瑞巴派特分散片的人体药动学及生物等效性

建立了液相色谱-串联质谱法测定健康志愿者口服瑞巴派特分散片(受试制剂)和普通片(参比制剂,膜固思达(R))后的血药浓度,估算两制剂的药动学参数并评价生物等效性.采用随机、开放、双周期交叉试验设计,22名男性健康志愿者单剂量口服受试或参比制剂0.1g后,血样经乙腈直接沉淀蛋白后进行LC-MS/MS分析,利用DAS2.1.1软件计算药动学参数,并进行生物等效性评价.受试和参比制剂在人血浆中瑞巴派特的cmax为(236.9±103.4)和(233.9±105.1) ng/ml,tmax为(2.7±1.1)和(2.9±1.4)h,t1/2为(2.0±0.8)和(2.3±1.5)h,AUC0→12h为(929.0±291.9)和(970.5±353.2) ng·h·ml1.受试制剂的相对生物利用度为(102.6±29.8)％.     

Virtual environments to study emotional responses to clinical communication: A scoping review

ObjectiveThis scoping review explores the potential for virtual environments (VE) to evaluate emotional outcomes in clinical communication research. Authors representing multiple disciplines use review results to propose potential research opportunities and considerations.MethodsWe utilized a structured framework for scoping reviews. We searched four literature databases for relevant articles. We applied multidisciplinary perspectives to synthesize relevant potential opportunities for emotion-focused communications research using VE.ResultsTwenty-one articles met inclusion criteria. They applied different methodological approaches, including a range of VE technologies and diverse emotional outcome measures, such as psychophysiological arousal, emotional valence, or empathy. Major research topics included use of virtual reality to provoke and measure emotional responses, train clinicians in communication skills, and increase clinician empathy.ConclusionResearchers may leverage VE technologies to ethically and systematically examine how characteristics of clinical interactions, environments, and communication impact emotional reactions and responses among patients and clinicians. Variability exists in how VE technologies are employed and reported in published literature, and this may limit the internal and external validity of the research. However, virtual reality can provide a low-cost, low-risk, experimentally controlled, and ecologically valid approach for studying clinician-patient communication.Practice implicationsFuture research should leverage psychophysiological measures to further examine emotional responses during clinical communication scenarios and clearly report virtual environment characteristics to support evaluation of study conclusions, study replicability, and meta-analyses.     

Interactive virtual reality assessment of aggressive social information processing in boys with behaviour problems: A pilot study

Children's aggressive behaviour is partly determined by how they process social information (e.g., making hostile interpretations or aiming to seek revenge). Such aggressive social information processing (SIP) may be most evident if children are emotionally engaged in actual social interactions. Current methods to assess aggressive SIP, however, often ask children to reflect on hypothetical vignettes. This pilot study therefore examined a new method that actually involves children in emotionally engaging social interactions: interactive virtual reality (VR). We developed a virtual classroom where children could play games with virtual peers. A sample of boys (N = 32; ages 8–13) from regular and special education reported on their SIP in distinct VR contexts (i.e., neutral, instrumental gain and provocation). They also completed a standard vignette-based assessment of SIP. Results demonstrated good convergent validity of interactive VR assessment of SIP, as indicated by significant moderate to large correlations of VR-assessed SIP with vignette-assessed SIP for all SIP variables except anger. Interactive VR showed improved measurement sensitivity (i.e., larger variances in SIP compared to vignettes) for aggressive responding, but not for other SIP variables. Discriminant validity (i.e., distinct SIP patterns across contexts) of interactive VR was supported for provocation contexts, but not for instrumental gain contexts. Last, children were more enthusiastic about the VR assessment compared to the vignette-based assessment. These findings suggest that interactive VR may be a promising tool, allowing for the assessment of children's aggressive SIP in standardized yet emotionally engaging social interactions.     

