title: Efficacy of mizoribine treatment in patients with Sjögren's syndrome: an open pilot trial.
abstract: Abstract The aim of this study was to evaluate the efficacy and safety of mizoribine in patients with Sjögren's syndrome. Forty patients with sicca syndrome, whose conditions were definitely diagnosed as Sjögren's syndrome, were given mizoribine orally at a dosage of 150 mg/day for 12 months. The percentage change in salivary secretion after 3, 6, and 12 months of the therapy increased to +112.2% (P < 0.001), +119.9% (P < 0.01), and +147.3% (P < 0.001), respectively, compared with the baseline. Serum IgG levels decreased significantly throughout the study, and the level was 1969.4 ± 620.0 mg/dl after treatment for 12 months compared with the pretreatment value of 2094.3 ± 746.6 mg/dl (P < 0.05). The patient's assessment of clinical signs and symptoms on a 10-cm visual analog scale improved significantly from 7.2 ± 2.3 cm at the start of the treatment to 5.0 ± 1.9 cm after 12 months (P < 0.001). There was a similar improvement in the physician's assessment using the 10-cm visual analog scale: 7.1 ± 1.6 cm at the start of the treatment and 5.2 ± 1.9 cm after 12 months (P < 0.001). With regard to safety, no serious adverse reactions were observed. Although a controlled study would be required to clarify the efficacy of mizoribine, these preliminary observations indicate its efficacy for ameliorating glandular symptoms through improvements in immune abnormalities in patients with Sjögren's syndrome.
authors.affiliation: First Department of Internal Medicine, University of Occupational and Environmental Health, School of Medicine , 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 , Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Nakayamada
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Saito
authors.forename: Keisuke
authors.initials: K
authors.lastname: Nakatsuka
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Nakano
authors.forename: Mikiko
authors.initials: M
authors.lastname: Tokunaga
authors.forename: Norifumi
authors.initials: N
authors.lastname: Sawamukai
authors.forename: Shizuyo
authors.initials: S
authors.lastname: Tsujimura
authors.forename: Masao
authors.initials: M
authors.lastname: Nawata
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka