輪狀病毒疫苗對幼兒預防輪狀病毒感染的成效?The effectiveness of rotavirus vaccine in preventing rotavirus infection?

1007 1

2019-09-01 已刊登
新刊登 綜 整 預防/治療/介入類型

作  者

李芷儀* 胡晏玨 酒小蕙

實證知識類別

A 類:實證健康照護綜整

PICO

治療/預防性問題

治療/介入措施

兒科醫學 Pediatrics

科別

  • 嬰幼兒及兒童照護 Infant and Child Care
  • 臨床指引/實證照護成效 Clinical Guidelines/Evidence Based Outcomes

中文關鍵詞

幼兒 輪狀病毒 預防

英文關鍵詞

child rotavirus vaccines prevent

機構名稱

臺北榮民總醫院

申請單位

護理部

中文摘要

形成臨床提問:
輪狀病毒在顯微鏡下外觀如輪子而得名,又因「高感染率」、「高就醫率」、「高住院率」而稱三高病毒,輪狀病毒是引起幼兒嚴重腹瀉及脫水的主要原因,以6個月至2歲幼兒最易感染,2歲內孩童95%都曾感染,年齡越小感染,病情會越嚴重。輪狀病毒感染是一項高罹病率的疾病,但我國並未列入常規疫苗項目,須自費購買,臨床上孩童家長關注是否自費使用輪狀病毒疫苗,疫苗的效果如何?安全性如何?有哪些副作用?因此本文旨在統整實證文獻探討輪狀病毒疫苗對幼兒預防輪狀病毒感染的成效為何。故病人(P)為為0-6歲幼兒及兒童、介入措施(I)為輪狀病毒疫苗、比較措施(C)為安慰劑或無介入措施,結果(O) 為腹瀉、腸炎、腸套疊、死亡率、不良事件反應,研究設計(S)為系統性文獻回顧、整合分析、隨機對照試驗。期望實證的結果,可作為臨床醫療人員衛教的依據,及家長選擇的參考。
文獻搜尋的方法與分析:
本研究以實證方式,PICO使用關鍵字Infant, children、Newborn、child、rotavirus vaccines、Rotavirus、Rotavirus Infections、diarrhoea、gastroenteritis、intussusception、death、adverse event,將關鍵字以照布林邏輯AND及OR的方式做聯集及交集,搜尋Cochrane、PubMed、以及CINAHL等資料庫,搜尋時間為2019年8月,納入條件為年齡為5歲內,及中英文文獻,共搜尋867篇,依標題刪除重覆之文章422篇,再由標題及摘要篩選,排除不符合納入條件之文章共443篇,其中有55篇RCT研究歸入其中一篇SR研究,203篇族群無限定為幼兒、115篇介入措施非輪狀病毒疫苗,另70篇研究內容完全與此主題無關。再由內文篩選,排除不符合文章共1篇,因介入措施不只有輪狀病毒疫苗,故最後納入1篇為Soares-Weiser, K.等人於2019所發表的 Vaccines for preventing rotavirus diarrhoea: vaccines in use系統文獻回顧性文章。
文獻的品質評讀:
本文採用Systematic Review Appraisal Sheet (University of Oxford, 2010)進行嚴格評讀一篇2019年的系統性分析文獻。評析等級為Level I。 此篇文章將55篇RCT試驗性研究文章納入分析,共216,480位參與者。其中36篇(119,114位參與者)評估Rotarix(RV1); 15篇(88,934位參與者)評估Rotateq(RV5);4篇(8,432位參與者)評估Rotavac。評估比較項目包括:腸套疊發生率、腹瀉發生機率、不良事件發生率、死亡率等。
結論與建議:
經由文獻統計發現羅特律輪狀病毒疫苗(Rotarix RV1)第1年預防效果達84%,第2年為82%,服用後副作用的發生情形腸套疊發生率為0.1%,發燒為32.2%,嘔吐為32.2%,1年後腹瀉發生率為0.2%,2年後為0.4%。輪達停輪狀病毒疫苗 (Rotateq RV5) 第1年預防效果達92%,第2年為82%,服用後副作用發生情形腸套疊發生率為0.04%,發燒為34.9%,嘔吐為34.9%,1年後腹瀉發生率為3.6%,2年後為2.5%。Rotavac:在高死亡率國家,如印度,預防輪狀病毒導致的嚴重腹瀉約50%。 (中度證據等級),在印度預防所有原因導致的嚴重腹瀉約18%。 (中度證據等級) ,在低死亡率國家尚未有此疫苗的隨機對照試驗研究。 研究結果顯示RV1、RV5製劑在服用後皆有80%以上預防效力。建議幼兒以口服疫苗對抗輪狀病毒,形成體內抗體阻擋輪狀病毒入侵。

