Is tocolytic magnesium sulphate associated with increased total paediatric mortality?
Is tocolytic magnesium sulphate associated with increased total paediatric mortality?
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DOI：
10.1016/s0140-6736(97)24047-x
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发表时间：
1997-11-22
期刊：
影响因子：
168.9
通讯作者：
Siegler, M
中科院分区：
文献类型：
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作者：
Mittendorf, R;Covert, R;Siegler, M
总体而言，在75例随机分配至MgSO 4组（65例单胎，10对双胎）的母体中，有10例儿科死亡（5例单胎，3对双胎，其中一名同胞死亡，1对双胎，其中两名同胞死亡[因此，9例单独妊娠]），在75例随机分配至其他对照组或生理盐水对照组（69例单胎，6对双胎）的母体中，有1例儿科死亡（单胎）。通过意向治疗分析，差异具有统计学显著性（风险差异10.7%，95% CI 2.9%-18.5%;双侧Fisher精确检验，p= 0.02）。在保胎组中，8例儿童死亡（3例单胎，3对双胞胎中有一个兄弟姐妹死亡，1对双胞胎中两个兄弟姐妹都死亡[因此，7例独特妊娠]）发生在46例母亲随机化中（37例单胎，9对双胎）接受MgSO 4，47例母亲随机化中无儿科死亡（42例单胎，5对双胎）与其他安胎药（风险差异15.2%，95%CI 4.4 - 26.0%; p= 0.01）。在预防性治疗组中，29例母体随机分配（28例单胎，1对双胎）至MgSO 4组发生2例儿科死亡（均为单胎），28例母体随机分配（27例单胎，1对双胎）至生理盐水组发生1例儿科死亡（不显著）。在测试随机化平衡时，我们发现暴露组之间的基线风险因素无差异，MgSO 4暴露除外（可根据要求提供随机化特征，数据未显示）。五名婴儿的死亡是意外和突然的，我们还没有一个生理上的解释（表）。在完成中期数据安全性监测后，我们通知了IRB，暂停了试验的进一步入组，并任命了内部和外部审查委员会。这些委员会建议我们在医学出版物中报告我们的初步结果，通知食品和药物管理局，召回子宫内暴露于MgSO 4的儿童进行检查;并通知父母
Overall, there were ten paediatric deaths (five singletons, three twin pairs in which one sibling died, one twin pair in which both siblings died [thus, nine unique pregnancies]) in 75 maternal randomisations (65 singletons, ten twin pairs) to MgSO4 and one paediatric death (singleton) among 75 maternal randomisations (69 singletons, six twin pairs) to other or saline control. With intent to treat analysis, the difference was statistically significant (risk difference 10· 7%, 95% CI 2· 9%–18· 5%; two-sided Fisher’s exact test, p= 0· 02). In the tocolytic arms, eight paediatric deaths (three singletons, three twin pairs in which one sibling died, one twin pair in which both siblings died [thus, seven unique pregnancies]) occurred in 46 maternal randomisations (37 singletons, nine twin pairs) to MgSO4 and no paediatric deaths in 47 maternal randomisations (42 singletons, five twin pairs) to other tocolytic (risk difference 15· 2%, 95% CI 4· 4–26· 0%; p= 0· 01). In the preventive arms, two paediatric deaths (both singletons) occurred in 29 maternal randomisations (28 singletons, one twin pair) to MgSO4 and one paediatric death in 28 maternal randomisations (27 singletons, one twin pair) to saline (not significant). On testing the randomisation for balance, we found no differences between the exposure groups in baseline risk factors except for MgSO4 exposure (randomisation profile available on request, data not shown). Five infant deaths were unexpected and sudden and we do not yet have a physiological explanation (table). After completing the interim data safety monitoring, we notified the IRB, suspended further enrolment in the trial, and appointed internal and external review committees. These committees recommended that we report our preliminary results in the medical publications, notify the Food and Drug Administration, recall for examination children exposed in utero to MgSO4; and, inform parents of