Albengres E, Abuaf N, D'Athis P, Guichoux J Y, Rotten D, Tillement J P
Service Hospitalo-Universitaires de Pharmacologie, Hôpital Intercommunal, Crétiel, France.
Int J Clin Pharmacol Ther Toxicol. 1991 Dec;29(12):486-93.
The aim of the study was to investigate the hypothesis that oral contraceptives (OC) lead to antiethinyl-estradiol antibody (AEEA) synthesis which might in turn be responsible for the thrombo-embolic complications observed in women users. The trial included 428 women divided into a) 204 healthy female volunteers as the control group (CONT), b) 139 women who had suffered thrombo-embolic accidents (THR), c) 85 women suffering from recurrent fetal loss (RFL). In each of these three categories, 50% were pill users (OC+) and 50% were not (OC-). Specific immune markers of systemic autoimmunity and anticardiolipin antibodies were looked for, as they are thought to be present in increased amounts in thrombosis or recurrent fetal loss. The AEEA prevalence differed significantly (p less than 0.05) between the CONT OC+ (32%) and the CONT OC- (13%) women. It also differed (p less than 10(-5)) between the RFL OC+ (60%) and the RFL OC- (12%) women. It did not differ between THR OC+ (36%) and THR OC- (39%) women. Within the OC+ women, the difference between the THR and the CONT groups was not found to be significant, whereas it was found to differ significantly between the RFL and the CONT groups (odds-ratio RFL/CONT estimated at 3.20, confidence interval 1.53, 6.69). Within the OC-women, the AEEA prevalence was found to differ significantly between the THR (39%) and the CONT (13%) groups (odds-ratio THR/CONT estimated at 4.40, confidence interval 2.07, 9.38%) but not between the RFL and the CONT groups.(ABSTRACT TRUNCATED AT 250 WORDS)
口服避孕药(OC)会导致抗乙炔雌二醇抗体(AEEA)的合成,而这反过来可能是导致女性使用者出现血栓栓塞并发症的原因。该试验纳入了428名女性,分为:a)204名健康女性志愿者作为对照组(CONT);b)139名曾发生血栓栓塞事故的女性(THR);c)85名患有复发性流产的女性(RFL)。在这三类人群中,各有50%是避孕药使用者(OC+),50%不是(OC-)。研究寻找了系统性自身免疫的特异性免疫标志物和抗心磷脂抗体,因为人们认为它们在血栓形成或复发性流产中含量会增加。CONT组的OC+女性(32%)和CONT组的OC-女性(13%)之间,AEEA患病率存在显著差异(p<0.05)。RFL组的OC+女性(60%)和RFL组的OC-女性(12%)之间也存在差异(p<10⁻⁵)。THR组的OC+女性(36%)和THR组的OC-女性(39%)之间没有差异。在OC+女性中,未发现THR组和CONT组之间存在显著差异,而RFL组和CONT组之间存在显著差异(RFL/CONT的优势比估计为3.20,置信区间为1.53, 6.69)。在OC-女性中,THR组(39%)和CONT组(13%)之间的AEEA患病率存在显著差异(THR/CONT的优势比估计为4.40,置信区间为2.07, 9.38%),但RFL组和CONT组之间没有差异。(摘要截取自250词)