Background: Licorice, a commonly used traditional Chinese medicine in clinical practice, and pharmaceuticals with glycyrrhiza or glycyrrhiza extract as the main component play an important role in the treatment of hepatic and biliary system diseases and other conditions. Its dual identities as a traditional Chinese material medica and a natural phytocomponent have led to the underestimation of its latent adverse drug reactions (ADRs) in clinical and research. Objective: This study adopted a retrospective literature analysis method and stratified subgroups based on the inherent attribute differences of different study types, aiming to explore the characteristic differences in ADRs induced by glycyrrhiza-containing Chinese patent medicines under different study designs and considering the individual differences among patients. Design: A retrospective literature analysis was conducted in this study. Methods: This study adopted a retrospective study design. We searched PubMed, Web of Science, Scopus, Google Scholar, CNKI, Wanfang, and VIP Database from index inception to August 2025. Data on patient demographics, ADRs details, medication regimens, and outcomes were extracted and analyzed via SPSS 23.0. Results: A total of 120 articles were included (110 case reports, 10 clinical trials: 2 case series, 8 RCTs). Patient-related high-risk factors included males aged >60 years, hepatic insufficiency, or drug allergy history. Drug-related risk factors included off-label dosage, specific administration routes, and concomitant use with thiazide diuretics, drugs that induce arrhythmias or electrolyte disturbances, as well as agents with high plasma protein binding rates. All these factors were associated with the incidence and severity of ADRs. Most symptoms were alleviated following timely drug withdrawal and targeted treatment. Conclusion: ADRs induced by Glycyrrhiza-containing Chinese patent medicines involve multiple organ systems. Early detection and prompt drug withdrawal are crucial for symptom alleviation. In clinical practice, such preparations should be administered in conjunction with patients’ individual characteristics to ensure rational drug use.
BackgroundBaclofen, a γ-aminobutyric acid (GABA) derivative, and Pregabalin, a GABA analogue, are widely prescribed for muscle spasm and neuropathic pain. This first-reported case demonstrates synergistic central nervous system (CNS) depression of Baclofen (30 mg/day) and Pregabalin (300 mg/day) in a patient with mild renal impairment [estimated glomerular filtration rate, (eGFR) = 77.26 mL/min].Case PresentationA 68-year-old female with renal impairment developed progressive CNS depression (somnolence, coma) following combined Baclofen (30 mg/day) and Pregabalin (300 mg/day) therapy after spinal fusion surgery. CNS depression was completely resolved 48 h after drug discontinuation.ConclusionClinicians should exercise heightened caution when combining Baclofen and Pregabalin in renal impairment. Dose adjustments based on creatinine clearance (CLcr) are strongly recommended. Particular attention should be given to initiating therapy with reduced starting doses in patients at elevated risk of CNS depression.
Objectives Through searching and summarizing the medication-related disputes and claims in Beijing, we found the factors that were most likely to cause disputes during the medication process. These provided a basis for further exploration of medication-related dispute prevention and control measures. Methods We took all medication-related dispute archives from the Beijing People’s Mediation Committee of Medical Disputes(BPMCMD)database from January 2013 to December 2019 as the research object, and used pre-designed forms for data extraction and entry. Results Medication-related disputes accounted for 2.43% of the total number of disputes, of which 158 disputes got the payment from hospitals. There were obviously more disputes between women than men. The most disputes occurred in outpatient clinics, followed by hospitalization and emergency treatment. Disputes were most likely to occur in pharmacy, respiratory medicine, pediatrics, neurology and orthopedics. Antibacterial drugs were the most common drugs that caused disputes, followed by herbal medicines or Chinese patent drugs, antineoplastic drugs, analgesic drugs, psycholeptics drugs and antithrombotic agents. Medication errors mainly concentrated in inappropriate drugs (within guidelines, but otherwise contraindicated); wrong drugs or strength dispensed; drug dose too high and no indications for drug. The main cause of disputes was adverse drug events. The total compensation for seven years was 15.19 million yuan. Conclusions We comprehensively displayed the dispute data from the patient, the doctor, the drug, and the compensation, etc. The research would help Beijing and other regions formulate the strategies to reduce medication errors, improve patient safety, and reduce medication-related dispute
BackgroundFollowing the Chinese guidelines’ recommendation to completely cancel routine cephalosporin skin tests, the choice of cephalosporin as surgical prophylactic medication was affected. This was due to the limited cognition of the predictive value of cephalosporin skin test or the desire to avoid medical disputes. The aim of this retrospective study was to evaluate whether the pharmacist-led perioperative antibiotic prophylaxis model could improve clinicians’ medical behavior in choosing cephalosporin antibiotics for surgical prophylaxis.MethodsFrom July 2021 to May 2022, a retrospective analysis was conducted on the selection of surgical preventive medication, skin test, postoperative infection and adverse drug reactions in foot and ankle surgery. The study was divided into three period: the rountine cephalosporin skin test period (Period I: Skin Test), the period when the routine cephalosporin skin test was cancelled but the pharmacist did not intervene (Period II: Cancel Skin Test), and the period when the pharmacist-led perioperative antibiotic prophylaxis was implemented after the cancellation of the cephalosporin skin test (Period III: Pharmacist Intervention).ResultsA total of 1,583 patients were enrolled in this study. There was no significant difference in the utilization rate of cefuroxime between the routine skin test stage and the skin test cancelled stage [74.92% (Period I) vs. 74.54% (Period II), P > 0.05]. However, in the pharmacist intervention stage, the usage rate of cefuroxime significantly increased compared to the initial stage when the skin test was cancelled [87.07% (Period III) vs. 74.54% (Period II), P < 0.05]. The use of cephalosporins also increased in patients with self-reported beta-lactam allergies between these stages [41.94% (Period III) vs. 3.22% (Period II), P < 0.05)]. There was no significant difference in the incidence of postoperative infection and adverse drug reactions among the three periods.ConclusionThe pharmacist-led perioperative antibiotic prophylaxis model can significantly improve the medical behavior of clinicians in choosing cephalosporin antibiotics as surgical prophylactic medication and optimize the perioperative medication plan.
