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美国疾控中心(CDC)针对感染猪流感病毒治疗和预防的临时指南 中英文  

2009-05-01 14:41:07|  分类: 默认分类 |  标签: |举报 |字号 订阅

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美国CDC针对感染猪流感病毒治疗和预防的临时指南

2009-4-29

美国国家疾病预防控制中心2008428发布——

针对感染AH1N1)型猪流感病毒的确诊病例、疑似病例和紧密接触者

进行治疗和预防的临时指南

 

情况说明:

1.美国CDC网站公布时间20084285时(北京时间2817时);

2.西安天隆科技有限公司检索到原文时间200842821时;

3.西安天隆科技有限公司在2823时到295时完成翻译,因时间仓促,翻译难免有疏漏甚至错误,以英文原文为准;

4.中(英)文全文请访问:http://www.medtl.com

5.转载请注明出处并附以上说明。

以下是原文翻译:

 

 

Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts

美国CDC针对感染猪流感病毒治疗和预防的临时指南

April 28, 2009 05:00 AM ET

20084285

 

Objective: To provide interim guidance on the use of antiviral agents for treatment and chemoprophylaxis of swine influenza A (H1N1) virus infection. This includes patients with confirmed, probable or suspected swine influenza A (H1N1) virus infection and their close contacts.

目的:针对感染AH1N1)型猪流感病毒的确诊病例、疑似病例以及紧密接触者进行抗病毒药物治疗和药物预防的临时指南。

Case Definitions for Infection with Swine Influenza A (H1N1) Virus

感染AH1N1)型猪流感病毒的相关定义

A confirmed case of swine influenza A (H1N1) virus infection is defined as a person with an acute febrile respiratory illness with laboratory confirmed swine influenza A (H1N1) virus infection at CDC by one or more of the following tests:

确诊病例具有急性发烧呼吸道疾病的临床症状并且经以下一个或多个实验室检测方法检验证实感染AH1N1)型猪流感病毒

1.real-time RT-PCR

1、实时荧光定量PCR  (real-time RT-PCR)

2.viral culture

2、病毒分离培养 (viral culture)

A probable case of swine influenza A (H1N1) virus infection is defined as a person with an acute febrile respiratory illness who is:

疑似病例具有急性发烧呼吸道疾病的临床症状并且经检验结果如下:

· positive for influenza A, but negative for H1 and H3 by influenza RT-PCR, or

l   经流感RT-PCR检验对A型流感病毒呈阳性且对H1H3呈阴性

· positive for influenza A by an influenza rapid test or an influenza immunofluorescence assay (IFA) plus meets criteria for a suspected case

l   或者经流感快速检测对A型流感病毒呈阳性或者经流感免疫荧光化验达到标准的可疑病例

A suspected case of swine influenza A (H1N1) virus infection is defined as a person with acute febrile respiratory illness with onset

可疑病例具有急性发烧呼吸道疾病的临床症状并且是由以下条件引发

·within 7 days of close contact with a person who is a confirmed case of swine influenza A (H1N1) virus infection, or

l   7日内与感染AH1N1)型猪流感的确诊病例有紧密接触

·within 7 days of travel to community either within the United States or internationally where there are one or more confirmed swine influenza A(H1N1) cases, or

l   或者7日内到美国或者其它具有一例或更多感染AH1N1)型猪流感病毒确诊病例的国家或地区旅游

·resides in a community where there are one or more confirmed swine influenza cases.

l   居住在具有一例或更多感染AH1N1)型猪流感病毒确诊病例的国家或地区

Infectious period for a confirmed case of swine influenza A (H1N1) virus infection is defined as 1 day prior to the case’s illness onset to 7 days after onset.

传染期感染AH1N1)型猪流感病毒的确诊病例的传染期定义为症状发作之前1天到发作后7

Close contact is defined as: within about 6 feet of an ill person who is a confirmed or suspected case of swine influenza A (H1N1) virus infection during the case’s infectious period.

紧密接触距离处于传染期的感染AH1N1)型猪流感病毒的确诊病例或者可疑病例6英尺之内的人

Acute respiratory illness is defined as recent onset of at least two of the following: rhinorrhea or nasal congestion, sore throat, cough (with or without fever or feverishness)

急性发烧呼吸道疾病最近至少有以下两种症状发作:鼻溢或鼻塞,咽喉痛,咳嗽(无论是否伴随发热或发烧)

High-risk groups: A person who is at high-risk for complications of swine influenza A (H1N1) virus infection is defined as the same for seasonal influenza (see MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008).

