[關(guān)鍵詞]
[摘要]
目的 對(duì)依達(dá)拉奉超適應(yīng)癥用藥治療病毒性腦炎的有效性及安全性進(jìn)行循證醫(yī)學(xué)評(píng)價(jià)。方法 檢索中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(CNKI)、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)、維普中文期刊全文數(shù)據(jù)庫(VIP)、萬方數(shù)據(jù)庫、the CochraneLibrary、PubMed和Embase數(shù)據(jù)庫中有關(guān)依達(dá)拉奉治療病毒性腦炎的隨機(jī)對(duì)照試驗(yàn)(RCT);檢索時(shí)間從建庫至2021年11月3日。利用RevMan 5.4.1軟件進(jìn)行數(shù)據(jù)分析、Cochrane手冊(cè)5.1.0風(fēng)險(xiǎn)偏倚評(píng)估工具進(jìn)行偏倚風(fēng)險(xiǎn)評(píng)估、GRADE系統(tǒng)進(jìn)行證據(jù)質(zhì)量評(píng)估分級(jí)。結(jié)果 共納入14項(xiàng)RCTs,包含1 128例患者。Meta分析顯示:試驗(yàn)組的有效率高于對(duì)照組[RR=1.20,95% CI(1.14,1.26),P<0.000 01];并且較對(duì)照組能顯著降低血清神經(jīng)元特異性烯醇化酶(NSE)水平[SMD=-1.73,95% CI(-2.28,-1.18),P<0.000 01]、血清S100B蛋白濃度[MD=-0.11,95% CI(-0.13,-0.10),P<0.000 01]、脂質(zhì)過氧化物(LPO)濃度[MD=-1.42,95% CI(-1.95,-0.89),P<0.000 01]和美國國立衛(wèi)生研究院卒中量表(NIHSS)評(píng)分[MD=-3.19,95% CI(-7.11,0.73),P=0.11],但血清過氧化氫酶(CAT)濃度[MD=0.98,95% CI(0.66,1.30),P<0.000 01]則顯著高于對(duì)照組;不良反應(yīng)或并發(fā)癥發(fā)生率與對(duì)照組比較差異無統(tǒng)計(jì)學(xué)意義[RD=-0.04,95% CI(-0.15,0.07),P=0.51]。GRADE評(píng)估為低或極低質(zhì)量證據(jù),推薦強(qiáng)度為弱推薦。結(jié)論 當(dāng)前證據(jù)表明依達(dá)拉奉超適應(yīng)癥治療病毒性腦炎具有一定的有效性和安全性,但因納入研究證據(jù)等級(jí)較低,樣本量較少,故此結(jié)論仍需要更多高質(zhì)量、高標(biāo)準(zhǔn)的研究證明。
[Key word]
[Abstract]
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.
[中圖分類號(hào)]
R978.7;R969.3
[基金項(xiàng)目]
國家自然科學(xué)基金面上資助項(xiàng)目(81573926;81173235);中央高?;究蒲袠I(yè)務(wù)費(fèi)專項(xiàng)項(xiàng)目(2019-JYB-TD-003)