Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-...Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.展开更多
回顾性分析了美国食品药品监督管理局制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库2021年1月至2024年6月的弹簧圈不良事件,结合山东省内医院调研和专家论证情况指出了弹簧圈在临床使用过...回顾性分析了美国食品药品监督管理局制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库2021年1月至2024年6月的弹簧圈不良事件,结合山东省内医院调研和专家论证情况指出了弹簧圈在临床使用过程中存在的风险点并进行了原因分析,提出了落实注册人的主体责任、提高使用单位的专业技能、强化监管部门的监管力度等改进措施,为弹簧圈的安全使用提供了参考。展开更多
针对频控阵多输入多输出(frequency diverse array multiple-input multiple-output,FDA-MIMO)雷达在目标定位过程中存在的角度和距离耦合问题,提出两种低复杂度角度-距离超分辨估计算法,即二维求根(two-dimensional rooting,2D-root)...针对频控阵多输入多输出(frequency diverse array multiple-input multiple-output,FDA-MIMO)雷达在目标定位过程中存在的角度和距离耦合问题,提出两种低复杂度角度-距离超分辨估计算法,即二维求根(two-dimensional rooting,2D-root)算法和重构旋转不变子空间(reduced dimensional estimation of signal parameters via rotational invariance techniques,RD-ESPRIT)算法。首先,提出角度-距离二维谱重构方法,将二维参数谱进行一维化等价剥离。区别于传统求根超分辨算法,2D-root算法利用矩阵化子空间求根方法,构造双重求根多项式,分别对角度和距离进行高精度估计及参数自动配对。同时,为了进一步减少求根运算的计算量,RD-ESPRIT算法利用重构后角度谱内在的线性关系,获得信号子空间的旋转不变性,从而实现目标角度的高效求解。计算机仿真实验结果表明,所提两种算法在降低传统搜索类目标定位算法复杂度的基础上,可提高参数估计精度。展开更多
文摘Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.
文摘回顾性分析了美国食品药品监督管理局制造商和用户设施设备体验(Manufacturer and User Facility Device Experience,MAUDE)数据库2021年1月至2024年6月的弹簧圈不良事件,结合山东省内医院调研和专家论证情况指出了弹簧圈在临床使用过程中存在的风险点并进行了原因分析,提出了落实注册人的主体责任、提高使用单位的专业技能、强化监管部门的监管力度等改进措施,为弹簧圈的安全使用提供了参考。
文摘针对频控阵多输入多输出(frequency diverse array multiple-input multiple-output,FDA-MIMO)雷达在目标定位过程中存在的角度和距离耦合问题,提出两种低复杂度角度-距离超分辨估计算法,即二维求根(two-dimensional rooting,2D-root)算法和重构旋转不变子空间(reduced dimensional estimation of signal parameters via rotational invariance techniques,RD-ESPRIT)算法。首先,提出角度-距离二维谱重构方法,将二维参数谱进行一维化等价剥离。区别于传统求根超分辨算法,2D-root算法利用矩阵化子空间求根方法,构造双重求根多项式,分别对角度和距离进行高精度估计及参数自动配对。同时,为了进一步减少求根运算的计算量,RD-ESPRIT算法利用重构后角度谱内在的线性关系,获得信号子空间的旋转不变性,从而实现目标角度的高效求解。计算机仿真实验结果表明,所提两种算法在降低传统搜索类目标定位算法复杂度的基础上,可提高参数估计精度。
