Goodwin T M, Valenzuela G J, Silver H, Creasy G
University of Southern California, Los Angeles, USA.
Obstet Gynecol. 1996 Sep;88(3):331-6. doi: 10.1016/0029-7844(96)00200-1.
To evaluate the minimal effective dose regimen of the oxytocin antagonist atosiban in the treatment of acute preterm labor and the effect of a bolus on uterine activity within the first 2 hours compared with no bolus and the same infusion rate.
A randomized, double-blind (except the ritodrine group), parallel group, multicenter study compared four different intravenous atosiban regimens (6.5 mg bolus plus 300 micrograms/minute, placebo bolus plus 300 micrograms/minute, 2mg bolus plus 100 micrograms/minute, and 0.6 mg plus 30 micrograms/minute) and intravenous ritodrine with respect to the cessation of uterine contractions for 1 hour or more during infusion, four or fewer contractions per hour in the last hour of therapy, and discontinuation because of adverse experiences. Three hundred two patients were enrolled.
The lowest dose of atosiban (0.6 mg plus 30 micrograms/minute) was significantly less effective than ritodrine with respect to cessation of contractions and four or fewer contractions per hour in the last hour of therapy. Other atosiban regimens were comparable to ritodrine, except for the drug discontinuation rate for adverse experiences. Bolus therapy with high-dose atosiban resulted in a significantly greater proportion of patients who stopped contracting within the first 2 hours of treatment (17 of 63) compared with those not receiving a bolus (six of 58, P = .017). Because of adverse experiences, the study drug was discontinued in one of 244 atosiban patients and 15 of 58 ritodrine patients.
Atosiban's effect on uterine activity in preterm labor was enhanced by bolus infusion and was similar to the effect of ritodrine, but with fewer side effects.
评估缩宫素拮抗剂阿托西班治疗急性早产的最小有效剂量方案，以及与不推注且输注速率相同的情况相比，推注对最初2小时内子宫活动的影响。
一项随机、双盲（利托君组除外）、平行组、多中心研究，比较了四种不同的静脉注射阿托西班方案（6.5毫克推注加300微克/分钟、安慰剂推注加300微克/分钟、2毫克推注加100微克/分钟、0.6毫克加30微克/分钟）和静脉注射利托君在输注期间子宫收缩停止1小时或更长时间、治疗最后1小时每小时宫缩4次或更少以及因不良事件停药方面的情况。共纳入302例患者。
就宫缩停止以及治疗最后1小时每小时宫缩4次或更少而言，最低剂量的阿托西班（0.6毫克加30微克/分钟）明显不如利托君有效。其他阿托西班方案与利托君相当，但不良事件停药率除外。与未接受推注的患者（58例中的6例，P = 0.017）相比，高剂量阿托西班推注治疗导致在治疗最初2小时内停止宫缩的患者比例显著更高（63例中的17例）。由于不良事件，244例阿托西班患者中有1例停用研究药物，58例利托君患者中有15例停用。
推注输注增强了阿托西班对早产子宫活动的作用，其作用与利托君相似，但副作用更少。
