Clinical Effectiveness of Erlova in EGFR-Mutated Non-Small Cell Lung Cancer: An Affordable Price with Clinical Benefit

Background: Thyrosin kinase inhibitors (TKIs) is approved for the first line treatment of non-small cell lung cancer (NSCLC) patients with  epidermal growth factor receptor (EGFR) mutation. This study performed to assess clinical effectiveness and safety of Erlova (generic form of Erlotinib). Methods: Somatic mutations of EGFR gene were studied in tumor tissue by polymerase chain reaction (PCR) and bi-directional sequencing in 513 chemonaive and histologically verified lung adenocarcinoma Iranian patients. Patients  with EGFR mutation received Erlova at 150 mg/day  as first line treatment. Primary endpoint was progression free survival (PFS). Results: About 21% (n=109) cases had EGFR mutation. Most EGFR mutations were  occurred at exon 19. Among them, sixty nine patients treated with Erlova. Median PFS was 11.4 months and objective response rate (ORR) was about  88%. Most frequent treatment related adverse events was  skin rash. Conclusion: Our findings showed Erlova had remarkable effectiveness. In  mutation-positive patients with EGFR, Erlova can be used  safely instead of  other tyrosine-kinase inhibitors.     

氯雷他定联合阿伐斯汀治疗慢性难治性荨麻疹的效果及安全性分析

目的 探讨氯雷他定联合阿伐斯汀治疗慢性难治性荨麻疹的效果及安全性。方法 选择2019年1月至2020年6月本院接收的慢性难治性荨麻疹患者85例,采用随机数字表法将其分为对照组(42例)和观察组(43例)。对照组采用阿伐斯汀胶囊口服治疗,在对照组基础上,观察组采用氯雷他定片口服治疗,治疗4周后,比较两组临床疗效、实验室相关指标[白细胞(WBC)、5-羟色胺(5-HT)、血清免疫球蛋白(IgE)]、安全性。结果 观察组临床总有效率(95.35%)高于对照组(78.57%),差异有统计学意义(χ2=5.308,P=0.021);治疗4周后,观察组5-HT水平(127.65±8.61)μg/L高于对照组的(104.52±9.32)μg/L,IgE水平(57.41±7.53)IU/mL、WBC水平(9.20±1.95)g/L低于对照组的(72.26±8.40)IU/mL、(11.31±2.04)g/L,差异有统计学意义(t=11.889、8.587、4.875,P均=0.000);观察组不良反应发生率(11.63%)与对照组(7.14%)对比,差异无统计学意义(χ2=0.501,P=0.713)。结论 予以慢性难治性荨麻疹患者氯雷他定联合阿伐斯汀治疗效果确切,可改善患者实验室相关指标,且未明显增加不良反应,安全性较高。     

Alzheimer's Disease THErapy With NEuroaid (ATHENE): A Randomized Double-Blind Delayed-Start Trial

ObjectivesPreclinical and clinical studies indicate a role for MLC901 (NeuroAiD II) in Alzheimer's disease (AD). The primary aim was to investigate its safety as add-on therapy to standard treatment and the secondary aims its effect on cognition and slowing disease progression.DesignRandomized double-blind placebo-controlled delayed-start study.Setting and ParticipantPatients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n = 125), were randomized to receive MLC901 (early starters) or placebo (delayed starters) for 6 months, followed by a further 6 months when all patients received MLC901, in a delayed-start design (clinical trial registration: ClinicalTrials.gov, NCT03038035).MethodsThe primary outcome measure was occurrence of serious adverse events (SAEs) at 6 months. Secondary outcomes included the Alzheimer's Disease Assessment Scale–Cognitive subscale (ADAS-Cog) and other assessment scales.ResultsThere was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference ?4.4%, 90% CI –16.9% to 8.3%). Similarly, there was no significant difference in the risk of adverse events and the occurrence of stroke or vascular events between early and delayed starters throughout the 12-month study period. Early starters did not differ significantly on ADAS-Cog from delayed starters at M6 [mean difference (MD) ?1.0, 95% CI –3.3 to 1.3] and M12 (MD –2.35, 95% CI –5.45 to 0.74) on intention-to-treat analysis. Other cognitive assessment scales did not show significant differences.Conclusions and ImplicationsThis study of 125 persons with dementia found no evidence of a significant increase in adverse events between MLC901 and placebo, thus providing support for further studies on both efficacy and safety. Analyses suggest the potential of MLC901 in slowing down AD progression, but this requires further confirmation in larger and longer studies using biomarkers for AD.     

