線維筋痛症治療アルゴリズム（EULAR2016）

医療状況を考慮したヨーロッパリウマチ学会（EULAR）提案の治療アルゴリズム（
本邦で保険適応のない薬物も含まれている）
出典
imgimg
1: EULAR revised recommendations for the management of fibromyalgia.
著者: Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT.
雑誌名: Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
Abstract/Text: OBJECTIVE: The original European League Against Rheumatism recommendations for managing fibromyalgia assessed evidence up to 2005. The paucity of studies meant that most recommendations were 'expert opinion'.
METHODS: A multidisciplinary group from 12 countries assessed evidence with a focus on systematic reviews and meta-analyses concerned with pharmacological/non-pharmacological management for fibromyalgia. A review, in May 2015, identified eligible publications and key outcomes assessed were pain, fatigue, sleep and daily functioning. The Grading of Recommendations Assessment, Development and Evaluation system was used for making recommendations.
RESULTS: 2979 titles were identified: from these 275 full papers were selected for review and 107 reviews (and/or meta-analyses) evaluated as eligible. Based on meta-analyses, the only 'strong for' therapy-based recommendation in the guidelines was exercise. Based on expert opinion, a graduated approach, the following four main stages are suggested underpinned by shared decision-making with patients. Initial management should involve patient education and focus on non-pharmacological therapies. In case of non-response, further therapies (all of which were evaluated as 'weak for' based on meta-analyses) should be tailored to the specific needs of the individual and may involve psychological therapies (for mood disorders and unhelpful coping strategies), pharmacotherapy (for severe pain or sleep disturbance) and/or a multimodal rehabilitation programme (for severe disability).
CONCLUSIONS: These recommendations are underpinned by high-quality reviews and meta-analyses. The size of effect for most treatments is relatively modest. We propose research priorities clarifying who will benefit from specific interventions, their effect in combination and organisation of healthcare systems to optimise outcome.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-2...

発症誘因（心理社会的要因）

2009年日本線維筋痛症学会診療ネットワーク患者調査2,278例の解析結果

発症誘因（身体的負荷）

2009年日本線維筋痛症学会診療ネットワーク患者調査1,090例の解析結果

続発性（二次性）線維筋痛症の併存疾患（原疾患）

厚生労働省研究班による全国疫学調査から得られた254例のなかで、続発性症例93例の基礎疾患

本邦線維筋痛症患者の臨床像

厚生労働省研究班による全国疫学調査から得られた254例の調査時の臨床症状の出現頻度

重症度分類（ステージ分類）（西岡試案）

日本語版FIQ（fibromyalgia impact questionnaire、J-FIQ）

海外で作成された線維筋痛症の疾患重症度評価尺度であるFIQを日本語版に作成されたものである。

線維筋痛症ACR分類基準1990記載の圧痛点

必ずしも圧痛点が必要なわけではないがイメージはしやすい。

薬物療法：抗てんかん薬など

エビデンスランク
S/CS：Systematic review（S）、Cochrane systematic reviews（CS）
M：メタ解析
Rs：複数のRCT
R：1つのRCT
C：コントロール試験（非ランダム化）
O：観察研究
J：国内ガイドライン
G：海外ガイドライン
推奨度：
推奨度1：（絶対必要な治療、検査）　Should do
推奨度2：may do
推奨度3：may not do
推奨度4：（禁忌絶対行ってはいけない治療、検査）　Should not do
https://clinicalsup.jp/jpoc/Recommendation.html
 
参考文献[123]：
 

薬物療法：抗うつ薬

エビデンスランク
S/CS：Systematic review（S）、Cochrane systematic reviews（CS）
M：メタ解析
Rs：複数のRCT
R：1つのRCT
C：コントロール試験（非ランダム化）
O：観察研究
J：国内ガイドライン
G：海外ガイドライン
推奨度：
推奨度1：（絶対必要な治療、検査）　Should do
推奨度2：may do
推奨度3：may not do
推奨度4：（禁忌絶対行ってはいけない治療、検査）　Should not do
https://clinicalsup.jp/jpoc/Recommendation.html
 

