Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines

With the advent of new vaccines targeted to highly endemic diseases in low- and middle-income countries (LMIC) and with the expansion of vaccine manufacturing globally, there is an urgent need to establish an infrastructure to evaluate the benefit-risk profiles of vaccines in LMIC. Fortunately the usual decade(s)-long time gap between introduction of new vaccines in high and low income countries is being significantly reduced or eliminated due to initiatives such as the Global Alliance for Vaccines and Immunizations (GAVI) and the Decade of Vaccines for the implementation of the Global Vaccine Action Plan. While hoping for more rapid disease control, this time shift may potentially add risk, unless appropriate capacity for reliable and timely evaluation of vaccine benefit-risk profiles in some LMIC's are developed with external assistance from regional or global level. An ideal vaccine safety and effectiveness monitoring system should be flexible and sustainable, able to quickly detect possible vaccine-associated events, distinguish them from programmatic errors, reliably and quickly evaluate the suspected event and its association with vaccination and, if associated, determine the benefit-risk of vaccines to inform appropriate action. Based upon the demonstrated feasibility of active surveillance in LMIC as shown by the Burkina Faso assessment of meningococcal A conjugate vaccine or that of rotavirus vaccine in Mexico and Brazil, and upon the proof of concept international GBS study, we suggest a sustainable, flexible, affordable and timely international collaborative vaccine safety monitoring approach for vaccines being newly introduced. While this paper discusses only the vaccine component, the same system could also be eventually used for monitoring drug effectiveness (including the use of substandard drugs) and drug safety.     

《医院文化建设丛书》编辑出版的创意与成效分析

先进的医院文化是医院持续发展的精神支柱和动力源泉,是医院内涵建设的重要组成部分。为创新医院文化建设,形成医院文化建设成果,编辑出版了6册不同的文化建设书籍。通过总结提炼、汇编成册,起到了学习、传播的作用,不失为医院文化建设行之有效的方法。     

老年轻度认知障碍综合干预效果初步研究

目的通过对老年轻度认知障碍患者综合干预的效果分析,评价综合干预方案的有效性。方法采用随机对照试验方法,将目标社区MCI患者（130例）随机分为干预组（65例）和对照组（65例）,对干预组采取认知干预和体力活动相结合的方法进行综合干预。结果干预组和对照组分别在干预前后3个月比较,差别都有统计学意义（各自P〈0.05）;两组分别在干预后3个月与6个月比较,差别都有统计学意义（各自P〈0.05）。结论认知干预和体育锻炼有益于维持或改善老年人的认知状况,并能给老年人的生活态度和精神状态产生积极的影响。     

Adherence to evidence-based statin guidelines reduces the risk of hospitalizations for acute myocardial infarction by 40%: a cohort study.

AIMS: To investigate the 'real world' effectiveness of robust statin therapy, focusing on the effect of dose and early treatment discontinuation on the risk of hospitalization for acute myocardial infarction (AMI). METHODS AND RESULTS: In the PHARMO database, including among others drug-dispensing and hospital discharge records for more than two million subjects in the Netherlands, 59,094 new users of statins in the period 1 January 1991 until 31 December 2004, >or=18 years of age were identified. In these patients, exposure to statins, both in terms of persistence and dose, was determined over the first two treatment years. To determine the risk for AMI, patients were followed from this 2-year time point until the first hospital admission for AMI, death, or end of the study period. A total of 31,557 patients (53%) discontinued statin use within 2 years; 20 883 patients (35%) were persistent users with an average equipotent dose>or=4. A 30% reduction in risk of hospitalization for AMI with persistent statin use was observed. The protective effect increased with a higher dose (20 and 40% risk reduction with an equipotent doseor=4, respectively). CONCLUSION: These results show that statins are suboptimally used in real life for having the maximum benefit in terms of preventing AMI.     

