lasted for 9 seconds, followed by a 2-3 seconds waiting period before retracting the needle tip. One needle was injected per 2 fields of view, progressing towards the proximal urethra of the verumontanum. The same method was used to treat the right lobe. For cases with significant median lobe enlargement, two fields of view were retracted at the bladder neck, and the needle was inserted at a 45° angle. The second needle was injected at intervals determined by the extent of median lobe enlargement. Each puncture point was observed for no significant bleeding, and the instrument was then removed, with an F16/F18 silicone catheter left in place. The operative time as well as indwelling catheter time were recorded. The clinical parameters such as IPSS, QOL, prostate volume, Qmax, PVR, QOL, IIEF-5 and MSHQ-EjD at preoperative and 12 to 22 weeks post operation were compared. Adverse events from the Rezūm procedure to 12-22 weeks postoperatively were recorded. Results:All the operations were successfully completed. The operation time of Rezūm system was 3.9±1.6 min, and the indwelling catheter time after operation was 4.8±1.1 days. The IPSS scores of 22 patients at 12-22 weeks after operation were 4.4±3.3, whose reduction was 14.9±4.4 compared with these at baseline( P<0.01). The PV was (37.7±8.4)ml, Qmax was (25.5±9.6)ml/s, PVR was (6.2±8.1)ml, and QOL was 1.6±0.9, all demonstrating statistically significant differences compared to preoperative values ( P<0.05). Among the 19 cases with sexual activity, the IIEF-5 score was 20.4±3.2, and the ejaculatory function score of MSHQ-EjD was 13.1±3.1, both showing statistically significant differences compared to preoperative scores ( P<0.05). The ejaculatory satisfaction score of MSHQ-EjD was 1.1±0.5, and there was no statistically significant difference compared to preoperative scores ( P>0.05). None of the 22 cases required medication or further surgical treatment for BPH after surgery. There were no urethral injuries, rectal or bladder perforations during the surgeries, and no severe complications such as rectal fistula or bladder neck contracture occurred postoperatively. There were no deaths reported. Postoperative discomfort in the urethra occurred in 19 cases, urethral pain in 8 cases, hematuria in 15 cases, poor sleep quality in 2 cases, and constipation in 1 case, all of which resolved within 7 to 10 days after surgery. Erectile dysfunction and retrograde ejaculation occurred in one case each at 4 to 5 weeks postoperatively but did not reoccur thereafter. Prostatitis and nodular hyperplasia of the middle lobe of the prostate occurred in one case each at 21 weeks and 25 weeks postoperatively, respectively, and no treatment was administered. Conclusions:In the real world, the short-term overall effect of Rezūm Water Vapor Thermal Therapy system in the treatment of benign prostatic hyperplasia is satisfactory, which shows good efficacy and safety.

Cigarros eletrônicos e suas consequências histopatológicas relacionadas à doenças pulmonares / E-cigarettes and histopathological consequences related to lung diseases

O cigarro eletrônico surgiu como uma tentativa para minimizar a dependência ao uso de tabaco, entretanto, engloba controvérsias e dúvidas acerca das reais implicações para o organismo humano. Diante disso, o presente estudo tem como objetivo realizar uma revisão da literatura a fim de relacionar o uso de cigarro eletrônico com suas consequências para os humanos. Os estudos analisados relatam experimentos in vitro e in vivo em camundongos, demonstrando menor concentração de poluentes e nocividades no cigarro eletrônico comparado ao convencional, porém, seu potencial efeito maléfico está relacionado à composição do e-líquido, à maneira do uso e à variedade de aromas presentes nos produtos. Além disso, foram verificadas lesões celulares, hiperreatividade das vias aéreas, liberação de citocinas ­ IL-8, IL-10 e TNF, redução da ação antimicrobiana de queratinócitos e potencial apoptose nas células alveolares. Foi observado também um aumento em até cinco vezes da concentração de carboxihemoglobina em comparação ao cigarro comum e um aumento na auto renovação de células de adenocarcinoma pulmonar de células não pequenas, devido à expressão de SOX2. Observa-se também que em casos de DPOC, o cigarro eletrônico não apresenta agravamentos na fisiologia respiratória, contrapondo outras ocorrências como asma, pneumonia, câncer de pulmão e doenças infecciosas que podem ser ocasionadas ou exacerbadas pelo seu uso. Contudo, pelo curto prazo de observação de seus efeitos, não é possível determinar com precisão a segurança dos cigarros eletrônicos, dessa forma, faz-se necessário que mais pesquisas longitudinais sejam desenvolvidas, auxiliando, assim, na construção de evidências sobre a segurança dos cigarros eletrônicos e na regulamentação futura do produto.

Electronic cigarettes emerged as an attempt to minimize tobacco dependence. However, its use is surrounded by controversies and doubts about the real implications for the human organism. Therefore, this study aims at performing a review of the most recent literature to corelate the use of e-cigarettes with their consequences for the human body. The analyzed studies relate in vitro and in vivo experiments on mice, demonstrating lower concentration of pollutants and harmfulness in the electronic cigarette than in conventional cigarettes. However, its potential harmful effect is related to the composition of the e-liquid, in its use and in the variety of aromas in the products. In addition, cellular lesions, airway hyperreactivity, release of IL-8, IL-10 and TNF cytokines could be observed, as well as reduced keratinocyte antimicrobial action and potential apoptosis in alveolar cells. An increase of up to five-fold the concentration of carboxyhemoglobin in comparison to ordinary cigarettes and an increase in self-renewal of non-small pulmonary adenocarcinoma cells due to the expression of SOX2 have also been related. It could also be observed that in COPD cases, e-cigarettes do not present worsening in respiratory physiology, which contrasts with other occurrences such as asthma, pneumonia, lung cancer, and infectious diseases that can be caused or exacerbated by its use. However, due to the short term of observation of the effects, the safety of e-cigarettes could not be accurately determined, thus, the need for further longitudinal research is necessary, which could be used to help build evidence about the safety of e-cigarettes and also to create future regulation of the product.