薬物療法：鎮痛薬

エビデンスランク
S/CS：Systematic review（S）、Cochrane systematic reviews（CS）
M：メタ解析
Rs：複数のRCT
R：1つのRCT
C：コントロール試験（非ランダム化）
O：観察研究
J：国内ガイドライン
G：海外ガイドライン
推奨度：
推奨度1：（絶対必要な治療、検査）　Should do
推奨度2：may do
推奨度3：may not do
推奨度4：（禁忌絶対行ってはいけない治療、検査）　Should not do
https://clinicalsup.jp/jpoc/Recommendation.html

薬物療法：生薬・漢方製剤、その他、ペインクリニック、サプリメントなど

推奨度：
実施する：行うことを強く推奨する
提案する：行うことを弱く推奨する
提案しない：行わないことを弱く推奨する
実施しない：行わないことを強く推奨する
推奨なし（全体パネル会議でデルファイ法による推奨度決定で意見がまとまらない場合）

薬物療法：併存症状に対するもの

エビデンスランク
S/CS：Systematic review（S）、Cochrane systematic reviews（CS）
M：メタ解析
Rs：複数のRCT
R：1つのRCT
C：コントロール試験（非ランダム化）
O：観察研究
J：国内ガイドライン
G：海外ガイドライン
推奨度：
推奨度1：（絶対必要な治療、検査）　Should do
推奨度2：may do
推奨度3：may not do
推奨度4：（禁忌絶対行ってはいけない治療、検査）　Should not do
https://clinicalsup.jp/jpoc/Recommendation.html

非薬物療法

推奨度：
実施する：行うことを強く推奨する
提案する：行うことを弱く推奨する
提案しない：行わないことを弱く推奨する
実施しない：行わないことを強く推奨する
推奨なし（全体パネル会議でデルファイ法による推奨度決定で意見がまとまらない場合）

厚生労働省　慢性疲労症候群（CFS）診断基準（2013年3月改訂）

大基準2項目に加えて、小基準の「症状基準8項目」以上か、「症状基準6項目+身体基準2項目」以上を満たすと「CFS」と診断する。
大基準2項目に該当するが、小基準で診断基準を満たさない例は「CFSの疑いあり」とする。
上記基準で診断されたCFS（「疑いあり」は除く）のうち、感染症が確診された後、それに続発して症状が発現した例は「感染後CFS」と呼ぶ。

線維筋痛症と各種リウマチ性疾患の鑑別診断の要点

線維筋痛症ACR診断予備基準2010

広範囲疼痛指数（widespread pain index、WPI：0～19点）、臨床徴候重症度（symptom severity、SS：0～12点）（メンタル系の症状が0～9点、自律神経系の調整障害を反映している諸症状に0～3点）を医師による評価を行い、WPI≧7、かつSS≧5、またはWPI：3～6かつSS≧9を認め、これらの症状が少なくとも3カ月以上続き、他の疼痛を示す疾患がない場合に線維筋痛症と診断するものである。

線維筋痛症改定診断基準（2011）

線維筋痛症の改定診断基準（2016）

線維筋痛症の臨床像

全身の疼痛以外に多彩な身体、精神・神経症状を大なり小なり伴う。身体所見には圧痛点の圧痛、アロディニア（異痛症）のみで、画像を含めた一般的臨床検査所見に異常がないことが特徴である。
出典
img
1: 著者提供

米国リウマチ学会（ACR）の線維筋痛症分類基準1990

分類基準であるが、診断基準として用いることができる。日本人での有用性も検証されている。
 
参考文献[11][22]

