Shaw Robert W, Symonds Ian M, Tamizian Onnig, Chaplain Julie, Mukhopadhyay Sambit
Academic Division of Obstetrics and Gynaecology, University of Nottingham, Derby, UK.
Aust N Z J Obstet Gynaecol. 2007 Aug;47(4):335-40. doi: 10.1111/j.1479-828X.2007.00747.x.
To compare the effectiveness of thermal balloon ablation (TBA) and levonorgestrel intrauterine system (LNG-IUS) in the management of idiopathic menorrhagia and changes in pictorial blood loss assessment chart (PBAC) scores in patients who had failed on oral medical treatment.
Phase III, single-centre, open randomised controlled trial. Following full screening and evaluation of 104 women, 33 were randomised to TBA and 33 to LNG-IUS. Primary outcomes were changes in PBAC scores from baseline to 12 months. Secondary outcomes were changes in haemoglobin and serum ferritin, at six months, continuation with treatment and hysterectomy rates at two years and changes in PBAC scores at three, six and nine months.
All patients randomised had a PBAC score of > or = 120. At all assessment times, median PBAC scores were less than baseline, the greatest reductions being seen at 12 months for both treatments. When the median PBAC for the LNG-IUS (26 (0-68)) was significantly different to the median PBAC for the TBA cohort (62 (0-142)) P < 0.001. Irregular bleeding problems were the most common reason for discontinuation of the LNG-IUS and resulted in more women (39.8%) seeking other treatment by two years than the TBA (23.1%) (P < 0.05) and more undergoing a hysterectomy (20.7% vs 13.3%, respectively) (p > 0.05). Patient acceptability of the LNG-IUS and TBA was similar at 12 and 24 months in terms of their perceived satisfaction of effect on menorrhagia.
Both TBA and LNG-IUS achieved significant decreases in PBAC scores, with those for the LNG-IUS being significantly greater at 12 months. However, prolonged days of bleeding resulted in fewer women continuing with the LNG-IUS at two years.
比较热球囊消融术（TBA）和左炔诺孕酮宫内节育系统（LNG-IUS）治疗特发性月经过多的有效性，以及口服药物治疗失败患者的图像失血评估图（PBAC）评分变化。
III期单中心开放随机对照试验。在对104名女性进行全面筛查和评估后，33名被随机分配至TBA组，33名被随机分配至LNG-IUS组。主要结局是从基线到12个月时PBAC评分的变化。次要结局是6个月时血红蛋白和血清铁蛋白的变化、两年时的持续治疗率和子宫切除率，以及3个月、6个月和9个月时PBAC评分的变化。
所有随机分组的患者PBAC评分均≥120。在所有评估时间点，PBAC评分中位数均低于基线，两种治疗在12个月时下降幅度最大。LNG-IUS组的PBAC评分中位数为26（0 - 68），与TBA组的中位数62（0 - 142）有显著差异，P < 0.001。不规则出血问题是停用LNG-IUS最常见的原因，导致两年内寻求其他治疗的女性（39.8%）多于TBA组（23.1%）（P < 0.05），接受子宫切除术的女性也更多（分别为20.7%和13.3%）（P > 0.05）。就对月经过多的治疗效果满意度而言，LNG-IUS和TBA在12个月和24个月时的患者接受度相似。
TBA和LNG-IUS均使PBAC评分显著降低，LNG-IUS在12个月时降低幅度更大。然而，出血天数延长导致两年内继续使用LNG-IUS的女性较少。
