中国绝经管理与绝经激素治疗指南(2018)
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摘要
《中国绝经管理与绝经激素治疗指南(2018)》由中华医学会妇产科学分会绝经学组的全体专家在2012版指南基础上修订,并采纳了国内相关学术领域专家的修改意见,旨在指导医疗保健专业人士优化绝经过渡期及绝经后妇女的健康管理。本指南综合了本领域近年来的研究进展,也借鉴了近几年全球各大绝经学会相应指南中的重要信息,并纳入了证据水平和建议等级;保留了2012版指南中的规范绝经激素治疗(menopause hormone therapy,MHT)诊疗流程,并有所改进;增加了绝经的分期系统——生殖衰老研讨会分期+10,便于理解生殖衰老过程的临床、生物学、内分泌变化;肯定了MHT的最佳适应证是治疗血管舒缩症状(vasomotor symptoms,VMS)、生殖泌尿道萎缩相关问题和预防绝经相关的低骨量及骨质疏松症。MHT的风险取决于药物类型、剂量、使用时间、管理方式、启动时间以及是否使用孕激素。MHT应依据现有最好的证据个体化进行,定期重新评估是否继续或停止MHT,以获得最大收益及最小风险。对年龄小于60岁或绝经10年内无MHT禁忌证的妇女,针对VMS、骨量丢失和骨折,启动MHT治疗的收益风险比最高。只要无禁忌证,早发性卵巢功能不全患者应给予激素补充治疗至普通女性自然绝经的平均年龄,之后按照绝经后MHT原则进行。
This guideline has been announced by experts of Menopause Group,Obstetrics and Gynecology Branch,Chinese Medical Association on menopause management and menopause hormone therapy( MHT) to help healthcare professionals in optimizing their management of transitionally menopausal and postmenopausal women. New results on MHT and menopause management after 2012 as well as all of the important information from main international guidelines were reviewed. Levels of evidence and grades of recommendations were also included. The standardized MHT flowcharts of diagnosis and treatment were retained and improved from the last version. The menopause staging system,Stages of Reproductive Aging Workshop +10( STRAW+10),was added to facilitate the understanding on clinical,biological,and endocrine changes in the reproductive aging process for doctors in this field. Vasomotor symptoms( VMS),genitourinary syndrome of menopause,and prevention ofmenopause-related low bone mass and osteoporosis were reconfirmed as the indications for MHT. The risks of MHT depend on types,dosages,time of use,management,start-up time,and whether progesterone is used. To maximize the benefits and minimize the risks,MHT should be individualized based on the updated evidence,and the benefit-risk ratio should be reassessed annually. For women within 10 years after menopause,or younger than 60 years old with no contraindications,MHT for the treatment of VMS and prevention of bone loss and fractures has the most favorable benefit-risk ratio. Premature ovarian insufficiency patients should be treated with hormone replacement therapy till the average age of natural menopause and followed by the postmenopausal MHT.
This guideline has been announced by experts of Menopause Group,Obstetrics and Gynecology Branch,Chinese Medical Association on menopause management and menopause hormone therapy( MHT) to help healthcare professionals in optimizing their management of transitionally menopausal and postmenopausal women. New results on MHT and menopause management after 2012 as well as all of the important information from main international guidelines were reviewed. Levels of evidence and grades of recommendations were also included. The standardized MHT flowcharts of diagnosis and treatment were retained and improved from the last version. The menopause staging system,Stages of Reproductive Aging Workshop +10( STRAW+10),was added to facilitate the understanding on clinical,biological,and endocrine changes in the reproductive aging process for doctors in this field. Vasomotor symptoms( VMS),genitourinary syndrome of menopause,and prevention ofmenopause-related low bone mass and osteoporosis were reconfirmed as the indications for MHT. The risks of MHT depend on types,dosages,time of use,management,start-up time,and whether progesterone is used. To maximize the benefits and minimize the risks,MHT should be individualized based on the updated evidence,and the benefit-risk ratio should be reassessed annually. For women within 10 years after menopause,or younger than 60 years old with no contraindications,MHT for the treatment of VMS and prevention of bone loss and fractures has the most favorable benefit-risk ratio. Premature ovarian insufficiency patients should be treated with hormone replacement therapy till the average age of natural menopause and followed by the postmenopausal MHT.
引文
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[2] Baber RJ,Panay N,Fenton A. 2016 IMS Recommendations on women's midlife health and menopause hormone therapy[J]. Climacteric,2016,19:109-150.
[3]中华医学会妇产科学分会绝经学组.绝经期管理与激素补充治疗临床应用指南(2012版)[J].中华妇产科杂志,2013,48:795-799.
[4] Royal College of Obstetricians and Gynaecologists. Development of RCOG Greentop Guidelines(Clinical Governance Advice No. 1)[EB/OL]. http://www. rcog. org. uk/greentop-development.
[5] Harlow SD,Gass M,Hall JE,et al. Executive summary of the Stages of Reproductive Aging Workshop+10:addressing the unfinished agenda of staging reproductive aging[J]. Climacteric,2012,15:105-114.
[6]中国营养学会.中国居民膳食指南(2016)[M].北京:人民卫生出版社,2016:10-11.
[7] The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society[J]. Menopause,2017,24:728-753.
[8] Committee on Gynecologic Practice. Committee Opinion No.698:Hormone Therapy in Pri-mary Ovarian Insufficiency[J]. Obstet Gynecol,2017,129:e134-e141.
[9] Sarri G,Davies M,Lumsden MA,et al. Diagnosis and management of menopause:summary of NICE guidance[J].BMJ,2015,351:h5746.
[10] Rossouw JE,Anderson GL,Prentice RL,et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women:principal results From the Women's Health Initiative random-ized controlled trial[J]. JAMA, 2002, 288:321-333.
[11] Moen MH,Rees M,Brincat M,et al. EMAS position statement:managing the menopause in women with a past history of endometriosis[J]. Maturitas,2010,67:94-97.
[12] Gallos ID,Shehmar M,Thangaratinam S,et al. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia:a systematic review and metaanalysis[J]. Am J Obstet Gynecol,2010,203:541-547.
[13] American College of Obstetricians and Gynecologists. ACOG committee opinion no. 556:Postmenopausal estrogen therapy:route of administration and risk of venous thromboembolism[J]. Obstet Gynecol,2013,121:887-890.
[14] Bergendal A,Kieler H,Sundstrom A,et al. Risk of venous thromboembolism associated with local and systemic use of hormone therapy in peri-and postmenopausal women and in relation to type and route of administration[J]. Menopause,2016,23:593-599.
[15] Liu B,Beral V,Balkwill A,et al. Gallbladder disease and use of transdermal versus oral hormone replacement therapy in postmenopausal women:prospective cohort study[J]. BMJ,2008,337:a386.
[16] Canonico M. Hormone therapy and hemostasis among postmenopausal women:a review[J]. Menopause,2014,21:753-762.
[17]马薇,金泉秀,吴云飞,等.乳腺增生症诊治专家共识[J].中国实用外科杂志,2016,36:759-762.
[18] Rebbeck TR,Friebel T,Wagner T,et al. Effect of shortterm hormone replacement therapy on breast cancer risk reduction after bilateral prophylactic oophorectomy in BRCA1and BRCA2 mutation carriers:the PROSE Study Group[J].J Clin Oncol,2005,23:7804-7810.
[19] Cummings SR,Ettinger B,Delmas PD,et al. The effects of tibolone in older postmenopausal women[J]. N Engl J Med,2008,359:697-708.
[20] Somboonporn W,Panna S,Temtanakitpaisan T,et al. Effects of the levonorgestrel-releasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women:systematic review and meta-analysis[J]. Menopause,2011,18:1060-1066.
[21]中华医学会妇产科学分会绝经学组.绝经相关激素补充治疗的规范诊疗流程[J].中华妇产科杂志,2013,48:155-158.
[22] de Villiers TJ,Stevenson JC. The WHI:the effect of hormone replacement therapy on fracture prevention[J]. Climacteric,2012,15:263-266.
[23] Hawkes N. HRT increases risk of blood clots and stroke,finds new analysis[J]. BMJ,2015,350:h1336.
[24] L'Hermite M. HRT optimization,using transdermal estradiol plus micronized progesterone,a safer HRT[J]. Climacteric,2013,16:44-53.
[25] Schierbeck LL,Rejnmark L,Tofteng CL,et al. Effect of hormone replacement therapy on cardiovascular events in recently postmenopausal women:randomised trial[J]. BMJ,2012,345:e6409.
[26] Harman SM,Black DM,Naftolin F,et al. Arterial imagingoutcomes and cardiovascular risk factors in recently menopausal women:a randomized trial[J]. Ann Intern Med,2014,161:249-260.
[27] Hodis HN,Mack WJ, Henderson VW, et al. Vascular Effects of Early versus Late Postmeno-pausal Treatment with Estradiol[J]. N Engl J Med,2016,374:1221-1231.
[28] Gleason CE,Dowling NM,Wharton W,et al. Effects of Hormone Therapy on Cognition and Mood in Recently Postmenopausal Women:Findings from the Randomized,Controlled KEEPS-Cognitive and Affective Study[J]. PLoS Med,2015,12:e1001833,e1001833.
[29] Bitoska I,Krstevska B,Milenkovic T,et al. Effects of Hormone Replacement Therapy on Insulin Resistance in Postmenopausal Diabetic Women[J]. Open Access Maced J Med Sci,2016,4:83-88.
[30] Stuenkel CA. Menopause, hormone therapy and diabetes[J]. Climacteric,2017,20:11-21.
[31] Maggiolini M,Picard D. The unfolding stories of GPR30,a new membrane-bound estrogen receptor[J]. J Endocrinol,2010,204:105-114.
[32] Greising SM,Baltgalvis KA,Lowe DA,et al. Hormone therapy and skeletal muscle strength:a meta-analysis[J]. J Gerontol A Biol Sci Med Sci,2009,64:1071-1081.
[33] Davey DA. Menopausal hormone therapy:a better and safer future[J]. Climacteric, 2018:1-8. doi:10. 1080/13697137. 2018. 1439915.[Epub ahead of print].
[34] Kotsopoulos J,Gronwald J,Karlan BY,et al. Hormone Replacement Therapy After Oopho-rectomy and Breast Cancer Risk Among BRCA1 Mutation Carriers[J]. JAMA Oncol,2018. doi:10. 1001/jamaoncol. 2018. 0211.[Epub ahead of print].
[35] Stute P,Wildt L,Neulen J. The impact of micronized progesterone on breast cancer risk:a systematic review[J]. Climacteric,2018,21:111-122.
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