Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China; Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China; Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
J Ethnopharmacol. 2024 Apr 6;323:117660. doi: 10.1016/j.jep.2023.117660. Epub 2023 Dec 29.
ETHNOPHARMACOLOGICAL RELEVANCE: Many researchers have adopted resolving phlegm and unblocking fu-organs (RPUF) therapy for acute ischemic stroke (AIS) patients and yielded beneficial results in terms of clinical symptoms. However, there has been no systematically pooled analysis of RPUF therapy for AIS to date. Therefore, a well-designed systematic review and meta-analysis is necessary. AIM: This systematic review aims to determine the efficacy and safety of traditional Chinese medicine (TCM) therapy for resolving phlegm and unblocking fu-organs (RPUF) for the treatment of acute ischemic stroke (AIS). METHODS: Eight databases were searched to identify eligible randomized controlled trials (RCTs) involving RPUF therapy for AIS. The primary outcome included the modified Rankin Scale (mRS), and the secondary outcomes were the National Institute of Health Stroke Scale (NIHSS), the Neurological Deficit Score (NDS), Barthel Index (BI), Fugel-Meyer assessment (FMA), and the Glasgow Coma Scale (GCS). The Cochrane Handbook for Systematic Reviews of Interventions was used to assess risk of bias. The quantitative synthesis was analyzed using RevMan 5.3 and Stata 14.0 software. RESULTS: The systematic review and meta-analysis comprised 61 RCTs with a total of 6056 participants. RPUF prescriptions combined with usual care were superior to usual care alone in individuals with AIS, as evidenced by decreased mRS (MD＝-0.34; 95%CI [-0.65, -0.03]; P＝0.03), NIHSS (MD＝-3.38; 95%CI [-4.07, -2.68]; P＜0.00001), and NDS (MD＝-3.65; 95%CI [-4.07, -3.24]; P＜0.00001), as well as improved BI (MD＝10.4; 95%CI [8.21, 12.59]; P＜0.00001), FMA (MD＝20.41; 95%CI [17.40, 23.41]; P＜0.00001), and GCS (MD＝3.08; 95%CI [1.95, 4.20]; P＜0.00001). No significant difference was observed in the incidence of adverse effects between the RPUF therapy group and the usual care group. CONCLUSION: RPUF therapy appears to be an effective and safe approach for treating AIS; it could decrease mRS, NIHSS, and NDS while improving BI, FMA, and GCS. However, the methodological quality of the included RCTs was far from sufficient, and further high-quality, well-designed RCTs with long-term follow-up are still required.
民族药理学相关性：许多研究人员采用化痰通腑（RPUF）疗法治疗急性缺血性中风（AIS）患者，并在临床症状方面取得了有益的结果。然而，迄今为止，还没有对 RPUF 疗法治疗 AIS 的系统汇总分析。因此，有必要进行精心设计的系统评价和荟萃分析。
目的：本系统评价旨在确定中药化痰通腑（RPUF）疗法治疗急性缺血性中风（AIS）的疗效和安全性。
方法：检索了 8 个数据库，以确定涉及 RPUF 治疗 AIS 的随机对照试验（RCT）。主要结局包括改良 Rankin 量表（mRS），次要结局包括国立卫生研究院卒中量表（NIHSS）、神经功能缺损评分（NDS）、巴氏指数（BI）、Fugel-Meyer 评估（FMA）和格拉斯哥昏迷量表（GCS）。使用 Cochrane 干预措施系统评价手册评估偏倚风险。使用 RevMan 5.3 和 Stata 14.0 软件进行定量综合分析。
结果：系统评价和荟萃分析包括 61 项 RCT，共 6056 名参与者。与单纯常规治疗相比，RPUF 联合常规治疗可改善 AIS 患者的 mRS（MD＝-0.34；95%CI [-0.65, -0.03]；P＝0.03）、NIHSS（MD＝-3.38；95%CI [-4.07, -2.68]；P＜0.00001）和 NDS（MD＝-3.65；95%CI [-4.07, -3.24]；P＜0.00001），以及 BI（MD＝10.4；95%CI [8.21, 12.59]；P＜0.00001）、FMA（MD＝20.41；95%CI [17.40, 23.41]；P＜0.00001）和 GCS（MD＝3.08；95%CI [1.95, 4.20]；P＜0.00001）。RPUF 治疗组与常规治疗组的不良反应发生率无显著差异。
结论：RPUF 疗法似乎是治疗 AIS 的一种有效且安全的方法；它可以降低 mRS、NIHSS 和 NDS，同时改善 BI、FMA 和 GCS。然而，纳入的 RCT 的方法学质量远非足够，仍需要进一步进行高质量、精心设计的长期随访 RCT。
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