DataSheet1_Efficacy of Ligustrazine Injection as Adjunctive Therapy in Treating Acute Cerebral Infarction: A Systematic Review and Meta-Analysis.docx

Background: 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.
Methods: 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.
Results: 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).
Conclusions: 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.

背景：近数十年来，川芎嗪注射液（Ligustrazine injection）在我国被广泛用作急性脑梗死（acute cerebral infarction, 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急性脑梗死辅助治疗方案的疗效。
方法：系统检索截至2020年11月的中国知网（CNKI, China National Knowledge Infrastructure）、中国科技期刊数据库（VIP, China Science and Technology Journal Database）、PubMed、Medline、谷歌学术（Google Scholar）、中国生物医学文献数据库（Chinese Biomedical Literature Database）、Cochrane图书馆、Embase、Sino-Med、万方数据库（Wanfang Database）以及中国科学引文数据库，搜集关于川芎嗪注射液治疗急性脑梗死的已发表随机对照试验（randomized controlled trials, RCTs）。以临床有效率为主要结局指标，以神经功能缺损评分（neurological deficit score, NDS）、纤维蛋白原、低切全血黏度（low shear blood viscosity, LBV）及高切全血黏度（high shear blood viscosity, HBV）为次要结局指标，开展Meta分析。依据改良Jadad量表（the refined Jadad scale）对纳入的随机对照试验进行质量评价。根据研究方法学质量、发表年份及样本量进行敏感性分析与亚组分析。
结果：本研究共纳入19项随机对照试验，涉及2022例患者。Meta分析结果显示，相较于单纯西医（Western medicine）治疗，川芎嗪注射液联合西医治疗急性脑梗死在临床有效率（相对危险度（Relative Risk, RR）=1.24；95%置信区间（95% CI）：1.19~1.29）、神经功能缺损评分（均数差（Mean Difference, MD）=-3.88；95% CI：-4.51~-3.61）、纤维蛋白原（MD=-0.59；95% CI：-0.76~-0.42）、低切全血黏度（MD=-2.11；95% CI：-3.16~-1.06）及高切全血黏度（MD=-0.88；95% CI：-1.20~-0.55）方面均表现更优。
结论：本研究表明，川芎嗪注射液作为辅助疗法治疗急性脑梗死的疗效优于单纯西医治疗。但由于纳入的随机对照试验方法学质量较低，仍需更多研究证据以证实川芎嗪注射液的临床疗效。