美国安进狄诺塞麦是地舒单抗吗?
(Denosumab), also known as denosumab and denosumab, was approved for marketing in the United States in 2010 and has been clinically used in many European and American countries. It has completed multiple Phase 3 and Phase 4 clinical trials. Denosumab can clearly improve patients' bone density values and reduce the incidence of osteoporosis-related fractures during the study period.
The FREEDOM study included 7868 postmenopausal osteoporosis patients. After 3 years of treatment observation, it was found that denosumab can significantly reduce (68%) the probability of new vertebral fractures, while the rates of non-vertebral fractures and hip fractures also significantly decreased (20%, 40%). In another study, denosumab could significantly reduce the incidence of new vertebral fractures and hip fractures in patients with high fracture risk (P <0.05). In patients with low fracture risk, the incidence of vertebral fractures was more statistically significant (P <0.001).
Similarly, in another study conducted abroad, denosumab treatment also showed significant significance in reducing the incidence of vertebral fractures and low-energy non-vertebral fractures compared with the placebo group without controlling for the patient's age, previous fracture status, and other anti-osteoporosis treatments. The overall adverse reactions of denosumab are relatively mild and mild. Previous observations generally believe that denosumab has a similar safety profile to bisphosphonates and is well tolerated after long-term use. At the same time, some studies have shown that its efficacy is stable in patients with mild and moderate renal insufficiency, and the risk of adverse events related to blood calcium and blood creatinine is low.
Amgen was founded in 1980 by a group of scientists and venture capitalists. Amgen is mainly engaged in the exploration, research and development, production and sales of innovative drugs for human use. It is committed to exploring the potential of biotechnology for the treatment of patients with serious diseases. Its research and development and production have been further promoted and applied.
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