COPDへの合成ヒトグレリン

COPDに合成ヒトグレリンを投与したRCTを紹介します。

Benjamin Levinson, Joseph Gertner. Randomized Study of the Efficacy and Safety of SUN11031 (synthetic Human Ghrelin) in Cachexia Associated with Chronic Obstructive Pulmonary Disease. e-SPEN Journal http://dx.doi.org/10.1016/j.clnme.2012.07.004

リサーチクエスチョンは以下の通りです。

P：COPD患者に
I：合成ヒトグレリンを投与（20μg/kgもしくは40μg/kgを1日2回皮下注射、12週間）すると
C：投与しない場合と比較して
O：体重（除脂肪体重）が増加し、身体機能が改善する
D：ランダム化比較試験

結果ですが、体重（20μg/kgで1.8kg、40μg/kgで2.4kg）、除脂肪体重は有意に増加しました。しかし、身体機能（SPPB、握力、呼吸機能）は有意な改善を示しませんでした。ただし、重度の悪液質で除脂肪体重が増加した群では、身体機能が改善しました。

以上より、COPD患者への合成ヒトグレリン投与は体重、除脂肪体重を増加させるという結論です。身体機能に関しては呼吸リハと適切な栄養療法で改善を期待できますので、合成ヒトグレリンを含めた包括的呼吸リハであれば、悪液質やサルコペニアの改善をより期待できると考えます。

Abstract

Background

Up to 40% of patients with chronic obstructive pulmonary disease (COPD) manifest cachexia characterized by sustained loss of lean body mass (LBM) associated with protein catabolism, and reduced physical function. The aim of this study was to determine the effects of SUN11031 on body mass and physical performance in cachectic patients with COPD.

Methods

International, multicenter, randomized trial (NCT 00698828) that measured change from baseline in distance walked on the 6 minute walk test (6MWT) after 12 weeks of treatment, results of the Short Physical Performance Battery (SPPB), handgrip strength, maximum inspiratory pressure (PI_max), body mass, body composition, appetite and lung function.

Results

SUN11031 at 20 and 40 μg/kg twice daily (bid) resulted in rapid and significant increases in body weight (1.8 and 2.4 kg, respectively; P = 0.020 and P<0 .001=".001" 40="40" a="a" and="and" as="as" associated="associated" bid.="bid." cachexia="cachexia" clinically="clinically" combination="combination" did="did" g="g" however="however" improvement="improvement" in="in" increase="increase" increased="increased" intent-to-treat="intent-to-treat" kg="kg" lbm.="lbm." lbm="lbm" meaningful="meaningful" measures="measures" more="more" not="not" of="of" on="on" outcome="outcome" p="p" particularly="particularly" patients="patients" performance="performance" physical="physical" population="population" received="received" respectively="respectively" result="result" severe="severe" sppb="sppb" sun11031="sun11031" the="the" was="was" who="who" whole.="whole." with="with">

Conclusions

SUN11031 was well-tolerated and resulted in increases in body weight and LBM. Improvement in physical performance was observed in patients with severe cachexia. Additional study is warranted.