我国医疗质量安全不良事件分类的思考

患者安全问题已经成为世界各国医疗质量管理关注的焦点,从国家层面对医疗质量安全不良事件进行统一定义和分类具有重要意义。通过总结世界卫生组织、美国、英国以及我国目前不良事件分类及严重程度分级情况,结合我国相关上报数据,分析存在问题,建议国家及各级卫生行政部门发挥引导推动作用,医疗机构利用现有国家医疗质量安全相关平台,参考借鉴相关分类,开展同质化医疗质量安全管理工作。     

患者安全文化调查问卷HS-OPSC 2.0版的评价与思考

患者安全文化测评有助于评估医疗机构的安全状况。美国医疗健康研究与质量机构（AHRQ）发布的HSOPSC是患者安全文化测评工具的典型代表。2019年,AHRQ根据相关意见和建议修订完成了HSOPSC 2.0版,在保留1.0版优势的基础上精简了维度和条目数量,具有良好的信度和效度,可以作为我国医疗机构患者安全文化测评的有效工具。但由于测量结果的定量特征,建议辅以定性研究对潜在文化价值和更深层次文化假设进行深入分析,同时思考如何将测评结果与干预措施结合起来,以更好地评估干预效果。     

基于精细化管理模式下对医学实验室安全管理的探究

医学高等院校实验室是培养医学生创新能力的主要场所,其建设和管理水平是高校科研实力、学科建设实力和人才培养能力的综合体现。将精细化管理模式引用到医学实验室安全管理中,为学生提供一个安全保障的实验环境,才能更有利于实验的顺利开展和高校对人才的培养。本文主要对医学实验室安全管理存在的主要问题进行剖析,并基于精细化管理模式下通过对强化安全教育管理、保障人员配备、引进现代化管理办法等方面创新实验室安全管理进行阐述,为医学高等院校实验室现代化建设提供基本保障。     

重复经颅磁刺激安全性的初步研究

目的 探讨重复经颅磁刺激的安全性。方法 对接受不同刺激频率和刺激量组经颅磁刺激大鼠的行为、组织病理形态、血清髓鞘碱性蛋白（MBP）及神经元特异性烯醇化酶（NSE）含量进行观察。结果 低频刺激组（5Hz）和高频刺激组（20Hz）在刺激过程中均未出现异常活动,无肢体强直、阵挛等,脑组织形态学包括大体观察、普通光镜改变不明显,其血清MBP和NSE含量与正常对照组比较,无显著性差异（P＞0．05）。结论 在一定强度和频率内经颅磁刺激是比较安全的。     

Safety of cyclin-dependent kinase4/6 inhibitor combined with palliative radiotherapy in patients with metastatic breast cancer

IntroductionCyclin-dependent kinase (CDK)4/6 inhibitor is a first-line therapy for metastatic ER+/HER2-breast cancer. However, there are limited data on safety of combined radiotherapy (RT) and CDK4/6 inhibition.MethodsWe conducted a retrospective study of women with metastatic breast cancer who received palliative RT within 14 days of CDK4/6 inhibitor use. The primary endpoint was toxicity per Common Terminology Criteria for Adverse Events v5. Secondary endpoints were pain response and local control based on clinical assessment and imaging.ResultsThirty patients underwent 36 RT courses with palbociclib (n = 34 courses, 94.4%) or abemaciclib (n = 2, 5.6%). RT was delivered before, concurrently or after CDK4/6 inhibitors in 7 (19.4%), 8 (22.2%), and 21 (58.3%) of cases with median 3.5 days from RT to closest CDK4/6 inhibitor administration. Median RT dose was 30Gy (range 8–40.05Gy). Treated sites included brain (n = 5, 11.6%), spine (n = 19, 44.2%), pelvis (n = 9, 20.9%), other bony sites (n = 6, 14.0%) and others (n = 4, 9.3%). No acute grade ≥3 non-hematologic toxicity occurred. No increased hematologic toxicity was attributable to RT with grade 3 hematologic toxicities rates 16.7%, 0%, and 6.7% before, during, and 2 weeks after RT completion. All but one patient (29/30) achieved symptom relief. Local control rates were 94.4%, 91.7% at 6 and 12 months.ConclusionsThe use of RT within 2 weeks of CDK4/6 inhibitors had low acceptable toxicity and high efficacy, suggesting that it is safe for palliation of metastatic breast cancer.     

9种试点食药物质的安全性评价及试点风险监测现况

按照传统既是食品又是中药材的物质简称为食药物质,传统中医药常使用食药物质来防治疾病或养生保健。随着我国大健康产业的迅速发展,食药物质成为健康领域关注的热点。近年来,随着食药物质品种的增加,研发产品的创新种类和应用增多,拟新增食药物质的安全性问题成为关注重点。现综述国家卫生健康委员会和市场监督管理总局开展的按照传统既是食品又是中药材物质管理试点工作的9种试点食药物质的食用与药用价值、安全性和不良反应、国内部分省份风险监测内容和方案,以期为9种试点食药物质的食品安全风险监测工作的开展提供参考,为食药物质的合理应用和资源开发提供一定的依据。     

The safety of BCG revaccination: A systematic review

IntroductionRevaccination with Bacillus Calmette-Guérin (BCG) vaccine is not generally recommended due to a lack of proven efficacy of repeat doses for protection against tuberculosis. However, there is a growing interest in the use of BCG vaccine for its ‘off-target’ effects which might involve revaccination. We did a systematic review of the safety of BCG revaccination.MethodsMEDLINE (1946 to March 2020) and the BCG World Atlas (updated 2017) were searched, limiting to studies of BCG administration by the intradermal or percutaneous route. Adverse events as well as patient and vaccine characteristics were reviewed.ResultsThe search identified 388 articles, of which 24 met the inclusion criteria. These reported 22 studies comprising eight randomised trials, four case-control studies, four observational studies and six case series or reports. Overall, there was evidence for a small increase in the rate of mild local and systemic reactions. No serious adverse events were reported in immunocompetent individuals.ConclusionsEvidence to date suggests that revaccination with BCG vaccine carries minimal risk. Future studies of BCG vaccine for novel applications should report adverse event data stratified by prior BCG vaccination status.     

Efficacy of a rational algorithm to assess allergy risk in patients receiving the BNT162b2 vaccine

Among 6146 hospital employees, 118 subjects with severe allergic background were identified through a screening questionnaire and stratified into 3 groups (Low-risk (LR), Intermediate (IR) and High-risk (HR) group), based on their allergic anamnesis.Data reports on hypersensitivity reactions (HypR) have been collected in both allergic and non-allergic subjects. Seventeen patients (14%) in the allergic population had a HypR after the first, the second or both doses. Skin manifestations were the most frequent ones. Allergic events were more frequent in HR (35%) than IR (10%; p = 0.005) or LR (0%; p = 0.074) subjects. No patient had anaphylaxis. All patients completed the vaccination schedule.13 HypR occurred in patients without severe allergic background (13/6028, 0,2%) including one (1/6148, 0.016% of total population) WAO grade-4 anaphylaxis.Our data suggest that BNT162b2 mRNA Covid-19 vaccine is relatively safe also in patients with severe allergic background; however, some precautions are required for high-risk patients.