狄诺塞麦是什么药？

Global clinical data, clinical results show that compared with zoledronic acid, denosumab effectively delays the incidence of first bone metastasis: lung cancer and other solid tumors - denosumab vs. zoledronic acid 20.5 months vs. 16.3 months; prostate cancer - denosumab vs. zoledronic acid 20.7 months vs. 17.1 months. Today let’s take a closer look at what kind of medicine denosumab is?

Denosumab indications: (1) Bone metastasis from solid tumors: It is suitable for preventing bone-related events in patients with bone metastases from solid tumors. (2) Important limitations of use: Not suitable for prevention of bone-related events in patients with multiple myeloma. Denosumab has a high affinity with RANKL, preventing RANK ligands from activating RANK on the surface of osteoclasts, inhibiting osteoclast activation and development, reducing bone resorption, increasing bone density and bone strength of both cortical bone and trabecular bone, promoting bone reconstruction, and reducing the incidence of vertebral, non-vertebral and hip fractures in postmenopausal osteoporotic women.

The effect of denosumab on bone reconstruction can be evaluated by measuring some bone renewal markers, such as the bone resorption marker N-telopeptide, the bone formation marker bone-specific alkaline phosphatase, etc.

A phase I clinical study conducted in healthy postmenopausal women showed that a dose-dependent decrease in morning urine NTX levels was observed on day 2 after administration. This decrease lasted for 6 months, with the maximum decrease reaching 84% compared with baseline. This effect is reversible. When serum denosumab levels disappear, NTX levels can be seen to rise again, which reflects the reversibility of its effect on bone reconstruction. As treatment continues, these effects will persist for a new cycle.

In 2013, the U.S. FDA approved denosumab produced by Amgen for the treatment of relapsed and refractory giant cell tumor of bone in adults and certain adolescents. Denosumab was first approved in the United States in 2010 for use in patients with solid tumor bone metastases to prevent bone-related events. In 2011, it was also approved in Europe for the same indication.

A phase II clinical trial showed that an average of 10 months of follow-up of 169 patients showed that 163 patients had no significant disease progression. Another phase II clinical trial showed that among 100 patients who were likely to suffer severe disability if treated with surgery, 74% avoided surgery. Among 26 patients who underwent surgery, 16 had significantly less disability after surgery than expected before surgery.

The above is the content of the drug introduction, I hope it can help you!