Intercambio desde los cigarrillos convencionales a los sistemas electrónicos de administración de nicotina: revisión sistemática rápida con metaanálisis y aspectos económicos / Switching from cigarettes to electronic nicotine delivery system: rapid systematic review and meta-analysis and economic aspects

RESUMEN Objetivos. Evaluar cómo y en qué medida se produce un intercambio desde los cigarrillos convencionales (CC) a los sistemas electrónicos de administración de nicotina (SEAN). Materiales y métodos. Se realizó una revisión sistemática hasta agosto de 2019. El desenlace primario fue la proporción de un intercambio completo o parcial de CC a los SEAN y sus aspectos económicos. Los desenlaces secundarios como medidas de resultado fueron la probabilidad de intercambio y la tendencia en el intercambio por países. Resultados. Se encontraron 3628 referencias y se incluyeron 49 estudios con datos epidemiológicos y económicos. Los estudios económicos sobre la elasticidad cruzada de precios mostraron que los CC son parcialmente intercambiables por SEAN. La mayoría de los estudios reportaron que la prevalencia del consumo de cigarrillos electrónicos se incrementó con el tiempo. Tres estudios reportaron una reducción significativa de los CC consumidos por día entre fumadores duales (convencionales más SEAN) en comparación con los consumidores de CC. El odds ratio ajustado y combinado de dejar los CC entre consumidores de SEAN en comparación con quienes nunca consumieron o lo hicieron en el pasado fue de 1,19 (IC95%: 1,09-1,30; heterogeneidad 0%). Los estudios longitudinales mostraron una creciente prevalencia del uso de cigarrillos electrónicos, principalmente en adolescentes. Se encontró una relación negativa entre el consumo y aumento de precio de CC y electrónicos. Conclusión. La probabilidad de dejar de fumar CC entre consumidores habituales de SEAN se incrementó respecto a los consumidores que nunca o que solían consumir SEAN. Estudios económicos reportaron que los cigarrillos electrónicos son parcialmente intercambiables por los CC.

ABSTRACT Objectives. To assess how and in what extent the electronic nicotine delivery systems (ENDS) use substituted the consumption of traditional combustible cigarettes (c-cigarettes, c-cig). Materials and Methods. We performed a systematic review of the literature up to August 2019 in scientific databases. Primary outcomes were proportion of complete or partial substitution of conventional to electronic cigarettes and related economic aspects. Secondary outcomes were odds ratio of substitution and country-wise time trends. Results. We retrieved 3,628 references and included 49 studies, providing economic and epidemiological data. Economic studies of cross-price elasticity showed that combustible cigarettes are partially substitutable for electronic cigarettes. Most studies reported that electronic cigarettes consumption prevalence increased over time. Three studies reported a significant reduction of combustible cigarettes consumed per day among dual users (combustible- plus electronic- cigarettes users) versus combustible-cigarettes users. The pooled adjusted odds ratio of quitting combustible cigarettes among electronic cigarettes users versus never or past electronic cigarettes (e-cigarettes, e-cig) users was 1.19 (95% confidence interval 1.09 to 1.30; heterogeneity score 0%). Longitudinal studies showed globally a growing prevalence of electronic cigarettes use, mainly in adolescents. A negative relationship between consumption and price increase of electronic and combustible cigarettes was found. Conclusion. The chance of quitting smoking combustible cigarettes among current electronic nicotine delivery systems users was increased with respect to never- or past- electronic nicotine delivery systems users. Economic studies reported that electronic cigarette is partially substitutable for combustible cigarettes.

Fatores relacionados à qualidade do vapor para esterilização de produtos para saúde / Factors related to quality of steam for sterilization of medical devices / Factores relacionados con la calidad del vapor para la esterilización de productos sanitarios

Objetivos: Identificar e discutir os fatores relacionados à qualidade do vapor e sua relação com as práticas do cotidiano do Centro de Material e Esterilização. Método: Pesquisa documental, construída com base na análise do referencial teórico normativo sobre a qualidade do vapor para esteriliza-ção de produtos para saúde. Resultados: Os fatores que estão diretamente relacionados à qualidade do vapor são: água de alimentação, contaminantes do vapor, flutuações de pressão na rede, gases não condensáveis, título e superaquecimento. Conclusão: O controle de fatores que impactam o sucesso de esterilização por vapor não é uma atribuição única da engenharia clínica, mas sim uma responsabilidade compartilhada com o gestor do centro de materiais. A segurança na esterilização pelo vapor não deve ser reduzida ao controle de tempo, à temperatura ou ao resultado de indicadores físicos, quí-micos e biológicos, mas incluir o controle da qualidade do vapor, que é o agente esterilizante.

Objectives: To identify and discuss the factors related to quality of steam and their relation to daily practices of the Central Sterile Supply Department (CSSD). Method: Documentary research based on the analysis of the normative theoretical framework about quality of steam for the ste-rilization of medical devices. Results: Factors that are directly related to quality of steam are: feedwater, steam contaminants, pipeline pressure fluctua-tions, non-condensable gases, steam dryness and superheating. Conclusion: Controlling factors that impact the success of steam sterilization is not an assignment for clinical engineering service only; it is a responsibility that should be shared with the manager of the CSSD. Safety in steam sterilization should not be reduced to monitoring of time, temperature or the result of physical, chemical and biological indicators, but include monitoring of the quality of steam, which is the sterilizing agent.

