中国中药杂志

2021, v.46(20) 5428-5435

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安宫牛黄丸辅助治疗脑出血有效性与安全性的系统评价
Systematic review of efficacy and safety of Angong Niuhuang Pills in adjuvant treatment of cerebral hemorrhage

刘芬芬;周亚博;路永坤;杨俊红;
LIU Fen-fen;ZHOU Ya-bo;LU Yong-kun;YANG Jun-hong;Henan University of Chinese Medicine;First Affiliated Hospital of Henan University of Chinese Medicine;

摘要(Abstract):

为系统评价安宫牛黄丸辅助治疗脑出血的疗效与安全性,检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献数据库(CBM)、PubMed、EMbase、Cochrane Library等建库至2020年11月收录的随机对照试验,由2位研究者根据纳入及排除标准筛选文献、提取资料,使用RevMan 5.3软件进行Meta分析。共纳入13项随机对照试验,1 196例脑出血患者(试验组599例,对照组597例),均采取内科治疗方法。Meta分析结果显示,与常规治疗相比,联用安宫牛黄丸能够提高脑出血患者的有效率(RR=1.25,95%CI[1.18,1.34],P<0.000 01),改善美国国立卫生研究院卒中量表(NIHSS)评分(MD=-5.18,95%CI[-8.12,-2.23],P=0.000 6)和格拉斯哥昏迷量表(GCS)评分(MD=1.12,95%CI[0.46,1.78],P=0.000 9),提高日常生活活动能力量表(ADL)评分(MD=15.70,95%CI[14.05,17.36],P<0.000 01),并可降低氧化应激指标丙二醛(MDA)(MD=-1.73,95%CI[-2.81,-0.64],P=0.002),但在脑血肿体积变化方面2组间差异无统计学意义。安全性方面,加用安宫牛黄丸治疗相较于常规治疗降低了不良反应发生率(RR=0.40,95%CI[0.28,0.57],P<0.000 01),且未见严重不良反应/事件发生。现有临床研究证据表明,安宫牛黄丸辅助治疗脑出血具有较好的疗效,可提高患者治疗有效率、日常生活活动能力,改善神经功能缺损症状,降低氧化应激反应,且安全性较好。但纳入研究方法学质量不高,以上结论尚需更多高质量研究予以验证。
To systematically review the efficacy and safety of Angong Niuhuang Pills in adjuvant treatment of cerebral hemorrhage. CNKI, VIP, Wanfang, CBM, PubMed, EMbase, Cochrane Library were retrieved to collect the randomized controlled trial(RCT) from the time of database establishment to November 2020. Two researchers screened out the literatures and extracted the data according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. A total of 13 RCTs were included, involving 1 196 patients with cerebral hemorrhage, with 599 in the treatment group and 597 in the control group, and all of them were treated with internal medicine. The results of Meta-analysis showed that compared with conventional therapy, the combined administration with Angong Niuhuang Pills could improve the effective rate in patients with cerebral hemorrhage(RR=1.25, 95%CI[1.18, 1.34], P<0.000 01), the National Institutes of Health stroke scale(NIHSS)score(MD=-5.18, 95%CI[-8.12,-2.23], P=0.000 6) and Glasgow coma scale(GCS) score(MD=1.12, 95%CI[0.46, 1.78], P=0.000 9), activity of daily living(ADL)(MD=15.70, 95%CI[14.05, 17.36 ], P<0.000 01), reduce the malondialdehyde(MDA)(MD=-1.73,95%CI[-2.81,-0.64],P=0.002), but with no statistically significant difference in hematoma volume changes between the two groups. In terms of safety, the combined administration with Angong Niuhuang Pills reduced the incidence of adverse reactions compared with the single administration of conventional therapy(RR=0.40, 95%CI[0.28, 0.57], P<0.000 01), with no serious adverse events. The existing clinical study evidences show that Angong Niuhuang Pills had a good effect in adjuvant treatment of cerebral hemorrhage, and can improve the treatment efficacy, activity of daily living and symptoms of neurological deficits, and reduce oxidative stress, with a higher safety. However, the methodological quality of the included studies is not high, so the above conclusions still need to be verified with more high-quality studies.

关键词(KeyWords): 安宫牛黄丸;脑出血;系统评价
Angong Niuhuang Pills;cerebral hemorrhage;systematic review

Abstract:

Keywords:

基金项目(Foundation): 全国中医药创新骨干人才培训项目(国中医药人教函[2019]128号);; 河南省中医药管理局项目(20-21ZY1044);; 河南省重点研发与推广专项科技攻关项目(182102311171)

作者(Author): 刘芬芬;周亚博;路永坤;杨俊红;
LIU Fen-fen;ZHOU Ya-bo;LU Yong-kun;YANG Jun-hong;Henan University of Chinese Medicine;First Affiliated Hospital of Henan University of Chinese Medicine;

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