美国安进地舒单抗注射液可以治疗哪些疾病

It is a humanized IgG2 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells through genetic engineering. Desosumab has a high affinity for RANKL, preventing RANK ligands from activating RANK on the surface of osteoclasts, inhibiting osteoclast activation and development, reducing bone resorption, increasing bone density and bone strength of both cortical bone and trabecular bone, promoting bone reconstruction, and reducing the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women.

Desosumab is produced by Amgen of the United States. In June 2010, the FDA approved denosumab for the treatment of osteoporosis in postmenopausal women. It was later approved for the treatment of male osteoporosis, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer.

Desosumab is administered by injection, 120 mg subcutaneously in the upper arm, upper thigh, or abdomen, once every 4 weeks, with calcium and vitamin D when needed to treat or prevent hypocalcemia. It should also be noted that patients taking denosumab concurrently with immunosuppressants or with compromised immune systems may be at increased risk of serious infections, and physicians need to fully consider the benefit-risk ratio before prescribing denosumab to such patients.

In terms of therapeutic effect, a 1-year double-blind, randomized controlled phase III clinical trial of DECIDE compared the effectiveness and safety of alendronate. The results showed that after 12 months, it could be observed that the BMD of both groups increased at all detection sites (hip, spine, femoral neck, trochanter, and distal 1/3 of the radius), but the increase in the denosumab treatment group was more significant than that of the alendronate control group (3.5 VS 2.6, P < 0. 0001).

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