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首页 > 药品资讯 > 帕拉米韦注射液

帕拉米韦注射液

2023-10-09     编辑:艾玉娇     阅读量:26212

一、药品说明书
【药品名称】
通用名:帕拉米韦氯化钠注射液
商品名:力纬®、艾培®
英文名称:Peramivir Injection
汉语拼音:PaLaMiWeiZhuSheYe
化学结构式:帕拉米韦结构.png
分子式:C15H28N4O4·3H2O
分子量:382.453
【成分】本品主要成份为帕拉米韦,所用辅料为氯化钠和稀盐酸。
【性状】本品为无色的澄明液体。
【适应症】用于治疗甲型或乙型流行性感冒。
【规格】
15ml150mg(按C15H28N4O4计);60ml0.3g(按C15H28N4O4计);20ml0.2g(按C15H28N4O4计)100ml0.3g(按C15H28N4O4计)
【用法用量】【不良反应】【禁忌】【注意事项】【孕妇及哺乳期妇女用药】【儿童用药】【老年用药】【药物相互作用】【药物过量】【药理毒理】【药代动力学】详细内容见说明书
【贮藏】遮光、密闭,25℃以下保存。
【包装】钠钙玻璃瓶
【有效期】24个月36个月
【执行标准】YBH00862017
【批准文号】国药准字H20233617、国药准字H20233886、国药准字H20233372、国药准字H20233789、国药准字H20233672、国药准字H20233678
【生产企业】
云南先施药业有限公司;扬子江药业集团四川海蓉药业有限公司;齐鲁制药(海南)有限公司;广州南新制药有限公司广东中润药业有限公司;成都百裕制药股份有限公司(排名无先后顺序)
【说明书】
1.云南先施药业有限公司
链接:https://view.officeapps.live.com/op/view.aspx?src=http%3A%2F%2Fwww.nhsa.gov.cn%2Fattach%2FYpsn2023%2FYPSW202300346%2FYPSW202300346-W1(ppt).pptx&wdOrigin=BROWSELINK
2.扬子江药业集团四川海蓉药业有限公司
链接:http://www.nhsa.gov.cn/attach/Ypsn2023/YPSW202300353/YPSW202300353-W1(ppt).pdf
3.成都百裕制药股份有限公司(持有人将转移给桂林南药股份有限公司)
链接:http://www.nhsa.gov.cn/attach/Ypsn2023/YPSW202300145/YPSW202300145-W1(ppt).pdf
4.广州南新制药有限公司
链接:https://zy.yaozh.com/instruct/sms20220809/5e76735f991a4914960ee26737138263_0.jpg

 二、信息查询
1.国家药品监督管理局(NMPA
链接:https://www.nmpa.gov.cn/datasearch/search-result.html
2.欧洲药品管理局(EMA
链接:https://www.ema.europa.eu/en/medicines?search_api_views_fulltext=Peramivir
3.美国药品信息查询(FDA
链接:https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
4.日本药品信息查询(PMDA
链接:https://www.pmda.go.jp/PmdaSearch/iyakuSearch

 三、指南或专家共识
1.四川省流行性感冒中西医结合诊疗专家共识(2023)
链接:https://guide.medlive.cn/guideline/28355
2.流行性感冒诊疗方案(2020年版)
链接:https://guide.medlive.cn/guideline/21925
3.2022-2023 AAP儿童流感的预防与控制建议
链接:https://publications.aap.org/pediatrics/article/150/4/e2022059274/189385/Recommendations-for-Prevention-and-Control-of?autologincheck=redirected
4.2022-23 ACIP建议:流感季节流感疫苗防控
链接:https://www.cdc.gov/mmwr/volumes/71/rr/rr7101a1.htm?s_cid=rr7101a1_w
5.成人流行性感冒诊疗规范急诊专家共识(2022版)
链接:https://guide.medlive.cn/guideline/27512

四、药物动力学/药效学
1.R292K突变对甲型H7N9流感病毒耐帕拉米韦的影响:分子动力学视角
(Impact of the R292K Mutation on Influenza A (H7N9) Virus Resistance towards Peramivir: A Molecular Dynamics Perspective)
作者:Sphamandla E Mtambo (Drug Research and Innovation Unit, Discipline of Medical Biochemistry, School of Laboratory Medicine and Medical Science, University of KwaZulu-Natal, South Africa)
链接:https://pubmed.ncbi.nlm.nih.gov/35268746/
2.经鼻雾化吸入和静脉注射后帕拉米韦在大鼠血浆和肺中的药代动力学行为
(Pharmacokinetic behavior of peramivir in the plasma and lungs of rats after trans-nasal aerosol inhalation and intravenous injection)
作者:Hao Ding(Department of Pharmacy, Fifth Medical Center of Chinese PLA General Hospital, China)
链接:https://pubmed.ncbi.nlm.nih.gov/32768954/
3.帕拉米韦三水合物氯化钠在健康人体的药代动力学
作者:赵侠(北京大学第一医院,药剂科,北京)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEhJ6Z2xjeWx4enoyMDEzMTAwMDkaCDhieHpsbTQ5

