Shao Huikai, He Xia, Zhang Lijuan, Du Shan, Yi Xiaoqing, Cui Xiaojiao, Liu Xinxia, Huang Shengfeng, Tong Rongsheng
Department of Pharmacy, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital, Chengdu, China.
Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Front Pharmacol. 2021 Nov 22;12:761722. doi: 10.3389/fphar.2021.761722. eCollection 2021.
Ligustrazine injection has been widely used as adjunctive therapy in the treatment of acute cerebral infarction (ACI) during the past decades in China, but its clinical efficacy is not yet well confirmed. This study aims to evaluate the efficacy of ligustrazine injection as adjunctive therapy for ACI. Databases including China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), PubMed, Medline, Google Scholar, Chinese Biomedical Literature Database, Cochrane Library, Embase, Sino-Med, Wanfang Database, and Chinese Science Citation Database were systematically searched for the published randomized controlled trials (RCTs) on ligustrazine injection in the treatment of ACI until November 2020. Meta-analysis was performed on the primary outcome measure (i.e., clinical effective rate) and the secondary outcome measure [i.e., neurological deficit score (NDS), fibrinogen, low shear blood viscosity (LBV), and high shear blood viscosity (HBV)]. The quality of the included RCTs was assessed according to the M scoring system (the refined Jadad scale). Sensitivity analysis and subgroup analysis were conducted according to the methodological quality, years of publication, and sample size. Nineteen RCTs, containing 2022 patients, were included in this study. Meta-analysis indicated that ligustrazine injection combined with Western medicine could achieve a better effect in the treatment of ACI than using Western medicine alone in terms of clinical effective rate (RR = 1.24; 95% CI, 1.19-1.29), NDS (MD = -3.88; 95%CI, -4.51 to -3.61), fibrinogen (MD = -0.59; 95% CI, -0.76 to -0.42), LBV (MD = -2.11; 95% CI, -3.16 to -1.06), and HBV (MD = -0.88; 95% CI, -1.20 to -0.55). This research indicated that ligustrazine injection as adjunctive therapy seemed to be more effective than using western medicine alone in treating ACI. However, more evidence is required to confirm the efficacy of ligustrazine injection due to the low methodological quality of the included RCTs.
在过去几十年里,川芎嗪注射液在中国已被广泛用作急性脑梗死(ACI)治疗的辅助疗法,但其临床疗效尚未得到充分证实。本研究旨在评估川芎嗪注射液作为ACI辅助治疗的疗效。系统检索了包括中国知网(CNKI)、维普中文科技期刊数据库(VIP)、PubMed、Medline、谷歌学术、中国生物医学文献数据库、考克兰图书馆、Embase、中国生物医学文献服务系统、万方数据库和中国科学引文数据库在内的数据库,以查找截至2020年11月发表的关于川芎嗪注射液治疗ACI的随机对照试验(RCT)。对主要结局指标(即临床有效率)和次要结局指标[即神经功能缺损评分(NDS)、纤维蛋白原、低切变率全血粘度(LBV)和高切变率全血粘度(HBV)]进行荟萃分析。根据M评分系统(改良的Jadad量表)评估纳入RCT的质量。根据方法学质量、发表年份和样本量进行敏感性分析和亚组分析。本研究纳入了19项RCT,共2022例患者。荟萃分析表明,在临床有效率(RR = 1.24;95%CI,1.19 - 1.29)、NDS(MD = -3.88;95%CI,-4.51至-3.61)、纤维蛋白原(MD = -0.59;95%CI,-0.76至-0.42)、LBV(MD = -2.11;95%CI,-3.16至-1.06)和HBV(MD = -0.88;95%CI,-1.20至-0.55)方面,川芎嗪注射液联合西药治疗ACI的效果优于单纯使用西药。本研究表明,川芎嗪注射液作为辅助治疗在ACI治疗中似乎比单纯使用西药更有效。然而,由于纳入的RCT方法学质量较低,需要更多证据来证实川芎嗪注射液的疗效。