中国脑血管病杂志
中國腦血管病雜誌
중국뇌혈관병잡지
Chinese Journal of Cerebrovascular Diseases
2015年
11期
577-580
,共4页
血管造影,数字减影%对比剂%碘克沙醇%神经介入放射学
血管造影,數字減影%對比劑%碘剋沙醇%神經介入放射學
혈관조영,수자감영%대비제%전극사순%신경개입방사학
Angiography,digital subtraction%Contrast media%Iodixanol%Interventional neuroradiology
目的：探讨国产对比剂碘克沙醇注射液在神经介入应用中的效果和安全性。方法采用前瞻性、多中心、非对照临床试验设计，纳入11家研究中心应用碘克沙醇注射液行全脑DSA检查或介入治疗的442例患者。记录和评价指标主要包括：用药后不良反应，用药前后肌酐、尿素氮指标的变化，DSA机型，DSA图像质量和对比剂使用剂量等。统计分析肾功能损害、药物不良反应发生率和影像质量。结果入组442例均完成检查或治疗。（1）术中造影质量评价均达到优良，其中优98.2％（434例），良1.8％（8例）；4种不同DSA机型（SIEMENS、PHILIPS、GE、TOSHIBA）的图像质量比较，差异有统计学意义（χ2＝31．518，P＜0.01）。（2）仅1例血肌酐浓度较注射对比剂前升高44.2μmol／L，未出现有临床意义的血肌酐和尿素氮异常，无一例出现肾功能不全。（3）术中有3例（0.7％）发生轻度药物不良反应，其中2例皮肤出现变态反应，1例为短暂性视物不清。结论国产碘克沙醇注射液在神经介入领域的临床应用安全有效，不良反应少。不同DSA机型可能对造影图像质量产生影响。
目的：探討國產對比劑碘剋沙醇註射液在神經介入應用中的效果和安全性。方法採用前瞻性、多中心、非對照臨床試驗設計，納入11傢研究中心應用碘剋沙醇註射液行全腦DSA檢查或介入治療的442例患者。記錄和評價指標主要包括：用藥後不良反應，用藥前後肌酐、尿素氮指標的變化，DSA機型，DSA圖像質量和對比劑使用劑量等。統計分析腎功能損害、藥物不良反應髮生率和影像質量。結果入組442例均完成檢查或治療。（1）術中造影質量評價均達到優良，其中優98.2％（434例），良1.8％（8例）；4種不同DSA機型（SIEMENS、PHILIPS、GE、TOSHIBA）的圖像質量比較，差異有統計學意義（χ2＝31．518，P＜0.01）。（2）僅1例血肌酐濃度較註射對比劑前升高44.2μmol／L，未齣現有臨床意義的血肌酐和尿素氮異常，無一例齣現腎功能不全。（3）術中有3例（0.7％）髮生輕度藥物不良反應，其中2例皮膚齣現變態反應，1例為短暫性視物不清。結論國產碘剋沙醇註射液在神經介入領域的臨床應用安全有效，不良反應少。不同DSA機型可能對造影圖像質量產生影響。
목적：탐토국산대비제전극사순주사액재신경개입응용중적효과화안전성。방법채용전첨성、다중심、비대조림상시험설계，납입11가연구중심응용전극사순주사액행전뇌DSA검사혹개입치료적442례환자。기록화평개지표주요포괄：용약후불량반응，용약전후기항、뇨소담지표적변화，DSA궤형，DSA도상질량화대비제사용제량등。통계분석신공능손해、약물불량반응발생솔화영상질량。결과입조442례균완성검사혹치료。（1）술중조영질량평개균체도우량，기중우98.2％（434례），량1.8％（8례）；4충불동DSA궤형（SIEMENS、PHILIPS、GE、TOSHIBA）적도상질량비교，차이유통계학의의（χ2＝31．518，P＜0.01）。（2）부1례혈기항농도교주사대비제전승고44.2μmol／L，미출현유림상의의적혈기항화뇨소담이상，무일례출현신공능불전。（3）술중유3례（0.7％）발생경도약물불량반응，기중2례피부출현변태반응，1례위단잠성시물불청。결론국산전극사순주사액재신경개입영역적림상응용안전유효，불량반응소。불동DSA궤형가능대조영도상질양산생영향。
Objective To investigate the safety and efficacy of domestic contrast iodixanol injection in the application of interventional neuroradiology. Methods A total of 442 patients from 11 research centers using iodixanol injection for whole brain DSA examination or interventional therapy were enrolled in a prospective,multicenter,and non-controlled clinical trial. The recording and evaluation indicators included the adverse reactions after drug treatment,changes of creatinine and urea nitrogen indicators before and after drug treatment,DSA types,DSA effects,the dosage of contrast agent,etc. The renal function damage, incidence of adverse drug reactions,and image quality were counted and analyzed. Results All the 442 patients were completed the examination or treatment. (1)All the results of intraoperative angiography achieved excellent,including 98. 2% (n = 434)were excellent and 1. 8% (n = 8)were good. There were significant differences in the comparison of angiographic results in the 4 different types of DSA (SIEMENS,PHILIPS,GE,and TOSHIBA)(χ2 = 31. 518,P < 0. 001 ). (2 )Only 1 patient had increased serum creatinine > 44. 2 μmol / L. There was no urea nitrogen abnormality of clinical signifi-cance. None of the patients had renal insufficiency. (3)Three patients had adverse drug reaction (0. 7%) during procedure,including 2 patients had dermal allergic reactions and 1 patient had transient blurred vision. Conclusion Domestic iodixanol injection is safe and effective and has less adverse reaction in the clinical application of interventional neuroradiology. The different types of DSA may impact on the contrast image quality.
