疑似预防接种异常反应(Adverse event following immunization,AEFI)被动监测是疫苗安全性评估的重要途径之一,通常采用传统的AEFI发生率比较或比例失衡分析方法检测可疑的疫苗安全性信号。近年来,基于反应发生时间间隔(Time-to-onset,T...疑似预防接种异常反应(Adverse event following immunization,AEFI)被动监测是疫苗安全性评估的重要途径之一,通常采用传统的AEFI发生率比较或比例失衡分析方法检测可疑的疫苗安全性信号。近年来,基于反应发生时间间隔(Time-to-onset,TTO)的检测方法应用于AEFI信号检测,且具有一定的优势和良好的检测能力。本文介绍了TTO间隔检测方法的原理、步骤和在AEFI信号检测中的应用,为中国疫苗上市后安全性评估提供参考。展开更多
<strong>Introduction: </strong>The risk of transmission of pathogens such as hepatitis B virus threatens the safety of transfused patients especially in high endemic areas. The aim of this study was to det...<strong>Introduction: </strong>The risk of transmission of pathogens such as hepatitis B virus threatens the safety of transfused patients especially in high endemic areas. The aim of this study was to determine the incidence and factors associated with hepatitis B virus surface antigen (HBsAg) seroconversion in blood donors at the Regional Blood Transfusion Centre of Ouagadougou. <strong>Methods:</strong> A retrospective cohort study of voluntary non-remunerated blood donors (VNRBD), was conducted from 2008 to 2017. Data on HBsAg seroconversion were collected. The Kaplan-Meier method and the Log-Rank test were used to estimate the survival curves. Cox’s regression identified the factors associated with this seroconversion. <strong>Results:</strong> Of 23,494 donors, 559 had HBsAg seroconversion. The number of donor years was 58,637.50 and the HBV incidence rate was 9.53 per 1000 donor years. The median seroconversion time was 75.73 months with extremes of 2.7 months and 107.12 months. The risk of seroconversion was 1.30 times higher among donors aged 21 to 24 years old (p = 0.007) and 2.49 times higher among those over 24 years old (p < 0.0001) than among donors under 21 years old. Female donors were 1.11 times more likely to seroconvert than male donors (p = 0.33). Donor residence was not significantly associated with HBsAg seroconversion (Hazard ratio = 1.12;p = 0.36). The risk of seroconversion decreased significantly with the number of blood donations (Hazard ratio = 0.58;p = 0.006). <strong>Conclusion: </strong>The incidence of HBsAg remains high among blood donors, which could have a negative impact on transfusion safety. The age of the blood donor was significantly associated to AgHBs seroconversion.展开更多
文摘疑似预防接种异常反应(Adverse event following immunization,AEFI)被动监测是疫苗安全性评估的重要途径之一,通常采用传统的AEFI发生率比较或比例失衡分析方法检测可疑的疫苗安全性信号。近年来,基于反应发生时间间隔(Time-to-onset,TTO)的检测方法应用于AEFI信号检测,且具有一定的优势和良好的检测能力。本文介绍了TTO间隔检测方法的原理、步骤和在AEFI信号检测中的应用,为中国疫苗上市后安全性评估提供参考。
文摘<strong>Introduction: </strong>The risk of transmission of pathogens such as hepatitis B virus threatens the safety of transfused patients especially in high endemic areas. The aim of this study was to determine the incidence and factors associated with hepatitis B virus surface antigen (HBsAg) seroconversion in blood donors at the Regional Blood Transfusion Centre of Ouagadougou. <strong>Methods:</strong> A retrospective cohort study of voluntary non-remunerated blood donors (VNRBD), was conducted from 2008 to 2017. Data on HBsAg seroconversion were collected. The Kaplan-Meier method and the Log-Rank test were used to estimate the survival curves. Cox’s regression identified the factors associated with this seroconversion. <strong>Results:</strong> Of 23,494 donors, 559 had HBsAg seroconversion. The number of donor years was 58,637.50 and the HBV incidence rate was 9.53 per 1000 donor years. The median seroconversion time was 75.73 months with extremes of 2.7 months and 107.12 months. The risk of seroconversion was 1.30 times higher among donors aged 21 to 24 years old (p = 0.007) and 2.49 times higher among those over 24 years old (p < 0.0001) than among donors under 21 years old. Female donors were 1.11 times more likely to seroconvert than male donors (p = 0.33). Donor residence was not significantly associated with HBsAg seroconversion (Hazard ratio = 1.12;p = 0.36). The risk of seroconversion decreased significantly with the number of blood donations (Hazard ratio = 0.58;p = 0.006). <strong>Conclusion: </strong>The incidence of HBsAg remains high among blood donors, which could have a negative impact on transfusion safety. The age of the blood donor was significantly associated to AgHBs seroconversion.
