Application of FMEA model and 6S management method in reducing dispensing errors in PIVAS of children’s hospitals / 中国药房

OBJECTIVE To reduce dispensing errors in pharmacy intravenous admixture service （PIVAS） of children’s hospitals. METHODS The risk of dispensing procedures in our PIVAS was identified by applying failure mode and effect analysis （FMEA） model. Potential failure modes that might lead to dispensing errors in each link were determined， and failure causes were analyzed. The severity， incidence and detection degree of potential failure modes were quantitatively scored， and their risk priority number （RPN） was calculated to screen failure modes that needed to be improved in priority； the corresponding improvement measures were developed by 6S management method from six aspects， namely， finishing （seiri）， rectifying （seiton）， sweeping （seiso）， sanitation （seiketsu）， literacy （shitsuke） and safety. The effect of intervention before and after rectification was evaluated. RESULTS Based on the RPN， 32 potential failure modes were selected， of which a total of 18 critical failure modes that needed to be improved in priority. After implementing corresponding measures according to 6S management method， the RPN of 18 critical failure modes decreased. The total RPN decreased from 497 to 142 with a decrease rate of 71.43%. The error rates of 15 critical failure modes were significantly lower than before implementation （P＜0.05）. CONCLUSIONS Applying FMEA model and 6S management method to the risk control of all aspects of PIVAS workflow can effectively reduce the risk of PIVAS dispensing errors and ensure the safety of children’s intravenous medication.

Data mining in traditional Chinese medicine product quality review / 中国中药杂志

The traditional Chinese medicine(TCM) enterprises have accumulated a large amount of product quality review(PQR) data. Mining these data can reveal the hidden knowledge in production and helps improve pharmaceutical manufacturing technology. However, there are few studies involving the mining of PQR data and thus enterprises lack the guidance to analyze the data. This study proposed a method to mine the PQR data, which consisted of 4 functional modules: data collection and preprocessing, risk classification of variables, risk evaluation by batches, and the regression analysis of quality. Further, we carried out a case study of the formulation process of a TCM product to illustrate the method. In the case study, the data of 398 batches of products during 2019-2021 were collected, which contained 65 process variables. The risks of variables were classified according to the process performance index. The risk of each batch was analyzed through short-term and long-term evaluation, and the critical variables with the strongest impact on the product quality were identified by partial least square regression. The results showed that 1 variable and 13 batches were of high risk, and the critical process variable was the quality of the intermediates. The proposed method enables enterprises to comprehensively mine the PQR data and helps to enhance the process understanding and improve the quality control.

An evaluation of occupational health risk assessment methodologies from South African enterprises: noise risk assessment field study

Background: The South African occupational health and safety regulations, prescribing risk assessments be conducted by employers, are non-prescriptive with regard to the tools and techniques to be used. Consequently, companies freely adopt the numerous available tools and techniques from which risk management decisions are derived. Thus, risk management, ensuing from the results derived from these tools and techniques, is likely to vary from company to company. Objective: The objective of the study was to evaluate risk assessment processes and methodologies that are used and recorded in noise risk assessment reports, in four manufacturing companies. Methods: This was a case study, whereby risk assessment records were obtained from four South African companies with different operational units, from the manufacturing and utilities sectors. Results: There were inter- and intra-company variations in the processes related to the legal context in which the risk assessments were conducted, the risk assessment tools and techniques used, the risk criteria definitions, the statements about the effectiveness of controls in use, and the risk evaluation outcomes. Inter- and intra-company variations in risk rankings and risk prioritisation outcomes were also observed ­ a consequence of the risk perceptions of the assessors assigning a risk level to the noise hazard. In some instances, the adopted risk assessment tools and techniques categorised the risk from noise that was at or above regulated health and safety standards as 'insignificant', which those companies used as justification for taking no further measures to eliminate or reduce the risk. Conclusion: The use of different risk assessment processes, tools and techniques resulted in some facilities categorising noise as an insignificant hazard, which may contribute to high noise emissions and uncontrolled exposures.

