Li Yunze, Yao Yangjing, Cao Xinran, Yi Nan, Chen Anqi, Li Jianjun, Wu Minghua
Jiangsu Provincial Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Nanjing University of Chinese Medicine, Nanjing, China.
Front Aging Neurosci. 2023 Jan 20;14:1090665. doi: 10.3389/fnagi.2022.1090665. eCollection 2022.
Danshen preparations are widely used in the treatment of ischaemic cerebrovascular disease. However, the clinical efficacy of such preparations remains unclear. Consequently, Danshen preparations are used to a lesser extent in vascular cognitive impairment (VCI).
In this study, we aimed to systematically assess the clinical efficacy and safety of Danshen preparations in VCI. To this end, we examined and performed a meta-analysis (MA) of the evidence available from randomised controlled trials (RCTs) of Danshen preparations conducted in patients with VCI.
We queried the following sources and collected all articles reporting on RCTs of Danshen preparations published prior to December 2021: PubMed, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chongqing VIP Database (CQVIP), and China Biology Medicine (CBM) disc databases. The assessment of treatments that were included in references were performed by RevMan 5.2 software based on guidelines from Cochrane Handbook for Systematic Reviews of Interventions.
We included a total of 12 RCTs that included data on clinical therapeutic effects. The evaluation criteria included the following: National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Barthel Index (BI), Mini-Mental State Assessment (MMSE), Montreal Cognitive Assessment (MOCA), Activities of Daily Living Scale (ADL), treatment effect index, and incidence of adverse reaction index. In the included studies, the observation groups included 656 cases and the control groups included 660 cases. The results of the MA were as follows: the mean difference (MD) value after combining the effect size for NIHSS was -2.91, with a 95% confidence interval (CI) of -4.22 to -1.59; the combined effect quantity hypothesis test revealed that = 4.33 ( < 0.00001), indicating that the score pertaining to the degree of neurological deficit (NIHSS) in the observation group after treatment was significantly lower than that in the control group. This result reveals that treatment with a Danshen preparation can reduce neurological deficit in VCI patients. The MD value after combining the effect size for mRS was -0.73, with a 95% CI of -0.85 to -0.61; the result of the combined effect quantity hypothesis test revealed that = 12.29 ( < 0.00001). These results indicate that the degree of disability was significantly reduced after treatment in the observation group. The MD value after combining the effect size for MMSE was 2.09, with a 95% CI of 0.33-3.84; the result of the combined effect quantity hypothesis test showed that = 2.33 ( = 0.02). These results indicate that the cognitive function score (MMSE) of the observation group after treatment was significantly higher than that of the control group and suggests that the cognitive function of VCI patients was improved after treatment with Danshen preparations. The MD value after combining the effect size for ADL was 8.79, with a 95% CI of 3.52 to 14.06; the result of the combined effect quantity hypothesis test indicated that = 3.27 ( = 0.001). These results showed that the life ability (ADL scale) scores of patients in the observation group after treatment were significantly higher than those in the control group, and reveals that after treatment with Danshen preparations, patients exhibited significant improvement in life ability. The MD value after combining the effect size for high-sensitivity C-reactive protein (hs-CRP) was -3.21, with a 95% CI of -4.21 to -2.22; the result of the combined effect quantity hypothesis test showed that = 6.31 ( < 0.00001), indicating that the hs-CRP level in the observation group was significantly decreased after treatment. The MD value after combining the effect size for interleukin (IL)-6 was -2.95, with a 95% CI of -3.86 to -2.04; the result of the combined effect quantity hypothesis test showed that = 6.36 ( < 0.00001). These results showed that the IL-6 level in the observation group was significantly decreased after treatment.
The existing clinical evidence shows that Danshen preparations exert significant therapeutic effects on VCI patients and can ameliorate inflammatory conditions in these patients. In addition, Danshen preparations are relatively safe.
丹参制剂广泛用于缺血性脑血管疾病的治疗。然而，此类制剂的临床疗效仍不明确。因此，丹参制剂在血管性认知障碍（VCI）中的应用程度较低。
在本研究中，我们旨在系统评估丹参制剂对VCI的临床疗效和安全性。为此，我们对VCI患者进行的丹参制剂随机对照试验（RCT）的现有证据进行了审查和荟萃分析（MA）。
我们查询了以下来源，并收集了2021年12月之前发表的所有关于丹参制剂RCT的文章：PubMed、中国知网（CNKI）、万方数据、重庆维普数据库（CQVIP）和中国生物医学（CBM）光盘数据库。根据《Cochrane系统评价干预措施手册》的指南，使用RevMan 5.2软件对参考文献中包含的治疗方法进行评估。
我们共纳入了12项包含临床治疗效果数据的RCT。评估标准包括：美国国立卫生研究院卒中量表（NIHSS）、改良Rankin量表（mRS）、Barthel指数（BI）、简易精神状态评估（MMSE）、蒙特利尔认知评估（MOCA）、日常生活活动量表（ADL）、治疗效果指数和不良反应发生率指数。在纳入的研究中，观察组656例，对照组660例。MA结果如下：合并NIHSS效应量后的平均差值（MD）值为-2.91，95%置信区间（CI）为-4.22至-1.59；合并效应量假设检验结果显示Z = 4.33（P < 0.00001），表明治疗后观察组神经功能缺损程度（NIHSS）评分显著低于对照组。该结果表明，丹参制剂治疗可降低VCI患者的神经功能缺损。合并mRS效应量后的MD值为-0.73，95%CI为-0.85至-0.61；合并效应量假设检验结果显示Z = 12.29（P < 0.00001）。这些结果表明，观察组治疗后残疾程度显著降低。合并MMSE效应量后的MD值为2.09，95%CI为0.33 - 3.84；合并效应量假设检验结果显示Z = 2.33（P = 0.02）。这些结果表明，治疗后观察组的认知功能评分（MMSE）显著高于对照组，提示丹参制剂治疗后VCI患者的认知功能得到改善。合并ADL效应量后的MD值为8.79，95%CI为3.52至14.06；合并效应量假设检验结果表明Z = 3.27（P = 0.001）。这些结果表明，观察组患者治疗后的生活能力（ADL量表）评分显著高于对照组，表明丹参制剂治疗后患者生活能力有显著改善。合并高敏C反应蛋白（hs-CRP）效应量后的MD值为-3.21，95%CI为-4.21至-2.22；合并效应量假设检验结果显示Z = 6.31（P < 0.00001），表明治疗后观察组hs-CRP水平显著降低。合并白细胞介素（IL）-6效应量后的MD值为-2.95，95%CI为-3.86至-2.04；合并效应量假设检验结果显示Z = 6.36（P < 0.00001）。这些结果表明，治疗后观察组IL-6水平显著降低。
现有临床证据表明，丹参制剂对VCI患者具有显著的治疗作用，并可改善这些患者的炎症状态。此外，丹参制剂相对安全。