高危人群 - AH1N1)型猪流感病毒感染及并发症的高位人群与季节性流感高危人群的定义相同(详见MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008)

 

Special Considerations for Children

针对儿童的特别声明

Aspirin or aspirin-containing products (e.g. bismuth subsalicylate – Pepto Bismol) should not be administered to any confirmed or suspected ill case of swine influenza A (H1N1) virus infection aged 18 years old and younger due to the risk of Reye syndrome. For relief of fever, other anti-pyretic medications are recommended such as acetaminophen or non steroidal anti-inflammatory drugs.

      阿司匹林或含有阿司匹林的产品(例如碱式水杨酸铋 - Pepto Bismol)不能给18岁或18岁以下的感染AH1N1)型猪流感病毒的确诊或可疑病患使用,它们可能引发瑞氏综合症。为了缓解发热症状可以使用其它退热药物,推荐对乙酰氨基酚或非甾体类抗炎药物。

Antiviral Resistance

病毒抗药性

This swine influenza A (H1N1) virus is sensitive (susceptible) to the neuraminidase inhibitor antiviral medications zanamivir and oseltamivir.  It is resistant to the adamantane antiviral medications, amantadine and rimantadine. 

      AH1N1)型猪流感病毒对神经胺酸酶抑制剂类(扎那米韦zanamivir和奥司他韦oseltamivir)抗病毒药物敏感,对金刚烷类(金刚烷胺amantadine 金刚乙胺rimantadine)抗病毒药物具有抗药性。

Antiviral Treatment Confirmed, Probable and Suspected Cases

抗病毒治疗(针对确诊,疑似和可疑病例)

Recommendations for use of antivirals may change as data on antiviral susceptibilities become available.

      当对抗病毒药物敏感性测试的数据完成后,推荐使用的药物可能会变化。

Empiric antiviral treatment should be considered for confirmed, probable or suspected cases of swine influenza A (H1N1) virus infection. Treatment of hospitalized patients and patients at higher risk for influenza complications should be prioritized.  Antiviral treatment with zanamivir or oseltamivir should be initiated as soon as possible after the onset of symptoms. Evidence for benefits from treatment in studies of seasonal influenza is strongest when treatment is started within 48 hours of illness onset. However, some studies of treatment of seasonal influenza have indicated benefit, including reductions in mortality or duration of hospitalization even for patients whose treatment was started more than 48 hours after illness onset. Recommended duration of treatment is five days. Recommendations for use of antivirals may change as data on antiviral susceptibilities and effectiveness become available.  Antiviral doses recommended for treatment of swine influenza A (H1N1) virus infection in adults or children 1 year of age or older are the same as those recommended for seasonal influenza (Table 1). Oseltamivir use for children < 1 year old was recently approved by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA), and dosing for these children is age-based (Table 2).

对感染AH1N1)型猪流感病毒的确诊、疑似和可疑病例可以考虑使用经验性抗病毒药物。对到医院就医和高危发生流感并发症的患者应优先医治。在病状发作后应尽早采用扎那米韦或奥司他韦进行抗病毒药物治疗。在季节性流感的研究中证明:在疾病发作后48小时内进行治疗效果最佳。然而,对季节性流感的一些研究发现,即使在病人的疾病发作48小时后开始治疗也有明显的好处,包括减小死亡率或缩短入院治疗时间。推荐的治疗时间是五天。在对抗病毒药物敏感性和有效性的测试数据完成后,推荐使用的药物可能变化。对于感染AH1N1)型猪流感病毒的成年人、1岁或更大的儿童的抗病毒药物用量建议参见表1,这与季节性流感相同。最近美国食品药品管理局(FDA)批准基于紧急使用授权(EUA)可以对小于1岁的儿童使用抗病毒药物奥司他韦,具体用量参见表2

 

Antiviral Chemoprophylaxis

抗病毒药物预防

For antiviral chemoprophylaxis of swine influenza A (H1N1) virus infection, either oseltamivir or zanamivir are recommended (Table 1). Duration of antiviral chemoprophylaxis post-exposure is 10 days after the last known exposure to an ill confirmed case of swine influenza A (H1N1) virus infection. For pre-exposure protection, chemoprophylaxis should be given during the potential exposure period and continued for 10 days after the last known exposure to an ill confirmed case of swine influenza A (H1N1) virus infection. Oseltamivir can also be used for chemoprophylaxis under the EUA (Table 3).

