PDCA循环法在抗肿瘤药物及其辅助用药规范化管理中的应用及效果评价

目的探讨PDCA循环法在抗肿瘤药物及其辅助用药规范化管理中的应用效果,促进药物的合理应用。方法2018年在我院抗肿瘤药物及其辅助用药管理中实施PDCA循环法,持续9个月。通过开展季度专项点评工作,每季度与上季度进行比较,统计分析PDCA循环法实施前3个月和实施3个月、6个月及9个月后抗肿瘤药物及其辅助用药使用合理率的改善情况,以此来评价管理效果。结果我院抗肿瘤药物及其辅助用药的使用合理率由PDCA循环法实施前的16.67%逐渐升高至实施9个月后的90.00%;其中,抗肿瘤药物的用药合理率每季度与上季度比较均有统计学差异(P<0.05);抗肿瘤辅助用药的用药合理率在实施9个月后与实施6个月后比较有显著统计学差异(P<0.01)。结论通过应用PDCA循环法进行质量管理,我院抗肿瘤药物及其辅助用药的用药合理率得到明显提高。     

以患者为中心的药物研发策略

介绍美国食品及药物管理局（FDA）以患者为中心的药物开发思路,展示了不同疾病、治疗收益、使用环境分别对应的临床结局评估（COA）工具,整理出5个已获批患者报告结局（PRO）工具的相关信息,并归纳了2010—2015年FDA获批新药中,应用PRO评估工具支持说明书相关声明的药品信息。旨在为业界选择适合的COA类型（PRO、ClinRO、ObsRO或PerfO评估工具）应用于药物研发提供借鉴,并建议将COA工具用于儿科、罕见病、认知障碍相关疾病以及中药的临床疗效评估;同时也为将患者的观点纳入药品监管流程提供参考。     

疫苗生产中基于风险评估的清洗剂变更

目的 在白喉-破伤风-无细胞百日咳疫苗生产车间玻璃瓶清洗剂的变更中,引入质量风险管理,对新清洗剂进行风险分析与评估,以确保更换清洗剂对产品质量无影响。方法 运用风险评估工具对新清洗剂进行相应风险评估,根据风险级别制定风险控制措施,对新清洗剂进行验证,确认其清洗效果以及对产品的影响。结果 清洗后玻璃瓶淋洗水中细菌内毒素含量≤0.25内毒素单位/ml、总好氧微生物计数≤100菌落形成单位/ml、总霉菌酵母菌计数≤10菌落形成单位/ml、总有机碳≤1.5 μg/cm2（淋洗水和擦拭取样）、电导率≤1.3 µS/cm,结果均符合要求。结论 在变更控制中运用质量风险管理,指导变更控制措施的制定和变更内容的实施,保证了新清洗剂的风险可接受且产品质量不受变更影响。     

临床药师参与门诊疼痛综合评定的工作实践

目的:探讨中山大学肿瘤防治中心临床药师参与门诊开展疼痛综合评定的工作模式及其效果。方法:采用回顾性病例对照研究方法,将2017年10月至2018年3月临床药师未参与疼痛综合评定时在疼痛门诊就诊的74例患者作为对照组(由医师进行癌性疼痛评估),2018年4月至2018年9月临床药师参与疼痛综合评定后在疼痛联合门诊就诊的78例患者作为疼痛综合评定组(由临床药师参与疼痛综合评定),比较两组患者入组前、入组2周后的疼痛控制、疼痛对生活质量的影响及用药依从性的变化。结果:入组2周后,两组患者的各项指标水平均较入组前明显改善,且疼痛综合评定组患者的疼痛控制、疼痛对生活质量的影响及用药依从性的变化均明显优于对照组,差异均有统计学意义(P<0.05)。结论:建立肿瘤专科医院临床药师参与疼痛联合门诊疼痛综合评定的工作模式,有助于提高患者的用药依从性,可明显改善患者的疼痛控制、疼痛对生活的影响。     

