今日の臨床サポート

女性の不定愁訴に対する漢方療法

著者: 武田卓 近畿大学 東洋医学研究所

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:2020/09/03
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

概要・推奨   

  1. 加味逍遥散はHRT無効症例のうち、特に精神症状を改善する(推奨度2)。
  1. 当帰芍薬散、加味逍遥散、桂枝茯苓丸は更年期の睡眠障害を改善し、特に加味逍遥散が改善効果に優れる(推奨度2)。
  1. 更年期障害患者において、桂枝茯苓丸はホルモン補充療法と異なり、趾先の血流を改善する(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
閲覧にはご契
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:
武田卓 : 講演料(株式会社ツムラ)[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.  定期レビューを行い、薬剤名を商品名から一般名へ変更した。

まとめ

まとめ  
ポイント:
  1. 産婦人科領域では、漢方療法はさまざまな疾患に対して用いられてきた。
  1. 婦人にみられる特有の生理現象に関連して起こる精神神経症状を基調とするさまざまな症状を、漢方の領域では「血の道症」と呼ぶ。
  1. 漢方治療は、本来は診断の結果でその患者のいわゆる「証」を決定し投薬を行う必要があるが、更年期障害に対しては女性 3 大漢方と呼ばれる「当帰芍薬散」「加味逍遥散」「桂枝茯苓丸」の3剤を中心に処方することにより、更年期症状治療のかなりの部分をカバーできると考えられている。また、女性のいわゆる不定愁訴とされる更年期障害・月経前症候群(PMS)、および月経困難症に対してもこれらの薬剤はよく用いられている。
  1. 西洋医学的な診断後に漢方治療の適否を判断する。
  1. なお、加味逍遥散が最も精神安定作用に優れ、当帰芍薬散は浮腫改善効果、桂枝茯苓丸は血流改善効果に優れる。
  1. 漢方製剤ならではの薬物有害事象(甘草による偽アルドステロン症等)に注意を払う。
 
当帰芍薬散・加味逍遥散・桂枝茯苓丸の使い分け:
  1. 更年期障害、月経前症候群、月経困難症は漢方治療における伝統医学的病態としては、「お血」(末梢循環不全)が原因として考えられており、「お血」改善薬のこれら3剤が経験的に臨床現場で汎用されている[1]
  1. 本来の漢方治療は伝統医学的診断に基づいて「証」を決定し投薬を行うことになるが、これらの疾患に対しては病名投与により、かなりの症状をカバーできると考えられている。
  1. 当帰芍薬散は利水作用にすぐれており、冷え症・貧血傾向・浮腫を目安に投薬する。
  1. 加味逍遥散は精神安定作用にすぐれており、疲労しやすい、不眠、イライラ感を目安に投薬する[2]
  1. 桂枝茯苓丸は「お血」改善作用にすぐれており、のぼせて赤ら顔で下腹部の抵抗や圧痛を目安に投薬する。
 
  1. 加味逍遥散はHRT無効症例のうち、特に精神症状を改善する。(推奨度2、O)
  1. 更年期障害のHRT無効例に対する加味逍遥散の有効性を後方視的に検討した。4週間の投与での検討では、73.3%が有効であった。加味逍遥散有効例の投与前の更年期症状を無効例と比較すると、不眠・うつ症状・めまいの各症状が有意に高かった[2]
  1. 後方視的検討であるが、漢方治療(特に加味逍遥散)の精神症状改善効果を示唆するデータである。

