Experiences with the Milan Automated Neurobehavioral System (MANS) in occupational neurotoxic exposure

It is known that in neurobehavioral toxicology, the data obtained by means of psychological testing can acquire sense only when testing conditions and procedures, among others, are kept under rigorous control. This demand, together with the diffusion of multicentered studies aimed at finding mutual agreement on the parameters to be measured and the interpretation criteria to be adopted, has determined our decision to convert six out of the seven tests of the WHO-NCTB into a computer-aided system (MANS). The choice of one of the two systems depends on the characteristics of the testing situation and on the different requirements of clinical, epidemiological and experimental studies. The validation of MANS, as to its reliability and sensitivity, is ongoing but some data have already been collected which show a high correlation of the computer-administered test results with the paper and pencil form as well as a good degree of discriminating power in different testing situations. The experience, made in the past three years, seems to show that the goal of having a simple, easy to handle and reliable instrument to be used and, if necessary easily adapted to a variety of situations and cultures, has been met. Further work is to be carried out to confirm its validity in the early detection of neurobehavioral impairments due to neurotoxic agents.     

亲子鉴定中的伦理道德再思考

我国对亲子鉴定尚无明确的法律规定，鉴定领域局面混乱，再加上社会婚姻状况不稳定、婚外性行为的增加和非婚生子女频繁出现的情况，以及在利益驱使下鉴定机构竟相展开鉴定竞争，致使亲子鉴定数量逐年增加，使得鉴定领域更加混乱。这种混乱局面部分是由于社会伦理道德存在的危机造成的。因此时亲子鉴定的伦理思考很有必要。     

Integration of experimental and computational analysis in the product development and proposals for the sharing of technical knowledge

The automotive industry with both vehicle manufactures and suppliers is a highly competitive branch. The rising customers’ demand for new models with lower prices and higher performances reinforces the pressure on the research and development departments. Design processes of highly complex and customer adjusted products is challenging and requires a high quantity of analysis. Designers’ proposals need to be optimised and verified. In general, several loops are necessary to fulfil all customers’ requests. One possibility to reduce the number of loops is the integration of a product or/and system orientated knowledge management system. In this work, an approach of a structured product/system-based knowledge identification and storage is presented. The first uses of the support highlight its interest and it can be shown how it acts as a boundary object. Different actors are enabled to discuss and share their opinion of expected or observed product/system behaviours. The present article is based on our work in the R and D department of an automotive supplier. The company develops and manufactures chains and timing chain drives for combustion engines. In these systems rotational vibrations emerge. In relation with the hydraulic or mechanic tensioning elements they create linear vibrations as well, and lead to highly complex non-linear systems. The knowledge necessary to design and optimise a chain drive is hence comprehensive and cannot be acquired easily.     

Advances in Prenatal Genetic Testing: Current Options, Benefits, and Limitations

Options in prenatal testing continue to expand as technology advances. These options allow for clarification of many diagnoses, which can assist in prenatal planning from medical and family perspectives. They can provide additional information to families before the birth of their child regarding diagnosis, underlying etiology, treatment options, short-term outcomes, and long-term outcomes. Our objective was to provide an overview of the available prenatal testing options while outlining the strengths and limitations of these options. In addition, we describe the additional testing that may be recommended in the neonatal period for further clarification of prenatal testing and diagnoses.     

A case of primary multidrug-resistant pulmonary tuberculosis with high minimum inhibitory concentration value for bedaquiline

Bedaquiline is a new ATP synthesis inhibitor developed as an anti-tuberculosis agent. It has resistance-associated variants (RAV), regardless of preceding bedaquiline exposure. Herein, we describe the case of a patient with multidrug-resistant tuberculosis (MDR-TB) who had no history of bedaquiline therapy but presented a relatively high minimum inhibitory concentration (MIC) of bedaquiline (1 μg/mL). Whole genome sequencing revealed a mutation in the resistance-associated gene Rv0678. The patient was first treated with a five-drug regimen (bedaquiline, delamanid, levofloxacin, cycloserine, and amikacin), which induced negative sputum culture conversion. Despite the successful treatment outcome, several questions remain regarding the efficacy of bedaquiline in this patient. Bedaquiline is an indispensable drug for MDR-TB treatment, but its clinical efficiency in the presence of Rv0678 mutations remains unclear. Therefore, evaluating the MIC of bedaquiline even in patients without a history of bedaquiline use is important for therapeutic regimen selection and may emphasize the importance of therapeutic drug monitoring in cases of bedaquiline RAV.     

