04_学術_造影検査マニュアル作成について.indd

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1 Arts and Sciences Manual for radiological examinations using contrast agents: Usefulness of the creatinine point - of - care handheld analyzer Key words: estimated glomerular filtration rate (egfr), Point-of-care, Contrast-induced nephropathy (CIN), Nephrogenic systemic fibrosis (NSF) Abstract Assessment of renal functions before a contrast-enhanced examination is recommended. In our hospital, we installed a device for the rapid measurement of renal functions called creatinine point-of-care handheld analyzer, and then authored a manual for its use. We also confirmed the high performance of the device. Estimated glomerular filtration rates (egfr) of 369 and 288 patients who were scheduled to undergo computed tomography (CT) and magnetic resonance imaging (MRI), respectively, were measured using the device. We found that 4.61% (egfr < 45) of CT patients and 0.69% (egfr < 30) of MRI patients were contraindicated for contrast-enhanced examinations. Accordingly, 4.86% of patients (egfr < 30 45) did not receive injections of gadolinium contrast medium, while the safety of other agents was discussed for 28.5% of the patients (egfr < 45 59). We debated issues of potential side effects that occurs after contrast-enhanced examinations with the staff by employing cards of side effects, which improved the safety of contrast-enhanced examinations and enabled the sharing of information about the side effects of the contrast medium. 04 CT 369 MRI 288 egfrct 4.61% egfr 45 MRI 0.69% egfr % egfr % egfr computed tomography CT magnetic resonance imaging MRI contrast-induced nephropathy CIN 1 nephrogenic systemic fibrosis NSF 2 Osamu Yamamuro East Nagoya Imaging Diagnosis Center Department of Imaging Technology 2 Division of Health Sciences, Graduate School of Medical Sciences, Kanazawa University CIN SCr 3 MRI GFR 4 Stat Sensor-i Nova Biomedical corporation

2 Table 1 Stat sensor use standard in this hospital Table 2 Inside the hospital enforcement decision right or wrong decision chart CT 3 2 Table 3 Inside the hospital enforcement decision right or wrong decision chart MRI Gd Table Table CT 30sec600mgI/kg 50sec500mgI/kg estimated glomerular filtration rate egfr 45mL/min/ 1.73m 2 CIN egfr45ml/min/1.73m 2 CIN 5 egfr45ml/min/1.73m mmol/kg vol.63 no.764

3 資 料 学 造影検査マニュアル作成について 携帯型迅速クレアチニン測定装置の有用性 Fig.1 Post-contrast enhancement explanation paper 術 Arts and Sciences Fig.3 Inside the hospital file management system 変動や 激しい運動時や肉の大量摂取時の上昇 タン パク摂取制限時には低下 シメチジン トリメトプリ ムは尿細管のクレアチニン排泄を減少させ 血清クレ アチニン値を上昇させる可能性がある 4 という留意点 を考慮している 50mL/min/1.73m2 という値は 45mL/min/1.73m2 の 10% を基準とした 添付文書の記載も ガドペンテ ト酸ジメグルミン注射液は禁忌項目に 重篤な腎障害 のある患者 とあるが ガドテル酸メグルミン注射液 ではその表記は警告に記載されているので 医師の判 断により慎重に使用している 造影後副作用発生時の対応 Fig.2 Contrast media side effect card 日本放射線科専門医会 医会 ホームページ 7 当院では造影剤を使用した患者全てに 検査後 看 護師による説明を行っている その時に使用している 用紙を Fig.1 に示す 使用した造影剤名 検査種の記 長期透析が行われている終末期腎障害 非透析例で 載があり 主に遅発性副作用についての対応の説明を egfr が 30mL/min/1.73m 未満の慢性腎不全 急 行っている また副作用が発生した場合は 一般社団 性腎不全に該当するがやむを得ずガドリニウム造影剤 法人 日本放射線科専門医会 医会 JCR のホーム を使用しなければならない場合には NSF 発症報告 ページ 7 よりダウンロードできる患者保管型造影剤 の多いガドリニウム造影剤の使用を避けるのが望まし 副作用カード Fig.2 を発行し 他施設での造影検査時 いとある には提示していただくよう説明している 造影剤が漏 2 当 院 で は egfr が 30mL/min/1.73m2 未 満 の 出した場合の帰宅後の対応も用紙を用いて説明してい 患者はガドリニウム使用造影検査を受け入れておら る 副作用の重症度にかかわらず報告書を作成し 院 ず さらに egfr30 44mL/min/1.73m に該当す 内ファイル管理システムに登録し各部署から閲覧でき る CKD の重症度分類で 中等度 高度低下 に値す るシステムを構築した Fig.3 2 る患者に関しては 造影剤の種類をガドテル酸メグル ミン注射液に変更している また egfr45 59mL/ 2-2 当院における推算糸球体濾過量 egfr 測定 min/1.73m に該当するうち egfr45 50mL/min/ 1.73m2 の範囲に該当する方に関しても 造影剤の種 携帯型迅速クレアチニン測定装置使用方法 類をガドテル酸メグルミン注射液に変更を考慮してい Sensor-i 本体と専用クレアチニンテストストリップ る これは 血清クレアチニン値の 10% 程度の日内 で このテストストリップは使い捨てである 本体の 2 測 定 方 法 を Fig.4 に 示 す 用 意 す る 物 は S t a t 学 術

