今日の臨床サポート

萎縮性腟炎

著者: 金井誠 信州大学 保健学科

監修: 小林裕明 鹿児島大学大学院医歯学総合研究科生殖病態生理学

著者校正/監修レビュー済:2021/02/24
参考ガイドライン:
  1. 日本産科婦人科学会:産婦人科診療ガイドライン-婦人科外来編2020
  1. 日本女性医学学会:ホルモン補充療法ガイドライン2017年度版
患者向け説明資料

概要・推奨   

  1. 症状のある萎縮性腟炎の治療は、エストリオール腟錠の使用が推奨される。腟錠の使用が困難な場合には、エストロゲンの全身投与が推奨される。性交痛を伴う場合は潤滑ゼリーの使用が推奨される(全て推奨度1)。
  1. 萎縮性腟炎の症状に更年期障害を伴う場合は、ホルモン補充療法が推奨される(推奨度2)。
  1. ホルモン補充療法は、子宮摘出後の症例にはエストロゲンのみを、子宮を有する症例にはエストロゲンと黄体ホルモンを使用することが推奨される(推奨度2)。
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧に
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
金井誠 : 特に申告事項無し[2021年]
監修:小林裕明 : 講演料(中外製薬株式会社,アストラゼネカ株式会社),奨学(奨励)寄付など(中外製薬株式会社)[2021年]

改訂のポイント:
  1. 産婦人科診療ガイドライン-婦人科外来編とホルモン補充療法ガイドラインの改訂、および評価・治療例(オーダーセット)の掲載中止に基づき、確認と修正を行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 萎縮性膣炎は、閉経後の女性に比較的多く認める疾患であり、60歳以上の健康女性の約半数に何らかの腟萎縮症状を認めるとの報告もある[1]
  1. 低エストロゲン状態が原因となり、腟壁や外陰皮膚が萎縮することによる炎症症状を認める。腟内の自浄作用が低下することによる細菌性腟症を呈することもある。
  1. 無症状の場合や特に症状が気にならない場合には、必ずしも治療は必要でない。
  1. 症状が気になる場合には、エストロゲン製剤を使用する。細菌性腟症を認める場合には、細菌性腟症に対する治療 を併用する。
問診・診察のポイント  
  1. 月経歴などの問診から、低エストロゲン状態であることを確認する。

今なら12か月分の料金で14ヶ月利用できます(個人契約、期間限定キャンペーン)

11月30日(火)までにお申込みいただくと、
通常12ヵ月の使用期間が2ヶ月延長となり、14ヵ月ご利用いただけるようになります。

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文献 

著者: J Suckling, A Lethaby, R Kennedy
雑誌名: Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001500. doi: 10.1002/14651858.CD001500.pub2. Epub 2006 Oct 18.
Abstract/Text BACKGROUND: Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring).
OBJECTIVES: The objective of this review was to compare the effectiveness, safety and acceptability of oestrogenic preparations for women who suffer from vaginal atrophy.
SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Register of trials (searched January 2006), The Cochrane Library (2006,Issue 2), MEDLINE (1966 to January 2006), EMBASE (1980 to January 2006), Current Contents (1993 to January 2006, Biological Abstracts (1969 to 2006), Social Sciences Index (1980 to January 2006), PsycINFO (1972 to February 2006), CINAHL (1982 to January 2006) and reference list of articles. We also contacted manufacturers and researchers in the field.
SELECTION CRITERIA: The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
DATA COLLECTION AND ANALYSIS: Thirty-seven trials were identified: of these 18 were excluded. Included trials were assessed for quality and two reviewer authors extracted data independently. The ratios for dichotomous outcomes and means for continuous outcomes were calculated. The outcomes analysed were categorised under the headings of: efficacy, safety and acceptability.
MAIN RESULTS: Nineteen trials with 4162 women were included in this review. The overall quality of the studies was good, although not all trials measured the same outcomes. All trials measured efficacy, with various outcome measures. When comparing the efficacy of different oestrogenic preparations (in the form of creams, pessaries, tablets and the oestradiol-releasing vaginal ring) in relieving the symptoms of vaginal atrophy, results indicated significant findings favouring the cream, ring, and tablets when compared to placebo and non-hormonal gel. Fourteen trials compared safety. Four looked at hyperplasia, four looked at endometrial overstimulation and seven looked at adverse effects. One trial showed significant adverse effects of the cream (conjugated equine oestrogen) when compared to tablets (oestradiol) which included uterine bleeding, breast pain and perineal pain (1 RCT; OR 0.18, 95% CI 0.07 to 0.50). Two trials showed significant endometrial overstimulation as evaluated by a progestagen challenge test with the cream (conjugated equine oestrogen) group when compared to the ring (OR 0.29, 95% CI 0.11 to 0.78). Although not statistically significant there was a 2% incidence of simple hyperplasia in the ring group when compared to the cream (conjugated equine oestrogen) and 4% incidence of hyperplasia (one simple, one complex) in the cream group (conjugated equine oestrogen) when compared to the tablet (oestradiol). Eleven studies compared acceptability to the participants by comparing: comfort of product use, ease of use, overall product rating, delivery system and satisfaction. Results showed a significant preference for the oestradiol-releasing vaginal ring.
AUTHORS' CONCLUSIONS: Creams, pessaries, tablets and the oestradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following use of the cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the oestradiol-releasing vaginal ring for ease of use, comfort of product and overall satisfaction.

PMID 17054136  Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001500. d・・・
著者: L Cardozo, G Bachmann, D McClish, D Fonda, L Birgerson
雑誌名: Obstet Gynecol. 1998 Oct;92(4 Pt 2):722-7.
Abstract/Text OBJECTIVE: To evaluate the efficacy of estrogen therapy in the treatment of postmenopausal women with symptoms and signs associated with urogenital atrophy, by meta-analysis of available data.
METHODS: We searched the literature (Excerpta Medica, Biosis, MEDLINE, and hand search) for studies published between January 1969 and April 1995. Criteria for inclusion were English-language articles, peer-reviewed original publications, and urogenital atrophy assessed by at least one of the following outcomes: patient symptoms, physician report, pH, or cytologic change. Data had to allow comparison between treated and control groups in controlled trials or an estimated change from baseline in uncontrolled series. Meta-analytic methods were applied separately to controlled clinical trials and uncontrolled studies.
RESULTS: Of the 77 relevant articles reviewed, nine contained ten randomized controlled trials. Meta-analysis of these using the Stouffer method revealed a statistically significant benefit of estrogen therapy for all outcomes studied. In 54 uncontrolled case series, the patient symptoms were treated by 24 different treatment modalities. All routes of administration appeared to be effective and maximum benefit was obtained between 1 and 3 months after the start of treatment. As expected, the least systemic absorption of estrogen was seen with estriol (administered orally or vaginally), then vaginal estradiol as measured by pretherapy and posttherapy serum estradiol and estrone.
CONCLUSION: Estrogen is efficacious in the treatment of urogenital atrophy and low-dose vaginal estradiol preparations are as effective as systemic estrogen therapy in the treatment of urogenital atrophy in postmenopausal women.

PMID 9764689  Obstet Gynecol. 1998 Oct;92(4 Pt 2):722-7.
著者: R Raz, W E Stamm
雑誌名: N Engl J Med. 1993 Sep 9;329(11):753-6. doi: 10.1056/NEJM199309093291102.
Abstract/Text BACKGROUND: Recurrent urinary tract infections are a problem for many postmenopausal women. Estrogen replacement restores atrophic mucosa, lowers vaginal pH, and may prevent urinary tract infections.
METHODS: We enrolled 93 postmenopausal women with a history of recurrent urinary tract infections in a randomized, double-blind, placebo-controlled trial of a topically applied intravaginal estriol cream. Midstream urine cultures were obtained at enrollment, monthly for eight months, and whenever urinary symptoms occurred. Vaginal cultures and pH measurements were obtained at entry and after one and eight months. The women were assigned to receive either estriol (n = 50) or placebo (n = 43), both administered intravaginally; 36 and 24, respectively, completed the eight months of follow-up.
RESULTS: The incidence of urinary tract infection in the group given estriol was significantly reduced as compared with that in the group given placebo (0.5 vs. 5.9 episodes per patient-year, P < 0.001). Survival analysis showed that more of the women in the estriol group than in the placebo group remained free of urinary tract infection (P < 0.001). Lactobacilli were absent in all vaginal cultures before treatment and reappeared after one month in 22 of 36 estriol-treated women (61 percent) but in none of the 24 placebo recipients (P < 0.001). With estriol the mean vaginal pH declined from 5.5 to 3.8 (P < 0.001), whereas there was no significant change with placebo. The rate of vaginal colonization with Enterobacteriaceae fell from 67 percent to 31 percent in estriol recipients but was virtually unchanged (from 67 to 63 percent) in the placebo recipients (P < 0.005). Side effects were minor, but caused 10 estriol recipients (28 percent) and 4 placebo recipients (17 percent) to discontinue treatment.
CONCLUSIONS: The intravaginal administration of estriol prevents recurrent urinary tract infection in postmenopausal women, probably by modifying the vaginal flora.

PMID 8350884  N Engl J Med. 1993 Sep 9;329(11):753-6. doi: 10.1056/NE・・・
著者: North American Menopause Society
雑誌名: Menopause. 2012 Mar;19(3):257-71. doi: 10.1097/gme.0b013e31824b970a.
Abstract/Text OBJECTIVE: This position statement aimed to update the evidence-based position statement published by The North American Menopause Society (NAMS) in 2010 regarding recommendations for hormone therapy (HT) for postmenopausal women. This updated position statement further distinguishes the emerging differences in the therapeutic benefit-risk ratio between estrogen therapy (ET) and combined estrogen-progestogen therapy (EPT) at various ages and time intervals since menopause onset.
METHODS: An Advisory Panel of expert clinicians and researchers in the field of women's health was enlisted to review the 2010 NAMS position statement, evaluate new evidence, and reach consensus on recommendations. The Panel's recommendations were reviewed and approved by the NAMS Board of Trustees as an official NAMS position statement.
RESULTS: Current evidence supports the use of HT for perimenopausal and postmenopausal women when the balance of potential benefits and risks is favorable for the individual woman. This position statement reviews the effects of ET and EPT on many aspects of women's health and recognizes the greater safety profile associated with ET.
CONCLUSIONS: Recent data support the initiation of HT around the time of menopause to treat menopause-related symptoms and to prevent osteoporosis in women at high risk of fracture. The more favorable benefit-risk ratio for ET allows more flexibility in extending the duration of use compared with EPT, where the earlier appearance of increased breast cancer risk precludes a recommendation for use beyond 3 to 5 years.

PMID 22367731  Menopause. 2012 Mar;19(3):257-71. doi: 10.1097/gme.0b01・・・
著者: Society of Obstetricians and Gynaecologists of Canada
雑誌名: Int J Gynaecol Obstet. 2005 Feb;88(2):222-8.
Abstract/Text OBJECTIVE: To support the practitioner in the diagnosis of vaginal atrophy and in the management of the related symptoms.
OPTIONS: The modalities of evaluation range from basic pelvic examination, examination of the vulva, and laboratory tests.
OUTCOMES: A comprehensive approach to the detection of vaginal atrophy and a discussion of available therapeutic and nontherapeutic options.
EVIDENCE: Published opinions of experts, supplemented by evidence from clinical trials, where appropriate.
VALUES: The quality of the Force on the Periodic Health Examination.
BENEFITS, HARMS AND COSTS: Diagnosis of vaginal atrophy is often a challenge because women are unwilling to report symptoms, which have the potential to significantly decrease their quality of life. Increased clinical suspicion is the first step in the diagnosis of vaginal atrophy, which will prompt the initiation of safe therapies with proven efficacy.
RECOMMENDATIONS: (1) Health-care providers should routinely assess postmenopausal women for the symptoms and signs of vaginal atrophy, a common condition that exerts significant negative effects on quality of life. (III-C) (2) Regular sexual activity should be encouraged to maintain vaginal health. (II-2B) (3) Women experiencing recurrent urinary tract infections should be instructed that consumption of pure cranberry-lingonberry juice, rather than cranberry drink, will decrease their risk of urinary infections. (I-A) (4) Vaginal moisturizers applied on a regular basis have an efficacy equivalent to local hormone replacement for the treatment of local urogenital symptoms such as vaginal itching, irritation, and dyspareunia, and should be offered to women wishing to avoid the use of hormone replacement therapy. (I-A) (5) Women experiencing vaginal atrophy can be offered any of the following effective vaginal estrogen replacement therapies: conjugated equine estrogen (CEE) cream (I-A), a sustained-release intravaginal estradiol ring (I-A), or a low-dose estradiol tablet. (I-A) (6) Although systematic absorption of estrogen can occur with local preparations, there is insufficient data to recommend annual endometrial surveillance in asymptomatic women using local estrogens. (III-C) (7) For menopausal women experiencing recurrent urinary tract infections and who have no contraindication to local hormone replacement, vaginal estrogen therapy should be offered. (I-A) VALIDATION: These guidelines have been reviewed by the joint committee of Clinical Practice Gynaecology and Urogynaecology and approved by the Execute and Council of the Society of Obstetricians and Gynaecologists of Canada.
SPONSOR: The Society of Obstetricians and Gynaecologists of Canada.

