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疫苗安全数据链中麻疹、腮腺炎和风疹疫苗在青少年及成人中的安全性

Safety of measles, mumps, and rubella vaccine in adolescents and adults in the vaccine safety Datalink.

作者信息

Hanson Kayla E, Marin Mona, Daley Matthew F, Groom Holly C, Jackson Lisa A, Sy Lina S, Klein Nicola P, DeSilva Malini B, Panagiotakopoulos Lakshmi, Weintraub Eric, Belongia Edward A, McLean Huong Q

机构信息

Center for Clinical Epidemiology & Population Health, Marshfield Clinic Research Institute, 1000 N Oak Ave, ML2, Marshfield, WI 54449, United States.

Division of Viral Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, MS H24-5, Atlanta, GA 30333, United States.

出版信息

Vaccine X. 2023 Feb 4;13:100268. doi: 10.1016/j.jvacx.2023.100268. eCollection 2023 Apr.

Abstract

BACKGROUND

Measles, mumps, and rubella vaccine (MMR) is routinely administered to children; however, adolescents and adults may receive MMR for various reasons. Safety studies in adolescents and adults are limited. We report on safety of MMR in this age group in the Vaccine Safety Datalink.

METHODS

We included adolescents (aged 9-17 years) and adults (aged ≥ 18 years) who received ≥ 1 dose of MMR from January 1, 2010-December 31, 2018. Pre-specified outcomes were identified by diagnosis codes. Clinically serious outcomes included anaphylaxis, encephalitis/myelitis, Guillain-Barré syndrome, immune thrombocytopenia, meningitis, and seizure. Non-serious outcomes were allergic reaction, arthropathy, fever, injection site reaction, lymphadenopathy, non-specific reaction, parotitis, rash, and syncope. All serious outcomes underwent medical record review. Outcome-specific incidence was calculated in pre-defined post-vaccination windows. A self-controlled risk interval design was used to determine the relative risk of each outcome in a risk window after vaccination compared to a more distal control window.

RESULTS

During the study period, 276,327 MMR doses were administered to adolescents and adults. Mean age of vaccinees was 34.8 years; 65.8 % were female; 53.2 % of doses were administered simultaneously with ≥ 1 other vaccine. Serious outcomes were rare, with incidence ≤ 6 per 100,000 doses for each outcome assessed, and none had a significant elevation in incidence during the risk window compared to the control window. Incidence of non-serious outcomes per 100,000 doses ranged from 3.4 for parotitis to 263.0 for arthropathy. Other common outcomes included injection site reaction and rash (157.0 and 112.9 per 100,000 doses, respectively). Significantly more outcomes were observed during the risk window compared to the control window for all non-serious outcomes except parotitis. Some variability was observed by sex and age group.

CONCLUSION

Serious outcomes after MMR are rare in adolescents and adults, but vaccinees should be counseled regarding anticipated local and systemic non-serious adverse events.

摘要

背景

麻疹、腮腺炎和风疹疫苗(MMR)通常用于儿童接种;然而,青少年和成人可能因各种原因接种MMR。针对青少年和成人的安全性研究有限。我们报告疫苗安全数据链中该年龄组MMR的安全性情况。

方法

我们纳入了在2010年1月1日至2018年12月31日期间接种≥1剂MMR的青少年(9至17岁)和成人(≥18岁)。通过诊断编码确定预先设定的结局。临床严重结局包括过敏反应、脑炎/脊髓炎、吉兰-巴雷综合征、免疫性血小板减少症、脑膜炎和癫痫发作。非严重结局为过敏反应、关节病、发热、注射部位反应、淋巴结病、非特异性反应、腮腺炎、皮疹和晕厥。所有严重结局均进行病历审查。在预先定义的疫苗接种后时间段内计算特定结局的发病率。采用自控风险区间设计来确定接种疫苗后风险窗口内各结局相对于更远端对照窗口的相对风险。

结果

在研究期间,共向青少年和成人接种了276,327剂MMR。疫苗接种者的平均年龄为34.8岁;65.8%为女性;53.2%的剂量与≥1种其他疫苗同时接种。严重结局罕见,每种评估结局的发病率每10万剂≤6例,且与对照窗口相比,风险窗口内发病率均无显著升高。每10万剂非严重结局的发病率从腮腺炎的3.4例到关节病的263.0例不等。其他常见结局包括注射部位反应和皮疹(分别为每10万剂157.0例和112.9例)。与对照窗口相比,除腮腺炎外,所有非严重结局在风险窗口内观察到的结局明显更多。在性别和年龄组之间观察到一些差异。

结论

MMR接种后青少年和成人中的严重结局罕见,但应向疫苗接种者提供有关预期的局部和全身非严重不良事件的咨询。

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