今日の臨床サポート 今日の臨床サポート

著者: 巽浩一郎1) 千葉大学 真菌医学研究センター 呼吸器生体制御学研究部門

著者: 植木純2) 順天堂大学 医療看護学研究科

監修: 巽浩一郎 千葉大学 真菌医学研究センター 呼吸器生体制御学研究部門

著者校正/監修レビュー済:2024/02/21
患者向け説明資料

改訂のポイント:
  1. 既存の内容をもとに、全面的な見直しを行った。
  1. 各論に「呼吸機能障害と酸素療法」を新たに追加した。
  1. 各論に「治療の進歩:ハイフローセラピー」を新たに追加した。

概要・推奨   

  1. 据え置き型酸素濃縮装置は吸着剤を用いて空気中の酸素を取り出し90%濃度の酸素を供給する。2022年時点で日本における在宅酸素療法(HOT患者数は約18万人である。
  1. 最近ではバッテリーで駆動する携帯可能な酸素濃縮装置も使用可能になった。
  1. 液体酸素は日本の住宅事情に合致していないこともあり、約1%のHOT患者が利用している。
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まとめ 

疾患情報(疫学・病態)  
  1. HOTの社会保険上の適用は、高度慢性呼吸不全、肺高血圧症、慢性心不全およびチアノーゼ型先天性心疾患である。
  1. HOTは慢性呼吸不全患者の組織低酸素を改善するための治療である。
  1. HOT導入により呼吸機能障害の経年的悪化は抑制できないが、心機能の悪化(慢性心不全)は抑制しうる。
  1. HOT導入の最大の目的は身体活動性の向上である。
  1. HOTを処方する前にリハビリテーションや薬物療法が十分に実施されていることが必要である。
  1. 全国の患者数は2022年の時点で推定で18万人である。
  1. 1日15時間以上のHOTは高度呼吸不全を呈する慢性閉塞性肺疾患患者の予後を改善することが示されている。
 
HOTの効果 MRC、NOTT

高度慢性呼吸不全を呈するCOPD患者においては1日15時間以上の酸素吸入で予後が改善し(MRC)、夜間のみ吸入(1日12時間)より1日17.7時間以上の連続吸入のほうが予後がよい。

出典

Rosa Güell Rous
Long-term oxygen therapy: are we prescribing appropriately?
Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7.
Abstract/Text Long-term oxygen therapy (LTOT) is the treatment proven to improve survival in chronic obstructive pulmonary disease (COPD) patients with chronic respiratory failure. It also appears to reduce the number of hospitalizations, increase effort capacity, and improve health-related quality of life. Standard LTOT criteria are related to COPD patients who have PaO2 < 60 mmHg, are in a clinical stable situation, and are receiving optimal pharmacological treatment. According to LTOT guidelines, oxygen should be prescribed for at least 18 hours per day although some authors consider 24 hours would be more beneficial. The benefits of LTOT depend on correction of hypoxemia. Arterial blood gases should be measured at rest. During exercise, an effort test should be done to assure adequate SaO2. During sleep, continuous monitoring of SaO2 and PaCO2 should be performed to confirm correction of SaO2 overnight. An arterial blood gas sample should be taken at awakening to assess PaCO, in order to prevent hypoventilation from the oxygen therapy. Several issues that need to be addressed are the use of LTOT in COPD patients with moderate hypoxemia, the efficacy of LTOT in patients who desaturate during exercise or during sleep, the optimal dosage of oxygen supplementation, LTOT compliance, and the LTOT prescription in diseases other than COPD.

PMID 18686732
 
  1. HOTの予後に関するエビデンス(COPD):高度慢性呼吸不全を呈するCOPD患者に対するHOTの予後に関するエビデンスは英国、米国で1980年代に示されている。(参考文献:[1][2]
  1. COPD患者に対するHOTの予後に関するエビデンスは英国、米国で1980年代に示されている。間質性肺炎や他の疾患に対しては、示されていないがCOPDの結果に準拠して用いられている。
 
