イートモ対訳のサンプル

2020年6月 9日 (火)

診察

こんにちは。

Medical Translator NARITAです。

 

東京は外気温が30度を超えたようです。

熱中症に気を付けて!。

 

さて、午前中は「診察」含有イートモについてスクリーニングしました。

73件。

 

そのうち最初の数件のみをご紹介します。

Shinsatzu

 

イートモを使えば簡単でしょ?

「診察~」なんて、英文の流れの中で0.数秒のオーダーで英訳しなくちゃならないのに、そんなの英訳するのに何分もかけていたら医学翻訳フリーランスで金になりませんぜ。

「診察~」の英訳の勘どころをつかむには実際の仕事を題材に実際にイートモ等を利用して訳してみる、イートモ翻訳トレーニングモードで自分のものにしておく必要があります。

法則のようなものはないのですよ。

やってみるしかないのです。

無理だと思ったら(適切な人に判断してもらってね)、とっとと医学翻訳フリーランスはやめて別の道を探してはどうでょう。

 

さて、昼寝をしたら、「受診」含有イートモをスクリーニングするか。

 

 

2020年6月 7日 (日)

condition→「調子」、「健康状態」、「病気」、「病状」、「事情」

Medical Translator NARITAです。

 

明日はcondition含有イートモ対訳を見直します。

400件弱。

 

「条件」の意味で使われる場合にはケアレスミスがなければ問題ないでしょう。

難しいのはconditionが「調子」、「健康状態」、「病気」、「病状」、「事情」のような意味で使われている場合です。

●主観が除かれるように、conditionとMedical Translator NARITAによる直訳的な和訳のペアになるように工夫するのに苦労します。

直訳的な和訳よりも意訳的な和訳のほうが明らかに自然な日本語になると判断される場合には、意訳的な和訳を採用しています。

固有名詞の処理に必要な編集を英文と和訳の両方に行っています。

あくまでもイートモ制作上の原則ですし、あくまでもイートモは参考資料ですし、いつも書いているようにお客さんからの指示に準じてください。

 

●主観が除かれるように、conditionとMedical Translator NARITAによる直訳的な和訳のペアになるように工夫するのが苦労します。

と関連することですが、機械翻訳×ポストエデットの時代に有用な資料となっています。

ていうか、機械翻訳×ポストエデットの時代には

1.最低でもデジタル化されていること

2.最低でもセンテンスベースであること

3.できれば英文とその和訳が対応していること

4.最低複数回のスクリーニングを経ていること

5.値段が格段に安いこと

といった条件が求められるのです。

 

これらの条件を満たしているイートモを入手できるのはまさに医学翻訳フリーランスの現在の特権なのです。

 

 

aim-2

こんにちは。

Medical Translator NARITAです。

 

午前中はaimを含む英文とその和訳の調査で終わり。

 

イートモ特長のページから・・・・

 

特長

●医薬品の非臨床文書(CMC、毒性、薬理、薬物動態等)、治験実施計画書、治験薬概要書、コモンテクニカルドキュメント(CTD)、治験総括報告書、照会事項並びその回答、審査報告、添付文書など、医薬分野で翻訳依頼される中心的な文書について約43,000件の対訳を収録しています。

日本人の医師や製薬会社の開発担当は、英文をどこの国の人が制作したのかが気になるようです。要は英米系のネーティブスピーカーが作成したものかどうかということね。この辺は深く突っ込まないように。実際、製薬会社をお客さんとして翻訳仕事をしていたときには、ネーティブチェックが入っているかを気にするお客さんが多かったです。そこで、イートモでも元となる英文は、英米系のネーティブスピーカーが作成したと思われる文書から入手してきました。しかし、近年のグローバル化の中、いろいろな地域から英語での情報提供があり、英米系のネーティブスピーカーによる英文と断定することがむずかしくなってきています。原則として、今後も、英米系のネーティブスピーカーが作成したと思われる文書から入手することにしますが、それに限定しないこととします。

●機械翻訳×PE時代でも有用な資料として利用できます。

後述するように、英文と和訳と対応が非常にわかりやすいので、機械翻訳×ポストエデットの時代に有用な資料となっています。

対訳はセンテンスを基本にしています。

上記のタイプの英文をMedical Translator NARITAが和訳し、英文と和文のペア形式にまとめました。イートモ対訳として有用性が単語ベースよりも格段にアップするセンテンスベースで提供しています。

●主観を除いて作成していますので、英文と和文の対応が非常にわかりやすいです。

上記英文とMedical Translator NARITAによる直訳的な和訳のペアを基本としています。

英文において、例えばaimが名詞として使われている場合には、和訳でも可能な限り名詞として訳しています(下図参照)。

英文において、aimが動詞その他で使われている場合には、和訳でも可能な限りそのように和訳しています(下図参照)。

 

Aim2

 

直訳的な和訳よりも意訳的な和訳のほうが明らかに自然な日本語になると判断される場合には、意訳的な和訳を採用しています。

固有名詞の処理に必要な編集を英文と和訳の両方に行っています。

あくまでもイートモ制作上の原則ですし、あくまでもイートモは参考資料ですし、いつも書いているようにお客さんからの指示に準じてください。

●収録されている対訳は複数の検索キーワードで絞り込み検索ができます。

●検索された対訳で英訳または和訳のトレーニングができます。

●最新の対訳はソフトのバージョンアップまではPDFファイルでネットで閲覧できます。

aim

おはようございます!