Testing patients during seizures: A European consensus procedure developed by a joint taskforce of the ILAE – Commission on European Affairs and the European Epilepsy Monitoring Unit Association

There is currently no international consensus procedure for performing comprehensive periictal testing of patients in the epilepsy monitoring units (EMUs). Our primary goal was to develop a standardized procedure for managing and testing patients during and after seizures in EMUs. The secondary goal was to assess whether it could be implemented in clinical practice (feasibility). A taskforce was appointed by the International League Against Epilepsy (ILAE)—Commission on European Affairs and the European Epilepsy Monitoring Unit Association, to develop a standardized ictal testing battery (ITB) based on expert opinion and experience with various local testing protocols. ITB contains a comprehensive set of 10 items that evidence the clinically relevant semiologic features, and it is adaptive to the dynamics of the individual seizures. The feasibility of the ITB was prospectively evaluated on 250 seizures from 152 consecutive patients in 10 centers. ITB was successfully implemented in clinical practice in all 10 participating centers and was considered feasible in 93% of the tested seizures. ITB was not feasible for testing seizures of very short duration.     

廊坊市部分MSM人群HIV检测咨询前后高危行为变化的分析

目的评价艾滋病病毒（HIV）检测咨询,对男男性行为人群（Men who have sex with men,MSM）艾滋病相关危险行为变化的影响。方法通过问卷调查,收集廊坊市200名MSM参加HIV检测咨询前后高危行为的变化,并进行艾滋病和主要性病的检查,比较艾滋病相关危险行为的变化。结果 200名MSM基线调查HIV抗体阳性率为7.3%,梅毒感染率为19.8%,淋球菌检出率为15.8%;三个月后的随访调查中,梅毒感染率为24.7%,淋球菌感染率为12.2%。随访调查中MSM中多性伴的比例、发生一夜情的比例、肛交以及性交中自己出血的比例,均有所下降（P〈0.05）。按照性病感染状态分层后发现,感染了性病的MSM,被告知检测结果后,发生肛交的比例由73%下降到38%（P〈0.01）,群交和性交过程中的出血情况分别由19.2%和23.1%下降到5.8%和5.8%（P〈0.05）。未感染性病的MSM,一夜情的比例从32.5%下降到17.2%（P=0.008）,口交比例由57.0%上升到78.5%（P=0.001）。感染了性病的MSM发生肛交的比例要低于健康MSM（χ2=5.189,P=0.023）。结论 HIV检测咨询对MSM艾滋病相关危险行为的改变有积极意义,建议在该人群中推广HIV检测咨询服务,促进高危行为的改变。     

Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors

There are now numerous in vitro and in silico ADME alternatives to in vivo assays but how do different industries incorporate them into their decision tree approaches for risk assessment, bearing in mind that the chemicals tested are intended for widely varying purposes? The extent of the use of animal tests is mainly driven by regulations or by the lack of a suitable in vitro model. Therefore, what considerations are needed for alternative models and how can they be improved so that they can be used as part of the risk assessment process? To address these issues, the European Partnership for Alternative Approaches to Animal Testing (EPAA) working group on prioritisation, promotion and implementation of the 3Rs research held a workshop in November, 2008 in Duesseldorf, Germany. Participants included different industry sectors such as pharmaceuticals, cosmetics, industrial- and agro-chemicals. This report describes the outcome of the discussions and recommendations (a) to reduce the number of animals used for determining the ADME properties of chemicals and (b) for considerations and actions regarding in vitro and in silico assays. These included: standardisation and promotion of in vitro assays so that they may become accepted by regulators; increased availability of industry in vivo kinetic data for a central database to increase the power of in silico predictions; expansion of the applicability domains of in vitro and in silico tools (which are not necessarily more applicable or even exclusive to one particular sector) and continued collaborations between regulators, academia and industry. A recommended immediate course of action was to establish an expert panel of users, developers and regulators to define the testing scope of models for different chemical classes. It was agreed by all participants that improvement and harmonization of alternative approaches is needed for all sectors and this will most effectively be achieved by stakeholders from different sectors sharing data.     

药品抽样检验中的问题及其改进措施

对本市食品药品检验所2008-2011年的检品信息进行统计分析,指出当前药品抽样检验工作中存在的问题,提出规范抽样、完善标准、跟进检测条件等改进措施,为推动基层药品监督工作提供参考。     

2010年度南通市药品抽验情况分析

目的总结2010年度南通市药品抽验情况,对不合格原因进行分析。方法对南通市2010年度抽验的2290批次检品分类进行统计分析。结果中药饮片、注射剂可见异物及中成药的补充检验等不合格率高,主要集中在个体经营药店及乡镇卫生院。结论建议继续加强药品的监管力度,保障人民用药安全有效。