Usher Institute, The University of Edinburgh, Edinburgh, UK.
Department of Chemistry, Oxford University, Oxford, UK.
Int J Stroke. 2023 Oct;18(9):1071-1083. doi: 10.1177/17474930231196648. Epub 2023 Sep 7.
Post-stroke fatigue (PSF) affects around 50% of stroke survivors. Previous systematic reviews of randomized controlled trials found insufficient evidence to guide practice, but most excluded Chinese studies. Furthermore, their searches are now out-of-date.
To systematically review and perform a meta-analysis of randomized placebo-controlled trials of pharmacological interventions for treating PSF.
We screened Airitri, CNKI, VIP, CINAHL, ClinicalTrials.gov, CENTRAL, Cochrane Stroke Group Trial Register, EMBASE, EU Clinical Trial Register, ISRCTN, MEDLINE, PsycINFO, Wanfang, and WHO ICTRP up to 11 November 2022. Our primary outcome was fatigue severity. We conducted subgroup analysis by drug type and sensitivity analysis after excluding the trials at high risk of bias. Secondary outcomes included mood and quality of life.
We screened 33,297 citations and identified 10 published completed trials, 6 unpublished completed trials, and 6 ongoing trials. Pharmacological treatments were associated with lower fatigue severity at the end of treatment (10 published completed trials, 600 participants, pooled standardized mean difference (SMD) = -0.80, 95% confidence interval (CI): -1.29 to -0.31; I = 86%, p < 0.00001), but not at follow-up (265 participants, pooled SMD = -0.14, 95% CI: -0.38 to 0.10; I = 0, p = 0.51). However, these trials were small and had considerable risk of bias. Beneficial effects were seen in trials with low risk of bias on randomization, missing outcome data, and reporting bias. There were insufficient data on secondary outcomes for meta-analysis, but six trials reported improved quality of life.
There is insufficient evidence to support a particular pharmacological treatment for PSF, thus current clinical guidelines do not require amendment.
中风后疲劳（PSF）影响约 50%的中风幸存者。先前对随机对照试验的系统评价发现，没有足够的证据来指导实践，但大多数研究都排除了中国的研究。此外，他们的搜索现在已经过时了。
系统评价和荟萃分析治疗 PSF 的药物干预的随机安慰剂对照试验。
我们筛选了 Airitri、CNKI、VIP、CINAHL、ClinicalTrials.gov、CENTRAL、Cochrane 中风组试验登记处、EMBASE、EU 临床试验登记处、ISRCTN、MEDLINE、PsycINFO、万方和世界卫生组织 ICTRP，截至 2022 年 11 月 11 日。我们的主要结局是疲劳严重程度。我们按药物类型进行了亚组分析，并在排除高偏倚风险的试验后进行了敏感性分析。次要结局包括情绪和生活质量。
我们筛选了 33297 条引文，确定了 10 项已发表的完成试验、6 项未发表的完成试验和 6 项正在进行的试验。药物治疗与治疗结束时的疲劳严重程度降低相关（10 项已发表的完成试验，600 名参与者，汇总标准化均数差（SMD）=-0.80，95%置信区间（CI）：-1.29 至 -0.31；I=86%，p<0.00001），但在随访时无相关性（265 名参与者，汇总 SMD=-0.14，95%CI：-0.38 至 0.10；I=0，p=0.51）。然而，这些试验规模较小，存在较大的偏倚风险。在随机分组、结局数据缺失和报告偏倚风险较低的试验中观察到了有益的效果。对于荟萃分析，次要结局的数据不足，但有 6 项试验报告了生活质量的改善。
没有足够的证据支持 PSF 的特定药物治疗，因此目前的临床指南不需要修改。
