上海市虹口区预防接种不良反应主动与被动监测情况分析

目的：为了解预防接种不良反应主动与被动监测情况，为AEFI监测体系提供科学依据。方法：采用对照比较的方法分析虹口区2005年1-9月主动与被动监测预防接种不良反应情况。结果：主动监测的发热、硬结、红肿反应发生率为731．53／10万、414．53／10万、170．69／10万显著高于被动监测73．78／10万、8．20／10万、16．40／10万，主动监测的过敏性皮疹反应率105．67／10万，显著高于被动监测6．56／10万。门诊自身前后比较，4-9月主动监测的发热、硬结、红肿反应发生率显著高于1-3月28．06／10万、56．12／10万、28．06／10万；1-3月被动监测异常反应为0,4-9月主动监测异常反应发生率为113．79／10万。结论：主动监测预防接种不良反应，敏感性高，特异性好，对于完善国家对异常反应的经济补偿政策：正确评估接种疫苗后可能发生的不良反应事件．并提出预防和处理建议．都具有重要意义。     

2004年浙江省洞头县流动儿童免疫接种情况分析

[目的]了解洞头县流动儿童免疫接种现状。[方法]于2004年11月调查全县374名流动儿童。按照卫生部《计划免疫技术管理规程》的规定进行合格接种判定。[结果]显示流动儿童“五苗”全程免疫覆盖率为58．85％，低于常住儿童的97.57％（P〈0.01）。[结论]流动儿童大多集中在县城及靠近县城的乡镇，提示城市计划免疫工作应重视流动儿童，加大宣传力度，尤其是对流动人群聚集地的计划免疫管理。     

A randomized phase II trial of capecitabine and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity.

BACKGROUND: To determine the efficacy, impact on quality-of-life (QoL) and tolerability of two different irinotecan administration schedules in combination with capecitabine as first-line treatment of metastatic colorectal cancer. PATIENTS AND METHODS: We carried out a randomized phase II trial to select one of the following treatment regimens for further investigation: weekly irinotecan at a dose of 70 mg/m(2) days 1, 8, 15, 22, 29 (arm A) or 3-weekly irinotecan at a dose of 300/240 mg/m(2) day 1 and days 22 (arm B) in combination with capecitabine 1000 mg/m(2) twice daily days 1-14 and days 22-35 every 6 weeks. RESULTS: Seventy-five patients with good performance status entered the trial. The two arms were well balanced for relevant patient and disease characteristics. The most frequent toxic effects were grade 3/4 diarrhea (arm A: 34%, B: 19%), grade 3/4 neutropenia (A: 5%, B: 19%) and grade 2/3 alopecia (A: 26%, B: 65%). Other grade 3/4 toxic effects were rare (<5%). Response rates were 34% [95% confidence interval (CI) 20% to 51%] in arm A and 35% (95% CI: 20% to 53%) in arm B. Median time to progression was 6.9 (4.6-10.1) and 9.2 (7.9-11.5) months and median overall survival was 17.4 (12.6-23.0+) and 24.7 (16.3-26.4+) months. Patients with an objective tumor response reported better physical well-being (P < 0.01), mood (P < 0.05), functional performance (P < 0.05) and less effort to cope (P < 0.05) compared with the non-responders and stable disease patients. CONCLUSIONS: The primary end point of this study was the objective response rate and based on the statistical design of the trial, the 3-weekly irinotecan schedule was selected over weekly irinotecan administration. The 3-weekly irinotecan schedule also seemed advantageous in terms of grade 3/4 diarrhea, time to progression, overall survival and patient convenience, but the study was not designed to detect differences in these parameters. In addition, tumor response was shown to have a beneficial effect on QoL indicators.     

一种新型重组(汉逊酵母)乙型肝炎疫苗人体安全性和免疫效果考核

为了观察一种新型重组 (汉逊酵母 )乙型肝炎 (乙肝 )疫苗的人体安全性、抗体应答和母婴传播阻断效果 ,在开封市筛选 6～ 9岁乙肝病毒 (HBV)感染指标 [乙肝病毒表面抗原 (HBsAg)与抗体 (抗 HBs)、乙肝病毒核心抗体 (抗 HBc) ]均阴性的健康儿童 2 0名 ,按 0、1、6个月程序接种 1批重组 (汉逊酵母 )乙肝疫苗 ,观察不良反应。完成 3针免疫观察未见严重不良反应后 ,选择 348名 6～ 9岁HBV感染指标阴性儿童 ,随机分为 3组 ,每组接种 1批重组 (汉逊酵母 )乙肝疫苗 ,进一步观察不良反应和抗体应答。筛选 4 5名怀孕期间HBsAg、乙肝病毒e抗原 (HBeAg)双阳性母亲所生的新生儿作为研究对象 ,并以 4 1名怀孕期间HBsAg阴性母亲所生的新生儿和 5名母亲HBsAg阳性、HBeAg阴性的新生儿作为对照 ,按 0、1、6个月免疫程序接种该乙肝疫苗。结果显示 :所有接种的儿童和新生儿 ,免疫后无 1人发现有严重不良反应。 348名接种乙肝疫苗的儿童中 ,除 5人次发热反应在 38 1℃～ 38 5℃外 ,体温升高均≤ 38℃。所有发热反应者和个别头痛者均在 1d内恢复正常。儿童接种 3批疫苗 ,第 1针免疫后 7个月时抗体阳转率分别为 98 2 5 % ( 112 / 114 )、10 0 0 0 % ( 10 7/ 10 7)、99 2 1% ( 12 6 / 12 7) ;抗体几何平均滴度 (GMT)分别为35 1     

曹县2000～2002年麻疹监测分析

目的　评价曹县麻疹监测现状 ,进一步完善监测系统 ,实现麻疹控制规划。方法　采用酶联免疫吸附实验 (ELISA)捕捉法 ,监测麻疹与风疹疑似病人血清IGM抗体 ,并对法定传染病报告系统和麻疹专报系统数据进行流行病学分析。结果　在疫情报告的敏感性方面 ,麻疹专报系统报告疑似病均高于法定传染病报告系统报告的病例数 ,麻疹专报系统数据提示麻疹发病有明显的季节性 ,4～ 5月份为发病高峰 ,发病年龄主要集中在 15岁以下儿童。结论　应加强麻疹专报系统管理 ,抓好麻疹疑似病例标本采集工作的落实 ,以高质量的麻疹常规免疫和强化免疫控制麻疹发生。     

医院工会对职工主观幸福感的现状调查分析

目的 调查北京天坛医院职工的主观幸福感情况,并分析影响因素,为改善医院职工心理健康提供循证参考。方法 采用分层抽样法随机选取北京天坛医院医生500人,护士800人,医技200人和其他岗位职工300人,资料收集时间为2019年11月1—8日,内容包括职工的一般人口学特征及主观幸福感评分,分析不同人口学特征对职工主观幸福感评分的影响。结果 调查共回收有效问卷1785份,问卷的信度和效度良好(克朗巴赫α系数为0.834; KM0值为0.978),被调查职工的主观幸福感评分为(77.00±5.25)分。不同年龄、婚姻状况、学历、岗位、职称和编制的职工主观幸福感评分比较,差异有统计学意义(P0.001),35岁以上年龄组职工的主观幸福感评分均显著低于35岁以下职工,差异有统计学意义(P0.001);相较于医技和护理岗位,医生的主观幸福感评分较低,差异有统计学意义(P0.001)。结论 医院应持续开展体验式心理服务项目,提高职工心理健康保健能力,积极改善工作-生活不平衡,提升职工共情能力,重视医生群体的主观幸福感,搭建跨学科交流平台,从而提升职工的主观幸福感。     

Vaccination rates and adherence in premature infants before and after pneumococcal conjugate vaccine schedule change for term infants – A claims database analysis in Germany

