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[安宫牛黄丸辅助治疗脑出血的疗效与安全性系统评价]

[Systematic review of efficacy and safety of Angong Niuhuang Pills in adjuvant treatment of cerebral hemorrhage].

作者信息

Liu Fen-Fen, Zhou Ya-Bo, Lu Yong-Kun, Yang Jun-Hong

机构信息

Henan University of Chinese Medicine Zhengzhou 450000, China.

First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Oct;46(20):5428-5435. doi: 10.19540/j.cnki.cjcmm.20210316.501.

Abstract

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.

摘要

系统评价安宫牛黄丸辅助治疗脑出血的疗效和安全性。检索中国知网、维普、万方、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆,收集从各数据库建库至2020年11月的随机对照试验(RCT)。由两名研究人员按照纳入与排除标准筛选文献并提取数据。采用RevMan 5.3软件进行Meta分析。共纳入13项RCT,涉及1196例脑出血患者,治疗组599例,对照组597例,均采用内科治疗。Meta分析结果显示,与常规治疗相比,安宫牛黄丸联合用药可提高脑出血患者的有效率(RR=1.25,95%CI[1.18,1.34],P<0.000 01)、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)、格拉斯哥昏迷量表(GCS)评分(MD=1.12,95%CI[0.46,1.78],P=0.000 9)、日常生活活动能力(ADL)(MD=15.70,95%CI[14.05,17.36],P<0.000 01),降低丙二醛(MDA)(MD=-1.73,95%CI[-2.81,-0.64],P=0.002),但两组间血肿体积变化差异无统计学意义。在安全性方面,与单纯常规治疗相比,安宫牛黄丸联合用药降低了不良反应发生率(RR=0.40,95%CI[0.28,0.57],P<0.000 01),无严重不良事件发生。现有临床研究证据表明,安宫牛黄丸辅助治疗脑出血效果良好,可提高治疗疗效、日常生活活动能力及神经功能缺损症状,减轻氧化应激,安全性较高。然而,纳入研究的方法学质量不高,因此上述结论仍需更多高质量研究加以验证。

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