狄诺塞麦治疗骨转移疗效怎样呢？

(denosumab, also known as AMC-162, trade name XGeva) is a bone resorption inhibitor with a unique mechanism of action. It specifically targets the receptor activator of NF-kB ligand (RANKL), inhibits osteoclast activation and development, reduces bone resorption, and increases bone density. On May 28, 2010, the European Commission approved this product for the treatment of bone loss related to hormone suppression in postmenopausal women with osteoporosis and prostate cancer patients. It can also be used in patients for whom other current treatments are ineffective or intolerable to reduce the risk of fractures. Is denosumab effective in treating bone metastases?

A 3-year randomized, double-blind, placebo-controlled phase III clinical trial FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) evaluated the effectiveness and safety of this product in the treatment of osteoporosis in postmenopausal women. Patients were randomly assigned to: treatment group (60 mg subcutaneous injection of this product every 6 months, n = 3902) or placebo (n = 3906). The primary evaluation indicator was the incidence of new vertebral fractures during the 3-year period, and secondary indicators included the incidence of hip fractures and non-vertebral fractures and the time to first fracture during the observation period. The subjects were aged between 60 and 90 years old, with an average age of 72.3 years. The basic value of spine or total hip T-score was between -4.0 and -2.5 (the average was -2.8). About 23% of the subjects had a history of at least one fracture before entering this trial. All patients also received daily supplements of 1000 mg of vegetarian calcium and 400 to 800 IU of vitamin D. The results showed that compared with the placebo group, the incidence of new vertebral fractures in the treatment group was reduced by 68% (2.3% in the treatment group and 7.2% in the placebo group, P < 0.000 1), the incidence of hip fractures was relatively reduced by 40% (0.7% in the treatment group and 1.2% in the placebo group, P = 0.036), and the incidence of non-vertebral fractures was relatively reduced by 20% (6.5% in the treatment group). , 8.0% in the placebo group, P =0.011).

Another randomized, placebo-controlled phase III clinical trial, DEFEND (Denosumab Fortifies Bone Density), evaluated the effect of this product in preventing osteoporosis in postmenopausal women. The average age of the subjects was 59.4 years old, and the spine T-scores were between -1.0 and -2.5 (mean -1.61). They were randomly divided into a treatment group (60 mg subcutaneous injection of this product, 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 vitamin D in the subjects was used to determine whether supplementation was needed. D. 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 the BMD value of the spine compared with placebo (an increase of 6.5% in the treatment group and a decrease of 0.6% in the placebo group). In addition, the BMD values ​​of all tested parts such as the hip bone and distal radius of the treatment group increased significantly. 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. To sum up, the treatment effect is still good, and patients can buy it with confidence.