《医疗质量管理办法》中医疗质量概念及相关问题探讨

采用文献复习和实证研究经验的方法对《医疗质量管理办法》中涉及的医疗质量概念及相关问题进行探讨。《医疗质量管理办法》中的医疗质量的定义存在重大缺失,没有涉及医疗服务的结果,特别是患者安全。医疗质量的定义应与国际相关权威机构保持一致,应高度重视医疗服务的结果,特别是患者安全。     

实习护生情绪智力、临床实习环境与病人安全感知能力的中介效应

目的:了解实习护生情绪智力、临床实习环境与病人安全感知能力现状并探讨三者关系。方法:采用情绪智力量表、临床实习环境量表和卫生职业教育病人安全感知量表对492名实习护生进行调查。结果:实习护生情绪智力总分为(123.81±18.69)分,临床实习环境总分为(119.48±22.16)分,病人安全感知能力总分为(67.16±12.06)分,情绪智力、临床实习环境与病人安全感知能力呈正相关(r值分别为0.723和0.720,P<0.01);情绪智力在临床实习环境和病人安全感知能力间起部分中介效应,中介效应估计值为0.286(28.6%)。结论:学校要举办人文课程活动以培养情绪智力;医院应制订计划增加学习机会,选拔给予护生充分支持的带教老师,改善临床实习环境。     

Travelers and travel vaccines at six health care systems in the Vaccine Safety Datalink

BackgroundStudying the safety of travel vaccines poses challenges since recipients may be traveling during the risk window for adverse events and the identification of a suitable comparison group can also be difficult. The examination of traveler characteristics, travel vaccination patterns, and health care utilization using electronic health record (EHR) data can inform the feasibility of future travel vaccine safety studies.MethodsA retrospective cohort study of health plan members in the Vaccine Safety Datalink Project aged 9 months and older who had a travel-related encounter or received a travel vaccine from 2009 to 2018 was performed. Travel regions visited, travel duration, type of travel vaccine received (typhoid, yellow fever, Japanese encephalitis, rabies, and cholera), and timing of vaccination date before departure date were described. Sociodemographic information, clinical characteristics, and health care utilization were compared between travelers who received travel vaccines and travelers who did not.ResultsA total of 1,026,822 unique travelers departing from the United States were identified; 612,795 travelers received 898,196 doses of travel vaccines. The most commonly administered travel vaccine was typhoid vaccine and 77% of all travel vaccines were given more than one week prior to departure. Compared with travelers without travel vaccines, travelers with travel vaccines were overall similar but as a group were slightly younger, healthier, and had lower Hispanic representation. Health care utilization dramatically decreased during travel. Outpatient visits decreased from 294.8 visits per 10,000 person-days before travel to 24.2 visits per 10,000 person-days during reported travel dates.ConclusionsThrough the EHR information from almost a million travelers, a departure date and duration of travel were successfully captured for the majority of travelers with corresponding health care utilization data. Time after vaccination and prior to departure can potentially be used in the future to compare travelers who receive travel vaccines with travelers who do not receive travel vaccines when looking at adverse events of interest after vaccination.     

Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

BackgroundGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.MethodsVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.ResultsFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.ConclusionsData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.     

