Halperin S A, McGrath P, Smith B, Houston T
Departments of Pediatrics and Microbiology and Immunology, Psychology, and Mathematics and Statistics, Dalhousie University and the IWK Grace Health Centre, Halifax, Nova Scotia.
J Pediatr. 2000 Jun;136(6):789-94.
Topical lidocaine 2.5% and prilocaine 2.5% (EMLA) is effective in decreasing the pain associated with minor procedures including immunization, although the effect on the antibody response to vaccine constituents has not been assessed.
To measure the antibody response to measles-mumps-rubella (MMR) vaccine, as well as pain reduction associated with the use of the EMLA patch.
One hundred sixty healthy infants at least 12 months old undergoing their first MM immunization in an ambulatory setting.
Randomized, double-blind, controlled trial of EMLA patch (5%-1 g) or placebo before MMR immunization. Blood sampling before and 28 to 35 days after immunization.
The primary outcome measure was the antibody response to measles by plaque reduction neutralization and to mumps and rubella by enzyme immunoassay. The secondary outcomes were pain scores by the Modified Behavioral Pain Scale and drug- and vaccine-associated adverse events.
There was no difference in the antibody response between the EMLA- and placebo-treated groups. The response rates in the EMLA group were 89.7%, 88.3%, and 92.3% to measles, mumps, and rubella, respectively, compared with rates of 91.1%, 94.9%, and 93.7% in the placebo group (P >.05 for all comparisons). EMLA recipients had less pain after immunization (mean Modified Behavioral Pain Scale score increase 3.1 compared with 3.8; P =.043) and less irritability (16% compared with 31%; P =.040) than did placebo recipients.
The EMLA patch has no adverse effect on the antibody response to MMR vaccine and significantly reduces the pain associated with the subcutaneous administration of the vaccine.
2.5%的利多卡因和2.5%的丙胺卡因复方制剂(EMLA)在减轻包括免疫接种在内的小手术相关疼痛方面有效,不过其对疫苗成分抗体反应的影响尚未得到评估。
测定对麻疹-腮腺炎-风疹(MMR)疫苗的抗体反应,以及使用EMLA贴剂相关的疼痛减轻情况。
160名至少12月龄的健康婴儿,在门诊接受首次MMR免疫接种。
在MMR免疫接种前,对EMLA贴剂(5%-1g)或安慰剂进行随机、双盲、对照试验。免疫接种前及接种后28至35天采集血样。
主要观察指标是通过蚀斑减少中和试验测定对麻疹的抗体反应,以及通过酶免疫测定法测定对腮腺炎和风疹的抗体反应。次要观察指标是改良行为疼痛量表的疼痛评分以及与药物和疫苗相关的不良事件。
EMLA治疗组和安慰剂治疗组之间的抗体反应没有差异。EMLA组对麻疹、腮腺炎和风疹的反应率分别为89.7%、88.3%和92.3%,而安慰剂组的反应率分别为91.1%、94.9%和93.7%(所有比较P>.05)。与安慰剂组相比,接受EMLA治疗的受试者免疫接种后疼痛较轻(改良行为疼痛量表平均评分增加3.1,而安慰剂组为3.8;P=.043),且烦躁程度较低(分别为16%和31%;P=.040)。
EMLA贴剂对MMR疫苗的抗体反应无不良影响,并显著减轻了与皮下接种疫苗相关的疼痛。