文献

J-GLOBAL ID：202002239498740329   整理番号：20A1027289

複雑でないPlasmodium falciparumマラリアに対する3つのアルテミシニンに基づく併用療法対アルテミシニンに基づく併用療法:多施設,オープンラベル,無作為化臨床試験【JST・京大機械翻訳】

Triple artemisinin-based combination therapies versus artemisinin-based combination therapies for uncomplicated Plasmodium falciparum malaria: a multicentre, open-label, randomised clinical trial

著者 (117件)： van der Pluijm Rob W (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  van der Pluijm Rob W (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  van der Pluijm Rob W (Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands) ,  Tripura Rupam (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Tripura Rupam (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Hoglund Richard M (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Hoglund Richard M (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Pyae Phyo Aung (Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar) ,  Lek Dysoley (National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia) ,  Lek Dysoley (School of Public Health, National Institute of Public Health, Phnom Penh, Cambodia) ,  ul Islam Akhter (Ramu Upazila Health Complex, Cox’s Bazar, Bangladesh) ,  Anvikar Anupkumar R (National Institute of Malaria Research, Indian Council of Medical Research, New Delhi, India) ,  Satpathi Parthasarathi (Midnapore Medical College, Midnapur, India) ,  Satpathi Sanghamitra (Ispat General Hospital, Rourkela, India) ,  Behera Prativa Kumari (Ispat General Hospital, Rourkela, India) ,  Tripura Amar (Agartala Medical College, Tripura, India) ,  Baidya Subrata (Agartala Medical College, Tripura, India) ,  Onyamboko Marie (Kinshasa Mahidol Oxford Research Unit (KIMORU), Kinshasa, Democratic Republic of the Congo) ,  Onyamboko Marie (Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo) ,  Chau Nguyen Hoang (Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam) ,  Sovann Yok (Pailin Provincial Health Department, Pailin, Cambodia) ,  Suon Seila (National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia) ,  Sreng Sokunthea (National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia) ,  Mao Sivanna (Sampov Meas Referral Hospital, Pursat, Cambodia) ,  Oun Savuth (Ratanakiri Referral Hospital, Ratanakiri, Cambodia) ,  Yen Sovannary (Ratanakiri Referral Hospital, Ratanakiri, Cambodia) ,  Amaratunga Chanaki (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Amaratunga Chanaki (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Amaratunga Chanaki (Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA) ,  Chutasmit Kitipumi (Phu Sing hospital, Phu Sing, Sisaket, Thailand) ,  Saelow Chalermpon (Phu Sing hospital, Phu Sing, Sisaket, Thailand) ,  Runcharern Ratchadaporn (Khun Han Hospital, Khun Han, Sisaket, Thailand) ,  Kaewmok Weerayuth (Khun Han Hospital, Khun Han, Sisaket, Thailand) ,  Hoa Nhu Thi (Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam) ,  Thanh Ngo Viet (Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam) ,  Hanboonkunupakarn Borimas (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Hanboonkunupakarn Borimas (Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Callery James J (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Mohanty Akshaya Kumar (Infectious Disease Biology Unit, IGH, Rourkela Research Unit of ILS, Bhubeneswar, DBT, Rourkela, India) ,  Heaton James (Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar) ,  Thant Myo (Defence Services Medical Research Centre, Yangon, Myanmar) ,  Gantait Kripasindhu (Midnapore Medical College, Midnapur, India) ,  Ghosh Tarapada (Midnapore Medical College, Midnapur, India) ,  Amato Roberto (Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK) ,  Amato Roberto (Wellcome Sanger Institute, Hinxton, UK) ,  Pearson Richard D (Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK) ,  Pearson Richard D (Wellcome Sanger Institute, Hinxton, UK) ,  Jacob Christopher G (Wellcome Sanger Institute, Hinxton, UK) ,  Goncalves Sonia (Wellcome Sanger Institute, Hinxton, UK) ,  Mukaka Mavuto (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Mukaka Mavuto (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Waithira Naomi (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Waithira Naomi (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Woodrow Charles J (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Woodrow Charles J (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Grobusch Martin P (Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands) ,  van Vugt Michele (Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands) ,  Fairhurst Rick M (Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA) ,  