Serra G B, Panetta V, Colosimo M, Romanini C, Lafuenti G B, Garcea N, Votano S, Agatensi L
Ospedale Cristo Re, Rome, Italy.
Clin Ther. 1992;14 Suppl A:57-73.
A total of 110 nonmenopausal women (mean age 42.1 years) presenting with symptomatic uterine leiomyomata and/or fibromatous uteri have been enrolled in this trial to evaluate the efficacy of the depot formulation of leuprorelin acetate in decreasing uterine volume and minimizing menorrhagia, dysmenorrhoea and pressure over the bladder. All patients were treated with an intramuscular injection of leuprorelin acetate depot 3.75 mg every 4 weeks for 16 weeks. Clinical examinations and hormonal and ultrasound determinations were performed before, during and at the end of treatment. Appropriate follow-up is still ongoing for most patients. At the end of the treatment period, of 88 women with enlarged fibromatous uteri, 33 (37.5%) showed a decrease in uterine volume of greater than or equal to 50% of the original size, while nine (10.2%) remained with unchanged uterine volume. Of 80 fibromas measurable separately, 47 (52.8%) decreased by greater than 50% of the initial volume and 16 (18%) remained unchanged or even increased. During treatment, clinically advantageous effects were observed in the associated symptomatology, mainly in the production of amenorrhoea and restoration of normal haemoglobin levels. Most of the patients were affected by irregular menstrual blood loss with consequent anaemia that in 29 patients was expressed by low levels of haemoglobin (mean 9.2 g/dl; SD 1.5; range 4.5-11.8 g/dl). By the end of the treatment, only one patient still had moderate vaginal blood loss. Haemoglobin levels rose to a mean value of 11.8 g/dl (SD 1.3; range 8.5-14.1 g/dl). Three patients (2.7%) failed to complete the 16-week treatment protocol, because of headache (one patient) and increased blood pressure (two patients). As a result of the treatment, of the 107 patients who were candidates for surgery and who were included in this study, only nine (8.4%) required surgery during leuprorelin acetate treatment. Of these, four operations were vaginal excision of the submucous myomata protruding into the cervix during treatment, and in five hysterectomy performed because of persistence of symptoms. In most patients the achievement of amenorrhoea minimized the fear of surgical emergency, facilitating an increased awareness of their clinical condition. With the exception of the three patients who dropped out, side effects were mild in all patients, consisting mainly of hot flushes, which were easily tolerated. In the following 8-12 months, the regrowth of uterine volume to original size has been usual in most of the 82 patients now in follow-up.(ABSTRACT TRUNCATED AT 400 WORDS)
共有110名有症状的子宫平滑肌瘤和/或纤维瘤性子宫的非绝经女性（平均年龄42.1岁）参与了本试验，以评估醋酸亮丙瑞林长效制剂在减小子宫体积以及使月经过多、痛经和膀胱压迫症状最小化方面的疗效。所有患者每4周接受一次3.75mg醋酸亮丙瑞林长效制剂的肌肉注射，共治疗16周。在治疗前、治疗期间和治疗结束时进行临床检查、激素测定和超声检查。大多数患者仍在进行适当的随访。在治疗期末，88名子宫纤维瘤增大的女性中，33名（37.5%）子宫体积减小至初始大小的50%或以上，而9名（10.2%）子宫体积无变化。在80个可单独测量的纤维瘤中，47个（52.8%）体积减小超过初始体积的50%，16个（18%）无变化甚至增大。在治疗期间，相关症状出现了临床上有益的效果，主要是闭经的产生和血红蛋白水平恢复正常。大多数患者受到不规则月经失血影响，进而导致贫血，29名患者表现为血红蛋白水平低（平均9.2g/dl；标准差1.5；范围4.5 - 11.8g/dl）。到治疗结束时，只有一名患者仍有中度阴道出血。血红蛋白水平升至平均11.8g/dl（标准差1.3；范围8.5 - 14.1g/dl）。三名患者（2.7%）未完成16周的治疗方案，原因是头痛（一名患者）和血压升高（两名患者）。由于治疗，本研究纳入的107名适合手术的患者中，只有9名（8.4%）在醋酸亮丙瑞林治疗期间需要手术。其中，4例手术是在治疗期间经阴道切除突入宫颈的黏膜下肌瘤，5例是因症状持续而进行子宫切除术。在大多数患者中，闭经的实现使对手术急症的恐惧最小化，有助于提高对自身临床状况的认识。除了三名退出的患者外，所有患者的副作用都很轻微，主要是潮热，很容易耐受。在接下来的8 - 12个月里，在目前接受随访的82名患者中，大多数患者子宫体积恢复到原来大小是常见的情况。（摘要截选至400字）
