Goldstein P, Berrier J, Rosen S, Sacks H S, Chalmers T C
Clinical Trials Unit, Mount Sinai School of Medicine, New York, NY.
Br J Obstet Gynaecol. 1989 Mar;96(3):265-74. doi: 10.1111/j.1471-0528.1989.tb02385.x.
The continued use of progestational agents in attempts to achieve a normal outcome of pregnancy in women with a 'high-risk' pregnancy (previous miscarriage, stillbirth or present preterm labour) prompted this meta-analysis of randomized control trials of such therapy. Of 20 trials of a progestogen 15 had combinable data. Combined comparisons, using odds ratios with confidence intervals, were made of the rates of livebirths at term or preterm and the sum of term and preterm deliveries, miscarriages, stillbirths and neonatal deaths. All but one comparison failed to show a significant benefit. Only the preterm delivery versus the term delivery comparison approached statistical significance. There were average deficiencies of quality apparent in the studies, and a test for heterogeneity among the studies was positive, but these caveats do not diminish the conclusion that progestogens should not be used outside of randomized trials at present. If trials are done, they should include only women with demonstrated hormonal abnormalities who are carrying a live fetus as shown by ultrasonography.
对于有“高危”妊娠史(既往流产、死产或目前早产)的女性,持续使用孕激素以期获得正常妊娠结局,促使人们对这类疗法的随机对照试验进行了此项荟萃分析。在20项孕激素试验中,15项有可合并的数据。采用带有置信区间的比值比,对足月或早产活产率、足月和早产分娩总数、流产、死产及新生儿死亡进行了合并比较。除一项比较外,其他所有比较均未显示出显著益处。只有早产与足月分娩的比较接近统计学显著性。研究中明显存在质量平均缺陷,且研究间异质性检验呈阳性,但这些注意事项并不能削弱目前不应在随机试验之外使用孕激素的结论。如果进行试验,应仅纳入经超声检查证实有激素异常且怀有活胎的女性。