多疗程的产前类固醇不建议用于早产


  December 22, 2008 — 根据发表于12月20/27日版The Lancet期刊中的研究结果,每14天一次的多疗程产前类固醇未能改善早产的结果,且与减少生产时体型有关,因此不建议使用。
  
  多伦多大学Mount Sinai医院的Kellie E. Murphy医师与MACS合作小组写道,一个疗程的产前皮质类固醇减少呼吸道窘迫症候群与新生儿死亡的风险。在单一疗程有效(较少呼吸道发病率)或者引起伤害(减少子宫内生长)之后,给予尚未生产妇女较低的剂量。我们目标在于发现多疗程的产前皮质类固醇是否可以减少新生儿发病率与死亡率且不会影响胎儿的生长。
  
  研究对象包括1,858名怀孕25至32周的高早产风险妇女,在最初的单一疗程产前皮质类固醇治疗之后14至21天仍尚未生产、且持续处于高风险者。病患随机分派接受多疗程的产前皮质类固醇(n = 937)或者安慰剂(n = 921),每14天一次,直到怀孕33周或者生产。
  
  本研究的主要终点为出生前后或者新生儿死亡、严重呼吸窘迫症候群、等级3或4的颅内出血、周脑室白质软化症(periventricular leukomalacia)、肺支气管发育不良(bronchopulmonary dysplasia)或者坏死性肠炎(necrotizing enterocolitis);全部病患与照护者对于治疗为双盲,分析采治疗意向分析。
  
  相较于安慰剂组的婴儿,多疗程产前皮质类固醇之婴儿的发病率与死亡率类似,分别有150人(12.9%) 和143人 (12.5%)发生主要研究终点。相较于安慰剂组的婴儿,多剂量皮质类固醇组的婴儿出生体重较低(2216 vs. 2330克;P = .0026)、身高较矮(44.5 vs. 45.4公分; P < .001)、头围较小(31.1 vs. 31.7公分; P < .001)。
  
  研究作者写道,每14天一次的多疗程产前皮质类固醇未能改善早产的结果,且体重、身高、头围都减少。因此,不建议此种治疗。
  
  西澳大学妇婴健康学院的John P. Newnham以及King Edward and Princess Margaret医院的Karen Simmer在编辑评论中指出,本研究中追踪的小孩有助于指出多疗程产前皮质类固醇的长期效果。
  
  Newnham医师与Simmer医师写道,需特别注意的是,针对其它结果如行为、成长、葡萄糖耐受与血压的研究。同时,证据显示产科医师对于重复给予产前皮质类固醇注射应慎思;单一疗程被认为有帮助,但我们应警觉重复给予时的潜在危险。
  
  加拿大健康研究中心支持本研究。Sunnybrook 健康科学中心、妇女学院医院以及多伦多大学妇产科提供资料协调中心资金。 Betamethasone以及安慰剂分别购自 Schering-Plough药厂 (Madison,纽泽西)以及Eminent Services公司(Gaithersburg,马里兰)。研究作者与编辑宣称没有相关资金上的往来。

Multiple Courses of Antenatal Steroids Not Recommended for Preterm Birth

By Laurie Barclay, MD
Medscape Medical News

December 22, 2008 — Multiple courses of antenatal steroids every 14 days do not improve preterm birth outcomes, are linked to decreased size at birth, and are therefore not recommended, according to the results of a study reported in the December 20/27 issue of The Lancet.

"One course of antenatal corticosteroids reduces the risk of respiratory distress syndrome and neonatal death," write Kellie E. Murphy, from Mount Sinai Hospital, University of Toronto in Toronto, Ontario, Canada, and colleagues from the MACS Collaborative Group. "Weekly doses given to women who remain undelivered after a single course may have benefits (less respiratory morbidity) or cause harm (reduced growth in utero). We aimed to find out whether multiple courses of antenatal corticosteroids would reduce neonatal morbidity and mortality without adversely affecting fetal growth."

The study sample consisted of 1858 women at 25 to 32 weeks of gestation who were at high risk for preterm birth, who were still undelivered 14 to 21 days after an initial course of antenatal corticosteroids, and who continued to be at high risk. Participants were randomly assigned to receive multiple courses of antenatal corticosteroids (n = 937) or placebo (n = 921), every 14 days until week 33 or delivery, whichever came first.

The main endpoint of the study was a composite of perinatal or neonatal death, severe respiratory distress syndrome, grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, or necrotizing enterocolitis. All patients and caregivers were blinded to treatment assignment, and analysis was by intent-to-treat.

Compared with infants exposed to placebo, those exposed to multiple courses of antenatal corticosteroids had similar morbidity and mortality rates, with the main study endpoint occurring in 150 (12.9%) vs 143 (12.5%). Compared with infants in the placebo group, those in the multiple-dose corticosteroid group had lower birth weight (2216 vs 2330 g; P = .0026), shorter length (44.5 vs 45.4 cm; P < .001), and smaller head circumference (31.1 vs 31.7 cm; P < .001).

"Multiple courses of antenatal corticosteroids, every 14 days, do not improve preterm-birth outcomes, and are associated with a decreased weight, length, and head circumference at birth," the study authors write. "Therefore, this treatment schedule is not recommended."

In an accompanying comment, John P. Newnham, from the School of Women's and Infants' Health, University of Western Australia in Perth, and Karen Simmer, from King Edward and Princess Margaret Hospitals in Perth, note that follow-up of the children in this study will help shed light on any long-term effects of multiple doses of antenatal corticosteroids.

"Particular attention should be paid to those areas in which other studies have suggested problems, including behaviour, growth, glucose tolerance, and blood pressure," Drs. Newnham and Simmer write. "In the meantime, the evidence suggests it is prudent for obstetricians not to prescribe repeat injections of antenatal corticosteroids. Single-course therapy is of considerable benefit, but we should be aware of the potential dangers of giving too much of a good thing."

The Canadian Institutes of Health Research supported this study. The data coordinating centre was supported by grants from Sunnybrook Health Sciences Centre, Women's College Hospital and the Department of Obstetrics and Gynaecology at the University of Toronto. Betamethasone and placebo were purchased from Schering-Plough Corporation (Madison, New Jersey) and Eminent Services Corporation (Gaithersburg, Maryland), respectively. The study authors and editorialists have disclosed no relevant financial relationships.

Lancet. 2008;372:2094-2095, 2143-2151.

    
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