Introduction - Several medications are available for the treatment of cancer, and monoclonal antibodies that target PD-1 and PD-L1 represent first-line options for cancer. PD-1 promotes the ability of the immune system to recognize and attack cancer cells by activating T cells. PD-1 also activates the autoimmune system. This activation causes healthy cells in the body to be attacked by the immune system, resulting in immune-related adverse events (irAE). The objective of this study was to comprehensively evaluate the adverse events of rejection reactions in real-world solid organ transplant patients using monoclonal antibodies that target PD-1/PD-L1. Methods. - Data from 2016-2021 were extracted from the U.S. Food and Drug Administration(FDA) Adverse Reporting System (FAERS) to describe the rejection reaction in patients with solid organ transplantation cases after using PD-1/PD-L1 inhibitors approved by the FDA. The reporting odds ratio (ROR) with 95% confidence interval (CI) for rejection reaction was calculated for each PD-1/PD-L1 inhibitor. A disproportionality signal was defined when the lower limit of 95% CI > 1. Results. - The FAERS database recorded 11,935 adverse events related to solid organ transplantation. Among these reports, 117 showed that various PD-1/PD-L1 inhibitors exhibited a strong correlation with solid organ transplantation rejection. The 3 medicines with the incidence of rejection reaction include avelumab (1), nivolumab (79) and pembrolizumab (37). The average time of solid organ transplantation rejection associated with PD1 / PD-L1 inhibitors was 40.64 days. Of those patients who experienced solid organ transplant rejection, a total of 24.79% died. Conclusion. - This study found that PD-1/PD-L1 inhibitor use in patients with solid organ transplantation was associated with donor organ rejection. This information serves as a pharmacovigilance signal that we need to continue to track in the real world. (c) 2022 Societe francaise de pharmacologie et de therapeutique. Published by Elsevier Masson SAS. All rights reserved.
药品质量管理及控制是医疗机构药事管理的重要内容,加强医疗机构药品质量管理及控制有助于提升医疗质量,从而为患者的用药安全提供有力的保障.为实施同质化的药品质量管理及控制,编制团队以科学性、通用性、指导性和可操作性为编写原则,通过梳理问题、征集意见、专家论证审议,最终形成国内首部对药品质量管理及控制全过程进行规范的团体标准.该文阐述药品质量管理及控制标准制订过程,并对标准内容进行解析,以期为各级各类医疗机构开展药品质量管理及控制提供建议和指导.
目的 了解利奈唑胺致视神经炎的临床特点.方法 检索PubMed、Elsevier Science Direct、Embase、Springer-link、Wiley Online Library、Scopus、CNKI、万方数据库,查阅文献报道利奈唑胺致视神经炎的临床特点.结果 共检索应用利奈唑胺致视神经炎患者36例,男16例,女19例,1例未提及性别,年龄范围6~81岁,用药原因包括结核、骨与关节感染等.用药剂量方面,1例患者用量为1.6 g·d-1,其余患者均未超说明书推荐剂量.患者用药后出现视神经炎的时间为10~1125 d,中位数时间为210 d,利奈唑胺累计剂量为16.8~894 g,中位数剂量为162 g.临床表现为不同程度的视力下降.患者均停药治疗,视力恢复时间7d~9个月,中位数时间为3个月.转归方面:2例患者视力未改善,其余患者均视力恢复.结论 利奈唑胺可引起视神经炎,用药疗程可能是相关危险因素.临床上应注意这一不良反应,保证患者用药安全.