Preferred Functions of Personal Health Records in Rural Primary Health Clinics in Canada: Health Care Team Perspectives

Background  Personal health records (PHR) provide opportunities for improved patient engagement, collection of patient-generated data, and overcome health-system inefficiencies. While PHR use is increasing, uptake in rural populations is lower than in urban areas. Objectives  The study aimed to identify priorities for PHR functionality and gain insights into meaning, value, and use of patient-generated data for rural primary care providers. Methods  We performed PHR preimplementation focus groups with rural providers and their health care teams from five primary care clinics in a sparsely populated mountainous region of British Columbia, Canada to obtain their understanding of PHR functionality, needs, and perceived challenges. Results  Eight general practitioners (GP), five medical office assistants, two nurse practitioners (NP), and two registered nurses (14 females and 3 males) participated in focus groups held at their respective clinics. Providers (GPs, NPs, and RNs) had been practicing for a median of 9.5 (range = 1–38) years and had used an electronic medical record for 7.0 (1–20) years. Participants expressed interest in incorporating functionality around two-way communication and appointment scheduling, previsit data gathering, patient and provider data sharing, virtual care including visits using videoconferencing tools, and postvisit sharing of educational materials. Three further themes emerged from the focus groups: (1) the context in which the providers'' practice matters, (2) the need for providing patients and providers with choice (e.g., which data to share, who gets to initiate/respond in communications, and processes around virtual care visits), and (3) perceived risks of system use (e.g., increased complexity for older patients and workload barriers for the health care team). Conclusion  Rural primary care teams perceived PHR opportunities for increased patient engagement and access to patient-generated data, while worries about changes in workflow were the biggest perceived risk. Recommendations for PHR adoption in a rural primary health network include setting provider-patient expectations about response times, ability to share notes selectively, and automatically augmented note-taking from virtual-care visits.     

Does a learning curve exist for accuracy in three-dimensional planning for maxillary positioning in bimaxillary orthognathic surgery?

The purpose of this study was to investigate the influence of time, and experience, on the accuracy of maxillary repositioning in bimaxillary orthognathic surgery performed using virtual surgical planning (VSP). Patients who had undergone bimaxillary orthognathic surgery were reviewed. Maxillary position on pre- and postoperative computed tomography scans was compared. The patients were divided into groups according to the year in which VSP was performed and surgery completed. Linear distances between upper jaw reference landmarks were measured in all three planes of space to determine accuracy between the preoperative VSP and the surgical outcome at various time points. One hundred subjects met the eligibility criteria for assessment and were allocated to groups: 2013 (n = 10), 2014 (n = 17), 2015 (n = 39), 2016 (n = 20), and 2017 (n = 14). Overall, the results demonstrated improved precision in maxillary position over the years, with more accurate results in patients who underwent surgery in 2015, 2016, and 2017. Mean linear differences between planned and obtained results demonstrated more accurate results in the horizontal direction, followed by transverse and vertical directions. An overall average difference within 1 mm was observed for 51.3% of the measurements included in the sample group. Time, and surgeon experience, can influence the accuracy of maxillary positioning in bimaxillary orthognathic surgery.     

实时弹性定量成像技术在腕管综合征正中神经病变中应用及与MRI正中神经扁平率相关性研究

[目的]评估VTIQ的剪切波速度(shear wave velocity,SWV)在CTS患者中的应用,同时分析与MRI钩骨钩水平正中神经扁平率(median nerve flattening ratio MNFR) 相关性,以探讨SWV在诊断CTS中的临床应用价值。[方法]对临床诊断为CTS 40例患者(67只腕关节)及20例健康对照组(40只腕关节)进行VTIQ检测及二维超声检测。评估指标是SWV及CSA。比较两指标CTS组与对照组组间差异。绘制两指标诊断CTS的ROC曲线。回顾性分析临床诊断CTS患者MRI资料,测量MNFR。评估SWV及CSA与MNFR相关性。[结果]CTS组SWV、CSA与对照组比较差异有统计学意义(P＜0.05)。正中神经SWV诊断CTS最佳截值3.30m/s,计算SWV的灵敏度、特异度和准确率高于CSA。两指标联合诊断效能灵敏度,准确率高于单一指标。SWV、CSA与MNFR之间存在相关性。[结论] CSA及SWV两指标的改变反映了CTS患者正中神经形态学增粗,组织学变硬。VTIQ技术与MRI测量结果有较好一致性。遵照规范及指南条件下应用VTIQ技术在诊断CTS患者正中神经病变中有较好的可行价值。VTIQ技术及正中神经横截面积联合应用可以减少漏诊率,可为患者正确规范化治疗CTS提供更丰富的影像诊断依据。     

