中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

A case of purulent pneumococcal pericarditis

Background

Purulent bacterial pericarditis is a rare and potentially fatal disease. The course may be fulminant, and the presentation may pose a diagnostic challenge.

Differentiating autoimmune pancreatitis from pancreatic ductal adenocarcinoma with CT radiomics features

PurposeThe purpose of this study was to determine whether computed tomography (CT)-based machine learning of radiomics features could help distinguish autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC).Materials and MethodsEighty-nine patients with AIP (65 men, 24 women; mean age, 59.7 ± 13.9 [SD] years; range: 21–83 years) and 93 patients with PDAC (68 men, 25 women; mean age, 60.1 ± 12.3 [SD] years; range: 36–86 years) were retrospectively included. All patients had dedicated dual-phase pancreatic protocol CT between 2004 and 2018. Thin-slice images (0.75/0.5 mm thickness/increment) were compared with thick-slices images (3 or 5 mm thickness/increment). Pancreatic regions involved by PDAC or AIP (areas of enlargement, altered enhancement, effacement of pancreatic duct) as well as uninvolved parenchyma were segmented as three-dimensional volumes. Four hundred and thirty-one radiomics features were extracted and a random forest was used to distinguish AIP from PDAC. CT data of 60 AIP and 60 PDAC patients were used for training and those of 29 AIP and 33 PDAC independent patients were used for testing.ResultsThe pancreas was diffusely involved in 37 (37/89; 41.6%) patients with AIP and not diffusely in 52 (52/89; 58.4%) patients. Using machine learning, 95.2% (59/62; 95% confidence interval [CI]: 89.8–100%), 83.9% (52:67; 95% CI: 74.7–93.0%) and 77.4% (48/62; 95% CI: 67.0–87.8%) of the 62 test patients were correctly classified as either having PDAC or AIP with thin-slice venous phase, thin-slice arterial phase, and thick-slice venous phase CT, respectively. Three of the 29 patients with AIP (3/29; 10.3%) were incorrectly classified as having PDAC but all 33 patients with PDAC (33/33; 100%) were correctly classified with thin-slice venous phase with 89.7% sensitivity (26/29; 95% CI: 78.6–100%) and 100% specificity (33/33; 95% CI: 93–100%) for the diagnosis of AIP, 95.2% accuracy (59/62; 95% CI: 89.8–100%) and area under the curve of 0.975 (95% CI: 0.936–1.0).ConclusionsRadiomic features help differentiate AIP from PDAC with an overall accuracy of 95.2%.     

In Vivo Kinematics of Functional Ankle Instability Patients and Lateral Ankle Sprain Copers During Stair Descent

Patients with mechanic ankle instability experience increased tibiotalar and subtalar joint laxity. However, in vivo joint kinematics in functional ankle instability (FAI) patients and lateral ankle sprain (LAS) copers, especially during dynamic activities, are poorly understood. Ten FAI patients, 10 LAS copers, and 10 healthy controls were included in this study. A dual fluoroscopic imaging system was used to analyze the tibiotalar and subtalar joint kinematics during stair descent. Five key poses of stair descent were analyzed. Kinematic data from six degrees of freedom were calculated utilizing a solid modeling software. The range of motion and joint positions in each degree of freedom were compared among the three groups. The tibiotalar joints of FAI patients and LAS copers were significantly more inverted than those of healthy controls during the foot strike (p = 0.016, = 0.264). The subtalar joints of FAI patients were significantly more anteriorly translated (pose 2, p = 0.003, = 0.352; pose 3, p < 0.001, = 0.454; pose 4, p = 0.004, = 0.334), inverted (pose 4, p = 0.027, = 0.234; pose 5,p = 0.034, = 0.221), and externally rotated (pose 4, p = 0.037, = 0.217; pose 5; p = 0.004, = 0.331) than those of healthy controls during the mid‐stance and the heel off. The FAI patients showed excessive tibiotalar inversion and subtalar joint hypermobility during stair descent. Meanwhile, the LAS copers maintained subtalar joint stability, and only showed excessive tibiotalar inversion in foot strike. These data provide insight into the mechanisms behind the development of FAI after initial LAS. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1860–1867, 2019     

The use of cadaver models to diagnose rib fractures: A pilot study

Background

In the emergency department, rib fractures are a common finding in patients who sustain chest trauma. Rib fractures may be a sign of significant, underlying pathology, especially in the elderly patients where rib fractures are associated with significant morbidity and mortality. To date, no studies have evaluated the ability of ultrasound to detect rib fractures using cadaver models and subsequently use this model as a teaching tool.

完全型雄激素不敏感综合征2例临床特点及处理

雄激素不敏感综合征(androgen insensitivity syndrome,AIS)又称为睾丸女性化综合征(testicular feminization syndrome,TFS),是一种X连锁遗传病,是男性假两性畸形中较常见的类型,可分为完全型AIS和不完全型AIS,其原因主要是雄激素受体(androgen receptor,AR)基因的突变导致其对雄激素产生抵抗和不应答。本文回顾南京医科大学附属妇产医院2例CAIS患者的临床资料及诊疗过程,以期能进一步提高对该病的认知及诊治水平。     

The technological imperative in tuberculosis care and prevention in Vietnam

ABSTRACT

A monocausal bacteriological understanding of infectious disease orients tuberculosis control efforts towards antimicrobial interventions. A bias towards technological solutions can leave multistranded public health and social interventions largely neglected. In the context of globalising biomedical approaches to infectious disease control, this ethnography-inspired review article reflects upon the implementation of rapid diagnostic technology in low- and middle-income countries. Fieldwork observations in Vietnam provided a stimulus for a critical review of the global rollout of tuberculosis diagnostic technology. To address local needs in tuberculosis control, health managers in resource-poor settings are readily cooperating with international donors to deploy novel diagnostic technologies throughout national tuberculosis programme facilities. Increasing investment in new diagnostic technologies is predicated on the supposition that these interventions will ameliorate disease outcomes. However, suboptimal treatment control persists even when accurate diagnostic technologies are available, suggesting that promotion of singular technological solutions can distract from addressing systemic change, without which disease susceptibility, propagation of infection, detection gaps, diagnostic delays, and treatment shortfalls persist.     

An electronic travel guide for visually impaired – vehicle board recognition system through computer vision techniques

Abstract

Purpose: In the context of assistive technology, mobility takes the meaning of “moving safely, gracefully, and comfortably”.The aim of this article is to provide a system which will be a convenient means of navigation for the Visually Impaired people, in the public transport system.

Method: A blind regular commuter who travels by public transport facility finds difficulty in identifying the vehicle that is nearing the stop. Hence, a real-time system that dynamically identifies the nearing vehicle and informs the commuters is necessary. This paper proposes such a system namely the “Vehicle Board Recognition System” (VBRS). Computer Vision techniques such as segmentation, object recognition, text detection and optical character recognition are utilized to build the system, which will detect, analyze, derive and communicate the information to the passengers.

Results: Thanks to the rapid development in technology, there are several navigation systems both hand held and wearable, available to help visually impaired (VI) people move comfortably both indoor and outdoor. Many blind people are not comfortable in using these devices or they are not affordable for them. Thus the proposed system gives them the comfort of navigation.

Conclusion: This system can be installed in the bus stop to assist the Visually Impaired, from externally rather than their hand held or wearable assistive devices.

• Implications for rehabilitation

• This proposed system will help the visually impaired to

• ensure secure navigation

• be independent of the others

• develop self confidence.

• overcome the training, affordability of wearable/ handheld devices.