Fairhurst Rick M (AstraZeneca, Gaithersburg, MD, USA) ,  Cheah Phaik Yeong (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Cheah Phaik Yeong (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Peto Thomas J (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Peto Thomas J (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  von Seidlein Lorenz (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  von Seidlein Lorenz (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Dhorda Mehul (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Dhorda Mehul (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Dhorda Mehul (WorldWide Antimalarial Resistance Network - Asia Regional Centre, Bangkok, Thailand) ,  Maude Richard J (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Maude Richard J (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Maude Richard J (The Open University, Milton Keynes, UK) ,  Maude Richard J (Harvard T H Chan School of Public Health, Harvard University, Boston, MA USA) ,  Winterberg Markus (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Winterberg Markus (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Thuy-Nhien Nguyen Thanh (Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam) ,  Kwiatkowski Dominic P (Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK) ,  Kwiatkowski Dominic P (Wellcome Sanger Institute, Hinxton, UK) ,  Imwong Mallika (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Imwong Mallika (Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Jittamala Podjanee (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Jittamala Podjanee (Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Lin Khin (Department of Medical Research, Pyin Oo Lwin, Myanmar) ,  Hlaing Tin Maung (Defence Services Medical Research Centre, Yangon, Myanmar) ,  Chotivanich Kesinee (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Chotivanich Kesinee (Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Huy Rekol (National Centre for Parasitology, Entomology and Malaria Control, Phnom Penh, Cambodia) ,  Fanello Caterina (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Fanello Caterina (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Fanello Caterina (Kinshasa Mahidol Oxford Research Unit (KIMORU), Kinshasa, Democratic Republic of the Congo) ,  Ashley Elizabeth (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Ashley Elizabeth (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Ashley Elizabeth (Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos) ,  Mayxay Mayfong (Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos) ,  Mayxay Mayfong (Institute of Research and Education Development (IRED), University of Health Sciences, Ministry of Health, Vientiane, Laos) ,  Newton Paul N (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Newton Paul N (Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU), Vientiane, Laos) ,  Hien Tran Tinh (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Hien Tran Tinh (Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam) ,  Valecha Neena (National Institute of Malaria Research, Indian Council of Medical Research, New Delhi, India) ,  Smithuis Frank (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Smithuis Frank (Myanmar-Oxford Clinical Research Unit, Yangon, Myanmar) ,  Pukrittayakamee Sasithon (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Pukrittayakamee Sasithon (Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Pukrittayakamee Sasithon (The Royal Society of Thailand, Dusit, Bangkok, Thailand) ,  Faiz Abul (Malaria Research Group and Dev Care Foundation, Dhaka, Bangladesh) ,  Miotto Olivo (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Miotto Olivo (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Miotto Olivo (Nuffield Department of Medicine and MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK) ,  Miotto Olivo (Wellcome Sanger Institute, Hinxton, UK) ,  Tarning Joel (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Tarning Joel (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Day Nicholas P J (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Day Nicholas P J (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  White Nicholas J (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  White Nicholas J (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK) ,  Dondorp Arjen M (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) ,  Dondorp Arjen M (Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK)
資料名： Lancet  (Lancet)
巻： 395  号： 10233  ページ： 1345-1360  発行年： 2020年 
JST資料番号： B0673A  ISSN： 0140-6736  CODEN： LANCA  資料種別： 逐次刊行物 (A)
記事区分： 原著論文  発行国： オランダ (NLD)  言語： 英語 (EN)

