1.To screen and evaluate the efficacy of antiviral drugs in duck animal model
Yi TAN ; Shimin GU ; Longting FU ; Rende SONG ; Haitao TONG ; Weimin XU ; Shanming WU
Chinese Journal of Infectious Diseases 2008;26(6):329-335
0bjective To study the potency of Entecavir Maleate(ETVM),Entecavir(ETV) and Adefovir(ADV) on suppressing duck hepatitis B virus (DHBV) replication.Methods DHBV DNA positive ducks were used as experimental animal model.Ail these ducks were randomized to different arms and respectively given high,medium and low dosage of ETVM,ETV and ADV.ETVM and ETV were given orally daily respectively for six weeks and ADV orally 3 times every week for six weeks.The serum DHBV DNA levels were tested every 2 weeks at day 0 and,after that,at week 2,4.6 and 8 respectively by real-time fluorescent quantitative polymerase chain reaction(PCR).The results were analyzed by paired-samples t test.Results The treatment resulted in the reduction of viral load among all ETVM.ETV or ADV treated groups.The viral load of DHBV DNA at pretreatment and week 6 in the ETVM high dosage group were(7.34±1.33)and(2.12±2.50)lg copy/mL,respectively(P
2.Retrospective multicenter nested case-control safety study of Ilaprazole sodium for injection
Jin LI ; Rende FANG ; Juan SONG ; Yongzhou ZHANG ; Fan ZHANG ; Qun ZHAO ; Suhua CAI ; Yi ZHANG ; Haitang HU ; Jianxiong DENG
China Pharmacy 2023;34(11):1379-1383
OBJECTIVE To understand the safety of Ilaprazole sodium for injection in clinical practice. METHODS From Jan. 1st 2019 to Feb. 29th 2020, the data of 3 926 valid hospitalized patients receiving Ilaprazole sodium for injection were collected prospectively from 5 third-level hospitals through CHPS, and the post-marketing safety analysis was performed by using retrospective multicenter single cohort study. At the same time, a nested case-control study (the ratio of trial group and control group was 1∶4) was used to confirm the baseline stability of this study cohort and the correlation between adverse reactions and Ilaprazole sodium for injection. RESULTS Among 3 926 patients, 3 patients experienced 5 adverse drug events after using Ilaprazole sodium for injection, with the incidence of 0.076%. There was no serious adverse event, and the occurrence time was 2 days after medication; adverse drug events mainly include elevated liver function indicators (alanine transaminase, aspartate transaminase, total bilirubin), which were mild and untreated, and all adverse drug events were improved. The results of the nested case-control study showed that the trial group and the control group belonged to the same background baseline, and the occurrence of adverse drug events was more closely related to Ilaprazole sodium for injection. CONCLUSIONS The overall safety of Ilaprazole sodium for injection is relatively high, and the occurrence of adverse events is more related to it.