2011年2月10日 星期四

(脊椎披裂)之研究開啟胎兒手術之門A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele

(spī'nə bĭf'ĭ-də) pronunciation
n.
A congenital defect in which the spinal column is imperfectly closed so that part of the meninges or spinal cord protrudes, often resulting in hydrocephalus and other neurological disorders. Also called schistorrhachis.

[New Latin spīna bifida : Latin spīna, spine + Latin bifida, feminine of bifidus, split in two.]

Spina Bifida(脊椎披裂)之研究開啟胎兒手術之門

我第一次點閱上文中的"嚴格的臨床測試" 對導引到原刊物的摘要
它的兩圖示相當好

Media in This Article

Figure 1Prenatal Repair of Myelomeningocele.
Figure 2Enrollment and Outcomes.



Original Article

A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele

N. Scott Adzick, M.D., Elizabeth A. Thom, Ph.D., Catherine Y. Spong, M.D., John W. Brock, III, M.D., Pamela K. Burrows, M.S., Mark P. Johnson, M.D., Lori J. Howell, R.N., M.S., Jody A. Farrell, R.N., M.S.N., Mary E. Dabrowiak, R.N., M.S.N., Leslie N. Sutton, M.D., Nalin Gupta, M.D., Ph.D., Noel B. Tulipan, M.D., Mary E. D'Alton, M.D., and Diana L. Farmer, M.D. for the MOMS Investigators

February 9, 2011 (10.1056/NEJMoa1014379)

Abstract
Article
References

Background

Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair.

Methods

We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function.

Results

The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P>

Conclusions

Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.)

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