Frank L, Revicki D A, Sorensen S V, Shih Y C
MEDTAP International, Bethesda, Maryland 20814, USA.
CNS Drugs. 2001 Jan;15(1):59-83. doi: 10.2165/00023210-200115010-00005.
The prevalence of depression and the high costs associated with its treatment have increased interest in pharmacoeconomic evaluations of drug treatment, particularly in the 1990s as the use of selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRIs) expanded substantially. This review presents results from specific studies representing the key study designs used to address the pharmacoeconomics of SSRI use: retrospective administrative database analyses, clinical decision analysis models, and randomised clinical trials. Methodological considerations in interpreting results are highlighted. In retrospective administrative database analyses, most comparisons have been made between SSRIs and tricyclic antidepressants (TCAs). A few studies have addressed differences between SSRIs. The studies focused on healthcare cost (to payer) and cost-related outcomes (e.g. treatment duration, drug switching). Although SSRIs are generally associated with higher drug acquisition costs than are TCAs, total healthcare costs are at least offset, if not decreased, by reductions in costs associated with use of SSRIs. Although studies from the early 1990s show some advantage for fluoxetine, the results are limited by use of data from shortly after the introduction of paroxetine and sertraline; studies from the mid- 1990s on that compare drugs within the SSRI class show general equivalence in terms of cost. Important methodological advances are occurring in retrospective studies, with selection bias and other design limitations being addressed statistically. Clinical decision analysis models permit flexibility in terms of ability to specify different alternative treatment scenarios and varying durations. Sensitivity analysis aids interpretability, although model inputs are limited by data availability. Results from short term (1 year duration or less) studies comparing SSRIs and TCAs suggest that SSRIs are more cost effective or that there is no difference. Longer term studies (lifetime Markov models) focus more on the impact of maintenance antidepressant therapy and show more mixed results, generally favouring SSRIs over TCAs. The results indicate that the effect of SSRIs is mainly through prevention of relapse. Important assumptions of these models include fewer serious adverse effects and lower treatment discontinuation rates with SSRIs. Naturalistic clinical trials provide greater generalisability than traditional randomised clinical trials. One naturalistic trial found that nearly half of TCA-treated patients switched to another antidepressant within 6 months; only 20% of SSRI-treated patients switched. Cost differences between groups were minimal. These studies indicate few differences in medical costs, depression outcomes and health-related quality of life between TCAs and fluoxetine, although fewer fluoxetine-treated patients switched treatment.
抑郁症的患病率及其治疗的高昂成本引发了人们对药物治疗的药物经济学评估的兴趣，尤其是在20世纪90年代，随着选择性5-羟色胺再摄取抑制剂（SSRI）的使用大幅增加。本综述展示了代表用于解决SSRI使用药物经济学问题的关键研究设计的具体研究结果：回顾性管理数据库分析、临床决策分析模型和随机临床试验。文中强调了解读结果时的方法学考量。在回顾性管理数据库分析中，大多数比较是在SSRI和三环类抗抑郁药（TCA）之间进行的。少数研究探讨了SSRI之间的差异。这些研究聚焦于医疗保健成本（对支付方而言）和与成本相关的结果（如治疗持续时间、换药）。虽然与TCA相比，SSRI通常与更高的药品采购成本相关，但与使用SSRI相关的成本降低至少抵消了（如果没有降低的话）总医疗保健成本。尽管20世纪90年代初的研究显示氟西汀有一些优势，但结果受到帕罗西汀和舍曲林推出后不久的数据使用的限制；20世纪90年代中期及以后比较SSRI类药物的研究表明，在成本方面总体相当。回顾性研究正在取得重要的方法学进展，选择偏倚和其他设计局限性正在通过统计学方法解决。临床决策分析模型在指定不同替代治疗方案和不同持续时间的能力方面具有灵活性。敏感性分析有助于解读，尽管模型输入受到数据可用性的限制。比较SSRI和TCA的短期（持续时间为1年或更短）研究结果表明，SSRI更具成本效益，或者没有差异。长期研究（终身马尔可夫模型）更多地关注维持性抗抑郁治疗的影响，结果更为复杂，总体上更倾向于SSRI而非TCA。结果表明，SSRI的作用主要是通过预防复发。这些模型的重要假设包括SSRI的严重不良反应较少且治疗停药率较低。自然主义临床试验比传统随机临床试验具有更强的普遍性。一项自然主义试验发现，近一半接受TCA治疗的患者在6个月内换用了另一种抗抑郁药；接受SSRI治疗的患者中只有20%换用了药物。两组之间的成本差异很小。这些研究表明，TCA和氟西汀在医疗成本、抑郁结局和与健康相关的生活质量方面几乎没有差异，尽管接受氟西汀治疗的患者换药的较少。