BackgroundIn 2015, the German Standing Committee on Vaccination (STIKO) changed the pneumococcal conjugate vaccination (PCV) schedule for mature infants from a 3+1 scheme (2, 3, 4, and 11–14 months of age) to a 2+1 scheme (2, 4, and 11–14 months of age). For premature infants, the 3+1 scheme remained. The aim of this study was to assess vaccination rates, completeness, and timeliness for PCV in premature infants before and after the modified recommendation.MethodsA retrospective claims data analysis using the “Institut für angewandte Gesundheitsforschung Berlin” Research Database was conducted. Premature infants born in 2013 and 2016 with an individual follow-up of 24 months were included. Hexavalent combination (HEXA) vaccination with a consistent 3+1 recommendation for mature and premature infants was analyzed as reference vaccination.ResultsAfter 24 months, the PCV rate for at least one dose remained stable in premature newborns of 2016 compared to 2013, while the HEXA vaccination rate increased slightly. However, a significant decrease of a completed PCV schedule (4 doses) in premature infants was noted, whereas the completeness of HEXA vaccination did not change. The timeliness of PCV in premature newborns increased for the first and the booster PCV, while the timeliness of HEXA immunization did not change from 2013 to 2016.ConclusionAlthough STIKO still recommends a 3+1 PCV schedule for premature infants in Germany, premature infants were vaccinated according to the changed recommendations for mature born infants. A substantial share of premature infants remained unvaccinated, and their vaccinations were often delayed.     

Near real-time surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2010/11 to 2013/14

BackgroundGuillain-Barré syndrome (GBS) is a serious acute demyelinating disease that causes weakness and paralysis. The Food and Drug Administration (FDA) began collaborating with the Centers for Medicare and Medicaid Services (CMS) to develop near real-time vaccine safety surveillance capabilities in 2006 and has been monitoring for the risk of GBS after influenza vaccination for every influenza season since 2008.MethodsWe present results from the 2010/11 to 2013/14 influenza seasons using the Updating Sequential Probability Ratio Test (USPRT), with an overall 1-sided α of 0.05 apportioned equally using a constant alpha-spending plan among 20 consecutive weekly tests, 5 ad hoc tests, and a 26th final end of season test. Observed signals were investigated using the self-controlled risk interval (SCRI) design.ResultsOver 15 million people were vaccinated in each influenza season. In the 2010/11 influenza season, we observed an elevated GBS risk during the season, with an end of season SCRI analysis finding a nonsignificant increased risk (RR = 1.25, 95% CI: 0.96–1.63). A sensitivity analysis applying the positive predictive value of the ICD-9 code for GBS from the 2009/10 season estimated a RR = 1.98 (95% CI: 1.42–2.76). Although the 2010/11 influenza vaccine suggested an increased GBS risk, surveillance of the identical vaccine in the 2011/12 influenza season did not find an increased GBS risk after vaccination. No signal was observed in the subsequent three influenza seasons.ConclusionsConducting near real-time surveillance using USPRT has proven to be an excellent method for near real-time GBS surveillance after influenza vaccination, as demonstrated by our surveillance efforts during the 2010/11–2013/14 influenza seasons. In the 2010/2011 influenza season, in addition to the 2009 H1N1 influenza pandemic, using near real-time surveillance we were able to observe a signal early in the influenza season and the method has now become routine.     

Transforming cold chain performance and management in lower-income countries

In many countries, one of the common factors limiting full and equitable access to effective immunization is the existence of gaps in cold chain and logistics (CCL) systems. This article focuses on the critical contribution that better management of CCL performance can make in addressing these barriers, as well as some essential practices needed to achieve and sustain these gains. These include (i) an emphasis on continuous improvement in CCL performance indicators, (ii) strong coordination and accountability across multiple stakeholders, and (iii) making the most of limited financial resources.This article is informed by the Clinton Health Access Initiative’s (CHAI’s) experience working with National Immunization Programs (NIPs) and immunization partners to improve the effectiveness and efficiency of CCL systems (including CCE deployment and maintenance, temperature monitoring and control, stock management and distribution) across ten Gavi-supported “focus” countries.