 

昨晩の東京は雷雨が激しかったようです。

階下から聞こえる雷鳴は初めてかも。

 

さて、今日も朝も早くからイートモ見直しです。

 

今日はaim

目的, 目標, 狙い, ((自動詞))(+at/to dp) 目的とする, 目標とする, 目指す

 

おおよその意味はライフサイエンス辞書でだいたいわかります。


プロの医学翻訳者には調べるまでもありませんが、時間的余裕があるときに基本を確認しておきたいところです。


医学翻訳フリーランスには原文の情報を反映するように英文または和文に訳して報酬が発生します
当たり前ですが、この点を勘ちがいしている医学翻訳フリーランスが多い。

要は原文に応じて訳出しなければ英語のテスト成績が良くても留学していようが普通1円にもなりません。

だから、何度も言っているように、普段から原文の情報が反映されるように、イートモ翻訳トレーニングモードを利用して英文または和文に翻訳するトレーニングをしておきましょう

Aim

2020年5月10日 (日)

「単独投与」と「単回投与」

Medical Translator NARITAです。

 

日曜日も医学翻訳の仕事や勉強、お疲れさまでした。

 

さて、混同しやすい専門用語に「単独投与」と「単回投与」があります。

(普通、医学翻訳者なら混同しないものですが、混同しやすいことにしてください)

 

混同しなくとも、英訳するのに迷うことはあります。

 

そこで、イートモで両者を検索することにしました。

 

「単独投与」

最新のイートモデータで211件ヒットしました。

最初の数件のみを提示します。

Tandokutouyo

 

「単回投与」

最新のイートモデータで194件ヒットしました。

最初の数件のみを提示します。

Tankaitouyo

 

最近はイートモを医学翻訳の学習に利用する人が増えています。

各自、ルールを守って下されば、いろいろ工夫して利用していただいて結構ですが、イートモを英訳に利用する場合には、ただ漫然と読むのではなく、このイートモ対訳はどのような和文の流れのときに利用できるかを常に想像しながらイートモの対訳を読んだり、英訳トレーニングをすると良いと思います

 

 

2020年2月 5日 (水)

並の医学翻訳者は不要になる

Medical Translator NARITAです。

 

久しぶりに医薬系和文原稿を機械に英訳させてみました。

http://www.pmda.go.jp/safety/info-services/drugs/calling-attention/revision-of-precautions/0312.html

 

和文原稿 みらいトランスレーターによる英訳
本剤によるPML発症のリスク因子として、抗JCウイルス(JCV)抗体陽性、免疫抑制剤による治療歴あり、長期間の投与が認められている。これらすべての因子を有する患者、または免疫抑制剤による治療歴はないが、抗JCV抗体価が高く、かつ本剤の治療歴が長い患者においてPMLの発症リスクがより高いことが報告されている。リスクとベネフィットの考慮に際しては、最新の各リスク因子保有患者別のPML発症状況(適正使用ガイド等)を確認すること。 The risk factors for PML associated with this product are positive anti-JC virus (JCV) antibody, history of treatment with immunosuppressants, and long-term administration. The risk of PML has been reported to be higher in patients with all of these factors or in patients who have not been treated with immunosuppressants but have high anti-JCV antibody titers and a long history of treatment with this drug. In considering risks and benefits, the current incidence of PML (Proper use guide, etc.) in patients with each risk factor should be confirmed.

 

なかなか良い出来です。

医学翻訳者が10人いたら、そのうち7人は機械に負けています。

スピードと持久力を考慮したら、10人のうち8人は不要になるかも。

 

全般的に和訳よりも英訳に向いているのかな?

 

さすがに、

「リスクとベネフィットの考慮に際しては~」

の下線部のような変な日本語には対応できない様子です。

でも、

「リスクとベネフィットの評価では~」

とシンプルに書けば機械も迷わないでしょう。

 

さて、私がこの和文原稿を取り上げたのは「治療歴」の英訳のしかたを検討するためです。

 

免疫抑制剤による治療歴あり

history of treatment with immunosuppressants

 

免疫抑制剤による治療歴はない

have not been treated with immunosuppressants

 

本剤の治療歴が長い

a long history of treatment with this drug

 

上と下でhistoryを使った表現となっています。Goodだけど、そればっかりではダサい。

中では工夫した表現となっていてとてもGoodです。

 

ライフサイエンス辞書には、治療歴には以下のような英語しか載っていません。

Chiryoreki

 

他にめぼしい医学専門用語辞書・表現辞典はないので、みなさん、何を参照しながら英訳しているのだろうか?

 

イートモでは「治療歴」で検索すると、現時点で40件がヒットします。

全体のSnippingができないので、最初の部分だけ載せます。

Chiryoreki1

 

イートモをどのように利用したらいいか迷う方がいるようですが、何度も言っているように、実際に仕事依頼された文書あるいは仕事依頼される可能性の高い文書(翻訳会社に教えてもらって)を自分で調査しながら実際に訳してみることです。

例えば、前記の文書がそのような文書であったとすれば、専門用語・専門的な表現を一つ一つ根気よく調査していく。

ざっと見ただけで赤字の部分を調査する必要があるでしょう。

 

本剤によるPML発症リスク因子として、抗JCウイルス(JCV)抗体陽性免疫抑制剤による治療歴あり長期間の投与認められている。これらすべての因子を有する患者、または免疫抑制剤による治療歴はないが、抗JCV抗体価が高く、かつ本剤の治療歴が長い患者においてPMLの発症リスクがより高いことが報告されているリスクとベネフィットの考慮に際しては、最新の各リスク因子保有患者別のPML発症状況(適正使用ガイド等)を確認すること

 

Googleで検索して参考資料を取り入れて訳語を確定させるという作業がメインになると思いますが、なるべくイートモでも調べてください。

イートモで調べるだけでなく翻訳トレーニングモードで実際に訳出することをおすすめします。

例えば「治療歴」で検索すれば、上記のように対訳が40件出てきます。

翻訳トレーニングモードに切り替えれば実際に訳出するトレーニングができます。

翻訳トレーニングの途中でわからない用語や表現に出会ったら、再びイートモで検索して、またまた翻訳トレーニングモードで訳出の練習と、際限なく続く、まさに地獄の翻訳トレーニング

楽しくはないけど、これこそが実戦的なトレーニングです。

この作業を繰り返し一定期間以上行っていれば、気が付いたときにはトライアル合格レベルなんていつの間にか突破しているはずです。

 

人それぞれ自分に合った勉強法があるかもしれませんが、医学翻訳フリーランスで稼ぐことを目指すのでしたら、半端なやり方や自分に甘いやり方では絶対に失敗します。

機械翻訳の性能が上がっているので、並の医学翻訳者のままのんびりしていたら干上がります。

何度も言っていますが、イートモを使いこなせる医学翻訳スキルを身につけて機械を利用する側に入るしかありません。

従来型のジジババ医学翻訳者は変化についてこれないでしょうから、若手のみなさん、チャンスですよ!

