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OBJECTIVE To establish a population pharmacokinetic (PK) model for rosuvastatin and investigate the effects of demographic data, clinical characteristics, and genetic polymorphisms (ABCG2, SLCO1B1, SLCO1B3, SLCO10A1, ABCB1, CYP2C9) on its PK parameters in Chinese population. METHODS A total of 944 steady-state concentration data were collected from 944 patients with hyperlipidemia. UPLC-MS/MS was used to determine the plasma concentration of rosuvastatin. DNA was extracted and measured for concentration, and the Sequenom MassArray technology platform was utilized for genetic typing. Eventually a population PK model was established with non-linear mixed-effects modeling software (NONMEM). RESULTS The population estimates for the apparent clearance, apparent volume of distribution and absorption rate constant were 253 L·h-1, 1 810 L and 0.318 h-1, respectively. The datasets were best described by a one-compartment model with first-order elimination. The steady-state concentration of rosuvastatin increased as estimated glomerular filtration rate(eGFR) decreased and the variant allele for rs2199936 increased, under the same dosage regimen. Carrying one or two variant alleles for the ABCG2 rs2199936 showed a decrease of 32.6% and 53.2% in apparent clearance relative to the value in individuals without the variant allele. CONCLUSION Both ABCG2 rs2199936 and the eGFR were found to be significant covariates for apparent clearance. The results suggest that Chinese individuals with renal impairment and one or two variant alleles for the rs21999336 polymorphism (ABCG2) who are undergoing coronary angiography (CAG) should avoid high doses of rosuvastatin.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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