五、临床研究
1.静脉注射帕拉米韦治疗住院儿童甲型H3N2流感和乙型/维多利亚流感的有效性
(Effectiveness of intravenous peramivir for the treatment of influenza A/H3N2 and influenza B/Victoria in hospitalized children)
作者:Jinna Wang(Suqian Hospital of Nanjing Drum Tower Hospital Group, China)
链接:
https://pubmed.ncbi.nlm.nih.gov/37178975/
2.流感的抗病毒治疗
(Antiviral therapies for influenza)
作者:Ken K P Chan(Division of Respiratory Medicine, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Hong Kong, China)
链接:
https://pubmed.ncbi.nlm.nih.gov/36752709/
3.奥司他韦与帕拉米韦治疗流感感染住院儿童(0-5岁)的疗效比较
(Comparative effectiveness of oseltamivir versus peramivir for hospitalized children (aged 0-5 years) with influenza infection)
作者:Ming Xu(Hunan Provincial Key Laboratory of Clinical Epidemiology, Xiangya School of Public Health, Central South University, Changsha, China)
链接:
https://pubmed.ncbi.nlm.nih.gov/36608788/
4.计算机研究表明,即使H7N9禽流感病毒获得进一步耐药性,帕拉米韦和扎那米韦仍是最佳治疗药物
(In Silico Studies Reveal Peramivir and Zanamivir as an Optimal Drug Treatment Even If H7N9 Avian Type Influenza Virus Acquires Further Resistance)
作者:Edita Sarukhanyan(Department of Bioinformatics, Biocenter, Am Hubland, University of Würzburg, Germany)
链接:
https://pubmed.ncbi.nlm.nih.gov/36144655/
5.帕拉米韦作为一种抗流感病毒药物,具有潜在的抗细胞因子风暴作用
(Peramivir, an Anti-Influenza Virus Drug, Exhibits Potential Anti-Cytokine Storm Effects)
作者:Chen-Xi Zhang(Institute of Translational Medicine, Shanghai University, Shanghai, China)
链接:
https://pubmed.ncbi.nlm.nih.gov/35296098/
6.神经氨酸酶抑制剂在流感患者中的疗效比较:系统评价和网状meta分析
(Comparative effectiveness of neuraminidase inhibitors in patients with influenza: A systematic review and network meta-analysis)
作者:Hui-Chen Su(Department of Pharmacy, Chi Mei Medical Center, Taiwan, China)
链接:
https://pubmed.ncbi.nlm.nih.gov/34840038/
7.连花清瘟颗粒联合帕拉米韦氯化钠注射液治疗流感的效能及血清炎症因子水平变化
(Potency of Lianhua Qingwen granule combined with paramivir sodium chloride injection in treating influenza and level changes of serum inflammatory factors)
作者:Jinhua Wu(Infectious Diseases Department I, Cangzhou Central Hospital Yunhe, China)
链接:
https://pubmed.ncbi.nlm.nih.gov/34306428/
8.急诊高危流感患者静注帕拉米韦与口服奥司他韦的比较:一项前瞻性随机对照研究的结果
(
Intravenous peramivir vs oral oseltamivir in high-risk emergency department patients with influenza: Results from a pilot randomized controlled study)
作者:Yu-Hsiang Hsieh(Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, USA)
链接:https://pubmed.ncbi.nlm.nih.gov/33006445/
9.帕拉米韦对流感病毒感染和已有慢性呼吸道疾病患者呼吸道症状改善的影响:一项随机、开放标签研究的结果
(Effect of peramivir on respiratory symptom improvement in patients with influenza virus infection and pre-existing chronic respiratory disease: Findings of a randomized, open-label study)
作者:Motokazu Kato(Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Japan)
链接:https://pubmed.ncbi.nlm.nih.gov/32677375/
10.静脉注射帕拉米韦与奥司他韦治疗住院患者流感的临床疗效比较
(Clinical Effectiveness of Intravenous Peramivir versus Oseltamivir for the Treatment of Influenza in Hospitalized Patients)
作者:Jin Seo Lee(Division of Infectious Disease, Department of Medicine, Hallym University Kangdong Sacred Heart Hospital, Republic of Korea)
链接:https://pubmed.ncbi.nlm.nih.gov/32547116/
11.比较帕拉米韦与其他神经氨酸酶抑制剂治疗流感的有效性和安全性的荟萃分析
(A Meta-Analysis Comparing the Efficacy and Safety of Peramivir with Other Neuraminidase Inhibitors for Influenza Treatment)|
作者:Jui-Yi Chen(Division of Nephrology, Department of Internal Medicine, Chi Mei Medical Center, Taiwan, China)
链接:https://pubmed.ncbi.nlm.nih.gov/32033501/
12.帕拉米韦氯化钠注射液治疗小儿流行性感冒的有效性及安全性
作者:刘沛(深圳市罗湖区妇幼保健院儿科,广东 深圳)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEhJsY3l4eWp5c2oyMDIzMTkwMjUaCHpsNnoxem4y
13.小儿豉翘清热颗粒联合帕拉米韦对儿童流感的疗效观察
作者:卢壮丽(湖南省涟源市人民医院)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEhB5eGxseXNqMjAyMzA3MDM4Ggh6bDZ6MXpuMg%3D%3D
14.帕拉米韦氯化钠注射液(力纬)治疗流行性感冒的疗效观察
作者:李鹏(鄢陵县人民医院内科,河南 鄢陵)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEhB4ZHpkeXpsMjAyMTE5MDI0Ggg4Ynh6bG00OQ%3D%3D