Observation of preventive effect of intervention strategy based on Caprini risk evaluation model on venous thromboembolism after total knee arthroplasty / 中国骨伤

OBJECTIVE@#To observe preventive effect of Caprini based thrombosis risk evaluation model on venous thromboembolism (VTE) after total knee replacement (TKA).@*METHODS@#Totally 257 TKA patients were admitted from May 2017 to December 2021 were selected. They were divided into conventional intervention strategies (121 patients in control group) and intervention strategies based on Caprini thrombosis risk evaluation model (136 patients in observation group), based on whether Caprini thrombosis risk evaluation model was introduced in May 2019. In normal gourp, there were 79 males and 42 females aged from 50 to 78 years old with an average of (63.10±11.86) years old;body mass index (BMI) ranged from 19 to 32 with an average of (25.21±4.95) kg/m2;55 patients on the left side and 66 on the right side. In observation group, there were 81 males and 55 females aged from 50 to 78 years old with an average of (64.35±10.54) years old;BMI ranged from 19 to 32 with an average of (24.43±5.18) kg/m2;87 patients on the left side and 49 on the right side. The incidence of VTE, visual analogue scale (VAS), Hospital for Special Surgery (HSS) score, affected limb swelling, mean velocity(Vm), peak velocity (PV), D-dimer (D-D), prothrombin time(PT), and incidence of complications were analyzed and compared.@*RESULTS@#The incidence of VTE in observation group was 1.47%(2/136), and 9.09%(11/121) in control group, and there was statistically difference between two groups (χ2=6.976, P=0.008). At 7 days after operation, VAS, HSS score and the difference in circumference of the affected limb in observation group were significantly better than those in control group, and had statistically differences (P<0.05). Blood flow Vm and PV levels between two groups were significantly increased (P<0.001), and blood flow Vm and PV levels in observation group were significantly higher than those in control group on the 7th day after operation, and had differences (P<0.001). The serum D-D level in observation group was significantly lower than that of in control group on the 7th day after operation, and PT level was significantly higher than that of in control group, and had difference(P<0.05). There was no difference in total incidence of complications between two groups (χ2=4.488, P=0.034).@*CONCLUSION@#Intervention strategy based on caprini thrombus risk evluation model could effectively reduce incidence of VTE and complications in TKA patients, improve swelling, hemodynamics and coagulation function of the affected limbs, and contribute to recovery of knee joint function.

Noise exposure abatement: a perspective from industry occupational health risk assessment reports

Background: Occupational health risk assessments are building blocks for occupational health programmes, allowing for the rating of identified risks and the continuous re-evaluation of the effectiveness of abatement measures. In South African industry, occupational health risk assessments are formally documented in reports, which can be presented as demonstration of legal compliance with legislation. Objective: To identify noise abatement measures recorded in noise risk assessment reports of four manufacturing companies and to rate their effectiveness. Methods: We analysed the occupational health risk assessment reports from 21 operational facilities in four South African companies from the manufacturing and utilities sectors to evaluate, through document analysis, the recorded noise abatement measures. Noise abatement measure effectiveness was rated using a preassigned effectiveness percentage scale. Results: Administrative controls and hearing protection devices were the most commonly used noise exposure abatement measures, but hearing conservation programmes were generally poorly formulated. There were inter- and intra-company differences in the qualitative risk assessment approaches used for rating or ranking the noise risk, which led to different risk conclusions and prioritisation outcomes. The calculated control effectiveness of the abatement measures showed that noise exposure remained largely unacceptable: 16 of the 21 operational units had unacceptable noise exposures, four had tolerable exposures, and one had broadly acceptable exposures. Conclusion: The four companies' common noise abatement measures, as elements of formalised hearing conservation programmes, which included administrative controls and hearing protection devices, were not effective in reducing noise exposure to the broadly acceptable level, reflective of limited use of engineering controls.

