Faculty of Nursing, Federal University of Goias, Brazil.
Int J Nurs Stud. 2010 Sep;47(9):1074-9. doi: 10.1016/j.ijnurstu.2010.01.009. Epub 2010 Feb 26.
Lowered immune response to hepatitis B vaccines has been found in individuals vaccinated into dorsogluteal site compared to vastus lateralis thigh muscle.
The aim of this study was to compare the immunogenicity and reactogenicity of a hepatitis B vaccine in infants vaccinated into ventrogluteal or anterolateral thigh sites.
Randomised controlled trial.
The recruitment of study participants was carried out from February to November 2007 in the five maternity hospitals located in the eastern region of Goiânia City, Central Brazil. Newborns up to 12h old weighing at least 2.5 kg were enrolled in the study.
A total of 580 newborns were randomised to receive three hepatitis B vaccine doses into ventrogluteal (n=286) or anterolateral thigh (n=294) sites. Of them, 474 (81.7%) completed the study: 224 from the ventrogluteal group (intervention group) and 250 from the anterolateral thigh group (control group). Fever and local adverse events were evaluated 48 h after each vaccine dose. Blood samples (3 mL) were collected between 45 and 60 days after the third vaccine dose, and anti-HBs antibody titres were determined by automatic analysis using the Microparticle Immunoenzymatic Test (AxSYM Ausab, Abbott, Germany).
The groups did not differ by gender, weight, length of time between vaccine doses, or maternal characteristics. The proportion of infants who developed protective anti-HB titres after full vaccination into the ventrogluteal site was 97.8% (95% confidence interval [CI]: 94.8-99.3; geometric mean titre: 427.5 mIU/mL; 95% CI: 344.9-530.0), similar to that of infants vaccinated into the anterolateral thigh site (97.6%; 95% CI: 94.8-99.1; geometric mean titre: 572.0 mIU/mL; 95% CI: 471.1-694.6). No complication was found after 1503 vaccine doses, but a lower proportion of fever and local adverse events was found among the intervention group (17.9%) vs. the control group (23.7%) (p<0.01).
Our results suggest that the ventrogluteal region is a suitable site for intramuscular injection in infants, particularly for the hepatitis B vaccine.
与大腿外侧股四头肌相比，乙型肝炎疫苗在臀部注射部位接种的个体中，免疫反应较低。
本研究的目的是比较乙型肝炎疫苗在婴儿接种于臀肌和股前外侧肌的免疫原性和反应原性。
随机对照试验。
本研究参与者的招募工作于 2007 年 2 月至 11 月在巴西中部戈亚尼亚市东部的五家产科医院进行。将 12 小时内体重至少 2.5 公斤的新生儿纳入研究。
共有 580 名新生儿被随机分为三组，每组 286 名新生儿接受三次乙型肝炎疫苗臀部注射，294 名新生儿接受三次乙型肝炎疫苗股前外侧肌注射。其中，474 名（81.7%）完成了研究：224 名来自臀肌组（干预组），250 名来自股前外侧肌组（对照组）。每次疫苗接种后 48 小时评估发热和局部不良事件。在第三次疫苗接种后 45 至 60 天采集 3 毫升血液样本，并使用自动分析微粒子酶免疫测定法（AxSYM Ausab，雅培，德国）测定抗-HBs 抗体滴度。
两组在性别、体重、疫苗接种间隔时间或产妇特征方面无差异。完全接种乙型肝炎疫苗后，臀肌组产生保护性抗-HB 滴度的婴儿比例为 97.8%（95%置信区间[CI]：94.8-99.3；几何平均滴度：427.5 mIU/ml；95%CI：344.9-530.0），与股前外侧肌组相似（97.6%；95%CI：94.8-99.1；几何平均滴度：572.0 mIU/ml；95%CI：471.1-694.6）。在 1503 次疫苗接种后未发现任何并发症，但干预组发热和局部不良反应的比例较低（17.9%）与对照组（23.7%）（p<0.01）。
我们的结果表明，臀肌是婴儿肌肉内注射的合适部位，特别是乙型肝炎疫苗。
