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外文期刊>Health technology assessment: HTA
>Hysterectomy, endometrial ablation and Mirena(R) for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis.
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Hysterectomy, endometrial ablation and Mirena(R) for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis.
OBJECTIVE: The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena(R) (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. DESIGN: Individual patient data (IPD) meta-analysis of existing randomised controlled trials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and second-generation ablative techniques and Mirena. SETTING: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. PARTICIPANTS: Women who were undergoing treatment for heavy menstrual bleeding were included. INTERVENTIONS: Hysterectomy, first- and second-generation EA, and Mirena. MAIN OUTCOME MEASURES: Satisfaction, recurrence of symptoms, further surgery and costs. RESULTS: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference) 3.0 days, 95% CI 2.9 to 3.1 days; p < 0.00001] and time to resumption of normal activities (WMD 5.2 days, 95% CI 4.7 to 5.7 days; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7-10.8) and 11.6 (7.9-14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated first-generation EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with second-generation ablation were pound1440 per additional QALY and pound970 per additional QALY, respectively. CONCLUSIONS: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA.
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机译：目的:这个项目的目的是确定临床有效性和成本效益的子宫切除术,首先,第二代子宫内膜消融(EA)宫内节育器曼月乐(R)(拜耳医疗药品,美国宾夕法尼亚州匹兹堡)治疗重月经出血。数据(IPD)现有随机的荟萃分析对照试验来确定短期中期子宫切除术的影响,EA和宫内节育器曼月乐。根据记录链接调查研究烧蚀技术和长期影响子宫切除术的失败率并发症。子宫切除术与第一代和第二代烧蚀技术和宫内节育器曼月乐。从女性治疗重型月经出血获得国家和国际吗试用苏格兰信息服务部门。参与者:妇女接受治疗为沉重的月经出血了。干预措施:子宫切除术,第一,第二代EA,宫内节育器曼月乐。措施:满意度、复发的症状,进一步的手术和成本。随机试验表明,在12个月更多的女性都不满意第一代EA比子宫切除术(比值比(或):2.46,95%可信区间(CI) 1.543.93;(加权平均差)3.0天,95% CI 2.93.1天;正常的活动(大规模杀伤性武器5.2天,95% CI 4.75.7天;子宫切除术。与第一代和第二代技术可比[12.2%(123/1006)和10.6% (110/1034);或1.20,95%可信区间0.88到1.62;宫内节育器曼月乐和第二代的不满EA相似[18.1%(17/94)和22.5% (23/102);或0.76,95%可信区间0.38到1.53;估计建议子宫切除术也比第二代EA(或2.32,95%可信区间1.27 - 4.24;的不满。子宫切除术比宫内节育器曼月乐是较弱的(或2.22,95%可信区间0.94到5.29;女性被EA或子宫切除和跟随的中位数(四分位范围(差))持续时间6.2(2.7 - -10.8)和11.6 (7.9 - -14.8)年,分别962/11,299(8.5%)的女性最初由EA接受进一步治疗妇科手术。两组手术是类似的调整危险比为0.80 (95% CI 0.56 - 1.15)),女性谁经历了烧蚀的可能性更低需要盆底修复(危害比调整0.62 (95% CI 0.50 - 0.77)]和张力阴道带手术压力尿尿失禁(调整危险比0.55(95%可信区间0.41到0.74)。较低的盆底修复手术的机会(危害比为0.54(95%可信区间0.45到0.64)]阴道子宫切除术。子宫内膜癌在EA是0.02%。子宫切除术是最划算的治疗。虽然比较贵,生产更多质量调整寿命(提升)第二代EA和宫内节育器曼月乐。成本效益比率子宫切除术与宫内节育器曼月乐,子宫切除术相比与第二代pound1440消融每额外QALY pound970每额外的分别提升。住院和恢复正常的时间活动,更多的女性感到满意子宫切除术后EA。
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