作者：Laurie Barclay, MD 齣處：WebMD醫學新聞 　　February 6, 2009 —美國預防接種谘詢委員會(ACIP)發錶嬰幼兒輪狀病毒腸胃炎的預防指引 以及輪狀病毒疫苗的 ACIP提齣輪狀病毒腸胃炎的預防指引 - 趣味新聞網

發表日期 2009-02-20T08:21:56+08:00

     本帖最後由 goodcat1111 於 2009-2-27 10:37 編輯

作者：Laurie Barclay, MD
齣處：WebMD醫學新聞

February 6, 2009 —美國預防接種谘詢委員會(ACIP)發錶嬰幼兒輪狀病毒腸胃炎的預防指引，以及輪狀病毒疫苗的最大適用年紀、禁忌癥、注意事項與使用的特殊狀況；發錶於2月6日每週死亡率與發病率報告的這些更新版建議，取代瞭2006 年ACIP之輪狀病毒腸胃炎預防聲明。

國傢免疫與呼吸道疾病中心、病毒感染癥小組的Margaret M. Cortese醫師與Umesh D. Parashar醫師寫道，輪狀病毒是全球嬰幼兒嚴重腸胃炎最常見的原因；輪狀病毒每年幾乎造成50萬名5歲以下小孩死亡，佔開發中國傢80%以上的死亡；在2006年展開輪狀病毒疫苗計畫之前，美國幾乎每個小孩在5歲前都感染過輪狀病毒；多數有腸胃炎，導緻1990年代與2000年代初期每年有將近410,000次的就診、205,000至272,000 次的急診、55,000至70,000次的住院，每年整體的直接與間接花費將近10億美元。

在他們的聲明中，ACIP提齣美國嬰兒使用RV5 和RV1這兩種輪狀病毒疫苗的建議；在2006年二月，美國食品藥物管理局(FDA)核準 RotaTeq (RV5；Merck藥廠製造)這種活性口服人-牛重組輪狀病毒疫苗；為瞭預防輪狀病毒腸胃炎，ACIP建議每個美國嬰兒均使用三劑的RV5。

2008年四月，FDA核準Rotarix (RV1；GlaxoSmithKline Biologicals公司製造)這種活性口服人類減毒輪狀病毒疫苗；RV1在2008年四月獲得美國核準用於嬰兒的兩劑，之後ACIP於2008年六月更新瞭有關輪狀病毒疫苗的建議，納入RV1的使用。

改版的ACIP聲明仍然建議美國小孩常規使用輪狀病毒疫苗，指齣RV5和RV1的成分和給藥時間錶不一樣；不過，ACIP未指齣優先選用RV5或RV1。

RV5和RV1都是口服給藥，RV5建議給予三劑、分彆在二、四、六個月大時；而RV1則是在二和四個月大時，共給予兩劑。

以下是2006 ACIP聲明的重要改變：
* 可以使用第二種輪狀病毒疫苗、RV1；此藥給予兩劑，在二和四個月大時。
* 使用第一劑輪狀病毒疫苗的最大年紀是14週又6天，比原本建議的12週延長。
* 使用最後一劑輪狀病毒疫苗的最大年紀是8個月0天，原本的建議是32週。
* 兩劑輪狀病毒疫苗之間，最少間隔四週，未設定最長間隔，原本建議兩劑之間的最長間隔為410週。
* 更新版指引支持曝露於HIV或感染HIV的嬰兒使用輪狀病毒疫苗。
* 2006年的聲明建議延遲接種疫苗，如果可能的話，須在接受含抗體的製劑之後42天。目前的聲明準許在使用任何血液製劑、包括含有抗體的
産品前、中、後的任何時間，同時給予輪狀病毒疫苗，遵照輪狀病毒疫苗的常規建議時間錶。

美國嬰兒常規使用輪狀病毒疫苗的特殊建議、以及這些建議的相關證據等級如下：
* 在二、四、六個月大時使用RV5，或者在二、四個月大時使用RV1 (證據等級1A)。
* 疫苗可用於哺餵母乳的嬰兒(證據等級1A)。
* 可以和DTap、Hib疫苗、不活化小兒麻痺疫苗、B型肝炎疫苗與肺炎鏈球菌結閤型疫苗同時使用(證據等級1A)。
* 可以用於輕微腸胃炎或者其他輕癥的嬰兒(證據等級1B)。
* 曾經對疫苗成分或者之前的疫苗發生嚴重過敏的嬰兒，使用上屬禁忌(證據等級 3B)。
* 使用疫苗的注意事項包括免疫能力改變；中到重癥，包括腸胃炎；慢性胃腸道疾病；腸套疊病史；脊柱裂或神經性膀胱的嬰兒(全都證據等級3C)。
* 報告中討論的特殊狀況包括早産兒(小於37週；證據等級1B)、與免疫功能不足者或孕婦同住的嬰兒、疫苗反胃、使用疫苗後住院、接受含抗體血液製劑的嬰兒(全都證據等級3C)。

聲明作者結論錶示，需要其他有價值的研究來評估早産嬰兒、免疫不佳、與免疫功能不足者同住、慢性胃腸道疾病、開始使用疫苗的時機延後等情況下，使用輪狀病毒疫苗的安全性和有效性。上市後的研究也可確認輪狀病毒疫苗在未給予足夠建議劑量時的相對有效性，與評估可能的次發疫苗病毒傳播。

ACIP Issues Guidelines for Prevention of Rotavirus Gastroenteritis

By Laurie Barclay, MD
Medscape Medical News

February 6, 2009 — The Advisory Committee on Immunization Practices (ACIP) has issued guidelines for the prevention of rotavirus gastroenteritis among infants and children, as well as maximum ages for doses, contraindications, precautions, and special situations regarding the administration of rotavirus vaccine. The new recommendations, which update and replace the 2006 ACIP statement for prevention of rotavirus gastroenteritis, are published in the February 6 issue of Morbidity and Mortality Weekly Report.

"Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide," write Margaret M. Cortese, MD, and Umesh D. Parashar, MBBS, MPH, from the Division of Viral Diseases, National Center for Immunization and Respiratory Diseases. "Rotavirus causes approximately half a million deaths each year among children aged <5 years, with >80% of deaths occurring in developing countries.... Before initiation of the rotavirus vaccination program in 2006, nearly every child in the United States was infected with rotavirus by age 5 years; the majority had gastroenteritis, resulting annually during the 1990s and early 2000s in approximately 410,000 physician visits, 205,000–272,000 emergency department...visits, 55,000–70,000 hospitalizations, and total annual direct and indirect costs of approximately $1 billion."

In their statement, the ACIP describes recommendations for use of 2 rotavirus vaccines in US infants, RV5 and RV1. In February 2006, the US Food and Drug Administration (FDA) licensed RotaTeq (RV5; Merck and Company), a live, oral, human-bovine reassortant rotavirus vaccine. For prevention of rotavirus gastroenteritis, ACIP recommends routine use among US infants of a 3-dose series of RV5.

In April 2008, the FDA licensed Rotarix (RV1; GlaxoSmithKline Biologicals), a live, oral, human attenuated rotavirus vaccine. After RV1 was licensed as a 2-dose series for use among US infants in April 2008, ACIP updated its rotavirus vaccine recommendations in June 2008 to include use of RV1.

The revised ACIP recommendations are for routine vaccination of US infants with rotavirus vaccine, noting that the composition and administration schedule are different for RV5 and RV1. However, ACIP does not express a preference for either RV5 or RV1.

Both RV5 and RV1 are administered orally. The administration schedule for RV5 is a 3-dose series, with doses given at ages 2, 4, and 6 months. The 2-dose series for RV1 calls for doses to be administered at ages 2 and 4 months.

Specific changes to recommendations from the 2006 ACIP statement are as follows:

Use of a second rotavirus vaccine, RV1, is acceptable. This is administered in a 2-dose series at ages 2 and 4 months.
The maximum age for dose 1 of rotavirus vaccine is now 14 weeks and 6 days, increased from the previous recommendation of 12 weeks.
The maximum age for the last dose of rotavirus vaccine is now to 8 months and 0 days, whereas the previous recommendation was 32 weeks.
Between doses of rotavirus vaccine, the minimum interval is now 4 weeks, and no maximum interval is set, whereas the previous recommendation was for a maximum interval of 410 weeks between doses.
The updated guidelines describe considerations that support rotavirus vaccination of HIV-exposed or HIV-infected infants.
Although the 2006 statement recommended deferring vaccination, if possible, for 42 days after receiving an antibody-containing product, the current statement allows for the administration of rotavirus vaccine at any time before, concurrent with, or after administration of any blood product, including antibody-containing products, following the routinely recommended schedule for rotavirus vaccine.
Specific recommendations for the routine use of rotavirus vaccine for US infants, and their accompanying level and strength-of-evidence rating, are as follows:

Routinely vaccinate with RV5 at ages 2, 4, and 6 months or with RV1 at ages 2 and 4 months (level of evidence, 1A).
Vaccine can be administered to breast-fed infants (level of evidence, 1A).
Vaccine can be coadministered with DTap, Hib vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, and pneumococcal conjugate vaccine (level of evidence, 1A).
Vaccine can be administered to infants with mild gastroenteritis or other mild illness (level of evidence, 1B).
Either vaccine is contraindicated for infants who have had a severe allergic reaction to a vaccine component or previous vaccine dose (level of evidence, 3B).
Precautions for use of the vaccine include altered immunocompetence; moderate to severe illness, including gastroenteritis; chronic gastrointestinal disease; history of intussusceptions; and infants with spina bifida or bladder extrophy (all level of evidence, 3C).
Special situations discussed in the report include preterm infants (younger than 37 weeks; level of evidence, 1B), infants living in households with immunocompromised persons or with pregnant women, regurgitation of vaccine, infants hospitalized after vaccination, and infants who have received antibody-containing blood products (all level of evidence, 3C).
"Additional studies would be valuable to evaluate the safety and efficacy of rotavirus vaccine administered to infants who are born preterm, have immune deficiencies, live in households with immunocompromised persons, have chronic gastrointestinal disease, or start the series late," the statement authors conclude. "Postlicensure studies also could determine the relative effectiveness of rotavirus vaccine when less than the full series is administered and evaluate possible secondary transmission of vaccine virus."

Morb Mortal Wkly Rep. 2009;58(RR02):1–25.

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