Fedele L, Parazzini F, Radici E, Bocciolone L, Bianchi S, Bianchi C, Candiani G B
Centro per lo Studio e la Terapia dell'Endometriosi, Università di Milano, Italy.
Am J Obstet Gynecol. 1992 May;166(5):1345-50. doi: 10.1016/0002-9378(92)91602-7.
We performed a randomized clinical trial to evaluate the efficacy of intranasal 400 micrograms buserelin three times daily for 6 months versus expectant management in the treatment of infertile women with pelvic endometriosis stage I or II of the revised American Fertility Society classification.
Seventy-one consecutive patients (mean age 32 years) were studied at the First Department of Obstetrics and Gynecology, University of Milan, and the Department of Obstetrics and Gynecology, Ospedali Riuniti, Bergamo, between February 1988 and June 1989. Thirty-five women were randomly allocated to buserelin treatment and 36 to expectant management. The baseline distribution of subjects for age, disease stage, and reproductive history was similar in the two groups. All patients were followed regularly; median follow-up was 17 months in the buserelin group and 18 months in the women given expectant management. If pregnancy did not occur within 12 months of randomization, cycles were monitored by ultrasonography and hormone measurements, and when abnormalities were detected clomiphene citrate and human chorionic gonadotropin were administered.
A total of 17 pregnancies were observed both in the buserelin-treated patients and in the expectant management group. The 1- and 2-year actuarial overall pregnancy rates were similar in the two groups, 30% and 61% in the former and 37% and 61% in the latter group, respectively. Spontaneous abortion occurred in five of the 17 pregnancies in the women treated with buserelin and in one of the 17 in those managed expectantly; this difference was, however, not statistically significant (chi 1(2) adjusted for disease stage and use of clomiphene citrate and human chorionic gonadotropin treatment = 3.01, p = 0.08). No fetal death or stillbirth was observed.
Our findings suggest that treatment with gonadotropin-releasing hormone agonists is unlikely to have a marked influence on the reproductive outcome of infertile women with minimal or mild endometriosis.
我们开展了一项随机临床试验，以评估每日三次经鼻给予400微克布舍瑞林，持续6个月的治疗方案与期待疗法相比，对患有美国生育协会修订分类中I期或II期盆腔子宫内膜异位症的不孕女性的治疗效果。
1988年2月至1989年6月期间，在米兰大学第一妇产科以及贝加莫联合医院妇产科对71例连续患者（平均年龄32岁）进行了研究。35名女性被随机分配至布舍瑞林治疗组，36名女性接受期待疗法。两组在年龄、疾病分期和生育史方面的基线分布相似。所有患者均接受定期随访；布舍瑞林组的中位随访时间为17个月，接受期待疗法的女性为18个月。如果在随机分组后12个月内未怀孕，则通过超声检查和激素测量监测月经周期，当检测到异常时，给予枸橼酸氯米芬和人绒毛膜促性腺激素。
布舍瑞林治疗组和期待疗法组均观察到17例妊娠。两组1年和2年的实际总妊娠率相似，前者分别为30%和61%，后者分别为37%和61%。布舍瑞林治疗的女性中17例妊娠中有5例发生自然流产，期待疗法组17例中有1例；然而，这种差异无统计学意义（根据疾病分期以及枸橼酸氯米芬和人绒毛膜促性腺激素治疗情况调整后的卡方检验χ1(2)=3.01，p = 0.08）。未观察到胎儿死亡或死产情况。
我们的研究结果表明，促性腺激素释放激素激动剂治疗不太可能对患有轻微或轻度子宫内膜异位症的不孕女性的生殖结局产生显著影响。
