地诺单抗可以治什么病症？

It is the first approved monoclonal antibody specifically targeting RANK ligand. RANK ligand is a transmembrane or soluble protein necessary for osteoclasts to maintain their structure, function and survival. Human RANKL mRNA is mainly found in bones, bone marrow and lymphoid tissues. Its main function in bones is to stimulate the differentiation and activity of osteoclasts and inhibit the apoptosis of osteoclasts. Osteoclasts are responsible for bone resorption, and osteoclast precursors must have low levels of macrophage colony-stimulating factor and RANKL during their differentiation into mature osteoclasts. This product has a high affinity with RANKL, prevents RANK ligand from activating RANK on the surface of osteoclasts, inhibits osteoclast activation and development, reduces bone resorption, increases bone density and bone strength of both cortical bone and trabecular bone, promotes bone reconstruction, and reduces the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women. The effect of this product on bone reconstruction can be evaluated by measuring some bone turnover markers (BTMs), such as the bone resorption marker N-telopeptide (NTX), the bone formation marker bone-specific alkaline phosphatase (BSAP), etc. A phase I clinical study conducted in healthy postmenopausal women showed that a dose-dependent decrease in morning urine NTX levels could be observed on day 2 after administration. This decrease could last for 6 months, with the maximum decrease reaching 84% compared with baseline. This effect is reversible. When serum denosumab levels disappear, NTX levels can be seen to rise again, which reflects the reversibility of its effect on bone reconstruction. As treatment continues, these effects will persist for a new cycle.

On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. Denosumab was approved for the first time in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, this product was approved by the FDA for marketing.

It can only be given by subcutaneous injection, not intravenous infusion, intramuscular infusion or intradermal injection. (1) Solid tumor bone metastasis: 120mg once every 4 weeks, injected subcutaneously in the upper arm, thigh or abdomen. (2) Giant cell tumor of bone: 120 mg once every 4 weeks, subcutaneous injection, and then 120 mg on d8 and d15 in the first month of treatment. (3) Administer calcium and vitamin D appropriately to prevent hypocalcemia.