《特殊管理药品标准》制订与解析

特殊管理药品包括麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品。监督、指导特殊管理药品的临床使用是医疗机构药事管理与药物治疗学委员会(组)的重要职责之一。《特殊管理药品标准》是由中国医院协会药事专业委员会牵头编制,对医疗机构特殊管理药品工作开展的组织管理、环节管理、质量控制管理三方面16个关键要素进行了规范,可用于指导各级各类医疗机构特殊管理药品工作的规范开展。该文阐述《特殊管理药品标准》制订的方法和内容,以期为医疗机构开展特殊管理药品药事管理以及日常开展相关工作提供参考和借鉴。

DDX5对白血病K562细胞生物学功能的影响及其机制

目的探讨DDX5解螺旋酶对白血病细胞系K562细胞增殖、凋亡和分化的影响。方法利用癌症基因数据库GEPIA中的数据分析DDX5 mRNA在白血病患者组织中的表达;生存曲线分析DDX5 mRNA表达水平与白血病患者预后关系;采用小干扰RNA(siRNA)瞬时转染K562细胞以敲低DDX5;使用实时荧光定量(RT-PCR)检测沉默效果;采用Western blot检测蛋白表达水平;采用CCK-8实验检查细胞增殖能力、采用Western blot和免疫荧光检测细胞增殖相关蛋白的表达水平;采用流式细胞术检测细胞凋亡;采用流式细胞术和Western blot检测细胞分化相关蛋白的表达水平。最后,通过RT-PCR和Western blot检测沉默DDX5对P21和P53蛋白表达水平的影响。结果GEPIA数据库分析结果显示DDX5在人白血病骨髓组织中的表达水平显著高于健康人群,低表达DDX5的患者具有更长的生存期。体外实验表明敲低DDX5可显著抑制K562细胞的增殖,流式细胞术检测结果表明可以促进细胞凋亡、促进CD11b和CD14蛋白的表达诱导细胞分化。沉默DDX5促进P21和P53蛋白的表达水平。结论DDX5可能通过靶向P53抑制白血病细胞系K562细胞增殖,促进凋亡诱导分化。

肾移植受者围手术期霉酚酸暴露量及不良反应分析

目的:分析肾移植受者围手术期霉酚酸(MPA)血药浓度监测结果和不良反应发生情况,以促进临床合理用药。方法:回顾性分析2022年10月1日至11月31日浙江大学医学院附属第一医院肾移植围手术期受者临床资料。52例受者均于肾移植术后第2天开始监测MPA血药浓度谷值(C0),其中29例于肾移植术后第4天监测MPA血药浓度-时间曲线下面积(AUC)。通过医院信息系统收集其年龄、性别、MPA-C0和MPA-AUC监测结果、白细胞水平以及腹泻和排斥反应发生情况等信息。两组间比较采用独立样本t检验,P<0.05为差异具有统计学意义。结果:52例肾移植受者术后监测MPA-C0平均为(4.1±2.3)mg/L,其中1.0~3.5 mg/L 24例(46.15%),>3.5 mg/L 28例(53.85%)。29例受者MPA-AUC平均为(54±23)mg·h^(-1)·L^(-1),其中30~60 mg·h^(-1)·L^(-1)14例(48.28%),<30 mg·h^(-1)·L^(-1)5例(17.24%),>60 mg·h^(-1)·L^(-1)10例(34.48%)。女性受者(n=9)MPA-AUC高于男性(n=20),分别为(68±16)和(48±23)mg·h^(-1)·L^(-1),差异有统计学意义(t=-2.31,P<0.05)。29例监测MPA-AUC肾移植受者中19例使用吗替麦考酚酯(MMF),10例使用麦考酚钠肠溶片(EC-MPS),MMF和EC-MPS AUC分别为(53±26)和(57±15)mg·h^(-1)·L^(-1),差异无统计学意义(t=0.46,P>0.05)。52例肾移植受者围手术期均未发生排斥反应。1例(1.92%)受者于肾移植术后第21天发生粒细胞减少。6例(11.54%)受者发生腹泻,在减少MPA剂量和使用蒙脱石散对症处理后症状缓解。结论:肾移植受者围手术期MPA暴露量差异较大,近半数受者MPA暴露量不符合指南要求。MPA不良反应发生率相对较低,较高的MPA暴露量与受者不良反应无关。

Failure mode and effect analysis of the risk management of non-integral-dosage drug dispensing in PIVAS

To mitigate risks associated with the prescription examination,marking,dispensing,checking,and review of non-integral-dosage drugs in Pharmacy Intravenous Admixture Service(PIVAS),we formed a project team.Employing the failure mode and effect analysis(FMEA)management method,we identified potential risks in four critical steps of the non-integral-dosage drug dispensing process within PIVAS drug management:prescription verification,mixed allocation,and verification.For each step,we assigned scores for severity,incidence,and detectability,subsequently calculating the Risk Priority Number(RPN)to prioritize identified risks.Targeted measures for improvement were developed for steps with the highest RPN values.A total of 31 risk factors were documented in the management of non-integral-dosage drugs,with the dispensing process being particularly vulnerable.Specific measures were devised for eight high RPN risks.Following a 3-month optimization and improvement period,RPN values and incidences of internal differences were significantly reduced.The implemented measures demonstrated effective risk control.Notably,we established a comprehensive conversion system for partial-dose drug dispensing,directly translating into a volume of suction fluid for dispensing personnel based on doctor orders.This eliminated the need for manual secondary calculations,thereby standardizing and automating the dispensing of non-integral-dosage drugs in PIVAS.Simultaneously,our project team conducted a dissolution test on 23 types of drugs with non-integral dosage,revealing that the solvent volume increased for 11 types after dissolution.The dosage conversion for partial dosage was recalibrated based on the volume of the final solution to ensure dosage accuracy.Through the application of failure mode and effect analysis,we systematically managed the risks associated with non-integral-dosage drugs in PIVAS.This approach addressed safety concerns in the dispensing process,reduced errors,and ensured the safe and precise administration of medication to patients.