Application of high-frequency ultrasound and shear wave elastography in preoperative evaluation of basal cell carcinoma / 中华皮肤科杂志

Objective:To investigate the value of high-frequency ultrasound and shear wave elastography in preoperative evaluation of basal cell carcinoma (BCC) .Methods:A total of 95 patients with histopathologically confirmed cutaneous BCC were enrolled from Department of Dermatology, Hospital of Traditional Chinese Medicine of Zhongshan from January 2017 to December 2020, all of whom had underwent preoperative conventional ultrasonography and shear wave elastography. Conventional ultrasonography parametres including the maximum diameter, maximum infiltration depth, maximum blood flow velocity and resistance index were recorded, so were shear wave elastography parametres including the average Young′s modulus (Eave) , Young′s modulus standard deviation (Esd) and average Young′s modulus ratio (Eratio) . All the patients were divided into high- and low-risk BCC groups according to pathologic subtypes. Paired t-test was used to compare conventional ultrasonography and shear wave elastography findings between the 2 groups. Results:There were 15 cases in the high-risk BCC group and 80 cases in the low-risk BCC group. Compared with the low-risk BCC group, the high-risk BCC group showed significantly increased maximum depth of tumor infiltration (8.5 ± 4.6 mm vs. 4.5 ± 1.6 mm, t = 6.150, P < 0.001) , Eave (32.7 ± 11.2 kPa vs. 20.6 ± 5.1 kPa, t = 4.065, P = 0.001) and Esd (7.0 ± 4.1 kPa vs. 4.2 ± 2.1 kPa, t = 2.632, P = 0.018) , while there were no significant differences in the other measurement data between the two groups (all P > 0.05) . The areas under the receiver operating characteristic curves of the maximum infiltration depth, Eave and Esd for the diagnosis of high-risk BCC were 0.775, 0.909 and 0.822 respectively, and Eave showed the best diagnostic performance. Using 25.7 kPa as the cut-off value, the sensitivity and specificity of Eave were 86.7% and 85.0% for the diagnosis of high-risk BCC, respectively. Conclusion:High-frequency ultrasound and shear wave elastography can facilitate differential diagnosis between high- and low-risk BCC.

Recent advance in recurrence risk prediction of ischemic stroke / 中华神经医学杂志

Ischemic stroke is prone to recurrence, which is the leading cause of death and disability in stroke. Using predictive model to assess the recurrence risk in patients with ischemic stroke, stratifying risk, and formulating corresponding interventions to reduce the recurrence rate are the core contents of secondary prevention. In this paper, research progress on the prediction of recurrence risks of ischemic stroke recently is summarized from the predicting content or factors, including clinical factors, imaging factors, biological markers and traditional Chinese Medicine syndrome differentiation, and the methods of constructing prediction models about traditional statistical methods and machine learning, in order to provide a reference for clinical work.

Validación prospectiva multicéntrica del EuroSCORE II en Argentina / Multicenter prospective validation of the EuroSCORE II in Argentina

Resumen Objetivo: Validar, en forma prospectiva y en múltiples centros, la precisión y utilidad clínica del European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) para predecir la mortalidad operatoria de la cirugía cardíaca en centros de Argentina Método: Entre enero de 2012 y febrero de 2018 se incluyeron en forma prospectiva 2,000 pacientes consecutivos que fueron sometidos a cirugía cardíaca en diferentes centros de Argentina. El punto final fue mortalidad hospitalaria por cualquier causa. La discriminación, calibración, precisión y utilidad clínica del EuroSCORE II se evaluaron en la cohorte global y en los diferentes tipos de cirugías, basándose en las curvas Receiver Operating Characteristics (ROC), bondad de ajuste de Hosmer-Lemeshow, razón de mortalidad observada/esperada, índice de Shannon y curvas de decisión. Resultados: El área ROC del EuroSCORE II estuvo entre 0.73 y 0.80 para todo tipo de cirugía, y el valor más bajo fue para la cirugía coronaria. La mortalidad observada y esperada fue 4.3 y 3.0%, respectivamente (p = 0.034). El análisis de la curva de decisión demostró un beneficio neto positivo para los umbrales por debajo de 0.24 para todo tipo de cirugía. Conclusiones: El EuroSCORE II tuvo un desempeño adecuado en términos de discriminación y calibración para todos los tipos de cirugía, aunque algo inferior para la cirugía coronaria. Si bien en términos generales subestimó el riesgo en los grupos de riesgo intermedio, el comportamiento global fue aceptable. El EuroSCORE II podría considerarse una opción de modelo genérico y actualizado de estratificación del riesgo operatorio para predecir la mortalidad hospitalaria de la cirugía cardíaca en nuestro contexto.