UPLC-MS/MS法测定人血浆中卡马西平浓度

目的:建立UPLC-MS/MS法测定人血浆中卡马西平浓度并进行方法验证,应用于室间质评的样品测定。方法:采用UPLC-MS/MS法,以卡马西平-d8为内标,XSelect CSH C18柱(2.1 mm×75 mm,2.5μm)为分析柱,流动相A为含0.05%甲酸的水溶液,流动相B为含0.05%甲酸的乙腈溶液,流速为0.3 mL·min^-1,梯度洗脱;采用电喷雾离子源,以多反应监测(MRM)正离子模式进行检测,用于定量分析的离子对为m/z 237.1→194.1(卡马西平)、m/z 245.0→202.1(卡马西平-d8)。结果:卡马西平在5~1000 ng·mL^-1范围内线性关系良好(r≥0.9993),批内批间精密度和准确度、回收率和基质效应以及稳定性均符合生物样品测定要求。应用该方法测定的室间质评样品结果全部通过。结论:该方法准确、灵敏、选择性好、重现性高,适用于血浆中卡马西平浓度测定及室间质评。     

Is Pain Assessment of Community-Dwelling Persons With Advanced Dementia by Family and Paid Care Workers Feasible?

ContextThe experience of pain is aggravated among older persons with advanced dementia (OPAD). It is often undetected and therefore untreated because of their limited capacity to identify and report their symptoms. Therefore, it is crucial to improve the pain identification skills of those who know and live with them.ObjectivesTo compare the identification of pain among OPAD between family members and paid care workers and to compare the detection of pain through the use of two common assessment tools.MethodsThis study is a cross-sectional comparison conducted between 82 dyads of informants: the family member of OPAD and the paid care worker, a total of 164 individuals.MeasurementsThe study used two previously validated pain assessment tools for persons suffering from dementia: the Pain Assessment in Noncommunicative Elderly persons tool (PAINE) and Pain Assessment in Advanced Dementia tool (PAINAD), and a general impression question.ResultsBoth family members and paid care workers were able to successfully use both tools. The correlation between family members' ratings and paid care workers' ratings was statistically significant for all the assessments. The correlations between raters were higher when family members lived with the OPAD. The correlations between PAINE and PAINAD scores were moderate and significant, both among family members and paid care workers.ConclusionThis study shows that it is feasible to improve the assessment and identification of pain among OPAD, through the use of validated tools by family members and paid care workers, suggesting the potential to improve quality of care and quality of life of OPAD.     

悬吊训练治疗脑卒中患者平衡功能障碍的临床研究

目的: 观察悬吊训练（SET）对脑卒中患者平衡功能恢复的影响。方法: 脑卒中平衡功能障碍患者40例,随机分为对照组和观察组各20例,2组均接受常规康复训练,在此基础上,观察组加以悬吊训练。治疗前和治疗4周后采用Berg平衡量表（BBS）、Barthel指数（BI）以及采集竖脊肌表面肌电平均肌电值（AEMG）和中位频率值（MF）对2组患者进行评定。结果: 治疗4周后,2组BBS、BI评分均明显高于治疗前（均P<0.01）,且观察组以上评分均明显高于对照组（均P<0.05）。治疗前,2组患者AEMG、MF值组内比较健侧均明显高于患侧（均P<0.05）;治疗４周后,2组患者健患侧竖脊肌AEMG、MF值均较治疗前明显提高（均P<0.05）,观察组健患侧AEMG、MF值均较对照组明显提高（均P<0.05）,但观察组健患侧AEMG、MF值之间无统计学差异。结论: SET能够改善脑卒中患者的竖脊肌AEMG、MF值及BBS和BI评分,提高脑卒中患者躯干肌肉运动功能,从而提高平衡功能以及日常生活活动能力,值得在临床推广应用。     

Fine-needle Aspiration Cytology of the Breast

Fine-needle aspiration cytology (FNAC) is an established, highly accurate, and cost-effective method for diagnosing lesions in different organs, including the breast. The method is minimally invasive without unwanted side effects. FNAC forms part of the triple assessment of breast lesions. Despite some shortcomings of the reporting categories, FNAC as part of the triple assessment has proved its value in describing the findings most accurately. The diagnostic impact depends on experience of the operator, quality of preparation, and diagnostic skills of the cytopathologist. The highest accuracy is achieved at centers with a multidisciplinary approach. FNAC is often palpation guided from palpable breast masses, whereas ultrasonography guidance is more widely used on nonpalpable lesions. Inadequate sampling with FNAC is particularly seen in collagenous lesions and in submitted specimens sampled by physicians lacking experience with the FNAC procedure. A diagnostic biopsy is recommended when FNAC provides scant material. FNAC is considered to be a safe method for screening purposes, although moderately less sensitive than core needle biopsy. FNAC is most accurate when experienced cytopathologists are available to assess the adequacy of the aspirated material and advise on additional aspirations for ancillary tests when needed.