1.Liver function changes in rheumatoid arthritis patients treated with tofacitinib: systematic review
Jiaqi LI ; Weihong GE ; Huaijun ZHU ; Zena CHANG ; Zhou HAN
Chinese Journal of Rheumatology 2017;21(6):392-397,后插2
Objective To evaluate the effects of tofacitinib on liver function in rheumatoid arthritis (RA) patients.Methods Literature search was performed in databases including PubMed,Cochrane Library,China National Knowledge Infrastructure and Wanfang to identify randomized controlled trials about RA treated with tofacitinib.The retrieval time was up to August 2016.Meta-analysis was conducted by Revman 5.5 software.Results A total of 7 studies were included,involving 2 965 patients.The results of Meta-analysis revealed that the incidence of alanine transaminase (ALT)>1 upper limit of normal (ULN) in patients receiving both 5 mg and 10 mg bid tofacitinib was significantly higher than placebo [5 mg bid tofacitinib:RR=1.48,95%CI (1.20,1.82),P=0.000 2;10 mg bid tofacitinib:RR=1.67,95%CI (1.37,2.05),P<0.01];there was no significant difference in the incidence of ALT>3 ULN [5 mg bid tofacitinib:RR=1.81,95%CI (0.57,5.79),P=0.32;10 mg bid tofacitinib:RR=1.36,95%CI (0.57,5.25),P=0.49];the incidence of aspartate transaminase (AST)>1 ULN was significantly higher than placebo [5 mg bid tofacitinib:RR=1.59,95%CI (1.25,2.03),P=0.000 2;10 mg bid tofacitinib:RR=1.90,95%CI(1.50,2.40),P<0.01],there was no significant difference in the incidence of AST>3 ULN [5 mg bid tofacitinib:RR=1.17,95%CI (0.27,5.17),P=0.83;10 mg bid tofacitinib:RR=0.95,95%CI (0.26,3.44),P=0.94].Conclusion Tofacitinib slightly increases ALT and AST in patient with RA.Due to the limited sources and lack of domestic studies,more randomized controlled trials are still needed to verify the above conclusion.
2.Effect of Shenkang Injection on the Irbesartan Pharmacokinetics in Rats in vivo
Zhenji JIN ; Zena CHANG ; Zhenhan ZHU ; Changqing YANG
China Pharmacy 2017;28(34):4815-4817
OBJECTIVE:To study the effect of Shenkang injection on the irbesartan pharmacokinetics in rats in vivo. METH-ODS:18 SD rats were randomly divided into control group(normal saline)and Shenkang injection(calculated by crude drug as 4 g/kg),9 in each group,which were intraperitoneally injected twice a day,for 7 d. After 1 h of last administration,25 mg/kg irbe-sartan was intragastrically administrated. 0.3 mL sample blood was taken in fundus venous plexus before administration of irbesartan and after 0.25,0.5,1,2,4,8,12,24,32,48,56,72,96 h of administration. Using biphenyl diester as inner standard,HPLC was adopted to determine the plasma concentration of irbesartan in plasma of rats,and pharmacokinetic parameters were calculated by using non-compartmental model in Phoenix WinNolin? 6.1 pharmacokinetic software. RESULTS:After intragastrically adminis-trated irbesartan in rats in control group and Shenkang injection group,AUC0-96 h were (28.82 ± 10.49),(35.64 ± 9.99) mg·h/L;cmax were(0.64±0.15),(0.76±0.33)mg/L;tmax were(13.07±16.70),(10.23±3.97)h;CLZ/F were(0.85±0.35),(0.63±0.21) L/(h·kg);VZ/F were (38.24 ± 24.87),(30.99 ± 9.75) mL/kg respectively,with no statistical significances (P>0.05). CONCLU-SIONS:Shenkang injection will not affect the in vivo pharmacokinetics process of irbesartan in normal dose on rats.