What is the efficacy of tobramycin inhalation solution in treating Pseudomonas aeruginosa infection?

It has relatively good efficacy in treating Pseudomonas aeruginosa infection, can effectively reduce the density of Pseudomonas aeruginosa in sputum, and is suitable for treating patients with cystic fibrosis caused by Pseudomonas aeruginosa.

Additionally, tobramycin inhalation solution is an effective treatment option with an acceptable safety profile for patients with bronchiectasis and Pseudomonas aeruginosa infection.

What is cystic fibrosis

Cystic fibrosis is an autosomal recessive congenital exocrine gland disease caused by genetic mutations in the cystic fibrosis transmembrane transcription regulator (CFTR) protein. This mutation leads to functional impairment of CFTR, which leads to mucus gland obstruction, causing cystic pulmonary fibrosis (CPF), intestinal obstruction, liver cirrhosis, pancreatic fibrosis, etc.

When the bronchus is involved, the airway mucus increases and becomes more viscous, making the phlegm thicker and difficult to cough up. Bacteria colonize and multiply, causing repeated infections of the bronchus and lungs, followed by CPF and pulmonary insufficiency.

tobramycin inhalation solution

Studies have shown that the occurrence of cystic pulmonary fibrosis is related to CFTR mutations, which directly lead to recurrent infections with Pseudomonas aeruginosa. Tobramycin inhalation solution has been proven to effectively reduce the density of sputum Pseudomonas aeruginosa and improve the symptoms of respiratory tract infection, cough, sputum production and dyspnea in patients with cystic pulmonary fibrosis, and has an acceptable safety profile.

Eligible patients with Pseudomonas aeruginosa cystic fibrosis were treated with tobramycin inhalation solution in a Phase 3, 16-week, multicenter, randomized, double-blind, placebo-controlled trial.

Compared with placebo, patients using tobramycin inhalation solution experienced significant improvements in scores for quality of life, respiratory symptoms of bronchiectasis, and sputum volume and sputum-pus. On Day 29, a higher proportion of patients using tobramycin inhalation solution had a negative culture for Pseudomonas aeruginosa than those in the placebo group.

In a randomized, double-blind, 3-cycle, placebo-controlled trial, a total of 247 eligible patients were randomized in a 2:1 ratio to receive 3 cycles of tobramycin inhalation solution (n=161) or placebo (n=86). As in Study 1, each cycle consisted of 28 days on treatment followed by 28 days off treatment.

Tobramycin inhalation solution significantly improved patients' lung function compared with placebo, based on the absolute change in FEV 1% predicted from baseline to the end of the "on" period of Cycle 3. Treatment with tobramycin inhalation solution and placebo resulted in an absolute increase in FEV of 1% predicted of 7% and 1%, respectively. The analysis was adjusted for covariates based on baseline FEV 1% predicted value, with multiple imputation of missing data.

tobramycin inhalation solution

Tobramycin inhalation solution is only for oral inhalation. The recommended dose for patients 6 years old and above is 1 disposable ampoule ((300mg/4 mL)), administered by oral inhalation, twice a day, with a repeat cycle of 28 days of administration, followed by 28 days of discontinuation. The administration time should be separated by 12 hours as much as possible, and the interval should not be less than 6 hours.

In general, tobramycin inhalation solution shows good efficacy and safety in treating cystic fibrosis patients with Pseudomonas aeruginosa infection, and is worthy of promotion in clinical use.

References:

Xiao Guirong, Xu Jue, Jiang Xuehua. Case analysis of antimicrobial treatment of cystic pulmonary fibrosis with Pseudomonas aeruginosa infection[C]//Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association. Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, 2014.

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