ヨウ化ヒプル酸ナトリウム(123I)注射液の第3相臨床試験 - 多施設による検討 -

Abstract

A multi-center clinical trial was performed to evaluate the clinical usefulness of 123I-orthoiodohippurate (123I-OIH) in patients with renal and urinary disorders. 123I-OIH was evaluated to be "safe" in all 259 cases it was injected. 123I-OIH was useful in all 248 cases analyzed for the overall clinical usefulness evaluated by the investigators. The clinical significance of the drug was also evaluated in terms of renal blood flow function, renal parenchymal function, urinary function and the ability to differentiate between renal and urinary disorders. In the comparison with 123I-OIH (90 cases), 123I-OIH was superior as evaluated by the investigators and the Committee both. In the comparison with 99mTc-DTPA (113 cases), 123I-OIH was evaluated as superior by the investigators, but no significant difference was found by the Committee. In image qualities, 123I-OIH was evaluated as superior to 131I-OIH and equal to 99mTc-DTPA by the Committee. In overall efficiency, 123I-OIH was evaluated as being more valuable than 131I-OIH in 92% of the 90 cases and more valuable than 99mTc-DTPA in 50% of the 113 cases. 123I-OIH was evaluated as being less valuable than 131I-OIH in no cases and less valuable than 99mTc-DTPA in 7% of the 113 cases. These results suggest that 123I-OIH is superior to 131I-OIH and equal or superior to 99mTc-DTPA as a radiopharmaceutical for gamma camera-renography.