流感疫苗接种后不良事件监测研究

目的研究流感大流行阶段应急接种人用禽流感疫苗不良事件监测的有效模式。方法以季节性流感疫苗模拟人用禽流感疫苗,在北京、江苏选取6个门诊接种共1218例,采用主动监测与被动监测相结合的方法开展集中接种疫苗后不良事件监测研究。结果收集不良事件报告36例;成人组报告数量最多,老年组报告数量最少;北京、江苏农村被动监测门诊均没有自愿报告;不良事件多为一般反应;各级疾病预防控制中心与药品不良反应监测机构建立了信息沟通交流机制。结论主动与被动相结合的监测模式,重点开展农村宣传教育活动,以及尽快建立各级疾病预防控制中心与药品不良反应监测机构的常规工作交流机制,均将促进应急状态下疫苗不良事件监测工作的开展。     

Brighton 协作组预防接种过敏症的病例定义

Brighton 协作组是致力于疫苗安全性监测领域病例定义标准化的国际机构.通过简要概述了Brighton 协作组有关工作,主要对过敏症病例定义的具体内容、事件分类以及确定诊断级别辅助工具等方面进行了较全面地介绍.该病例定义在疫苗安全性监测领域的推广使用,将有利于促进疫苗安全性监测数据的分析和比较,进一步促进对于疫苗安...     

安徽省2009年麻疹疫苗强化免疫疑似预防接种异常反应监测分析

目的了解安徽省2009年麻疹疫苗强化免疫活动（supplementaryimmunizationactivity,SIA）中,疑似预防接种异常反应（adverseeventsfollowingimmunization,AEFI）的发生特征,探讨麻疹疫苗的安全性。方法采用描述性流行病学方法,对AEFI监测系统中的相关数据进行统计分析。结果安徽省2009年麻疹疫苗SIA共报告AEFI41例,AEFI报告发生率3．86／100万剂。78．05％AEFI发生于接种后1d以内,82．93％AEFI发生于接种第1剂麻疹疫苗后。临床损害以发热、过敏性皮疹等为主。结论安徽省2009年SIA的麻疹疫苗安全性良好。接种麻疹疫苗后≤1d是AEFI的监测重点。     

Approaches to monitoring intussusception following rotavirus vaccination

Introduction: In 1998, the first licensed rotavirus vaccine was associated with intussusception, an unexpected adverse event, following reports of this condition to an adverse event reporting system. This rotavirus vaccine was withdrawn from the market and newer rotavirus vaccines have been extensively evaluated for an association with intussusception.

Areas covered: We review the different study designs that have been used both pre- and post-licensure to evaluate the association of rotavirus vaccines with intussusception and discuss the pros and cons of each design. Each of these study designs has their own strengths and weaknesses and the choice of the design often depends on the objective and the timing of the study and the resources available. For post-licensure monitoring of rotavirus vaccines, the self-controlled case-series design has become the most commonly used design to monitor this association.

Expert opinion: Use of this common study design has enabled comparison of findings across diverse settings. As new rotavirus vaccines enter the market, use of the self-controlled case-series design will enable examination of this association in a timely manner.     

2011-2012年华泾镇预防接种不良反应监测分析

目的：了解华泾镇2011—2012年预防接种后不良反应发生情况。方法：根据WHO对AEFI的定义与分类,收集华泾镇2011-2012年AEFI监测和接种率监测数据,进行描述统计。结果：共报告AEFI65例,发生率为141．70／10万。一般反应57例,占AEFI总病例数的87．69％;异常反应8例,占12．31％。19种疫苗中有13种出现不良反应,其中百白破疫苗的报告发生率最高,为493．33／10万,其次为肺炎疫苗,为369．78／10万。结论：2011-2012年华泾镇AEFI监测系统运转良好,今后需进一步探讨AEFI主动监测模式,提高疫苗安全性监测的敏感性。     

Reporting of vaccine safety data in publications: systematic review

PURPOSE: To assess current reporting practices of immunisation safety data in the scientific literature. METHODS: Systematic literature search for recent prospective clinical studies on vaccines in humans. The main outcome measures were methodological differences in the assessment, definition, analysis and presentation of 'adverse events following immunisation' (AEFI). RESULTS: In total, 182 published articles possibly satisfied defined inclusion criteria, of which 149 were included. Overall, the presentation of data on AEFI was inadequate: 45% of articles did not mention AEFI at all; if mentioned, case definitions of AEFI were not specified in the majority of articles; there was inconsistency of AEFI reporting between 'Methods' and 'Results' in up to 24% of articles; the observation period following immunisation and the method of follow-up with study subjects was not reported in 28% and 32% of studies respectively. CONCLUSIONS: We identified a lack of reporting of AEFI data as well as a heterogeneity of case definitions and methods for data collection, analysis and presentation of AEFI in recently published articles. Guidelines for standardised collection, analysis and publication of such data and standardised case definitions for AEFI are needed. Ideally, journal editors would agree on a minimum set of guidelines for structured presentation of vaccine safety data in publications.     

