地诺单抗(Xgeva)是什么药？

It is a fully human monoclonal antibody and the only RANKL inhibitor currently on the market. It has attracted more and more attention because of its advantages such as easy administration, no drug plateau period, and long-term treatment can significantly improve bone density in various parts of the body.

About denosumab (Xgeva)

Denosumab is a humanized IgG2 monoclonal antibody with high affinity for NF-κB receptor activator ligand (RANKL), which acts by binding to the RANKL signaling pathway. In 2009, denosumab was approved by the US FDA for the treatment of osteoporosis (OP) in postmenopausal women, and was approved for marketing in my country in 2019. Denosumab inhibits osteoclast bone resorption by inhibiting RANKL, and has been proven to delay the progression of joint destruction and improve joint destruction. At present, there have been a number of randomized controlled trials (RCTs) at home and abroad for the treatment of OP in RA patients with denosumab, and its clinical application is gradually increasing.

The role of denosumab

Denosumab is a fully human monoclonal antibody (IgG2 class) that can selectively bind to RANKL and has high affinity. It can prevent RANKL from binding to RANK on the surface of osteoclasts and their precursors, inhibit osteoclast activity, and reduce their bone resorption levels.

Denosumab usage and dosage

The recommended dose of denosumab is subcutaneously administered every 4 weeks. The injection site can be the upper arm, upper thigh, or abdomen. The dose per injection is 120mg.

Single-use vials of denosumab contain 120 mg of the drug in a volume of 1.7 mL and a concentration of 70 mg/mL. This means that the entire vial of medication can be used in one injection. Before use, it is necessary to ensure the correct injection dose and concentration to ensure the effectiveness and safety of the drug. When using, follow your doctor's instructions and read the drug instructions carefully.

Denosumab efficacy

Research purpose: To observe the clinical efficacy of denosumab in the treatment of postmenopausal osteoporosis (PMO).

Research methods: 100 PMO patients were injected with denosumab 60 mg subcutaneously every 6 months. Bone metabolism indexes, hip and lumbar spine bone mineral density (BMD), and VAS pain scores were compared before treatment and at 6 and 12 months of treatment. Observe drug-related adverse reactions.

Research results: Compared with before treatment, the bone metabolism index levels and VAS pain scores were reduced at the 6th and 12th months of treatment, while the BMD of the hip and lumbar spine were increased (P<0.05). Compared with the 6th month of treatment, the levels of bone-specific alkaline phosphatase, type I collagen N-terminal extended peptide and VAS pain scores were reduced at the 12th month of treatment, while the BMD of the hip and lumbar spine increased (P≤0.05). The total clinical effectiveness rate is 94%. No drug-related adverse reactions occurred.

Research conclusion: Denosumab is safe and effective in the treatment of PMO. It can reduce patients' bone metabolism indicators, increase BMD, and relieve bone pain symptoms.

Denosumab side effects

The main side effects of denosumab found in experiments include back pain, limb pain, hypercholesterolemia, cystitis, musculoskeletal pain, atrial fibrillation, peripheral edema, pharyngitis, pneumonia, abdominal pain, flatulence, herpes zoster, upper respiratory tract infection, insomnia, weakness, rash, spinal osteoarthritis, sciatica, itching, dizziness, anemia, angina pectoris, gastroesophageal reflux disease, etc.

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