若年性線維筋痛症診断基準

参考文献[24]：
 
出典
img
1: 著者提供

わが国の線維筋痛症患者の診断が確定するまでの臨床診断名および疑診名

線維筋痛症問診票

米国線筋痛症患者の自殺による累積生存率の比較

自殺と自殺以外の原因による累積生存率の比較。
わが国の線維筋痛症患者の自殺に関する報告はなく、非公式に医療間、マスメディアで語られる程度である。
出典
imgimg
1: Mortality in fibromyalgia: a study of 8,186 patients over thirty-five years.
著者: Wolfe F, Hassett AL, Walitt B, Michaud K.
雑誌名: Arthritis Care Res (Hoboken). 2011 Jan;63(1):94-101. doi: 10.1002/acr.20301. Epub 2010 Jul 26.
Abstract/Text: OBJECTIVE: To determine if mortality is increased among patients diagnosed as having fibromyalgia.
METHODS: We studied 8,186 fibromyalgia patients seen between 1974 and 2009 in 3 settings: all fibromyalgia patients in a clinical practice, patients participating in the US National Data Bank for Rheumatic Diseases (NDB), and patients invited to participate in the NDB who refused participation. Internal controls included 10,087 patients with osteoarthritis. Deaths were determined by multiple source communication, and all patients were also screened in the US National Death Index (NDI). We calculated standardized mortality ratios (SMRs) based on age- and sex-stratified US population data, after adjustment for NDI nonresponse.
RESULTS: There were 539 deaths, and the overall SMR was 0.90 (95% confidence interval [95% CI] 0.61-1.26). Among 1,665 clinic patients, the SMR was 0.92 (95% CI 0.81-1.05). Sensitivity analyses varying the rate of NDI nonidentification did not alter the nonassociation. Adjusted for age and sex, the hazard ratio for fibromyalgia compared with osteoarthritis was 1.05 (95% CI 0.94-1.17). The standardized mortality odds ratio (OR) compared with the US general population was increased for suicide (OR 3.31, 95% CI 2.15-5.11) and for accidental deaths (OR 1.45, 95% CI 1.02- 2.06), but not for malignancy.
CONCLUSION: Mortality does not appear to be increased in patients diagnosed with fibromyalgia, but the risk of death from suicide and accidents was increased.

Copyright © 2011 by the American College of Rheumatology.
Arthritis Care Res (Hoboken). 2011 Jan;63(1):94-101. doi: 10.1002/acr....

線維筋痛症患者の経時的疾患重症度の変化

線維筋痛症の重症度の12年間の経時的変化をみたものである。
出典
imgimg
1: The longitudinal outcome of fibromyalgia: a study of 1555 patients.
著者: Walitt B, Fitzcharles MA, Hassett AL, Katz RS, Häuser W, Wolfe F.
雑誌名: J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrheum.110026. Epub 2011 Jul 15.
Abstract/Text: OBJECTIVE: To describe the diagnosis status and outcome of patients diagnosed with fibromyalgia (FM) by US rheumatologists.
METHODS: We assessed 1555 patients with FM with detailed outcome questionnaires during 11,006 semiannual observations for up to 11 years. At entry, all patients satisfied American College of Rheumatology preliminary 2010 FM criteria modified for survey research. We determined diagnosis status, rates of improvement, responder subgroups, and standardized mean differences (effect sizes) between start and study completion scores of global well-being, pain, sleep problems, and health related quality of life. (QOL) RESULTS: The 5-year improvement rates were pain 0.4 (95% CI 0.2, 0.5), fatigue 0.4 (95% CI 0.2, 0.05), and global 0.0 (95% CI -0.1, 0.1). The standardized mean differences were patient global 0.03 (95% CI -0.02, 0.08), pain 0.22 (95% CI 0.16, 0.28), sleep problems 0.20 (95% CI 0.14, 0.25), physical component summary of the Short-form 36 (SF-36) 0.11 (95% CI -0.14, -0.07), and SF-36 mental component summary 0.03 (95% CI -0.07, 0.02). Patients switched between criteria-positive and criteria-negative states, with 716 patients (44.0%) failing to meet criteria at least once during 4228.5 patient-years (7448 observations). About 10% of patients had substantial improvement and about 15% had moderate improvement of pain. Overall, FM severity worsened in 35.9% and pain in 38.6%.
CONCLUSION: Although we found no average clinically meaningful improvement in symptom severity overall, 25% had at least moderate improvement of pain over time. The result that emerged from this longitudinal study was one of generally continuing high levels of self-reported symptoms and distress for most patients, but a slight trend toward improvement.
J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrheum.110026. Epub...