Abstract Objective: To validate prospectively in multiple centers, the accuracy and clinical utility of the European System for Cardiac Operative Risk Evaluation (EuroSCORE II) to predict the operative mortality of cardiac surgery in Argentina. Methods: Between January 2012 and February 2018, 2,000 consecutive adult patients who underwent cardiac surgery in different centers in Argentina were prospectively included. The end-point was in-hospital all-cause mortality. Discrimination, calibration, precision and clinical utility of the EuroSCORE II were evaluated in the global cohort and in the different types of surgeries, based on ROC (Receiver Operating Characteristics) curves, Hosmer-Lemeshow goodness-of-fit test, observed/expected mortality ratio, Shannon index and decision curves analysis. Results: ROC area of the EuroSCORE II was between 0.73 and 0.80 for all types of surgery, being the lowest value for coronary surgery. The observed and expected mortality was 4.3% and 3.0%, respectively (p = 0.034). The decision curve analysis showed a positive net benefit for all thresholds below 0.24, considering all type of surgeries. Conclusion: The EuroSCORE II showed an adequate performance in terms of discrimination and calibration for all types of surgery, although somewhat inferior for coronary surgery. Though in general terms this model underestimated the risk in intermediate risk groups, its overall performance was acceptable. The EuroSCORE II could be considered an optional updated generic model of operative risk stratification to predict in-hospital mortality after cardiac surgery in our context.

Reducción del Riesgo en Equipos Biomédicos y en Instalaciones Eléctricas de Entornos Clínicos / Risk Reduction in Electrical Networks and Safety of Biomedical Equipment in Clinical Settings

Resumen Se analizan 112 auditorías de instalaciones eléctricas y seguridad de equipos biomédicos en 78 Institutos de Medicina Altamente Especializada (IMAE) del Uruguay, realizadas a lo largo de 14 años, clasificando el nivel de riesgo y de cumplimiento de normas desde el punto de vista de Ingeniería Clínica. Cada visita incluye una encuesta al personal encargado de mantener y gestionar la infraestructura eléctrica y el equipamiento biomédico, que abarca el estado de mantenimiento, el control y la documentación de las instalaciones eléctricas y del equipamiento biomédico. Se evalúa el riesgo con un puntaje de 0 a 4. En 2004-2007 el 74% de los IMAE tenía irregularidades en la instalación eléctrica, gestión de equipamiento, control de calidad o documentación. Además, un 15% de los que tenían problemas, tenía en particular equipamiento indicado como "equipo peligroso". En los períodos siguientes esta proporción baja paulatinamente hasta 0% en 2016-2017. No obstante, continúa existiendo un déficit en la gestión del equipamiento y en la documentación formal. El aporte de la Universidad en el seguimiento técnico de los IMAE se ha materializado en una mejora en materia de seguridad.

