一项前瞻性随机开放研究比较戈舍林加手术和单独手术治疗卵巢子宫内膜异位瘤

Robert Shaw, Ray Garry, Lindsay McMillan, Christopher Sutton, Simon Wood, Robert Harrison, Rajiv Das
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引用次数: 13

摘要

目的测定戈舍林(ZoladexTM;阿斯利康(AstraZeneca,伦敦,英国)联合手术治疗卵巢子宫内膜异位瘤优于单纯手术治疗。前瞻性、多中心、随机、开放标签、平行组研究。干预措施术前抽吸子宫内膜异位症后,超声测量其大小,腹腔镜确诊子宫内膜异位症并评估其严重程度。根据子宫内膜瘤大小对患者进行分层,随机分为两组:1组(G1;N = 21)每月(每28天)皮下注射戈舍雷林3.6 mg,持续3个月(12周);第二组(G2);N = 27)未接受治疗。3个月时,两组在最终切除前重新评估子宫内膜瘤的大小。两组在术后6个月重新评估。主要观察指标:最大子宫内膜异位瘤从进入到切除前的大小变化。结果G1组子宫内膜瘤大小的平均变化为- 2.29 cm, G2组为- 1.29 cm。结果(调整后)平均差异为- 1.25 cm,具有统计学意义,有利于G1 (P = 0.036, 95% CI为- 2.42至- 0.08 cm)。G1组4例(22%)和G2组10例(46%)手术困难。G1组平均手术时间74.2 min, G2组平均手术时间86.4 min。与G2相比,G1术后6个月的平均植入物添加剂直径(ADI)评分有更大的下降趋势(- 65.9比- 56.6)。两组在手术中完全切除子宫内膜囊肿的次数、手术出血量、修订的美国生育学会(R-AFS)评分和盆腔症状方面具有可比性。戈舍雷林耐受性良好。结论腹腔镜下子宫内膜异位瘤抽吸后每月服用3.6 mg戈舍雷林3个月,与单独腹腔镜下抽吸相比,3个月时子宫内膜异位瘤明显变小,ADI评分有更大下降的趋势。
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A prospective randomized open study comparing goserelin (Zoladex) plus surgery and surgery alone in the management of ovarian endometriomas

Objective

To determine whether goserelin (ZoladexTM; AstraZeneca, London, UK), plus surgery offers advantages over surgery alone in the management of ovarian endometriomas.

Design

Prospective, multicentre, randomized, open-label, parallel-group study.

Interventions

Following preoperative aspiration of endometriomas, they were sized by ultrasound, a diagnosis of endometriosis confirmed by laparoscopy and its severity assessed. Patients were stratified according to endometrioma size and randomly allocated to one of two groups: group 1 (G1; n = 21) received a monthly (every 28 days) subcutaneous injection of goserelin 3.6 mg for 3 months (12 weeks); group 2 (G2; n = 27) received no treatment. At 3 months, the size of endometriomas was reassessed in both groups before definitive excision. Both groups were reassessed at 6 months postsurgery.

Main outcome measures

Change in size of the largest endometrioma from entry to just prior to excision.

Results

The mean change in endometrioma size was −2.29 cm in G1 and −1.29 cm in G2. The resulting (adjusted) mean difference of −1.25 cm was statistically significant in favour of G1 (P = 0.036, 95% CI −2.42 to −0.08 cm). Very difficult surgery was reported in four (22%) patients in G1 and 10 (46%) patients in G2. Mean duration of surgery was 74.2 min in G1 and 86.4 min in G2. There was a trend towards a greater reduction in mean Additive Diameter of Implants (ADI) score at 6 months postsurgery in G1 compared with G2 (−65.9 vs. −56.6). Both groups were comparable in terms of the number of complete excisions of their endometrial cysts at surgery, blood loss at surgery, Revised American Fertility Society (R-AFS) scores and pelvic symptoms. Goserelin was well tolerated.

Conclusions

Laparoscopic aspiration of endometriomas followed by a monthly goserelin 3.6 mg depot for 3 months compared with laparoscopic aspiration alone results in significantly smaller endometriomas at 3 months and a trend towards a greater reduction in ADI score.

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