HOTの予後

出典

Abstract/Text A controlled trial of long term domiciliary oxygen therapy has been carried out in three centres in the U.K. The 87 patients, all under 70 years of age, who took part had chronic bronchitis or emphysema with irreversible airways obstruction, severe arterial hypoxaemia, carbon dioxide retention, and a history of congestive heart failure. The patients were randomised to oxygen therapy (treated) or no oxygen (controls). Oxygen was given by nasal prongs for at least 15 h daily, usually at 2 1/min. The two groups were well matched, both clinically and in terms of lung function and other laboratory findings. 19 of the 42 oxygen treated patients died in the five years of survival follow-up compared with 30 out of 45 controls: in the 66 men in this trial the survival advantage of oxygen did not emerge until 500 days had elapsed. Survival for the 12 female controls was surprisingly poor, 8 of them being dead at 3 years. Mortality was not easy to predict, though a summation of arterial carbon dioxide tension and red cell mass was helpful. Neither time spent in hospital because of exacerbations of respiratory failure nor work attendance were affected by oxygen therapy, but these patients were very ill at the start of the trial and many had already retired on grounds of age or ill-health. Physiological measurements suggested that oxygen did not slow the progress of respiratory failure in those who died early. However, in longer term survivors on oxygen, arterial oxygenation did seem to stop deterioration.

PMID 6110912
Abstract/Text At six centers, 203 patients with hypoxemic chronic obstructive lung disease were randomly allocated to either continuous oxygen (O2) therapy or 12-hour nocturnal O2 therapy and followed for at least 12 months (mean, 19.3 months). The two groups were initially well matched in terms of physiological and neuropsychological function. Compliance with each oxygen regimen was good. Overall mortality in the nocturnal O2 therapy group was 1.94 times that in the continuous O2 therapy group (P = 0.01). This trend was striking in patients with carbon dioxide retention and also present in patients with relatively poor lung function, low mean nocturnal oxygen saturation, more severe brain dysfunction, and prominent mood disturbances. Continuous O2 therapy also appeared to benefit patients with low mean pulmonary artery pressure and pulmonary vascular resistance and those with relatively well-preserved exercise capacity. We conclude that in hypoxemic chronic obstructive lung disease, continuous O2 therapy is associated with a lower mortality than is nocturnal O2 therapy. The reason for this difference is not clear.

PMID 6776858
 
  1. HOT患者の生存率の変化:1980年代に示された生存率と比して、近年総合的な治療も加わり、生存率の改善が見られる
  1. 1980年代に示された生存率と比して、近年総合的な治療も加わり、生存率がよくなっている[3]
 
HOT患者の生存率の変化

5つの研究報告に基づき算出された、長期酸素療法を受ける慢性閉塞性肺疾患および慢性呼吸不全患者の生存率。新しい研究ほど生存率が高くなる傾向に注意すること。

出典

S Rennard, M Carrera, A G Agustí
Management of chronic obstructive pulmonary disease: are we going anywhere?
Eur Respir J. 2000 Dec;16(6):1035-6.
Abstract/Text
PMID 11292101
 
  1. 酸素療法の意義(参考文献:[4]
  1. HOTの意義を患者に説明することは、HOTを有効かつ安全に継続するうえで重要となる。必要性、効果を繰り返し伝える。
  1. 低酸素血症による障害:肺高血圧、多血症、運動能力の低下、呼吸困難、記憶力の低下、睡眠障害、右心不全など
  1. 酸素吸入による効果:生存率の向上、運動能力の向上、入院日数・回数の減少、呼吸困難減少、精神神経機能改善など
問診・診察のポイント  
  1. 経皮酸素飽和度(SpO2)でのPaO2値の推定
  1. 動脈血液ガス分析によるPaO2、PaCO2値の測定
  1. 呼吸困難(息切れ)の程度 mMRCでの評価

