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Piperacillin/tazobactamの副作用および相互作用に関する疫学研究

門村, 将太 北海道大学

2021.09.24

概要

医薬品による副作用は、患者の健康を脅かし、入院期間の延長や医療費の増大を招く 1,2)。入院患者における副作用は、重篤なものが 6.7％、致死的なものが 0.3％の患者に発 生したと報告されている 3)。そして、副作用の発生に関連する薬剤は、抗菌薬および抗 血栓薬が多かったとの報告がある 4)。副作用はおよそ半数が予防可能と考えられており、入院に至る患者の割合はおよそ 1/4 を占めるとされている 5)。また、医薬品の相互作用 は、併用薬が標的薬物の血中濃度を変動させる、あるいは薬理学的作用を増強させることにより、副作用のリスクを高める 6)。薬物相互作用は、薬物動態学的薬物間相互作用、 薬力学的薬物間相互作用、薬物－疾患相互作用、薬物－食物相互作用など多岐に渡る 7)。このことより、医薬品の副作用リスクが患者の併存疾患や併用薬など様々な要因と複雑 に関わり合っていると言える。薬物相互作用は、入院患者においておよそ 10 人に 1 人 の割合で発生していると言われている 8)。そして、薬物相互作用もまた、入院期間の延 長や医療費の増加を招く要因となることから 9)、薬剤師は医薬品が投与された患者の副 作用や相互作用などのケアに責任を持って努めることが求められる 10)。薬剤師が薬学 的ケアを実践することにより、医薬品の副作用を低減できることが報告されており 11)、本邦においても、病院薬剤師が薬学的問題点（DRP）に介入することによって、不適切 投与、副作用、薬物相互作用などの回避につながり、医療コストを抑制できたことが明 らかとなっている 12,13)。さらには、薬剤師がエビデンスが不十分な医薬品の副作用およ び相互作用について、実臨床におけるアウトカムに関する疫学研究を実施することは、医薬品の適正使用の推進につながり、さらには臨床薬学における新たなエビデンスの構 築や研究の新たなシーズの発見にもなり得る。

抗菌薬は、感染症の治療や予防のために広く用いられ、医療において不可欠な医薬品である。また、抗菌薬は、併用薬との薬物間相互作用により、重篤な副作用を生じることもある 6)。抗菌薬に起因する副作用による外来患者の救急受診は、抗凝固薬に次いで多い 14)。また、入院患者における副作用の原因薬剤として、抗菌薬が全体のおよそ 20％を占めており、投与期間が長引くほど頻度が高くなると報告されている 15)。このことから、抗菌薬に関連した副作用および薬物間相互作用について疫学研究を行い、これらの危険因子を見出すことは、副作用リスクを把握するために重要である。

Piperacillin/tazobactam （ PIPC/TAZ ）は、ウレイドペニシリン系抗生物質である Piperacillin（PIPC）と、βラクタマーゼ阻害剤である tazobactam（TAZ）とが配合された抗菌薬であり、緑膿菌をはじめとする各種細菌に対して広域な抗菌スペクトラムを有している。また、PIPC/TAZ は、重症肺炎 16)、腹腔内感染症 17)、敗血症 18)、発熱性好中球減少症 19)などの様々な感染症における診療ガイドラインで推奨されており、その対象の多くは高齢者、悪性腫瘍の患者、免疫不全患者である。これらの患者は、感染症の再発率が高く、それに伴って抗菌薬の曝露回数が健常者と比較して多いことから、薬剤耐性菌の保有率が高い 20–24)。そのため、これらの患者は最も広い抗菌スペクトラムを有するカルバペネム系抗菌薬が使用される機会も多くなる 25–27)。しかしながら、カルバペネム系抗菌薬などの広域抗菌薬の濫用は、ペニシリン系抗菌薬と比べて、耐性菌の増加 28）、副作用の増加、さらに入院期間延長や医療費の増大につながる 29,30)。PIPC/TAZ は、このようなカルバペネム系抗菌薬の濫用を抑制するためのキードラッグ、いわゆる sparing agent の１つに位置づけられている 31–34)。従って、PIPC/TAZ を有効かつ安全に使用することが、結果として抗菌薬適正使用につながると考えられる。

PIPC/TAZ は、本邦における広域抗菌薬の中で使用頻度が最も高い一方で、副作用の 発生数もまた多かったことが報告されている 35)。PIPC/TAZ を適用される患者の多くが、高齢者や悪性腫瘍を有する患者、免疫不全患者などであることから、その併存疾患の治 療のために併用薬がある場合も多いと考えられ、薬物間相互作用にも注意が必要である。 PIPC/TAZ の副作用として、過敏症、好中球減少、急性腎障害などが知られている。 PIPC/TAZ 投与患者における好中球減少は、累積投与量との関連性が指摘されている 36)。 PIPC/TAZ の薬物間相互作用のひとつとして、vancomycin（VCM）との併用による腎障 害のリスク増加が報告され 37,38)、PIPC/TAZ の添付文書改訂に至った。また、PIPC/TAZ は、warfarin との併用による抗凝固作用の増強について、添付文書に併用注意として記 載されている。この他にも、PIPC/TAZ はmethotrexate（MTX）との併用による MTX の 排泄遅延があり、重篤な副作用を生じた症例が報告されている 39)。しかしながら、これ らの知見は症例報告などに限られるものも多く、十分な検討がなされているとは言い難 い。

近年、電子カルテの普及によって、後方視的なカルテ調査などを行う臨床研究は比較的実施しやすくなってきた。また、多施設共同研究には大きな労力を要するが、医薬品医療機器総合機構（PMDA）が提供する医薬品副作用データベース（JADER）や米国医薬品食品局（FDA）が提供する医薬品副作用データベース（FAERS）などの自発的副作用報告、レセプトや DPC データといった医療情報データベースなどのいわゆるリアルワールドデータを利活用することにより、大規模な実臨床の薬剤疫学研究もまた実施可能となっている。

以上のことから、本研究では、PIPC/TAZ 投与によって生じる副作用として急性腎障害を、また PIPC/TAZ の薬物間相互作用として warfarin および MTX 投与患者に対する影響を、それぞれ実臨床のデータを用いて疫学的に解明することを目的とした。

本研究において、第一章では、PIPC/TAZ 投与患者の急性腎障害について第 4 世代セファロスポリン系抗菌薬 cefepime（CFPM）を比較対照として調査を行った。第二章では、warfarin 服用患者において PIPC/TAZ の投与が抗凝固作用におよぼす影響を検討した。第三章では、PIPC/TAZ 投与が大量 MTX 療法患者において MTX 排泄遅延を生ずるのかについて検証した。本研究によって得られる知見は、PIPC/TAZ 投与患者において安全な薬物療法を行うための一助となり得る。

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