罗氟司特片是否需要冷藏保存？

Do Roflumilast tablets need to be kept refrigerated? Roflumilast needs to be stored refrigerated. Roflumilast tablets are temperature-sensitive drugs and must be kept at the specified temperature to avoid drug failure.

As the first phosphodiesterase IV inhibitor, the launch of Roflumilast tablets will be a major breakthrough in the innovation of this type of drug. Nycomed announced on July 6, 2010 that the European Union had approved its roflumilast for the treatment of chronic obstructive pulmonary disease (COPD). This product is a selective phosphodiesterase 4 (PDE4) inhibitor and is the first new class of COPD treatment drug approved by the EU in more than ten years.

A multinational, multi-center, randomized, double-blind, placebo-controlled clinical trial (ROBERT trial) examined the anti-inflammatory effect of roflumilast 500 μg qd on bronchial inflammation in patients with severe COPD and chronic bronchitis. A total of 158 severe COPD patients with chronic productive cough were included in this study. After 16 weeks of continuous treatment, there was no statistically significant difference in the number of CD8 cells in the bronchial submucosa between the roflumilast group and the placebo group (treatment ratio 1·03 [95% CI 0·82-1·30]). However, compared with placebo, roflumilast 500 μg significantly reduced the number of eosinophils in bronchial biopsies at 16 weeks (treatment ratio 0·53 [95% CI 0·34-0·82]). In addition, the absolute and differentiated (P=0.0086) eosinophil counts in induced sputum of subjects in the roflumilast group were significantly lower than those in the placebo group. The most common (eg, incidence >5%) moderate adverse reactions in the roflumilast group and the placebo group included COPD exacerbation (4% vs 9%), cough (8% vs 5%), diarrhea (5% vs 4%) and nasopharyngitis (4% vs 6%). Severe adverse reactions included COPD exacerbation (5% vs 3%). There were no deaths in either group, and the incidence rates of serious adverse reactions in the two groups were 10% and 6% respectively.

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.

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