美国安进地舒单抗注射液怎么样

In China, clinical treatment methods for bone metastases are limited. Currently, the main treatment method is regular monthly intravenous administration of bisphosphonate drugs (disodium pamidronate, zoledronic acid). In severe cases, radiotherapy and other treatments can be used. However, in countries and regions such as Europe, the United States, and Hong Kong, it is the first choice for the treatment of bone metastases. Multiple clinical studies have shown that denosumab is significantly more effective than zoledronic acid in patients with solid tumor bone metastases.

Phase II clinical trials evaluate the effectiveness and safety of this product in the treatment of osteoporosis in postmenopausal women. Patients were randomly divided into 7 denosumab treatment groups [41 to 54 subjects in each group, subcutaneous injection of denosumab 6, 14, 30 mg (all once every 3 months), 14, 60, 100 or 210 mg (all once every 6 months)], an active control group (oral alendronate sodium 70 mg, once a week) and a placebo group. The main evaluation index is the change of the patient's spinal bone mineral density (BMD) from the baseline level after treatment. The results showed that after 12 months, compared with the baseline level, the spinal BMD of patients in the treatment group increased by 3.0% to 6.7%, that in the control group increased by 4.9%, and that in the placebo group decreased by 0.8% (P < 0.001). After 24 months, the spinal BMD of patients in the treatment group increased by 4.13% to 8.89%, while that in the placebo group decreased by 1.18%.

Patients were randomly divided into: treatment group (60 mg subcutaneous injection of this product, once every 6 months, n = 594), control group (oral administration of 70 mg alendronate sodium, once every 6 months, n = 595). All subjects were supplemented with 500 mg of calcium every day, and the dose of vitamin D was adjusted according to plasma 25-hydroxyvitamin D levels. After 12 months, it can 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 treatment group was more significant than that of the control group (the primary endpoint of the total hip BMD increased by 3.5 and 2.6, respectively, P<0.0001). The incidence of adverse reactions was similar between the two groups. A questionnaire survey of patients showed that the majority of patients (77%) preferred to receive subcutaneous denosumab twice a year.

It is manufactured by Amgen, which was founded in 1980 by a group of scientists and venture capitalists. Amgen is principally engaged in the discovery, development, production and sales of innovative drugs for human use, and is committed to exploring the potential of biotechnology for the treatment of patients with serious diseases. By leveraging cutting-edge human genetics and other tools, Amgen seeks to unravel the complexity of disease and lay the foundation for understanding human biology.

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