 

 

2020年1月26日 (日)

「bioavailability」

Medical Translator NARITAです。

 

今日は朝からイートモ6.4への切り替えや、メールの送信など、忙しかった~。

イートモユーザーのみなさん、無事にイートモ6.4をダウンロードできているといいのですが。。。

 

みなさん、セキュリティソフトを使っていると思うので、イートモをダウンロードするときに警告メッセージが出るかもしれません。

また、ウェブブラウザの種類によっても警告が出て、ビックリするかもしれませんが、ダウンロードの実行や継続を進めてください。

http://i-honyaku.cocolog-nifty.com/blog/2019/07/post-f4dad3.html

パソコンの扱いは難しいですね。私も苦手です。

でも、他の方も言っていましたが、

医学翻訳者にはパソコンのスキルがあるかないかが重要なんです‼️

もっと言うと、医学翻訳で圧倒的な実力差をつけるのは難しいので、パソコンスキルでアピールしましょう。

さらに付け加えると、翻訳会社のコーディネーターとのメールのやり取りを丁寧にしたり、電話応対で好印象を与えられれば、尚可。

医学翻訳仕事の現場では、翻訳の出来と同じか、それよりも大切なことがあるのですよ。

 

さて、落ち着いたところで、私は次のアップデートに向けて再びイートモの見直しと増量に取り組んでいます。

見直しをすると必ずエラーが見つかります。まー、完璧はないとわかっていても、延々と続く道を歩いているような気になります。ゆっくり歩くことにします。

また、見直しをしているといろいろ気付くことがあります。

今回は"bioavailability"。

またまた漢字表記にするかカタカナ表記にするかという問題です。

以前は「生物学的利用率」とか「生物学的利用能」と漢字表記することが多かった気がしますが、最近はどうなのかなと。


例によって、PMDAサイトで調べてみました。

 

"生物学的利用率"の検索結果 約1,364 件
 

"生物学的利用能"の検索結果 約90 件
 

"バイオアベイラビリティ"の検索結果 約5,006 件

 

てなわけで、「バイオアベイラビリティ《生物学的利用率》」とすると見にくくなるので、イートモではとりあえず「バイオアベイラビリティ」としておきます。

 

医薬系でもカタカナ表記が増えています。

 

イートモでbioavailabilityを検索すると、70件ヒットしました。

Bioavailability

 

2020年1月16日 (木)

REDUCE-IT試験

Medical Translator NARITAです。

 

リョウさんから情報をいただきました。ありがとうございます。

Vas

 

Vascepaで検索するとたくさんプレスリリースが見つかります。

https://www.bloomberg.co.jp/news/articles/2019-11-15/Q0ZDART1UM0W01

https://dresources.jp/archives/3859

これらのプレスリリースでVascepaの概略を知った上で、みなさん大好きなNEJMのarticleを対訳化してみよう。

すでに魚油関係の対訳は収録されていますが、さらに充実させようと思います。

日本の製薬会社も絡んでいるようだから、対訳化しておく価値はありそうです。

 

念のため、NEJMによる和訳も吟味しておきます。

後で。

 

https://www.nejm.org/doi/full/10.1056/NEJMoa1812792

Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia

 

Abstract

BACKGROUND

Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events.

 

METHODS

We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

 

RESULTS

A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001). The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06).

 

CONCLUSIONS

Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361. opens in new tab.)

https://www.nejm.jp/abstract/vol380.p11

高トリグリセリド血症に対するイコサペント酸エチルによる心血管リスクの低減

 

背景

トリグリセリド高値の患者は虚血性イベントのリスクが高い.高純度エイコサペンタエン酸エチルエステルであるイコサペント酸エチルはトリグリセリド値を低下させるが,虚血性イベントに及ぼす影響を明らかにするためのデータが必要である.

 

方 法

心血管疾患を有する患者,または糖尿病と他の危険因子を有する患者で,スタチン療法を受けており,空腹時トリグリセリド値 135~499 mg/dL(1.52~5.63 mmol/L),低比重リポ蛋白コレステロール値 41~100 mg/dL(1.06~2.59 mmol/L)の例を対象に,多施設共同無作為化二重盲検プラセボ対照試験を行った.患者を,イコサペント酸エチル 2 g を 1 日 2 回(1 日量 4 g)投与する群とプラセボを投与する群に無作為に割り付けた.主要評価項目は,心血管死亡,非致死的心筋梗塞,非致死的脳卒中,冠血行再建,不安定狭心症の複合とした.主な副次的評価項目は,心血管死亡,非致死的心筋梗塞,非致死的脳卒中の複合とした.

 

結 果

8,179 例を登録し(70.7%は心血管イベントの二次予防目的),中央値 4.9 年間追跡した.主要評価項目イベントは,イコサペント酸エチル群の 17.2%で発生したのに対し,プラセボ群では 22.0%であり(ハザード比 0.75,95%信頼区間 [CI] 0.68~0.83,P<0.001),対応する主な副次的評価項目の発生率はそれぞれ 11.2%と 14.8%であった(ハザード比 0.74,95% CI 0.65~0.83,P<0.001).イコサペント酸エチル群のほうがプラセボ群よりも,事前に規定した階層的手法で評価した,追加の虚血性イベント評価項目の発生率,たとえば心血管死亡率(4.3% 対 5.2%,ハザード比 0.80,95% CI 0.66~0.98,P=0.03)などが有意に低かった.心房細動や心房粗動による入院の割合は,イコサペント酸エチル群のほうがプラセボ群よりも高かった(3.1% 対 2.1%,P=0.004).重篤な出血イベントは,イコサペント酸エチル群の 2.7%とプラセボ群の 2.1%で発生した(P=0.06).