超声介入医师训练实时影像虚拟导航系统辅助肝癌消融的学习曲线分析

目的分析超声介入医师行实时影像虚拟导航系统（RVS）辅助肝癌消融的学习曲线。 方法回顾性分析2018年10月至2019年9月就诊于浙江中医药大学附属杭州市西溪医院的,由同一名具有5年以上超声引导下肝癌消融经验的医师,行RVS引导下辅助肝癌消融的第1~60例肝癌患者资料。按照治疗顺序分为A、B、C组,每组各20例。采用方差分析比较各组间RVS术前融合时间和肿瘤消融时间的差异,组间两两比较采用LSD-t检验;采用Fisher确切概率法分析患者组间肿瘤1次性消融成功率和术后1个月肿瘤的完全灭活率的差异。绘制RVS辅助肝癌消融的术前融合时间曲线图。 结果A组的RVS术前融合时间、肿瘤消融时间明显大于B组及C组［（20.9±6.7）min vs （9.7±1.2）min vs （9.6±2.7）min;（23.1±7.9）min vs （19.6±5.0）min vs （19.2±3.7）min］,差异具有统计学意义（t=7.4,P＜0.001;t=1.9,P=0.035）,B组与C组之间比较,差异均无统计学意义（P均＞0.05）;A组的肿瘤1次性消融成功率［74.1%（20/27）］小于B组［96.4%（27/28）］和C组［96.4%（27/28）］,差异具有统计学意义（P均=0.025）,B组与C组之间比较,差异无统计学意义（P＞0.05）。3组RVS辅助肝癌消融术后1个月肿瘤完全灭活率比较［92.6%（25/27） vs 92.9%（26/28） vs 92.9%（26/28）］,差异均无统计学意义（P均＞0.05）。操作者积累约20例患者后,术前融合时间趋于稳定,学习进入平台期。 结论对于期望熟练掌握RVS辅助肝癌消融的介入医师,操作者积累约20例患者RVS辅助肝癌消融可以明显缩短术前融合时间和肿瘤消融时间,提高融合精准度、团队契合度及肿瘤1次性消融成功率,之后学习曲线进入平台期。     

缬沙坦氨氯地平片在中国健康人体内的生物等效性研究

目的 评价缬沙坦氨氯地平片受试制剂与参比制剂在中国健康人体内的生物等效性和观察两制剂的安全性。方法 采用单中心、随机、开放、3周期、部分重复交叉设计。受试者经高脂高热餐后/空腹单剂量口服缬沙坦氨氯地平片受试制剂或参比制剂,采血至给药后72 h,周期间的清洗期为14 d。采用经方法学验证的LC-MS/MS检测血浆中缬沙坦和氨氯地平的浓度。选择Phoenix WinNonlin 软件(8.0版本),以非房室模型(non-compartmental analysis,NCA)计算缬沙坦、氨氯地平的药动学参数。采用参比制剂校正的平均生物等效性(reference-scaled average bioequivalence,RSABE)和平均生物等效性(average bioequivalence,ABE)方法评价缬沙坦的生物等效性,ABE方法评价氨氯地平的生物等效性。结果 缬沙坦在空腹条件下的Cmax、AUC0-t和AUC0-∞和在餐后条件下的Cmax的个体内变异系数均>0.294,采用参比制剂标度的平均生物等效性方法。计算得到单侧95%置信上限<0和几何均值比估计值为80.00%~125.00%。缬沙坦餐后条件下的AUC0-t和AUC0-∞的个体内变异系数<0.294,采用平均生物等效性方法,受试制剂与参比制剂的AUC0-t、AUC0-∞经对数转换后的几何均值比值的90%置信区间均在80.00%~125.00%内。综上,两制剂中的缬沙坦具有生物等效性。氨氯地平的Cmax、AUC0-t和AUC0-∞的个体内变异系数<0.294,采用平均生物等效性方法,受试制剂与参比制剂的Cmax、AUC0-t和AUC0-∞经对数转换后的几何均值比值的90%置信区间均在80.00%~125.00%内,表明两制剂中的氨氯地平具有生物等效性。结论 缬沙坦氨氯地平片受试制剂和参比制剂在中国健康人体内具有生物等效性。