四川医疗器械产品质量监督抽验现状及对策探讨

目的：探索四川医疗器械产品质量监督抽验优势与不足,促进产品质量监管的规范化、制度化。方法：通过文献查阅,到质量监管部门调研与访谈,分析影响因素,提出思考与对策。结果：四川产品质量监督取得显著成绩的同时,在抽验品种数、范围和抽样任务等方面不适应产品发展需要。结论：要保证产品质量,必须扩大抽验范围、增加样品来源、提高抽验人员素质、强化政府监管职能,才能促进四川医疗器械健康发展。     

Intraoperative 3D imaging control during subthalamic Deep Brain Stimulation procedures using O-arm® technology: Experience in 15 patients

ObjectiveO-arm^® now gives us the opportunity not only to perform 2D but also 3D scans during deep brain stimulation (DBS) procedures. We present our experience with the intraoperative use of this device. Our objective was to measure the geometrical accuracy of electrode placement during surgical procedures driven under O-arm^® control.MethodsFifteen patients underwent STN-DBS. For the first 4 patients, 3D scans were performed at the end of the procedure. We calculated the accuracy of electrode positioning, i.e. the distance between final electrode positioning and the planned trajectory. For the next 11 patients, who underwent both intraoperative and final 3D scan, we also calculated the accuracy of the microelectrode positioning.ResultsAverage stimulation-induced improvement of UPDRS-III score was 52.5 ± 15%. For the first 4 patients, the mean electrode positioning accuracy was 1.46 ± 0.56 mm. For the 11 patients who underwent intraoperative 3D scan, the mean microelectrodes positioning accuracy was 1.59 ± 1.1 mm. Aberrant positioning was detected in two cases, and was analyzed by fusing 3D scan with preoperative MR images. The definite electrodes positioning accuracy was 1.05 ± 0.54 mm.ConclusionIntraoperative 3D scan is feasible, and can help us detect and correct early aberrant trajectories.     

Editorial comment: variables affecting the presence of mesenchymal stromal cells in the peripheral blood and their relationship with apheresis product

Paediatric haematology began to establish itself as a speciality in the UK just over 60 years ago. In that time, clinical trials involving all the specialist centres in the country, and based on scientific advances, have dramatically improved the outlook for children with a range of malignant and non-malignant disorders, but particularly acute leukaemia. As in many specialties, multidisciplinary teams have played a major role in delivering these advances. With these structures in place at a national level, perhaps, of all specialities, paediatric haematology is poised to benefit from the new developments in precision medicine, gene editing and immunotherapy.     

Lyophilization Process Design and Development: A Single-Step Drying Approach

High-throughput lyophilization process was designed and developed for protein formulations using a single-step drying approach at a shelf temperature (T_s) of ≥40°C. Model proteins were evaluated at different protein concentrations in amorphous-only and amorphous-crystalline formulations. Single-step drying resulted in product temperature (T_p) above the collapse temperature (T_c) and a significant reduction (of at least 40%) in process time compared to the control cycle (wherein T_p < T_c). For the amorphous-only formulation at a protein concentration of ≤25 mg/mL, single-step drying resulted in product shrinkage and partial collapse, whereas a 50 mg/mL concentration showed minor product shrinkage. The presence of a crystallizing bulking agent improved product appearance at ≤25 mg/mL protein concentration for single-step drying. No impact to other product quality attributes was observed for single-step drying. Vial type, fill height, and scale-up considerations (i.e., choked flow, condenser capacity, lyophilizer design and geometry) were the important factors identified for successful implementation of single-step drying. Although single-step drying showed significant reduction in the edge vial effect, the scale-up considerations need to be addressed critically. Finally, the single-step drying approach can indeed make the lyophilization process high throughput compared to traditional freeze-drying process (i.e., 2-step drying).     

盐制对杜仲治疗去卵巢大鼠骨质疏松症影响的研究

目的：研究杜仲及其盐制品对去卵巢大鼠骨质疏松症的治疗作用,并探讨盐制对其治疗作用的影响。方法40只SD雌性大鼠分为伪手术组、模型对照组、杜仲生品治疗组和杜仲盐制品治疗组,除假手术组施行假手术外,其余均行手术彻底摘除卵巢,术后4周开始杜仲生品及盐制品水提液灌胃给药（4．0 g／kg?d）,实验过程称体质量,连续给药12周后,颈动脉取血,测定血钙（S－Ca）、血磷（S－P）含量,ELISA试剂盒双抗体夹心法测定血清碱性磷酸酶（ALP）、骨钙素（OCN）、雌二醇（E2）含量;动物处死后剥取完整子宫称重,采用HE染色法进行子宫病理学检查,剥离双侧股骨,双能X射线衍射法测定大鼠股骨骨密度。 HE染色法观察股骨骨小梁形态和成骨细胞数量,micro－CT扫描观察股骨骨小梁微体系结构。结果杜仲生品及盐制品能有效抑制去卵巢所致的大鼠体重增加,升高血清钙、雌二醇的含量,降低血磷、碱性磷酸酶和骨钙素的含量。增加大鼠股骨骨密度,改善股骨骨小梁微体系结构,增加股骨骨小梁成骨细胞数量,且长期用药对子宫无明显刺激作用。结论杜仲生品及盐制品对于大鼠去卵巢所引起的骨质疏松症有良好治疗作用,且盐制品效果优于生品。     

Development of a transmission-blocking malaria vaccine: Progress,challenges, and the path forward

New interventions are needed to reduce morbidity and mortality associated with malaria, as well as to accelerate elimination and eventual eradication. Interventions that can break the cycle of parasite transmission, and prevent its reintroduction, will be of particular importance in achieving the eradication goal. In this regard, vaccines that interrupt malaria transmission (VIMT) have been highlighted as an important intervention, including transmission-blocking vaccines that prevent human-to-mosquito transmission by targeting the sexual, sporogonic, or mosquito stages of the parasite (SSM-VIMT). While the significant potential of this vaccine approach has been appreciated for decades, the development and licensure pathways for vaccines that target transmission and the incidence of infection, as opposed to prevention of clinical malaria disease, remain ill-defined. This article describes the progress made in critical areas since 2010, highlights key challenges that remain, and outlines important next steps to maximize the potential for SSM-VIMTs to contribute to the broader malaria elimination and eradication objectives.     

A note on implementation of decaying product correlation structures for quasi‐least squares

This note implements an unstructured decaying product matrix via the quasi‐least squares approach for estimation of the correlation parameters in the framework of generalized estimating equations. The structure we consider is fairly general without requiring the large number of parameters that are involved in a fully unstructured matrix. It is straightforward to show that the quasi‐least squares estimators of the correlation parameters yield feasible values for the unstructured decaying product structure. Furthermore, subject to conditions that are easily checked, the quasi‐least squares estimators are valid for longitudinal Bernoulli data. We demonstrate implementation of the structure in a longitudinal clinical trial with both a continuous and binary outcome variable. Copyright © 2014 John Wiley & Sons, Ltd.     

Chemically Accessible Hsp90 Inhibitor That Does Not Induce a Heat Shock Response

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