      针对AH1N1)型猪流感病毒的抗病毒药物预防,推荐使用扎那米韦或奥司他韦,用量参见表1。暴露后抗病毒药物预防的持续时间为10天,在最后已知暴露在一例确诊感染AH1N1)型猪流感病毒的病人之后。奥司他韦也可以基于FDA紧急使用授权下用于药物预防,参见表3

Antiviral chemoprophylaxis (pre-exposure or post-exposure) with either oseltamivir or zanamivir is recommended for the following individuals:

对下列人群,抗病毒药物预防(暴露前或暴露后)推荐使用奥司他韦或扎那米韦:

1.Household close contacts who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women) of a confirmed, probable or suspected case.

1、与具有高危流感并发症的确诊、疑似或可疑患者有家庭紧密接触的人(例如:有特定慢性疾病的人,65岁及以上老人,5岁以下儿童和孕妇)

2.School children who are at high-risk for complications of influenza (children with certain chronic medical conditions) who had close contact (face-to-face) with a confirmed, probable, or suspected case.

2、与确诊、疑似或可疑患者有紧密接触(面对面)的学校儿童,流感并发症的高危人群(有特定慢性疾病的儿童)

3.Travelers to Mexico who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women).

3、到墨西哥的旅游者,流感并发症的高危人群(例如:有特定慢性疾病的人,65岁及以上老人,5岁以下儿童和孕妇)

4.Health care workers or public health workers who were not using appropriate personal protective equipment during close contact with an ill confirmed, probable, or suspect case of swine influenza A (H1N1) virus infection during the case’s infectious period.

4、与处于传染期的确诊、疑似或可疑的感染AH1N1)型猪流感病毒患者紧密接触,并且未能正确采取个人保护装备的医疗机构工作人员或者公共医疗工作人员。

Pre-exposure antiviral chemoprophylaxis with either oseltamivir or zanamivir can be considered for the following:

对下列人群,暴露前抗病毒药物预防推荐使用奥司他韦或扎那米韦:

1.Any health care worker who is at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women) who is working in an area of the healthcare facility that contains patients with confirmed swine influenza A (H1N1) cases, or who is caring for patients with any acute febrile respiratory illness.

1、流感并发症的高危医疗工作者(例如:有特定慢性疾病的人,65岁及以上老人,5岁以下儿童和孕妇),其工作的医疗机构中有确诊的感染AH1N1)型猪流感病毒患者,或者照顾急性发烧呼吸道疾病病人的医疗工作者

2.Non-high risk persons who are travelers to Mexico, first responders, or border workers who are working in areas with confirmed cases of swine influenza A (H1N1) virus infection.

2、到墨西哥旅行的非高危人群,工作地有确诊的感染AH1N1)型猪流感病毒患者的第一报道人或边界工作者。

 

 

Table 1. Swine influenza antiviral medication dosing recommendations.

1.  猪流感抗病毒药物治疗与预防的剂量参考

(Table extracted from IDSA guidelines for seasonal influenza .)

药物,人群

治疗

预防

奥司他韦(Oseltamivir)

成年人

每天两粒75mg胶囊,5

每天一粒75mg胶囊

儿童(年龄12月或更大)体重

15kg或更轻

每天60mg分两次服用

每天30mg

15-23kg

每天90mg分两次服用

每天30mg

24-30kg

每天120mg分两次服用

每天60mg

大于30kg

每天150mg分两次服用

每天75mg

扎那米韦(Zanamivir)

成年人

每次吸入2*5mg(共10mg),每天两次

每次吸入2*5mg(共10mg),每天一次

儿童

每次吸入2*5mg(共10mg),每天两次(7岁及以上)

每次吸入2*5mg(共10mg),每天一次(5岁及以上)

 

 

Children Under 1 Year of Age

1岁以下儿童

Children under one year of age are at high risk for complications from seasonal human influenza virus infections. The characteristics of human infections with swine H1N1 viruses are still being studied, and it is not known whether infants are at higher risk for complications associated with swine H1N1 infection compared to older children and adults.  Limited safety data on the use of oseltamivir (or zanamivir) are available from children less than one year of age, and oseltamivir is not licensed for use in children less than 1 year of age.  Available data come from use of oseltamivir for treatment of seasonal influenza. These data suggest that severe adverse events are rare, and the Infectious Diseases Society of America recently noted, with regard to use of oseltamivir in children young than 1 year old with seasonal influenza, that "…limited retrospective data on the safety and efficacy of oseltamivir in this young age group have not demonstrated age-specific drug-attributable toxicities to date." (See IDSA guidelines for seasonal influenza .)

