Hauth J C, Goldenberg R L, Parker C R, Philips J B, Copper R L, DuBard M B, Cutter G R
University of Alabama, Department of Obstetrics and Gynecology, Birmingham 35233-7333.
Am J Obstet Gynecol. 1993 Apr;168(4):1083-91; discussion 1091-3. doi: 10.1016/0002-9378(93)90351-i.
Our aim was to test the hypothesis that acetylsalicylate (aspirin) treatment reduces the incidence or severity of pregnancy-associated hypertension.
Patients were nulliparous, healthy, and with a singleton gestation at between 20 and 22 weeks' gestation. A sample size of 600 patients was calculated on the basis of p < or = 0.05 and 90% power of observation. A 2-week placebo-controlled "run-in" was used to select compliant patients. Randomization occurred at 24 weeks, with 60 mg of aspirin or placebo treatment from randomization to delivery.
Follow-up was maintained on 99% of the patients. The randomized patients had a 94% pill compliance index. At randomization, serum thromboxane medians were similar in both groups. Thromboxane B2 levels in the aspirin group decreased significantly from baseline at 29 to 31 weeks, 34 to 36 weeks, and at delivery as compared with an overall increase in the placebo group. Preeclampsia developed in five of 302 women (1.7%) who received aspirin versus 17 of 302 (5.6%) who received the placebo (p = 0.009). Preeclampsia was severe in one aspirin and in six placebo recipients (p = 0.06).
Daily ingestion of 60 mg of aspirin beginning at 24 weeks' gestation significantly reduced the occurrence of preeclampsia.
我们的目的是检验乙酰水杨酸（阿司匹林）治疗可降低妊娠相关高血压的发病率或严重程度这一假设。
患者为初产妇，身体健康，单胎妊娠，妊娠周数在20至22周之间。根据p≤0.05和90%的观察效能计算出600例患者的样本量。采用为期2周的安慰剂对照“导入期”来选择依从性好的患者。在24周时进行随机分组，从随机分组至分娩给予60毫克阿司匹林或安慰剂治疗。
99%的患者得到随访。随机分组的患者服药依从性指数为94%。随机分组时，两组的血清血栓素中位数相似。与安慰剂组总体上升相比，阿司匹林组在29至31周、34至36周以及分娩时的血栓素B2水平较基线显著下降。302例接受阿司匹林治疗的女性中有5例（1.7%）发生子痫前期，而302例接受安慰剂治疗的女性中有17例（5.6%）发生子痫前期（p = 0.009）。1例接受阿司匹林治疗和6例接受安慰剂治疗的患者发生重度子痫前期（p = 0.06）。
妊娠24周开始每日摄入60毫克阿司匹林可显著降低子痫前期的发生率。
