安公牛黄丸治疗病毒性脑炎的辅助疗效：随机对照试验的Meta分析
Summary
在这里，我们提出了一个方案来分析安宫牛黄丸治疗病毒性脑炎的有效性和安全性。
Abstract
这项荟萃分析旨在评估安公牛黄丸 （ANP） 作为辅助疗法治疗病毒性脑炎的疗效。纳入7个数据库（PubMed、Cochrane Library、Embase、SinoMed、CNKI、VIP和WanFang）进行文献检索，检索时间截至2023年7月。比较ANP联合常规治疗与单独常规治疗的随机对照试验是合格的。计算合并效应量和 95% 置信区间 （CI） 以评估疗效和安全性。进行了敏感性分析和发表偏倚评估，以分析研究结果的不确定性。纳入13项研究，涉及1045例病例进行meta分析。与常规治疗相比，ANP辅助治疗使总有效率的概率增加了17%（RR=1.17,95%CI [1.08,1.27]）。ANP辅助治疗后临床综合征和体征消失时间显著减少，包括退热时间（加权均数差（WMD）=-1.59， 95%CI [-2.09， -1.09]）、意识恢复时间（WMD = -1.79， 95%CI [-2.06， -1.51]）、头痛消失时间（WMD = -1.51， 95%CI [-1.93， -1.08]）、抽动消失时间（WMD = -1.88， 95%CI [-2.39， -1.36]）。ANP辅助治疗病毒性脑炎（VE）的疗效似乎提高了总有效率，缩短了临床综合征的消失时间。需要更多高质量的随机对照试验（RCTs）来支持我们的研究结果。
Introduction
脑炎被定义为脑实质炎症，死亡率高，以神经系统病理体征、发热、精神状态异常以及脑电图 （EEG） 和神经影像学改变为特征 1,2。脑炎的发病率为每 100,000 人 7 至 15 例 3,4,5。大约一半的脑炎病例的病因尚不清楚，病毒性脑炎 （VE） 约占诊断病例的 20%-50% 5,6。常见病毒包括人肠道病毒、人疱疹病毒、单纯疱疹病毒、人免疫缺陷病毒和巨细胞病毒7型。VE患者需要密切监测和支持措施，以维持生命体征和缓解脑部炎症8.阿昔洛韦是所有 VE9 病例的经验性治疗。使用糖皮质激素、免疫球蛋白和干扰素α的证据不一致8。安公牛黄丸（ANP）是著名的开孔药之一，广泛用于重大疾病引起的精神和意识异常。中国医学教育协会推荐ANP为A级推荐强度和II级证据质量（来自非随机研究或随机对照试验的证据）10。
系统评价 （SR） 是对符合纳入标准的所有临床研究的全面收集和严格评估。Meta分析是SR中一种定量分析的方法。 与基本meta分析方法不同，采用修剪和填充程序来检验效应量估计对发表偏倚评估的稳健性11。少数研究被删除，直到新的效应量使情节对称。根据插补的镜像研究，将其他研究重新添加到图中。如果修整和填充程序前后重新计算的合并估计值（PE）的差值小于0.05，则发表偏倚的效应量估计值是稳健的。使用TSA 0.9.5.10软件降低了假阳性结果的风险，并计算了所需信息量（RIS），这有利于使我们的结果更加稳健。鉴于没有对ANP治疗VE的症状、体征、生化指标和不良反应改善的数据进行系统评价，因此我们对现有的随机对照试验进行了这项meta分析。
Protocol
1. 协议注册 注册系统评价。注：PROSPERO（材料表）由美国国家卫生研究所（National Institute for Health Research）建立，用于系统评价的注册。该系统审查协议已在编号CRD42022301182下注册。 2. 软件安装 EndNote 软件安装购买EndNote软件，并从EndNote的官方网站（材料表）下载exe文件作为安装程序。 解?…
Representative Results
搜索结果和研究特征系统检索产生了122项研究，手动检索增加了9篇相关文献。在删除了49篇重复文献后，仍有82项研究有待通过摘要和全文进行筛选。最终，13项研究（12,13,14,15,16,17,18,19,20,21,22,23,24）被纳入meta分析，涉及1045例（图1）。<s…
Discussion
这项荟萃分析提供的证据表明，辅助 ANP 可将 VE 患者的总有效率提高 17%。ANP辅助治疗可显著缩短阳性病理体征和症状的消失时间。从ANP中提取的Xingnaojing（XNJ）注射液广泛用于与脑病相关的意识异常。最近的一项荟萃分析验证了 XNJ 治疗 VE 的辅助作用，有助于增加治愈病例数并缩短症状缓解时间25.XNJ 的组件与 ANP 并不完全相同。根据中华人民共和国药典（2020年版）），ANP由牛黄…
Disclosures
The authors have nothing to disclose.
Acknowledgements
这项工作得到了国家自然科学基金（第81973919号）、广东省国家自然科学基金（No.2019A1515011299）和广东省教育厅创新强校项目（No.2016KTSCX015）的支持。
Materials
| PROSPERO | National Institute for Health and Care Research | https://www.crd.york.ac.uk/PROSPERO/ | |
| STATA | StataCorp | https://www.stata.com/ | |
| TSA | Copenhagen Trial Unit, Centre for Clinical Intervention Research | https://ctu.dk/tsa/downloads/ | |
| PubMed | National Library of Medicine | https://pubmed.ncbi.nlm.nih.gov/ | |
| Cochrane Library | Cochrane Library | https://www.cochranelibrary.com/ | |
| Embase | Elsevier | https://www.embase.com/search/quick | |
| SinoMed | SinoMed | http://www.sinomed.ac.cn/index.jsp | |
| CNKI | China National Knowledge Infrastructure | https://www.cnki.net/ | |
| VIP | Chongqing VIP Information Co., Ltd. | http://www.cqvip.com/ | |
| WanFang database | Wanfang Data Knowledge Service Platform | https://www.wanfangdata.com.cn/index.html |
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Cite This Article
Huang, C., Wang, R., Lv, J., Zheng, N., Wei, Z., Wu, X., Wang, Q., Zhao, W. The Adjuvant Efficacy of Angong Niuhuang Pill in the Treatment of Viral Encephalitis: A Meta-Analysis of Randomized Controlled Trials. J. Vis. Exp. (206), e65969, doi:10.3791/65969 (2024).