 

結 論

スタチンを使用していてもトリグリセリド高値の患者において,心血管死亡などの虚血性イベントのリスクは,イコサペント酸エチル 2 g を 1 日 2 回投与した例のほうが,プラセボ投与例よりも有意に低かった.(Amarin Pharma 社から研究助成を受けた.REDUCE-IT 試験:ClinicalTrials.gov 登録番号 NCT01492361)

 

本文については、NEJMによる和訳がないので、機械にかけながら、イートモ用に対訳化・編集する予定です。

時間のある時に。

一応、ブログ上にキープします。

 

こんな作業を毎日続けていれば、翻訳会社のトライアル水準よりもいつの間にかはるか上に行くわけです。

その上、ビジネスマナーが良ければ翻訳会社は手放しませんよ。

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翻訳スクールに行ったり、翻訳関係の検定を受けたり、トライアルとか検定合格を目標にする意味がわからん。

 

そこのあなた!

翻訳スクールや検定なんかでもたもたしていないで、イートモで一気にジャンプして、早く機械を利用する側に入らんと、今までの努力が無駄になりまっせ。w

いやホント。

 

Among patients with cardiovascular risk factors who are receiving treatment for secondary or primary prevention, the rates of cardiovascular events remain high.1-3 Even in patients receiving appropriate treatment with statins, a substantial residual cardiovascular risk remains.4 In such patients, an elevated triglyceride level serves as an independent marker for an increased risk of ischemic events, as shown in epidemiologic and mendelian randomization studies.5-9 In randomized trials, medications that reduce triglyceride levels, such as extended-release niacin and fibrates, have not reduced the rates of cardiovascular events when administered in addition to appropriate medical therapy, including statins.10 Contemporary trials and recent meta-analyses of n−3 fatty acid products have not shown a benefit in patients receiving statin therapy.11-13

 

In the Japan EPA Lipid Intervention Study (JELIS), 18,645 Japanese patients with hypercholesterolemia were randomly assigned to receive either low-intensity statin therapy plus 1.8 g of eicosapentaenoic acid (EPA) daily or statin therapy alone (there was no placebo group). The risk of major coronary events was significantly lower, by 19%, in the group that received EPA plus statin therapy than in the group that received statin therapy alone.14

 

These considerations led to the design of the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT).15 Icosapent ethyl is a highly purified and stable EPA ethyl ester that has been shown to lower triglyceride levels and is used as an adjunct to diet in adult patients who have triglyceride levels of at least 500 mg per deciliter (5.64 mmol per liter).16,17 In addition, icosapent ethyl may have antiinflammatory, antioxidative, plaque-stabilizing, and membrane-stabilizing properties.18-21 We hypothesized that the risk of cardiovascular events would be lower with icosapent ethyl therapy than with placebo among patients in whom elevated triglyceride levels served as a marker of residual risk despite statin therapy.

 

Methods

TRIAL DESIGN

The design of REDUCE-IT has been published previously.15 In brief, REDUCE-IT was a phase 3b randomized, double-blind, placebo-controlled trial comparing icosapent ethyl (2 g twice daily with food [total daily dose, 4 g]) with a placebo that contains mineral oil to mimic the color and consistency of icosapent ethyl. Randomization was stratified according to cardiovascular risk stratum (secondary-prevention cohort or primary-prevention cohort, with primary prevention capped at 30% of enrolled patients), use or no use of ezetimibe, and geographic region. Further details of the study design are provided in Figure S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org. Patients were enrolled and followed at 473 participating sites in 11 countries. The first patient underwent randomization on November 28, 2011, and the last on August 4, 2016.

 

The trial was sponsored by Amarin Pharma. The steering committee, which consisted of academic physicians (see the Supplementary Appendix), and representatives of the sponsor developed the protocol, available at NEJM.org, and were responsible for the conduct and oversight of the study, as well as the interpretation of the data. The sponsor was responsible for the collection and management of the data. The protocol was approved by the relevant health authorities, institutional review boards, and ethics committees. All the data analyses were performed by the sponsor, and the primary, secondary, and tertiary adjudicated end-point analyses were validated by an independent statistician from the data and safety monitoring committee. The first author vouches for the completeness and accuracy of the data and analyses and for the fidelity of the trial to the protocol.

 

ELIGIBILITY

Patients could be enrolled if they were 45 years of age or older and had established cardiovascular disease or were 50 years of age or older and had diabetes mellitus and at least one additional risk factor. Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter (1.69 to 5.63 mmol per liter) and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter) and had been receiving a stable dose of a statin for at least 4 weeks; because of the intraindividual variability of triglyceride levels, the initial protocol allowed for a 10% lower triglyceride level from the target lower limit, which permitted patients to be enrolled if they had a triglyceride level of at least 135 mg per deciliter (1.52 mmol per liter). The first protocol amendment in May 2013 changed the lower limit of the acceptable triglyceride level from 150 mg per deciliter to 200 mg per deciliter (2.26 mmol per liter), with no allowance for variability. Patients were excluded if they had severe heart failure, active severe liver disease, a glycated hemoglobin level greater than 10.0%, a planned coronary intervention or surgery, a history of acute or chronic pancreatitis, or known hypersensitivity to fish, shellfish, or ingredients of icosapent ethyl or placebo. Further details regarding inclusion and exclusion criteria are provided in Tables S1 and S2 in the Supplementary Appendix. Written informed consent was obtained from all patients.

