左炔诺孕酮宫内节育系统与低剂量复方口服避孕药治疗特发性月经过多的随机临床试验比较。
Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial.
机构信息
Faculty of Medicine, Department of Obstetrics and Gynecology, Assiut University, Assiut 71526, Egypt.
出版信息
Contraception. 2011 Jan;83(1):48-54. doi: 10.1016/j.contraception.2010.06.011. Epub 2010 Aug 7.
BACKGROUND
This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia.
STUDY DESIGN
A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities.
RESULTS
At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean ± S.D.) (39.3 ± 6.7 vs. 38.7 ± 5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean ± S.D.) (29.6 ± 5.9 vs. 31.1 ± 5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean ± S.D.) was significantly more in the LNG-IUS group (87.4 ± 11.3%) compared to the COC group (34.9 ± 76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6 ± 17.0%) group was significantly more compared to the COC group (2.5 ± 93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean ± S.D.) were noted (from 10.2 ± 1.3 to 11.4 ± 1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8 ± 2.6 to 1.6 ± 2.4 days, p=.003).
CONCLUSION
The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC.
背景
本研究比较了左炔诺孕酮宫内释放系统（LNG-IUS）与低剂量复方口服避孕药（COC）在治疗特发性月经过多中的疗效。
研究设计
一项单中心、开放、随机临床试验。112 名因月经过多而寻求避孕的女性抱怨过度月经，随机分为 LNG-IUS 或 COC 组。治疗失败定义为在随访期间需要医疗或手术治疗。其他结局包括：碱性血红素和图示出血评估图表（PBLAC）评估的月经出血量（MBL）、血红蛋白水平和评估因身体或精神健康而导致参与女性无法进行日常活动的天数。
结果
在基线时，LNG-IUS（n=56）和 COC（n=56）组在年龄（均值±标准差）（39.3±6.7 岁 vs. 38.7±5.2 岁，p=.637）、产次（中位数和范围）[3（1-6.4）vs.3（2-6），p=.802]和 BMI（均值±标准差）（29.6±5.9 千克/米² vs. 31.1±5.7 千克/米²，p=.175）方面无差异。LNG 组的治疗失败时间长于 COC 组，LNG-IUS 组共有 6 名（11%）患者治疗失败，而 COC 组有 18 名（32%）患者治疗失败，风险比为 0.30（95%CI，0.15-0.73，p=.007）。使用碱性血红素，LNG-IUS 组的 MBL 减少（均值±标准差）明显大于 COC 组（87.4±11.3% vs. 34.9±76.9%，p=.013）。使用 PBLAC 评分，LNG-IUS 组（86.6±17.0%）的 MBL 减少明显大于 COC 组（2.5±93.2%，p<.001）。在 LNG-IUS 组，血红蛋白和铁蛋白水平（均值±标准差）升高（从 10.2±1.3 克/分升升至 11.4±1.0 克/分升；p<.001；失血量减少（从 6.8±2.6 天减少至 1.6±2.4 天，p=.003）。
结论
与 COC 相比，LNG-IUS 是治疗特发性月经过多更有效的方法。
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