文档介绍：磷酸奧司他韦临床使用再认知
奥司他韦的适用范围
奥司他韦的联合用药
奥司他韦足疗程应用的必要性
奥司他韦全球应用近二十年
1999
9006
2008
2012
2018
FDA批准奥司他授权中国生产销售自主研发颗粒剂型更改说明书,应上市近20年
韦用于1岁以上儿
童及***甲、乙
用人群拓宽至14我国应用近15年
型流感治疗;13
天以上婴儿
岁以上人群预防
FDA批准奥司他韦用于14天以上幼儿用药的审评报告
CENTER FOR DRUG EVALUATION AND
RESEARCH
The current submission provides data to support the use of Tamiflu for the treatment of
influenza in pediatric patients less than I year of age. The Applicant has submitted final study
reports and datasets from two clinical trials to support extension of the treatment indication to
IPPLICATION NUMBER
CASGI14(WP20749)-A pharmacokinetic/pharmacodynamic and safety evaluation
of oseltamivir(Tamiflu) in the treatment of children less than 24 months of age with
0210870rigl62
onfirmed influenza Infection, and
021246rigl045
WP22849-An open label, prospective pharmacokinetic/pharmacodynamic and safety
evaluation of oseltamivir (Tamiflu) in the treatment of infants 0 to< 1] months of age
with confirmed influenza infection
SUMMARY REVIEW
These two trials form the basis for the fda reviews and conclusions
Tablel: Number of subjects earolled dose administered by age groups
≤1 month
1-3month
6~9month
>9month
(s30day5)(31-90days)(91-18days)(181-270days)
(2271days)
CASG114(dose) N=8(3mg/kg) N=14(3mg/kg) N=10(3mg/kg)N=22( 3mg/kg) N=16(3 or 3. 5mg/kg)
WP22849(dose) N=5 (2mg/kg) N=20() N=13(3mg/kg) N=13(3mg/kg) N=14(3mg/kg)
Total by Age group
13
34
23
35
奥司他韦广泛被国内外儿科指南收录、推荐
项非盲安全性观察试验中,选取了1065例小于24个月的婴幼儿,研究奥司他韦的不良反应事件
究显示:24个月以下的婴幼儿对奥司他韦的治疗及预防剂量耐受性好,无新的不良事件发生1
美cDc在2016年2月最新发布的流感预防与治疗建议中指出2:
Antiviral
Recommended No
Recommended
for Use in
「奥司他韦可用于治疗全年龄段的流感
Oseltamivir Influenza Treatment Any
A and B
患儿及3个月以上儿童的流感预防,且
无不推荐使用项
prophylaxis!
[1] Pharmacoepidemiology and Drug Safety 2015, 24: 286-296
2]http:/'professionals/antivralsisummary-
AAP、cDC和美国感染病协会都继续推荐奧司他韦治疗流感首选用药
Reviewers of available studies by
the CDC, the WHO, an