Efficacy and side effects of budesonide sustained-release capsules

IgA nephropathy (IgAN) is a common primary glomerulonephritis worldwide, accounting for 52.66% of primary glomerulonephritis in my country. 25% to 30% of IgAN patients will progress to end-stage renal disease within 20 years after diagnosis, becoming a heavy burden on families and the national economy. There is currently no effective and safe treatment option for IgAN. In recent years, research on new drugs for the treatment of IgAN has been progressing rapidly, among which Shishi is the world's first drug for the treatment of IgAN. So, what are the effects and side effects of budesonide sustained-release capsules?

What are the benefits of budesonide sustained-release capsules?

Budesonide enteric-coated capsules, as a glucocorticoid targeted to the intestinal tract, show unique advantages in the treatment of IgAN. It targets the mucosal B cells released in the terminal ileum and achieves the effect of reducing the production of Gd-IgA1 that induces IgAN from upstream, thereby treating IgAN.

Professor Bengt C Fellström from Uppsala University in Sweden conducted a study on targeted therapy for IgAN. The results of the study have been published in The Lancet. This is a randomized, double-blind controlled trial, currently in phase 2b. Its purpose is to evaluate the efficacy and safety of the new TRF-budesonide in the treatment of IgAN. This drug can be targeted for release in the terminal ileum and is highly aggregated, preventing the activation of B lymphocytes to produce IgA. Only 10% of the budesonide of this drug enters the systemic circulation.

In the trial, 150 patients with primary IgAN were randomly divided into 3 groups, who were given budesonide 8 mg/d, 16 mg/d, and placebo respectively, with basic RAS blocking therapy. After 9 months of treatment, the urinary protein creatinine of patients in the TRF-budesonide group (16 mgld, 8 mg/d) decreased by 24.4% (27.3%, 21.5%) compared with the baseline. , while the urinary protein and creatinine in the placebo group only decreased by 0.74% compared with the baseline, and there was no significant difference in the incidence of adverse events among the three groups.

Budesonide extended-release capsules side effects

The main ones observed in the experiment were dyspnea, muscle spasm, facial edema, peripheral edema, hypertension, acne, dermatitis, weight gain, hirsutism, indigestion, fatigue, etc.

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