PMID 15779109  Int J Gynaecol Obstet. 2005 Feb;88(2):222-8.
著者: Rhoda H Cobin, Walter Futterweit, Samara Beth Ginzburg, Neil F Goodman, Michael Kleerekoper, Angelo A Licata, A Wayne Meikle, Steven M Petak, Karen L Porte, Rena V Sellin, Keith D Smith, M Antonia Verso, Nelson B Watts, AACE Menopause Guidelines Revision Task Force
雑誌名: Endocr Pract. 2006 May-Jun;12(3):315-37. doi: 10.4158/EP.12.3.315.
Abstract/Text
PMID 16772207  Endocr Pract. 2006 May-Jun;12(3):315-37. doi: 10.4158/E・・・
著者: American College of Obstetricians and Gynecologists Women's Health Care Physicians
雑誌名: Obstet Gynecol. 2004 Oct;104(4 Suppl):106S-117S. doi: 10.1097/01.AOG.0000138795.50777.af.
Abstract/Text
PMID 15458941  Obstet Gynecol. 2004 Oct;104(4 Suppl):106S-117S. doi: 1・・・
著者: E Weiderpass, J A Baron, H O Adami, C Magnusson, A Lindgren, R Bergström, N Correia, I Persson
雑誌名: Lancet. 1999 May 29;353(9167):1824-8. doi: 10.1016/S0140-6736(98)10233-7.
Abstract/Text BACKGROUND: Urogenital symptoms are common among postmenopausal women. Such symptoms may be alleviated by low-potency oestrogen formulations administered orally or vaginally. Although low-potency oestrogen formulations are assumed to have few, if any, adverse effects on the endometrium, risk of endometrial neoplasia has not been quantified.
METHODS: In a nationwide population-based case-control study in Sweden of endometrial cancer among postmenopausal women, we obtained detailed information on hormone replacement from 789 cases of endometrial cancer and 3368 population controls. In a histopathological review, 80 cases were reclassified as having endometrial atypical hyperplasia. Odds ratios and 95% CI were calculated with unconditional logistic regression.
FINDINGS: After multivariate adjustment, oral use of oestriol 1-2 mg daily increased the relative risk of endometrial cancer and endometrial atypical hyperplasia: the odds ratios for at least 5 years of use compared with never use were 3.0 (95% CI 2.0-4.4) and 8.3 (4.0-17.4), respectively. The association was stronger for well-differentiated cancers and those with limited invasion. The excess relative risk was lost rapidly after cessation of treatment. Only weak associations were observed between vaginal application of low-potency oestrogen formulations and relative risk of endometrial neoplasia.
INTERPRETATION: Oral, but not vaginal, treatment with low-potency oestrogen formulations increases the relative risk of endometrial neoplasia. Thus close surveillance of patients is needed, and addition of a progestagen should be considered.

PMID 10359406  Lancet. 1999 May 29;353(9167):1824-8. doi: 10.1016/S014・・・

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