儿童疑似预防接种异常反应监测及分析

目的分析儿童疑似预防接种异常反应（AEFI）发生情况,以减少AEFI的发生。方法收集2010～2013年儿童疫苗接种及AEFI的登记资料,并进行分析。结果 2010～2013年儿童累计预防接种疫苗146 348例次,出现AEFI 198例,发生率为135/10万。其中一般反应156例（占78.8%）,异常反应26例（占13.1%）,偶合症12例（占6.1%）,心因性反应4例（占2.0%）。发生率前4位的疫苗是甲型流感疫苗、23价肺炎疫苗、B型流感嗜血杆菌疫苗、百白破疫苗;除1例脊髓灰质炎疫苗相关病例遗留下肢活动障碍外,其余病例均治愈。结论 AEFI多种疫苗均可发生,接种前应注意询问受种者过敏史和近期健康状况,规范接种,做好接种后医学观察,有利于减少AEFI的发生。     

Adverse drug events in emergency department population: a prospective Italian study

PURPOSE: There is little evidence concerning adverse drug events (ADEs) in outpatients and related hospital admissions. In Italy, only one investigation was conducted on this important health issue. We therefore carried out a study to determine ADE incidence and ADE-related hospital admissions among emergency department (ED) visits, and to identify the risk factors for serious ADE leading to ED visit. METHODS: During the year 2000, we performed a prospective study in two observational periods of 10 days each in 22 Italian EDs. Demographic, clinical and pharmacological data about all patients admitted to ED were collected by trained and qualified monitors. Records related to ADE were analysed and validated by a specific scientific committee. RESULTS: On 18,854 enrolled patients, 629 (3.3%) were affected by ADE. Among these, 244 (38.8% of ADE patients) reported a serious event. Patients with ADE, accounting for 4.3% (193 cases) of total hospitalisations, were significantly more likely to be hospitalised (30.7% vs. 23.7%; p<0.0001), females (57.2% vs. 46.3%; p<0.0001) and elders, compared with the total sample. Serious ADE resulted significantly associated with male gender and old age. NSAIDs (16.5% of total ADE visits) and antibiotics (12.9%) were the drugs mostly involved in ADE occurrence. ADE affected mostly skin (213 ADE visits) and gastrointestinal system (211). CONCLUSION: Old age and male gender resulted risk factors involved in the development of serious ADE. The high ADE-related hospitalisation incidence highlights the need for prevention strategies targeted to reduce the impact of ADE in the general population.     

天津市 2011—2013 年疑似预防接种异常反应主动监测分析与被动监测评价

目的 分析天津市疑似预防接种异常反应 （AEFI） 主动监测数据的发生特征, 评价同期被动监测系统的敏感性。方法 2011—2013 年, 分层选择 4 个区县的 8 家接种门诊作为主动监测点, 通过主动回访收集到的 AEFI 为主动监测 AEFI 数据, 通过全国信息系统收集全市范围自愿就医的被动监测数据。组织 AEFI 调查诊断专家组对除明确诊断为一般反应以外的 AEFI 开展调查诊断分类。结果 共有效主动监测 32 698 例, AEFI 病例 235 例, 发生率为 718.70/10 万剂。3 年间 AEFI 主动监测发生率差异无统计学意义（849.01/10 万剂 vs 599.32/10 万剂 vs 686.72/10万剂, χ2=5.07）; 被动监测 AEFI 4 164 例, 发生率为 34.09/10 万剂; 3 年间 AEFI 被动监测发生率逐年上升（20.05/10万剂 vs 31.35/10 万剂 vs 50.51/10 万剂, χ2=572.02, P < 0.05）; 各年度主动监测 AEFI 发生率均高于被动监测（均 P <0.05）。主动监测 AEFI 的一般反应所占比例（95.32%）高于被动监测（85.09%）, 异常反应低于被动监测（3.83% vs13.32%, 均 P < 0.05）, 偶合症、 心因性反应差异均无统计学意义。二者均未监测到疫苗质量事故和接种事故, AEFI发生率居前 5 位的疫苗中均有 7 价肺炎、 麻疹、 进口百白破疫苗。结论 AEFI 主动监测可发现更多的轻微一般反应, 天津市被动监测系统的敏感性逐年上升, 能够满足工作需求。应建立针对严重 AEFI 病例的统一分类诊断标准。      

