Geng JinSong, Dong JianCheng, Li Youping, Ni Hengjian, Jiang Kui, Shi Li Li, Wang GuoHua
Evidence-based Medicine Center, Medical School of Nantong University, 19 Qixiu Road, Medical School of Nantong, Nantong, Jiangsu, China, 226001.
Cochrane Database Syst Rev. 2017 Jul 4;7(7):CD008557. doi: 10.1002/14651858.CD008557.pub3.
Epilepsy is a common neurological condition, with an estimated incidence of 50 per 100,000 persons. People with epilepsy may present with various types of immunological abnormalities, such as low serum immunoglobulin A (IgA) levels, lack of the immunoglobulin G (IgG) subclass and identification of certain types of antibodies. Intravenous immunoglobulin (IVIg) treatment may represent a valuable approach and its efficacy has important implications for epilepsy management. This is an updated version of the original Cochrane review published in Issue 1, 2011.
To examine the effects of IVIg on the frequency and duration of seizures, quality of life and adverse effects when used as monotherapy or as add-on treatment for people with epilepsy.
For the latest update, we searched the Cochrane Epilepsy Group Specialized Register (2 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (2 February 2017), MEDLINE (Ovid, 1946 to 2 February 2017), Web of Science (1898 to 2 February 2017), ISRCTN registry (2 February 2017), WHO International Clinical Trials Registry Platform (ICTRP, 2 February 2017), the US National Institutes of Health ClinicalTrials.gov (2 February 2017), and reference lists of articles.
Randomized or quasi-randomized controlled trials of IVIg as monotherapy or add-on treatment in people with epilepsy.
Two review authors independently assessed the trials for inclusion and extracted data. We contacted study authors for additional information. Outcomes included percentage of people rendered seizure-free, 50% or greater reduction in seizure frequency, adverse effects, treatment withdrawal and quality of life.
We included one study (61 participants). The included study was a randomized, double-blind, placebo-controlled, multi-centre trial which compared the treatment efficacy of IVIg as an add-on with a placebo add-on in patients with refractory epilepsy. There was no significant difference between IVIg and placebo in 50% or greater reduction in seizure frequency. The study reported a statistically significant effect for global assessment in favour of IVIg. No adverse effects were demonstrated. We found no randomized controlled trials that investigated the effects of IVIg monotherapy for epilepsy. Overall, the included study was rated as low/unclear risk of bias. Using GRADE methodology, the quality of the evidence was rated as low.
AUTHORS' CONCLUSIONS: We cannot draw any reliable conclusions regarding the efficacy of IVIg as a treatment for epilepsy. Further randomized controlled trials are needed.
癫痫是一种常见的神经系统疾病,估计发病率为每10万人中有50例。癫痫患者可能会出现各种类型的免疫异常,如血清免疫球蛋白A(IgA)水平低、免疫球蛋白G(IgG)亚类缺乏以及某些类型抗体的识别。静脉注射免疫球蛋白(IVIg)治疗可能是一种有价值的方法,其疗效对癫痫管理具有重要意义。这是2011年第1期发表的原始Cochrane综述的更新版本。
研究IVIg作为单一疗法或附加疗法治疗癫痫患者时对癫痫发作频率和持续时间、生活质量及不良反应的影响。
为获取最新更新内容,我们检索了Cochrane癫痫小组专业注册库(2017年2月2日)、通过Cochrane在线研究注册库检索的Cochrane对照试验中央注册库(CENTRAL,2017年2月2日)、MEDLINE(Ovid,1946年至2017年2月2日)、科学引文索引(1898年至2017年2月2日)、ISRCTN注册库(2017年2月2日)、世界卫生组织国际临床试验注册平台(ICTRP,2017年2月2日)、美国国立卫生研究院临床试验.gov(2017年2月2日)以及文章的参考文献列表。
IVIg作为单一疗法或附加疗法治疗癫痫患者的随机或半随机对照试验。
两位综述作者独立评估试验是否纳入并提取数据。我们联系研究作者以获取更多信息。结局指标包括无癫痫发作患者的百分比、癫痫发作频率降低50%或更多、不良反应、治疗中断及生活质量。
我们纳入了一项研究(61名参与者)。纳入的研究是一项随机、双盲、安慰剂对照、多中心试验,比较了IVIg作为附加疗法与安慰剂附加疗法在难治性癫痫患者中的治疗效果。IVIg与安慰剂在癫痫发作频率降低50%或更多方面无显著差异。该研究报告在整体评估方面IVIg有统计学显著效果。未显示出不良反应。我们未找到研究IVIg单一疗法治疗癫痫效果的随机对照试验。总体而言,纳入的研究被评为低/偏倚风险不明确。使用GRADE方法,证据质量被评为低。
我们无法就IVIg作为癫痫治疗方法的疗效得出任何可靠结论。需要进一步的随机对照试验。