抄録/ポイント： マラリア原虫におけるアルテミシニンとパートナ薬物耐性はマラリア防除と除去に対する主要な脅威である。既存の共製剤化ACTsをゆっくり除去された第二パートナー薬物と組み合わせた三重アルテミシニンに基づく併用療法(tact)は,抗マラリア薬耐性の効果的な治療と遅延出現を提供する可能性がある。この多施設において,オープンラベル,無作為化試験,著者らは,8つの国における18の病院および健康診療所において,複雑でないP falciparumマラリアを有する患者を募集した。適格患者は2~65歳で,急性,複雑でないP falciparumマラリア単独または非熱帯性種と混合し,37人の5°Cまたはそれ以上の温度,または過去24時間の発熱歴を有した。患者をランダムに割り当てた(1:1)。タイ,カンボジア,ベトナム,およびミャンマー患者におけるブロックランダム化を用いた2つの治療の1つに,ジヒドロアルテミシニン-ピペキンまたはジヒドロアルテミシニン-ピペキン+メフロキンのどちらかを割り当てた。カンボジアにおける3つのサイトで,それらはアルテスナート-メフロキンまたはジヒドロアルテミシニン-ピペキン+メフロキンのどちらかに割り当てられた;そして,Laos,ミャンマー,バングラデシュ,インド,およびコンゴの民主共和国において,それらはアルテメテル-ルメファントリンまたはアルテメテル-ルメファントリン+アジアキンのどちらかに割り当てられた。すべての薬物を経口投与し,用量を薬物併用と部位によって変化させた。患者を42日間毎週追跡した。一次エンドポイントは,42日のPCRで補正された適切な臨床的および寄生虫学的反応によって定義された有効性であった。一次分析は治療を意図した。研究薬剤の安全性と忍容性の詳細な評価を,治療にランダムに割り当てられたすべての患者で行った。本研究は,ClinicalTrials.gov,NCT02453308に登録され,完全である。Aug7,2015,およびFeb8の間で,2018人の患者にジヒドロアルテミシニン-ピペキン(183[17%]),ジヒドロアルテミシニン-ピペラシリン+メフロキン(269[24%]),アルテスナート-メフロキン(73[7%]),アルテメテル-ルメファントリン(289[26%])またはアルテメテル-ルメファントリン(286[26%])を与えた。年齢の中央値は23歳(IQR13~34歳)で,1100名の患者の854名(78%)は男性であった。カンボジア,タイ,ベトナムにおいて,ジヒドロアルテミシニン-ピペラシリン+メフロキン後の42日PCR補正効果は98%(152;95%CI94~100),ジヒドロアルテミシニン-ピペキンは48%(141%,95%CI39~56,95%CI42~59;p<0)であった。ミャンマーにおける3つのサイトにおけるジヒドロアルテミシニン-ピペキン+メフロキンの有効性は,ジヒドロアルテミシニン-ピペキン(リスク差9%,95%CI1~17;p=0 12)後に91%(46;95%CI79~98)対100%(42,95%CI92~100)であった。カンボジアの3か所(リスク差1%;95%CI-6~8;p=1)において,ジヒドロアルテミシニン-ピペラシリン+メフロキンの42日PCR補正有効性(96%[71;95%CI88~99])はアルテスナート-メフロキンのそれより劣っていた(95%[69;95%CI87から99])。アルテメテル-ルメファントリン+アジアキンの全体的な42日のPCR補正有効性(98%[281;95%CI97~99])は,アルテメテル-ルメファントリンのそれと類似していた(97%[279,95%CI94~98]),リスク差2%,95%CI-1~4;p=0。2つのtactは,ジヒドロアルテミシニン-ピペキン+メフロキン(794の30[3 8%])後,ジヒドロアルテミシニン-ピペラシリン(543;p=0 0 012)の後より高頻度であったが,初期嘔吐(1時間以内)はより頻繁であった。アルテメテル-ルメファントリン+アジアキン(22[1%3%])とアルテメテル-ルメファントリン(11[0%6%])後の嘔吐はまれであった。アルテメテル-ルメファントリンにアジアキンを加えると,心電図補正QT間隔が延長されたが,ジヒドロアルテミシニン-ピペキンに対するメフロキンを加えると,ジヒドロアルテミシニン-ピペキンに対する平均増加はなかった。ジヒドロアルテミシニン-ピペキン+メフロキンおよびアルテメテル-ルメファントリン+アジアキンは,アルテミシニンおよびACTパートナー-薬剤耐性を有する領域を含む,複雑でないP falciparumマラリアの有効で,耐容性があり,安全な治療である。英国は,国際開発,Welle Trust,Bill & Melinda Gates Foundation,英国医科研究会,米国国立衛生研究所についての研究を行っている。Copyright 2020 Elsevier B.V., Amsterdam. All rights reserved. Translated from English into Japanese by JST.【JST・京大機械翻訳】

シソーラス用語： 心電図 ,  抗マラリア薬 ,  *マラリア ,  薬物耐性 ,  カンボジア王国 ,  マラリア原虫 ,  熱帯 ,  熱症状 ,  *併用療法 ,  有効性 ,  *Plasmodium falciparum ,  防除 ,  ランダム化比較試験 ,  窒素複素環化合物 ,  有機フッ素化合物 ,  芳香族縮合化合物 ,  第二アルコール ,  脂環式化合物 ,  ラクトン ,  架橋化合物

分類 (1件)： 抗原虫薬・駆虫薬の基礎研究  (GW17080G)

物質索引 (2件)： メフロキン ,  アルテミシニン

タイトルに関連する用語 (7件)： Plasmodium ,  マラリア ,  アルテミシニン ,  併用療法 ,  施設 ,  ラベル ,  無作為化臨床試験