Xu Na, Song Zaiwei, Jiang Dan, Zhao Rongsheng
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Department of Pharmacy, Hebei Provincial Mental Health Center, Baoding, China.
Front Psychiatry. 2023 Apr 27;14:1144573. doi: 10.3389/fpsyt.2023.1144573. eCollection 2023.
Within the framework of individualized psychopharmacotherapy, therapeutic drug monitoring (TDM) has gained increasing relevance. In the absence of high-quality evidence, the TDM of citalopram (CIT) and the recommended therapeutic ranges of the plasma concentrations have been proposed by guidelines. However, the correlation between the plasma concentration of CIT and treatment outcomes has not been well established. Therefore, the aim of this systematic review was to evaluate the relationship between plasma CIT concentration and treatment outcomes in depression.
PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Chinese databases (CNKI, Wanfang Data and Sinomed) were searched up to August 6, 2022. We included clinical studies evaluating the correlation between the plasma CIT concentration and treatment outcomes in patients with depression receiving CIT treatment. Outcomes measured included efficacy, safety, medication adherence, and cost-related outcomes. A narrative synthesis was performed to summarize findings from individual studies. This study was performed according to the Preferred Reporting Items for Systematic Reviews, Meta-Analysis (PRISMA) and the reporting guideline for Synthesis without meta-analysis (SWiM).
Eleven studies involving 538 patients were included in total. The reported outcomes were mainly efficacy ( = 11) and safety ( = 3); one study reported the duration of hospitalization, and no study reported medication adherence. Regarding the efficacy outcomes, three studies revealed the plasma CIT concentration-response relationship and proposed a lower limit of 50 or 53 ng/mL, whereas this was not found in the rest of the studies. Regarding adverse drug events (ADEs), one study reported more ADEs in the low-concentration group (<50 ng/mL vs. >50 ng/mL), which is not convincing from the perspective of pharmacokinetics/pharmacodynamics. Regarding the cost-related outcomes, only one study reported that the high CIT concentration group (≥50 ng/mL) contributed to shortening the hospitalization duration, but it did not provide detailed information, including direct medical expenses and multiple potential factors contributing to longer hospital stays.
A definite correlation between plasma concentration and clinical or cost-related outcomes of CIT cannot be drawn, whereas a tendency toward improved efficacy in patients with plasma concentration above 50 or 53 ng/mL was suggestive from limited evidence.
在个体化心理药物治疗的框架内，治疗药物监测（TDM）的相关性日益增加。在缺乏高质量证据的情况下，指南提出了西酞普兰（CIT）的TDM及血浆浓度的推荐治疗范围。然而，CIT血浆浓度与治疗结果之间的相关性尚未得到充分确立。因此，本系统评价的目的是评估抑郁症患者血浆CIT浓度与治疗结果之间的关系。
检索截至2022年8月6日的PubMed、Embase、Cochrane对照试验中心注册库（CENTRAL）和中文数据库（CNKI、万方数据和中国生物医学文献数据库）。我们纳入了评估接受CIT治疗的抑郁症患者血浆CIT浓度与治疗结果之间相关性的临床研究。测量的结果包括疗效、安全性、药物依从性和成本相关结果。进行叙述性综合以总结个体研究的结果。本研究按照系统评价和Meta分析的首选报告项目（PRISMA）以及非Meta分析的综合报告指南（SWiM）进行。
共纳入11项研究，涉及538例患者。报告的结果主要是疗效（n = 11）和安全性（n = 3）；一项研究报告了住院时间，没有研究报告药物依从性。关于疗效结果，三项研究揭示了血浆CIT浓度-反应关系，并提出下限为50或53 ng/mL，而其他研究未发现此关系。关于药物不良事件（ADEs），一项研究报告低浓度组（<50 ng/mL与>50 ng/mL）的ADEs更多，从药代动力学/药效学角度来看，这并不令人信服。关于成本相关结果，只有一项研究报告高CIT浓度组（≥50 ng/mL）有助于缩短住院时间，但未提供详细信息，包括直接医疗费用和导致住院时间延长的多个潜在因素。
无法得出CIT血浆浓度与临床或成本相关结果之间的确切相关性，而有限的证据表明血浆浓度高于50或53 ng/mL的患者疗效有改善趋势。
