森 義弘¹, 早川 晶子¹, 阿部 研自², 谷川 雅俊¹, 高橋 周美¹, 成瀬 英典¹, 山口 文恵¹

Yoshihiro MORI¹, Akiko HAYAKAWA¹, Kenji ABE², Masatoshi TANIGAWA¹, Megumi TAKAHASHI¹, Hidenori NARUSE¹, Fumie YAMAGUCHI¹

¹第一三共株式会社学術調査部, ²第一三共株式会社データサイエンス部

¹Post Marketing Studies Management Department, Business Intelligence Division, DAIICHI SANKYO CO., LTD., ²Clinical Data and Biostatistics Department, R&D Division, DAIICHI SANKYO CO., LTD.

キーワード : Sonazoid, perflubutane, contrast-enhanced ultrasonography, post-marketing surveillance

目的：Sonazoid^®注射用16μL（一般名ペルフルブタン）発売後，使用患者数が年々増えているが，様々な基礎疾患や合併症を持つ患者における多施設，多数例での安全性，有効性に関するデータは現在のところ報告されていない．そこで本剤の日常診療における安全性，有効性の新たな問題点の把握を目的として使用成績調査を実施した．対象と方法：本剤の効能・効果である「超音波検査における肝腫瘤性病変の造影」の目的でペルフルブタンを投与した患者を対象とし，3,000例を収集目標として全国の医療機関で調査を実施した．結果と考察：全国の257施設より3,655例の調査票を収集した．安全性評価対象3,418例のうち副作用は16例（21件）発現し，発現率は0.5％であった．重篤な副作用は無かった．また，本剤の使用にあたり新たな注意喚起を必要とする問題点は認められなかった．有効性評価対象3,283例における全目的の有効率は，血管相動脈優位相における血管描出能92.5％，後血管相における実質描出能93.2％，総合評価94.1％であった．検査目的別，撮像時相別の有効率は83.0‐97.5％の範囲であり，日常診療において一定の評価が確立されたと考えられた．結論：ペルフルブタンを用いた造影超音波検査法は肝腫瘤性病変の精査・確定診断，局所治療への応用，治療効果判定などの様々な目的で安全に使用可能なモダリティの一つとして位置付けられた．

Purpose: Although the number of patients undergoing contrast-enhanced ultrasound (CEUS) with perflubutane has increased continuously since its introduction, its safety and efficacy in multiple patients with various chronic and concomitant disease and from multiple institutions has remained unreported. We therefore carried out a drug-use results survey to assess the safety and efficacy of perflubutane in clinical practice. Subjects and Methods: Subjects were patients to whom perflubutane had been administered for ultrasound contrast imaging of focal hepatic lesions, for which perflubutane is indicated. The survey was conducted nationwide in an attempt to collect data from 3,000 subjects. Results and Discussion: We collected data from 3,655 subjects in 257 institutions. Adverse reactions occurred in 16 of the 3,418 subjects deemed eligible for safety evaluation, and the incidence of adverse reactions was 0.5%. However, none of adverse reactions were serious. Moreover, no concerns requiring special safety measures were identified. Among the 3,283 subjects eligible for efficacy evaluation, the efficacy in tests for all purposes for CEUS in vascular imaging, in post vascular imaging, and in overall efficacy was 92.5%, 93.2%, and 94.1%, respectively. Efficacy ranged between from 83.0% and 97.5% throughout, for all purposes and in each imaging, indicating that the efficacy in clinical practice had been demonstrated. Conclusion: CEUS with perflubutane has the potential to become a safe modality for both diagnosis and therapy of hepatic focal lesions, including such uses as US-guided RFA and evaluation of therapeutic effects.