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塞来昔布单药治疗新型冠状病毒肺炎感染后中度抑郁症状的疗效和安全性:一项随机、双盲、安慰剂对照试验

Efficacy and safety of celecoxib monotherapy for treatment of moderate depressive symptoms following COVID-19 infection: A randomized, double-blind, placebo-controlled trial.

作者信息

Ansari Sahar, Sanjari Moghaddam Hossein, Basti Fatemeh A, Salehi Mohammadreza, Akhondzadeh Shahin

机构信息

Psychosomatic Medicine Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Psychosom Res. 2023 Nov;174:111471. doi: 10.1016/j.jpsychores.2023.111471. Epub 2023 Aug 21.

DOI:10.1016/j.jpsychores.2023.111471
PMID:37660680
Abstract

OBJECTIVE

Celecoxib, a nonsteroidal anti-inflammatory agent, was found to be an effective add-on treatment for unipolar and bipolar depression. We investigated the potential beneficial effect of celecoxib monotherapy on depressive symptoms after Coronavirus disease (COVID-19).

METHODS

This was a randomized, double-blind, placebo-controlled clinical trial investigating the therapeutic effects of celecoxib monotherapy in patients with moderate depressive symptoms following COVID-19 infection. Patients were randomized to receive either a celecoxib capsule (100 mg) twice daily or a placebo capsule twice daily for 6 weeks. Participants were assessed with the Hamilton Depression Rating Scale (HDRS) and the side effect checklist at baseline and weeks 3 and 6.

RESULTS

A total of 62 patients were included. GLM repeated-measures showed a significant effect of time × treatment (F = 12.95, df = 1.98, p < 0.001) for celecoxib, suggesting superior improvement of depressive symptoms in celecoxib compared to placebo from baseline to the study endpoint. HDRS scores in the celecoxib group showed a greater decline from baseline to both week 3 (t = 4.12, p < 0.001, Cohen's d = 1.10) and week 6 (t = 4.76, p < 0.001, Cohen's d = 1.27), compared to the placebo group. Rate of response to treatment (70% vs 9%, p < 0.001) and remission (67% vs 0%, p < 0.001) was significantly higher in celecoxib compared to the placebo group at week 6. Adverse event frequencies were not significantly different between the two groups.

CONCLUSION

We demonstrated that treatment with celecoxib significantly improved depression scores of patients with depressive symptoms following COVID-19 infection. Further trials with larger sample sizes and longer study periods should assess our findings before any suggestion for clinical use. The trial was prospectively registered at the Iranian registry of clinical trials (www.irct.ir; registration number: IRCT20090117001556N142).

摘要

目的

塞来昔布是一种非甾体抗炎药,被发现是治疗单相和双相抑郁症的有效附加治疗药物。我们研究了塞来昔布单药治疗对冠状病毒病(COVID-19)后抑郁症状的潜在有益作用。

方法

这是一项随机、双盲、安慰剂对照的临床试验,研究塞来昔布单药治疗对COVID-19感染后中度抑郁症状患者的治疗效果。患者被随机分为每日两次接受塞来昔布胶囊(100毫克)或每日两次接受安慰剂胶囊,持续6周。在基线以及第3周和第6周,使用汉密尔顿抑郁评定量表(HDRS)和副作用清单对参与者进行评估。

结果

共纳入62例患者。广义线性模型重复测量显示,塞来昔布的时间×治疗有显著效应(F = 12.95,自由度 = 1.98,p < 0.001),表明从基线到研究终点,塞来昔布组的抑郁症状改善优于安慰剂组。与安慰剂组相比,塞来昔布组的HDRS评分从基线到第3周(t = 4.12,p < 0.001,科恩d值 = 1.10)和第6周(t = 4.76,p < 0.001,科恩d值 = 1.27)下降幅度更大。在第6周,塞来昔布组的治疗反应率(70%对9%,p < 0.001)和缓解率(67%对0%,p < 0.001)显著高于安慰剂组。两组的不良事件频率无显著差异。

结论

我们证明,塞来昔布治疗可显著改善COVID-19感染后有抑郁症状患者的抑郁评分。在提出任何临床应用建议之前,应进行更大样本量和更长研究周期的进一步试验以评估我们的研究结果。该试验已在伊朗临床试验注册中心(www.irct.ir;注册号:IRCT20090117001556N142)进行前瞻性注册。

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