This study analyzed case and prescription data of children aged 12 to 18 years diagnosed with influenza A from the outpatient and emergency departments at the Women and Children’s Hospital of Ningbo University during...This study analyzed case and prescription data of children aged 12 to 18 years diagnosed with influenza A from the outpatient and emergency departments at the Women and Children’s Hospital of Ningbo University during the influenza epidemic period between February and April 2023.Patients were categorized into two groups based on their medication:the Baloxavir Marboxil group(196 cases)and the Oseltamivir group(126 cases).SPSS Statistics 24.0 software was utilized to compare variables between the two groups,including age,sex,weight,first visit department,number of visits,average prescription cost per patient,drug varieties used,hospitalization rate,and the combined medication usage,to evaluate the relative advantages and disadvantages of the two treatments.The results indicated that the number of visits in the Baloxavir Marboxil group was significantly lower than in the Oseltamivir group,whereas the average prescription cost per patient was higher(P<0.05).There were no significant differences between the two groups regarding age,sex,weight,first visit department,number of drug types used,hospitalization rate,or combined medication usage(P>0.05).When comparing the use of single-class combined drugs,only the quantity of antiviral drugs differed significantly(P<0.05).The Oseltamivir group required more adjuvant treatment with both Chinese and Western antiviral medications.The distribution of the number of combined drug types was concentrated around three and two types in both groups(Baloxavir Marboxil group:41.34%and 39.66%;Oseltamivir group:44.54%and 36.97%).This study highlighted that the new drug,Baloxavir Marboxil,offered certain therapeutic benefits over Oseltamivir in treating influenza among children aged 12 to 18 years,including advantages in single-dose administration,oral compliance,and specific treatment outcomes.The higher unit cost associated with Baloxavir Marboxil might be a factor for further consideration.These findings provided a new reference point for the clinical selection of anti-influenza medications.展开更多
流行性感冒发病率高,传染性强,且流感并发症的发病率和死亡率最高。2018年10月,美国食品药品管理局(Food and Drug Administration,FDA)加速批准新型的帽依赖性核酸内切酶抑制剂baloxavir marboxil上市,用于治疗12岁及以上有流感症状且...流行性感冒发病率高,传染性强,且流感并发症的发病率和死亡率最高。2018年10月,美国食品药品管理局(Food and Drug Administration,FDA)加速批准新型的帽依赖性核酸内切酶抑制剂baloxavir marboxil上市,用于治疗12岁及以上有流感症状且不超过48 h的急性单纯型流感患者。临床研究显示,baloxavir marboxil对流感有较好的客观缓解率。本文对其药理作用、临床评价、安全性及用法用量等进行简要概述。展开更多
巴洛沙韦玛波西酯(baloxavir marboxil)是近20年来首创的新作用机制的抗流行性感冒(流感)病毒新药,由日本盐野义(Shionogi)制药株式会社首先研制,作用于流感病毒基因组转录所必需的聚合酶酸性蛋白的内切酶,对甲型和乙型流感病毒均有很...巴洛沙韦玛波西酯(baloxavir marboxil)是近20年来首创的新作用机制的抗流行性感冒(流感)病毒新药,由日本盐野义(Shionogi)制药株式会社首先研制,作用于流感病毒基因组转录所必需的聚合酶酸性蛋白的内切酶,对甲型和乙型流感病毒均有很强的抑制活性。日本厚生省新药审批部门:日本医药品医疗器械综合机构(Pharmaceuticals and Medical Devices Agency,PMDA)于2015年11月给予该公司单剂治疗≥12岁、无并发症的急性流感优先评审待遇,2018年2月予以加速许可,用于治疗甲型和乙型流感,并于2018年2月23日批准上市,商品名为Xofluza~®。2016年2月盐野义制药公司与瑞士罗氏制药公司签署合作协议,授予罗氏公司除日本和中国台湾地区之外的全球开发与经营权,只保留在美国共同开发权。瑞士罗氏制药集团公司属下的基因泰克(Genentech)制药公司于2018年6月26日获得美国食品药品监督管理局(FDA)优先审评资格,并于2018年10月24日获准上市,商品名为Xofluza~®。该文对巴洛沙韦玛波西酯的非临床和临床药理毒理学、临床研究、不良反应、适应证、剂量与用法、用药注意事项及知识产权状态和国内外研究进展等进行介绍。展开更多
Baloxavir marboxil is a polymerase acidic(PA)endonuclease inhibitor,which is approved by the U.S Food and Drug Administration(FDA)on October 25,2018,for the treatment of uncomplicated influenza patients aged 12 years ...Baloxavir marboxil is a polymerase acidic(PA)endonuclease inhibitor,which is approved by the U.S Food and Drug Administration(FDA)on October 25,2018,for the treatment of uncomplicated influenza patients aged 12 years and older.In the present work,we reviewed the pharmacodynamics,pharmacokinetics,drug interactions,clinical trials and adverse reactions of baloxavir marboxil.展开更多
