论文标题
双相抑郁症的拉莫三嗪疗法：自我报告的患者数据的分析
Lamotrigine Therapy for Bipolar Depression: Analysis of Self-Reported Patient Data
论文作者
论文摘要
背景：躁郁症患者的抑郁症是长期残疾的主要原因，可能导致早期死亡率，目前存在有限的安全有效疗法。进行了一项双盲随机安慰剂对照试验（Cequel研究），以评估Lamotrigine Plus Quetiapine与Quetiapine单药治疗I对双极性I型或II型疾病患者的疗效。 目的：我们研究的目的是重新分析Cequel数据，并确定主动拉莫三嗪与安慰剂的无偏分类精度。我们还想确定该药物提供统计学意义的结果所花费的时间。 方法：在2008年10月21日至2012年4月27日之间，将来自英国27个地点的202名参与者随机分配给两种治疗方法； 101：拉莫三嗪，101：安慰剂。用于估计抑郁症状的主要变量是基于抑郁症状自我报告版本16（QIDS-SR16）的快速清单。我们使用功能工程和简单分类器分析数据。 结果：从第10周到第14周，两组之间QIDS -SR16等级的平均差异为-1.6317（p = .09；样本量= 81，77; 95％CI -0.2403至3.5036）。从第48周到52周，平均差异为-2.0032（p = .09；样本尺寸= 54、48; 95％CI -0.3433至4.3497）。变异系数和下降波动分析（DFA）指数α具有最大的解释能力。在第12周后报告超过10次的138名参与者的样本外分类准确性为62％。在第44周获得了高于无信息基准的一致分类精度。 结论：拉莫三嗪加喹硫平的治疗减轻了患者的抑郁症状，但具有很大的时间不稳定。需要至少44周的试验才能获得一致的结果。
Background: Depression in people with bipolar disorder is a major cause of long-term disability, possibly leading to early mortality and currently, limited safe and effective therapies exist. A double-blinded randomized placebo-controlled trial (CEQUEL study) was conducted to evaluate the efficacy of Lamotrigine plus Quetiapine versus Quetiapine monotherapy in patients with bipolar type I or type II disorders. Objective: The objective of our study was to reanalyze CEQUEL data and determine an unbiased classification accuracy for active lamotrigine versus placebo. We also wanted to establish the time it took for the drug to provide statistically significant outcomes. Methods: Between October 21, 2008 and April 27, 2012, 202 participants from 27 sites in United Kingdom were randomly assigned to two treatments; 101: lamotrigine, 101: placebo. The primary variable used for estimating depressive symptoms was based on the Quick Inventory of Depressive Symptomatology-self report version 16 (QIDS-SR16). We analyze the data using feature engineering and simple classifiers. Results: From weeks 10 to 14, the mean difference in QIDS-SR16 ratings between the groups was -1.6317 (P=.09; sample size=81, 77; 95% CI -0.2403 to 3.5036). From weeks 48 to 52, the mean difference was -2.0032 (P=.09; sample size=54, 48; 95% CI -0.3433 to 4.3497). The coefficient of variation and detrended fluctuation analysis (DFA) exponent alpha had the greatest explanatory power. The out-of-sample classification accuracy for the 138 participants who reported more than 10 times after week 12 was 62%. A consistent classification accuracy higher than the no-information benchmark was obtained in week 44. Conclusions: Lamotrigine plus Quetiapine treatment decreased depressive symptoms in patients, but with substantial temporal instability. A trial of at least 44 weeks was required to achieve consistent results.