Abstract 112 field inspections to 78 high technology medical centers (IMAE is the Spanish acronym) over 14 years are analyzed. All visits were evaluated as to Clinical Engineering good practices and were assigned a risk level. All audits included a questionaire to maintenance management personnel on electrical network operation as well as on biomedical equipment follow-up and documentation from acquisition to disposal. Risk is assigned a level 0 to 4 at each visit. In 2004-2007, 74% of IMAEs had safety problems in one or more of electrical network, maintenance management or documentation, and 15% of the IMAEs with safety problems had one piece of equipment described as simply "dangerous". Electrical safety problems were eventually reduced to 0% in 2016-2017, probably as a consequence of regular audit and counseling by this University Clinical Engineering Program.

Depletion of occupational performance effectiveness in electric power engineering industry: psychophysiological factors and risk evaluation

Background: The modern society cause the increase of workload and impact of environment factors on performance efficiency of occupational duties and health safety of workers. Emergencies and expert mistakes often arise not so much from rules ignorance of object management, but due to insufficient development of worker’s own psychophysiological qualities. The goal of our investigation is to develop the estimation technique for evaluation the risk of depletion in efficiency performance of occupational duties for operative service workers in electric power engineering industry.Methods: In our investigation, we examined the materials of psychophysiological survey by the multivariate statistics, dispersion analysis and regression binary choice models. The study is based on workers’ survey, encompassed exogenous psychophysiological indicators that included the observation of 466 operative service workers of in electric power engineering industry in Ukraine.Results: We determined seven psychophysiological indicators that are significant important risk cause of critical depletion in worker’s occupational efficiency. We estimated the multivariate regression logit model that evaluate the impact of each factor taking into account the age of worker.Conclusions: For workers with high values of average reaction time, regardless of the age group, we predict a high risk of occupational effective performance loss. The analysis showed that for workers with average values of other factors, the increase of adaptability and variability lead to decrease in risk of occupational professional efficiency depletion. Based on developed approach, we estimated that, in electric power engineering industry in Ukraine, the risk of effectiveness loss is less than 0.5 for 84% of workers.

Contributors to Fatigue of MineWorkers in the South African Gold and Platinum Sector

BACKGROUND: Mine workers in South Africa face challenges relating to poor health and safety, including fatigue risks, and poor socioeconomic and living conditions. Fatigue results in impaired mental and physical performance. The aim of this study was to assess contributors to fatigue of mine workers in South Africa. METHODS: Data collection took place at four gold mines and one platinum mine in South Africa. A total of 21 focus groups were held with individuals in management, union representatives, and mine workers, and 564 questionnaires were completed by mine workers to gather information about fatigue and potential contributors to fatigue at these mines. RESULTS: Qualitatively (through focus groups), fatigue was attributed to extended working hours, harsh working conditions, high workloads, production pressure, and resource constraints, along with aspects relating to demographic and socioeconomic factors, living conditions, lifestyle, health, and wellness. Greater fatigue was significantly associated with younger age, indebtedness, a lack of exercise, poor nutrition, less sleep, increased alcohol use, poor self-reported health, more sick leave, higher stress, and lower job satisfaction. CONCLUSION: The aim of the study was achieved; numerous work-, sociodemographic-, lifestyle-, and wellness-related factors were linked to fatigue in the participating mine workers. Contributors to fatigue should be addressed to improve health, safety, and sustainability in the industry.

Characteristic analysis among MSM-users of the "Online HIV Acquisition Risk Assessment System" in Guangzhou / 中华流行病学杂志