基层医疗卫生机构居家护理服务的安全支持和医务人员服务意愿调查研究

背景 人口老龄化趋势下，罹患多种慢性病的失能或半失能老年人对居家医疗护理服务需求迫切，但基层医务人员提供居家医疗护理服务存在较大的医疗风险和安全隐患，加强居家医疗护理服务的安全管理，有利于提高基层医务人员提供居家医疗护理服务的意愿。 目的 调查基层医疗卫生机构对居家护理服务的安全支持情况和医务人员的服务意愿，为进一步推动居家医疗护理服务发展提供参考依据。 方法 2021年8—10月，采用便利抽样法在四川省五大经济区抽取49所基层医疗卫生机构的1 131例医务人员。自行设计调查问卷，以"问卷星"电子问卷的形式收集资料。问卷内容包括医务人员的一般情况（8个条目）、提供居家医疗护理服务的经历（2个条目）、医疗机构对医务人员的安全支持（7个条目）、医务人员的居家医疗护理服务意愿（1个条目）。比较不同特征医务人员提供居家医疗护理服务的意愿，采用二元Logistic回归分析医务人员提供居家医疗护理服务意愿的影响因素。 结果 1 131例基层医务人员中，692例（61.18%）报告有过居家医疗护理服务的经历，193例（17.06%）报告在服务过程中发生过不良事件/安全事件，531例（46.95%）报告其所在医疗机构未评估过患者接受居家医疗护理服务的安全风险，199例（17.60%）表示所在机构评估了医务人员提供居家医疗护理服务的安全风险，299例（26.44%）在居家医疗护理服务过程中使用APP定位系统，273例（24.14%）由机构配备报警、延迟预警等设备，807例（71.35%）表示居家医疗护理服务过程中没有获得所在机构内其他医务人员的支持措施，303例（26.79%）表示机构曾组织居家医疗护理服务的专项研讨活动，352例（31.12%）表示接受过有关居家医疗护理服务专项培训，853例（75.42%）表示愿意提供居家医疗护理服务。二元Logistic回归分析结果显示，就职的基层医疗卫生机构类型，目前受聘的专业技术职称，医疗机构是否评估过患者接受居家医疗护理服务的安全风险，在居家医疗护理服务过程中是否配备报警、延迟预警等设备，是否参加过有关居家医疗护理服务的专项培训，对医务人员提供居家医疗护理服务意愿有影响（P<0.05）。 结论 现阶段居家医疗护理服务的安全支持不足，多种因素影响基层医务人员提供居家医疗护理服务的意愿。基层医疗卫生机构应加强对患者接受居家医疗护理服务安全风险的评估，为提供居家医疗护理服务的医务人员配备报警、延迟预警等设备，积极举办居家医疗护理服务相关的专项培训并鼓励医务人员参加，以降低医务人员提供居家医疗护理服务的风险，保障其人身安全。     

基于正交试验的肾造瘘管固定方案研究

目的 探讨基于正交试验的肾造瘘管不同固定方案的比较效果。方法 将14Fr硅胶肾造瘘管固定在聚乙烯展板和拉力显示器上，以固定材料、固定方法、面积为3个影响因素，每个因素3个水平，每组进行3次试验再求平均值作为最后拉力值F，共进行9个固定方案共27次试验。利用L9（33）正交试验矩阵研究不同材料（医用橡皮膏、医用透气胶带、医用无纺布胶带）、固定方法（交叉固定法、“工”字固定法和改良“工”字固定法）及面积(16 cm2、24 cm2、32 cm2）对肾造瘘管固定强度的影响。结果 正交试验所选的3种影响因素中，对拉力值影响显著性排序为：材料＞方法＞面积；3种固定材料中，医用橡皮膏固定强度最大。结论 肾造瘘管固定方案中，最佳固定组合为以医用橡皮膏结合改良“工”字法固定，可为临床管道固定方案的选择提供参考。