Objetivos: Identificar y discutir los factores relacionados con la calidad del vapor y su relación con las prácticas cotidianas en el Centro de Material y Esterilización. Método: Investigación documental, construida a partir del análisis del marco teórico normativo sobre la calidad del vapor para esterilización de productos sanitarios. Resultados: Los factores que están directamente relacionados con la calidad del vapor son: agua de alimentación, contaminantes del vapor, fluctuaciones de presión en la red, gases no condensables, titulación y sobrecalentamiento. Conclusión: El control de los facto-res que impactan el éxito de la esterilización por vapor no es una tarea única de la ingeniería clínica, sino una responsabilidad compartida con el gerente del centro de materiales. La seguridad en la esterilización por vapor no debe reducirse al control del tiempo, la temperatura o el resultado de indicadores físicos, químicos y biológicos, sino que debe incluir el control de la calidad del vapor, que es el agente esterilizante.

Análise crítica das especificações técnicas em processos de licitação para aquisição de autoclaves / Critical Analysis of Technical Specifications in Bidding Processes for the Acquisition of Autoclaves / Análisis crítico de especificaciones técnicas en procesos de licitación para adquisición de autoclaves

Objetivo: Analisar as especificações técnicas em processos de licitação para aquisição de autoclaves com mais de 90 L, com base na normatização relacionada. Método: Pesquisa descritiva, documental, com abordagem quantitativa, baseada em processos de licitação disponíveis online. Resultados: Foram analisados 112 processos, dos quais 106 (94,6%) foram provenientes do Brasil e seis (5,4%) do México, Honduras, El Salvador, Panamá e Paraguai. Os documentos foram analisados de acordo com aspectos construtivos, ciclos de esterilização, itens opcionais, itens de segurança e ferramentas de gestão. Conclusão: As especificações técnicas, em sua maioria, estão desatualizadas, em alguns casos comprometendo a segurança no processo de esterilização.

Objective: To analyze technical specifications in bidding processes for the acquisition of autoclaves with more than 90 L, based on the related standards. Method: Descriptive, documentary research, with a quantitative approach, based on bidding processes available online. Results: 112 bidding processes were analyzed, of which 106 (94.6%) came from Brazil and six (5.4%) from Mexico, Honduras, El Salvador, Panama and Paraguay. The documents were assessed according to construction aspects, sterilization cycles, optional items, safety items and management tools. Conclusion: Most of the technical specifications are outdated, in some cases compromising safety in the sterilization process.

Objetivo: Analizar las especificaciones técnicas en los procesos de licitación para la adquisición de autoclaves con más de 90 L, en base a la estandarización relacionada. Método: Investigación descriptiva, documental, con enfoque cuantitativo, basada en procesos de licitación disponibles online. Resultados: Se analizaron 112 casos, de los cuales 106 (94,6%) procedían de Brasil y seis (5,4%) de México, Honduras, El Salvador, Panamá y Paraguay. Los documentos fueron analizados según aspectos constructivos, ciclos de esterilización, opcionales, elementos de seguridad y herramientas de gestión. Conclusión: La mayoría de las especificaciones técnicas están desactualizadas, en algunos casos comprometiendo la seguridad en el proceso de esterilización.

Establishment of a cocrystal characterization method for sacubitril valsartan sodium / 药学学报

Sacubitril valsartan sodium (LCZ696) is an ionic cocrystal drug. The purpose of this study was to explore the cocrystal features of LC696 by establishing a variety of characterization methods, and thus provide basic research data for effective quality control. The cocrystal characteristics of LCZ696 and its tablets were identified by applying analytical means including powder X-ray diffraction (PXRD), fourier transform infrared spectroscopy (FTIR), Raman spectra (RM), differential scanning calorimetry (DSC) and solid-state nuclear magnetic resonance spectroscopy (ssNMR). The crystalline water and hygroscopicity of LCZ696 were analyzed by thermogravimetric analysis (TGA), dynamic vapor sorption (DVS), hygroscopicity test and Karl Fischer reaction method. The results show that PXRD, FTIR, DSC and ssNMR can effectively distinguish the features of LCZ696 cocrystal, sacubitril monomer, valsartan monomer, and sacubitril-valsartan (1∶1) mixture. RM can be used as a supplementary approach. Combined with the analysis by TGA, DVS, hygroscopicity test and Karl Fischer reaction method results, LCZ696 contains 2.5 crystalline water molecules and is very hygroscopic; we recommend that LCZ696 be stored in an environment with a relative humidity below 60%. By characterizing the crystal features we can establish quality control measure and evaluate the stability of the drug tablets. This study provides data in support for the establishment of the LCZ696 quality standard.

Electrostatic dry powder coated moisture barrier films for Compound Danshen Tablets / 中草药

Objective: Using ultrafine hydroxypropyl cellulose (HPC) powders as coating material to prepare moisture barrier coating film for Compound Danshen Tablets by an innovative electrostatic powder coating technology. The effects of coating prescription and process parameters on coating efficiency and coating film properties were investigated, so as to provide new ideas for moistureproof coating of moisture sensitive traditional Chinese medicine such as Compound Danshen Tablets. Methods: Free films were prepared by applying an electrostatic deposition process, and the effects of liquid plasticizer on the mechanical properties and the water vapor permeability were investigated. And the Compound Danshen Tablets were dry coated with ultrafine powders by the electrostatic coating technology. The effects of coating formulations and processing conditions on the moisture sorption behavior of the barrier film coated tablets were studied. Results: The coating efficiency could be manipulated by adjusting the charging voltage of the electrostatic spray gun and the amount of the liquid plasticizer. Compared with static curing process, dynamic curing process was capable to produce a satisfactory film with an enhanced moisture barrier function for the herbal medicines. The best coating process parameters were plasticizer spraying time 3 min and titanium dioxide addition ratio 1%. The minimum hygroscopicity was achieved when the coating level was increased to 6.7%. Conclusion: The moisture-protective effect by using a novel electrostatic coating technology with ultrafine powders was efficiently achieved, suggesting that it was a promising alternative for the protection for the moisture sensitive drugs.