Objective@#To analyze the characteristics of levels related to the risk through self-evaluation system, among MSM users in Guangzhou, between 2015 and 2017.@*Methods@#Between 2015 and 2017, data was collected from the users of a self-evaluation system network related to HIV infection, based on the previous 'HIV health risk appraisal model’. Information on risk factors was collected to calculate the scores and levels of risks and to estimate the incidence of HIV. Taking the reference of R value on risks as (R=0.9-1.1) in general population. The ones with very low risk, with low risk, moderate risk, high risk and very high risk were set as R≤0.5, 0.5<R≤0.9, 0.9<R≤1.1, 1.1< R≤2.0 and R>2.0, respectively. The scores of modifiable risk factors were compared with different subgroups of MSM.@*Results@#A total of 4 601 MSM were involved in this study, with the following features presented as: aged 16-64 (28.38±7.11) years, proportions of residence from Guangzhou, Guangdong province or other provinces as 38.6%(1 776/4 601)、35.4%(1 629/4 601) and 26.0%(1 197/4 601), 59.6%(2 742/4 601) received bachelor or above degrees. 81.3%(3 741/4 601) of them claimed as having homosexual orientation. R values of risk level on very low risk, low risk level, moderate risk, high risk and very high risk appeared as 12.9%(594/4 601), 50.9%(2 342/4 601), 17.0%(783/4 601), 14.8%(682/4 601) and 4.3%(200/4 601), respectively. Scores of modifiable risk factors decreased year by year (P<0.05), among MSM in this study. In either of the groups that experiencing insertive or receptive sex, the ones with heterosexual orientation presented the highest scores of modifiable risk factors (P<0.05).@*Conclusions@#The risk levels on HIV infections called for special attention among the users of the self-evaluation network system. Among the MSM that carrying either insertive or receptive sex role, the ones with heterosexual orientation had the highest risk levels and scores of modifiable risk factors in Guangzhou. Further study should be explored to better understand the causes of related risks.

The utility of autonomic nerve function tests in the quantitative diagnosis and risk evaluation in pediatric unex-plained syncope / 中华实用儿科临床杂志

To management of unexplained syncope (UPS)in children,the primary objectives are etiological diagnosis and risk evaluation. The head - up tilt test (HUTT)has a certain risk and limitation,though it is still an im-portant tool to diagnose and identify UPS at present. Now,the utility of other several autonomic nerve function tests in the quantitative diagnosis and risk evaluation in pediatric UPS were described,including 24 hours ambulatory blood pressure monitoring,QT interval dispersion,heart rate recovery,heart rate variability,autonomic testing.

The reliability and validity of the Chinese version of The Pressure Ulcer Risk Primary or Secondary Evaluation Tool / 中国实用护理杂志

Objective To translate The Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) into Chinese,and assess its reliability and validity in Chinese hospitalized patients. Methods The original PURPOSE-T was translated into Chinese and back translated and modified for cultural adaptation according to guidelines.The reliability and validity of the Chinese version of PURPOSE-T were tested in 230 hospitalized patients. Results The Chinese version of PURPOSE-T consists of three parts and contains 25 entries. The inter-rater consistency Kappa coefficient was 0.798, the weighted Kappa coefficient was 0.843. The evaluation results were compared with binary variables with a Kappa coefficient of 0.745. The test-retest reliability Kappa coefficient and the weighted Kappa coefficient were 0.863 and 0.892. Two classified assessment Kappa coefficient was 0.857. The item content validity index ranged from 0.83 to 1.00, and the scale content validity index was 0.98. The phi correlation coefficient of PURPOSE-T and Braden scale was 0.781; the phi correlation coefficient of Waterlow Scale evaluation result was 0.777. The correlation coefficient between Chinese PURPOSE-T items and Braden scale items ranged from 0.605 to 0.877 (P<0.01), and the Waterlow Scale items ranged from 0.599 to 0.887 (P<0.01). Conclusions The Chinese version of PURPOSE-T appears to possess adequate validity, test-retest reliability and internal consistency. The newly translated Chinese version of PURPOSE-T may be used to assess the risk of pressure injury in inpatients in China.

