Colitis following the use of immune checkpoint inhibitors: A real-world analysis of spontaneous reports submitted to the FDA adverse event reporting system

BackgroundAlthough colitis has been reported in patients treated with immune checkpoint inhibitors (ICIs), associations between colitis and ICIs had not been thoroughly assessed in real-world studies. Here, we identified and characterized significant colitis-associated with ICIs.MethodsBased on the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to December 2019, the disproportionality analysis and Bayesian analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were adopted to data mining of the suspected adverse events of colitis after ICIs administrating. Clinical characteristics of patients with ICIs-associated colitis and the time to onset of colitis following different ICI regimens were collected.ResultsA total of 3786 reports of colitis adverse events were identified with ICIs. Seven ICI monotherapies were associated with the reporting of colitis. Statistically significant ROR, PRR, information component (IC), and empirical Bayesian geometric mean (EBGM) emerged for all ICI monotherapies and combination therapies. ICIs-associated colitis affected mostly male (53.51%), with a wide mean age range (60.65 to 72 years). Colitis adverse events were commonly reported in patients with melanoma and lung cancer. Adverse outcomes of colitis concerning ICI were mainly outcomes of hospitalization-initiated or prolonged and other serious. Among colitis cases, 17.43% cases of colitis concerning ICI lead to death. The adverse event of colitis occurred earliest in ipilimumab monotherapy with a median time to onset of 64.21 days (IQR: 27–69 days) among all monotherapies.ConclusionsICI may lead to severe and disabling ICIs-associated colitis during therapy. Analysis of FAERS data identified signals for adverse events of colitis with ICI regimens. Practitioners should consider the factors that may increase the likelihood of colitis. The findings support a continued surveillance and risk factor identification studies.     

基于SWOT模型分析下天津市医联体模式实施现状及对策研究

目的:结合我国医疗卫生现状及相关政策分析天津市开展医联体工作的实施现状,为医联体模式在天津市全面开展提供理论依据,对医疗卫生服务体系整体格局平衡具有现实的指导意义。方法:目的性选取天津市16个建立医联体的三级医院和基层医疗机构的20名人员进行半结构式访谈,采用Colaizzi内容分析法将资料整理分析,应用SWOT模型,归纳总结出天津市医联体模式在实施过程中的优势、劣势、机遇和挑战。结果:天津市开展医联体的优势包括提高基层医生医务能力,应用信息网络搭建沟通平台,提升社区整体水平;劣势包括基层医生工作繁多、压力大、积极性不高,药品管理制度限制患者基层就医,医保制度限制医联体运行;机遇包括医联体建设有国家政策支持,设立专人专岗从事医联体工作;挑战包括基层缺乏吸引人才的机制、区域发展不平衡、缺乏统一管理。结论:天津市医联体模式在实施过程中应加强用经济激励医务人员积极性、建立医联体统一管理制度、完善相关医保政策和药品管理制度,维持医疗卫生服务体系整体格局平衡,促进天津市医联体的全面开展。     

患者安全目标:加强医学装备安全与警报管理

阐述医疗器械使用安全与警报管理的意义和内涵，分析医疗器械使用安全与警报的风险点，探讨建立医疗器械使用安全与警报风险防范体系的方案，列举了医疗器械使用安全与警报管理的实践案例。     

基于中医传承辅助平台探讨清代方剂专著论述泄泻用药规律＊

目的 基于中医传承辅助平台软件（V2.5）提供的数据分析平台，研究清代方剂专著论述泄泻的用药规律，供现代中医临床辨证用药参考。方法 查阅中华医典（第5版）中的79部清代方剂专著，选择其中10部专门论述“泄泻”的方剂专著，建立数据库，通过中医传承辅助平台软件（V2.5）集成的药物“频次统计”、“规则分析”等功能，对治疗泄泻的用药规律进行分析。结果 本研究共筛选出93首泄泻处方，含药物119味，挖掘出高频（频次 ≥ 5）药物20味，高频（频次 ≥ 13）药物组合12组，演化得到19个核心药物组合和6首新处方。结论 清代方剂专著中治疗泄泻的方剂，多用利水消肿药、补益药，切合本病脾虚湿盛的病机。中医传承辅助平台（V2.5）可实现对于方剂数据的录入、管理、查询和分析，是一个富有价值的辅助中医药研究的工具。     

医院药库药房智能管理系统设计及应用的分析

在信息技术不断改进和优化的背景下,医院应用智能化管理系统是首要的趋势,医院药库药房作为医院管理期间十分重要的一部分,其对于医院管理效率的提升和后期运行有着直接性的影响。该文逐一分析了医院药库药房智能管理系统的设计和应用情况,希望在此基础上实现各个环节的规范性和信息化管理目标。     

基于数据挖掘方法总结王树声教授治疗上尿路结石的用药经验

目的:运用中医传承辅助平台系统(V2.5)深入分析王树声教授治疗上尿路结石的用药经验，挖掘其核心经验 方组成和辨证用药规律。方法:收集王教授门诊治疗上尿路结石的治疗验方304 首，将方药信息录入系统，采用药物频次统计、 关联规则分析和熵聚类分析等方法分析处方用药规律。结果:304 首处方中涉及中药97 味，用药频次超过100 次的有14 味。所用药物药性多寒、温、平，药味多甘、苦，主归肝、肾、脾经；共得出25 组核心组合和9 首新处方。结论:王教授治疗 上尿路结石以益气固本、清热通淋为主，用药的关键在于“扶正固本”的把握和“祛邪通淋”的权衡，为临证用药和新方 开发提供参考。     

Highlights of the 15th annual scientific meeting of the Society of Cardiovascular Computed Tomography

The 15th Society of Cardiovascular Computed Tomography (SCCT) annual scientific meeting (ASM) welcomed 770 digital attendees from 44 countries, over 2 days, with a program that included 30 sessions across three simultaneously streaming channels, 10 exhibitors and a diverse range of scientific abstracts. In addition, #SCCT2020 generated >5900 tweets from nearly 700 engaged social media participants resulting in an estimated 38 million digital impressions and becoming #1 trending medical meeting in social media in the world during the meeting time period. This article summarizes the many themes and topics of presentation and discussion in this meeting, and the many technical advances that are likely to impact future clinical practice in cardiovascular computed tomography.     

宣白承气汤单独用药及联合用药治疗肺炎痰热壅肺证Meta分析

目的:系统评价宣白承气汤单用及联合用药治疗肺炎痰热壅肺证的临床疗效。方法:检索CNKI、万方、CBM、PubMed等数据库,筛选宣白承气汤治疗肺炎的随机对照试验(RCT),运用Cochrane协作网偏倚风险评价工具进行文献质量评价,使用Revman 5.3 软件进行Meta分析。结果:最终纳入16项研究,共1393例患者,纳入文献质量不高。Meta分析结果表明,与单纯西医治疗相比,使用宣白承气汤可明显提高肺炎痰热壅肺证的临床总有效率[RR=1.29,95%,CI(1.22,1.36),P<0.00001],且亚组分析显示单用或联用宣白承气汤的组间差异无统计学意义; 可明显改善APACHE II评分、CPIS评分,明显降低炎症因子水平,改善中医证候积分。结论:宣白承气汤可有效治疗肺炎痰热壅肺证,但鉴于纳入临床研究在质量上存在一定局限性,得出的阳性结果仅作为临床诊疗的提示与参考,急需开展更多的高质量大规模的RCT来进一步验证。