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文献 

Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party.
Lancet. 1981 Mar 28;1(8222):681-6.
Abstract/Text A controlled trial of long term domiciliary oxygen therapy has been carried out in three centres in the U.K. The 87 patients, all under 70 years of age, who took part had chronic bronchitis or emphysema with irreversible airways obstruction, severe arterial hypoxaemia, carbon dioxide retention, and a history of congestive heart failure. The patients were randomised to oxygen therapy (treated) or no oxygen (controls). Oxygen was given by nasal prongs for at least 15 h daily, usually at 2 1/min. The two groups were well matched, both clinically and in terms of lung function and other laboratory findings. 19 of the 42 oxygen treated patients died in the five years of survival follow-up compared with 30 out of 45 controls: in the 66 men in this trial the survival advantage of oxygen did not emerge until 500 days had elapsed. Survival for the 12 female controls was surprisingly poor, 8 of them being dead at 3 years. Mortality was not easy to predict, though a summation of arterial carbon dioxide tension and red cell mass was helpful. Neither time spent in hospital because of exacerbations of respiratory failure nor work attendance were affected by oxygen therapy, but these patients were very ill at the start of the trial and many had already retired on grounds of age or ill-health. Physiological measurements suggested that oxygen did not slow the progress of respiratory failure in those who died early. However, in longer term survivors on oxygen, arterial oxygenation did seem to stop deterioration.

PMID 6110912
Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group.
Ann Intern Med. 1980 Sep;93(3):391-8.
Abstract/Text At six centers, 203 patients with hypoxemic chronic obstructive lung disease were randomly allocated to either continuous oxygen (O2) therapy or 12-hour nocturnal O2 therapy and followed for at least 12 months (mean, 19.3 months). The two groups were initially well matched in terms of physiological and neuropsychological function. Compliance with each oxygen regimen was good. Overall mortality in the nocturnal O2 therapy group was 1.94 times that in the continuous O2 therapy group (P = 0.01). This trend was striking in patients with carbon dioxide retention and also present in patients with relatively poor lung function, low mean nocturnal oxygen saturation, more severe brain dysfunction, and prominent mood disturbances. Continuous O2 therapy also appeared to benefit patients with low mean pulmonary artery pressure and pulmonary vascular resistance and those with relatively well-preserved exercise capacity. We conclude that in hypoxemic chronic obstructive lung disease, continuous O2 therapy is associated with a lower mortality than is nocturnal O2 therapy. The reason for this difference is not clear.

PMID 6776858
S Rennard, M Carrera, A G Agustí
Management of chronic obstructive pulmonary disease: are we going anywhere?
Eur Respir J. 2000 Dec;16(6):1035-6.
Abstract/Text
PMID 11292101
植木 純(監修)、福地 義之助:呼吸を楽にして健康増進―呼吸のセルフマネジメント― 照林社、2011.
日本呼吸器学会COPDガイドライン第6版作成委員会編:COPD(慢性閉塞性肺疾患)診断と治療のためのガイドライン 第6版.メディカルレビュー社、2022.
「診療報酬の算定方法の一部改正に伴う実施上の留意事項について(通知)平成24年3月5日保医発0305第1号.
Kazuma Nagata, Takashi Kikuchi, Takeo Horie, Akira Shiraki, Takamasa Kitajima, Toru Kadowaki, Fumiaki Tokioka, Naohiko Chohnabayashi, Akira Watanabe, Susumu Sato, Keisuke Tomii
Domiciliary High-Flow Nasal Cannula Oxygen Therapy for Patients with Stable Hypercapnic Chronic Obstructive Pulmonary Disease. A Multicenter Randomized Crossover Trial.
Ann Am Thorac Soc. 2018 Apr;15(4):432-439. doi: 10.1513/AnnalsATS.201706-425OC.
Abstract/Text RATIONALE: A growing evidence base suggests a benefit of using high-flow nasal cannula oxygen therapy in the acute setting. However, the clinical benefit of domiciliary use of high-flow nasal cannula oxygen therapy in patients with chronic hypercapnic respiratory failure due to chronic obstructive pulmonary disease remains unclear.
OBJECTIVES: To evaluate the efficacy and safety of high-flow nasal cannula oxygen therapy use in patients with stable chronic obstructive pulmonary disease.
METHODS: We conducted a multicenter, randomized crossover trial comparing high-flow nasal cannula oxygen therapy plus long-term oxygen therapy with long-term oxygen therapy only in 32 adults with stable hypercapnic chronic obstructive pulmonary disease. Participants were randomized to receive either 6 weeks of high-flow nasal cannula oxygen therapy/long-term oxygen therapy using the myAIRVO 2 device followed by another 6 weeks of long-term oxygen therapy only or long-term oxygen therapy only followed by high-flow nasal cannula oxygen therapy/long-term oxygen therapy. The primary outcome was the change in quality of life as assessed by St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease. A linear mixed-effects model was used to account for treatment effect, time effect, allocation effect, and participant effect.
RESULTS: Of 32 study participants, 29 completed the study. At the end of 12 weeks, high-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment improved the mean total St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease score compared with long-term oxygen therapy only (7.8 points; 95% confidence interval, 3.7 to 11.9; P < 0.01). Similarly, high-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment improved the arterial partial pressure of carbon dioxide (adjusted treatment effect, -4.1 mm Hg; 95% confidence interval, -6.5 to -1.7 mm Hg), pH (adjusted treatment effect, +0.02; 95% confidence interval, 0.01 to 0.02), and median nocturnal transcutaneous carbon dioxide pressure (adjusted treatment effect, -5.1 mm Hg; 95% confidence interval, -8.4 to -1.8 mm Hg). High-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment did not improve the arterial partial pressure of oxygen, dyspnea, spirometry, lung volume, 6-minute walk test, or physical activity. The most frequent high-flow nasal cannula oxygen therapy-related adverse event encountered was nocturnal sweating (n = 6 [20.7%]). Four severe adverse events occurred (two in each group) and were deemed unrelated to the intervention.
CONCLUSIONS: Six weeks of treatment with high-flow nasal cannula oxygen therapy improved health-related quality of life and reduced hypercapnia in patients with stable hypercapnic chronic obstructive pulmonary disease. Clinical trial registered with www.clinicaltrials.gov (NCT02545855) and www.umin/ac.jp (UMIN000017639).

