社團法人臺灣臨床藥學會

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【原著】某區域醫院病人使用含碘顯影劑產生立即性不良反應之研究
Investigation of Immediate Adverse Reactions to Iodine Contrast Media in a Regional Hospital
含碘顯影劑、立即性不良反應、相對危險性、Iodine Contrast Media, Acute Adverse Reaction, Relative Risk
張意宜I-I Chang1 、江村煌Chun-Huang Chaing2 、東雅惠Yaa-Hui Dong*3
1汐止國泰綜合醫院藥劑科 、2汐止國泰綜合醫院放射科 、3臺大流行病學與預防醫學研究所
目的: 含碘顯影劑給藥後1 小時內發生的立即性不良反應廣被探討,但國內卻少有其安全性之資料。故本研究針對其發生風險性進行探討。
方法: 以回溯性方法分析2005 年12 月至2009 年9 月期間,某區域醫院使用過含碘顯影劑病人的資料。將病人第一次含碘顯影劑的使用記錄,以羅吉斯回歸分析顯影劑種類及可能危險因子與發生立即性不良反應的相關性。
結果: 2005 年12 月至2009 年9 月期間,共計12,472 人次(相當於9,192 人)使用過含碘顯影劑。約80% 病人使用非離子性含碘顯影劑,僅使用過1 次含碘顯影劑的病人達80%。9,192 人中立即性不良反應發生比率為1.8%,嚴重度以輕度居多。依據病人第一次使用含碘顯影劑之記錄,使用離子性顯影劑的病人有較高的立即性不良反應比率(離子性顯影劑:5.4%,非離子性顯影劑:0.7%,p < 0.0001),離子性顯影劑相較於非離子性顯影劑發生立即性不良反應之危險性較高(勝算比:7.092;95% 信賴區間:5.025 ~ 10.000)。另18 ~ 64 歲之病人群、有氣喘疾病者,發生立即性不良反應的相對風險性較高,尤其在使用離子性顯影劑病人群,相對風險性更高。
結論: 本研究指出離子性顯影劑發生立即性不良反應的風險7 倍於非離子性顯影劑;氣喘病人相對於非氣喘病人有高達3 倍的風險。此結果可提供國內用藥安全之參考。
 
Purpose: The immediate adverse reactions of iodine contrast medium have been widely discussed;however, there are only few safety data in Taiwan. Therefore, we aimed to explore the risk of the immediate adverse reactions associated with iodine contrast media in Taiwan.
Methods: We retrospectively analyzed data derived from a local hospital in the period of December 2005 till September 2009. We performed a logistic regression analysis to evaluate the correlation between the immediate adverse reaction and type of iodine contrast media and other potential risk factors.
Results: A total of 9,192 patients experienced 12,472 prescriptions of iodine contrast media. Most patients used non-ionic contrast media, 80% of which only received one prescription. The risk of immediate adverse reactions was 1.8% and most episodes were mild. Based on the first prescription record of iodine contrast media, we found that patients using ionic contrast media had a higher risk of adverse reactions (ionic vs non-ionic : 5.4% vs 0.7%, p < 0.0001). Ionic contrast media was associated with an increased risk of immediate adverse reactions compared with non-ionic contrast media (adjusted OR: 7.092; 95% CI: 5.025-10.000). Patients 18 to 64 years of age and with asthma also had a higher risk of immediate adverse reactions, especially those who using ionic contrast media.
Conclusion: This study demonstrated that patients using ionic iodine contrast media and patients with asthma had 7-fold and 3-fold increased risk of immediate adverse reactions, respectively. Ionic iodine contrast media should be used with caution in clinical settings.
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