Effect of dlc films with and without silver nanoparticles deposited on titanium alloy

Abstract Diamond-like carbon (DLC) film is a biocompatible hard coating material that can prevent the leaching of metal ions. This study evaluates the structural characteristics of DLC, with and without silver nanoparticles, deposited by plasma (PECVD) on titanium alloy (Ti-6Al-4V) and bone formation in contact with DLC films. Sixty Ti-6Al-4V samples were used divided in: uncoated, coated with DLC and coated with DLC-Ag. After structural characterization, samples were fixed bilaterally at the rabbit's mandible. After 15 and 90 days, samples were characterized again and bone formation in the area was analyzed by histomorphometry. Statistical analysis was performed by two-way ANOVA. Both the DLC and DLC-Ag films were firmly adhered and showed a high electrical resistance without significant changes in the Raman spectrum after in vivo integration. After 15 days, there were immature bone trabeculae in the interface and partially covering the surface. After 90 days, mature bone filled the interface and coved the surface. There was no statistically significant difference among the three groups in both periods. In conclusion, osseointegration with DLC, DLC-Ag and uncoated Ti-6Al-4V is similar. However, DLC and DLC-Ag coverings have the advantage of electrical insulation and can presumably control bacterial activity and ion leaching.

Resumo O filme de carbono semelhante a diamante (DLC) é um material de revestimento duro e biocompatível que pode impedir a corrosão com liberação de íons metálicos. Este estudo avaliou as características estruturais do filme de DLC, com e sem nanopartículas de prata (Ag), depositadas por plasma (PECVD) em liga de titânio (Ti-6Al-4V) e formação óssea em contato com filmes de DLC. Foram utilizadas 60 amostras de Ti-6Al-4V divididas em: não recobertas, recobertas com DLC e recobertas com DLC-Ag. Após caracterização estrutural, amostras foram fixadas bilateralmente na mandíbula de coelhos. Após 15 e 90 dias, as amostras foram novamente caracterizadas e a formação óssea na área foi analisada por histomorfometria. A análise estatística foi realizada por ANOVA dois fatores. Ambos os filmes DLC e DLC-Ag foram firmemente aderidos e mostraram uma alta resistência elétrica sem alterações significativas no espectro Raman após a osseointegração in vivo. Após 15 dias, havia trabéculas ósseas imaturas na interface e cobrindo parcialmente a superfície. Após 90 dias, o osso maduro preencheu a interface e a superfície. Não houve diferença estatisticamente significante entre os três grupos nos dois períodos. Em conclusão, a osseointegração com DLC, DLC-Ag e Ti-6Al-4V não revestido é similar. No entanto, os revestimentos DLC e DLC-Ag têm a vantagem do isolamento elétrico e podem presumivelmente controlar a atividade bacteriana e a corrosão com liberação de íons.

Does Sterilization Affect the Push Out Bond Strength of Experimental Dentin Posts? / ¿Afecta la esterilización la fuerza de adherencia de los postes de dentina experimentales?

ABSTRACT The purpose of this preliminary study is to evaluate the push-out bond strength (PBS) of experimental dentin posts (EDPs) obtained from human and bovine teeth sterilized by autoclaving and gamma radiation. Eighty-four mandibulary premolars were obturated and divided into three post groups: the glass fiber group (Fb) human EDP group (Hm) and the bovine EDP group (Bv). Three subgroups (n=12) were obtained for each EDP groups according to the sterilization methods; no sterilization (Cnt), steam autoclaving (Aut), and gamma radiation (Rad) a total dose of 25 kGy. All posts were cemented to root canals using a dual cured resin cement (Panavia SA). After the micro slices (1mm in thickness) were obtained of each subgroup, PBS test was performed. Data were analyzed using two-way ANOVA and Tukey's multiple comparison tests (α=.05). The post type and sterilization method was significantly effective on the PBS values according to the ANOVA (P<.001). No sterilization apllied EDP groups showed significantly higher PBS values than the sterilized groups (P<.001). Bv_Cnt (9.42 ±1.31) showed significantly lower PBS values than both Fb (12.36 ±1.54) and Hm_Cnt (11.06 ±1.38) groups (P<.001). Both steam autoclaving and gamma radiation affect the PBS values and fracture modes of EDPs negatively. The bovine EDPs are not as effective as human EDPs with regard to the PBS to the root dentin.

RESUMEN El propósito de este estudio preliminar es evaluar el push-out bond strength de los postes de dentina experimentales (PDE) obtenidos de dientes humanos y bovinos esterilizados por autoclave y radiación gamma. Ochenta y cuatro premolares mandibulares fueron obturadores y se dividieron en tres grupos experimentales de postes: el grupo de fibra de vidrio (Fb) grupo PDE humano (Hm) y el grupo PDE bovino (Bv). Se obtuvieron tres subgrupos (n=12) para cada grupo de PDE según los métodos de esterilización; sin esterilización (Cnt), autoclave a vapor (Aut) y radiación gamma (Rad) con una dosis total de 25 kGy. Todos los postes se cementaron a los conductos radiculares utilizando un cemento de resina de curado doble (Panavia SA). Después de que se obtuvieron las micro rebanadas (1 mm de espesor) de cada subgrupo, se realizó una prueba de push-out bond strength. Los datos se analizaron utilizando ANOVA de dos vías y las pruebas de comparación múltiple de Tukey (α=.05). El tipo de poste y el método de esterilización fueron significativamente efectivos en los valores de push-out bond strength según el ANOVA (P <.001). Los grupos de PDE no aplicados a la esterilización mostraron valores de push-out bond strength significativamente mayores que los grupos esterilizados (p <0,001). Bv_Cnt (9.42 ±1.31) mostró valores de push-out bond strength significativamente más bajos que los grupos Fb (12.36 ±1.54) y Hm_Cnt (11.06 ±1.38) (P <.001). Tanto el autoclave al vapor como la radiación gamma afectan negativamente los valores de push-out bond strength y los modos de fractura de los PDE. Los PDE bovinos no son tan efectivos como los PDE humanos con respecto a la fuerza de adhesión a la dentina de la raíz.

