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新成年和青少年抑郁症病例中 5 种常见抗抑郁药副作用的发生率:一项回顾性美国理赔研究。

Rates of 5 common antidepressant side effects among new adult and adolescent cases of depression: a retrospective US claims study.

机构信息

University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Denver, CO, USA.

出版信息

Clin Ther. 2012 Jan;34(1):113-23. doi: 10.1016/j.clinthera.2011.11.024. Epub 2011 Dec 16.

Abstract

BACKGROUND

Antidepressants are the first-line treatment for depression, yet medication-related side effects may be associated with antidepressant discontinuation before reaching a period of exposure believed to result in effectiveness. There is a gap in knowledge of the prevalence of side effects across commonly prescribed antidepressants and the effect of the type of antidepressant on the likelihood of side effects in real-world clinical practice.

OBJECTIVE

The aim of this study was to estimate and compare the prevalence of headaches, nausea or vomiting, agitation, sedation, and sexual dysfunction among patients diagnosed with depression who initiated monotherapy across different classes of antidepressants and to estimate the effect of the type of antidepressant on the likelihood of each of the 5 side effects.

METHODS

A retrospective cohort of patients aged ≥13 who were newly diagnosed with depression and began antidepressant monotherapy was created using LifeLink managed care claims from 1998 to 2008. Antidepressant groups included selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), bupropion, phenylpiperazine, and tetracyclic antidepressants. Prevalence of headache, nausea or vomiting, agitation, sedation, and sexual dysfunction were compared across antidepressant groups. Propensity-adjusted Cox proportional hazards regression was used to estimate the likelihood of each of the 5 side effects for each antidepressant group compared with SSRIs, adjusted for demographic, clinical, and treatment characteristics.

RESULTS

The study cohort included 40,017 patients (3617 adolescents, aged 13-18 years, and 36,400 adults, aged ≥19 years; mean age = 45 years; 67% female) with a new episode of depression who were initiated on antidepressant monotherapy within 30 days of diagnosis (SSRI [66%], bupropion [14%], SNRI [12%], other [8%]). The most common side effects were headache (up to 17/1000 person-months of therapy in adults and adolescents) and nausea (up to 7.2/1000 in adults, 9.3/1000 in adolescents). Relative to adults receiving SSRIs, adults receiving SNRIs had a higher risk of nausea (hazard ratio [HR] = 1.26; 95%CI,1.05-1.51). Adults (HR = 0.78; 95% CI, 0.62-0.96) and adolescents (HR = 0.43; 95% CI, 0.21-0.87) taking bupropion were less likely to experience headaches compared with adults and adolescents, respectively, taking an SSRI. Adolescents receiving a tetracyclic were more likely to experience headaches than adolescents receiving an SSRI (HR = 3.16; 95%CI, 1.13-8.84).

CONCLUSIONS

Prevalence and risk of the 5 side effects varied across types of antidepressants for both adults and adolescents. Results from this study were consistent with prior clinical trials, suggesting that variation in side effect profiles exists in a more generalized managed care population.

摘要

背景

抗抑郁药是治疗抑郁症的首选药物,但与药物相关的副作用可能会导致在达到被认为有效的暴露期之前停止使用抗抑郁药。目前,对于在广泛应用于临床的各类抗抑郁药物中,副作用的普遍发生率,以及抗抑郁药类型对抗抑郁药副作用发生的可能性的影响,人们知之甚少。

目的

本研究旨在评估和比较在不同抗抑郁药类别中,诊断为抑郁症的患者在开始单药治疗时出现头痛、恶心或呕吐、激越、镇静和性功能障碍的发生率,并估计抗抑郁药类型对 5 种副作用中每一种发生的可能性的影响。

方法

本研究使用了 LifeLink 管理式医疗索赔数据,创建了一个 1998 年至 2008 年间年龄≥13 岁、新诊断为抑郁症并开始接受抗抑郁药单药治疗的患者回顾性队列。抗抑郁药组包括选择性 5-羟色胺再摄取抑制剂(SSRIs)、5-羟色胺和去甲肾上腺素再摄取抑制剂(SNRIs)、三环类抗抑郁药(TCAs)、单胺氧化酶抑制剂(MAOIs)、安非他酮、苯哌嗪和四环类抗抑郁药。比较了抗抑郁药组之间头痛、恶心或呕吐、激越、镇静和性功能障碍的发生率。使用倾向评分调整的 Cox 比例风险回归来估计与 SSRIs 相比,每种抗抑郁药组发生 5 种副作用的可能性,调整了人口统计学、临床和治疗特征。

结果

该研究队列包括 40017 名(13-18 岁青少年 3617 名,≥19 岁成人 36400 名;平均年龄 45 岁;67%为女性)在诊断后 30 天内接受抗抑郁药单药治疗的新发抑郁症患者(SSRIs [66%]、安非他酮 [14%]、SNRI [12%]、其他 [8%])。最常见的副作用是头痛(成人和青少年中高达每 1000 人-月 17 例)和恶心(成人中高达 7.2/1000,青少年中高达 9.3/1000)。与服用 SSRIs 的成年人相比,服用 SNRIs 的成年人恶心的风险更高(风险比 [HR] = 1.26;95%CI,1.05-1.51)。成年人(HR = 0.78;95%CI,0.62-0.96)和青少年(HR = 0.43;95%CI,0.21-0.87)服用安非他酮的头痛发生率低于分别服用 SSRIs 的成年人和青少年。与服用 SSRIs 的青少年相比,服用四环类抗抑郁药的青少年头痛的发生率更高(HR = 3.16;95%CI,1.13-8.84)。

结论

在成年人和青少年中,5 种副作用的发生率和风险在不同类型的抗抑郁药之间存在差异。本研究结果与之前的临床试验一致,表明在更广泛的管理式医疗人群中存在副作用谱的差异。

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