布地奈德上市没?
(Budesonide, Budenofalk) was first developed and marketed by AstraZeneca Pharmaceutical Company in 1981. It was approved for marketing by the US FDA in August 2000, and my country approved its import in November 2001.
Budesonide (Budenofalk) is a glucocorticoid with highly effective local anti-inflammatory effects. It can enhance the stability of endothelial cells, smooth muscle cells and lysosomal membranes, inhibit immune responses and reduce antibody synthesis, thereby reducing the release and activity of allergic active mediators such as histamine. It can also reduce the enzymatic process triggered when antigens and antibodies are combined, inhibit the synthesis and release of bronchoconstrictive substances and reduce the contractile response of smooth muscles. Acute, subacute and long-term toxicity studies have found that the systemic effects of budesonide, such as weight loss, lymphoid tissue and adrenal cortex atrophy, are weaker than or equivalent to other glucocorticoids. After systematic evaluation in six different experimental tests, budesonide has no mutagenic or carcinogenic effects.
Clinical trials in 946 children aged 12 months to 8 years showed that budesonide 0.25 mg once daily (1 trial), 0.25 mg twice daily, and 0.5 mg twice daily significantly reduced daytime and nighttime asthma symptom scores compared with placebo. At doses of 1 mg once daily and 0.5 mg once daily (1 trial), this product significantly reduced nighttime or daytime asthma symptom scores, but not both. Reduction of symptoms in response to treatment with inhaled budesonide occurs across gender and age. Budesonide significantly reduced the need for bronchodilators at all doses studied. Analysis of the subgroup of patients who were able to complete pulmonary function testing showed that improvements in lung function were associated with treatment with inhaled budesonide. Compared with the placebo treatment group, patients showed a significant improvement in FEV1.
From the above information, we can know that it was approved for import and listing as early as 2001.
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