Reduction Error Rate of Homing the Withdrawn Drugs in PIVAS of Our Hospital by Using FMEA / 中国药房

OBJECTIVE:To reduce the error rate of homing the withdrawn drugs in pharmacy intravenous admixture service (PIVAS). METHODS:Using risk priority(RPN),the potential failure modes for links of homing the withdrawn drugs in PIVAS were evaluated by using failure mode and effects analysis (FMEA) method. Combining with the links of homing the withdrawn drugs,the reasons for errors were investigated,the feasible scheme to reduce error rates was proposed and the intervention effect was evaluated after 3 months. RESULTS:In the PIVAS links of homing the withdrawn drugs,8 high-risk failure modes had been found in total,such as poor double check system(RPN was 100),unfamiliarity of seemingly drugs(RPN was 36),a large num-ber of the withdrawn drugs(RPN was 20),etc. Thus,risk control measures had been formulated,including reinforcing the double check system,optimizing the management system of PIVAS and so on. After 3 months of intervention management,RPN of the first 3 items were reduced to 20,16,8;error rate of homing the withdrawn drugs was reduced from 1.98% to 0.62%(P<0.05). CONCLUSIONS:The application of FMEA management method in PIVAS of our hospital has reduced the error rate of homing the withdrawn drugs.

Reduction Error Rate of Homing the Withdrawn Drugs in PIVAS of Our Hospital by Using FMEA / 中国药房

OBJECTIVE:To reduce the error rate of homing the withdrawn drugs in pharmacy intravenous admixture service (PIVAS). METHODS:Using risk priority(RPN),the potential failure modes for links of homing the withdrawn drugs in PIVAS were evaluated by using failure mode and effects analysis (FMEA) method. Combining with the links of homing the withdrawn drugs,the reasons for errors were investigated,the feasible scheme to reduce error rates was proposed and the intervention effect was evaluated after 3 months. RESULTS:In the PIVAS links of homing the withdrawn drugs,8 high-risk failure modes had been found in total,such as poor double check system(RPN was 100),unfamiliarity of seemingly drugs(RPN was 36),a large num-ber of the withdrawn drugs(RPN was 20),etc. Thus,risk control measures had been formulated,including reinforcing the double check system,optimizing the management system of PIVAS and so on. After 3 months of intervention management,RPN of the first 3 items were reduced to 20,16,8;error rate of homing the withdrawn drugs was reduced from 1.98% to 0.62%(P<0.05). CONCLUSIONS:The application of FMEA management method in PIVAS of our hospital has reduced the error rate of homing the withdrawn drugs.

Risk Evaluation of Abnormal Liver Function Associated with LMWH in 76 PTE Patients of Our Hospital / 中国药学杂志

OBJECTIVE: To explore the clinical regularities and risk factor of abnormal liver function associated with LMWH in pulmonary thromboembolism patients. METHODS: Clinical date of pulmonary thromboembolism patients in use of LMWH was collected and analyzed from January 2008 to December 2016. RESULTS: 97 cases were enrolled. Of them, there were 76 cases were assessed as probable or possible. Single factor analysis showed the the levels of Scr (P=0.000), ALT (P=0.000), AST (P=0.000), γ-GGT (P=0.000), ALP (P=0.023), co-infection (P=0.024) and Ccr (P=0.026) had statistically significant difference. Multivariate analysis indicated that co-infection (OR=1.982, P=0.022) and high level of Scr (OR=1.045, P=0.000) were the independent risk factors of abnormal liver function associated with LMWH in PTE. CONCLUSION: The incidence of abnormal liver function due to LMWH in PTE patients is high. With high level of Scr and/or co-infection patients are high-risk persons of abnormal liver function. It is necessary to dynamically evaluate the liver function during hospitalization. Symptomatic treatment can be significant if the liver function become abnormal.

