Immediate Adverse Drug Reactions in Computed Tomography with Slow Injection Rate: Comparing Iothalamate Meglumine with Iopromide

以慢速給藥進行電腦斷層檢查發生立即性藥物不良反應之情形：比較Iothalamate Meglumine與Iopromide

謝任富(Ren-Fu Shie) ； 潘廣澤(Kuang-Tse Pan) ； 朱崧毓(Sung-Yu Chu) ； 曾振輝(Jeng-Hwei Tseng) ； 饒啓明(Kee-Min Yeow) ； 洪建福(Chien-Fu Hung)

《中華放射線醫學雜誌》 33卷4期 (2008/12) Pp. 233-238

摘要

一般認為非離子性含碘顯影劑較離子性含碘顯影劑產生較少的立即性藥物不良反應。我們試著觀察以慢速給藥（每秒不超過2.0毫升）執行電腦斷層檢查時發生立即性藥物不良反應之情形。
此研究是觀察Conray®60%（康利造影劑60注射液）與Ultravist®370（優照維斯370注射液）用於電腦斷層檢查時發生立即性藥物不良反應之情形。收案時間為八個月。注射速率控制在等於或小於每秒兩毫升。在百分之九十五信心水準下以費雪法(Fisher's exact test)及勝算比(odds ratio)作為統計分析之工具。
收案時間內共有8776筆在本醫院的電腦斷層檢查紀錄，包含2766筆使用Conray與6010筆使用Ultravist的紀錄。總共的立即性藥物不良反應發生率於Conray為百分之1.84，於Ultravist為百分之1.26，具有統計上很小的差異性。而以嚴重度區分開來的話，則這兩種顯影劑比較起來並無明顯的差異性。
在慢速給藥（等於或小於每秒兩毫升）的前提下，此研究顯示Conray和Ultravist比較起來只有稍高的總和立即性藥物不良反應發生率。而當病人以藥物不良反應的嚴重度區分開來時，這兩種造影劑並無明顯統計上的差異性。因此，以慢速給藥時，使用Ultravist並不會比使用Conray產生較少的立即性藥物不良反應。

並列摘要

Non-ionic iodinated contrast media (NICM) are believed to cause less immediate adverse drug reactions (ADRs) than ionic iodinated contrast media (ICM). We undertook an observational study to compare the immediate ADRs caused by ICM and NICM during computed tomography (CT) examinations with a slow injection rate not greater than 2.0 mL/sec.
This study was designed to compare the immediate ADRs by using Iothalamate meglumine (Conray(superscript ®)60%) and Iopromide (Ultravist(superscript ®)370) for patients undergoing CT examinations in a period of 8 months. The injection rate was equal or less than 2.0 mL/sec. Immediate ADRs were classified by severity grading system. The statistical methods used were Fisher's exact test and odds ratio with 95% confidence intervals.
Totally 8776 subjects were enrolled in our study, including 2766 subjects using Iothalamate and 6010 subjects using Iopromide. The overall incidence of immediate ADRs had statistical but small difference (p=0.04) between Iothalamate (1.84%) and Iopromide (1.26%). In each group classified by severity grading system, the incidence of immediate ADRs between subjects using Iothalamate and Iopromide did not show statistical difference.
Under the setting of slow injection rate (≦2mL/sec), Iothalamate was associated with a higher total incidence of immediate ADRs than Iopromide, but the difference was small. When patients were classified into groups of different ADR severity, no significant difference was found between these two contrast media. Therefore, at an injection rate not greater than 2.0mL/sec, using Iopromide may not cause less immediate ADRs than using Iothalamate.