英文摘要

Ask an answerable question (PICO):
Rotavirus have wheel shapes in microscope .As a high virus due to "high infection rate", "high rate of medical treatment" and "high hospitalization rate".Rotavirus is the main cause of severe diarrhea and dehydration from 6 months to 2 years age children. It’s the most susceptible to infection about 95% of children within2 years of age. Taiwan is not included in the routine vaccine program, must be purchased at their own expense. Parents ask “Does the vaccine safe?”“ What are the side effects?” Then,the group of patient is child, the intervention is rotavirus vaccines, the outcome is diarrhoea、gastroenteritis、intussusception、death、adverse event.Therefore, the empirical results can be used as the basis for the clinical medical staff, and parents choose the reference.
The Method and Analysis of Literature Review:
The keywords include Infant, children、Newborn、child、rotavirus vaccines、Rotavirus、Rotavirus Infections、diarrhoea、gastroenteritis、intussusception、death、adverse event. Boolean logical AND and OR, searching for databases such as Cochrane, PubMed, and Huayi (CEPS). The search time is August 2019, and the conditions are 5 years old. And Chinese and English literature, a total of 867 articles were searched, and 422 articles of repeated articles were deleted according to the title, and then the title and abstract were selected to exclude 443 articles that did not meet the inclusion criteria, of which 55 RCT studies were included in one of them. In the SR study, 203 ethnic groups were not limited to young children, 115 interventional non-rotavirus vaccines, and 70 studies were completely unrelated to this topic. Then, the text was screened and excluded from the article. Since the intervention is not only a rotavirus vaccine, the last one is the Vaccines for preventing rotavirus diarrhoea: vaccines published by Soares-Weiser, K. et al. in 2019. In use systematic literature retrospective article.
Critical Appraisal:
This article uses Systematic Review Appraisal Sheet (University of Oxford, 2010) to conduct a rigorous review of a systematic analysis of 2019. The rating is Level I. This article included 55 RCT experimental studies in a total of 216,480 participants. Of these, 36 (119,114 participants) evaluated RV1; 15 (88,934 participants) evaluated RV5; and 4 (8,432 participants) evaluated Rotavac. The evaluation comparison items included the incidence of intussusception, the incidence of diarrhea, the incidence of adverse events, and mortality.
Conclusions and Recommendations:
According to literature statistics, the preventive effect of Rotary Rotavirus vaccine (Rotarix RV1) was 84% in the first year and 82% in the second year. The incidence of side effects was 0.1% and the fever was 32.2%. Vomiting was 32.2%. The incidence of diarrhea was 0.2% after 1 year and 0.4% after 2 years. Rotateq RV5 has a preventive effect of 92% in the first year and 82% in the second year. After taking the side effects, the incidence of intussusception is 0.04%, fever is 34.9%, and vomiting is 34.9%. The incidence of diarrhea was 3.6% after 1 year and 2.5% after 2 years. Rotavac: In countries with high mortality rates, such as India, prevention of rotavirus-induced severe diarrhea is about 50%. (Moderate level of evidence), prevention of severe diarrhea caused by all causes in India is about 18%. (Moderate level of evidence), a randomized controlled trial of this vaccine has not been available in countries with low mortality. The results of the study showed that both RV1 and RV5 preparations had more than 80% prophylaxis after administration. It is recommended that infants use oral vaccines against rotavirus to form antibodies that block rotavirus invasion in vivo.