 

END POINTS

The primary efficacy end point was a composite of cardiovascular death, nonfatal myocardial infarction (including silent myocardial infarction), nonfatal stroke, coronary revascularization, or unstable angina in a time-to-event analysis. While the steering committee and the sponsor remained unaware of the trial-group assignments, a second protocol amendment in July 2016 designated the key secondary end point as a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in a time-to-event analysis. After the primary efficacy end-point analysis was performed, the prespecified secondary efficacy end points were examined in a hierarchical fashion in the following order: the key secondary efficacy end point; a composite of cardiovascular death or nonfatal myocardial infarction; fatal or nonfatal myocardial infarction; emergency or urgent revascularization; cardiovascular death; hospitalization for unstable angina; fatal or nonfatal stroke; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke; and death from any cause. Prespecified tertiary end points are listed in the Supplementary Appendix. Adjudication of all the above events was performed by an independent clinical end-point committee whose members were unaware of the trial-group assignments and lipid levels.

 

STATISTICAL ANALYSIS

In this event-driven trial, it was estimated that approximately 1612 adjudicated primary end-point events would be necessary to provide the trial with 90% power to detect a 15% lower risk of the primary composite end point in the icosapent ethyl group than in the placebo group. We estimated that a sample size of approximately 7990 patients would be required to reach that number of primary end-point events. The primary efficacy analysis was based on the time from randomization to the first occurrence of any component of the primary composite end point. If the risk of the primary composite end point was significantly lower with icosapent ethyl than with placebo at a final two-sided alpha level of 0.0437 (as determined with the use of O’Brien–Fleming boundaries generated with the Lan–DeMets alpha-spending function approach after accounting for two prespecified interim efficacy analyses), the key secondary end point and other prespecified secondary end points were to be tested in a hierarchical fashion at the same final alpha level of 0.0437. All analyses were performed according to the intention-to-treat principle. Hazard ratios and 95% confidence intervals were generated with the use of a Cox proportional-hazards model that included trial-group assignment as a covariate, stratified according to cardiovascular risk category, geographic region, and use of ezetimibe. Log-rank P values from a Kaplan–Meier analysis that was stratified according to the three randomization factors are reported to evaluate the timing of events in the two trial groups. With respect to the tertiary and subgroup efficacy analyses, 95% confidence intervals (which were not adjusted for multiple comparisons) are reported. An independent data and safety monitoring committee oversaw the study and performed two prespecified interim efficacy reviews.

 

Results

PATIENTS

A total of 19,212 patients were screened, of whom 8179 (43%) underwent randomization. At the time of database lock, vital status was available for 99.8% of the patients; 152 patients (1.9%) did not complete the final study visits, and 578 patients (7.1%) withdrew consent. Details regarding the disposition of the patients are provided in Figure S2 in the Supplementary Appendix.

The baseline characteristics of the patients are shown in Table 1. Among the patients who underwent randomization, 70.7% were enrolled on the basis of secondary prevention (i.e., patients had established cardiovascular disease) and 29.3% on the basis of primary prevention (i.e., patients had diabetes mellitus and at least one additional risk factor). The median age of the patients was 64 years; 28.8% were female, and 38.5% were from the United States. At baseline, the median LDL cholesterol level was 75.0 mg per deciliter (1.94 mmol per liter), the median high-density lipoprotein cholesterol level was 40.0 mg per deciliter (1.03 mmol per liter), and the median triglyceride level was 216.0 mg per deciliter (2.44 mmol per liter).22

 

FOLLOW-UP AND EFFECTS ON LIPIDS

The median duration of follow-up was 4.9 years (maximum, 6.2 years). The median change in triglyceride level from baseline to 1 year was a decrease of 18.3% (−39.0 mg per deciliter [−0.44 mmol per liter]) in the icosapent ethyl group and an increase of 2.2% (4.5 mg per deciliter [0.05 mmol per liter]) in the placebo group; the median reduction from baseline (as estimated with the use of the Hodges–Lehmann approach) was 19.7% greater in the icosapent ethyl group than in the placebo group (a 44.5 mg per deciliter [0.50 mmol per liter] greater reduction; P<0.001). The median change in LDL cholesterol level from baseline was an increase of 3.1% (2.0 mg per deciliter [0.05 mmol per liter]) in the icosapent ethyl group and an increase of 10.2% (7.0 mg per deciliter [0.18 mmol per liter]) in the placebo group — a 6.6% (5.0 mg per deciliter [0.13 mmol per liter]) lower increase with icosapent ethyl than with placebo (P<0.001). The results with respect to levels of EPA and lipid, lipoprotein, and inflammatory biomarkers are provided in Table S4 in the Supplementary Appendix.

 

CLINICAL END POINTS

Figure 1.

 

Cumulative Incidence of Cardiovascular Events.

A total of 1606 adjudicated primary end-point events occurred. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001), an absolute between-group difference of 4.8 percentage points (95% CI, 3.1 to 6.5); the number needed to treat to avoid one primary end-point event was 21 (95% CI, 15 to 33) over a median follow-up of 4.9 years.23,24 The event curves based on a Kaplan–Meier analysis of the primary efficacy end point are provided in Figure 1A. The results of time-to-event analyses of each component of the primary end point are provided in Figure S3 in the Supplementary Appendix. A key secondary efficacy end-point event (Figure 1B) occurred in 11.2% of the patients in the icosapent ethyl group, as compared with 14.8% of the patients in the placebo group (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001), corresponding to an absolute between-group difference of 3.6 percentage points (95% CI, 2.1 to 5.0); the number needed to treat to avoid one key secondary end-point event was 28 (95% CI, 20 to 47) over a median follow-up 4.9 years.23,24

 

 

 

As a result of the review of the submitted plan for the post-marketing surveillance, PMDA has concluded as follows:

 Since the data submitted in the present application contain only a limited amount of information on the safety of crizotinib in Japanese patients, it is necessary to promptly collect relevant information. Therefore, the post-market surveillance should be conducted involving all patients treated with crizotinib.

