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复方丹参注射液联合西药治疗血管性痴呆的疗效与安全性系统评价

[Systematic review of efficacy and safety of Compound Danshen Injection combined with Western medicine in treatment of vascular dementia].

作者信息

Chen Xin-Xin, Jin Xin-Yao, Pang Wen-Tai, Li Nan, Wang Ke-Yi, Zheng Wen-Ke

机构信息

Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.

Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Jan;46(1):247-252. doi: 10.19540/j.cnki.cjcmm.20200317.501.

Abstract

To evaluate the efficacy and safety of Compound Danshen Injection combined with Western medicine in the treatment of vascular dementia. Databases of Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP, Wanfang Data were electronically retrieved for collecting randomized controlled trial(RCT)about vascular dementia treated with Western medicine alone or combined with Compound Danshen Injection from the year of database establishment to January 2020. Two researchers independently screened out li-teratures, extracted data, and evaluated the risk of bias for inclusion in the study. Meta-analysis was conducted using RevMan 5.3 software. A total of 5 RCTs were included, involving 588 patients, with 299 in treatment group and 289 in control group. Meta-analysis results showed that compared with Western medicine alone, Compound Danshen Injection combined with Western medicine was better in the effective rate(RR=1.23,95%CI[1.14,1.33],P<0.000 01), MMSE score(MD=3.54,95%CI[3.01,4.06],P<0.000 01), ADL score(MD=11.49,95%CI[8.05,14.93],P<0.000 01), the level of CRP(MD=-0.72,95%CI[-1.25,-0.20],P=0.007) and the level of IL-6(MD=-7.64,95%CI[-9.65,-5.63],P<0.000 01). Adverse reactions mainly included rash and skin prick, which did not affect the treatment effect. Based on the findings, the combination of Compound Danshen Injection in the treatment of vascular dementia could improve the effective rates, relieve the mental state damage and improve the daily living ability, with mild adverse reactions and a low incidence. However, due to the low quality of the included literatures, high-quality and large-scale randomized controlled trials are needed for further verification.

摘要

评估复方丹参注射液联合西药治疗血管性痴呆的疗效及安全性。通过电子检索Cochrane图书馆、PubMed、EMbase、中国知网、中国生物医学文献数据库、维普资讯、万方数据等数据库,收集自建库至2020年1月期间关于单用西药或联合复方丹参注射液治疗血管性痴呆的随机对照试验(RCT)。由两名研究人员独立筛选文献、提取数据,并评估纳入研究的偏倚风险。采用RevMan 5.3软件进行Meta分析。共纳入5项RCT,涉及588例患者,治疗组299例,对照组289例。Meta分析结果显示,与单用西药相比,复方丹参注射液联合西药治疗血管性痴呆的有效率更高(RR=1.23,95%CI[1.14,1.33],P<0.000 01)、简易精神状态检查表(MMSE)评分更高(MD=3.54,95%CI[3.01,4.06],P<0.000 01)、日常生活能力量表(ADL)评分更高(MD=11.49,95%CI[8.05,14.93],P<0.000 01),血清C反应蛋白(CRP)水平更低(MD=-0.72,95%CI[-1.25,-0.20],P=0.007),白细胞介素-6(IL-6)水平更低(MD=-7.64,95%CI[-9.65,-5.63],P<0.000 01)。不良反应主要包括皮疹和皮肤瘙痒,不影响治疗效果。基于研究结果,复方丹参注射液联合西药治疗血管性痴呆可提高有效率,减轻精神状态损害,提高日常生活能力,不良反应轻微且发生率低。然而,由于纳入文献质量较低,需要高质量、大规模的随机对照试验进一步验证。

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