提示: 手机请竖屏浏览!

子宫肌瘤行子宫动脉栓塞术与子宫肌瘤切除术的比较
Uterine-Artery Embolization or Myomectomy for Uterine Fibroids


Isaac Manyonda ... 妇产科和儿科 • 2020.07.30
相关阅读
• 子宫肌瘤的药物治疗既应考虑GnRH激动剂也应考虑GnRH拮抗剂 • 药物治疗改善子宫肌瘤患者的生活质量 • 子宫肌瘤所致月经过多的激素治疗方案

摘要


背景

子宫肌瘤是育龄女性最多发的肿瘤类型,并且与月经大量出血、腹部不适、生育力低下和生活质量下降相关。对于希望保留子宫和药物治疗无效的女性,子宫肌瘤切除术和子宫动脉栓塞术是可选治疗方案。

 

方法

我们开展了一项多中心、随机、开放标签试验,目的是在不愿意接受子宫切除术的有症状子宫肌瘤患者中评估子宫肌瘤切除术,并与子宫动脉栓塞术进行比较。子宫肌瘤切除术的可选术式包括开腹、腹腔镜或宫腔镜手术。主要结局是2年时,应用子宫肌瘤症状和生活质量(Uterine Fibroid Symptom and Quality of Life,UFS-QOL)问卷的健康相关生活质量维度评分(评分范围为0~100分,评分较高表示生活质量较好)判定的子宫肌瘤相关生活质量;此项分析针对基线评分进行了校正。

 

结果

我们将英国29家医院招募的共计254名女性随机分组:子宫肌瘤切除术组127名(其中105名接受了子宫肌瘤切除术),子宫动脉栓塞术组127名(其中98名接受了栓塞术)。我们获得了206名女性(81%)的主要结局。在意向治疗分析中,在子宫肌瘤切除术组和子宫动脉栓塞术组中,2年时UFS-QOL问卷的健康相关生活质量维度平均(±SD)评分分别为84.6±21.5分和80.0±22.0分(完整病例分析中的平均校正差异,8.0分;95%置信区间[CI],1.8~14.1;P=0.01。对缺失回复进行填补后的平均校正差异,6.5分;95% CI,1.1~11.9)。在所有初次手术(不论是否遵循分配的手术)中,子宫肌瘤切除术组29%的女性和子宫动脉栓塞术组24%的女性发生了围手术期和术后并发症。

 

结论

在有症状的子宫肌瘤患者中,接受子宫肌瘤切除术的女性在2年时的子宫肌瘤相关生活质量优于接受子宫动脉栓塞术的女性(由英国国家卫生研究院医疗技术评估计划[National Institute for Health Research Health Technology Assessment Program]资助;FEMME在Current Controlled Trials注册号为ISRCTN70772394)。





作者信息

Isaac Manyonda, Ph.D., Anna-Maria Belli, F.R.C.R., Mary-Ann Lumsden, M.D., Jonathan Moss, M.B., Ch.B., William McKinnon, Ph.D., Lee J. Middleton, M.Sc., Versha Cheed, M.Sc., Olivia Wu, Ph.D., Fusun Sirkeci, M.D., Jane P. Daniels, Ph.D., and Klim McPherson, Ph.D. for the FEMME Collaborative Group*
From St. George’s Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) — all in the United Kingdom. Address reprint requests to Dr. Daniels at the Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham NG7 2RD, United Kingdom, or at jane.daniels@nottingham.ac.uk. *A complete list of investigators in the FEMME Collaborative Group is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG 2017;124:1501-1512.

2. Lurie S, Piper I, Woliovitch I, Glezerman M. Age-related prevalence of sonographicaly confirmed uterine myomas. J Obstet Gynaecol 2005;25:42-44.

3. Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet 2015;131:117-122.

4. Downes E, Sikirica V, Gilabert-Estelles J, et al. The burden of uterine fibroids in five European countries. Eur J Obstet Gynecol Reprod Biol 2010;152:96-102.

5. Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol 2013;209(4):319.e1-319.e20.

6. Somigliana E, Vercellini P, Daguati R, Pasin R, De Giorgi O, Crosignani PG. Fibroids and female reproduction: a critical analysis of the evidence. Hum Reprod Update 2007;13:465-476.

7. Pritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril 2009;91:1215-1223.

8. Sundermann AC, Velez Edwards DR, Bray MJ, Jones SH, Latham SM, Hartmann KE. Leiomyomas in pregnancy and spontaneous abortion: a systematic review and meta-analysis. Obstet Gynecol 2017;130:1065-1072.

9. Metwally M, Cheong YC, Horne AW. Surgical treatment of fibroids for subfertility. Cochrane Database Syst Rev 2012;11:CD003857-CD003857.

10. Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol 2008;31:73-85.

11. Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli A-M. Uterine artery embolization versus myomectomy: impact on quality of life — results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol 2012;35:530-536.

12. Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev 2012;5:CD005073-CD005073.

13. El Shamy T, Amer SAK, Mohamed AA, James C, Jayaprakasan K. The impact of uterine artery embolization on ovarian reserve: a systematic review and meta-analysis. Acta Obstet Gynecol Scand 2020;99:16-23.

14. Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol 2006;126:226-233.

15. Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002;99:290-300.

16. Harding G, Coyne KS, Thompson CL, Spies JB. The responsiveness of the Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL). Health Qual Life Outcomes 2008;6:99-106.

17. Coyne KS, Margolis MK, Murphy J, Spies J. Validation of the UFS-QOL-hysterectomy questionnaire: modifying an existing measure for comparative effectiveness research. Value Health 2012;15:674-679.

18. Flyckt R, Soto E, Nutter B, Falcone T. Comparison of long-term fertility and bleeding outcomes after robotic-assisted, laparoscopic, and abdominal myomectomy. Obstet Gynecol Int 2016;2016:2789201-2789201.

19. Goodwin SC, Spies JB, Worthington-Kirsch R, et al. Uterine artery embolization for treatment of leiomyomata: long-term outcomes from the FIBROID Registry. Obstet Gynecol 2008;111:22-33.

20. Narayan A, Lee AS, Kuo GP, Powe N, Kim HS. Uterine artery embolization versus abdominal myomectomy: a long-term clinical outcome comparison. J Vasc Interv Radiol 2010;21:1011-1017.

21. Edwards RD, Moss JG, Lumsden MA, et al. Uterine-artery embolization versus surgery for symptomatic uterine fibroids. N Engl J Med 2007;356:360-370.

22. Jun F, Yamin L, Xinli X, et al. Uterine artery embolization versus surgery for symptomatic uterine fibroids: a randomized controlled trial and a meta-analysis of the literature. Arch Gynecol Obstet 2012;285:1407-1413.

23. McPherson K, Manyonda I, Lumsden M-A, et al. A randomised trial of treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy (the FEMME study): study protocol for a randomised controlled trial. Trials 2014;15:468-468.

24. EuroQol Group. EuroQol — a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.

25. Higham JM, O’Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990;97:734-739.

26. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005;14:1523-1532.

27. Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. New York: Springer, 2000.

28. Little RJ, Rubin DB. Statistical analysis with missing data. 2nd ed. New York: John Wiley, 2002.

29. Cohen J. Statistical power analysis for the behavioral sciences. Abingdon-on-Thames, United Kingdom: Routledge, 1977.

30. Fonseca MCM, Castro R, Machado M, Conte T, Girao MJBC. Uterine artery embolization and surgical methods for the treatment of symptomatic uterine leiomyomas: a systemic review and meta-analysis followed by indirect treatment comparison. Clin Ther 2017;39(7):1438.e2-1455.e2.

服务条款 | 隐私政策 | 联系我们