目的 对依达拉奉超适应症用药治疗病毒性脑炎的有效性及安全性进行循证医学评价。方法 检索中国学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、维普中文期刊全文数据库（VIP）、万方数据库、the CochraneLibrary、PubMed和Embase数据库中有关依达拉奉治疗病毒性脑炎的随机对照试验（RCT）；检索时间从建库至2021年11月3日。利用RevMan 5.4.1软件进行数据分析、Cochrane手册5.1.0风险偏倚评估工具进行偏倚风险评估、GRADE系统进行证据质量评估分级。结果 共纳入14项RCTs，包含1 128例患者。Meta分析显示：试验组的有效率高于对照组［RR＝1.20，95% CI（1.14，1.26），P＜0.000 01］；并且较对照组能显著降低血清神经元特异性烯醇化酶（NSE）水平［SMD＝-1.73，95% CI（-2.28，-1.18），P＜0.000 01］、血清S100B蛋白浓度［MD＝-0.11，95% CI（-0.13，-0.10），P＜0.000 01］、脂质过氧化物（LPO）浓度［MD＝-1.42，95% CI（-1.95，-0.89），P＜0.000 01］和美国国立卫生研究院卒中量表（NIHSS）评分［MD＝-3.19，95% CI（-7.11，0.73），P＝0.11］，但血清过氧化氢酶（CAT）浓度［MD＝0.98，95% CI（0.66，1.30），P＜0.000 01］则显著高于对照组；不良反应或并发症发生率与对照组比较差异无统计学意义［RD＝-0.04，95% CI（-0.15，0.07），P＝0.51］。GRADE评估为低或极低质量证据，推荐强度为弱推荐。结论 当前证据表明依达拉奉超适应症治疗病毒性脑炎具有一定的有效性和安全性，但因纳入研究证据等级较低，样本量较少，故此结论仍需要更多高质量、高标准的研究证明。

Objective To evaluate the efficacy and safety of the off-label use of edaravone in the treatment of viral encephalitis. Methods Data was retrieved from CNKI, CBM, VIP, Wanfang Database, the Cochrane Library, PubMed, and Embase, and screening randomized controlled trial (RCT) of edaravone in the treatment of viral encephalitis; the search time was from the establishment of the database to November 2021 3rd. GRADE system carries out evidence quality assessment and classification, the Cochrane Handbook Risk Bias Assessment Tool provided bias risk assessment and uses Rev Man 5.4.1 software to carried out metaanalysis. Results A total of 14 RCTs were included, including 1 128 patients. Meta analysis showed that the effective rate of the experimental group was higher than that of the control group [RR = 1.20, 95%CI(1.14, 1.26), P<0.000 01], and compared with the control group, it could significantly reduce the serum NSE level [SMD = -1.73, 95%CI(-2.28, -1.18), P<0.000 01], serum S100B concentration [MD = -0.11, 95%CI(-0.13, -0.10), P<0.000 01], serum LPO concentration [MD = -1.42, 95%CI(-1.95, -0.89), P<0.000 01], and NIHSS score [MD = -3.19, 95%CI(-7.11 ,0.73), P＝ 0.11], serum CAT concentration [MD = 0.98, 95%CI(0.66, 1.30), P<0.000 01] was significantly higher than the control group; but the incidence of adverse reactions or complications was not statistically significant compared with the control group [RD = -0.04,95%CI(-0.15, 0.07), P＝ 0.51]. GRADE evaluates as low or very low-quality evidence, and the recommendation strength was weak recommendation. Conclusion The current evidence shows that edaravone is effective and safe in the treatment of viral encephalitis. However, due to the low level of evidence in the included studies and the small sample size, this conclusion still needs more high-quality and high-standard research evidence.

R978.7;R969.3

国家自然科学基金面上资助项目(81573926;81173235);中央高校基本科研业务费专项项目(2019-JYB-TD-003)