 Among adverse events requiring caution in administering crizotinib, ILD in particular may occur with a higher incidence in Japanese patients than in foreign patients. ILD resulted in death in some patients [see “4.(iii).B.(3).2) ILD” of the Review Report (1)]. Therefore, the number of patients analyzed should be adjusted so that predicting factors for ILD can be identified in the all-case surveillance.

 The maximum observation period may be set at 52 weeks, as planned by the applicant. The follow-up of patients treated with crizotinib for >52 weeks should be performed separately from the all-case surveillance so that the final results of the all-case surveillance can be obtained promptly. In addition, it is necessary to analyze the information obtained from the all-case surveillance at an early stage and, based on the results of the analysis, to re-design the surveillance plan.

The surveillance plan should be designed to make sure that the following information on the priority items of the all-case surveillance be collected:

 Characteristic features of ILD (e.g., patient background, imaging findings, severity, time to onset and outcome, outcome, treatment given, response to the treatment, predicting factors)

 Clinical characteristics of visual disturbance (e.g., time to onset, symptom duration, signs of aggravation)

 Safety of crizotinib in patients with hepatic impairment

 Safety of crizotinib in patients with severe renal impairment

 Clinical characteristics of neuropathy (e.g., reversibility)

 Incidence and clinical characteristics of photosensitivity (e.g., reversibility)

 

The above conclusion of PMDA was supported by the expert advisors at the Expert Discussion, with the following comments:

 To allow detailed investigation of ILD, the plan should be designed in such a way that the

applicant can obtain the data of chest imaging in patients with ILD (i) before the start of crizotinib administration, (ii) during crizotinib administration, (iii) at the onset of ILD, and (iv) after treatment with corticoid or other drugs.

 It is recommended to collect information in the post-marketing surveillance on the safety and the method of dose reduction in patients in whom crizotinib dose is reduced, temporarily withdrawn, or discontinued.

 

PMDA considered it necessary to appropriately address the expert advisors’ opinion on information collection from patients in whom crizotinib dose is reduced, interrupted, or discontinued as a result of chest imaging for ILD. Therefore, PMDA instructed the applicant to revise the design of the surveillance plan to allow the collection of the above information on patients with ILD, in addition to the revision to ensure information collection as described above.

 

The applicant accepted it.

Taking also account of the comments from the Expert Discussion, PMDA instructed the applicant to re-examine the planned number of patinets analyzed to allow the analysis of predictive factors of ILD, etc.

 

The applicant responded as follows:

Currently, the incidence of ILD in Japanese patients in Studies A8081001, A8081005, A8081007, and A8081014 was 3.6% (4 of 111 patients*). Therefore, the incidence of crizotinib-induced ILD was assumed to be 4%. By referring to the results of surveillance on the predictive factors of ILD in other antineoplastic agents, the incidence of ILD in the low risk population is assumed to be 2.5%, and the planned number of patients is changed to 2000 to allow the detection, at a certain statistical power by χ2 test with a significance level of 0.05, of factors with a risk ratio of 2.0 when the range of the case composition ratio of factors studied is between 1:3 and 3:1. Assuming that 2000 patients are analyzed by χ2 test with a significance level of 0.15, the statistical power is ≥85% when the composition ratio is between 1:3 and 3:1. The applicant considers that it is possible to detect and investigate potential predictive factors by multivariate analysis of these and other factors.

*: Studies A8081007 and A8081014 are currently ongoing randomized, parallel group, comparative study and the accurate number of patients is unknown. The calculation is based on the assumption that, a half of patients treated with the investigational product on or before December 6, 2011 received crizotinib.

 

PMDA further instructed the applicant to collect the follow-up information of patients treated with crizotinib for >52 weeks separately from the all-case surveillance so that the final results of the allcase surveillance can be obtained promptly, and to address the PMDA’s conclusion that it is necessary to analyze the information obtained from the all-case surveillance at an early stage and, based on the results of the analysis, to re-design the surveillance plan.

 

The applicant responded as follows:

Re-examination of the available data showed that there were no adverse events that occurred with an increased incidence with the increase of treatment duration. Therefore, the follow-up of patients treated with crizotinib for >52 weeks will not be performed. Information obtained from the all-case surveillance will be subjected to analysis at an early stage and, based on the results of the analysis, additional safety measures will be taken and the surveillance plan will be re-designed, as necessary.

PMDA accepted the explanation of the applicant. Results of the early stage analysis of data obtained from the all-case surveillance should be provided to the medical practice, as appropriate.

Since the currently available safety and efficacy information on crizotinib is extremely limited, results of the ongoing 2 global phase III studies and other information to be obtained in future are very important. PMDA instructed the applicant that, when new information related to crizotinib, including the results of clinical studies, becomes available, it should be promptly supplied to the medical practice, to which the applicant agreed.

 

The rates of the primary and key secondary efficacy end points in selected prespecified subgroups are provided in Figures 2 and Figure 3; the findings show a consistent benefit with icosapent ethyl. Baseline triglyceride levels (≥150 vs. <150 mg per deciliter or ≥200 or <200 mg per deciliter) had no influence on the primary or key secondary efficacy end points (Figure 2 and Figure 3). The attainment of triglyceride levels of 150 mg per deciliter or higher or below 150 mg per deciliter at 1 year after randomization also had no influence on the efficacy of icosapent ethyl as compared with placebo with respect to the primary or key secondary efficacy end point (Fig. S4 in the Supplementary Appendix). In a post hoc analysis, we found no substantial difference in the benefit of icosapent ethyl as compared with placebo with respect to the primary end point according to whether the patients who received placebo had an increase in LDL cholesterol levels at 1 year or had no change or a decrease in LDL cholesterol levels.

 

Figure 4.

 

Hierarchical Testing of End Points.