4 Table 4 sex/age distinction change of egfr Fig.4 Method for measurement Thing to prepare input of the patient information Insertion of strip measurement 3 対 象 Fig.5 QC solution and expectation 準備としてストリップのロット番号 患者 ID 年齢 範囲 成人 小児 18 歳以下 年齢 性別などを入力 またはスキャンする 年齢範囲で小児 18 歳以下を選 択した場合 身長を入力する必要がある 測定血液は 指先から採取する ランセットを使用し指先を穿刺し 血液を出す 血液が見えたら テストストリップの先 2014 年 1 月から 3 月末までに当院で行われた CT MRI の造影検査件数 657 件 CT 369 件 MRI 288 件 の egfr 値を調べた 主疾患に腎疾患を持たない患者 で性別は男性 283 人 女性 374 人であり 平均年齢は 男性 63.4 歳 女性 56.9 歳である 日本人の egfr 値は 式 1 にあるように年齢と性別を基に計算される 6 egfr ml/min/1.73m2 =194 Cr Age なお 女性の場合は上式 1 に を乗じる 端を血液に点着させる テストストリップのウェルに 血液が満たされるとビープ音が鳴り 30 秒後に測定 結果が得られる 4 結 果 同一の egfr 値でも男性女性とも年齢とともに低 携帯型迅速クレアチニン測定装置の精度管理 下し 女性は男性より低い結果となった Table 4 Stat Sensor-i の測定精度を保つため精度管理が必 要となる 日常管理として専用クレアチニン QC 溶液 を使用し管理を行っている 専用クレアチニン QC 溶 液はレベル とありそれぞれに期待値範囲が決 められており QC テストの結果がその範囲から外れ ていないか確認する Fig.5 この結果は 日本腎臓学会のデータと同じ傾向を示し 日本診療放射線技師会誌 vol.63 no.764 この測定器の精度に問題はないと判断した egfr 値 を基に院内のマニュアルに当てはめた結果 CT にお いては 17 件 4.61% egfr 45 で検査中止も しくは単純検査に変更となった MRI においては 2 件 0.69% egfr 30 で検査中止もしくは単純検

5 Arts and Sciences % egfr % egfr Stat Sensor-i 9 10 Stat Sensor-i egfr egfr 1 CT MRI5% egfr CIN NSF MRI 30% QC 6 Stat Sensor-i Web Table 1 Stat Sensor Table 2 CT Table 3 MRI Table 4 egfr Fig.1 Fig.2 Fig.3 Fig.4 Fig.5 QC

6 1 Davidson CJ, Hlatky M, Morris KG, et al.: Cardiovascular and renal toxicity of a nonionic radiographic contrast agent after cardiac catherization. Ann Intern Med, 110, , Grobner T: Nephrol Dial Transpiant. 21(4), , ,, NSF Stacul F, van der Molen AJ, et al.: Contrast Media Safety Committee of European Society of Urogenital Radiology (ESUR): Contrast induced nephropathy: updated ESUR Contrast Media Safety Commitee guidelines. Eur Radiol, 21, , CKD JCR Morita S, Suzuki K, Masukawa A, Ueno E: Assessing renal function with a rapid, handy, point-of-care whole blood creatinine meter befor using contrast materials. Japanese Journal of Radiology, 29(3), , Diagnostic Evidence Co-operative Oxford: Point-of- Care Creatinine Testing for the Detection and Monitoring of Chronic Kidney Disease. National Institute for Health Reserch. Horizon Scan Report 0038 March Korpi-Steiner NL, Willamson EE, Karon BS: Comparison of three whole blood creatinine methods for estimation of glomerular filtration rate before radiographic contrast administration. American Journal of Clinical Pathology, 132(6), , vol.63 no.764

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