Shen Wei, Fan Xueming, Wang Liuding, Zhang Yunling
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Front Pharmacol. 2022 Feb 14;13:816333. doi: 10.3389/fphar.2022.816333. eCollection 2022.
Post-stroke cognitive impairment (PSCI) affects more than one-third of stroke patients, and causes much greater harm to long-term function than the initial brain damage. No conventional Western medications have shown convincing clinical effectiveness for treating PSCI. Research shows that Traditional Chinese medicine (TCM) can improve cognitive function in patients. However, the clinical efficacy and safety remain controversial. The aim of this study was to examine the effectiveness and harmful effects of TCMs in the treatment of PSCI. We searched seven databases and two clinical registration websites for randomized controlled trials (RCTs). The revised Cochrane risk of bias tool (RoB 2.0) was used to evaluate the methodological quality and RevMan 5.4 was used for data analysis. This study has been submitted to PROSPERO with registration number is CRD42020149299. We included 34 studies in this review. The results of this study showed that TCM adjuvant therapy improved scores on the MoCA [MD = 2.55, 95% CI (1.56, 3.53), < 0.00001; MD = 3.07, 95% CI (1.98, 4.17), < 0.00001 at treatment duration of <3 and 3 months, respectively], MMSE [MD = 2.55, 95% CI (1.99, 3.10), < 0.00001; MD = 2.53, 95% CI (1.59, 3.47), < 0.00001; MD = 2.91, 95% CI (1.26, 4.56), = 0.0006; MD = 3.11, 95% CI (-0.04, 6.27), = 0.05 at treatment duration of <3, 3, 4, and 6 months, respectively], and BI [MD = 7.34, 95% CI (3.83, 10.85), < 0.0001; MD = 8.98, 95% CI (4.76, 13.21), < 0.0001 at treatment duration of <3 and 3 months, respectively] and reduced scores on the ADL (MD = -8.64, 95% CI (-9.83, -7.45), < 0.00001; MD = -2.00, 95% CI (-2.94, -1.06), < 0.0001 at treatment duration of 3 and 4 months, respectively], NIHSS [MD = -2.48, 95% CI (-4.97, 0.00), = 0.05; MD = -3.81, 95% CI (-6.21, -1.40), = 0.002 at treatment duration of <3 and 3 months, respectively], and CSS [MD = -2.47, 95% CI (-3.49, -1.45), < 0.00001 at a treatment duration of 3 months]. No serious adverse reactions were observed. Despite the significant positive results, the present evidence supports, to a limited extent because of the methodological flaws and herbal heterogeneity, that TCM adjuvant therapy can be used for patients with PSCI. While, further rigorous RCTs are warranted to confirm the efficacy and safety of TCM. https://www.crd.york.ac.uk/prospero, identifier CRD42020149299.
中风后认知障碍（PSCI）影响超过三分之一的中风患者，且对长期功能造成的损害远大于最初的脑损伤。尚无传统西药在治疗PSCI方面显示出令人信服的临床疗效。研究表明，中药可改善患者的认知功能。然而，其临床疗效和安全性仍存在争议。本研究旨在探讨中药治疗PSCI的有效性和有害作用。我们检索了七个数据库和两个临床注册网站以查找随机对照试验（RCT）。使用修订后的Cochrane偏倚风险工具（RoB 2.0）评估方法学质量，并使用RevMan 5.4进行数据分析。本研究已提交至国际前瞻性系统评价注册库（PROSPERO），注册号为CRD42020149299。我们在本综述中纳入了34项研究。本研究结果表明，中药辅助治疗在治疗时长分别小于3个月和3个月时，改善了蒙特利尔认知评估量表（MoCA）得分[MD = 2.55，95%CI（1.56，3.53），P < 0.00001；MD = 3.07，95%CI（1.98，4.17），P < 0.00001]、简易精神状态检查表（MMSE）得分[治疗时长分别小于3个月、3个月、4个月和6个月时，MD = 2.55，95%CI（1.99，3.10），P < 0.00001；MD = 2.53，95%CI（1.59，3.47），P < 0.00001；MD = 2.91，95%CI（1.26，4.56），P = 0.0006；MD = 3.11，95%CI（-0.04，6.27），P = 0.05]以及巴氏指数（BI）得分[治疗时长分别小于3个月和3个月时，MD = 7.34，95%CI（3.83，10.85），P < 0.0001；MD = 8.98，95%CI（4.76，13.21），P < 0.0001]，并降低了日常生活活动能力（ADL）得分[治疗时长分别为3个月和4个月时，MD = -8.64，95%CI（-9.83，-7.45），P < 0.00001；MD = -2.00，95%CI（-2.94，-1.06），P < 0.0001]、美国国立卫生研究院卒中量表（NIHSS）得分[治疗时长分别小于3个月和3个月时，MD = -2.48，95%CI（-4.97，0.00），P = 0.05；MD = -3.81，95%CI（-6.21，-1.40），P = 0.002]以及中国卒中量表（CSS）得分[治疗时长为3个月时，MD = -2.47，95%CI（-3.49，-1.45），P < 0.00001]。未观察到严重不良反应。尽管结果呈显著阳性，但由于方法学缺陷和草药异质性，目前的证据仅在有限程度上支持中药辅助治疗可用于PSCI患者。同时，仍需要进一步严格的随机对照试验来证实中药的疗效和安全性。https://www.crd.york.ac.uk/prospero，标识符CRD42020149299
