経口メチルプレドニソロンのIgA腎不全患者の臨床結果への影響: TESTING ランダム化臨床試験

Jicheng Lv¹, Hong Zhang², Muh Geot Wong³

¹Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China2The George Institute for Global Health, University of New South Wales, Sydney, Australia.

JAMA

|August 2, 2017

まとめ

メチルプレドニソロンなどのコルチコステロイドは,IgA腎不全患者の腎臓を保護しますが,深刻な感染症のリスクを高めます. 研究は早期に中止され,治療の効果に関する決定的な結論は限られた.

科学分野:

腎臓科
免疫学
臨床試験

背景:

ガイドラインでは,IgA腎不全 (IgAN) の治療にコルチコステロイドを推奨しています.
これらの治療法の有効性と安全性は不明であり,さらなる調査が必要である.

研究の目的:

疾患進行のリスクのあるIgA腎不全患者におけるコルチコステロイドの有効性と安全性を評価する.
メチルプレドニゾロンが腎臓に与える影響と有害事象の評価

主な方法:

IgANと1g/ d以上のタンパク質尿を有する患者を対象とした多センター,ダブルブラインド,ランダム化臨床試験 (TESTING研究).
参加者は2ヶ月間経口メチルプレドニソロンまたはプラセボを受け,その後は離乳期間でした.

主要な成果:

メチルプレドニソロン群の重篤な有害事象,主に重篤な感染症が多すぎたため,試験は早期に中止された.
メチルプレドニソロン群では,主治性腎疾患 (末期腎疾患など) がより少なく見られたが,確固たる結論は限られている.

結論:

メチルプレドニソロン治療は,重篤な有害事象,特に感染症のリスクの増加と関連していました.
臨床試験の早期終了は,IgANに対するコルチコステロイドの有効性に関する決定的な結論を妨げています.

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