美国安进地舒单抗注射液的效果好吗

In a phase I clinical trial to verify efficacy in 35 patients with recurrent or refractory giant cell tumors of bone, denosumab was administered as a subcutaneous injection of 120 mg once every 4 weeks, with an additional dose on the 8th and 15th days of the first month; 30 of 35 cases (86%) had a tumor response, and the giant cells with clear pathology on re-biopsy almost completely disappeared (all cases), and the condition was stable on imaging 6 months later (10 of 15 cases).

Although pain or quality of life were not assessed in this confirmatory study, the data still showed that 26 of 35 patients had pain relief or improved function, and 9 had radiographic bone repair. After 4 weeks of treatment, rapid changes in metabolic uptake were seen on fluorodeoxyglucose-positron emission computed tomography (FDG-PET), indicating a therapeutic response. Bone metabolism inhibition, including a decrease in urinary N-telopeptide and blood C-telopeptide, appeared as early as 28 days after taking the drug, and continued throughout the entire study.

Treatment with denosumab was well tolerated, with no treatment-related serious adverse reactions. This study shows that denosumab can block the RANKL signaling pathway in patients with relapsed or refractory giant cell tumors of bone, resulting in significant changes in tumor composition and reduced bone destruction, demonstrating clinical effectiveness.

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