Early Pregnancy and Gynaecology Assessment Unit, King's College Hospital, London, UK.
Hum Reprod. 2010 Sep;25(9):2264-9. doi: 10.1093/humrep/deq188. Epub 2010 Jul 27.
Submucous fibroids are common benign tumours responsible for menorrhagia, subfertility and miscarriage. They can be readily removed by hysteroscopic transcervical resection of myoma (TCRM). To facilitate resection, pre-operative GnRH analogues have been suggested, but the value of this treatment is uncertain. Our aim was to assess the value of pre-operative GnRH analogues for the resection of submucous fibroids.
This was a prospective, double-blind, placebo-controlled, randomized trial. Women found to have submucous fibroids on three-dimensional saline infusion sonohysterography (3D SIS) were randomized to receive GnRH or placebo. Following treatment patients underwent TCRM by a single operator blinded to the group allocation. Women were followed up 6 weeks after their operation to ascertain resolution of symptoms. The primary outcome measure of the study was completeness of fibroid resection. Secondary outcome measures included the duration of the TCRM, the fluid deficit recorded at TCRM, the resolution of symptoms post-operatively and the number of subsequent fibroid related operations.
Forty-seven women were randomized to GnRH or placebo. On the basis of intention-to-treat analysis, there was no significant difference in the number of complete fibroid resections between women who received GnRH analogues [14/24, 58.3% (95% CI 38.6-78.1)] and those who received placebo [16/23, 69.6% (50.8-88.4)] (RR 0.84, 95% CI 0.54-1.29; P = 0.43). Similarly there was no significant difference between the groups in any of the secondary outcome measures.
Our study does not support routine administration of GnRH analogues before transcervical resection of fibroid as we did not identify any benefit in such treatment.
黏膜下肌瘤是常见的良性肿瘤,可导致月经过多、不孕和流产。它们可以通过宫腔镜下经宫颈子宫肌瘤切除术(TCRM)轻松切除。为了便于切除,术前已建议使用 GnRH 类似物,但这种治疗的价值尚不确定。我们的目的是评估术前 GnRH 类似物在切除黏膜下肌瘤中的价值。
这是一项前瞻性、双盲、安慰剂对照、随机试验。在三维盐水灌注超声造影(3D SIS)上发现黏膜下肌瘤的女性被随机分配接受 GnRH 或安慰剂治疗。治疗后,由一位对分组分配不知情的单一操作人员进行 TCRM。术后 6 周对女性进行随访,以确定症状是否缓解。本研究的主要结局测量指标是肌瘤切除的完整性。次要结局测量指标包括 TCRM 的持续时间、TCRM 时记录的液体不足、术后症状的缓解以及随后与肌瘤相关的手术次数。
47 名女性被随机分配到 GnRH 或安慰剂组。根据意向治疗分析,接受 GnRH 类似物治疗的女性中完全切除肌瘤的比例[14/24,58.3%(95%CI 38.6-78.1)]与接受安慰剂治疗的女性[16/23,69.6%(50.8-88.4)]之间没有显著差异(RR 0.84,95%CI 0.54-1.29;P = 0.43)。同样,两组在任何次要结局测量指标上也没有显著差异。
我们的研究不支持在 TCRM 切除肌瘤前常规使用 GnRH 类似物,因为我们没有发现这种治疗有任何益处。