Faculty of Chinese Medicine and State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Taipa, Macau, China; National Traditional Chinese Medicine Clinical Research Base and Department of Cardiovascular, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, China.
Department of Neurology, Hospital (T.C.M) Affiliated to Southwest Medical University, Luzhou, Sichuan, China.
Phytomedicine. 2021 Jun;86:153566. doi: 10.1016/j.phymed.2021.153566. Epub 2021 Apr 9.
Zhilong Huoxue Tongyu capsule (ZL) is a Chinese patent medicine and used for the treatment of acute cerebral infarction (ACI) and its clinical application has gradually been widely recognized in China. However, the effects of ZL for patients with ACI have never been systematically evaluated.
A systematic review and meta-analysis was performed to evaluate the efficacy of ZL in ACI.
A systematic review and meta-analysis of randomized clinical trials (RCTs).
A systematic review and meta-analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The comprehensive literature search was accomplished in 6 electronic databases to find relevant randomized controlled trials from their inception until October 31, 2020. The Cochrane Handbook for Systematic Reviews of Interventions was used for methodological quality and independent evaluation. Review Manager 5.3 was used to analyze all the data obtained. The Clinical Effective Rate (CER) was the primary outcome, and the National Institutes of Health Stroke Score (NIHSS), Barthel Index (BI), and Modified Rankin Scale (MRS) were the secondary outcomes.
Seven clinical studies recruiting 571 eligible patients were included in this meta-analysis. The results of meta-analysis suggested that compared with conventional treatment alone, ZL combined with conventional treatment significantly improved CER (RR = 1.20, 95% CI: 1.12-1.29, p < 0.00001), decrease National Institutes of Health Stroke Scale Score (NIHSS) (MD = -2.60, 95% CI: -3.41-1.79, p < 0.00001), Barthel Index (BI) (MD = -9.75, 95% CI: 7.15-12.36, p < 0.00001) and Modified Rankin Scale (MRS) (MD = -0.57, 95% CI: -0.84-0.30, p < 0.00001). There were no reported adverse events in the studies. Most results were robust and the quality of evidence was from moderate to low.
ZL combined with conventional treatment can improve the short-term outcomes of ACI patients, indicating ZL is a promising treatment choice for ACI and may be used as adjunctive treatment to the conventional treatment of ACI. However, due to the limitations of included clinical trials, high-quality clinical trials with longer follow-ups are still needed to further assess the effectiveness and safety of ZL for ACI patients.
蛭龙活血通瘀胶囊（ZL）是一种中药，用于治疗急性脑梗死（ACI），其临床应用在中国逐渐得到广泛认可。然而，ZL 治疗 ACI 的疗效尚未得到系统评价。
系统评价和荟萃分析评估 ZL 治疗 ACI 的疗效。
随机对照试验（RCT）的系统评价和荟萃分析。
按照系统评价和荟萃分析的首选报告项目进行系统评价和荟萃分析。全面文献检索在 6 个电子数据库中进行，以查找从成立到 2020 年 10 月 31 日的相关随机对照试验。采用 Cochrane 干预系统评价手册对方法学质量和独立评估进行评价。使用 Review Manager 5.3 分析所有获得的数据。临床有效率（CER）是主要结局，国立卫生研究院卒中量表（NIHSS）、巴氏指数（BI）和改良 Rankin 量表（MRS）是次要结局。
本荟萃分析纳入了 7 项临床研究，共招募了 571 名合格患者。荟萃分析结果表明，与单纯常规治疗相比，ZL 联合常规治疗显著提高了 CER（RR=1.20，95%CI：1.12-1.29，p<0.00001），降低了 NIHSS 评分（MD=-2.60，95%CI：-3.41-1.79，p<0.00001）、BI（MD=-9.75，95%CI：7.15-12.36，p<0.00001）和 MRS（MD=-0.57，95%CI：-0.84-0.30，p<0.00001）。研究中未报告不良反应。大多数结果是稳健的，证据质量从中等到低。
ZL 联合常规治疗可改善 ACI 患者的短期结局，表明 ZL 是治疗 ACI 的一种有前途的治疗选择，可作为 ACI 常规治疗的辅助治疗。然而，由于纳入临床试验的局限性，仍需要进行高质量、随访时间更长的临床试验，以进一步评估 ZL 治疗 ACI 患者的疗效和安全性。
