title: Efficacy and Safety of High-Dose Mizoribine Combined With Cyclosporine, Basiliximab, and Corticosteroids in Renal Transplantation: A Japanese Multicenter Study.
abstract: Mizoribine (MZR) is an immunosuppressive agent that exhibits a less potent immunosuppressive effect at doses up to 3 mg/kg/d. We investigated whether high-dose MZR is effective and safe for renal transplant patients in conjunction with cyclosporine (CsA), basiliximab, and corticosteroids. Ninety Japanese renal transplant patients were administered MZR (6 mg/kg/d), CsA (7 mg/kg/d), prednisolone (maintenance dose, 10 mg/d), and basiliximab (20 mg/body). They were compared with a control group of 81 renal transplant patients who received mycophenolate mofetil (MMF; 1500 mg/d), CsA, prednisolone, and basiliximab. The 2-year patient and graft survival rates were 98.9% and 97.8% in the MZR group and 98.8% and 97.5% in the MMF group, respectively. The rejection rate within 2 years after transplantation was 21.1% in the MZR group and 16.0% in the MMF group; the difference was nonsignificant. None of the MZR group developed cytomegalovirus (CMV) disease, whereas 12.3% of the MMF group contracted CMV (P < .0001). CMV viremia developed in 28.9% of the MZR group vs 46.9% of the MMF group (P < .0001); their peak antigen levels were 20.4 ± 44.1 and 252.8 ± 527.0 (P < .01). Furthermore, the incidence of gastrointestinal disorder, hyperlipidemia, and blood disorder was significantly lower in the MZR group than in the MMF group. The combination of high-dose MZR with CsA, basiliximab, and corticosteroids not only provides satisfactory immunosuppression but is also associated with a low incidence of CMV infection and gastrointestinal and blood disorders.
authors.affiliation: Department of Transplantation and Regenerative Surgery, Kyoto Prefectural University of Medicine, Kyoto City, Japan. Electronic address: ushi@koto.kpu-m.ac.jp.
authors.forename: H
authors.initials: H
authors.lastname: Ushigome
authors.affiliation: Department of Organ Transplant Surgery, Aichi Medical University, Nagakute, Aichi, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Uchida
authors.affiliation: Department of Urology, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Hyogo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Nishimura
authors.affiliation: Department of Surgery, Omihachiman Community Medical Center, Omihachiman, Shiga, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Akioka
authors.affiliation: Department of Surgery, Koseiren Hiroshima General Hospital, Hatsukaichi, Hiroshima, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Fukuda
authors.affiliation: Department of Surgery, Mito Medical Center, Ibaragi-cho, Ibaragi, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Yuzawa
authors.affiliation: Department of Urology, Kobe University, Kobe, Hyogo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Fujisawa
authors.affiliation: Department of Surgery, Yonago Medical Center, Yonago, Tottori, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Sugitani
authors.affiliation: Department of Urology, Gifu University, Gifu, Japan.
authors.forename: S-I
authors.initials: SI
authors.lastname: Ito
authors.affiliation: Department of Urology, Osaka City University, Abeno-ku, Osaka, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Nakatani
authors.affiliation: Department of Transplant Surgery, Kochi Health Sciences Center, Kochi, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Horimi
authors.affiliation: Department of Transplantation and Regenerative Surgery, Kyoto Prefectural University of Medicine, Kyoto City, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Yoshimura
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000453:epidemiology; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D016022:Case-Control Studies; D016572:Cyclosporine / Q000627:therapeutic use; D003586:Cytomegalovirus Infections / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D016030:Kidney Transplantation; D007970:Leukopenia / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000627:therapeutic use; D009894:Opportunistic Infections / Q000453:epidemiology; D011239:Prednisolone / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012263:Ribonucleosides / Q000627:therapeutic use; D014766:Viremia / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D012263:Ribonucleosides; C010052:mizoribine; D016572:Cyclosporine; D000077552:Basiliximab; D011239:Prednisolone; D009173:Mycophenolic Acid