Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Serum voriconazole trough concentrations |
If all patients were administrated by loading dose, voriconazole trough samples were taken immediately 30 minutes before voriconazole administration on the Third day. If all patients were not administrated by loading dose, voriconazole trough samples were taken immediately 30 minutes before voriconazole administration on the sixth day. Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min. Serum trough concentrations were determined by a high-performance liquid chromatography method as previously described. A initial steady-state trough concentration blood sample was obtained before dose adjustment for all patients. Each patient received at least one steady-state blood sample. The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University. |
0.5 hour before voriconazole administration on the Third or sixth day. |
|
| Primary |
CYP2C19 Genotyping |
CYP2C19 genotype was determined from peripheral blood, which was extracted and stored in an EDTA anticoagulant tube. Real-time fluorescence quantitative PCR (ThermoFisher Applied Biosystems 7500 fast PCR) was performed using a Human CYP2C19 gene detection kit (PCR-fluorescence probe method, Wuhan YZY Medical Science and Technology Co., Ltd, China) following the manufacturer's instructions. Genomic DNA was isolated from whole blood using QIAamp DNA blood kits (Qiagen, Hilden, Germany). According to nomenclature by the Clinical Pharmacogenetics Implementation Consortium (CPIC®), the CYP2C19 genotype was classified as ultrarapid metabolizer (*17/*17), rapid metabolizer (*1/*17), normal metabolizer (*1/*1), intermediate metabolizer (*1/*2, *1/*3, *2/*17, *3/*17), or poor metabolizer (*2/*2, *2/*3, *3/*3). |
Unlimited blood drawing time. |
|
| Primary |
The difference of average voriconazole serum trough concentration between group A and group B |
The differences were counted between group A and group B by measuring each patient's voriconazole serum trough concentration. |
From July 2018 to June 2023 |
|
| Primary |
Analysis of factors affecting voriconazole serum trough concentration |
A multiple linear stepwise regression analysis was performed by using voriconazole serum trough concentration (Y) as the dependent variable, and sex (x1), age (x2), body weight (x3), VCZ route of administration (x4), CYP2C19 phenotype (x5), the average daily dose (x6), PPIs (x7), methylprednisolone (x8), CRP (x9) , PCT (x10), IL-6 (x11), Albumin (x12), ALP (x13), and TBIL (x14) as independent variables. Linear regression analysis reveals the regression equation and independent risk factors affecting voriconazole serum trough concentration. |
From July 2018 to June 2023 |
|
| Secondary |
C-reaction protein (CRP) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
Alanine aminotransferase (ALT) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
Aspartatrtransaminase (AST) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
Gamma-glutamyl transferase(GGT) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
Alkaline phosphatase (ALP) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
Total bilirubin (TBIL) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
procalcitonin(PCT) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
| Secondary |
interleukin- 6(IL-6) |
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center. |
before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy |
|
