Yagi Nobuyuki, Okada Kenya, Sudo Yohei, Itoh Hiromichi, Yoshida Hisao, Kuroda Tatsuhiko
Scientific Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Post-Marketing Surveillance Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
SAGE Open Med. 2014 May 8;2:2050312114533960. doi: 10.1177/2050312114533960. eCollection 2014.
To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study.
Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites.
Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7%) of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%). No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months.
The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.
通过开展一项为期3年的上市后监测研究，确定长期使用咪唑立宾的安全性和有效性。
研究对象为2003年10月1日至2005年9月30日期间在合同研究地点开始接受咪唑立宾治疗的所有狼疮性肾炎患者。
在由281个合同研究地点招募的946名患者中，有946名患者满足入选标准后进入安全性分析集，其中881名狼疮性肾炎患者接受了咪唑立宾治疗。在946名受试者中，有196名（20.7%）发生了301起药物不良反应事件。31名患者（3.2%）发生了34起严重药物不良反应事件。血液学和生化检测值未见恶化，但免疫学检测显示C3、CH50和抗DNA抗体滴度有显著改善。蛋白尿阴性率也随时间增加。治疗开始时，类固醇的中位剂量为15毫克/天，但在12个月时降至10毫克/天，在36个月时降至8毫克/天。
这项为期3年的长期药物使用监测研究结果表明，咪唑立宾可长期使用，药物不良反应相对较少，表明其适用于维持药物治疗。
