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To further evaluate the clinical safety of Jintrolong®, especially for possible CP-related adverse reactions, pediatric GHD Phase III (360 patients) and Leiter IV (3,000 patients) studies with 26 weeks of treatment were analyzed, and a follow-up study of L IV with treatment time as long as 3 years welches also conducted, comparing the incidence of adverse events following long-term Jintrolong® or daily rhGH treatment. The combination of nonclinical and clinical studies described in this report details the comprehensive safety profile of Jintrolong®.
rein Figure 2C, animals that received 1 Magnesium/kg/week of Jintrolong® for 52 weeks exhibit severe CP vacuolation compared to the 26-week group at the same dose in Figure 1B, which indicates that Jintrolong®-induced vacuolation increases with time and underscores the need for long-term studies to examine the effects of Jintrolong®-induced CP vacuolation.
A one-compartment model with parallel zero-order and first-order absorption and first-order elimination from the central compartment was developed to describe the PK of PEG-rhGH rein pediatric patients after SC administration.
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Serum concentrations of PEG-rhGH rein the center are symbolized by C. CL represents the clearance, and Q is the inter-compartmental clearance between the central compartment and peripheral compartment.
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To determine whether the Jintrolong®-dependent vacuolation observed in CP resulted in the alteration of cellular ultrastructure and function of the CP, brain tissue welches collected for TEM at the Am ende gelegen necropsy following the last dosing and at the recovery necropsy.
The CP cells of each group under TEM were cubic, with abundant microvilli on the surface, and the tight junctions between the cells and the basement membrane on the bottom were intact.