Xiao Yousheng, Huang Jianyi, Luo Hongye, Wang Jin
Department of Neurology, The First Affiliated Hospital, Guangxi Medical University, No. 22, Shuang Yong Lu, Nanning, Guangxi, China, 530021.
Cochrane Database Syst Rev. 2014 Feb 7;2014(2):CD010242. doi: 10.1002/14651858.CD010242.pub2.
Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system and a leading cause of disability in young and middle-aged adults. Mycophenolate mofetil (MMF) is an immunosuppressive agent that has been used for the prevention of allograft rejection after renal, cardiac, or liver transplant and in patients with autoimmune diseases such as active relapsing-remitting (RRMS) and progressive MS.
To assess the efficacy and safety of MMF for preventing disease activity in patients with RRMS.
We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register (January 14, 2013). We searched three Chinese databases (January 2013) and checked reference lists of identified trials. We contacted authors and pharmaceutical companies to ask for additional information. We applied no language restrictions.
We included randomized controlled trials with a follow-up of at least 12 months that compared MMF as monotherapy or in combination with other treatments versus placebo, another drug, or the same cointervention as the treated group.
Two review authors independently selected the trials for inclusion, assessed trial quality, and extracted data.
One included study involving 26 participants with new-onset RRMS investigated the efficacy and safety of MMF (13 participants) versus placebo in interferon β-1a-treated participants. It was assessed to be at high risk of bias, and had a small numbers of participants receiving treatment with short-term duration. There was inadequate information provided by the study to determine the effect of MMF in reducing relapses, preventing disability progression, or developing new T2- or new gadolinium (Gd)-enhanced lesions on magnetic resonance imaging (MRI) after a 12-month follow-up period. No data were available at 24 months. No serious adverse effects were reported. All participants in the MMF-treated group suffered from gastrointestinal upset, but none of them discontinued therapy as a result.
AUTHORS' CONCLUSIONS: The evidence we found from one small study was insufficient to determine the effects of MMF as an add-on therapy for interferon β-1a in new-onset RRMS participants.
多发性硬化症（MS）是一种中枢神经系统的免疫介导疾病，是中青年人群残疾的主要原因。霉酚酸酯（MMF）是一种免疫抑制剂，已用于预防肾、心脏或肝移植后的同种异体移植排斥反应，以及用于患有自身免疫性疾病（如活动性复发缓解型多发性硬化症（RRMS）和进展型多发性硬化症）的患者。
评估MMF预防RRMS患者疾病活动的疗效和安全性。
我们检索了Cochrane多发性硬化症和中枢神经系统罕见病专题注册库（2013年1月14日）。我们检索了三个中文数据库（2013年1月），并查阅了已识别试验的参考文献列表。我们联系了作者和制药公司以获取更多信息。我们未设语言限制。
我们纳入了随访至少12个月的随机对照试验，这些试验比较了MMF单药治疗或与其他治疗联合使用与安慰剂、另一种药物或与治疗组相同的联合干预措施。
两位综述作者独立选择纳入试验、评估试验质量并提取数据。
一项纳入26例新发RRMS患者的研究，调查了MMF（13例患者）与安慰剂相比在接受干扰素β-1a治疗的患者中的疗效和安全性。该研究被评估为具有高偏倚风险，且接受治疗的参与者数量少、治疗持续时间短。该研究提供的信息不足，无法确定MMF在12个月随访期后减少复发、预防残疾进展或在磁共振成像（MRI）上出现新的T2或新的钆（Gd）增强病灶方面的效果。24个月时没有可用数据。未报告严重不良反应。MMF治疗组的所有参与者均出现胃肠道不适，但均未因此停药。
我们从一项小型研究中发现的证据不足以确定MMF作为新发RRMS参与者干扰素β-1a附加治疗的效果。