Pacotes molhados: o aumento do tempo de secagem aumenta o consumo de água (recurso natural escasso)? / Paquetes mojados: el aumento del tiempo de secado aumenta el consumo de agua (recurso natural escaso)? / Wet packs: Is extending drying time increasing water (scarce natural resource) consumption?

Resumo Objetivo: Este estudo tem como objetivo comparar o consumo de água e energia em quatro configurações do ciclo (número de pulsos na fase de condicionamento, tempo de secagem e valor de ajuste da profundidade do vácuo) para esterilização a vapor. Métodos: Estudo descritivo de quatro diferentes configurações de ciclo: na configuração A, os pulsos de vácuo da fase de condicionamento foram ajustados no total de três, com a profundidade de vácuo em 90 mbar e o ponto positivo de pressão em 1500 mbar. A fase de secagem foi ajustada em 45 minutos com a profundidade de vácuo em 90 mbar. Os consumos de água e energia foram medidos durante toda a fase de condicionamento e a cada 15 minutos durante a fase de secagem. Na configuração B, a profundidade de vácuo na fase de condicionamento foi de 150 mbar e os outros parâmetros foram idênticos aos da configuração A. Nas configurações C e D, o número de pulsos de vácuo foi ajustado no total de cinco, com o ponto positivo de pressão em 1500 mbar nas duas configurações e a profundidade de vácuo de 90 mbar e 150 mbar, respectivamente. Resultados: A água consumida durante a fase de secagem teve grande impacto sobre o consumo total de água durante todo o ciclo. Conclusão: Este estudo evidenciou que o aumento do tempo de secagem para solucionar pacotes molhados aumenta o consumo de água, um recurso natural escasso, que deve ser utilizado como última opção para obter pacotes secos ao fim do ciclo.

Resumen Objetivo: Este estudio tiene el objetivo de comparar el consumo de agua y energía en cuatro configuraciones del ciclo (número de pulsos en la fase de acondicionamiento, tiempo de secado y valor de ajuste de la profundidad del vacío) para esterilización a vapor. Métodos: Estudio descriptivo de cuatro diferentes configuraciones de ciclo: en la configuración A, los pulsos de vacío de la fase de acondicionamiento se ajustaron en el total de tres, con la profundidad de vacío en 90 mbar y el punto positivo de presión en 1500 mbar. La fase de secado se ajustó en 45 minutos con la profundidad de vacío en 90 mbar. Los consumos de agua y energía fueron medidos durante toda la fase de acondicionamiento y cada 15 minutos durante la fase de secado. En la configuración B, la profundidad de vacío en la fase de acondicionamiento fue de 150 mbar y los otros parámetros fueron idénticos a los de la configuración A. En las configuraciones C y D, el número de pulsos de vacío se ajustó en el total de cinco, con el punto positivo de presión en 1500 mbar en las dos configuraciones y la profundidad de vacío de 90 mbar y 150 mbar, respectivamente. Resultados: El agua consumida durante la fase de secado tuvo un gran impacto en el consumo total de agua durante todo el ciclo. Conclusión: Este estudio evidenció que el aumento del tiempo de secado para solucionar paquetes mojados aumenta el consumo de agua, un recurso natural escaso, que debe ser utilizado como última opción para obtener paquetes secos al final del ciclo.

Abstract Objective: This study aims to compare water and power consumption in four cycle configurations (number of pulses in the conditioning phase, drying time, and vacuum depth set point) for steam sterilization. Methods: A descriptive study of four different cycle configurations: In configuration A, conditioning phase vacuum pulses were set to a total of three, with a lower vacuum set point of 90 mbar and a higher pressure set point of 1500 mbar. The drying phase was set for 45 minutes with a vacuum level of 90 mbar. Water and power consumption were measured during the entire conditioning phase, and every 15 minutes during the drying phase. In configuration B the conditioning phase vacuum set point was adjusted to 150 mbar and the other parameters were identical to configuration A. On configurations C and D, the quantity of vacuum pulses was set to five, with higher pressure adjusted to 1500 mbar in both configurations. The lower vacuum set point was adjusted to 90 mbar in configuration C and to 150 mbar in configuration D. Results: Water consumption at the drying phase had the most impact on the total water consumption for the entire cycle. Conclusion: This study shows that increasing drying time to solve wet packs will increase water consumption, a scarce natural resource, and should be the last option to achieve dry loads at the end of the cycle.

Hygroscopicity Study of Vitamin B12 Chemical Reference Substance / 中国药学杂志

OBJECTIVE: To investigate the hygroscopicity of vitamin B12 and the related problems of its chemical reference substance (CRS) that should be paid attention to. METHODS: UV absorption coefficient was determined at 361 nm, using water as solvent. Dynamic vapor absorption analysis (DVS) was applied to evaluate the moisture sorption trend and capacities of vitamin B12 under different humilities. RESULTS: Owing to the strong hygroscopicity of vitamin B12, deviation in the process of weighing might result in smaller UV absorption coefficient compared with the actual value, especially for dried and low moisture content raw materials in high-humidity environment. CONCLUSION: In the study of drug quality control for vitamin B12, the strong hygroscopicity of the raw material should be paid attention to, particularly in the research and application of vitamin B12 CRS.