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文献 

著者: Bochen Pan, Yasuhito Kato, Kazuo Sengoku, Naoyuki Takuma, Noriyasu Niizeki, Mutsuo Ishikawa
雑誌名: Gynecol Obstet Invest. 2004;57(3):144-8. doi: 10.1159/000076003. Epub 2003 Dec 30.
Abstract/Text Hormone replacement therapy (HRT) is not successful or is contraindicated for the treatment of climacteric symptoms in some patients. To investigate whether certain herbal formulas of traditional Chinese medicine (Kampo in Japanese) could be used as an alternative treatment, a longitudinal 'before and after' comparative study was carried out in 18 Japanese women, and the results were compared with those of 16 women who underwent HRT. Kampo improved all the climacteric symptoms. In contrast, improvement of cold limbs, sleeping disorders, shoulder stiffness/lumbago, and fatigue in the HRT group was either not significant or of limited extent. In addition, the serum level of estradiol in postmenopausal women was raised by the combined use of two Kampo formulas. These results suggest that Kampo may be considered an alternative to HRT for the treatment of climacteric symptoms, but vigorous monitoring for potential side effects of increased estrogen levels in some postmenopausal patients is needed.

Copyright 2004 S. Karger AG, Basel
PMID 14707474  Gynecol Obstet Invest. 2004;57(3):144-8. doi: 10.1159/0・・・
著者: Takao Hidaka, Rika Yonezawa, Shigeru Saito
雑誌名: J Obstet Gynaecol Res. 2013 Jan;39(1):223-8. doi: 10.1111/j.1447-0756.2012.01936.x. Epub 2012 Jul 6.
Abstract/Text AIM: Hormone replacement therapy (HRT) for climacteric symptoms is effective for vasomotor symptoms, such as hot flushes and sweating, but not for various psychological symptoms, such as anxiety, depression, and irritability. In such cases, prescribing Kampo, traditional herbal medicine, is sometimes considered. However, the effectiveness of Kampo has not been clearly shown. We examined the clinical effect of Kami-shoyo-san, a herbal formula commonly prescribed for climacteric symptoms in a Japanese Kampo clinic.
METHODS: There were 180 patients who initially consulted our Kampo Outpatient Clinic due to the absence of a response to HRT or unsatisfactory improvement. Out of 180 patients, 45 patients received a Kami-shoyo-san extract for 4 weeks based on patient-centered Kampo diagnosis. We evaluated the severity of climacteric symptoms based on the visual analogue scale (VAS) score before and after 4 weeks of Kami-shoyo-san administration. Furthermore, the severity of each symptom before treatment was compared between the responders and non-responders.
RESULTS: Kami-shoyo-san was effective in 33 (73.3%) of the 45 patients. After treatment, on the whole, the VAS score significantly decreased (P < 0.0001). Concerning vasomotor symptoms and psychological symptoms, each VAS score significantly decreased (P<0.0001). When comparing the severity of pretreatment symptoms between responders and non-responders, symptoms, such as 'insomnia', 'depression', and 'vertigo' were significantly more marked in the responders (P<0.05).
CONCLUSION: The results of this study suggest that Kami-shoyo-san relieved both vasomotor and psychological symptoms, and especially in patients with marked psychological symptoms, it exhibited potent effects.

