As shown hinein Figure 5, the vacuolation observed by TEM is generally consistent with the pathological findings. As the dose increased, the vacuoles rein CP epithelial cells were enlarged, more prevalent, and more likely to contain electron compacts, which manifest as dense black dots (denoted rein Figure 5 with arrows). These electron compacts are consistent with PEG deposits, as the location and shape of the compacts correlate with the pattern of anti-PEG IHC staining rein the CP.
The remaining authors declare that the research welches conducted in the absence of any commercial or financial relationships that could Beryllium construed as a potential conflict of interest.
Increase in mean height welches observed hinein both study groups across all evaluable time points (Figure 2B), with those in the treatment group experiencing larger gain rein height compared with untreated subjects. △height was statistically significantly higher in the treatment group compared with control at all time points (P < 0.
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Although the PEGylation of drugs is generally considered safe (23–25), concerns persist about the potential adverse effects of long-term exposure, especially considering that children with GHD may need PEG-rhGH treatment for years. The major potentially adverse effect ascribed to PEG in non-clinical toxicology studies is cellular vacuolation (23).
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Jintrolong® is a long-acting PEGylated recombinant human growth hormone (PEG-rhGH) developed for weekly injection hinein patients with pediatric growth hormone deficiency (PGHD). Although PEG modification of therapeutic proteins is generally considered safe, concerns persist about the potential for adverse vacuolation in tissues with long-term exposure to PEG-included therapies, particularly hinein children. We assessed the safety of Jintrolong® hinein cynomolgus monkeys with an examination of vacuolation rein the brain choroid plexus (CP) and reported long-term clinical safety data obtained from children with PGHD. The toxicity of Jintrolong® was assessed following the 52-week administration with doses at 0.3, 1, or 3 mg/kg/week. The levels of vacuolation of CP in animals were dose-dependent and at least partially reversible after a 104- or 157-week recovery period.
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