Feasibility of vapor permeation technology for separating of Asari Radix et Rhizoma essential oil-bearing water / 中草药

Objective: To verify the feasibility of vapor-permeable membrane technology for the separation of water bodies containing essential oil of Asari Radix et Rhizoma (ARR) essential oil, and then to apply vapor permeate technology to the separation of more essential oils of traditional Chinese medicine. Methods: The polydimethylsiloxane/polyvinylidene fluoride (PDMS/PVDF) composite flat membrane and polyvinylidene fluoride (PVDF) flat membrane were collected as the membrane material. The oil-bearing water body of ARR volatile oil was separated by vapor permeate technology, and the oil penetration rate of two kinds of membranes was calculated. At the same time, the changes of the composition and content of the essential oil before and after the membrane were analyzed by gas chromatography-mass spectrometry (GC-MS). Results: The results showed that the essential oil penetration rate was significantly higher than that of PDMS/PVDF membrane when PVDF membrane was used as membrane material. GC-MS qualitative analysis results showed that the composition of the essential oil in the penetrants of the two membranes was basically the same as that of the essential oil obtained by the traditional steam distillation method. The content of α-pinene, β-pinene, 3,5-dimethoxytoluene, and methyl eugenol were determined by double internal standard method. The results showed that the content of each component in the PVDF membrane permeation was significantly higher than that of the PDMS/PVDF membrane permeation solution. Conclusion: It is feasible to separate the oil containing water from the essential oil of ARR by vapor permeation membrane technology. Compared with the PDMS/PVDF membrane, the PVDF membrane is more suitable for separating the oil containing water of the essential oil of ARR.

Protocolo de avaliação de mudança para o processo de esterilização a vapor / Change assessment protocol for steam sterilization process / Protocolo de evaluación para el proceso de esterilización a vapor

Objetivo: Relatar a experiência da criação de um protocolo de avaliação de mudança do processo de esterilização a vapor. Método: Relato de experiência, com base no fundamento teórico e na validação de novos equipamentos do Centro de Material e Esterilização. A validação ocorreu entre maio e julho de 2016, e testou a adequação ao processo e ao material, utilizando a NBR ISO 17665-1. O protocolo contempla os principais pontos para influenciar a decisão de manter ou reavaliar o equipamento. A validação do protocolo ocorreu por cinco enfermeiros atuantes no Centro de Material e Esterilização. Resultados: O protocolo foi composto por seis ações, que exigem requalificação do equipamento, e três ações que não impactaram em nenhum ponto crítico do processo. O ponto mais crítico observado ocorreu com materiais úmidos. O protocolo foi validado pelos enfermeiros do Centro de Material e Esterilização e apresentado na forma de fluxograma. Conclusão: O protocolo favorece que enfermeiros atuem de forma crítica na manutenção corretiva e preventiva do equipamento de esterilização a vapor

Objective: To report on the experience of creating a protocol, which evaluates changes in the steam sterilization process. Method: Experience report, based on the theoretical basis and validation of new equipment at the Central Sterile Supply Department. The validation occurred between May and July of 2016, and tested the suitability of the process and the material, using ISO 17665-1. The protocol includes main points that influence the decision of whether to maintain or re-evaluate the equipment. The protocol validation was carried out by five nurses from the Central Sterile Supply Deparment. Results: The protocol was composed of six actions, which required verification of the equipment, and three actions that did not impact any critical points in the process. The most critical point observed was with wet materials. The protocol was validated by the nurses from the Central Sterile Supply Department, and presented as a flowchart. Conclusion: The protocol promotes the idea of nurses acting critically in corrective and preventive maintenance of steam sterilization equipment.

Objetivo: Informar la experiencia de la creación de un protocolo de evaluación del proceso de esterilización a vapor. Método: Relato de experiencia, basado en el fundamento teórico y en la validación de nuevos equipos del Centro de Material y Esterilización. La validación ocurrió entre mayo y julio de 2016, y probó la adecuación al proceso y al material, utilizando la NBR ISO 17665-1. El protocolo contempla los principales puntos para influir en la decisión de mantener o reevaluar el equipo. La validación del protocolo fue realizado por cinco enfermeros actuantes en el Departamento Central de Abastecimiento de Esterilización. Resultados: El protocolo fue compuesto por seis acciones, que exigen recalificación del equipo, y tres acciones que no impactan en ningún punto crítico del proceso. El punto más crítico observado ocurrió con materiales húmedos. El protocolo fue validado por los enfermeros del Departamento Central de Abastecimiento de Esterilización y presentado en forma de diagrama de flujo. Conclusión: El protocolo favorece que los enfermeros actúen de forma crítica en el mantenimiento correctivo y preventivo del equipo de esterilización a vapor.

Study of relationship among solution concentration-boiling point-saturation vapor pressure for glycyrrhizic acid solution / 中草药

Objective Based on the theory of dynamic method for measuring the boiling point-saturated vapor pressure, the functional relationship between the boiling point and saturation vapor pressure was studied for the glycyrrhizic acid solution. To build the relationship among the mass fraction of glycyrrhizic acid solution, boiling point and saturation vapor pressure, in order to provide the experimental data and theoretical basis for the related studies of traditional Chinese medicine concentration process. Methods The concentration of glycyrrhizic acid was determined by UPLC for different concentration of glycyrrhizic acid solution. Also, the surface tension of glycyrrhizic acid solution was measured by platinum plate method. Based on dynamic method, the boiling point was measured with the changing saturated vapor pressure at the different mass fractions of solution. Results The concentration of glycyrrhizin in the original extract was 99.25 mg/mL, which accounted for 21.5% of the total solid soluble substance. The dilution process is fully even and conforms to the gradient ratio. When the solution mass fraction was more than 18%, the micelle was formed gradually in the liquid, reducing the surface tension of the solution. It can be found that the boiling point showed the downward trend with increasing solution concentration of glycyrrhizic acid, while the pressure was maintained constant in the environment. When the temperature of solution was hold constant, the saturation vapor pressure of the solution increased with increasing solution concentration of glycyrrhizic acid, but the trend of this interaction was not obvious between the temperature range (313.0—343.0 K). Conclusion According to the experimental results, the functional relationship among the concentration, boiling point and saturated vapor pressure of glycyrrhizic acid solution was constructed. While maintaining the concentration vacuum and the heating energy consumption unchanged in the production process, the glycyrrhizic acid solution temperature should slowly decrease and the evaporation rate should be moderately accelerated with the increasing mass fraction of solution.