探究小剂量轻比重腰麻-硬膜外联合麻醉在老年下肢骨折的有效性

目的：探讨小剂量轻比重腰麻-硬膜外联合麻醉在老年下肢骨折的有效性,寻找适合老年下肢骨折病人的最佳麻醉模式。方法该次研究资料选取2012年3月—2014年9月期间在该院接受诊治的86例老年下肢骨折病人,以随机法将其划分成两个小组,即实验组以及对照组。其中,43例对照组研究对象接受连续硬膜外麻醉,而43例实验组研究对象则接受小剂量轻比重腰麻-硬膜外联合麻醉,同时对比及分析两组研究对象麻醉阻滞具体完善时间、麻醉药物整体使用剂量以及麻醉阻滞具体起效时间等基本信息。结果两组研究对象在麻醉阻滞具体起效时间及完善时间、麻醉药物整体使用剂量等方面的比较差异有统计学意义(P<0.05)。结论临床上小剂量轻比重腰麻-硬膜外联合麻醉在老年下肢骨折病人中的利用效果较为显著,除了可以有效控制药物使用剂量之外,还可以加快神经阻滞基本完善时间,有助于提升镇痛效率,具有安全性高、副作用小等临床优势,因此建议推广。     

Long term effectiveness of adjuvanted influenza A(H1N1)pdm09 vaccine in children

BackgroundImmunological studies have indicated that the effectiveness of AS03 adjuvanted monovalent influenza A(H1N1)pdm09 vaccine (Pandemrix^®) may be of longer duration than what is seen for non-adjuvanted seasonal influenza vaccines. Sixty-nine percent of children 6 months–18 years of age in Stockholm County received at least one dose of Pandemrix^® during the 2009 pandemic. We studied the effectiveness of the vaccine during the influenza seasons 2010–2011 and 2012–2013 in children hospitalized with virologically confirmed influenza. The season 2011–2012 was not included, since influenza A(H3N2) was the predominant circulating strain.MethodsIn a retrospective case-control study using a modified test-negative design we compared the percentage vaccinated with Pandemrix^® among children diagnosed with influenza A(H1N1)pdm09 (cases), with that of those diagnosed with influenza A(H3N2) or influenza B (controls) during the two seasons. We excluded children born after July 1, 2009, since only children who were 6 months of age or older received the pandemic vaccine in October–December 2009.ResultsDuring the 2010–2011 season, 3/16 (19%) of children diagnosed with influenza A(H1N1)pdm09, vs. 32/41 (78%) of those with influenza A(H3N2) or influenza B had been vaccinated with Pandemrix^® in 2009. The odds ratio, after adjustment for sex, age and underlying diseases, for becoming a case when vaccinated with Pandemrix^® was 0.083 (95%CI 0.014, 0.36), corresponding to a VE of 91.7%. During the season 2012–2013, there was no difference between the two groups; 59% of children diagnosed with influenza A(H3N2)/B and 60% of those with influenza A(H1N1)pdm09 had been vaccinated with Pandemrix^® in 2009.ConclusionThe AS03 adjuvanted monovalent influenza A(H1N1) pdm09 vaccine (Pandemrix^®) was effective in preventing hospital admission for influenza A(H1N1)pdm09 in children during at least two seasons.     

Influenza vaccine effectiveness against laboratory confirmed influenza in Greece during the 2013–2014 season: A test-negative study

BackgroundIn 2013–2014 Greece experienced a resurgence of severe influenza cases, coincidental with a shift to H1N1pdm09 predominance. We sought to estimate Vaccine Effectiveness (VE) for this season using available surveillance data from hospitals (including both inpatients and outpatients).MethodsSwab samples were sent by hospital physicians to one of three laboratories, covering the entire country, to be tested for influenza using RT-PCR. The test-negative design was employed, with patients testing positive serving as cases and those testing negative serving as controls. VE was estimated using logistic regression, adjusted for age group, sex, region and calendar time, with further adjustment for unknown vaccination status using inverse response propensity weights. Additional age group stratified estimates and subgroup estimates of VE against H1N1pdm09 and H3N2 were calculated.ResultsOut of 1310 patients with known vaccination status, 124 (9.5%) were vaccinated, and 543 patients (41.5%) tested positive for influenza. Adjusted VE was 34.5% (95% CI: 4.1–55.3%) against any influenza, and 56.7% (95% CI: 22.8–75.7%) against H1N1pdm09. VE estimates appeared to be higher for people aged 60 and older, while in those under 60 there was limited evidence of effectiveness. Isolated circulating strains were genetically close to the vaccine strain, with limited evidence of antigenic drift.ConclusionsThese results suggest a moderate protective effect of the 2013–2014 influenza vaccine, mainly against H1N1pdm09 and in people aged 60 and over. Vaccine coverage was very low in Greece, even among groups targeted for vaccination, and substantial efforts should be made to improve it. VE can and should be routinely monitored, and the results taken into account when deciding on influenza vaccine composition for next season.