Jiang Chao, Yang Xiaojuan, Dong Ju, Li Guochun
Department of Public Health, Nanjing University of Chinese Medicine, Nanjing, China.
Front Pharmacol. 2020 Apr 15;11:437. doi: 10.3389/fphar.2020.00437. eCollection 2020.
As a traditional Chinese medicine (TCM) prescription for acute stroke, Liangxue Tongyu formula (LXTYF) was widely used as auxiliary treatment measure in some clinical practice. This study aimed to evaluate the clinical efficacy and safety of LXTYF combined western conventional medicine (WCM) with WCM only for acute intracerebral hemorrhage (ICH).
We systematically searched PubMed, Embase, Cochrane Library, CMB (Chinese biomedicine database), CNKI (China National Knowledge Infrastructure), WanFang, and VIP until August 2019 to confirm relevant randomized controlled trials (RCTs) compared the combination of LXTYF and WCM with WCM alone for the treatment of acute ICH. Two investigators independently assessed the risk of bias, and extracted and analyzed the data from the identified studies using RevMan 5.3.0 software following Cochrane's standard and PRISMA guidelines. The herbal compositions of LXTYF were also assessed.
15 RCTs were identified, totally recruiting 1648 patients with acute intracerebral hemorrhage. Compared with the WCM alone, the combination therapy of LXTYF with WCM could improve the clinical effective rate (, 1.21; 95% CI, 1.15-1.25, < 0.05) and ADL score (MD, 18.09; 95% CI, 12.11-24.07; < 0.05), and reduce syndrome scores of the TCM (MD, -4.11; 95% , -4.69 to -3.53; < 0.05) and the Glasgow outcome score(GOS) (=0.43, 95%: 0.06 to 0.79, =0.02) Moreover, there was no sufficient evidence to indicate the adverse effects would increase compared with WCM alone.
Based on current evidence, we concluded that the combined therapy had some benefits in treating acute intracerebral hemorrhage. However, considering the potential biases and limitations of our study, additional large, high-quality RCTs are required in the future to confirm or refute the effects of LFTYF combined with WCM in acute stroke.
凉血通瘀方(LXTYF)作为治疗急性脑卒中的中药方剂,在一些临床实践中被广泛用作辅助治疗措施。本研究旨在评估凉血通瘀方联合西药(WCM)与单纯西药治疗急性脑出血(ICH)的临床疗效和安全性。
我们系统检索了截至2019年8月的PubMed、Embase、Cochrane图书馆、中国生物医学数据库(CMB)、中国知网(CNKI)、万方和维普,以确认比较凉血通瘀方联合西药与单纯西药治疗急性脑出血的相关随机对照试验(RCT)。两名研究者独立评估偏倚风险,并按照Cochrane标准和PRISMA指南,使用RevMan 5.3.0软件从纳入研究中提取和分析数据。还对凉血通瘀方的草药成分进行了评估。
共纳入15项RCT,共招募1648例急性脑出血患者。与单纯西药相比,凉血通瘀方联合西药治疗可提高临床有效率(RR,1.21;95%CI,1.15 - 1.25,P < 0.05)和日常生活活动能力(ADL)评分(MD,18.09;95%CI,12.11 - 24.07;P < 0.05),降低中医证候评分(MD, - 4.11;95%CI, - 4.69至 - 3.53;P < 0.05)和格拉斯哥预后评分(GOS)(RR = 0.43,95%CI:0.06至0.79,P = 0.02)。此外,没有足够证据表明与单纯西药相比不良反应会增加。
基于现有证据,我们得出联合治疗在治疗急性脑出血方面有一定益处的结论。然而,考虑到本研究潜在的偏倚和局限性,未来需要更多大规模、高质量的RCT来证实或反驳凉血通瘀方联合西药在急性脑卒中中的疗效。