研究Ⅱにはいくつかの限界があった。ひとつは無作為の割り付けにもかかわらず
HES群でより年齢が若く、術前の心機能が悪かった。またCPB時間がHES群でよ り長かった。年齢が若いことは術後AKIの危険性を減じ、低心機能とより長いCPB 時間は術後AKIの危険性を増すと考えられ、多変量解析によりこれらの因子を補正 した結果では依然としてHES群と晶質液群でAKI発症に差がなかった。しかし今 後より偏りのない症例での検討が必要であろう。
また対象症例の手術中の出血量が少なく、結果としてHES130/0.4の使用量が
27.7ml/kgと少なかったことがAKI発症を減少させた可能性がある。HES130/0.4の
一日最大使用量である50ml/kgを使用した場合での検討も必要かと思われた。
【結論】
Ⅰ 東北医科薬科大学病院おける心臓手術後AKIは37.9%に認められ、文献的な報 告とほぼ同じであった。またAKI発症の危険因子は肥満、術前の腎機能障害、術前 の低心機能、術式（CABG＋弁手術）、CPB時間、術中尿量であった。
Ⅱ 比較的腎機能の保たれた患者ではHES130/0.4の術中投与は重炭酸リンゲル液 との比較でCPBを用いた心臓手術後30日間のAKI発症とその病期に違いがなかっ た。
【文献】
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図 1
図1．研究Ⅲ：研究参加者のフローダイアグラム
適格性の評価（n = 119）
除外 （n = 59）
◆ 選択基準に含まれない(n = 38)
◆ 参加辞退（n = 21）
解析された（n = 28） 追跡不能 （n = 0）
間質性肺炎の急性増悪により体 外式膜型人工肺装着（n = 1） 術式の変更（n = 1）
HES群へ割付（n = 30）
◆ HES 130/0.4 の投与
追跡不能 （n = 0）
術式の変更（n = 2） 晶質液群へ割付 （n = 30）
◆ 重炭酸リンゲル液の投与
解析された（n = 28）
割付
解析 追跡
ランダム化（n = 60）
組み入れ
HES（hydroxyethyl starch; ヒドロキシエチルデンプン）
表 1
表1．研究Ⅰ：術前・術中因子（全症例；n = 214）
術前因子 術中因子
年齢，歳 69 ± 11 術式
性別，男／女 118/96 CABG 33 (15.4)
Body mass index，kg/m2 23.1 ± 3.1 弁手術 122 (57.0)
術前検査データ CABG＋弁手術 47 (22.0)
血清クレアチニン，mg/dl 0.87 ± 0.31 その他 12 (5.6)
eGFR，ml/min/1.73m2 65.2 ± 18.9 手術時間，分 278 ± 77
ヘモグロビン，g/dl 12.6 ± 1.7 人工心肺時間，分 152 ± 47
術前心エコー 大動脈遮断時間，分 107 ± 34
左室拡張終期径，mm 53.4 ± 8.8 HES使用量，ml 237 ± 322
左室収縮終期径，mm 37.6 ± 8.9 出血量，ml 495 ± 449
左室駆出率，％ 56.2 ± 12.4 尿量，ml 634 ± 383
既往歴
高血圧，n (%) 128 (59.8) 糖尿病，n (%) 63 (29.4) 慢性閉塞性肺疾患，n (%) 42 (24.3)*
末梢動脈疾患，n (%) 36 (17.8)*
術前使用薬
ACEI/ARB，n (%) 142 (66.4) NSAIDs，n (%) 82 (38.3)
結果は平均±標準偏差または症例数（％）で示す．
*n = 173（慢性閉塞性肺疾患），n = 202（末梢動脈疾患）．
eGFR（estimated glomerular filtration rate; 推算糸球体濾過量)，ACEI（angiotensin converting enzyme inhibitor; アンジオテンシン変換酵素阻害薬），ARB（angiotensin Ⅱ receptor blocker; アンジオテンシン受容 体遮断薬），NSAIDs（non-steroidal anti-inflammatory drugs; 非ステロイド性抗炎症薬），CABG（coronary artery bypass grafting; 冠動脈バイパス術），HES（hydroxyethyl starch; ヒドロキシエチルデンプン）．
表 2
