地舒单抗(Denosumab)的功效作用及副作用与注意事项？

Denosumab is a RANKL inhibitor that can bind to RANKL. The approved indications for this drug are bone-related events in patients with bone metastatic solid tumors and osteoporosis with a high risk of fracture. Common side effects include back pain, limb pain, myalgia, cystitis, etc.

Indications for Denosumab

1. Treatment of postmenopausal osteoporotic women with high risk of fracture:

Denosumab is indicated for the treatment of postmenopausal osteoporotic women with high risk of fracture (defined as a history of osteoporotic fracture or multiple fracture risk factors), or patients who have failed or are intolerant to other available osteoporosis therapies.

Reduced incidence of vertebral, nonvertebral, and vertebral fractures in postmenopausal women with osteoporosis.

2. Treatment to increase bone mass in men with osteoporosis:

Denosumab is indicated for the treatment of osteoporotic men with a high risk of fracture (defined as a history of osteoporotic fracture or multiple fracture risk factors) to increase their bone mass, or for patients who have failed or are intolerant to other available osteoporosis treatments.

3. Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer:

Denosumab is a treatment used to increase bone mass in men with non-metastatic prostate cancer who are at high risk of fracture and receiving androgen deprivation therapy. Denosumab also reduced the incidence of vertebral fractures in these patients.

4. Treatment of bone loss in breast cancer patients after receiving adjuvant aromatase inhibitor therapy:

Denosumab can be used to increase bone mass in women with a high risk of fracture who receive adjuvant aromatase inhibitor therapy for breast cancer.

Denosumab Efficacy

Osteoporotic fractures carry a significant burden of morbidity and mortality, but pharmacological treatment can prevent such fractures in high-risk individuals. Antiresorptive drugs (eg, bisphosphonates, estrogens, denosumab) reduce bone turnover through different mechanisms.

Denosumab is a human monoclonal antibody used as an anti-resorptive drug to treat osteoporosis. Denosumab binds to the cytokine RANKL (receptor activator of nfκB ligand), a factor necessary to initiate bone renewal.

RANKL inhibition blocks the maturation, function and survival of osteoclasts, thereby reducing bone resorption. In contrast, bisphosphonates bind bone minerals where they are taken up by mature osteoclasts, inducing osteoclast apoptosis and inhibiting resorption. These mechanistic differences influence the initiation and reversibility of treatment.

Effective drug therapy is necessary for patients at high risk of fracture. There are significant differences in mechanism and dosage among treatment options for postmenopausal osteoporosis. Denosumab works through a novel mechanism and is given by subcutaneous injection twice a year.

Denosumab is identified as a first-line drug for the treatment of postmenopausal osteoporosis by the Osteoporosis Canadian Clinical Practice Guidelines and is an important addition to treatment options.

Side effects

Denosumab treats different diseases differently:

1. Postmenopausal osteoporosis:

The most common adverse reactions are back pain, musculoskeletal pain and cystitis, limb pain, and hypercholesterolemia. Pancreatitis has been reported in clinical trials.

2. Male osteoporosis:

The most common adverse reactions are back pain, joint pain and nasopharyngitis.

3. Bone loss caused by cancer hormone ablation:

The most common adverse reactions are joint pain and back pain. Extremity pain and musculoskeletal pain have also been reported in clinical trials.

How to deal with side effects

1. Nasopharyngitis: In terms of diet, patients can consume foods rich in high-quality protein, such as milk, fish, eggs, beef, etc. At the same time, they should avoid bad habits such as nose picking, nose hair pulling, and excessive nose blowing. If necessary, you can use antiviral drugs and antibacterial drugs as directed by your doctor.

2. Hypercholesterolemia: When patients have elevated cholesterol, they should pay attention to controlling their diet and eat less or no greasy, high-cholesterol foods, such as egg yolks, animal offal, fried foods, seafood, beef, pork, etc. Patients can eat more light foods, such as fresh fruits and vegetables, rice porridge, etc.

3. Joint pain: Patients can use hot towels, hot water bottles and other methods to apply heat to joints, which can improve local blood circulation and relieve pain. They can also use analgesic drugs as directed by the doctor.

4. Back pain: Symptoms can be relieved through local massage, but you should be careful to ask a professional doctor to perform the operation and do not choose to massage without authorization.

Effectiveness of Denosumab in the treatment of osteoporosis

A study observed the clinical efficacy of Denosumab in the treatment of postmenopausal osteoporosis.

Objective: To observe the clinical efficacy of Denosumab in the treatment of postmenopausal osteoporosis (PMO).

Methods: 100 PMO patients received denosumab 60 mg subcutaneously every 6 months. Bone metabolism indexes, hip and lumbar spine bone mineral density (BMD), and VAS pain scores were compared before treatment and at 6 and 12 months of treatment. Observe drug-related adverse reactions.

Results: Compared with before treatment, the bone metabolism index levels and VAS pain scores decreased at the 6th and 12th months of treatment, while the BMD of the hip and lumbar spine increased (P<0.05). Compared with the 6th month of treatment, the levels of bone-specific alkaline phosphatase, type I collagen N-terminal extended peptide and VAS pain scores were reduced at the 12th month of treatment, while the BMD of the hip and lumbar spine increased (P<0.05). The clinical total is 94%. No drug-related adverse reactions occurred.

Conclusion: Denosumab is safe and effective in the treatment of PMO. It can reduce patients' bone metabolism indicators, increase BMD, and relieve bone pain symptoms.

Notes

1. Hypocalcemia: must be corrected before starting. May worsen, especially in patients with impaired renal function. Provide patients with adequate calcium and vitamin D supplements.

2. Osteonecrosis of the jaw: It has been reported in the literature, and patients should pay attention to symptom monitoring during treatment.

3. Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out femoral fracture.

4. Serious infections may occur: including skin infections, including infections leading to hospitalization. Advise patients to seek immediate medical care if they develop signs or symptoms of infection, including cellulitis.

5. Skin reactions: Dermatitis, rash and eczema have been reported. If severe symptoms occur, consider stopping Denosumab.

6. Pain symptoms: Severe bone, joint, and muscle pain may occur. If severe symptoms occur, stop using Denosumab.

7. Inhibition of bone turnover: It has been proven to have a significant inhibitory effect and monitor the consequences of excessive bone compression.

8. The same active ingredient: Patients taking the same active ingredient as Denosumab should not take Denosumab to avoid adverse reactions caused by drug superposition.

9. Allergic reaction: Patients may have allergic reactions during treatment. If clinically significant reactions occur, use will be permanently discontinued.

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