通过疼痛性躯体症状的早期改善预测重度抑郁症的治疗结果：度洛西汀双盲、安慰剂对照试验的汇总分析
Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine.
作者信息
Tokuoka Hirofumi, Nishihara Makoto, Fujikoshi Shinji, Yoshikawa Aki, Kuga Atsushi
机构信息
Bio-Medicine, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe.
Multidisciplinary Pain Center, Aichi Medical University, Nagakute, Aichi.
出版信息
Neuropsychiatr Dis Treat. 2017 Sep 25;13:2457-2467. doi: 10.2147/NDT.S143093. eCollection 2017.
OBJECTIVE
We determined if early improvement in painful physical symptoms (PPS) can be a predictor of remission in the treatment of major depressive disorder (MDD).
METHODS
We included randomized, double-blind, parallel-group clinical trials of duloxetine (40-60 mg/day) versus placebo for the acute treatment of MDD with associated PPS. Only those studies using the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Brief Pain Inventory - Short Form (BPI-SF) were included. Three studies met all criteria and included male or female outpatients aged ≥18 years who met the diagnostic criteria for MDD, had a MADRS total score ≥20, and had at least moderate pain (BPI-SF average pain score ≥3). Positive predictive values (PPVs) and negative predictive values (NPVs) of early improvement in PPS for remission were analyzed. PPVs were the proportion of patients with remission (MADRS total score ≤10) at week 8 out of patients who experienced early improvement in BPI-SF average pain score (≥30% decrease from baseline at week 1, 2, or 4). NPVs were the proportion of patients without remission (MADRS total score >10) at week 8 out of patients who did not experience early improvement in PPS.
RESULTS
Data from 1,320 patients were analyzed (duloxetine N=641 and placebo N=679). The overall remission (MADRS total score ≤10 at week 8) rate for the duloxetine group was significantly higher than the placebo group (38.5% vs 21.8%; <0.0001). For both treatment groups, PPVs of early improvement in BPI-SF (30% improvement from baseline) were higher than the overall remission rate for all weeks examined (weeks 1, 2, and 4); in general, NPVs of early improvement in BPI-SF for nonremission were higher than the overall nonremission rate.
CONCLUSION
Early improvement in PPS can be a useful clinical indicator of subsequent treatment outcome for MDD patients with associated PPS.
目的
我们确定了疼痛性躯体症状（PPS）的早期改善是否可作为重度抑郁症（MDD）治疗中缓解的预测指标。
方法
我们纳入了度洛西汀（40 - 60毫克/天）与安慰剂用于伴有PPS的MDD急性治疗的随机、双盲、平行组临床试验。仅纳入那些使用蒙哥马利 - 阿斯伯格抑郁评定量表（MADRS）和简明疼痛问卷 - 简表（BPI - SF）的研究。三项研究符合所有标准，纳入了年龄≥18岁、符合MDD诊断标准、MADRS总分≥20且至少有中度疼痛（BPI - SF平均疼痛评分≥3）的男性或女性门诊患者。分析了PPS早期改善对缓解的阳性预测值（PPV）和阴性预测值（NPV）。PPV是在第8周时BPI - SF平均疼痛评分有早期改善（在第1、2或4周时较基线下降≥30%）的患者中缓解（MADRS总分≤10）的患者比例。NPV是在第8周时PPS未出现早期改善的患者中未缓解（MADRS总分>10）的患者比例。
结果
分析了1320例患者的数据（度洛西汀组N = 6,41例，安慰剂组N = 679例）。度洛西汀组的总体缓解率（第8周时MADRS总分≤10）显著高于安慰剂组（38.5%对21.8%；<0.0001）。对于两个治疗组，BPI - SF早期改善（较基线改善30%）的PPV均高于所有检查周（第1、2和4周）的总体缓解率；一般而言，BPI - SF早期改善对未缓解的NPV高于总体未缓解率。
结论
PPS的早期改善可为伴有PPS的MDD患者后续治疗结果提供有用的临床指标。
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