表2．研究Ⅰ：急性腎障害の発症と病期
n 214
30日以内でのAKI発症
AKIなし，n (%) 133 (62.1) AKIあり，n (%) 81 (37.9) AKI病期，
AKIなし，n (%) 133 (62.1) ステージ1，n (%) 63 (29.4) ステージ2，n (%) 17 (7.9) ステージ3，n (%) 1 (0.5) 結果は症例数（％）で示す．
AKI（acute kidney injury; 急性腎障害）．
表 3
表3．研究Ⅰ：AKI群と非AKI群の比較（術前因子）
AKI群（n = 81) 非AKI群（n = 133) P値
年齢，歳 72 ± 10 67 ± 12 0.0013
性別，男／女 48/33 70/63 0.3444
Body mass index，kg/m2 24.0 ± 3.5 22.6 ± 2.8 0.0038 術前検査データ
eGFR，ml/min/1.73m2 58.2 ± 19.9 69.4 ± 17.0 < 0.0001 ヘモグロビン，g/dl 12.3 ± 1.8 12.8 ± 1.7 0.0390 術前心エコー
左室拡張終期径，mm 55.8 ± 8.6 52.0 ± 8.6 0.0023 左室収縮終期径，mm 40.0 ± 9.6 36.2 ± 8.2 0.0024
左室駆出率，％ 54.2 ±13.6 57.4 ± 11.6 0.0660
既往歴
高血圧，n (%) 54 (66.7) 74 (55.6) 0.1105
糖尿病，n (%) 30 (37.0) 33 (24.8) 0.0570
慢性閉塞性肺疾患，n (%) 21 (35.0)* 21 (18.6)** 0.0165 末梢動脈疾患，n (%) 20 (25.6)* 16 (12.9)** 0.0213 術前使用薬
ACEI/ARB，n (%) 60 (74.1) 82 (61.7) 0.0622 NSAIDs，n (%) 39 (48.1) 43 (32.3) 0.0210
結果は平均±標準偏差または症例数で示す．P値は対応のないｔ検定またはカイ二乗検定による．
eGFR（estimated glomerular filtration rate; 推算糸球体濾過量)，ACEI（angiotensin converting enzyme inhibitor; アンジオテンシン変換酵素阻害薬），ARB（angiotensin Ⅱ receptor blocker; アンジオテンシン受 容体遮断薬），NSAIDs（non-steroidal anti-inflammatory drugs; 非ステロイド性抗炎症薬）．
*n = 60（慢性閉塞性肺疾患），n = 78（末梢動脈疾患）．**n = 113（慢性閉塞性肺疾患），n = 124（末 梢動脈疾患）
表 4
表4．研究Ⅰ：AKI群と非AKI群の比較（術中因子）
AKI群（n = 81) 非AKI群（n = 133) P値
術式 < 0.0001
CABG 9 (11.1) 24 (18.0)
弁手術 37 (45.7) 85 (63.9)
CABG＋弁手術 33 (40.7) 14 (10.5)
その他 2 (2.5) 10 (7.5)
手術時間，分 310 ± 80 259 ± 69 < 0.0001
人工心肺時間，分 176 ± 50 137 ± 38 < 0.0001
大動脈遮断時間，分 122 ± 35 98 ± 29 < 0.0001
HES使用量，ml 267 ± 380 218 ± 281 0.3207
出血量，ml 612 ± 544 424 ± 364 0.0067
尿量，ml 521 ± 355 704 ± 384 0.0006
結果は平均±標準偏差または症例数（％）で示す．P値は対応のないｔ検定またはカイ二乗検定による．
CABG（coronary artery bypass grafting; 冠動脈バイパス術），HES（hydroxyethyl starch; ヒドロキシエ チルデンプン）．
表 5
表5．研究Ⅰ：急性腎障害発症に関連する術中術後因子の多変量解析
下限値 上限値
術前因子
年齢 ≧ 80歳 1.97 0.81 4.81 0.1362
Body mass index ≧ 25 kg/m2 2.27 1.07 4.83 0.0333 eGFR ＜ 45 ml/min/1.73m2 3.69 1.27 10.74 0.0164
ヘモグロビン ＜ 10 g/dl 1.45 0.36 5.92 0.6043
左室拡張終期径 ≧ 55 mm 1.40 0.48 4.10 0.5365
左室収縮終期径 ≧ 40 mm 2.95 0.81 10.79 0.1024
左室駆出率 ＜ 50% 0.27 0.08 0.89 0.0321
糖尿病 1.34 0.63 2.88 0.4474
ACEI/ARB 2.01 0.94 4.31 0.0722
NSAIDs 1.14 0.51 2.56 0.7442
術中因子
CABG＋弁手術 2.83 1.18 6.82 0.0203
手術時間 ≧ 300分 1.32 0.52 3.38 0.5580
人工心肺時間 ≧ 150分 3.76 1.30 10.88 0.0144
大動脈遮断時間 ≧ 120分 0.58 0.20 1.70 0.3219
出血量 ≧ 1000 ml 2.47 0.71 8.62 0.1568
尿量 ＜ 300 ml 3.82 1.16 12.63 0.0278
95%信頼区間
オッズ比 P値
eGFR（estimated glomerular filtration rate; 推算糸球体濾過量)，ACEI（angiotensin converting enzyme inhibitor; アンジオテンシン変換酵素阻害薬），ARB（angiotensin Ⅱ receptor blocker; アンジオテンシン 受容体遮断薬），NSAIDs（non-steroidal anti-inflammatory drugs; 非ステロイド性抗炎症薬），CABG
（coronary artery bypass grafting; 冠動脈バイパス術）．
表 6
表6．研究Ⅱ：術前因子
HES群 (n = 28) 晶質液群 (n = 28) P値
年齢，歳 67 [63 - 72] 74 [65 - 79] 0.0372
性別，男／女 20/8 14/14 0.1007
身長，m 1.61 [1.59 - 1.70] 1.57 [1.47 - 1.68] 0.1192
体重，kg 60.1 [51.7 - 67.1] 56.5 [47.4 - 64.5] 0.3175 Body mass index，kg/m2 21.3 [20.2 - 24.0] 22.8 [20.5 - 24.1] 0.6820 術前検査データ
血清クレアチニン，mg/dl 0.87 [0.75 - 1.05] 0.78 [0.70 - 0.95] 0.1315 eGFR，ml/min/1.73m2 63 [50 - 74] 61 [54 - 75] 0.7616 ヘモグロビン，g/dl 13.2 [11.5 - 14.0] 12.6 [11.7 - 14.4] 0.7061 術前心エコー
左室拡張終期径，mm 59.4 [53.3 - 64.5] 53.5 [49.5 - 60.1] 0.0143 左室収縮終期径，mm 40.7 [36.0 - 49.5] 34.5 [32.4 - 39.1] 0.0136 左室駆出率，％ 60 [38.2 - 65.1] 63.7 [55.9 - 65.8] 0.1157 既往歴
高血圧，n (%) 14 (50) 15 (53.6) 0.7891
糖尿病，n (%) 7 (25) 5 (17.9) 0.5148
慢性閉塞性肺疾患，n (%) 4 (14.3) 4 (14.3) 1.0000
末梢動脈疾患，n (%) 3 (10.7) 2 (7.1) 0.6393
術前使用薬
ACEI/ARB，n (%) 15 (53.6) 13 (46.4) 0.5930
NSAIDs，n (%) 6 (21.4) 3 (10.7) 0.2750
結果は中央値［第1 - 第3四分位数］または症例数で示す．P値はマンホイットニーのU検定またはカイ二乗検定による．
HES（hydroxyethyl starch; ヒドロキシエチルデンプン），eGFR（estimated glomerular filtration rate; 推算糸球体濾過 量)，ACEI（angiotensin converting enzyme inhibitor; アンジオテンシン変換酵素阻害薬），ARB（angiotensin Ⅱ receptor blocker; アンジオテンシン受容体遮断薬），NSAIDs（non-steroidal anti-inflammatory drugs; 非ステロイド性 抗炎症薬）．