1岁以下儿童是季节性人类流感并发症高危人群。人类感染H1N1猪流感病毒的特征仍在研究中,目前还不知道婴儿相对于年纪大的儿童和成年人来说,是否是与H1N1猪流感病毒相关并发症的更高位人群。对婴儿使用奥司他韦或扎那米韦的安全数据相对于1岁的儿童更少,而且奥司他韦不允许用于1岁以下儿童。现有数据来自使用奥司他韦治疗季节性流感,这些数据建议严重的副作用很少,最近美国传染病协会表示,对1岁以下儿童采用奥司他韦治疗季节性流感对于年幼的人群,有限的安全有效地使用奥司他韦的回顾数据表明,目前没有证明有与年龄相关的药物毒性

Because infants typically have high rates of morbidity and mortality from influenza, infants with swine influenza A (H1N1) influenza infections may benefit from treatment using oseltamivir.

因为婴儿对流感有很高的发病率和死亡率,所有对感染AH1N1)型猪流感病毒的婴儿使用奥司他韦可能会有疗效。

Healthcare providers should be aware of the lack of data on safety and dosing when considering oseltamivir use in a seriously ill young infant with confirmed swine H1N1 influenza or who has been exposed to a confirmed swine H1N1 case, and carefully monitor infants for adverse events when oseltamivir is used.

医护人员应该知道:由于安全数据和剂量的缺乏,当考虑使用奥司他韦治疗确诊感染AH1N1)型猪流感病毒的危重婴儿时,用药后要谨慎监测其对婴儿的副作用。

 

Table 2. Dosing recommendations for antiviral treatment of children younger than 1 year using oseltamivir.

Age

Recommended treatment dose for 5 days

<3 months

12 mg twice daily

3-5 months

20 mg twice daily

6-11 months

25 mg twice daily

 

2.  1岁以下儿童采用奥司他韦进行抗病毒药物治疗的剂量参考

年龄

5天推荐治疗剂量

小于3个月

12mg,每天两次

3-5个月

20mg,每天两次

6-11个月

25mg,每天两次

 

 

Table 3. Dosing recommendations for antiviral chemoprophylaxis of children younger than 1 year using oseltamivir.

Age

Recommended prophylaxis dose for 10 days

<3 months

Not recommended unless situation judged

critical due to limited data on use in this age group

3-5 months

20 mg once daily

6-11 months

25 mg once daily

 

 

3.  1岁以下儿童采用奥司他韦进行抗病毒药物预防的剂量参考

年龄

10天推荐预防剂量

小于3个月

不推荐

3-5个月

20mg,每天一次

6-11个月

25mg,每天一次

 

Pregnant Women

孕妇

Oseltamivir and zanamivir are "Pregnancy Category C" medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. Because of the unknown effects of influenza antiviral drugs on pregnant women and their fetuses, oseltamivir or zanamivir should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus; the manufacturers' package inserts should be consulted. However, no adverse effects have been reported among women who received oseltamivir or zanamivir during pregnancy or among infants born to women who have received oseltamivir or zanamivir, Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. Because zanamivir is an inhaled medication and has less systemic absorption, some experts prefer zanamivir over oseltamivir for use in pregnant women when feasible.

奥司他韦和扎那米韦对孕妇来说是C类药物,这说明还没有临床研究来评估这些药物对孕妇的安全性。因为这类抗流感病毒药物对孕妇和胎儿的效果未知,所以孕期中只有当药物对胎儿和孕妇潜在的好处大于潜在的危险时才能使用;需要参考药物制造商的说明。然而,在服用奥司他韦或扎那米韦的孕妇中没有报道说这些药物对孕妇或胎儿有副作用,所有怀孕不应成为使用奥司他韦或扎那米韦的禁忌。因为扎那米韦是吸入的药物,身体系统吸收的较少,所有如果对孕妇药用可行的话一些专家更倾向于扎那米韦。

Adverse events and contraindications

副作用和禁忌

For further information about influenza antiviral medications, including contraindications and adverse effects, please see the following:

关于抗流感病毒药物的更多信息,包括禁忌和副作用,请参考:

·Antiviral Agents for Seasonal Influenza: Side Effects and Adverse Reactions

l   Antiviral Agents for Seasonal Influenza: Side Effects and Adverse Reactions

·MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008

l   MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008

MMWR August 8, 2008 / 57(RR07);1-60

MMWR August 8, 2008 / 57(RR07);1-60

Adverse events from influenza antiviral medications should be reported through the U.S. FDA Medwatch website .

抗病毒药物的副作用参见美国FDA的报告。

 

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