该文采取大样本、多中心、前瞻性、注册登记式医院集中监测嵌套前瞻性巢式病例对照设计方法,从参芪扶正注射液上市后临床应用真实世界着眼,监测使用参芪扶正注射液患者30 026例,共发生药品不良反应(adverse drug reaction,ADR)51例,包括...该文采取大样本、多中心、前瞻性、注册登记式医院集中监测嵌套前瞻性巢式病例对照设计方法,从参芪扶正注射液上市后临床应用真实世界着眼,监测使用参芪扶正注射液患者30 026例,共发生药品不良反应(adverse drug reaction,ADR)51例,包括1例严重不良反应,计算ADR发生率为0.17%;采集发生过敏反应的患者及其匹配患者的血液样本,对过敏反应相关生物指标进行统一检测与分析,以探讨过敏反应发生机制,从而促进临床安全合理用药。展开更多
Background: Reports about the relationships between insulin concentrations and CHD risk are controversial. The objective of this survey was to study the association between insulin levels and CHD risk in middle-aged m...Background: Reports about the relationships between insulin concentrations and CHD risk are controversial. The objective of this survey was to study the association between insulin levels and CHD risk in middle-aged male participants of the PRIME Study after 5 years of follow-up. Methods: Our study adopted a nested case-control design including 294 cases of CHD and 536 controls randomly selected among healthy participants from the PRIME cohort. Data were obtained by questionnaires(medical history, lifestyle), standardised clinical measurements(blood pressure, anthropometric measurements), and a blood sample was obtained for biological measurements. Odds-Ratios for associations of four ordered classes of insulin concentration with CHD risk after adjustment for confounding factors were estimated using conditional logistic regression. Results: In Belfast, a significant trend(p< 0.03) was observed between insulin classes and CHD risk in bivariate analyses, but this association lost its significance after multiple adjustments. In the French centres, a high risk of CHD(OR=3.24 [1.80-5.85], p< 0.0001) was observed only for the second class of insulin concentration(6.5 to 9.9 mIU/l), compared with the reference class(< 6.5 mIU/l). After multiple adjustments, this association remained highly significant(OR=2.92[1.44-5.92], p< 0.005). Conclusions: In Belfast(high-risk population), a significant trend was observed between insulin concentration classes and CHD risk but hyperinsulinaemia lost its association with CHD risk in multivariate analyses. In the French centres(lower risk population), slightly increased insulin concentrations were associated with a high risk of CHD, independently of cardiovascular risk factors and other features of the metabolic syndrome, but very high insulin concentrations were not.展开更多
文摘该文采取大样本、多中心、前瞻性、注册登记式医院集中监测嵌套前瞻性巢式病例对照设计方法,从参芪扶正注射液上市后临床应用真实世界着眼,监测使用参芪扶正注射液患者30 026例,共发生药品不良反应(adverse drug reaction,ADR)51例,包括1例严重不良反应,计算ADR发生率为0.17%;采集发生过敏反应的患者及其匹配患者的血液样本,对过敏反应相关生物指标进行统一检测与分析,以探讨过敏反应发生机制,从而促进临床安全合理用药。
文摘Background: Reports about the relationships between insulin concentrations and CHD risk are controversial. The objective of this survey was to study the association between insulin levels and CHD risk in middle-aged male participants of the PRIME Study after 5 years of follow-up. Methods: Our study adopted a nested case-control design including 294 cases of CHD and 536 controls randomly selected among healthy participants from the PRIME cohort. Data were obtained by questionnaires(medical history, lifestyle), standardised clinical measurements(blood pressure, anthropometric measurements), and a blood sample was obtained for biological measurements. Odds-Ratios for associations of four ordered classes of insulin concentration with CHD risk after adjustment for confounding factors were estimated using conditional logistic regression. Results: In Belfast, a significant trend(p< 0.03) was observed between insulin classes and CHD risk in bivariate analyses, but this association lost its significance after multiple adjustments. In the French centres, a high risk of CHD(OR=3.24 [1.80-5.85], p< 0.0001) was observed only for the second class of insulin concentration(6.5 to 9.9 mIU/l), compared with the reference class(< 6.5 mIU/l). After multiple adjustments, this association remained highly significant(OR=2.92[1.44-5.92], p< 0.005). Conclusions: In Belfast(high-risk population), a significant trend was observed between insulin concentration classes and CHD risk but hyperinsulinaemia lost its association with CHD risk in multivariate analyses. In the French centres(lower risk population), slightly increased insulin concentrations were associated with a high risk of CHD, independently of cardiovascular risk factors and other features of the metabolic syndrome, but very high insulin concentrations were not.
