Dickersin Kay, Munro Malcolm G, Clark Melissa, Langenberg Patricia, Scherer Roberta, Frick Kevin, Zhu Qi, Hallock Linda, Nichols John, Yalcinkaya Tamer M
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205, USA.
Obstet Gynecol. 2007 Dec;110(6):1279-89. doi: 10.1097/01.AOG.0000292083.97478.38.
To compare the effectiveness of hysterectomy and endometrial ablation in women with dysfunctional uterine bleeding.
The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding was a multicenter, randomized controlled trial. Eligible women were premenopausal with dysfunctional uterine bleeding and aged 18 years or older. Primary outcomes were problems that led the woman to seek care solved, bleeding, pain, and fatigue at 12 months. Additional outcomes included quality of life, adverse events, reoperation, and others at 24 months and up to 5 years.
We randomly assigned 237 women between January 1998 and June 2001. Follow-up ended in June 2003. We completed 24 months of follow-up on 114 of 123 women assigned to endometrial ablation and 111 of 114 assigned to hysterectomy. Approximately 85% of women were aged younger than 45 years; 76.4% classified themselves as white, 18.6% as African American, less than 1% as Asian, 4.6% as American Indian, and 8.4% as Hispanic (classification within more than one category possible). Both endometrial ablation and hysterectomy were effective at 24 months in solving the problem that led women to seek care (84.9% compared with 94.4%), and in relieving bleeding, pain, fatigue, and other symptoms, although hysterectomy was more effective for bleeding. By 48 months, 32 of the 110 women initially receiving endometrial ablation required reoperation. Adverse events were more frequent with hysterectomy.
Both endometrial ablation and hysterectomy are effective treatments in women with dysfunctional uterine bleeding. Hysterectomy (as the index surgery) was associated with more adverse events and a substantial number of patients receiving endometrial ablation had reoperation.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00114088
I.
比较子宫切除术与子宫内膜去除术治疗功能失调性子宫出血的疗效。
功能失调性子宫出血手术治疗结果项目是一项多中心随机对照试验。符合条件的女性为18岁及以上的绝经前功能失调性子宫出血患者。主要结局为在12个月时使女性寻求治疗的问题得到解决、出血、疼痛和疲劳情况。其他结局包括24个月及长达5年时的生活质量、不良事件、再次手术情况等。
1998年1月至2001年6月期间，我们随机分配了237名女性。随访于2003年6月结束。在分配接受子宫内膜去除术的123名女性中的114名以及分配接受子宫切除术的114名中的111名中，我们完成了24个月的随访。约85%的女性年龄小于45岁；76.4%将自己归类为白人，18.6%为非裔美国人，不到1%为亚洲人，4.6%为美洲印第安人，8.4%为西班牙裔（可能属于多个类别）。子宫内膜去除术和子宫切除术在24个月时均有效地解决了使女性寻求治疗的问题（分别为84.9%和94.4%），并缓解了出血、疼痛、疲劳及其他症状，尽管子宫切除术在治疗出血方面更有效。到48个月时，最初接受子宫内膜去除术的110名女性中有32名需要再次手术。子宫切除术的不良事件更频繁。
子宫内膜去除术和子宫切除术都是治疗功能失调性子宫出血的有效方法。子宫切除术（作为索引手术）与更多不良事件相关，并且大量接受子宫内膜去除术的患者需要再次手术。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00114088
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