Risk of local adverse events by gender following cardiac catheterization

PURPOSE: To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization. METHODS: The data used in this study were obtained from a portion of the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR), which included 13 878 patients who underwent cardiac catheterization at one of 59 participating cardiac catheterization institutions throughout the United States during late 2003. Rates of serious local vascular adverse events were calculated by gender following cardiac catheterization, by type of vascular hemostasis used, stratified by arterial sheath size. RESULTS: Serious local vascular events were reported in 3.54% of patients, most commonly hematoma (2.00%). The relative risk for women of any vascular complication was 1.40 [95%CI = 1.17, 1.67, p = 0.0002]. A statistically significant relative risk for woman was evident when collagen plug devices or manual compression alone were used as the first method for hemostasis. The rate of vascular complications increased progressively with increasing sheath size, more so in women than in men. CONCLUSIONS: High relative risk for women of local vascular complications following cardiac catheterization was demonstrated with use of manual compression, as well as with collagen plug devices to control femoral artery bleeding. Large sheath size is associated with both a relatively high absolute risk and a high relative risk for women. Knowledge of this information should be considered by interventional cardiologists in making decisions on how to achieve hemostasis following cardiac catheterization.     

A review of the safety and tolerability of aripiprazole

It seems that the efficacy of aripiprazole for treating schizophrenia is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors. Aripiprazole has also received approval for the treatment of bipolar disorder as adjunctive therapy or monotherapy (manic or mixed episodes) as well as an augmentation therapy of major depressive disorder (MDD) by the US FDA. The overall safety and tolerability of aripiprazole is favorable compared to other atypical antipsychotics across the approved indications. Aripiprazole showed a minimal propensity for clinically significant weight gain and metabolic disruption. However, extrapyramidal side effects, such as akathisia, are reported and may limit its clinical use in some cases, particularly in patients with bipolar disorder and MDD. This review focuses on the tolerability and safety of aripiprazole across a broad spectrum of psychiatric disorders while taking into consideration results from registrational studies as well as findings from studies in the naturalistic setting. In conclusion, whereas the comparative safety and tolerability of aripiprazole has not been systematically evaluated in comparator studies, tolerability and safety issues commonly associated with atypical antipsychotics such as weight gain and metabolic syndrome are less prominent with aripiprazole.     

免疫接种的安全性及不良事件

免疫接种是预防和控制传染病的重要手段之一,随着免疫接种覆盖率的提高,疑似免疫接种不良事件（AEFI）也日益增多。中国疾病预防控制中心将AEFI分为7类,包括疫苗本身的不良反应（一般反应和异常反应）、疫苗质量、实施差错、非疫苗引起的偶合反应、心因性反应和不明原因的反应。本文概述了乙型肝炎疫苗、卡介苗、口服脊髓灰质炎疫苗、麻疹/麻疹-腮腺炎-风疹疫苗、百白破疫苗、乙型脑炎疫苗、B型流感嗜血杆菌偶联疫苗、狂犬病疫苗和甲型H1N1流感疫苗等9种疫苗不良事件的发生情况,以及AEFI的监测和管理措施,旨在为增强免疫接种的安全性提供参考。     

昆明市西山区2014－2018年疑似预防接种异常反应监测分析

目的  评价昆明市西山区疫苗接种的安全性和预防接种服务质量。方法  通过中国免疫规划信息管理系统收集2014—2018年西山区疑似预防接种异常反应（adverse event following immunization,AEFI）个案数据,采用描述性方法对相关监测指标及发生特征进行流行病学分析。结果  2014－2018年昆明市西山区共报告AEFI 294例。辖区10个街道办事处均有病例报告,无疫苗接种事故报告。年均AEFI报告发生率12.27/10万剂;其中一般反应167例,占报告病例数的56.80%,报告发生率为6.97/10万剂;异常反应79例,占报告病例数的26.87%,异常反应报告发生率3.3/10万剂,无死亡病例。异常反应以荨麻疹、斑丘疹、过敏性皮疹、麻疹猩红热样皮疹为主（66例,0.28/10万剂）,卡介苗引起腋下淋巴结肿大（4例,0.17/10万剂）、热性惊厥（3例,0.13/10万剂）、血小板减少性紫癜（3例,0.13/10万剂）。属于严重的异常反应7例（卡介苗引起肺部感染1例、热性惊厥3例、血小板减少性紫癜3例）,发生率为0.29/10万。结论  西山区AEFI监测的敏感性逐年提高,疫苗接种的安全性和接种服务质量好。