目的系统评价玛巴洛沙韦治疗儿童流行性感冒的有效性和安全性。方法检索PubMed、Embase、Web of Science、Cochrane Library、中国生物医学文献数据库、中国知网、万方和维普等数据库,检索时间为建库至2023年11月15日,选取关于玛巴洛沙...目的系统评价玛巴洛沙韦治疗儿童流行性感冒的有效性和安全性。方法检索PubMed、Embase、Web of Science、Cochrane Library、中国生物医学文献数据库、中国知网、万方和维普等数据库,检索时间为建库至2023年11月15日,选取关于玛巴洛沙韦治疗儿童流感病毒感染的随机对照试验和队列研究,分别采用Cochrane风险偏倚评价工具和纽卡斯尔-渥太华量表(Newcastle-Ottawa Scale,NOS)进行文献质量评价,采用Rev‐Man 5.3软件进行Meta分析。结果共纳入11篇文献,包括3篇随机对照试验和8篇队列研究。与神经氨酸酶抑制剂(奥司他韦、扎那米韦、帕拉米韦和拉尼米韦)相比,玛巴洛沙韦治疗乙型流感的中位发热持续时间较短(17.0 h vs.48.3 h,P<0.01)。与奥司他韦相比,在甲流和乙流亚组中,玛巴洛沙韦组发热持续时间(甲流:MD=-6.30,95%CI:-10.12~-2.49,P=0.001;乙流:MD=-26.94,95%CI:-47.11~-6.77,P=0.009)、症状持续时间[甲流:MD=-11.13,95%CI:-19.34~-2.93,P=0.008;乙流:(4.9±1.3)d vs.(5.4±2.4)d,P<0.01]均更短;在甲流亚组中,玛巴洛沙韦组的中位病毒清除率(单位:log10拷贝数/d)更高[0.81(0.52,1.12)vs.0.63(0.44,0.93),P=0.007];玛巴洛沙韦组复诊率更低(8.05%vs.24.84%,P<0.001)。与扎那米韦相比,玛巴洛沙韦的中位病毒清除率(单位:log10拷贝数/d)差异无统计学意义[甲流:0.81(0.52,1.12)vs.0.90(0.65,1.08),P>0.05;乙流:0.77(0.38,1.04)vs.0.55(0.27,0.77),P>0.05]。与拉尼米韦相比,玛巴洛沙韦的中位病毒清除率(单位:log10拷贝数/d)[甲流:0.81(0.52,1.12)vs.0.76(0.45,1.06),P>0.05;乙流:0.77(0.38,1.04)vs.0.37(0.29,0.56),P>0.05]、复诊率差异无统计学意义(8.05%vs.12.35%,P=0.79)。在安全性方面,玛巴洛沙韦与奥司他韦相比,药物相关不良事件发生率更低(OR=0.66,95%CI:0.44~0.98,P<0.05),总不良事件发生率差异无统计学意义(OR=0.85,95%CI:0.69~1.05,P>0.05)。结论玛巴洛沙韦治疗儿童流感的有效性和安全性良好,还需开展更高质量研究进一步验证。展开更多
基金Ningbo Top Medical and Health Research Program(Grant No.2022020405)Wu Jieping Medical Foundation(Grant No.320.6750.2023-25-3).
文摘This study analyzed case and prescription data of children aged 12 to 18 years diagnosed with influenza A from the outpatient and emergency departments at the Women and Children’s Hospital of Ningbo University during the influenza epidemic period between February and April 2023.Patients were categorized into two groups based on their medication:the Baloxavir Marboxil group(196 cases)and the Oseltamivir group(126 cases).SPSS Statistics 24.0 software was utilized to compare variables between the two groups,including age,sex,weight,first visit department,number of visits,average prescription cost per patient,drug varieties used,hospitalization rate,and the combined medication usage,to evaluate the relative advantages and disadvantages of the two treatments.The results indicated that the number of visits in the Baloxavir Marboxil group was significantly lower than in the Oseltamivir group,whereas the average prescription cost per patient was higher(P<0.05).There were no significant differences between the two groups regarding age,sex,weight,first visit department,number of drug types used,hospitalization rate,or combined medication usage(P>0.05).When comparing the use of single-class combined drugs,only the quantity of antiviral drugs differed significantly(P<0.05).The Oseltamivir group required more adjuvant treatment with both Chinese and Western antiviral medications.The distribution of the number of combined drug types was concentrated around three and two types in both groups(Baloxavir Marboxil group:41.34%and 39.66%;Oseltamivir group:44.54%and 36.97%).This study highlighted that the new drug,Baloxavir Marboxil,offered certain therapeutic benefits over Oseltamivir in treating influenza among children aged 12 to 18 years,including advantages in single-dose administration,oral compliance,and specific treatment outcomes.The higher unit cost associated with Baloxavir Marboxil might be a factor for further consideration.These findings provided a new reference point for the clinical selection of anti-influenza medications.