目的:了解国内外单克隆抗体药物的研究热点,分析可能的研究趋势.方法:以中国知网和PubMed上公开发表的单克隆抗体药物研究文献为基础数据(检索时间为1982年1月至2022年1月),运用CiteSpace工具,对2个文献数据库进行分析,得出国内外研究的热点和不同之处.结果:通过对2个数据库文献的知识图谱分析,可以看到乳腺癌、抗体偶联药物、临床试验、靶向治疗等均是国内外文献研究的热点.结论:CiteSpace的文献研究提示,单克隆抗体药物的研究正处在大幅提升期,在肿瘤、自身免疫、代谢等疾病领域显示出独特的优势和前景;我国单克隆抗体药物研究相关的发文量居世界第4位,在此研究方面占有重要的地位.
药学病例讨论是临床药学工作的主要内容.《药学病例讨论标准》以药学病例讨论开展全过程为主线,以政策法规为依据,以协调性、一致性、适用性和统一性为编写原则,根据医院等级评审的标准和行业发展的现状,综合行业专家的建设性意见,对基本条件、讨论准备、讨论过程、质量管理与评价改进 4 个环节进行规范,可作为药师开展药学病例讨论的参考.
目的 研究散瞳药物环喷托酯滴眼液导致中枢神经系统这一特殊不良反应的临床特点,以保障临床安全合理用药.方法 检索PubMed、Elsevier、Science Direct、Embase、Springer Link、FAERS、VigiBase、万方、中国知网数据库,检索时间为从建库至2022 年8 月7 日,收集环喷托酯滴眼液引起的中枢神经系统不良反应个案报道,并对患者基本信息、用法用量、基础疾病、合并用药、不良反应发生时间、表现、处理及转归10 个方面进行分析.结果 共检索到18 篇个案文献报道,涉及18 例患者,男性占比72%,年龄11 个月~82 岁,其中小于18 岁占比67%.患者应用环喷托酯滴眼液后,出现不同程度的中枢神经系统不良反应,主要表现为嗜睡、恶心、流涎、共济失调、语无伦次、幻觉等症状,其中16 例(89%)患者在24 h内症状完全缓解,2 例(11%)患者症状无明显缓解,转入相关科室行进一步治疗.结论 环喷托酯滴眼液局部应用可诱发严重中枢神经系统不良反应,特别对于年龄小于18 岁的儿童以及自身患有神经系统相关疾病的患者,应在给药后密切监护,对于可能发生的中枢神经系统不良反应,能够及时恰当处理.
OBJECTIVE To explore the standardized training mode oriented to improve the clinical medication therapy ability of resident pharmacists, which was suitable for the present and future hospital pharmacy work.And to evaluate the teaching effect of resident pharmacists who were trained under this mode.All of these can provide some reference for improving the pharmaceutical care in Chinese hospital.METHODS(1)We conducted a survey which including the examination forms, core skills and daily training work, on the resident pharmacists who participated in the first-stage skill assessment in Beijing in 2020,and the examination scores of these resident pharmacists was analyzed.(2)The training mode aimed at improving the weak skill was explored in the resident pharmacists of our hospital.The learning content of clinical pharmacy in the rotation process of drug dispensing group was increased, and the learning effect of the resident pharmacists under the exploring training mode and traditional training mode were compared by questionnaires.RESULTS(1)The subjective evaluation and the skill assessment scores of the resident pharmacists for the examination related to medication therapy management was lower than other examination contents.(2)The exploration of standardized training mode for improving the clinical medication therapy ability can improve the core competence of resident pharmacists and make the training content more close to clinical work.CONCLUSION The standardized training mode oriented to improving the clinical medication therapy ability of resident pharmacists can improve the core professional competitiveness of hospital pharmacists and promote the transformation and development of hospital pharmacy.
目的 探索建立基于循证医学的药品目录遴选方法,并修订北京市医疗机构抗菌药物临床使用分级管理目录,为科学形成药品目录和合理应用抗菌药物提供支持.方法 北京市卫生健康委员会建立多学科的目录工作组根据目录计划书,整合药品数据、药品证据和专家意见,按照纳入排除标准,通过德尔菲法对北京市医疗机构抗菌药物临床使用分级管理目录形成专家共识.结果 遴选的目录共纳入99种药品,与上版目录相比,新增10种抗菌药物,调出38种抗菌药物;另有5种和13种抗菌药物分别上调和下调了管理级别.结论 以循证医学思想和方法为指导,通过全面的证据和数据支持、结合多学科专家的经验、科学的共识方法,可以提高药品目录修订的科学性和合理性.
