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超免疫球蛋白不能预防胎儿或新生儿先天性巨细胞病毒感染
作者:小柯机器人 发布时间:2021/7/31 23:09:21

美国杜克大学医学院Brenna L. Hughes团队研究了超免疫球蛋白预防先天性巨细胞病毒感染的效果。该项研究成果发表在2021年7月28日出版的《新英格兰医学杂志》上。

妊娠期原发性巨细胞病毒(CMV)感染有先天性感染的风险,并可能有严重后遗症。目前还没有建立预防先天性巨细胞病毒感染的干预措施。

在这项多中心、双盲试验中,研究组招募在妊娠24周前诊断为原发性CMV感染的孕妇,将其随机分配到分娩前每月输注CMV超免疫球蛋白(剂量为每公斤体重100 mg)或匹配的安慰剂。主要结局为先天性CMV感染,如果胎儿或新生儿未进行CMV检测,则主要结局为胎儿或新生儿死亡。

2012-2018年,共有206082名孕妇在妊娠23周前接受了原发性CMV感染筛查;在712名检测呈阳性的参与者(0.35%)中,399名(56%)接受了随机分组。试验因无效而提前终止。

394名受试者获得了关于主要结局的数据;在接受超免疫球蛋白治疗组的203名孕妇中有46名(22.7%)胎儿或新生儿发生主要结局事件,安慰剂组191名孕妇中有37名(19.4%),相对风险为1.17。

超免疫球蛋白组有4.9%的胎儿或新生儿死亡,安慰剂组有2.6%,相对危险度为1.88;早产发生率分别为12.2%和8.3%,相对危险度为1.47;出生体重低于第5百分位的发生率分别为10.3%和5.4%,相对危险度为1.92。超免疫球蛋白组的一名参与者对首次输注有严重过敏反应。超免疫球蛋白组患者在接受输液时头痛和发抖的发生率高于安慰剂组。

研究结果表明,在妊娠24周前开始输注巨细胞病毒超免疫球蛋白,与安慰剂相比,并没有降低先天性CMV感染或围产期死亡的复合发病率。

附:英文原文

Title: A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection

Author: Brenna L. Hughes, M.D.,, Rebecca G. Clifton, Ph.D.,, Dwight J. Rouse, M.D.,, George R. Saade, M.D.,, Mara J. Dinsmoor, M.D., M.P.H.,, Uma M. Reddy, M.D.,, Robert Pass, M.D.,, Donna Allard, R.N.,, Gail Mallett, R.N.,, Lida M. Fette, M.S.,, Cynthia Gyamfi-Bannerman, M.D.,, Michael W. Varner, M.D.,, William H. Goodnight, M.D.,, Alan T.N. Tita, M.D., Ph.D.,, Maged M. Costantine, M.D.,, Geeta K. Swamy, M.D.,, Ronald S. Gibbs, M.D.,, Edward K. Chien, M.D.,, Suneet P. Chauhan, M.D.,, Yasser Y. El-Sayed, M.D.,, Brian M. Casey, M.D.,, Samuel Parry, M.D.,, Hyagriv N. Simhan, M.D.,, Peter G. Napolitano, M.D.,, and George A. Macones, M.D.

Issue&Volume: 2021-07-28

Abstract:

Background

Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae. There is no established intervention for preventing congenital CMV infection.

Methods

In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks’ gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin (at a dose of 100 mg per kilogram of body weight) or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed.

Results

From 2012 to 2018, a total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization. The trial was stopped early for futility. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women (22.7%) in the group that received hyperimmune globulin and of 37 of 191 women (19.4%) in the placebo group (relative risk, 1.17; 95% confidence interval [CI] 0.80 to 1.72; P=0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth occurred in 12.2% and 8.3%, respectively (relative risk, 1.47; 95% CI, 0.81 to 2.67), and birth weight below the 5th percentile occurred in 10.3% and 5.4% (relative risk, 1.92; 95% CI, 0.92 to 3.99). One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion. Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo.

Conclusions

Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks’ gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo.

DOI: 10.1056/NEJMoa1913569

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1913569

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home