目的 系統(tǒng)評價阿加曲班（AGB）聯合阿替普酶（rt-PA）治療急性缺血性腦卒中（AIS）的有效性和安全性。方法 檢索PubMed、Embase、Cochrane Library、中國生物醫(yī)學文獻數據庫（CBM）、中國學術期刊全文數據庫（CNKI）、萬方數據庫（Wanfang Data）和維普中文期刊全文數據庫（VIP），搜集關于AGB聯合rt-PA治療AIS的隨機對照試驗（RCT），檢索時限均由建庫至2022年6月28日。由2名研究者獨立篩選文獻、提取資料，并利用RevMan 5.3軟件進行Meta分析、GRADE系統(tǒng)進行證據質量評估分級。結果 共納入22個RCTs，包括1 921例患者。Meta分析結果顯示：與對照組比較，試驗組可提高總有效率［RR=1.22，95% CI（1.16，1.27）、P<0.000 01］，改善美國國立衛(wèi)生研究院卒中量表（NIHSS）評分［MD=-1.92，95% CI（-2.46，-1.38），P<0.000 01］、Barthel指數評分［MD=8.97，95% CI（6.64，11.30），P<0.000 01］和改良Rankin量表評分［MD=-0.58，95% CI（-1.05，-0.10），P=0.02］；試驗組與對照組比較，出血發(fā)生率無明顯增加［Peto OR=0.66，95% CI（0.44，1.01），P=0.05］、顱內出血發(fā)生率無明顯增加［Peto OR=0.66，95% CI（0.32，1.36），P=0.26］，兩組差異均無統(tǒng)計學意義。GRADE評估為中、低或極低質量證據，推薦強度為弱推薦。結論 當前證據顯示，AGB聯合rt-PA治療AIS具有一定的有效性和安全性，但因納入研究證據等級較低，此結論仍需更多高質量、高標準的證據。

Objective To evaluate the efficacy and safety of acute ischemic stroke (AIS) with combination therapy of argatroban and alteplase. Methods Data were electronically searched from PubMed, Embase, Cochrane Llibrary, CBM, CNKI, Wanfang Data and VIP from the establishment of the databases to June 28, 2022 for randomized controlled trials (RCT) of AIS with combination therapy of argatroban and alteplase. Two researchers independently screened the literature and extracted the data. Meta-analysis was performed by RevMan 5.3 software, evidence quality assessment and classification was made with GRADE system. Results A total of 22 RCTs involving 1 921 patients were included. The results of Meta-analysis suggested that, compared with the control group (therapy of alteplase), experimental group (therapy of argatroban and alteplase) could improve the clinical efficacy[RR=1.22, 95%CI (1.16, 1.27)、P<0.000 01], significantly improve the difference before and after treatment in NIHSS scores[MD=-1.92, 95%CI (-2.46, -1.38), P<0.000 01], Barthel scores[MD=8.97, 95%CI (6.64, 11.30), P<0.000 01] and mRS scores[MD=-0.58, 95%CI (-1.05, -0.10), P=0.02]. Compared with the control group, the incidence of hemorrhage in the experimental group was not significantly increased[Peto OR=0.66, 95%CI (0.44, 1.01), P=0.05], and the incidence of intracranial hemorrhage was not significantly increased[Peto OR=0.66, 95%CI (0.32, 1.36), P=0.26]. There was no significant difference between the two groups. GRADE assessment was moderate, low or very low quality evidence, and recommendation strength was weak recommendation. Conclusion The current evidence indicates that combination therapy of argatroban and alteplase is effective and safe in the treatment of AIS. However, due to the low level of evidence in the included studies, this conclusion still needs more high-quality and high-standard research evidence.

R969.3;R971

國家重點研發(fā)計劃資助項目（2020YFC2006005）