Clinical study on transurethral laser shovel type vapor-resection-enucleation of the prostate based on the inter-layer of surgical capsule for the treatment of benign prostatic hyperplasia / 中华泌尿外科杂志

Objective To evaluate the efficacy and safety of transurethral laser shovel type vaporresection-enucleation of the prostate (LS-VREP) based on the inter-layer of surgical capsule for the treatment of benign prostatic hyperplasia (BPH),which was less 80 g weight.Methods From September 2013 to August 2016,a retrospective study was performed including 1 369 cases of BPH patients,who were treated by 120-160 W transurethral laser (straight green-light) shovel type vapor-resection-enucleation of the prostate (LS-VREP group,n =1 008) and transurethral resection of the prostate (TURP group,n =361).The preoperative data,including average age,prostate weight,IPSS,QOL,Qmax and PVR was reviewed.There was no significant difference of the above data between the two groups (P ＞ 0.05).Operative time,changes of hemoglobin and serum sodium concentration,postoperative bladder irrigation time,catheter indwelling duration,hospital stay,pre-and 3 months post-operative IPSS,QOL,Q PVR were recorded.In addition,complications were monitored.Results Mean operation time of LS-VREP group was (46.1 ± 18.6) min,while TURP group was (48.2 ± 15.2) min,and there was no difference between the two groups (P ＞ 0.05).Post-operative mean hemoglobin concentration and serum sodium concentration of LS-VREP group decreased (1.6 ± 1.2) g/L and (1.2 ± 0.6) mmol/L respectively,while those of TURP group decreased (5.7 ± 3.6) g/L and (3.2 ± 1.2) mmol/L,and the differences were statistically significant (P ＜ 0.05).Mean post-operative catheter indwelling time,and post-operative hospital stay of LS-VREP group was (42.9 ± 12.7) h and (3.2 ± 0.6) d,while TURP group was (65.7 ± 15.4) h and (5.4 ± 1.2) d,and the differences were statistically significant (P ＜ 0.05).Comparatively IPSS,QOL,Qmax and PVR were all improved significantly in both groups at 3 months after operation (P ＜ 0.05),but no significant difference was found between the two groups (P ＞ 0.05).After three months' follow-up of post-operation,as for the complication rate,including TURS,bleeding requiring reoperation,incontinence,dysuria and erectile dysfunction,LS-VREP group (15/1 008) was less than that of TURP group (30/361,P ＜ 0.05).Conclusions The LS-VREP based on the inter-layer of surgical capsule is safe and effective for the treatment of BPH patients whose prostate weight was less than 80 g.LS-VREP showed less intraoperative bleeding,faster postoperative recovery,and high safety,which is considered a safe,effective and optimized minimally invasive surgery.

Two Cases of Corneal Edema Due to Vaporized Amine

PURPOSE: We report two cases of corneal edema in patients who presented with bilateral blurry vision due to vaporized amines while working in a polyurethane processing plant. CASE SUMMARY: A 28-year-old male presented with bilateral blurred vision. His work involved solidifying polyurethane liquid and he often found himself exposed to polyurethane heat and gas. On examination, the patient's uncorrected visual acuity (UCVA) was 20/40 (right) and 30/50 (left). A slit lamp examination revealed subepithelial microbullae in both eyes. The central corneal thickness (CCT) was also increased in both eyes, measuring 698 µm (right) and 672 µm (left). After prescribing 0.5% moxifloxacin and, 1% fluorometholone eye drops for 3 days in both eyes, the UCVA recovered to 20/40 (right) and 20/20 (left). The CCT decreased to 644 µm (right) and 651 µm (left), and the microbullae improved significantly in the left eye. The second patient was a 34-year-old female who presented with bilateral decreased visual acuity while at work. She worked in a factory that produced car seat filling. Her UCVA was 20/25 (right) and 20/20 (left). The CCT by specular microscopy was 537 µm (right) and 541 µm (left). On slit lamp examination, both eyes demonstrated bilateral central subepithelial edema. The patient did not attend any follow-up outpatient appointments after the initial presentation. CONCLUSIONS: Exposure to vaporized amines such as polyurethane may causereversible corneal toxicityeven without direct contact. Further consideration should be given to ocular safety and protection from amine compounds in the industrial field.

Study on essential oil separation from Forsythia suspensa oil-bearing water body based on vapor permeation membrane separation technology / 中国中药杂志

To investigate the feasibility of vapor permeation membrane technology in separating essential oil from oil-water extract by taking the Forsythia suspensa as an example. The polydimethylsiloxane/polyvinylidene fluoride (PDMS/PVDF) composite flat membrane and a polyvinylidene fluoride (PVDF) flat membrane was collected as the membrane material respectively. Two kinds of membrane osmotic liquids were collected by self-made vapor permeation device. The yield of essential oil separated and enriched from two kinds of membrane materials was calculated, and the microscopic changes of membrane materials were analyzed and compared. Meanwhile, gas chromatography-mass spectrometry (GC-MS) was used to compare and analyze the differences in chemical compositions of essential oil between traditional steam distillation, PVDF membrane enriched method and PDMS/PVDF membrane enriched method. The results showed that the yield of essential oil enriched by PVDF membrane was significantly higher than that of PDMS/PVDF membrane, and the GC-MS spectrum showed that the content of main compositions was higher than that of PDMS/PVDF membrane; The GC-MS spectra showed that the components of essential oil enriched by PVDF membrane were basically the same as those obtained by traditional steam distillation. The above results showed that vapor permeation membrane separation technology shall be feasible for the separation of Forsythia essential oil-bearing water body, and PVDF membrane was more suitable for separation and enrichment of Forsythia essential oil than PDMS/PVDF membrane.

