双颞电惊厥治疗联合抗惊厥药物:一项临床和神经生物学应用的随机对照试验

G. Rakesh, J. Thirthalli, C. Kumar, K. Muralidharan, V. Phutane, B. Gangadhar
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引用次数: 11

摘要

背景电痉挛疗法(ECT)是治疗重大情感障碍的有效方法。联合使用电痉挛和抗惊厥情绪稳定剂是一种常见的临床方案。缺乏系统的研究使用这种组合关于临床或认知结果。目的/假设我们的目的是比较仅接受电痉挛治疗的患者与接受电痉挛治疗和抗惊厥药物治疗的患者的临床改善和认知不良反应。我们假设只接受电痉挛治疗的患者改善最快。方法采用随机对照试验方法,将同时服用抗惊厥药物的患者随机分为全剂量(FD)、半剂量(HD)和停药3组。一名盲评员使用评定量表[杨氏躁狂症评定量表(YMRS)和临床总体印象]评定患者的临床改善和认知不良反应(研究生院记忆量表)。分析使用混合效应模型来描述在ECT治疗过程中临床和认知结果的差异。结果在招募的54例患者中,36例患者按照初始随机化计划进入治疗分配组。处方的主要抗惊厥药是丙戊酸钠和卡马西平。三组患者临床特征具有可比性。最常见的诊断是双相情感障碍-伴有当前的躁狂发作。总的来说,当作为治疗意向(ITT)或“已治疗”进行分析时,三组的最终临床结果评分(YMRS和临床总体印象)没有差异。在两项分析中,当比较FD抗惊厥组和HD组从基线到最后一次ECT的YMRS评分趋势时,组×时间相互作用是显著的(ITT组P = 0.0435,治疗组P = 0.0055)。FD组患者改善速度快于HD组。在ITT分析中,三组在认知不良反应方面没有差异;“治疗分析”显示,HD患者在某些领域表现不佳。三组间癫痫发作参数差异无统计学意义。结论:这是一项初步的前瞻性研究,旨在探讨电痉挛同时服用抗惊厥药是否会影响临床或认知结果。本研究最重要的结论是,与剂量减半(HD)的抗惊厥药相比,使用FD抗惊厥药进行ECT治疗时,YMRS评分显著降低。这种差异在ITT和处理后的分析中都有体现。需要更多的前瞻性研究来检验这个临床问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Concomitant Anticonvulsants With Bitemporal Electroconvulsive Therapy: A Randomized Controlled Trial With Clinical and Neurobiological Application
Background Electroconvulsive therapy (ECT) is an effective treatment for major affective disorders. The combined use of ECT and anticonvulsant mood stabilizers is a common clinical scenario. There is dearth of systematic studies on the use of this combination with regard to clinical or cognitive outcomes. Objective/Hypothesis We aimed to compare clinical improvement and cognitive adverse effects between patients who received only ECT versus those who received ECT and anticonvulsants. We hypothesized that improvement would be fastest in patients who received only ECT. Methods We conducted a randomized controlled trial in which patients prescribed ECT while being treated with anticonvulsants were randomized into 3 groups: full-dose (FD), half-dose (HD), and stop anticonvulsant. A blind rater assessed clinical improvement in patients using rating scales [Young’s Mania Rating Scale (YMRS) and Clinical Global Impression] for clinical improvement and cognitive adverse effects (Postgraduate Institute memory scale). Analysis was done using mixed-effects modeling to delineate differences in clinical and cognitive outcomes across the 3 arms of the study over the course of ECT. Results Of the 54 patients recruited, 36 patients went into treatment allocation arms per the initial randomization plan. The main anticonvulsants prescribed were sodium valproate and carbamazepine. Patients in the 3 groups were comparable on clinical features. The most common diagnosis was bipolar affective disorder—with current episode of mania. Overall, there was no difference across the 3 groups in final clinical outcome scores (YMRS and Clinical Global Impression) when analyzed as intention to treat (ITT) or “as treated.” In both analyses, group × time interaction was significant when comparing trend of YMRS scores between the FD anticonvulsant group and the HD group from baseline to last ECT (P = 0.0435 in ITT and P = 0.0055 in as treated). Patients in the FD group improved faster than those in the HD group. There were no differences across the 3 groups with regard to their cognitive adverse effects in the ITT analysis; “as-treated analysis” showed the HD patients to have performed poorly on some domains. Seizure parameters showed no significant difference across the 3 groups. Conclusion This is a preliminary prospective study examining whether coprescription of anticonvulsants with ECT affected clinical or cognitive outcomes. The most important takeaway point from this study is the significant reduction in YMRS scores when ECT was given with FD anticonvulsant compared with halving the dose (HD) of anticonvulsant. This difference was shown in both ITT and as-treated analysis. There is a need for more prospective studies to examine this clinical question.
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