Lin Wenjian, Hou Jingjing, Han Tianxiong, Zheng Li, Liang Huazheng, Zhou Xiaoyu
Department of Neurology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.
Tongji University School of Medicine, Shanghai, China.
Front Pharmacol. 2022 Sep 28;13:942657. doi: 10.3389/fphar.2022.942657. eCollection 2022.
Although blood-activating Chinese medicine (BACM) has been reported as adjuvant therapy for intracranial hemorrhage (ICH) in China, high-quality evidence is still lacking. Our study aimed to collect the latest high-quality randomized controlled trials (RCTs) and to evaluate the efficacy and safety of BACM for ICH. RCTs published between January 2015 and March 2022 were searched in databases, including China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Sino-Med, Wanfang, PubMed, Web of Science, Cochrane Library, and Embase without language restrictions. Eligible RCTs were included and both primary (clinical efficacy evidenced by decreased neurological deficit scores) and secondary outcomes (increased Barthel index, decreased NIHSS, hematoma volume, the volume of cerebral edema, the incidence of side effects, and mortality) were analyzed. The quality of included RCTs was assessed using the Cochrane risk of bias tool. In the meta-analysis, the pooled results were analyzed using Review Manager 5.3 and STATA14.0. Finally, The GRADEpro GDT software (Guideline Development Tool) was used to summarize the results. Sensitivity and subgroup analyses were conducted based on the follow-up time. Fifteen RCTs, involving 1,579 participants, were included for analysis in our study. The pooled outcomes indicated that BACM combined with western medicine treatment (WMT) was superior to WMT alone for patients with ICH, demonstrated by the improvements in efficacy (RR = 1.22 (95% CI, [1.13 to 1.32], < 0.001), neurological functions (MD = -2.75, 95% CI [-3.74 to -1.76], < 0.001), and activities of daily living (MD = 5.95, 95% CI [3.92 to 7.98], < 0.001), as well as decreased cerebral hematoma, cerebral edema (MD cerebral hematoma = -2.94, 95% CI [-3.50 to -2.37, < 0.001 and MD = -2.66, 95% CI [-2.95 to -2.37], < 0.001), side effects and mortality (RR = 0.84 (95% CI [0.60 to 1.19], = 0.330 and RR = 0.51 (95% CI, [0.16 to 1.65], = 0.260). In addition, [Apiaceae], [Theaceae], and (Nakai) C.D.Chu [Apiaceae]) were the most frequently used herbs in the treatment of ICH. Recently, there was a trend toward the extensive use of another two herbs, including [Polygonaceae], [Fabaceae]) for ICH. BACM combined with WMT seems to be superior to WMT alone for patients with ICH. Further high-quality RCTs are warranted to confirm the efficacy and safety of BACM.
尽管在中国，活血化瘀类中药已被报道可作为颅内出血（ICH）的辅助治疗方法，但仍缺乏高质量证据。我们的研究旨在收集最新的高质量随机对照试验（RCT），并评估活血化瘀类中药治疗ICH的疗效和安全性。在包括中国知网（CNKI）、维普中文科技期刊数据库（VIP）、中国生物医学文献数据库（Sino-Med）、万方数据库、PubMed、科学引文索引（Web of Science）、考克兰图书馆和Embase等数据库中检索了2015年1月至2022年3月发表的RCT，检索无语言限制。纳入符合条件的RCT，并对主要结局（通过神经功能缺损评分降低证明的临床疗效）和次要结局（Barthel指数增加、美国国立卫生研究院卒中量表（NIHSS）降低、血肿体积、脑水肿体积、副作用发生率和死亡率）进行分析。使用Cochrane偏倚风险工具评估纳入RCT的质量。在荟萃分析中，使用Review Manager 5.3和STATA14.0对汇总结果进行分析。最后，使用GRADEpro GDT软件（指南制定工具）总结结果。基于随访时间进行敏感性和亚组分析。本研究纳入了15项RCT，涉及1579名参与者进行分析。汇总结果表明，对于ICH患者，活血化瘀类中药联合西医治疗（WMT）优于单纯WMT，疗效（风险比（RR）=1.22（95%置信区间，[1.13至1.32]，<0.001））、神经功能（平均差（MD）=-2.75，95%置信区间[-3.74至-1.76]，<0.001））和日常生活活动能力（MD=5.95，95%置信区间[3.92至7.98]，<0.001）均有改善，同时脑血肿、脑水肿减少（脑血肿MD=-2.94，95%置信区间[-3.50至-2.37]，<0.001；脑水肿MD=-2.66，95%置信区间[-2.95至-2.37]，<0.001），副作用和死亡率降低（RR=0.8（95%置信区间[0.60至1.19]，P=0.330）和RR=0.51（95%置信区间，[0.16至1.65]，P=0.260））。此外，[伞形科]、[山茶科]和（中井）C.D.朱[伞形科]）是治疗ICH最常用的草药。最近，另外两种草药[蓼科]、[豆科]）在ICH治疗中的使用有广泛应用的趋势。对于ICH患者，活血化瘀类中药联合WMT似乎优于单纯WMT。需要进一步的高质量RCT来证实活血化瘀类中药治疗的疗效和安全性。
