Vercellini P, Crosignani P G, Fadini R, Radici E, Belloni C, Sismondi P
First Department of Obstetrics and Gynaecology, University of Milan, Italy.
Br J Obstet Gynaecol. 1999 Jul;106(7):672-7. doi: 10.1111/j.1471-0528.1999.tb08366.x.
To ascertain whether the frequency of pelvic pain recurrence is reduced and time to symptoms recurrence is prolonged in women with symptomatic endometriosis undergoing conservative surgery and post-operative hormonal therapy compared with women treated with surgery only. Pregnancy rates and time to conception in women wanting children were also evaluated.
A multicentre, prospective, randomised controlled study.
Nineteen Italian academic departments and teaching hospitals specialising in reparative and reconstructive surgery.
A total of 269 women undergoing conservative surgery for mild to severe symptomatic endometriosis.
After surgery the women were assigned to treatment with subcutaneous goserelin depot injections for six months or to expectant management. Dysmenorrhoea, deep dyspareunia, nonmenstrual pain and general discomfort were graded according to a verbal rating scale from 0 (absent) to 3 (severe) and the scores summed to give a total symptoms score. Only patients with at least one preoperative moderate or severe symptom were enrolled. The women were evaluated regularly for two years.
Post-operative pain recurrences (total symptoms scores > or = 5), time to recurrence, pregnancy rates and time to conception in the two study groups.
At one- and two-year follow up visits, 14/107 (13.1%) and 19/81 (23.5%) patients had moderate or severe symptoms recurrence in the goserelin group compared with, respectively, 22/103 (21.4%) and 27/74 (36.5%) in the expectant management group (P = 0.143 at 1 year and 0.082 at 2 years). Time to symptoms recurrence was significantly longer in the goserelin group according to survival analysis (Wilcoxon test, P = 0.041). Among women wanting children, few conceptions occurred in both the goserelin (8/69, 11.6%) and the expectant management group (14/76, 18.4%). There was no significant difference at survival analysis (Wilcoxon test, P = 0.427).
Post-operative treatment with goserelin significantly prolonged the pain-free interval after conservative surgery for symptomatic endometriosis and did not influence reproductive prognosis.
确定与仅接受手术治疗的女性相比,接受保守手术及术后激素治疗的症状性子宫内膜异位症女性盆腔疼痛复发频率是否降低,症状复发时间是否延长。还评估了有生育意愿女性的妊娠率及受孕时间。
一项多中心、前瞻性、随机对照研究。
19个意大利专门从事修复与重建手术的学术部门及教学医院。
共269例因轻至重度症状性子宫内膜异位症接受保守手术的女性。
术后,将女性分为皮下注射戈舍瑞林长效制剂治疗6个月组或期待治疗组。痛经、深部性交痛、非经期疼痛及全身不适根据言语评定量表从0(无)至3(严重)进行分级,分数相加得出总症状评分。仅纳入至少有一项术前中度或重度症状的患者。对女性进行为期两年的定期评估。
两个研究组的术后疼痛复发(总症状评分≥5)、复发时间、妊娠率及受孕时间。
在1年和2年随访时,戈舍瑞林组分别有14/107(13.1%)和19/81(23.5%)患者出现中度或重度症状复发,而期待治疗组分别为22/103(21.4%)和27/74(36.5%)(1年时P = 0.143,2年时P = 0.082)。根据生存分析,戈舍瑞林组症状复发时间显著更长(Wilcoxon检验,P = 0.041)。在有生育意愿的女性中,戈舍瑞林组(8/69,11.6%)和期待治疗组(14/76,18.4%)受孕者均较少。生存分析无显著差异(Wilcoxon检验,P = 0.427)。
戈舍瑞林术后治疗显著延长了症状性子宫内膜异位症保守手术后的无痛间期,且不影响生殖预后。