精神科护士夜班经历创伤事件后成长体验的质性研究

目的 探讨精神科护士夜班经历创伤事件后的成长体验,以期为护士不同阶段心理情况进行针对性干预和指导,并为护士职业生涯早期心理建设提供方向。方法 采用扎根理论的研究方法,2020年3月—7月对广东省某三级甲等医院12名夜班经历创伤事件的精神科护士进行深度访谈,采用Strauss和Corbin扎根理论分析资料,分为开放式登录、轴心式登录和选择式登录3个阶段,持续比较分析资料。结果 发现精神科护士夜班经历创伤事件后经历了应激期、调适期、成长期3个不同阶段。结论 精神科护士夜班经历创伤事件后的成长为动态过程,管理者或干预者可根据不同阶段进行针对性干预和指导,并在护士早期培训中促使其提前做好相关知识、技能的储备和必备心理素质的塑造。     

FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

Characterizing Standardized Functional Data at Inpatient Rehabilitation Facilities

ObjectiveThe Improving Medicare Post-Acute Care Transformation Act of 2014 mandates using standardized patient functional data across post-acute settings. This study characterized similarities and differences in clinician-observed scores of self-care and transfer items for the standardized section GG functional domain and the functional independent measure (FIM) at inpatient rehabilitation facilities.DesignWe conducted secondary analyses of 2017 Uniform Data System for Medical Rehabilitation national data. Patients were assessed by clinicians on both section GG and FIM at admission and discharge. We identified 7 self-care items and 6 transfer items in section GG conceptually equivalent with FIM. Clinician-assessed scores for each pair of items were examined using score distributions, Bland-Altman plot, correlation (Pearson coefficients), and agreement (kappa and weighted kappa) analyses.Setting and ParticipantsIn all, 408,491 patients were admitted to Uniform Data System for Medical Rehabilitation-affiliated inpatient rehabilitation facilities with one of the following impairments: stroke, brain dysfunction, neurologic condition, orthopedic disorders, and debility.MeasuresSection GG and FIM.ResultsPatients were scored as more functionally independent in section GG compared with FIM, but change score distributions and score orders within impairment groups were similar. Total scores in section GG had strong positive correlations (self-care: r = 0.87 and 0.95; transfer: r = 0.82 and 0.90 at admission and discharge, respectively) with total FIM scores. Weak to moderate ranking agreements with total FIM scores were observed (self-care: kappa = 0.49 and 0.60; transfers: kappa = 0.43 and 0.52 at admission and discharge, respectively). Lower agreements were observed for less able patients at admission and for higher ability patients of their change scores.Conclusions and ImplicationsOverall, response patterns were similar in section GG and FIM across impairments. However, variations exist in score distributions and ranking agreement. Future research should examine the use of GG codes to maintain effective care, outcomes, and unbiased reimbursement across post-acute settings.     

Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

基层医生的儿童功能性便秘诊疗能力研究

背景 功能性便秘（FC）是儿童常见健康问题，也是儿童父母在基层医疗卫生机构门诊就诊中咨询频率较高的问题。尽管便秘不是急症，但如果处理不当，可能会引起严重的并发症，进而影响儿童及其家庭的生活质量。 目的 了解基层医生的儿童FC诊疗水平，为针对性提高基层医生的儿童FC诊疗与管理能力提供依据。 方法 于2020年7月，在北京市西城区基层医疗卫生机构中选取在日常诊疗中能接触到儿童患者的医生130例。采用本研究组自行设计的问卷对纳入医生开展调查，内容包括对≥6个月儿童FC诊断中常见症状的认知，以及对儿童FC的推荐治疗方法、推荐治疗药物、药物治疗时机及治疗持续时间等。 结果 108例（83.1%）基层医生的问卷被有效回收，其中全科医生34例（31.5%）、儿科医生30例（27.8%）、中医科医生30例（27.8%），平均每月门诊接触儿童患者（10.1±4.4）例。对于儿童FC的诊断：当≥6个月患儿出现排便次数少、大便坚硬、排便时出血、大便失禁、排便困难、排出稠便前哭泣症状时，分别有40.7%（44/108）、39.8%（43/108）、23.1%（25/108）、9.3%（14/108）、39.8%（43/108）、23.1%（25/108）的基层医生会考虑将其诊断为FC；51.9%（56/108）的基层医生认为同时存在排便次数少、排便困难两种症状时可诊断为FC；25.0%（27/108）的基层医生认为，同时存在排便次数少、大便坚硬、排便时出血、排便困难4种症状时可诊断为FC。对于儿童FC的治疗：37.0%（40/108）的基层医生推荐将药物治疗作为儿童FC的首选治疗方法；63.0%（68/108）的基层医生推荐将非药物治疗作为首选治疗方法，其中88.2%（60/68）推荐腹部按摩，85.3%（58/68）推荐高纤维饮食，82.4%（56/68）推荐如厕训练，72.1%（49/68）推荐增加液体摄入量。75.9%（82/108）的基层医生推荐使用乳果糖治疗；27.8%（30/108）的基层医生推荐联合应用柠檬酸钠、十二烷基磺基乙酸钠、山梨糖醇的微灌肠为直肠治疗方法，64.8%（70/108）的基层医师建议在患儿排便特别困难时进行直肠给药。基层医生认为，患儿开始治疗到有阳性反应的平均时间为（4.1±2.6）d；基层医生对儿童FC的平均治疗时间为（21.2±4.3）d；88.9%（96/108）的基层医生认为，便秘平均平均治疗（46.0±9.3）d可终止；当排便频率和/或稠度恢复正常/患者不再有不适时，88.9%（96/108）的基层医生会考虑停止治疗。 结论 尽管基层医生对儿童FC的诊断和治疗有一定认识，但总体认知水平有待提高。建议进一步提升现有基层医生对儿童FC的认知和综合管理能力，并制定基层医疗卫生机构的儿童FC综合管理模式，以提高对儿童FC的管理水平，从而降低患病率、提升治愈率。     

Ovine Iliac Vein Model for Endovascular Thrombectomy of Acute Deep Venous Thrombosis

An ovine iliac vein thrombosis model was devised to test a wall-contacting rotational thrombectomy device. Thrombosis was successfully induced in 9 sheep with an average clot length of 31 mm ± 12 and >60% vessel occlusion on angiography. The thrombus was subsequently removed, maintaining normal intraoperative pulmonary arterial pressure (5.9 mm Hg ± 3.6) and complete distal reperfusion after thrombectomy. Additionally, the sheep were without signs of vascular trauma or embolic complications on gross necropsy and histopathologic analysis. The findings from this study support the use of an ovine iliac deep vein thrombosis model for testing of a lower extremity thrombectomy device.     

US Food and Drug Administration approvals for Bruton tyrosine kinase inhibitors in patients with chronic lymphocytic leukemia: Potential inefficiencies in trial design and evidence generation

The US Food and Drug Administration granted acalabrutinib approval as the second Bruton tyrosine kinase (BTK) inhibitor to treat patients with chronic lymphocytic leukemia and small lymphocytic lymphoma as monotherapy or in combination with obinutuzumab. This approval was based on 2 phase 3 trials: ELEVATE-TN and ASCEND. There are several concerns with the design of these trials, including suboptimal treatment of patients in the control arm, expansion of the trial population, and lack of data regarding efficacy or tolerability compared with ibrutinib, a first-in-class drug. The Food and Drug Administration approval of acalabrutinib for patients with chronic lymphocytic leukemia and small lymphocytic lymphoma represents concerning drug approval patterns in the United States and a weakness in evidence generation.     

欧盟草药药品监管模式对中国中药注册管理的启示＊

对药品实行注册管理制度是确保公众健康的全球通用的监管措施。中药作为承载中医药理论与用药实践的主要载体，对中药产品的注册管理又具有其特殊性。2017年正式实施的《中医药法》提出了建立符合中医药特点管理制度的发展方针，研究制定配套文件或修订现行规章以适应衔接其立法精神是当前重要的现实问题之一。欧盟在植物药监管领域取得了良好成效，本文旨在系统分析欧盟对其注册管理的法规体系，深入剖析其监管特点和对中国中药注册管理的启示，以期为当前《中医药法》背景下中药监管制度的改革提供参考。