© 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.
PMID 22765925  J Obstet Gynaecol Res. 2013 Jan;39(1):223-8. doi: 10.11・・・
著者: Masakazu Terauchi, Shiro Hiramitsu, Mihoko Akiyoshi, Yoko Owa, Kiyoko Kato, Satoshi Obayashi, Eisuke Matsushima, Toshiro Kubota
雑誌名: Arch Gynecol Obstet. 2011 Oct;284(4):913-21. doi: 10.1007/s00404-010-1779-4. Epub 2010 Dec 1.
Abstract/Text PURPOSE: To assess the effects of Kampo, a traditional Japanese adaptation of Chinese herbal medicine, on peri- and postmenopausal women with sleep disturbances.
METHODS: Among the records of 1,523 peri- and postmenopausal women who are enrolled in the Health and Nutrition Education Program at the Tokyo Medical and Dental University, Menopause Clinic, during 1995-2009, about 151 women suffering from moderate to severe sleep disturbances were retrospectively analyzed. These women had received only health/nutrition education (control; n = 77) or received treatment with one of the three major Kampo formulae: Tokishakuyakusan (TJ-23; n = 42), Kamishoyosan (TJ-24; n = 16), or Keishibukuryogan (TJ-25; n = 16) according to their "Sho" or symptom patterns. Subjective sleep parameters, menopausal symptoms, health-related quality of life, body composition, blood pressure, and pulse rate were compared before and after the intervention.
RESULTS: The TJ-25 group had significantly higher body weight, body mass index, body fat, lean body mass, resting energy expenditure, and relatively high blood pressure and heart rate at baseline than the other groups. After ~5-month follow up, TJ-23 reduced the sleep disruption frequency, increased lean body mass, and decreased diastolic pressure. TJ-24 alleviated subjective sleep disturbances; improved difficulties in initiating sleep, disrupted sleep, and non-restorative sleep; and relieved headache/dizziness. TJ-25 improved subjective sleep disturbances, alleviated perspiration, and reduced systolic/diastolic pressure and heart rate.
CONCLUSIONS: Each of the Kampo formulae effectively alleviated sleep disturbances in Japanese peri- and postmenopausal women. Middle-aged female patients having sleeping disorder could successfully be treated using Kampo medicines.

PMID 21120510  Arch Gynecol Obstet. 2011 Oct;284(4):913-21. doi: 10.10・・・
著者: Takahisa Ushiroyama, Atsushi Ikeda, Kou Sakuma, Minoru Ueki
雑誌名: Am J Chin Med. 2005;33(2):259-67. doi: 10.1142/S0192415X05002813.
Abstract/Text We investigated the association between blood flow in the extremities and hot flashes, and compared change in blood flow following hormone replacement therapy (HRT) and Gui-zhi-fu-ling-wan (Keishi-bukuryo-gan), a herbal therapy in post-menopausal women with hot flashes. Three hundred and fifty-two post-menopausal women aged 46-58 years (mean: 53.4 +/- 3.6 years) with climacteric complaints participated in the study. One hundred and thirty-one patients with hot flashes were treated with HRT (64 cases) or herbal therapy (67 cases). Blood flow was measured with laser doppler fluxmetry under the jaw, in the middle finger and in the third toe. Post-menopausal women with hot flashes (129 cases) showed significantly higher blood flow under the jaw (13.6 +/- 4.13) than women without hot flashes (166 cases) (5.48 +/- 0.84) (p < 0.0001). Blood flow at this site decreased significantly with either therapy (p < 0.0001). On the other hand, the administration of Gui-zhi-fu-lingwan significantly increased (p = 0.002) the blood flow in the lower extremities, whereas HRT decreased the blood flow. Thus, we have demonstrated that Gui-zhi-fu-ling-wan did not affect the activity of vasodilator neuropeptides on sensory neurons of systemic peripheral vessels uniformly. Therefore, Gui-zhi-fu-ling-wan, rather than HRT, is suggested as an appropriate therapy for treatment of hot flashes in the face and upper body with concomitant coldness in the lower body, which is one of the symptoms of menopause.

PMID 15974485  Am J Chin Med. 2005;33(2):259-67. doi: 10.1142/S0192415・・・
著者: Toshiaki Kogure, Katsuhiko Ito, Hiroko Sato, Tomoyuki Ito, Yuko Oku, Jun Horiguchi, Izumi Takeyoshi, Takeshi Tatsumi
雑誌名: Int J Clin Oncol. 2008 Apr;13(2):185-9. doi: 10.1007/s10147-007-0718-2. Epub 2008 May 8.
Abstract/Text We report a 39-year-old woman with premenopausal breast cancer who developed estrogen-deficiency symptoms associated with chemotherapy-related amenorrhea, and was successfully treated with Nyoshinsan/TJ-67, a Japanese traditional herbal medicine (Kampo). Six other breast cancer survivors with menopausal symptoms were also treated with Nyoshinsan/TJ-67, and five of the six patients showed noticeable improvement without adverse effects. Managing estrogen-deficiency symptoms in breast cancer survivors is still problematic, and Nyoshinsan/TJ-67 may be a useful and safe agent for such symptoms in these patients.

