【摘要】 目的 评价儿童8月龄和18月龄接种麻腮风联合减毒活疫苗(Measles, mumps and rubella combined attenuated live vaccine, MMR)的免疫原性和不良反应。方法 采用前瞻、随机、对照设计，在山东省招募8月龄儿童并随机分为MMR+MMR组(8月龄和18月龄各接种1剂MMR)和麻疹风疹联合减毒活疫苗(Measles and rubella combined attenuated live vaccine, MR)+MMR组(8月龄和18月龄分别接种MR和MMR)开展观察。采用酶联免疫吸附试验检测儿童8月龄和/或18月龄接种前后血清麻疹、风疹和腮腺炎IgG抗体，计算两组抗体阳性率和几何平均浓度(Geometric mean concentration, GMC);分析8月龄接种MMR和MR后6周内不良反应发生率。结果 MMR+MMR组纳入观察对象396例，8月龄MMR接种前vs接种后麻疹、风疹、腮腺炎抗体阳性率分别为0.51%vs 99.40%、1.52%vs 92.47%、0.76%vs 88.86%,GMC分别为9.25 vs 1 627.05 mIU/mL、3.09 vs 57.98 IU/mL、3.64 vs 276.06 IU/mL;18月龄MMR接种前vs接种后相应抗体阳性率分别99.32%vs 99.65%、94.22%vs 99.65%、64.63%vs 96.19%,GMC分别为2 021.16 vs 2 466.61 mIU/mL、81.32 vs 115.80 IU/mL、150.42 vs 1 031.34 IU/mL。MR+MMR组纳入观察对象330例，18月龄MMR接种前vs接种后麻疹、风疹、腮腺炎抗体阳性率分别为93.64%vs 100%、93.03%vs 99.35%、7.27%vs 94.19%,GMC分别为1 120.99 vs 1 900.20 mIU/mL、97.45 vs 119.10 IU/mL、10.60 vs 339.00 IU/mL。8月龄接种MMR、MR后不良反应(均为一般反应)发生率分别为7.32%(29/396)、2.73%(9/330)(χ~2=7.67,P=0.006),其中发热发生率分别为5.30%(21例)、2.42%(8例),出疹发生率分别为1.01%(4例)、0.00%(0例)。结论 儿童8月龄和18月龄接种MMR具有良好的免疫原性，与分别接种MR和MMR相比显著提高了腮腺炎抗体水平；不良反应均为轻微的一般反应。更多还原

【Abstract】 Objective To evaluate the immunogenicity and adverse reaction profiles of measles, mumps and rubella combined attenuated live vaccine(MMR) administered to children at 8 months and 18 months of age.Methods We recruited children 8 months of age in Shandong province and randomized them into an MMR+MMR group(MMR given at 8 and 18 months of age) and an measles and rubella combined attenuated live vaccine(MR)+MMR group(MR at 8 months and MMR at 18 months) for a prospective, randomized, controlled study. We tested sera for IgG antibodies against measles, mumps, and rubella before and after vaccination at 8 months and 18 months of age using enzyme-linked immunosorbent assays to determine positivity rates and geometric mean concentrations(GMC) of antibodies in the two groups. We compared incidences of adverse reactions within 6 weeks after MMR and MR vaccination at 8 months of age.Results Among 396 children included in the MMR+MMR group, positivity rates of measles, mumps, and rubella antibodies before vs after vaccination at 8 months of age were 0.51% vs 99.40%, 1.52% vs 92.47%, and 0.76% vs 88.86%, with GMCs of 9.25 vs 1 627.05 mIU/mL, 3.09 vs 57.98 IU/mL, and 3.64 vs 276.06 IU/mL, respectively; corresponding positivity rates before vs after vaccination at 18 months of age were 99.32% vs 99.65%, 94.22% vs 99.65%, 64.63% vs 96.19%, with GMCs of 2 021.16 vs 2 466.61 mIU/mL, 81.32 vs 115.80 IU/mL, and 150.42 vs 1 031.34 IU/mL. Among 330 children in the MR+MMR group, positivity rates of measles, mumps, and rubella antibodies before vs after vaccination at 18 months of age were 93.64% vs 100%, 93.03% vs 99.35%, 7.27% vs 94.19%, with GMCs of 1 120.99 vs 1 900.20 mIU/mL, 97.45 vs 119.10 IU/mL, and 10.60 vs 339.00 IU/mL. Incidences of adverse reactions(all mild, common reactions) after MMR and MR at 8 months of age were 7.32%(29/396) and 2.73%(9/330)(χ~2=7.67, P=0.006), with incidences of 5.30%(21 cases) and 2.42%(8 cases) for fever, and 1.01%(4 cases) and 0.00%(0 cases) for rash.Conclusions MMR vaccination at 8 months and 18 months of age had good immunogenicity and significantly increased mumps antibody levels compared with an MR followed by MMR regimen. All adverse reactions were mild, common reactions.更多还原