Pre-operative risk evaluation on massive cerebral infarction secondary to acute epidural hematoma and concurrent cerebral herniation / 中华神经医学杂志

Objective To develop and validate a novel preoperative risk evaluating system for surgical decision on decompressive craniectomy for patients with massive cerebral infarction (MCI) secondary to acute epidural hematoma (EDH) and concurrent cerebral herniation.Methods Clinical data of a retrospective patient cohort (from January 2006 to January 2012,n=151) were analyzed by multivariate Logistic regression analysis for the risk factors correlated with postoperative MCI so as to establish a preoperative risk scoring system,whose clinical accuracy of surgical decision-making were validated in another prospective patient cohort (from February 2012 to December 2014,n=97).Results Incidences of secondary cerebral infarction were 19.2％ (29/151) and 18.6％ (18/97) in the retrospective and prospective patient cohorts,respectively.Regression analyses indicated that 6 clinical factors were identified to be independently correlated with postoperative MCI,including temporal hematoma (P=0.005),preoperative hemorrhagic shock (P=0.003),hematoma volume greater than 100 mL (P=0.003),bilateral mydriasis (P=0.015),duration of cerebral herniation longer than 90 min (P=0.001),and Glasgow Coma Scale (GCS) scores ≤ 5 (P=0.070).A novel preoperative risk scoring system was established by totting-up the standardized partial regression coefficients of each identified risk factor (EDH-MCI scale,with total scores of 0-18).Results suggested that the incidence and mean volume of cerebral infarction increased along with risk scores in a stair-stepping manner.Therefore,three intervals were divided into low (0-9),borderline (10-12),and high risk intervals (13-18) according to the EDH-MCI scores.Clinical reliability of surgical decision-making guided by novel EDH-MCI scale was validated by a prospective clinical study.As compared with traditional empirical surgical strategy,EDH-MCI scale-guided prospective surgical strategy exhibited remarkable superiority that it significantly increased the accuracy of surgical decision (low risk interval,100.00％ vs.91.92％,P=0.046;borderline risk interval,77.78％ vs.46.67％,P=0.034;high risk interval,100.00％ vs.68.18％,P=0.023;overall accuracy,95.88％ vs.79.47％,P=0.000).Conclusion The established preoperative risk scoring system can make a precise judgment on the clinical risks of postoperative massive cerebral infarction secondary to cerebral herniation from isolated acute epidural hernatoma and thereby provide a reliable reference on the surgical decision of decompressive craniectomy.

Study on spray drying technology of Fengke Granule based on QbD concept / 中草药

Objective: To establish and validate the design space of spray drying process of Fengke Granule using the concept of quality by design (QbD). Methods: Using Fengke Granule formula to extract the concentrated solution as model drug, the risk assessment and Plackeet-Burmann design on influence factors of screening, to determine the liquid inlet velocity and pressure of atomization is the critical process parameters. Then, the central composite design was used to optimize the key parameters and establish the process design space. Finally, four experimental points were selected to test the predictive power of the model. Results: Analysis of variance results showed that regression model P values were less than 0.01, which showed that the model had a good prediction, and the optimal range of key parameters of inlet velocity was determined and pressure of atomization were 11%-14% and 41.3-45.0 mmHg, the process parameters in this range could meet the target requirements. Conclusion: The design space of spray drying process is established based on QbD, which could improve the flexibility and stability of spray drying process, and provide reference for the pilot study in the future.

Risk evaluation and mitigation strategy in oncology products / 中国药学杂志

OBJECTIVE: To review and analyze the specificity and dynamic changes in developing the Risk Evaluation and Mitigation Strategy (REMS) in oncology products. METHODS: Based on FDA's requirement for REMS for some high-risk drugs and biologics, the REMS literatures of oncology products were tracked and accessed. The approved and released REMS programs of anti-cancer drugs were summarized and analyzed. RESULTS: REMS is a key tool for FDA to help manage and ensure the safe use of the medications. Though a disproportionate number of drugs with complex REMS are required in patients with cancer, the percentage of the oncology drugs with REMS requirement is not much higher than non-oncology products. This mainly resulted from the specificity of cancer and chemotherapy, in which much collaborative interaction among health care practitioners as well as the emerging target therapy with highly specificity and selectivity may contribute to minimize risk from medications.CONCLUSION: The necessity of developing REMS for an oncology product depends on its properties and the new circumstances in oncology practice.