Japanese
Title転移性骨腫瘍に伴う骨性疼痛に対する放射性ストロンチウム (89Sr) 製剤SMS.2Pの有用性 - 多施設における第III相臨床試験 -
Subtitle技術報告
Authors木村良子1, 濱本研2,**, 古舘正從3, 福田寛4, 宍戸文男5, 遠藤啓吾6, 油井信春7, 日下部きよ子8, 鈴木謙三9,**, 川上憲司10, 石井勝己11, 小泉潔12, 横山邦彦13, 久田欣一14, 中川毅15, 笠木寛治16, 小西淳二16,**, 一矢有一17, 増田康治17, 中條政敬18, 久保敦司19,***, 鳥塚莞爾*
Authors(kana)
Organization*治験総括医師, 京都大学・福井医科大学名誉教授, **幹事, ***コントローラー, 1愛媛大学医学部放射線科, 2愛媛大学名誉教授, 3北海道大学名誉教授, 4東北大学加齢医学研究所核医学診療科, 5福島県立医科大学放射線科, 6群馬大学医学部核医学科, 7千葉県がんセンター核医学診療部, 8東京女子医科大学放射線科, 9東京都立駒込病院放射線科, 10東京慈恵会医科大学放射線科, 11北里大学医学部放射線科, 12山梨医科大学放射線科, 13金沢大学医学部核医学科, 14金沢大学名誉教授, 15三重大学医学部放射線科, 16京都大学医学部核医学科, 17九州大学医学部放射線科, 18鹿児島大学医学部放射線科, 19慶應義塾大学医学部放射線科
Journal核医学
Volume33
Number12
Page1347-1358
Year/Month1996/12
Article報告
Publisher日本核医学会
Abstract「要旨」 骨性疼痛を有する悪性腫瘍(前立腺癌53例, 乳癌18例, その他の腫瘍19例)の骨転移患者90例を対象とし, 塩化ストロンチウム(89Sr)注射液(SMS.2P)の第III相臨床試験を行った. 投与後, 一時的な疼痛増強や悪心・嘔吐などがみられたが, いずれも回復し, 臨床使用上の安全性に問題となるような副作用は認められなかった. 既報と同様, 血液学的検査値, 特に白血球数および血小板数の減少がみられ, 本剤による骨髄抑制もその一因と考えられた. 鎮痛効果における有効率は58%, 短期的な軽度改善例も含めると70%の患者で何らかの疼痛改善が得られた. 疼痛緩和に伴い睡眠の改善や活動性の向上など患者のQOLも改善し, 通常の日常活動に復帰した例もあった. 疼痛の緩和が得られた患者の64%に投与後数日から1週間までに鎮痛効果が現れ, 半数で2〜3か月間効果が持続し, 長いものでは試験観察期間を超す鎮痛効果が得られた.
Practice臨床医学：一般
KeywordsStrontium-89, Pain palliation, Bone metastases, Quality of life
English
TitleEffectiveness of the Radioactive Strontium (89Sr) Chloride Agent, SMS.2P for Pain Palliation in Patients with Metastatic Bone Tumor in Phase III Multicenter Clinical Trial
SubtitleTechnical Reports
AuthorsYoshiko KIMURA1, Ken HAMAMOTO2,**, Masayori FURUDATE3, Hiroshi FUKUDA4, Fumio SHISHIDO5, Keigo ENDO6, Nobuharu YUI7, Kiyoko KUSAKABE8, Kenzo SUZUKI9,**, Kenji KAWAKAMI10, Katsumi ISHII11, Kiyoshi KOIZUMI12, Kunihiko YOKOYAMA13, Kinichi HISADA14, Tsuyoshi NAKAGAWA15, Kanji KASAGI16, Junji KONISHI16,**, Yuichi ICHIYA17, Kouji MASUDA17, Masayuki NAKAJO18, Atsushi KUBO19,***, Kanji TORIZUKA*
Authors(kana)
Organization*Principal Investigator, Professor Emeritus, Kyoto University and Fukui Medical School, **Members of Executive Committee, and***Controller, 1Department of Radiology, Ehime University School of Medicine, 2Professor Emeritus, Ehime University, 3Professor Emeritus, Hokkaido University, 4Department of Nuclear Medicine and Radiology, Aging and Cancer, Tohoku University, 5Department of Radiology, Fukushima Medical College, 6Department of Nuclear Medicine, Gunma University School of Medicine, 7Department of Nuclear Medicine, Chiba Cancer Center Hospital, 8Department of Radiology, Tokyo Women's Medical College, 9Department of Radiology, Tokyo Metropolitan Komagome Hospital, 10Department of Radiology, Jikei University School of Medicine, 11Department of Radiology, Kitasato University School of Medicine, 12Department of Radiology, Yamanashi Medical University, 13Department of Nuclear Medicine, Kanazawa University School of Medicine, 14Professor Emeritus, Kanazawa University, 15Department of Radiology, Mie University Faculty of Medicine, 16Department of Nuclear Medicine, Kyoto University Faculty of Medicine, 17Department of Radiology, Kyushu University Faculty of Medicine, 18Department of Radiology, Kagoshima University Faculty of Medicine, and 19Department of Radiology, Keio University School of Medicine
JournalThe Japanese Journal of nuclear medicine
Volume33
Number12
Page1347-1358
Year/Month1996/12
ArticleReport
PublisherTHE JAPANESE SOCIETY OF NUCLEAR MEDICINE
Abstract[Summary] The phase III clinical trial of strontium-89 chloride agent (SMS.2P) was performed in 90 patients with painful bone metastases secondary to prostate (53), breast (18) and other types of cancer (19). Some patients experienced a transient increase in pain or nausea and vomiting. However both symptoms subsided and serious side effects were not observed in any of the patients. As reported, we confirmed some abnormal changes in peripheral blood picture. A decrease in the number of white blood cells and platelets was considered to be partly a result of bone marrow suppression due to 89Sr irradiation. Pain was substantially improved after 89Sr therapy in 58% of the patients and there was some alleviation in 12%. The release from pain was accompanied by an improved quality of life for these patients including sleep patterns and morbidity. Some patients were able to resume their former life styles. Most of the improved patients experienced pain relief from days to one week following 89Sr therapy and in half cases, this remained effective for 2 or 3 months. There were even cases in which the pain relief continued over an observation period of time of clinical study.
PracticeClinical medicine
KeywordsStrontium-89, Pain palliation, Bone metastases, Quality of life

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