六、不良反应
1.使用上市后监测的药物诱导的神经精神不良事件
(
Drug-induced Neuropsychiatric Adverse Events Using Post-Marketing Surveillance)
作者:Tomohito Wakabayashi(Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences, Japan.)
链接:
https://pubmed.ncbi.nlm.nih.gov/33588740/
2.帕拉米韦治疗危重儿科患者H1N1流感的结局和不良反应
(Outcomes and Adverse Effects With Peramivir for the Treatment of Influenza H1N1 in Critically Ill Pediatric Patients)
作者:Robert Witcher
链接:
https://pubmed.ncbi.nlm.nih.gov/31719811/
3.帕拉米韦致史蒂文斯-约翰逊综合征的临床药学监护
作者:陈嘉宁(肇庆市高要区人民医院药学部临床药学室,广东肇庆)
链接:
https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEg56Z2NmeTIwMjEwNjAxORoIOGJ4emxtNDk%3D
4.帕拉米韦氯化钠注射液致急性肾损伤1例
作者:邱彦龙(平邑县人民医院临床药学科 山东平邑)
链接:
https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEg16Z3lzMjAyMDAyMDI3Ggg5eHNoMzRvMg%3D%3D

七、药物经济学
1.日本成人门诊环境中神经氨酸酶抑制剂治疗流感病毒感染的成本-效果分析
(A Cost-Effectiveness Analysis of Neuraminidase Inhibitors for Influenza Virus Infections in an Adult-Outpatient Setting in Japan)
作者:Naoto Nakagawa (School of Pharmaceutical Sciences, Ohu University, Koriyama, Japan)
链接:https://pubmed.ncbi.nlm.nih.gov/33556804/
2.帕拉米韦治疗儿童流行性感冒的循证药物经济学评价
作者:黄光亮(河北医科大学第二医院,石家庄)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEg1la3l4MjAyMjAyMDAzGghzbGsyc3dzOQ%3D%3D
3.帕拉米韦对比奥司他韦治疗儿童流感的系统评价和药物经济性分析
作者:陈昕晟(镇江市第一人民医院,镇江)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEhJqc3l4eWxjeWoyMDIyMDEwMTQaCHpsNnoxem4y
4.帕拉米韦对比奥司他韦治疗流行性感冒合并热性惊厥患儿的药物经济学评价
作者:陈圣洁(河北省儿童医院药学部,石家庄)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEg16Z3lmMjAyMDAxMDEzGgh6bDZ6MXpuMg%3D%3D
5.帕拉米韦氯化钠注射液对流感病毒A型肺炎患儿的成本-效益分析
作者:刘燕汝(西安交通大学附属第一医院财务科 陕西西安)
链接:https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjMwODMxEg1zd2N4MjAyMTA0MDE2GghvMmJ4M2prNA%3D%3D