Pulmozyme有哪些不良反应？

The most common adverse reactions observed in clinical trials in patients with cystic fibrosis (CF) (occurring in ≥3% of patients who received PULMOZYME instead of placebo) included: voice changes, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC ≥10%, pyrexia, and dyspnea.

About Pulmozyme

Pulmozyme (Dornase alfa) is a recombinant human DNaseI preparation currently used for clinical treatment of cystic fibrosis. It targets the dissolution of DNA components in alveolar fluid through inhalation. It has shown good efficacy in the treatment of COVID-19 in recent years. The DNA-MPO complex in the alveolar lavage fluid of patients who inhaled Dornase alfa was significantly reduced, and the oxygenation index was also improved.

Pulmozyme is mainly reflected in the following studies:

placebo controlled trial

1. Test 1

Trial 1 was a randomized, placebo-controlled clinical trial in patients with predicted FVC ≥40%. In this trial, more than 600 patients received PULMOZYME once or twice daily for six months. The most common adverse reaction (risk difference ≥5%) was voice changes.

The proportions of most adverse events were similar in the PULMOZYME and placebo groups, which may reflect sequelae of the underlying lung disease. In most cases, the increased effects are mild, transient in nature, and do not require a dose change. Few patients experienced adverse reactions leading to permanent discontinuation of PULMOZYME, and discontinuation rates were similar for placebo (2%) and PULMOZYME (3%). Compared with the placebo treatment group, patients in the Pulmozyme treatment group had a higher proportion of adverse reactions (greater than 3%), see Table 1.

2. Test 2

Trial 2 was a randomized, placebo-controlled trial in patients with advanced lung disease (FVC <40% predicted) who received 12 weeks of treatment. In this trial, the safety profile of PULMOZYME was similar to that reported in patients with less severe lung disease (FVC ≥40% of predicted). Adverse reactions reported in this trial occurred in a high proportion (greater than 3%) of patients treated with Pulmozyme and are listed in Table 1.

Table 1: Adverse reactions increased by 3% or more in patients treated with Pulmozyme compared with placebo in CF clinical trials

Mortality rates were similar in placebo- and PULMOZYME-treated patients observed in controlled trials. Causes of death were consistent with progression of cystic fibrosis and included apnea, cardiac arrest, cardiopulmonary arrest, cor pulmonale, heart failure, massive hemoptysis, pneumonia, pneumothorax, and respiratory failure.

Other experiments

The safety of inhaled Pulmozyme 2.5 mg taken daily for 2 weeks was studied in 98 pediatric patients with cystic fibrosis (65 3 months to < 5 years and 33 5 years to ≤ 10 years). The PARI baby reusable nebulizer (using a mask rather than a mouthpiece) was used in patients who were unable to demonstrate the ability to inhale or exhale through the mouth throughout the treatment period (54/65, 83% of younger patients and 2/33, 6% of older patients).

Overall, the nature of adverse effects was similar to that seen in placebo-controlled trials. Compared with older age groups, more patients in the younger age group reported cough (29/65, 45% vs. 10/33, 30%), and more patients reported moderate to severe cough (24/65, 37% vs. 6/33, 18%). Compared with older age groups, a higher number of patients reported rhinitis in the younger age group (23/65, 35% vs. 9/33, 27%), and a higher number reported rash (4/65, 6% vs. 0/33).

allergic reaction

There have been no reports of allergic reactions due to the use of Pulmozyme. Mild to moderate urticaria and mild rash have been observed and are transient. Across all studies, a small proportion (average 2-4%) of patients treated with PULMOZYME developed serum antibodies to PULMOZYME. None of these patients experienced allergic reactions, and the clinical significance of serum anti-lysozyme antibodies is unknown.

Recommended hot articles: