先発医薬品パラプラチン^Ⓡ注射液から後発医薬品カルボプラチン点滴静注液「NK」への変更による安全性についての検討

抄録

Although the Japanese government is promoting the use of generic drugs in order to reduce medical costs, providing information to physicians and pharmacists on the quality, safety or utility of generic drugs compared to the original drugs is insufficient. Carboplatin is a platinum-containing antineoplastic agent that is used for the treatment of several types of cancer. Carboplatin Intravenous Infusion “NK” (GE-CBDCA) is a generic drug of Paraplatin^® Injection (OR-CBDCA). In this study, we investigated the quality and safety of OR-CBDCA and GE-CBDCA. Purity tests conducted using high performance liquid chromatography showed that there were no clear differences between the two drugs with respect to contaminant or related substances. As a result of susceptibility testing performed in vitro by using five types of tumor cells, both drug products showed similar receptivity. For comparison of adverse drug reactions, the incidence of adverse events was surveyed in 72 patients who underwent chemotherapy switched from OR-CBDCA to GE-CBDCA. No significant differences were found in seven of eight parameters. Hematological tests of hemoglobin and white blood cell counts tended to show a higher incidence of more serious adverse reactions in the group treated with GE-CBDCA, and the GE-CBDCA-treated group also showed significant higher neutrophil counts (P = 0.029). However, it was supposed that the total dosage and the administering period of the Carboplatin were factors of the adverse reaction in the GE-CBDCA-treated group, therefore, the quality and safety of the two drug products were considered to be similar.