文摘流行性感冒发病率高,传染性强,且流感并发症的发病率和死亡率最高。2018年10月,美国食品药品管理局(Food and Drug Administration,FDA)加速批准新型的帽依赖性核酸内切酶抑制剂baloxavir marboxil上市,用于治疗12岁及以上有流感症状且不超过48 h的急性单纯型流感患者。临床研究显示,baloxavir marboxil对流感有较好的客观缓解率。本文对其药理作用、临床评价、安全性及用法用量等进行简要概述。
文摘巴洛沙韦玛波西酯(baloxavir marboxil)是近20年来首创的新作用机制的抗流行性感冒(流感)病毒新药,由日本盐野义(Shionogi)制药株式会社首先研制,作用于流感病毒基因组转录所必需的聚合酶酸性蛋白的内切酶,对甲型和乙型流感病毒均有很强的抑制活性。日本厚生省新药审批部门:日本医药品医疗器械综合机构(Pharmaceuticals and Medical Devices Agency,PMDA)于2015年11月给予该公司单剂治疗≥12岁、无并发症的急性流感优先评审待遇,2018年2月予以加速许可,用于治疗甲型和乙型流感,并于2018年2月23日批准上市,商品名为Xofluza~®。2016年2月盐野义制药公司与瑞士罗氏制药公司签署合作协议,授予罗氏公司除日本和中国台湾地区之外的全球开发与经营权,只保留在美国共同开发权。瑞士罗氏制药集团公司属下的基因泰克(Genentech)制药公司于2018年6月26日获得美国食品药品监督管理局(FDA)优先审评资格,并于2018年10月24日获准上市,商品名为Xofluza~®。该文对巴洛沙韦玛波西酯的非临床和临床药理毒理学、临床研究、不良反应、适应证、剂量与用法、用药注意事项及知识产权状态和国内外研究进展等进行介绍。
文摘Baloxavir marboxil is a polymerase acidic(PA)endonuclease inhibitor,which is approved by the U.S Food and Drug Administration(FDA)on October 25,2018,for the treatment of uncomplicated influenza patients aged 12 years and older.In the present work,we reviewed the pharmacodynamics,pharmacokinetics,drug interactions,clinical trials and adverse reactions of baloxavir marboxil.
文摘目的系统评价玛巴洛沙韦治疗儿童流行性感冒的有效性和安全性。方法检索PubMed、Embase、Web of Science、Cochrane Library、中国生物医学文献数据库、中国知网、万方和维普等数据库,检索时间为建库至2023年11月15日,选取关于玛巴洛沙韦治疗儿童流感病毒感染的随机对照试验和队列研究,分别采用Cochrane风险偏倚评价工具和纽卡斯尔-渥太华量表(Newcastle-Ottawa Scale,NOS)进行文献质量评价,采用Rev‐Man 5.3软件进行Meta分析。结果共纳入11篇文献,包括3篇随机对照试验和8篇队列研究。与神经氨酸酶抑制剂(奥司他韦、扎那米韦、帕拉米韦和拉尼米韦)相比,玛巴洛沙韦治疗乙型流感的中位发热持续时间较短(17.0 h vs.48.3 h,P<0.01)。与奥司他韦相比,在甲流和乙流亚组中,玛巴洛沙韦组发热持续时间(甲流:MD=-6.30,95%CI:-10.12~-2.49,P=0.001;乙流:MD=-26.94,95%CI:-47.11~-6.77,P=0.009)、症状持续时间[甲流:MD=-11.13,95%CI:-19.34~-2.93,P=0.008;乙流:(4.9±1.3)d vs.(5.4±2.4)d,P<0.01]均更短;在甲流亚组中,玛巴洛沙韦组的中位病毒清除率(单位:log10拷贝数/d)更高[0.81(0.52,1.12)vs.0.63(0.44,0.93),P=0.007];玛巴洛沙韦组复诊率更低(8.05%vs.24.84%,P<0.001)。与扎那米韦相比,玛巴洛沙韦的中位病毒清除率(单位:log10拷贝数/d)差异无统计学意义[甲流:0.81(0.52,1.12)vs.0.90(0.65,1.08),P>0.05;乙流:0.77(0.38,1.04)vs.0.55(0.27,0.77),P>0.05]。与拉尼米韦相比,玛巴洛沙韦的中位病毒清除率(单位:log10拷贝数/d)[甲流:0.81(0.52,1.12)vs.0.76(0.45,1.06),P>0.05;乙流:0.77(0.38,1.04)vs.0.37(0.29,0.56),P>0.05]、复诊率差异无统计学意义(8.05%vs.12.35%,P=0.79)。在安全性方面,玛巴洛沙韦与奥司他韦相比,药物相关不良事件发生率更低(OR=0.66,95%CI:0.44~0.98,P<0.05),总不良事件发生率差异无统计学意义(OR=0.85,95%CI:0.69~1.05,P>0.05)。结论玛巴洛沙韦治疗儿童流感的有效性和安全性良好,还需开展更高质量研究进一步验证。