PMID 29283682
Line Hust Storgaard, Hans-Ulrich Hockey, Birgitte Schantz Laursen, Ulla Møller Weinreich
Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure.
Int J Chron Obstruct Pulmon Dis. 2018;13:1195-1205. doi: 10.2147/COPD.S159666. Epub 2018 Apr 16.
Abstract/Text BACKGROUND: This study investigated the long-term effects of humidified high-flow nasal cannula (HFNC) in COPD patients with chronic hypoxemic respiratory failure treated with long-term oxygen therapy (LTOT).
PATIENTS AND METHODS: A total of 200 patients were randomized into usual care ± HFNC. At inclusion, acute exacerbation of COPD (AECOPD) and hospital admissions 1 year before inclusion, modified Medical Research Council (mMRC) score, St George's Respiratory Questionnaire (SGRQ), forced expiratory volume in 1 second (FEV1), 6-minute walk test (6MWT) and arterial carbon dioxide (PaCO2) were recorded. Patients completed phone interviews at 1, 3 and 9 months assessing mMRC score and AECOPD since the last contact. At on-site visits (6 and 12 months), mMRC, number of AECOPD since last contact and SGRQ were registered and FEV1, FEV1%, PaCO2 and, at 12 months, 6MWT were reassessed. Hospital admissions during the study period were obtained from hospital records. Hours of the use of HFNC were retrieved from the high-flow device.
RESULTS: The average daily use of HFNC was 6 hours/day. The HFNC group had a lower AECOPD rate (3.12 versus 4.95/patient/year, p<0.001). Modeled hospital admission rates were 0.79 versus 1.39/patient/year for 12- versus 1-month use of HFNC, respectively (p<0.001). The HFNC group had improved mMRC scores from 3 months onward (p<0.001) and improved SGRQ at 6 and 12 months (p=0.002, p=0.033) and PaCO2 (p=0.005) and 6MWT (p=0.005) at 12 months. There was no difference in all-cause mortality.
CONCLUSION: HFNC treatment reduced AECOPD, hospital admissions and symptoms in COPD patients with hypoxic failure.

PMID 29713153
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、渡邉裕次、井ノ口岳洋、梅田将光および日本医科大学多摩永山病院 副薬剤部長 林太祐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。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※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、実際の保険適応の査定において保険適応及び保険適応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応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:
巽浩一郎 : 特に申告事項無し[2024年]
植木純 : 未申告[2024年]
監修:巽浩一郎 : 特に申告事項無し[2024年]

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