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新型中枢型苯二氮䓬受体显像剂123I-碘美西尼的3期临床试验(第1部分)——关于其在多种脑部疾病诊断中的临床应用报告

[A phase 3 clinical trial of 123I-iomazenil, a new central-type benzodiazepine receptor imaging agent (Part 1)--report on clinical usefulness in diagnosis of various brain diseases].

作者信息

Torizuka K, Uemura K, Toru M, Shinohara Y, Nishimura T, Yonekura Y, Nakagawara J, Matsuda H, Sakai F, Matsuda K, Fukuyama H, Morimoto K

机构信息

Fukui Medical School, Japan.

出版信息

Kaku Igaku. 1996 Mar;33(3):293-301.

PMID:8622263
Abstract

Iomazenil (IMZ) is a partial inverse agonist of central-type benzodiazepine receptors (BZR) which binds specifically to BZR with high affinity. The safety and clinical effectiveness of 123I-IMZ SPECT in the diagnosis of brain diseases were evaluated in 655 patients with various brain diseases, such as epilepsy, cerebrovascular diseases, degenerative diseases and mental disorders relating to BZR. This was a Phase 3 study conducted as a multicenter trial at 52 collaborating institutions. There was no significant adverse reactions in the clinical symptoms or abnormal laboratory test values. The investigators judged 123I-IMZ SPECT to be effective in 95% of 638 analyzed cases. The injected dose did not correlate with the image quality or the clinical effectiveness of 123I-IMZ SPECT, suggesting that these items depend largely on the characteristics of the apparatus used, the disease or pathology of the patients, rather than the dose. We conclude that 123I-IMZ imaging is safe and provides effective information based on BZR binding which is useful in the diagnosis of various brain diseases.

摘要

碘美普尔(IMZ)是中枢型苯二氮䓬受体(BZR)的部分反向激动剂,它以高亲和力特异性结合BZR。对655例患有各种脑部疾病(如癫痫、脑血管疾病、退行性疾病以及与BZR相关的精神障碍)的患者,评估了123I-IMZ单光子发射计算机断层扫描(SPECT)在脑部疾病诊断中的安全性和临床有效性。这是一项在52个合作机构进行的多中心3期研究。临床症状或实验室检查值异常方面均无显著不良反应。在638例分析病例中,研究人员判定123I-IMZ SPECT在95%的病例中有效。注射剂量与123I-IMZ SPECT的图像质量或临床有效性无关,这表明这些指标很大程度上取决于所用设备的特性、患者的疾病或病理情况,而非剂量。我们得出结论,123I-IMZ成像安全,且基于BZR结合提供有效信息,对各种脑部疾病的诊断有用。

相似文献

1
[A phase 3 clinical trial of 123I-iomazenil, a new central-type benzodiazepine receptor imaging agent (Part 1)--report on clinical usefulness in diagnosis of various brain diseases].新型中枢型苯二氮䓬受体显像剂123I-碘美西尼的3期临床试验(第1部分)——关于其在多种脑部疾病诊断中的临床应用报告
Kaku Igaku. 1996 Mar;33(3):293-301.
2
[A phase 3 clinical trial of 123I-iomazenil, a new central-type benzodiazepine receptor imaging agent (Part 2)--Report on clinical usefulness in diagnosis of degenerative neurological diseases and mental disorders].新型中枢型苯二氮䓬受体显像剂123I-碘美西尼的3期临床试验(第2部分)——关于其在退行性神经疾病和精神障碍诊断中的临床应用报告
Kaku Igaku. 1996 Mar;33(3):303-18.
3
[A phase 3 clinical trial of 123I-iomazenil, a new central-type benzodiazepine receptor imaging agent (Part 3)--Report on clinical usefulness in epilepsy].新型中枢型苯二氮䓬受体显像剂123I-碘美西尼的3期临床试验(第3部分)——癫痫临床应用报告
Kaku Igaku. 1996 Mar;33(3):319-28.
4
[Phase 2 clinical study of 123I-iomazenil in various cerebral diseases: part 2--clinical evaluation of central-type benzodiazepine receptor imaging with 123I-iomazenil SPECT].123I-碘美托咪定在各种脑部疾病中的二期临床研究:第二部分——123I-碘美托咪定单光子发射计算机断层扫描中枢型苯二氮䓬受体成像的临床评估
Kaku Igaku. 1996 Feb;33(2):191-205.
5
[A phase 3 clinical trial of 123I-iomazenil, a new central-type benzodiazepine receptor imaging agent (Part 4)--Report on clinical usefulness in diagnosis of cerebrovascular diseases].新型中枢型苯二氮䓬受体显像剂123I-碘美西尼的3期临床试验(第4部分)——关于对脑血管疾病诊断的临床应用报告
Kaku Igaku. 1996 Mar;33(3):329-44.
6
[Phase 2 clinical study of 123I-iomazenil in various cerebral diseases: part 1--examination of injection dose and clinical indications].123I-碘美西泮用于各种脑部疾病的Ⅱ期临床研究:第1部分——注射剂量及临床适应证的研究
Kaku Igaku. 1996 Feb;33(2):179-90.
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[Phase 1 clinical study of 123I-iomazenil: a new probe to evaluate central-type benzodiazepine receptor with SPECT].123I-碘马西尼的1期临床研究:一种用单光子发射计算机断层扫描评估中枢型苯二氮䓬受体的新探针
Kaku Igaku. 1995 Jan;32(1):87-97.
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[Compartment analysis of 123I-iomazenil brain on early and delayed SPECT].
Kaku Igaku. 1997 Jun;34(6):371-7.
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[Usefulness of 123I-iomazenil SPECT in pediatric patients with neurological disease].[123I-异氟烷酯单光子发射计算机断层扫描在小儿神经疾病患者中的应用价值]
No To Hattatsu. 2012 Jan;44(1):5-12.
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[Benzodiazepine receptor and cerebral blood flow in early Alzheimer's disease--SPECT study using 123I-iomazenil and 123I-IMP].[早期阿尔茨海默病中的苯二氮䓬受体与脑血流量——使用123I-碘美西尼和123I-异丁基安非他明的单光子发射计算机断层扫描研究]
Kaku Igaku. 1996 Jan;33(1):49-56.

引用本文的文献

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Is central benzodiazepine receptor imaging useful for the identification of epileptogenic foci in localization-related epilepsies?中枢苯二氮䓬受体成像对定位相关癫痫中致痫灶的识别有用吗?
Eur J Nucl Med Mol Imaging. 2003 Feb;30(2):325-8. doi: 10.1007/s00259-002-1083-z. Epub 2002 Dec 17.