自评量表在评估使用艾司氯胺酮鼻喷剂的难治性抑郁症患者病情的可行性探讨
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Feasibility of self-rating scales in assessing the condition of patients with treatment-resistant depressivedisorder using esketamine nasal spray
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    摘要:

    目的 探讨使用艾司氯胺酮鼻喷剂治疗的抑郁症患者中症状评估和整体状态评估的自评 量表与他评量表的相关性。方法 收集2018年6月—2021年2月在首都医科大学附属北京安定医院参与 艾司氯胺酮鼻喷剂治疗临床试验的32例抑郁症患者的病例资料,所有患者入组艾司氯胺酮的临床试验后 随机分为给予艾司氯胺酮鼻喷治疗的试验组(18例)和安慰剂鼻喷治疗的对照组(14例),予以持续4周、每 周2次的鼻喷给药治疗。给药期的第15天(D15)和第28天(D28)、随访期的第2 周(W2)、第5 周(W5)和第 8 周(W8)采用蒙哥马利-艾斯伯格抑郁量表(MADRS)、广泛性焦虑症量表(GAD-7)、临床总体印象-疾病 的严重程度量表(CGI-S)、欧洲五维健康量表五级水平版本(EQ-5D-5L)对患者进行评估,并使用Pearson 相关分析和重复测量的线性回归模型分析其变化量的相关性。结果 所有受试者中,治疗期和随访 期自评的GAD-7 与他评的MADRS 均呈中等强度的相关(D28:r=0.420,P=0.017;W5:r=0.417,P=0.022; W8:r=0.568,P=0.001);治疗期自评的EQ-5D-5L 与他评的CGI-S 变化量无相关性(D15:P=0.393,D28: P=0.187),但在随访期呈中等强度的相关(W5:r=0.402,P=0.028;W8:r=0.473,P=0.008)。在氯胺酮给 药的试验组受试者中,所有评分点的CGI-S 减分值与EQ-5D-5L加分率均无相关性(P > 0.05)。在安慰 剂对照组中,治疗期第15 天、随访期第2 周、第5 周和第8 周,CGI-S 减分值与EQ-5D-5L加分率呈显著 正相关(D15:r=0.740,P=0.003;W2:r=0.594,P=0.025;W5:r=0.675,P=0.016;W8:r=0.599,P=0.031)。 结论 在艾司氯胺酮鼻喷剂治疗过程中,抑郁症患者对整体状态的自评与他评没有显著相关,而对症 状的评估存在中等强度相关性,自评与他评结合有助于更全面地评估。

    Abstract:

    Objective To investigate the correlation between self-rating and other-rating scales for symptom assessment and overall state assessment in depressive disorder patients treated with esketamine nasal spray. Methods Data were collected from 32 patients with depressive disorder who participated in a clinical trial of esketamine nasal spray treatment from June 2018 to February 2021 at Beijing Anding Hospital, Capital Medical University. All patients were randomly divided into the experimental group( 18 cases) and the control group( 14 cases) treated with esketamine nasal spray for 4 weeks and twice a week after the clinical trial of esketamine. Patients were assessed using the Montgomery-Asberg Depression Rating Scale( MADRS), Generalized Anxiety Disorder( GAD-7), Clinical Global Impression-Severity of Illness Scale( CGI-S), and the European Quality of Life-5 Dimensions 5 Levels( EQ-5D-5L) on days 15( D15) and 28( D28) of the treatment period, and weeks 2( W2), 5( W5), and 8( W8) of the follow-up period. The correlation of the amount of change was analyzed using Pearson's correlation and linear regression with repeated measures. Results In all subjects, the self-rating GAD-7 correlated moderately with the other-rating MADRS during the treatment and follow-up periods( D28: r=0.420, P=0.017; W5: r=0.417, P=0.022; W8: r=0.568, P=0.001). The amount of change in the self-rating EQ-5D-5L during the treatment period did not correlate statistically with the amount of change in the other-rating CGI-S( D15: P=0.393, D28: P=0.187), but showed a moderate correlation during the follow-up period( W5: r=0.402, P=0.028; W8: r=0.473, P=0.008). In the experimental group of ketamine administration, there was no correlation between the CGI-S reduction score of all scoring points and the EQ-5D- 5L addition rate( P>0.05). In the placebo control group, there was a significant positive correlation between CGI-S score reduction and EQ-5D-5L score increase rate on the 15 th day of treatment, the 2 nd week, the 5 th week and the 8 th week of follow-up( D15:r=0.740,P=0.003;W2:r=0.594,P=0.025;W5:r=0.675,P=0.016; W8:r=0.599,P=0.031). Conclusions During treatment with esketamine nasal spray, self-rating of overall state in depressive disorder patients do not correlate significantly with other-rating, whereas there is a moderate correlation in the assessment of symptoms, and the combination of self-rating and other-rating contributes to a comprehensive assessment.

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邓齐英,伍庭芳,李安宁,安凤荣,王刚.自评量表在评估使用艾司氯胺酮鼻喷剂的难治性抑郁症患者病情的可行性探讨[J].神经疾病与精神卫生,2025,25(7):503-508
DOI :10.3969/j. issn.1009-6574.2025.07.007.

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  • 在线发布日期: 2025-07-22