Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research.
Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research.
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DOI：
10.1136/ard.2008.093690
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发表时间：
2009-07
影响因子：
27.4
通讯作者：
van der Heijde D
中科院分区：
文献类型：
--
作者：
Salliot C;van der Heijde D
对甲氨蝶呤(MTX)单一疗法治疗类风湿关节炎(RA)的长期安全性进行系统的文献综述。检索Medline、Cochrane和EMBASE。研究对象为接受MTX单一治疗2年以上的成年RA患者。纳入88项已发表的研究。经过12年的治疗，MTX的毒性终止率低于柳氮磺胺吡啶、金、d-青霉胺，高于羟氯喹(证据水平为2a-2b)。长期使用MTX似乎不是包括带状疱疹(2b-4)在内的严重感染的危险因素，并可能通过降低心血管死亡率而提供生存益处(2b)。肝酶升高的患病率(超过正常上限的两倍以上)接近13%；3.7%的患者因肝脏毒性而永久停止MTX(2b)。关于肝纤维化/肝硬变风险的数据相互矛盾：一项荟萃分析显示，服用MTX 4年(2a)后，肝纤维化发生率为2.7%。然而，另外两项关于连续肝活组织检查的研究没有显示出发生严重损害的证据(2b)。没有足够的数据来充分评估淋巴瘤和恶性肿瘤的风险，尽管没有强有力的证据表明风险增加(2b-4)。这项系统的文献搜索显示，在至少两年的时间里，使用相对较低剂量的MTX单一疗法具有良好的长期安全性。
To perform a systematic literature review of the long-term safety of methotrexate (MTX) monotherapy in rheumatoid arthritis (RA). A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.
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影响因子：
3.3
作者：
KAMEL, OW;VANDERIJN, M;DORFMAN, RF
通讯作者：
DORFMAN, RF
影响因子：
4
作者：
Schnabel, A;Herlyn, K;Gross, WL
通讯作者：
Gross, WL
影响因子：
3.4
作者：
Franck, H;Rau, R;Herborn, G
通讯作者：
Herborn, G
影响因子：
--
作者：
FRIES, JF;WILLIAMS, CA;BLOCH, DA
通讯作者：
BLOCH, DA
影响因子：
--
作者：
Kremer, JM
通讯作者：
Kremer, JM