Résumé
OBJECTIVE@#To investigate the impacts of two herbal preparations for human immunodeficiency virus/aquired immune deficiency syndrome (HIV/AIDS) patients, Shenling Fuzheng Capsule (, SLFZC) and Qingdu Capsule (, QDC), on the efficacy of highly active antiretroviral therapy (HAART).@*METHODS@#HIV/AIDS patients met the criteria were all enrolled in a 1-year cohort study, in which patients receiving HAART alone were designated as Group A, those receiving HAART in combination with SLFZC were designated as Group B, and those receiving HAART in combination with QDC were designated as Group C, 100 cases in each group. The dose of SLFZC was 1.48 g (4 capsules), 3 times daily, and QDC 1.56 g (4 capsules), 3 times daily. T cell subsets, HIV RNA and HIV-1 drug resistance were detected at enrollment and 1 year after treatment. Patients were followed up every 3 months, during which side-effects and other clinical data were recorded.@*RESULTS@#After 1-year treatment, the median increment in CD counts was 165.0, 178.0 and 145.0 cells/μL for Group A, B and C, respectively. HIV RNA was undetectable in 94% of patients in Group A, 96% in Group B and 92% in Group C. There were no differences regarding the increment in CD counts, HIV RNA and frequency of HIV-1 drug resistance mutations. Two of the 14 suspected side-effect symptoms, i.e. fatigue and dizziness, were lower in Groups B and C than in Group A (P<0.05, respectively) CONCLUSIONS: SLFZC and QDC do not have a negative impact on immunological and virological response to HAART; however, these preparations are not as potent in reducing HAART-associated side-effects as anticipated.
Résumé
OBJECTIVE: To assess the influence of Qingdu (QD) capsule on the pharmacokinetic of HAART. METHODS: The 36 SD rats were divided into 3 groups. Rats in Group HAART were given, using an intragastric gavage needle, highly active antiretroviral therapy (HAART) containing zidovudine (AZT), 2',3'-dideoxy-3'-thiacytidine (3TC) and efavirenz (EFV). Group HAART+QD were given HAART and QD capsule simultaneously. Group HAART+QD (2 h interval) were given HAART and then given QD capsule 2 h later. Blood samples were collected at 0, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 h. AZT, 3TC, and EFV concentrations were tested with high performapce liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Pharmacokinetic parameters were compared among different groups. RESULTS: The t1/2 of AZT were statistically different among the three groups (P<0.05), Group HAART+QD (2 h interval) had the lease t1/2 of AZT than the other two groups. There were no statistical differences among groups for the AUC0-12, tmax, ρmax and CL of AZT, and all five parameters of 3TC and EFV. CONCLUSION: QU doesn't show influence on pharmacokinetic parameters of AZT+3TC+EFV regimen, but intention should be paid to individual differences.