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Health Yuan Tobramycin Inhalation Solution Approved for Marketing, Treating Bronchiectasis
Published Time：
2022-10-14
Bronchiectasis is a chronic respiratory disease characterized by permanent dilation of the bronchi, and airway remodeling lesions are difficult to reverse significantly. The incidence and prevalence of bronchiectasis are increasing globally, especially in China.
Tobramycin is an aminoglycoside antibiotic with a concentration-dependent bactericidal mechanism. Traditional systemic administration has poor lung tissue penetration, low local drug concentration in the lungs, and a high risk of bacterial resistance. High systemic drug exposure also leads to ototoxicity and nephrotoxicity, limiting its long-term use in patients with stable bronchiectasis.
Tobramycin inhalation solution changes the route of administration from intravenous injection to local inhalation, increasing the effective drug concentration in the lungs while avoiding systemic toxicity and significantly reducing the risk of drug resistance. It is suitable for long-term maintenance therapy.
This clinical trial, presided over by Academician Zhong Nanshan of the Guangzhou Institutes of Respiratory Health, globally pioneered two clinical efficacy endpoints: changes in bacterial load and quality of life scores for bronchiectasis patients. It achieved the world's first dual-positive significant efficacy conclusion with good safety.
Source: Pharmaceutical Cube
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