查詢結果分析
來源資料
頁籤選單縮合
題 名 | Assessment of the Adverse Reactions of Gadobenate Dimeglumine (Gd-BOPTA) from Preliminary Clinical Experience in Taiwan=Gadobenate Dimeglumine (Gd-BOPTA)的不良反應:以臺灣的初步臨床經驗作評估 |
---|---|
作 者 | 鄭慶明; 戴淑卿; 王永成; 孔慶惠; 李紋瑜; 楊展明; 張筱筠; 吳昭瑩; 黃永堅; 王裕仁; | 書刊名 | 中華放射線醫學雜誌 |
卷 期 | 30:5 民94.10 |
頁 次 | 頁257-262 |
分類號 | 418.346 |
關鍵詞 | MR顯影劑; MR造影; MR顯影劑的安全性; Gadobenate dimeglumine; Gd-BOPTA; MR contrast media; MR imaging; Safety of MR contrast media; MultiHance; |
語 文 | 英文(English) |
中文摘要 | Gd-BOPTA(Gadobenate Dimeglumine, MultiHance@, Bracco Imaging SpA, Milano, Italy)屬於釓類MRI顯影劑。它於2004年3月經衛生署核准在台灣使用。它以無菌清澄無色的隨時可用0.5M液體包裝供應。本文針對於2004年10月至2005年2月首先利用Gd-BOPTA 在本院進行增強對比MRI 檢查的1041 名患者進行本劑的安全性研究。所有患者的使用劑量為 0.2ml/kg(體重)(0.1 mmol/kg)芴其中第一組為年齡22-96歲(平均57.5歲)的188女性和214男性芴本組未預先禁食並用手快速注射(2 mL/秒)緻第二組為年齡21-94歲(平均58.6歲)的323 女性和316 男性芴本組預先禁食4 小時及用手緩慢注射(10 mL/分)。總共有16 名(1.5%)患者的不良反應確定和Gd-BOPTA 有關芴全部屬於輕微不良反應(ARs)芴而且都完全消退。在兩組的ARs包括噁心、嘔吐、皮疹、暈眩、寒顫等並無有意義的差異。在9名91歲的受檢者都未發生ARs。我們的結果確定Gd-BOPTA 是一種可以在所有例行MRI檢查安全使用的顯影劑芴同時顯示Gd-BOPTA 的ARs並不受注射速度和注射前禁食所影響。 |
英文摘要 | Gd-BOPTA (MultiHance@) is a gadolinium-based contrast agent that was approved in Taiwan in March, 2004. It was supplied as sterile, clear, color-less solution with the concentration of 0.5M in a ready-for-use form. We conducted this study to eval-uate the safety profile of this particular gadolinium chelate in 1041 patients referred for contrast-enhanced MRI studies in our hospital between October 2004 and February 2005. Of these cases, 188 females and 214 males aged between 22-96 years (mean, 57.5 years) without fasting were injected with hand-push single bolus injection (2 mL/second) of a dosage of 0.2ml/kg body weight (0.1 mmol/kg). The other 323 females and 316 males aged between 21-94 years (mean, 58.6 years) with 4 hours fasting were injected by slow injection (10 mL/minute). A total of 16 (1.54%) cases experienced adverse reac-tions (ARs) considered to have definite relationship to Gd-BOPTA. All ARs were graded as mild and each of the patients recovered fully without sequelae. No definite serious Gd-BOPTA-related ARs occurred in our cases. There is no significant difference of the incidences of ARs including nausea, vomiting, skin rash, dizziness and chillness between these two groups. There were completely no ARs in all 9 cases older than 91 years. Our results confirm Gd-BOPTA (Gadobenate Dimeglumine, MultiHance) is a safe contrast agent for routine MRI studies in clinical patients. Our experiences also showed that the incidence of its ARs is not sig-nificantly influenced by the injection rate and fasting status prior to injection of the agent. |
本系統中英文摘要資訊取自各篇刊載內容。