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下腿潰瘍

著者: 末木博彦 昭和大学医学部 皮膚科学講座

監修: 戸倉新樹 掛川市・袋井市病院企業団立 中東遠総合医療センター 参与/浜松医科大学 名誉教授

著者校正/監修レビュー済:2021/02/03
患者向け説明資料

概要・推奨   

  1. 下肢静脈瘤血管内レーザー焼灼術が保険適用(所定の研修を終了した医師に限り算定)<静脈瘤治療としては推奨度1>
  1. 血管内高周波(ラジオ波)焼灼術が保険適用(所定の研修を終了した医師に限り算定)<静脈瘤治療としては推奨度1>
  1. 静脈瘤血管内治療の適応と除外基準を遵守する。
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:
末木博彦 : 特に申告事項無し[2021年]
監修:戸倉新樹 : 講演料(田辺三菱,サノフィ,マルホ,協和キリン),研究費・助成金など(ノバルティス,レオファーマ)[2021年]

改訂のポイント:
  1. 定期レビューを行い、新規治療法および血管内焼灼術の適応と禁忌につき加筆した

病態・疫学・診察

疫学情報・病態・注意事項  
  1. 「下腿潰瘍」とは種々の原因により下腿に生ずる難治性潰瘍の総称である。
  1. 患者の80%以上は静脈うっ滞に起因するため、狭義の「下腿潰瘍」はこの病態を指すことが多い。
  1. 静脈性潰瘍は下腿内側下1/3に好発し、比較的浅い潰瘍で虫食い状になりやすく、壊死物質は少なく、周囲にうっ滞性皮膚炎と色素沈着を伴いやすいという特徴がある。
  1. 皮膚潰瘍を生じやすい下腿の解剖・生理学的特性として、外傷や物理的刺激を受けやすいこと、動脈の交感神経支配が強く皮膚血流量が少ないこと、重力によるうっ滞や血栓を生じやすいことが挙げられる。
  1. 静脈うっ滞以外の病態として、動脈性血行障害、リンパ管循環障害、膠原病・膠原病類縁疾患・血管炎、異常蛋白血症、感染症、皮膚悪性腫瘍などがある。
  1. 椅子に座る生活習慣、運動量減少による静脈のポンプ機能低下、食事の欧米化による血栓・塞栓の頻度増加により下腿潰瘍は増加傾向にある。
 
  1. (参考文献:[1]
問診・診察のポイント  
 
  1. 下腿潰瘍の原因は多岐にわたるため、現病歴・既往歴を中心に丁寧に問診する。

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文献 

著者: I C Valencia, A Falabella, R S Kirsner, W H Eaglstein
雑誌名: J Am Acad Dermatol. 2001 Mar;44(3):401-21; quiz 422-4. doi: 10.1067/mjd.2001.111633.
Abstract/Text UNLABELLED: Venous ulcers are the most common form of leg ulcers. Venous disease has a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Although the exact pathogenic steps leading from venous hypertension to venous ulceration remain unclear, several hypotheses have been developed to explain the development of venous ulceration. A better understanding of the current pathophysiology of venous ulceration has led to the development of new approaches in its management. New types of wound dressings, topical and systemic therapeutic agents, surgical modalities, bioengineered tissue, matrix materials, and growth factors are all novel therapeutic options that may be used in addition to the "gold standard," compression therapy, for venous ulcers. This review discusses current aspects of the epidemiology, pathophysiology, clinical presentation, diagnostic assessment, and current therapeutic options for chronic venous insufficiency and venous ulceration. (J Am Acad Dermatol 2001;44:401-21.)
LEARNING OBJECTIVE: At the conclusion of this learning activity, participants should be familiar with the 3 main types of lower extremity ulcers and should improve their understanding of the epidemiology, pathogenesis, risk factors, clinical presentation, diagnostic assessment, and current therapies for chronic venous insufficiency and venous ulcers.

PMID 11209109  J Am Acad Dermatol. 2001 Mar;44(3):401-21; quiz 422-4. ・・・
著者: C L Wilson, J Cameron, S M Powell, G Cherry, T J Ryan
雑誌名: Clin Exp Dermatol. 1991 Jul;16(4):250-3.
Abstract/Text A retrospective review of patch test results from all new patients with venous leg ulcers was performed for the preceding 11 months. Eighty one patients referred from general practitioners and district nurses with venous stasis ulcers were included. Positive patch tests were found in 54 patients (67%), including a continued high incidence of allergy to lanolin and topical antibiotics. Multiple allergies were found in 48 patients (58%). In addition, a new problem of allergy to cetearyl alcohol, a constituent of commonly used creams and paste bandages, was identified in 13 patients. There is a continuing high incidence of contact sensitivity in patients with venous stasis ulcers which has important implications for the management of these patients.

PMID 1794164  Clin Exp Dermatol. 1991 Jul;16(4):250-3.
著者: B T Baldursson, M A Hedblad, H Beitner, B Lindelöf
雑誌名: Br J Dermatol. 1999 Jun;140(6):1148-52.
Abstract/Text We have studied 25 cases of squamous cell carcinoma in chronic venous leg ulcers. Twenty-three of the patients were dead and two were alive. The mean age at cancer diagnosis was 78.5 years. The median survival was 1 year. Eleven tumours were well-differentiated, 10 moderately and four poorly. All patients with a poorly differentiated tumour died within a year. Metastases were certain in eight cases. The disease was lethal in 10 cases which included all poorly differentiated tumours. The survival of the study group was significantly shortened compared with a control group of patients with lower limb non-melanoma skin cancer (n = 433) from the Swedish Cancer Registry (P = 0.0084). When diagnosed, squamous cell carcinoma in chronic leg ulcers merits a thorough investigation of the degree of differentiation and spread. Assertive treatment is indicated as poorly differentiated tumours and some moderately differentiated tumours may be fatal.

PMID 10354087  Br J Dermatol. 1999 Jun;140(6):1148-52.
著者: A Fletcher, N Cullum, T A Sheldon
雑誌名: BMJ. 1997 Sep 6;315(7108):576-80.
Abstract/Text OBJECTIVE: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers.
METHODS: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted.
MAIN OUTCOME MEASURES: Rate of healing and proportion of ulcers healed within a time period.
STUDY SELECTION: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers.
RESULTS: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems.
CONCLUSIONS: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers.

PMID 9302954  BMJ. 1997 Sep 6;315(7108):576-80.
著者: Wijnand B van Gent, Wim C Hop, Marinus C van Praag, Albert J Mackaay, Edith M de Boer, Cees H Wittens
雑誌名: J Vasc Surg. 2006 Sep;44(3):563-71. doi: 10.1016/j.jvs.2006.04.053.
Abstract/Text BACKGROUND: The prevalence of venous leg ulcers is as high as 1% to 1.5%, and the total costs of this disease are 1% of the total annual health care budget in Western European countries. Treatment modalities are conservative or surgical. Subfascial endoscopic perforating vein surgery (SEPS) combined with superficial vein ligation is performed in many centers to address vein incompetence in patients with chronic venous leg ulcers. Several reports describe good healing and low recurrence rates, although a randomized trial to compare surgical treatment including SEPS and treatment of the superficial venous system to conservative modalities has never been performed. Therefore, a prospective, randomized, multicenter trial was conducted to study whether ambulatory compression therapy with venous surgery is a better treatment than just ambulatory compression therapy in venous leg ulcer patients.
METHODS: Patients with an active (open) venous leg ulcer (CEAP C6) qualified for the study. The study consisted of two treatment groups. All patients were treated by standardized ambulatory compression therapy, and half of the patients received SEPS. Concomitant superficial venous incompetence was also treated in the second group. For allocation to both treatment groups, each patient was assigned by a computer program at the randomization center. The primary goal of the study was to compare the ulcer-free period during follow-up in both study groups. Secondary end points were ulcer healing and recurrence rates.
RESULTS: From April 1997 until January 2001, 200 ulcerated legs (170 patients) were included in the study in 12 centers in The Netherlands. A total of 97 ulcers were allocated to the surgical group and 103 to the conservative group. Patient characteristics were similar in the two treatment groups at baseline, with the exception of a higher proportion in the conservative group of diabetes mellitus. Healing rates were 83% in the surgical group and 73% in the conservative group (not significant; median time to healing, 27 months). Recurrence rates were the same in both treatment groups (22% surgical vs 23% conservative). During follow-up of a mean of 29 months (median, 27 months) in the surgical group and 26 months (median, 24 months) in the conservative group, we found that in the surgical group, the ulcer-free rate was 72%, whereas in the conservative group this rate was 53% (P = .11; Mann-Whitney test). Patients with recurrent ulceration or medially located ulcers in the surgical group had a longer ulcer-free period than those treated in the conservative group (P = .02 for both). A first-time ulcer and one of the centers also had a positive effect on the ulcer-free period during follow-up (P < .001 and P = .02), independent of the treatment group. Deep vein incompetence did not affect the ulcer-free period.
CONCLUSIONS: In conclusion, we suggest that patients with medial and/or recurrent ulceration should receive surgery combined with ambulatory compression therapy. A dedicated center should provide care for those patients.

PMID 16950434  J Vasc Surg. 2006 Sep;44(3):563-71. doi: 10.1016/j.jvs.・・・
著者: Simon Palfreyman, E Andrea Nelson, Jonathan A Michaels
雑誌名: BMJ. 2007 Aug 4;335(7613):244. doi: 10.1136/bmj.39248.634977.AE. Epub 2007 Jul 13.
Abstract/Text OBJECTIVE: To review the evidence of effectiveness of dressings applied to venous leg ulcers.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: Hand searches of journals and searches of electronic databases, conference proceedings, and bibliographies up to April 2006; contacts with dressing manufacturers for unpublished studies.
STUDIES REVIEWED: All randomised controlled trials that evaluated dressings applied to venous leg ulcers were eligible for inclusion. Data from eligible studies were extracted and summarised independently by two reviewers using a data extraction sheet. Methodological quality was assessed independently by two reviewers.
RESULTS: The search strategy identified 254 studies; 42 of these fulfilled the inclusion criteria. Hydrocolloids were no more effective than simple low adherent dressings used beneath compression (eight trials; relative risk for healing with hydrocolloid 1.02, 95% confidence interval 0.83 to 1.28). For other comparisons, insufficient evidence was available to allow firm conclusions to be drawn. None of the dressing comparisons showed evidence that a particular class of dressing healed more ulcers. Some differences existed between dressings in terms of subjective outcome measures and ulcer healing rates. The results were not affected by the size or quality of trials or the unit of randomisation. Insufficient data were available to allow conclusions to be drawn about the relative cost effectiveness of different dressings.
CONCLUSIONS: The type of dressing applied beneath compression was not shown to affect ulcer healing. The results of the meta-analysis showed that applying hydrocolloid dressings beneath compression produced no benefit in terms of ulcer healing compared with applying simple low adherent dressings. No conclusive recommendations can be made as to which type of dressing is most cost effective. Decisions on which dressing to apply should be based on the local costs of dressings and the preferences of the practitioner or patient.

PMID 17631512  BMJ. 2007 Aug 4;335(7613):244. doi: 10.1136/bmj.39248.6・・・

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