In the prespecified hierarchical testing of end points (Figure 4), the rates of all individual and composite ischemic end points (except for death from any cause — the last secondary end point in the hierarchy) were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). The rate of death from any cause was 6.7% in the icosapent ethyl group and 7.6% in the placebo group (hazard ratio, 0.87; 95% CI, 0.74 to 1.02). The results for selected prespecified tertiary end points, which were not adjusted for multiple comparisons, are provided in Table S3 in the Supplementary Appendix. Among these results, the rates of adjudicated sudden cardiac death were 1.5% in the icosapent ethyl group and 2.1% in the placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.96), and the rates of cardiac arrest were 0.5% and 1.0%, respectively (hazard ratio, 0.52; 95% CI, 0.31 to 0.86).

 

SAFETY AND ADVERSE EVENTS

The overall rates of adverse events that occurred while the patients were in the trial and the rates of serious adverse events leading to discontinuation of the trial drug or placebo did not differ significantly between the trial groups (Table S5 in the Supplementary Appendix). The only serious adverse event that occurred at a frequency of at least 2% was pneumonia (2.6% in the icosapent ethyl group and 2.9% in the placebo group, P=0.42). Adverse events that occurred in at least 5% of patients are reported in Table S6 in the Supplementary Appendix. The rate of atrial fibrillation was significantly higher in the icosapent ethyl group than in the placebo group (5.3% vs. 3.9%), as was the rate of peripheral edema (6.5% vs. 5.0%), but the rate of anemia was significantly lower in the icosapent ethyl group than in the placebo group (4.7% vs. 5.8%), as were the rates of diarrhea (9.0% vs. 11.1%) and gastrointestinal adverse events (33.0% vs. 35.1%) (Table S7 in the Supplementary Appendix). The rate of the prespecified adjudicated tertiary end point of heart failure did not differ significantly between the icosapent ethyl group and the placebo group (4.1% and 4.3%, respectively). The rate of the prespecified adjudicated tertiary end point of hospitalization for atrial fibrillation or flutter was significantly higher in the icosapent ethyl group than in the placebo group (3.1% vs. 2.1%, P=0.004). The overall rates of serious adverse bleeding events that occurred while the patients were in the trial were 2.7% in the icosapent ethyl group and 2.1% in the placebo group (P=0.06), although there were no fatal bleeding events in either group; there were no significant differences between the icosapent ethyl group and the placebo group in the rates of adjudicated hemorrhagic stroke (0.3% vs. 0.2%, P=0.55), serious central nervous system bleeding (0.3% vs. 0.2%, P=0.42), or gastrointestinal bleeding (1.5% vs. 1.1%, P=0.15) (Table S8 in the Supplementary Appendix).

 

Discussion

In REDUCE-IT, the risk of the primary composite end point of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina, assessed in a time-to-event analysis, was significantly lower, by 25%, among the patients who received 2 g of icosapent ethyl twice daily than among those who received placebo, corresponding to an absolute between-group difference of 4.8 percentage points in the rate of the end point and a number needed to treat of 21. The risk of the key secondary composite end point of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in a time-to-event analysis was also significantly lower, by 26%, in the icosapent ethyl group than in the placebo group, corresponding to an absolute between-group difference of 3.6 percentage points in the rate of the end point and a number needed to treat of 28. Prespecified hierarchical testing of other secondary end points revealed that the risks of a variety of fatal and nonfatal ischemic events were lower in the icosapent ethyl group than in the placebo group, including a 20% lower risk of cardiovascular death. The benefits were observed against a background of appropriate statin use among patients who had a median LDL cholesterol level of 75.0 mg per deciliter at baseline.

 

The overall rates of adverse events were similar in the trial groups. Serious adverse events related to bleeding occurred in more patients in the icosapent ethyl group than in the placebo group, although the overall rates were low; there were no fatal bleeding events in either group, and the rates of adjudicated hemorrhagic stroke, serious central nervous system bleeding, and serious gastrointestinal bleeding were not significantly higher in the icosapent ethyl group than in the placebo group. The rate of hospitalization for atrial fibrillation or flutter was significantly higher in the icosapent ethyl group than in the placebo group, although the rates were low. The rates of adverse events and serious adverse events leading to discontinuation of trial drug were similar in the two groups.

 

The results of REDUCE-IT stand apart from the negative findings of several contemporary trials of other agents that also lower triglyceride levels, including other n−3 fatty acids, extended-release niacin, fenofibrate, and cholesteryl ester transfer protein inhibitors.10-13 It is not known whether the lack of benefit from n−3 fatty acids in previous trials may be attributable to the low dose or to the low ratio of EPA to docosahexaenoic acid (DHA).12,13 Both the formulation (a highly purified and stable EPA ethyl ester) and dose (total daily dose of 4 g) used in REDUCE-IT were different from those in previous outcome trials of n−3 fatty acids. JELIS, which compared a combination of statin therapy and pure EPA with statin therapy alone, showed that the risk of ischemic events was significantly lower in the group that received the combination treatment than in the group that received statin therapy alone.14 Although the dose of EPA administered in JELIS (1.8 g daily) was lower than the EPA-equivalent dose used in REDUCE-IT (4 g daily), it resulted in a plasma EPA level (170 μg per milliliter in a Japanese population) similar to that attained in a previous 12-week lipid study in which a total daily dose of 4 g of icosapent ethyl was used in a Western population (183 μg per milliliter)25,26 and similar to that attained in the current trial. However, unlike the current trial, JELIS included an open-label design without a placebo group, used a low-intensity statin, and was conducted in a single country; patients also had higher levels of LDL cholesterol at baseline (182 mg per deciliter [4.71 mmol per liter] before initiation of statin therapy) and lower baseline triglyceride values (151 mg per deciliter [1.70 mmol per liter]) than the patients in REDUCE-IT.

 

Metabolic data provide evidence that icosapent ethyl–based formulations do not raise LDL cholesterol levels, whereas DHA-based formulations do.27 The results of the current trial should not be generalized to other n−3 fatty acid preparations — in particular, dietary-supplement preparations of n−3 fatty acid mixtures, which are variable and unregulated and which have not been shown to have clinical benefit.