《医疗机构药事管理与药学服务》第3-4部分:药学保障服务用药监护(简称《用药监护标准》)是中国医院协会团体标准之一,该标准规范了医疗机构药师开展用药监护工作的基本要求、监护过程和质量管理与评价改进 3 个环节中的 11 项要素,可用于建议和指导各级各类医疗机构用药监护工作的规范开展.该文阐述《用药监护标准》的构建方法和内容并解析其要点,以加深对该标准的理解,促进其落地执行.
中国医院协会药事专业委员会围绕医疗机构药事管理与药学服务现状和行业发展方向,通过文献调研、问卷调查、医疗案例分析等方法,依据循证结果,系统梳理归纳了医疗机构临床药学服务、药学保障服务和药事管理等领域的重点问题,研究近年来国内外相关文献,参照国内现行的法律法规、规章制度及国内外标准,借鉴国内外标准化管理经验,研究建立了中国医院协会《医疗机构药事管理与药学服务》团体标准体系架构,内容包括总则、临床药学服务、药学保障服务、药事管理 4 个部分 51 个分册.
静脉用药集中调配是药学服务的重要组成部分,对规范医疗机构药事管理工作具有积极作用.该文介绍了静脉用药集中调配标准.该标准是中国医院协会药事专业委员会牵头制订的团体标准的一部分.标准内容涵盖静脉用药集中调配的基本要求、药品与耗材管理、流程管理、质量管理与评价改进四个关键环节,共包含 15 个要素.该文对静脉用药集中调配标准的制订过程和重点内容进行解析.
药学科普是指以健康科普的方式将药学领域科学知识、科学方法、科学思想和科学精神传播给公众的,以培养提高公众用药相关健康素养为目的的活动.《医疗机构药事管理与药学服务》第 2-12 部分:临床药学服务 药学科普是中国医院协会团体标准之一,其对药学科普工作的基本要求、过程管理、质量评价与持续改进三方面进行了规范,是药师开展药学科普工作的参考和依据.该文旨在介绍和解析该标准内容要点,为后续开展药学科普工作提供指导.
治疗药物监测是临床药学服务的重要内容之一,助力个体化药物治疗.根据医院评审标准要求,结合行业现状,该标准制订中参照国内外已发布的相关指南、共识及规范,梳理了治疗药物监测实施过程中的问题.遵循科学性、通用性、指导性和可操作性的编写原则,经过"内部意见征集-论证会-外部意见征集-审议会"等多轮意见征集,从"基本要求、服务过程、质量管理与评价改进"三方面进行规范.该标准是国内首部对治疗药物监测全过程进行规范的团体标准.该文阐述标准制订过程,并对其内容进行解析,以期指导二级及以上各类医疗机构规范化开展治疗药物监测工作,促进个体化药学服务高质量发展.
药学会诊是指医疗机构药师应临床科室或医务部门的邀请,出于诊疗需要对患者的药物治疗方案进行优化和药学监护的药学服务.基于国家相关法规和规范性文件,结合国内外相关指南文献、行业专家意见,中国医院协会药事专业委员会遵循科学性、通用性、指导性和可操作性原则组织制订了《药学会诊标准》.该标准对药学会诊基本要求、服务过程、质量管理与评价改进进行了规范和标准化,是医疗机构药师开展药学会诊服务的依据.该文介绍了《药学会诊标准》的制订过程,并针对标准中的重点内容进行简要解析,旨在为医疗机构药师开展药学会诊工作提供参考,进一步提高其工作质量.
目的:分析与抗结核药物性肝损伤(anti-tuberculosis drug-induced liver injury,ATB-DILI)相关医疗纠纷的规律及特点,为合理用药提供参考.方法:检索"中国裁判文书网"从建库到2021年12月31日与ATB-D1LI相关的医疗损害责任纠纷的裁判文书,建立数据库,回顾性分析纠纷的分布特点,用药错误原因等相关内容.结果:共检索到判决书2 970 篇,纳入ATB-DILI相关有责案件34例.2017-2020年的判决案例数是2013-2016年的1.6倍.男性多于女性,有基础肝病的患者数量约占总患者数量的38.24%.25例(73.53%)患者死亡或进行了肝移植,6例(17.65%)患者发生肝衰竭.有肝脏基础疾病的患者发生死亡或肝移植的比例为84.61%,稍高于无肝脏基础疾病的患者的66.67%.从开始使用抗结核药至发现肝损伤的时间(潜伏期)最短为1 d,最长为182 d,中位时间为34 d,26例(76.47%)潜伏期≤60 d.引发纠纷的前3条错误原因分别为不良反应的识别或处理不当,告知不足及用药前对肝病重视不足.结论:医师应该加强对抗结核药物性肝损伤的重视程度,正确识别和处理抗结核药物性肝损伤,充分履行告知义务,减少ATB-DILI对患者造成的生命安全威胁及用药纠纷.