Zhao Shuang, Zheng Hong, Du Yawei, Zhang Runlei, Chen Peilin, Ren Rong, Wu Shengxian
Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5, Haiyuncang, Dongcheng District, Beijing 100700, China.
First Clinical Medical School, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing 100029, China.
Evid Based Complement Alternat Med. 2021 Dec 9;2021:4265219. doi: 10.1155/2021/4265219. eCollection 2021.
leaf preparations (GLPs) are widely used in ischemic stroke, and uncertainty remains regarding their clinical efficacy. To evaluate systematically the clinical efficacy and safety of GLPs in the treatment of ischemic stroke, we examine evidence from randomized controlled trials (RCTs).
We examine studies published prior to November 2021 that were found from searching the following sources: PubMed, China National Knowledge Infrastructure (CNKI), WANFANG DATA, Chongqing VIP (CQVIP) databases, and Chinese Biomedical Literature (CBM). We evaluated the quality of the included references according to the Cochrane Manual of Systematic Evaluation and Meta-analysis (MA) performed using RevMan 5.2 software.
We included a total of 13 RCTs with clinical therapeutic effects, the National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), hemorheology index, and adverse reaction index as evaluation criteria. There were 631 cases in the observation group and 629 cases in the control group. MA results showed the following: NIHSS WMD = -3.89, 95% CI: [-4.22, -3.56], = 19%, < 0.00001. This index is often used with nerve injury and can also be used to judge the recovery of nerve function. A lower score means less nerve damage and a better chance of recovery. The BI results were WMD = 11.30, 95% CI: [9.83, 12.77], = 7%, < 0.00001. This index was used to assess patients' ability to take care of themselves, with a higher score indicating a stronger ability to live independently. Clinical effective rate results were WMD = 3.79, 95% CI: [2.49, 5.78], = 0%, < 0.00001, and this measure can be used to evaluate the effect of treatment clearly and objectively. Hemorheological index results show that plasma viscosity has WMD = -0.16, 95% CI: [-0.20, -0.12], = 40%, < 0.00001 and fibrinogen (FIB) has WMD = -1.13, 95% CI: [-1.23, -1.04], = 0%, < 0.00001. Plasma viscosity is mainly related to the amount of fibrinogen, and fibrinogen degradation is an important function of the fibrinolytic system. The imbalance of the fibrinolytic system plays an important role in the pathogenesis of cerebral infarction. Fibrinogen is a risk factor of ischemic cerebrovascular disease. Studies have shown that the infarct size of patients with secondary cerebral infarction after CEREBRAL infarction is correlated with their FIB level. In addition, FIB elevation is also one of the risk factors for early infarction after thrombolysis. Therefore, FIB can be used as a detection index for the prevention of cerebral infarction recurrence adverse reactions. Our MA results for FIB show WMD = 0.81, 95% CI: [0.38, 1.73], = 0%, = 0.58, and RR < 1.
The existing clinical evidence shows that GLP has a good therapeutic effect on patients with ischemic stroke and can improve their hemorheology indices. In addition, GLP is shown to be relatively safe.
银杏叶制剂（GLPs）广泛应用于缺血性卒中，但其临床疗效仍存在不确定性。为系统评价GLPs治疗缺血性卒中的临床疗效和安全性，我们检索了随机对照试验（RCTs）的证据。
我们检索了2021年11月之前发表的研究，检索来源包括：PubMed、中国知网（CNKI）、万方数据、重庆维普（CQVIP）数据库和中国生物医学文献数据库（CBM）。我们根据Cochrane系统评价和Meta分析手册评估纳入文献的质量，并使用RevMan 5.2软件进行Meta分析。
我们共纳入13项具有临床治疗效果的RCTs，以美国国立卫生研究院卒中量表（NIHSS）、Barthel指数（BI）、血液流变学指标和不良反应指数作为评价标准。观察组631例，对照组629例。Meta分析结果显示：NIHSS加权均数差（WMD）=-3.89，95%置信区间（CI）：[-4.22，-3.56]，I²=19%，P<0.00001。该指标常用于评估神经损伤，也可用于判断神经功能恢复情况。分数越低，神经损伤越小，恢复机会越大。BI结果为WMD=11.30，95%CI：[9.83，12.77]，I²=7%，P<0.00001。该指标用于评估患者的自理能力，分数越高表明独立生活能力越强。临床有效率结果为WMD=3.79，95%CI：[2.49，5.78]，I²=0%，P<0.00001，该指标可清晰、客观地评估治疗效果。血液流变学指标结果显示，血浆黏度WMD=-0.16，95%CI：[-0.20，-0.12]，I²=40%，P<0.00001；纤维蛋白原（FIB）WMD=-1.13，95%CI：[-1.23，-1.04]，I²=0%，P<0.00001。血浆黏度主要与纤维蛋白原含量有关，纤维蛋白原降解是纤溶系统的重要功能。纤溶系统失衡在脑梗死发病机制中起重要作用。纤维蛋白原是缺血性脑血管病的危险因素。研究表明，脑梗死继发脑梗死患者的梗死灶大小与其FIB水平相关。此外，FIB升高也是溶栓后早期梗死的危险因素之一。因此，FIB可作为预防脑梗死复发不良反应的检测指标。我们对FIB的Meta分析结果显示WMD=0.81，95%CI：[0.38，1.73]，I²=0%，P=0.58，相对危险度（RR）<1。
现有临床证据表明，GLP对缺血性卒中患者具有良好的治疗效果，可改善其血液流变学指标。此外，GLP显示相对安全。
