地诺单抗怎么购买？

How to buy denosumab? Denosumab is a new foreign drug that is not currently on the market in China. It is a drug for treating solid tumors and is a prescription drug. Patients can purchase denosumab in person in the country where denosumab is listed, or through regular domestic overseas medical service companies.

Denosumab is a bone resorption inhibitor with a unique mechanism of action. It specifically targets the receptor activator of NF-kB ligand (RANKL), inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density. The FDA approved denosumab for use in postmenopausal women with osteoporosis who are at high risk for fractures. It can help reduce the incidence of vertebral, non-vertebral and hip fractures in postmenopausal women with osteoporosis. This product is also used in patients for whom other current treatments are ineffective or intolerable to reduce the risk of fractures.

A randomized, placebo-controlled, phase II clinical trial evaluated the efficacy and safety of denosumab in the treatment of osteoporosis in postmenopausal women. Patients were randomly divided into 7 treatment groups of this product [41 to 54 subjects in each group, respectively subcutaneously injected with 6, 14, 30 mg of this product (all once every 3 months), 14, 60, 100 or 210 mg (all once every 6 months)], a positive control group (orally administered alendronate sodium 70 mg, once a week) and a placebo group. The main evaluation index is the change of the patient's spinal bone mineral density (BMD) from the baseline level after treatment. The results showed that after 12 months, compared with the baseline level, the spinal BMD of patients in the treatment group increased by 3.0% to 6.7%, that in the control group increased by 4.6%, and that in the placebo group decreased by 0.8% (P < 0.001). After 24 months, the spinal BMD of patients in the treatment group increased by 4.13% to 8.89%, while the BMD of the placebo group decreased by 1.18%. The BMD of the hip and distal 1/3 of the radius in the treatment group was also significantly increased compared with the placebo. During this period, there were no significant differences in patient tolerability, BTM levels, and adverse reaction rates between groups. Among the 7 treatment groups, the 60 mg (once every 6 months) group has an ideal balance point in terms of safety and efficacy.