Nakayamada Shingo, Saito Kazuyoshi, Umehara Hisanori, Ogawa Noriyoshi, Sumida Takayuki, Ito Satoshi, Minota Seiji, Nara Hiroyuki, Kondo Hirobumi, Okada Jun, Mimori Tsuneyo, Yoshifuji Hajime, Sano Hajime, Hashimoto Naoaki, Sugai Susumu, Tanaka Yoshiya
First Department of Internal Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Mod Rheumatol. 2007;17(6):464-9. doi: 10.1007/s10165-007-0627-2. Epub 2007 Dec 20.
This multicenter clinical trial was performed to evaluate the efficacy and safety of mizoribine for the treatment of Sjögren's syndrome. Fifty-nine patients with a definite diagnosis of Sjögren's syndrome received 150;Smg of mizoribine daily for 16 weeks. The salivary secretion volume was determined at baseline, at weeks 8 and 16 after the start of the study treatment by the Saxon test, and clinical manifestations were assessed by the investigator and the patients using a 10-cm visual analog scale (VAS). Adverse drug reactions were reported in 18 patients, of whom 6 patients had to discontinue the study due to such adverse reactions; however, no serious adverse drug reactions definitely related to the study drug were noted. The salivary secretion volume, the rate of change in salivary secretion, the patients' own assessments of dry mouth and dry eyes, the investigators' assessment of oral sicca symptoms, and the investigators' overall assessment improved following the treatment regimen with statistical significance at week 16 after the start of treatment in comparison to the baseline values. These results suggested that mizoribine may be effective in producing a subjective and objective amelioration of the glandular symptoms in patients with Sjögren's syndrome, without observing any serious adverse effects related to this drug.
本多中心临床试验旨在评估咪唑立宾治疗干燥综合征的疗效和安全性。59例确诊为干燥综合征的患者每天服用150mg咪唑立宾，持续16周。在研究治疗开始时的基线、第8周和第16周，通过萨克森试验测定唾液分泌量，研究者和患者使用10厘米视觉模拟量表（VAS）评估临床表现。18例患者报告了药物不良反应，其中6例患者因这些不良反应不得不停止研究；然而，未发现明确与研究药物相关的严重药物不良反应。与基线值相比，治疗方案实施后，唾液分泌量、唾液分泌变化率、患者自身对口干和眼干的评估、研究者对口腔干燥症状的评估以及研究者的总体评估在治疗开始后第16周有统计学意义的改善。这些结果表明，咪唑立宾可能有效改善干燥综合征患者的腺体症状，且未观察到与该药物相关的任何严重不良反应。
