美国安进地舒单抗注射液效果到底好不好

It is a drug that targets the RANK ligand. Compared with bisphosphonates that have been clinically used for a long time, denosumab has the advantage of significantly prolonging the occurrence time of bone damage-related events.

As the manufacturer of denosumab, Amgen Biopharmaceutical Company (Amgen) is the world's leading innovative biopharmaceutical R&D and production company and one of the largest biopharmaceutical companies in the world. The company was founded by scientist George B. It was co-founded in 1980 by Dr. Rathmann, Dr. Joseph Rubinfeld and other venture capitalists. It takes "drug innovation" as its core concept and attaches great importance to the accumulation of R&D capabilities. It has achieved major breakthroughs in the fields of human genome, tumor biology, neuroscience, hematology and other fields.

So is Amgen’s denosumab injection effective?

Desosumab (denosumab, also known as AMG-162, trade name Prolia) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits osteoclast activation and development, reduces bone resorption, and increases bone density.

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. For the first time, denosumab was approved in 27 EU member states, as well as Norway, Iceland, and Liechtenstein. In June of the same year, denosumab was approved by the FDA for marketing.

A randomized, placebo-controlled phase III clinical trial, DEFEND (Denosumab Fortifies Bone Density), evaluated the effect of denosumab in preventing osteoporosis in postmenopausal women. The average age of the subjects was 59.4 years old, and the spine T-scores ranged from -1.0 to -2.5 (the average was -1.61). They were randomly divided into a treatment group (denosumab 60 mg subcutaneous injection, once every 6 months, n = 166) or a placebo group ( n = 166). All patients were supplemented with 1000 mg of calcium every day, and the level of plasma 25-hydroxyvitamin D in the subjects was used to determine whether vitamin D supplementation was needed.

The main evaluation index is the change in spinal BMD measured by dual energy X-ray absorptiometry (DXA) compared with the baseline level. The results showed that after 24 months, denosumab significantly increased spine BMD compared with placebo (a 6.5% increase in the treatment group versus a 0.6% decrease in the placebo group).

In addition, the BMD values of all tested sites, including the hip and distal radius, increased significantly in the treatment group. At the same time, markers of bone resorption and formation were significantly reduced. The overall incidence of adverse reactions in the treatment group was similar to that in the placebo group during the observation period. This shows that the therapeutic effect on bone metastases is still good.

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