药物难治性癫痫的电刺激:一项基于证据的分析。

Electrical stimulation for drug-resistant epilepsy: an evidence-based analysis.

作者信息

Chambers A, Bowen J M

出版信息

Ont Health Technol Assess Ser. 2013 Oct 1;13(18):1-37. eCollection 2013.

DOI:
Abstract

OBJECTIVE

The objective of this analysis was to evaluate the effectiveness of deep brain stimulation (DBS) and vagus nerve stimulation (VNS) for the treatment of drug-resistant epilepsy in adults and children.

DATA SOURCES

A literature search was performed using MEDLINE, EMBASE, the Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 2007 until December 2012.

REVIEW METHODS

Systematic reviews, meta-analyses, randomized controlled trials (RCTs), and observational studies (in the absence of RCTs) of adults or children were included. DBS studies were included if they specified that the anterior nucleus of thalamus was the area of the brain stimulated. Outcomes of interest were seizure frequency, health resource utilization, and safety. A cost analysis was also performed.

RESULTS

The search identified 6 studies that assessed changes in seizure frequency after electrical stimulation: 1 RCT on DBS in adults, 4 RCTs on VNS in adults, and 1 RCT on VNS in children. The studies of DBS and VNS in adults found significantly improved rates of seizure frequency, but the study of VNS in children did not find a significant difference in seizure frequency between the high and low stimulation groups. Significant reductions in hospitalizations and emergency department visits were found for adults and children who received VNS. No studies addressed the use of health resources for patients undergoing DBS. Five studies reported on adverse events, which ranged from serious to transient for both procedures in adults and were mostly transient in the 1 study of VNS in children.

LIMITATIONS

We found no evidence on DBS in children or on health care use related to DBS. The measurement of seizure frequency is self-reported and is therefore subject to bias and issues of compliance.

CONCLUSIONS

Based on evidence of low to moderate quality, both DBS and VNS seemed to reduce seizure frequency in adults. In children, VNS did not appear to be as effective at reducing seizure frequency, but children had significantly fewer hospitalizations and ED visits after VNS implantation. Despite the considerable risks associated with these invasive procedures, long-term adverse events appear to be limited.

PLAIN LANGUAGE SUMMARY

Electrical stimulation of specific areas of the brain is a procedure used to control epileptic seizures when more conventional treatments are not working. Most adults and children with epilepsy are able to control their seizures with medication, but for some patients, drugs are not effective and surgery to remove the part of the brain where the seizures start is not an appropriate option. This study looked at the research available on the effectiveness, safety, and cost of two types of electrical stimulation devices currently licensed for treatment of epilepsy for adults and children in Canada: vagus nerve stimulation (VNS) and deep brain stimulation (DBS). Both approaches appear to be effective at reducing the frequency of seizures in adults. However, the evidence on DBS is limited to a single study with adults; we found no studies of DBS with children. Studies on VNS showed that both adults and children had fewer hospitalizations and emergency department visits after the procedure. Both procedures carry serious risks, but several longer-term studies have found that adverse events appear to be limited. The cost of VNS, including the process of assessing whether or not patients are good candidates for the procedure, is estimated to be about $40,000 per person (and higher for DBS because the device is more expensive and the operating time is longer). Of the 70,000 people in Ontario with epilepsy, about 1,400 (300 children and 1,110 adults) may be candidates for VNS to reduce their seizures.

摘要

目的

本分析旨在评估深部脑刺激(DBS)和迷走神经刺激(VNS)治疗成人及儿童耐药性癫痫的有效性。

数据来源

利用MEDLINE、EMBASE、Cochrane图书馆及综述与传播中心数据库检索2007年1月至2012年12月发表的研究。

综述方法

纳入成人或儿童的系统评价、荟萃分析、随机对照试验(RCT)及观察性研究(如无RCT)。若DBS研究明确指出刺激的脑区为丘脑前核,则纳入该研究。感兴趣的结局指标为癫痫发作频率、卫生资源利用及安全性。同时进行了成本分析。

结果

检索到6项评估电刺激后癫痫发作频率变化的研究:1项关于成人DBS的RCT、4项关于成人VNS的RCT及1项关于儿童VNS的RCT。成人DBS和VNS研究发现癫痫发作频率显著改善,但儿童VNS研究未发现高刺激组与低刺激组癫痫发作频率有显著差异。接受VNS的成人和儿童住院及急诊就诊次数显著减少。未检索到关于接受DBS患者卫生资源利用情况的研究。5项研究报告了不良事件,成人两种手术的不良事件从严重到短暂不等,儿童VNS的1项研究中不良事件大多为短暂性。

局限性

未找到关于儿童DBS及与DBS相关卫生保健利用情况的证据。癫痫发作频率的测量为自我报告,因此可能存在偏差及依从性问题。

结论

基于低至中等质量的证据,DBS和VNS似乎均可降低成人癫痫发作频率。在儿童中,VNS在降低癫痫发作频率方面似乎效果欠佳,但儿童在植入VNS后住院及急诊就诊次数显著减少。尽管这些侵入性手术存在相当大的风险,但长期不良事件似乎有限。

通俗易懂的总结

当更传统的治疗方法无效时,对脑特定区域进行电刺激是一种用于控制癫痫发作的方法。大多数癫痫成人和儿童能够通过药物控制癫痫发作,但对一些患者而言,药物无效且切除癫痫起始脑区的手术并非合适选择。本研究审视了加拿大目前已获许可用于治疗成人及儿童癫痫的两种电刺激设备——迷走神经刺激(VNS)和深部脑刺激(DBS)——在有效性、安全性及成本方面的现有研究。两种方法似乎均能有效降低成人癫痫发作频率。然而,关于DBS的证据仅限于一项成人研究;未找到儿童DBS的研究。VNS研究表明,成人和儿童在手术后住院及急诊就诊次数均减少。两种手术均有严重风险,但多项长期研究发现不良事件似乎有限。VNS的成本,包括评估患者是否适合该手术的过程,估计约为每人40,000美元(DBS更高,因为设备更昂贵且手术时间更长)。安大略省70,000名癫痫患者中,约1400人(300名儿童和1110名成人)可能适合接受VNS以减少癫痫发作。

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