A Pre-Protocol/Post-Protocol Quality Improvement Initiative Specific to One Hospital for Security of Pathologic Specimen

ObjectiveThe objective of this study was to reduce errors in a pathologic specimen with the help of a protocol systematizing the pathology specimen management process in the operating room.Materials and methodThis quasi-experimental study was carried out in the operating room unit of a research and training hospital. A protocol systematizing the process of specimen management in secure surgical pathology and prepared in light of the current literature was used as an intervention, and the effectiveness of the protocol was tested.ResultsIt was determined that the rate of adverse events decreased from .3226% (68 of 21,078) to .032% (6 of 18,706) after the protocol systematizing the surgical pathology specimen management process prepared by the researchers, and the protocol was found to be effective by 90% (P = .03).ConclusionBased on the data obtained in this study, we recommend the use of a pathologic specimen management protocol in the operating room.     

PKP术中不同注入量高粘度骨水泥治疗骨质疏松性腰椎骨折的疗效分析

目的探讨经皮椎体后凸成形术（PKP）术中不同注入量高粘度骨水泥治疗骨质疏松性腰椎骨折（OLVF）的疗效及安全性。 方法前瞻性收集2016年9月至2018年9月本院OLVF患者150例，男84例，女66例，年龄（60±8）岁。依据随机数字表分为高量组、中量组、低量组，每组50例，高量组、中量组、低量组PKP术中高粘度骨水泥注入量分别为5.0~7.0 ml、3~4.9 ml、<3.0 ml，比较三组疗效及安全性。 结果150例患者获得满意随访，随访时间（19±7）个月。高量组、中量组、低量组手术时间、术中出血量比较，差异无统计学意义（P>0.05）；高量组和中量组术后3、6个月椎体前缘高度[（27.3±3.1）mm、（26.0±2.7）mm和（26.9±3.0）mm、（25.7±2.8）mm]明显高于低量组[（23.8±2.8）mm、（21.3±2.5）mm]，高量组和中量组术后3、6个月Cobb角及疼痛视觉模拟评分法（VAS）、Oswestry功能障碍指数问卷表（ODI）评分[（40.2±4.7）°、（41.5±4.8）°、（2.6±0.4）分、（1.6±0.3）分、（25.8±3.5）分、（26.9±3.5）分和（40.9±4.8）°、（42.1±4.8）°、（2.6±0.4）分、（1.6±0.3）分、（26.2±3.5）分、（27.2±3.7）分]明显低于低量组[（46.3±5.3）°、（47.8±5.6）°、（3.3±0.4）分、（2.3±0.4）分、（33.3±4.1）分、（34.3±4.2）分]，差异有统计学意义（F=25.371、18.914、29.334、22.457、34.276、30.217、29.364、20.071，均P<0.001）；高量组骨水泥渗漏率（28.00%）明显高于中量组和低量组（8.00%和4.00%），差异有统计学意义（χ²=10.241，P=0.005）。 结论PKP术中不同注入量高粘度骨水泥治疗OLVF的疗效及安全性存在一定的差异，其中注入中量（3~4.9 ml）高粘度骨水泥可获得良好的疗效及安全性，值得临床推广。     

Efficacy,immunogenicity, and safety of available vaccines in children on biologics: A systematic review and meta-analysis

Vaccinations are essential for preventing infectious diseases in children with chronic diseases as they have increased risk of infection from frequent use of biologics. Response to immunizations in this group is not well known.ObjectiveA systematic review was performed to evaluate three primary outcomes: efficacy; immunogenicity; and safety of vaccines in children with chronic conditions treated with biologics.MethodsThe protocol for our systematic review and meta-analysis was registered and published with PROSPERO. We searched electronic bibliographic databases for studies published from 2009 to 2019, focusing on vaccinations in children with chronic conditions treated with biologics.ResultsWe retrieved 532 records. Thirty-one full-text articles were selected, and 14 were included in the meta-analysis. No significant publication bias was found. Efficacy: limited data are available regarding the efficacy of vaccination, as most studies have focused on immunogenicity as surrogate outcome for efficacy. Immunogenicity: patients receiving anti-TNF-alpha therapy had a statistically significant risk of poor seroconversion (p = 0.028) and seroprotection by the serotype B influenza vaccine [inflammatory bowel disease (IBD) p = 0.013; juvenile idiopathic arthritis (JIA) p = 0.004]. We found adequate responses with H1N1 and H3N2 serotypes. Few studies existed for pneumococcal, hepatitis A virus, hepatitis B virus, varicella-zoster virus, Measles Mumps Rubella virus, and multiple vaccine administration. Safety: vaccine administration was not associated with serious side effects, but JIA patients on anti-TNF alpha therapy had a statistically significant risk of presenting with myalgia or arthralgia postinfluenza vaccine (p = 0.014).ConclusionsMore evidence concerning efficacy, immunogenicity, and safety of vaccinations is needed to guide physicians in the vaccine decision process for this pediatric population.     

造影剂碘普罗胺在妇科盆腔CT检查中的效果及其安全性

目的 探究与分析造影剂碘普罗胺在妇科盆腔CT检查中的效果及其安全性。方法 运用回顾性研究方法，选取我院2018年2月—2021年1月收治的78例接受妇科盆腔CT增强检查者作为研究对象，观测全部患者的影像质量、全身及局部耐受性和相关不良反应。结果 在78例检查中，影像质量优良率为97.44%，患者耐受度为97.44%。患者出现恶心呕吐、头晕头痛、局部痛感、面部潮红的轻度不良反应占8.98%；有2例患者分别出现剧烈呕吐和胸闷气促，并伴有全身性皮疹的中度不良反应，给予相应处置后，患者均恢复正常。结论 非离子型造影剂碘普罗胺在妇科盆腔CT增强检查中能获得良好的影像质量，碘普罗胺的不良反应发生率低于离子型碘造影剂，但高于其他非离子型造影剂。     

Importance of human papillomavirus vaccination leaflets focusing on the safety profile targeted pediatricians in Japan

ObjectivesTo investigate the association between providing leaflets to support pediatricians in explaining the safety of the human papillomavirus (HPV) vaccine and mother’s decision to vaccinate their daughters in Japan.MethodsIn this cross-sectional study, we conducted a survey of mothers to evaluate the effect of leaflets that were created to support pediatricians in explaining the safety profile of the HPV vaccine. Mothers who provided consent for vaccination before receiving an explanation were excluded from the study. The primary outcome was the mother’s decision to vaccinate their daughters with the HPV vaccine after receiving an explanation from pediatricians using our leaflets.ResultsAmong 161 eligible mothers, 101 decided on HPV vaccination (decided group) and 60 did not (decided against group). There was no difference in the maternal background between the 2 groups. The decided group had a significantly more positive impression of the leaflets than the undecided group. In multivariable logistic regression analysis, a detailed explanation for possible adverse events and specific solutions to them was associated with the mother's decision to have their daughters vaccinated (odds ratio 2.35, 95% confidence interval 1.02–5.44), but not the pathology of cervical cancer and the HPV vaccination process.ConclusionLeaflets emphasizing an explanation of adverse events may contribute to mothers’ decision making for HPV vaccination.     

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。     

Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings

We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S-910823 antigen (5 μg [n = 24] and 10 μg [n = 24]) with an oil-in-water emulsion formulation and compared against placebo (n = 12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein peptides stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted.