罗氟司特副作用

Roflumilast is a selective phosphodiesterase 4 (PDE4) inhibitor. Roflumilast is the first new class of chronic obstructive pulmonary disease (COPD) treatment drug approved by the EU in more than a decade. Four phase III clinical studies laid the foundation for the approval of this product. More than 3,000 patients with chronic obstructive pulmonary disease (COPD) were included in two pivotal placebo-controlled clinical studies. Studies have shown that roflumilast can significantly improve patients with moderate to severe exacerbations and prediastolic FEV1, regardless of whether it is combined with a long-acting beta2 agonist. The study also demonstrated that roflumilast film tablets significantly improved patients' lung function compared with placebo.

In one study, patients were randomized to receive either roflumilast or placebo, along with a fixed inhaled corticosteroid and a long-acting beta2-agonist. Tiotropium bromide is allowed. After a 1-year study, Poisson regression analysis showed that compared with placebo, the proportion of moderate to severe COPD exacerbations decreased by 13.2% in the roflumilast group, but there was no significant difference between the two groups.

However, a predefined sensitivity analysis using negative binomial regression showed that the difference was significant. Additionally, roflumilast consistently improved post-bronchodilator lung function (56 mL) compared with placebo.

Roflumilast side effects: diarrhea/weight loss/nausea/headache/back pain/flu/insomnia/dizziness/loss of appetite, etc.

Treatment with roflumilast film tablets may result in psychiatric events including suicidal behavior: Advise patients, their caregivers, and families to be alert to the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and to contact their healthcare provider if such changes occur. Carefully weigh the risks and benefits of treatment with roflumilast film tablets in patients with a history of depression and/or suicidal thoughts or behaviors.

Treatment with roflumilast film tablets may result in weight loss: monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuing roflumilast.

Pay attention to drug interactions when receiving roflumilast: it is not recommended to use it with strong cytochrome P450 enzyme inducers (such as rifampicin/phenobarbital/carbamazepine/phenytoin).

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.