为预防RSV Nirsevimab健康晚期早产儿和足月婴儿。

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密特会,达冈R,元Y,秋雨Cots M, Bosheva M, Madhi SA,穆勒WJ, Zar HJ,布鲁克斯D, Grenham, Wahlby Hamren U, Mankad VS,任P,塔卡T,亚伯兰我,浸出,格里芬MP, Villafana T

为预防RSV Nirsevimab健康晚期早产儿和足月婴儿。

郑传经地中海J。2022年3月3;386 (9):837 - 846。doi: 10.1056 / NEJMoa2110275。

PubMed ID

35235726 (在PubMed

]

文摘

背景:呼吸道合胞体病毒(RSV)是下呼吸道感染的主要原因和住院婴儿。Nirsevimab RSV融合蛋白的单克隆抗体,半衰期延长。nirsevimab的功效和安全健康的晚期早产儿和足月婴儿是不确定的。方法:我们随机分配,在2:1的比率,婴儿出生的胎龄至少35周接受肌内注射一nirsevimab RSV的赛季开始前或安慰剂。主要疗效终点是医学上参加RSV-associated下呼吸道感染通过注射后150天。次要疗效终点是RSV-associated住院治疗下呼吸道感染通过注射后150天。结果:共有1490名婴儿进行了随机试验:994年被分配到496年nirsevimab组和安慰剂组。医学上参加RSV-associated下呼吸道感染发生在12个婴儿nirsevimab组(1.2%)和在25个婴儿在安慰剂组(5.0%);这些发现对应的疗效74.5%(95%可信区间(CI), 49.6 - 87.1;nirsevimab P < 0.001)。 Hospitalization for RSV-associated lower respiratory tract infection occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy, 62.1%; 95% CI, -8.6 to 86.8; P = 0.07). Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group. Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo. CONCLUSIONS: A single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection. (Funded by MedImmune/AstraZeneca and Sanofi; MELODY ClinicalTrials.gov number, NCT03979313.).

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药物

Nirsevimab