プレガバリンの用量依存的疼痛緩和効果

プレガバリンの用量依存的に疼痛緩和効果がみられる。
出典
imgimg
1: Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports.
著者: Straube S, Derry S, Moore RA, McQuay HJ.
雑誌名: Rheumatology (Oxford). 2010 Apr;49(4):706-15. doi: 10.1093/rheumatology/kep432. Epub 2010 Jan 7.
Abstract/Text: OBJECTIVES: Meta-analysis of pregabalin trials in FM using company trial reports, which provide more detailed information about trials than published papers. FM is a common condition with a significant impact on quality of life.
METHODS: Reports of five high-quality randomized trials (3808 patients) of pregabalin in FM were obtained from Pfizer. Four trials (2754 patients) were of classical trial design and one was an enriched enrolment randomized withdrawal design. Outcomes for meta-analysis from the four trials with classical design were pooled in an intention-to-treat analysis.
RESULTS: Significant benefit of pregabalin over placebo was seen for a variety of outcomes including mean pain and sleep scores, the proportion of patients achieving at least 50% pain relief and most of the individual domains of short-form 36. Only a minority of patients achieve moderate or substantial pain relief. The proportions of patients with any adverse event, somnolence or dizziness were also significantly greater with pregabalin than with placebo. There was no difference with regard to serious adverse events. A dose-response relationship was apparent for at least 50% pain relief and for adverse event outcomes.
CONCLUSIONS: Pregabalin is effective in treating FM and is relatively safe. The size of therapeutic effect is similar to that with other recent interventions such as duloxetine and the combination of tramadol and paracetamol. Enriched enrolment randomized withdrawal design gives similar results to classical trial designs in FM.
Rheumatology (Oxford). 2010 Apr;49(4):706-15. doi: 10.1093/rheumatolog...

痛みの新しい分類（世界疼痛学会提唱2017）
 

痛覚変調性疼痛の用語は国内疼痛関連10学会合同で2021年に提唱された。
参考文献[5][6]：
 
出典
img
1: 著者提供

初診時の線維筋痛症管理計画

出典
img
1: 著者提供

線維筋痛症治療アルゴリズム（EULAR2016）

医療状況を考慮したヨーロッパリウマチ学会（EULAR）提案の治療アルゴリズム（
本邦で保険適応のない薬物も含まれている）
出典
imgimg
1: EULAR revised recommendations for the management of fibromyalgia.
著者: Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT.
雑誌名: Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
Abstract/Text: OBJECTIVE: The original European League Against Rheumatism recommendations for managing fibromyalgia assessed evidence up to 2005. The paucity of studies meant that most recommendations were 'expert opinion'.
METHODS: A multidisciplinary group from 12 countries assessed evidence with a focus on systematic reviews and meta-analyses concerned with pharmacological/non-pharmacological management for fibromyalgia. A review, in May 2015, identified eligible publications and key outcomes assessed were pain, fatigue, sleep and daily functioning. The Grading of Recommendations Assessment, Development and Evaluation system was used for making recommendations.
RESULTS: 2979 titles were identified: from these 275 full papers were selected for review and 107 reviews (and/or meta-analyses) evaluated as eligible. Based on meta-analyses, the only 'strong for' therapy-based recommendation in the guidelines was exercise. Based on expert opinion, a graduated approach, the following four main stages are suggested underpinned by shared decision-making with patients. Initial management should involve patient education and focus on non-pharmacological therapies. In case of non-response, further therapies (all of which were evaluated as 'weak for' based on meta-analyses) should be tailored to the specific needs of the individual and may involve psychological therapies (for mood disorders and unhelpful coping strategies), pharmacotherapy (for severe pain or sleep disturbance) and/or a multimodal rehabilitation programme (for severe disability).
CONCLUSIONS: These recommendations are underpinned by high-quality reviews and meta-analyses. The size of effect for most treatments is relatively modest. We propose research priorities clarifying who will benefit from specific interventions, their effect in combination and organisation of healthcare systems to optimise outcome.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-2...

発症誘因（心理社会的要因）

2009年日本線維筋痛症学会診療ネットワーク患者調査2,278例の解析結果