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The Japanese Journal of Rehabilitation Medicine Volume 54, Issue 4 （April 2017）

The Japanese Journal of Rehabilitation Medicine 54巻4号（2017年4月発行）

Japanese English

原著

回復期リハビリテーション病棟において，補中益気湯は脳血管障害後遺症患者の炎症性合併症発症率を抑制する—多施設ランダム化比較試験による検討 Hochuekkito Reduced the Incidence of Inflammatory Complications in Patients with Sequelae of Cerebrovascular Disease in Convalescent Rehabilitation Wards : A Randomized Multicenter Study 福村直毅 ¹ , 山本ひとみ ¹ , 北原正和 ¹ , 鎌倉嘉一郎 ² , 植木昭彦 ³ , 牛山雅夫 ¹ Naoki Fukumura ¹ , Hitomi Yamamoto ¹ , Masakazu Kitahara ¹ , Kaichiro Kamakura ² , Akihiko Ueki ³ , Masao Ushiyama ¹ ¹健和会病院リハビリテーション科 ²函館稜北病院リハビリテーション科 ³高松協同病院リハビリテーション科 ¹Department of Rehabilitation Medicine, Kenwakai Hospital ²Department of Rehabilitation Medicine, Hakodate Ryohoku Hospital ³Department of Rehabilitation Medicine, Takamatsu Kyodo Hospital キーワード：補中益気湯 , Hochuekkito , 脳血管疾患 , cerebrovascular disease , 機能的自立度評価表 , Functional Independence Measure , 炎症性合併症発症率 , incidence of inflammatory complication , ランダム化比較試験 , randomized controlled trial Keyword: 補中益気湯 , Hochuekkito , 脳血管疾患 , cerebrovascular disease , 機能的自立度評価表 , Functional Independence Measure , 炎症性合併症発症率 , incidence of inflammatory complication , ランダム化比較試験 , randomized controlled trial pp.303-314

発行日 2017年4月18日 Published Date 2017/4/18

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要旨

【目的】機能的自立度評価表（FIM）による分類が重症（FIM総得点≦40点）患者の日常生活動作（ADL）や栄養・免疫状態低下に対する補中益気湯の有効性および安全性について検討した．

【方法】片麻痺を伴う脳血管障害後遺症でリハビリテーション施行患者31例を対象に補中益気湯（TJ-41）投与群と非投与群に無作為に割付し，24週間観察した．評価はADL，炎症性合併症発症率などである．

【結果】FIM総得点は両群ともに治療前後で有意に改善したが，FIM利得に群間差はなかった．炎症性合併症発症率はTJ-41投与群で有意に低かった（p＝0.049）．FIM運動得点が20点以下の症例において，治療前後の総リンパ球数変化比はTJ-41投与群で増加傾向が認められた．本研究において副作用はなかった．

【結論】補中益気湯は脳血管疾患などのリハビリテーションにおいて炎症性合併症対策に有用である可能性が示唆された．

Abstract

Objective：The aim of this study was to examine the efficacy and safety of hochuekkito to address reduced activities of daily living (ADL), nutritional status, and immunity in patients with severe conditions, represented by a functional independence measure (FIM) total score of ≤ 40.

Methods：Thirty-one patients who were undergoing rehabilitation for hemiplegia after cerebrovascular disease were randomized into 2 groups：those treated with hochuekkito (TJ-41 group) and those treated without hochuekkito (control group). Their conditions were observed for 24 weeks, focusing on items such as ADL and incidence of inflammatory complications.

Results：The FIM total score markedly improved after treatment in both groups, but the changes in the score between admission and discharge were similar between the two groups. The incidence of inflammatory complications was significantly lower in the TJ-41 group (P = 0.049). Among the patients with a motor FIM score of ≤ 20, those in the TJ-41 group showed a tendency of increase in total lymphocyte count after treatment. No adverse drug reactions were observed during the study period.

Conclusion：These results suggest that hochuekkito is effective in reducing the incidence of inflammatory complications in patients undergoing rehabilitation for cerebrovascular or other diseases.