Riesgos ambientales y de seguridad en calderas a carbón de las pequeñas y medianas empresas «PYME¼, ubicadas en el municipio de Itagüí, Antioquia / Safety and environmental risks of coal fired boilers in small and medium-sized enterprises «SMEs¼, located in Itagüí town, Antioquia

RESUMEN Objetivo Caracterizar los riesgos ambientales y de seguridad presentes en calderas con combustible de carbón de las pequeñas y medianas empresas, ubicadas en el municipio de Itagüí. Método Estudio descriptivo transversal: Se seleccionó una muestra a conveniencia de ocho calderas y sus operadores. La caracterización de las calderas se realizó por medio de la aplicación de cuatro instrumentos para evaluar y valorar los riesgos de seguridad, el nivel de seguridad, los riesgos ambientales y los impactos ambientales. Resultados El resultado del riesgo de seguridad mostró que el 62 % de las calderas presentó un nivel de riesgo no aceptable. El resultado del nivel de seguridad presentó que el 62 % de las calderas obtuvieron una valoración deficiente. El resultado del riesgo ambiental indicó que el 100 % de las calderas presentó un nivel de riesgo alto de afectación al entorno ambiental y un nivel de riesgo medio de afectación a los operadores. Con respecto a la valoración del impacto ambiental se observó que el 100 % de las calderas en estudio presentaban afectación de significancia alta sobre el componente aire, y afectación de significancia media sobre los componentes agua y suelo. Conclusiones Debido al bajo nivel de seguridad y al alto nivel de riesgo ambiental encontrado en las calderas estudiadas, las PYME deben conocer los riesgos existentes con el fin de disminuir la prevalencia de afectación de la salud de los calderistas e impactos al medio ambiente. Así mismo, implementar medidas de gestión encaminadas a la prevención y control de los riesgos caracterizados.(AU)

ABSTRACT Objective To describe the environmental and safety risks present in coal fired boilers in small and medium-sized enterprises, located in Itagüí town. Method Cross sectional descriptive study: An appropriate sample of 8 boilers with its corresponding operators was selected. The description of the boilers was carried out through the implementation of four instruments to evaluate and assess security risks; Its level of safety, the environmental risks and the environmental impacts. Results The security risk outcome showed that 62 % of the boilers presented an unacceptable level of risk. The safety level outcome showed that 62 % of boilers obtained a poor rating. The environmental risk outcome indicated that 100 % of the boilers had a high level of environmental impact and a medium level of impact for operators. Regarding the environmental impact assessment, 100 % of the boilers under study showed a high level of impact on the air component and medium level of impact on water and soil components. Conclusions Due to the low level of safety and the high level of environmental risk found in the boilers under study; SMEs should be aware of the current risks in order to reduce the exposure of the operators to health danger and the environme tal impacts as well. Moreover, it is needed to implement management measures aimed to prevent and control the risks described.(AU)

Esterilização pelo vapor: aspectos fundamentais e recursos técnicos para redução do consumo de água / Steam sterilization: fundamental aspects and technical resources to reduce water consumption / Esterilización por vapor: fundamentos y recursos técnicos para reduccion del consumo de água

Objetivo: Discorrer sobre os aspectos fundamentais da esterilização pelo vapor e os recursos técnicos que podem ser utilizados para a redução do consumo de água no processo de esterilização. Método: Revisão da literatura e de normas técnicas nacionais e internacionais relacionadas aos aspectos construtivos, funcionais e de operação de equipamentos de esterilização pelo vapor saturado sob pressão. Resultados: A redução do consumo de água pode ser obtida pela aquisição preferencial de equipamentos com bombas water free, desligamento da fonte geradora de vapor quando o equipamento não estiver em uso, utilização de equipamentos com desgasificadores incorporados, montagem da carga de forma a facilitar a penetração do vapor e a diminuição do tempo de secagem, readequação da profundidade do vácuo para reduzir o tempo de uso da bomba de vácuo e manutenção preventiva dos purgadores da linha de vapor. Adicionalmente, a utilização de sistemas de pré-tratamento pode reduzir o rejeito de sistemas de tratamento de água por osmose reversa para geração de vapor. Conclusão: O conhecimento dos aspectos fundamentais da esterilização pelo vapor saturado sob pressão permite a implementação de medidas para a redução do consumo de água no processo de esterilização.

Objective: To discuss the fundamentals of steam sterilization and the technical resources that can be used for a reduction of water consumption in the sterilization process. Method: Review of literature and technical and international standards related to the principles of construction, operation, and use of sterilization equipment by saturated steam under pressure. Results: The reduction in water consumption can be obtained by preferential acquisition of equipment with free water pumps, shutdown of the source of steam-generating power when the equipment is not in use, use of equipment with built-in degassers, assembly of the load in a way to facilitate vapor penetration and reduction of drying time, re-adjustment of the depth of the vacuum to the low time of use of the vacuum pump, and the preventive maintenance of the steam line traps. In addition, a pretreatment system can reduce the waste from reverse osmosis water treatment systems for steam generation. Conclusion: Knowledge of the fundamentals of sterilization by saturated steam under pressure allows an implementation of measures for a reduction of water consumption in the sterilization process.

Objetivo: Discurrir sobre los aspectos fundamentales de la esterilización por el vapor y los recursos técnicos que pueden ser utilizados para la reducción del consumo de agua en el proceso de esterilización. Método: Revisión de la literatura y de normas técnicas nacionales e internacionales relacionadas a los aspectos constructivos, funcionales y de operación de equipos de esterilización por el vapor saturado bajo presión. Resultados: La reducción del consumo de agua puede ser obtenida por la adquisición preferencial de equipos con bombas water free, desconexión de la fuente generadora de vapor cuando el equipo no estuviera en uso, utilización de equipos con desgasificadores incorporados, montaje de la carga de forma de facilitar la penetración del vapor y la disminución del tiempo de secado, readecuación de la profundidad del vacío para reducir el tiempo de uso de la bomba de vacío y manutención preventiva de los purgadores de la línea de vapor. Adicionalmente, la utilización de sistemas de pre-tratamiento pode reducir el rechazo de sistemas de tratamiento de agua por osmosis reversa para generación de vapor. Conclusión: El conocimiento de los aspectos fundamentales de la esterilización por el vapor saturado bajo presión permite la implementación de medidas para la reducción del consumo de agua en el proceso de esterilización.