伊曲莫德的副作用与注意事项
Itramod is a novel selective sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. The drug exerts an immunomodulatory effect by regulating lymphocyte migration, but it may also cause various adverse reactions such as increased risk of infection, bradycardia, and liver damage. This article will systematically introduce the common side effects, clinical use precautions and efficacy of itrimod in the treatment of UC.
Side Effects of Itrimod
Adverse reactions involve multiple systems, and their incidence and severity are closely related to the immunomodulatory properties of the drug.
Common adverse reactions
Headache (the highest incidence), elevated liver enzymes and dizziness are common common reactions. Infections include urinary tract infection and herpes virus infection. These reactions are mostly mild to moderate and usually appear in the early stages of treatment.
Effects on cardiovascular system
Asymptomatic bradycardia may occur after the first dose, and systolic and diastolic blood pressure may increase. Blood pressure changes need to be monitored.
Special organ toxicity
Liver damage manifests as ALT>3 times the upper limit of normal, and macular edema may affect vision. The risk of skin malignancies (basal cell carcinoma, squamous cell carcinoma, etc.) is increased and regular skin examinations are required. A decrease in FEV₁ may occur in the respiratory system (mean 79mL).
Itramod has a wide spectrum of side effects, and timely identification will help to take targeted intervention measures.
Precautions for Itrimod
Safe use of Itrimod requires strict monitoring and management practices to minimize treatment risks.
Pre-medication assessment
Complete blood count, electrocardiogram, liver function and fundus examination before treatment. People with no history of chickenpox infection should be tested for VZV antibodies. Those who are negative need to complete vaccination and postpone treatment for 4 weeks. When using live attenuated vaccines, vaccination should be completed at least 4 weeks before treatment.
Monitoring during treatment
Heart rate changes need to be monitored after the first dose. Patients with prolonged QT interval or use of antiarrhythmic drugs require cardiology consultation. Regularly review liver function and fundus, and evaluate immediately if there are changes in vision or symptoms of liver injury. Avoid the use of live attenuated vaccines during treatment and within 5 weeks after stopping treatment.
Management of high-risk groups
Use with caution in those with uncontrolled cardiovascular disease and resting heart rate <50bpm. Contraindicated in patients with Child-Pugh Class C hepatic impairment. It is contraindicated during pregnancy, and women of childbearing age need effective contraception until 1 week after stopping the drug. Although the elderly do not need to adjust the dose, they need to strengthen monitoring due to more comorbidities.
Standardized pre-medication assessment and continuous monitoring are the keys to safe use of itrimod.
Efficacy of Itrimod
Itrimod has shown significant clinical benefits in the treatment of moderately to severely active UC, and its efficacy has been verified by multiple studies.
Clinical remission rate
Itrimod 2 mg once daily can significantly improve the clinical remission rate of patients, and the efficacy lasts until 52 weeks. Patients who have failed previous treatments with biological agents or JAK inhibitors can still achieve clinical responses, providing a new treatment option for refractory UC.
Endoscopic improvement
The endoscopic response rate and tissue-endoscopic mucosal healing rate of patients in the treatment group were significantly better than those on placebo. Endoscopic improvement usually occurs after 12 weeks of treatment and continues to improve over time.
Advantages of mechanism of action
As an S1P receptor modulator, itrimod selectively acts on S1P1/4/5 receptors, reducing the migration of lymphocytes to inflammatory sites while avoiding the impact on S1P3 receptors and reducing the risk of cardiovascular adverse reactions. Its 30-hour half-life supports once-daily dosing, improving patient compliance.
Itrimod provides an oral treatment option with both efficacy and safety for patients with moderate to severe active UC, and is especially suitable for those who have failed biologic treatment.
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