Comparison of the Effectiveness and Safety of Intensified Dose and Standard Dose of Mycophenolic Acids for Adult Renal Transplant Recipients ：A Meta-analysis / 中国药房

ABSTRACT

OBJECTIVE：To compare the effectiveness and safety of int ensified dose and standard dose of mycophenolic acids （MPA）for kidney transplant recipients ，and to provide evidence-based reference for clinical use of drugs. METHODS ：Retrieved from Embase ，PubMed，Cochrane library ，Clinical trials ，CNKI，Wanfang database and CBM ，randomized controlled trial （RCT） and cohort study about intensified dose and standard dose of clinical commonly used Mycophenotate mofetil （MMF） and Mycophenolate sodium enteric-coated tablet （EC-MPS）for adult kidney transplant recipients were collected during the inception to Mar. 2020. After literature screening and data extraction ，the quality of RCTs were evaluated with bias risk evaluation tool recommended by Cochrane system evaluator manual 5.0. The quality of cohort study was evaluated by NOS scale. Meta-analysis was performed by using Rev Man 5.3 software，and sensitivity analysis was conducted. RESULTS ：A total of 8 studies were included，involving 6 RCTs，2 cohort studies ，with 1 637 patients involved. Meta-analysis results showed that ，the incidence of biopsy-proven acute rejection （BPAR）[RR＝0.65，95％CI（0.48，0.89），P＝0.007] and cytomegalovirus （CMV）infection [RR ＝ 0.39，95％CI（0.17，0.91），P＝0.03] in intensified dose groupwere significantly lower than control group. Subgroup analysis by drug showed that the incidence of BPAR in MMF intensive dose group [RR ＝0.72，95％CI（0.53，0.99），P＝0.04] and EC-MPS intensive dose group [RR ＝0.19，95％ CI （0.04， 0.81），P＝0.03] was significantly lower than that in standard zhaorongsheng@bjmu.edu.cn dose group ； there was n o statistical significance in the incidence of CMV infection in MMF intensive dose group [RR ＝0.16，95％CI（0.02，1.33），P＝0.09] and EC-MPS intensive dose group [RR ＝0.51，95％CI（0.20，1.30），P＝0.16]，compared with standard dose group （P＞0.05）. There was no significant difference in the incidence of rejection，treatment failure ，graft loss ，termination of treatment ，death，overall adverse events ， infection（overall），BK virus infection ，urinary tract infection ，hematological adverse events （overall），leucopenia，anemia， thrombocytopenia，gastrointestinal adverse events （overall），nausea，vomiting or diarrhea between 2 groups（P＞0.05）. Sensitivity analysis showed that the incidence of rejection ，CMV infection and leukopenia were generally stable. CONCLUSIONS ：The efficacy and safety of early intensive dose of MPA in adult renal transplant recipients were similar to those of standard dose ，but the incidence of rejection ，CMV infection and leucopenia should be carefully interpreted.