 

A triglyceride level of 150 mg per deciliter or higher was an initial inclusion criterion in REDUCE-IT (although the required level was subsequently changed to ≥200 mg per deciliter); however, owing to allowance for variability in these levels, 10.3% of enrolled patients had triglyceride levels lower than 150 mg per deciliter at baseline. The observed cardiovascular benefits were similar across baseline levels of triglycerides (<150, ≥150 to <200, and ≥200 mg per deciliter). In addition, the significantly lower risk of major adverse cardiovascular events with icosapent ethyl than with placebo appeared to occur irrespective of the attained triglyceride level at 1 year (≥150 or <150 mg per deciliter), which suggests that the cardiovascular risk reduction was not associated with attainment of a more normal triglyceride level. These observations suggest that at least some of the effect of icosapent ethyl that resulted in a lower risk of ischemic events than that with placebo may be explained by metabolic effects other than a reduction of triglyceride levels.28

 

Mechanisms responsible for the benefit of icosapent ethyl observed in REDUCE-IT are currently not known. The timing of the divergence of the Kaplan–Meier event curves suggests a delayed onset of benefit, which may reflect the time that is needed for a benefit from a reduction in triglyceride levels to be realized or may indicate that other mechanisms are involved. The modestly higher rate of bleeding events with icosapent ethyl suggests that there may be an antithrombotic mechanism of action. However, it is unlikely that an antithrombotic effect would reduce the rate of elective revascularization. Also, if the full explanation involved an antiplatelet or anticoagulant effect, one might expect a large increase in the rate of major bleeding events, which was not observed.29 It is possible that membrane-stabilizing effects could explain part of the benefit.20,21,30 Stabilization or regression of coronary plaque (or both) may also play a part.19,31 Our observation of lower rates of cardiac arrest and sudden cardiac death with icosapent ethyl than with placebo in the current trial might support that mechanism, although these findings should be viewed as exploratory. It is also possible that the difference in high-sensitivity C-reactive protein level observed in REDUCE-IT may contribute to the benefit; the Canakinumab Antiinflammatory Thrombosis Outcome Study (CANTOS) showed a significant reduction in the risk of ischemic events with treatment targeted at inflammation.32-35 Blood samples obtained during REDUCE-IT have been banked for biomarker and genetic analyses that may provide more information regarding mechanisms of action.

 

Ongoing trials of moderate-to-high doses of pure EPA ethyl ester will provide further information on the effects of these agents.10,36 These trials include the Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and EPA (RESPECT-EPA; UMIN Clinical Trials Registry number, UMIN000012069. opens in new tab), a secondary prevention outcomes trial involving statin-treated patients in Japan, and the Effect of Vascepa on Improving Coronary Atherosclerosis in People with High Triglycerides Taking Statin Therapy (EVAPORATE; ClinicalTrials.gov number, NCT02926027. opens in new tab), which is examining changes in coronary plaque over 9 to 18 months.

 

Our trial has certain limitations. First, at the time the trial was designed, there was relatively little use of ezetimibe or data supporting its use.37 However, subgroup analyses do not suggest a differential benefit for patients taking ezetimibe. Similarly, proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitors were not available for the majority of the patients in the trial.38 Second, if mineral oil in the placebo affected statin absorption in some patients, this might have contributed to differences in outcomes between the groups. However, the relatively small differences in LDL cholesterol levels between the groups would not be likely to explain the 25% lower risk observed with icosapent ethyl, and a post hoc analysis suggested a similar lower risk regardless of whether there was an increase in LDL cholesterol level among the patients in the placebo group. Although JELIS was designed as an open-label study that did not use a mineral oil placebo, it showed a 19% lower risk of ischemic events with statin therapy plus EPA than with statin therapy alone.

 

In conclusion, among patients with elevated triglyceride levels who were receiving statin therapy, the risk of major ischemic events, including cardiovascular death, was significantly lower with 2 g of icosapent ethyl twice daily (total daily dose, 4 g) than with placebo.

 

 

 

2020年1月11日 (土)

「パイプライン」

Medical Translator NARITAです。

 

連休中も医学翻訳の仕事や学習、お疲れさまです。

 

昨日あたりから目の疲労がかなりあるので、今日は午後8時前にはパソコンを切ろうと思います。

 

今日最後に見直したのがpipelineを含むイートモ対訳でした。

製薬企業に勤めている方でしたらすぐにピンとくるはずです。

https://answers.ten-navi.com/dictionary/cat04/2511/

 

要は「開発中」という意味。

製薬業界では「パイプライン」がわかりやすいので、イートモ対訳の場合、英文にpipelineと入っている場合には和文では「パイプライン」という表現を使うことにします。

和文で「パイプライン」となっているけど、「開発中」という意味があることを知った上で、イートモを利用してください。

「開発中」を英文表現したい場合には、当然developを使うわけですが、文脈によってはpipelineも使えることを知っておいてください。

 

どのような場合にpipeline含有表現が適しているか、実際のイートモ対訳のサンプルを以下に示します。

14件がヒットしました。その最初の部分です。

Pipeline

 

このように、イートモを活用するにはある一定レベル以上の実力が必要です。

トライアルを受ける一歩手前くらいの実力が必要です。

 

それよりも下のレベルの人にはイートモを利用するのは難しいかもしれません。

でも、イートモを活用できるレベルにならないと医学翻訳業界で活躍するなんてとても無理です。

悩ましいね。

 

2020年1月 9日 (木)

古いイートモサンプルを削除しました

Medical Translator NARITAです。

 

イートモサンプルのダウンロード【販促用】

としてイートモで検索したときのサンプルを提示しています。

 

イートモ対訳は常に見直し(修正および差し替え)を行っていますので、古いサンプルは不適切になっている可能性があります。

 

そこで、半年以上前に提示したイートモサンプルの記事をすべて削除しました。

 

今後も新しいイートモサンプルをご紹介しますので、要チェックです

 

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