狄诺塞麦的作用和副作用

(Alias: denosumab) is a RANK ligand (RANKL) inhibitor that was first approved for marketing in 2010. It is a fully humanized monoclonal antibody (IgG2 monoclonal antibody) that specifically targets receptor activator of nuclear factor-kappa B ligand (RANKL). Different from the mechanism of action of drugs that have been approved to reduce tumor bone complications, denosumab prevents RANKL from binding to its receptor substances, inhibits osteoclast activation and development, reduces bone resorption, and increases bone density. 

What denosumab does:

A randomized, double-blind, placebo-controlled Phase III clinical trial called FREEDOM evaluated the efficacy and safety of denosumab in the treatment of osteoporosis in postmenopausal women for a period of 3 years. The primary outcome measure was the incidence of new vertebral fractures over the 3-year period, and secondary outcomes included the incidence of hip and nonvertebral fractures and the time to first fracture during the observation period.

The results showed that the incidence rate of new vertebral fractures in the treatment group was 2.3%, and that in the placebo group was 7.2%. The incidence rate in the treatment group was reduced by 68% compared with the placebo group. The incidence of hip fracture was 0.7% in the treatment group and 1.2% in the placebo group, a relative reduction of 40% (P=0.036), and the incidence of nonvertebral fractures was reduced by 20% (6.5% in the treatment group and 8.0% in the placebo group, P=0.011). 

Denosumab side effects:

No matter what drug it is, some side effects will occur after long-term use. Common side effects of denosumab include back pain (incidence rate 34.7%), musculoskeletal pain, hypercholesterolemia, limb pain and cystitis. The most common side effects leading to drug withdrawal are breast cancer, back pain and constipation.

(Denosumab) has significant effects, but the degree of side effects varies from person to person. Patients should do relevant examinations during the medication period to understand their physical conditions in a timely manner.