PMID 18463968  Int J Clin Oncol. 2008 Apr;13(2):185-9. doi: 10.1007/s1・・・
著者: Kazuo Yamada, Shigenobu Kanba
雑誌名: Psychiatry Clin Neurosci. 2007 Jun;61(3):323-5. doi: 10.1111/j.1440-1819.2007.01649.x.
Abstract/Text The purpose of the present paper was to investigate the efficacy of kamishoyosan (TJ-24), a traditional Japanese herbal formula (kampo), for outpatients with premenstrual dysphoric disorder (PMDD) as an alternative treatment. Thirty patients with PMDD were treated with TJ-24 for six menstrual cycles. Nineteen patients (63.3%) had >50% improvement in the total score of the Hamilton Depression Rating Scale (HAM-D) Scale (17 items) in the late luteal phase. Fourteen patients (46.7%) went into remission (total HAM-D score <7). In the present study many patients with PMDD were successfully treated with TJ-24.

PMID 17472603  Psychiatry Clin Neurosci. 2007 Jun;61(3):323-5. doi: 10・・・
著者: Kazuo Yamada, Gohei Yagi, Shigenobu Kanba
雑誌名: Clin Neuropharmacol. 2003 May-Jun;26(3):112-4.
Abstract/Text Selective serotonin reuptake inhibitors (SSRIs) are apt to cause gastrointestinal adverse events such as nausea and dyspepsia. Gorei-san (TJ-17), which is composed of five herbs (Alismatis rhizoma, Atractylodis lanceae rhizoma, Polyporus, Hoelen, and Cinnamomi cortex), is a Japanese herbal medicine that has been used to treat nausea, dry mouth, edema, headache, and dizziness. The authors investigated the efficacy of TJ-17 for patients who experienced nausea or dyspepsia induced by SSRIs. Twenty outpatients who experienced nausea or dyspepsia induced by SSRIs were recruited for the study. Seventeen patients were female, three were male, and patient age ranged from 21 to 74 years (49.8 +/- 17.0 years). TJ-17 was added to the previous regimen. Nausea and dyspepsia disappeared completely in nine patients, decreased in four patients, decreased slightly in two patients, and did not change in five patients. No adverse events were associated with the addition of TJ-17 in any patient.

PMID 12782911  Clin Neuropharmacol. 2003 May-Jun;26(3):112-4.
著者: T Tanaka
雑誌名: Clin Exp Obstet Gynecol. 2001;28(1):20-3.
Abstract/Text The therapeutic effects of certain Japanese herbal medicines on menopausal symptoms induced by gonadotropin-releasing hormone agonist therapy were examined in Japanese women with endometriosis, adenomyosis, or leiomyoma. Menopausal symptoms occurred in 17 of the 22 patients. Toki-shakuyaku-san, Shakuyaku-kanzo-to, Keishi-bukuryo-gan, Kami-shoyo-san, Tokaku-joki-to, or Keishi-to was administered to 13 of the 17 patients with menopausal symptoms, and efficacy was observed in all 13. Eleven patients with hot flashes were treated with Toki-shakuyaku-san, and all II patients experienced some relief; four experienced total relief. Three patients complaining of severe shoulder stiffness were treated with Shakuyaku-kanzo-to and were completely relieved of symptoms. There was no significant change in serum estradiol levels after treatment with the Japanese herbal medicines. Our results indicate that Japanese herbal medicines can be recommended for menopausal symptoms induced by gonadotropin-releasing hormone agonists without a negative effect on serum estradiol levels.

PMID 11332582  Clin Exp Obstet Gynecol. 2001;28(1):20-3.

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